Page Range | 46067-46347 | |
FR Document |
Page and Subject | |
---|---|
83 FR 46103 - Addition of Certain Entities to the Entity List, Revision of Entries on the Entity List and Removal of Certain Entities From the Entity List | |
83 FR 46347 - Continuation of the Exercise of Certain Authorities Under the Trading With the Enemy Act | |
83 FR 46345 - National Days of Prayer and Remembrance, 2018 | |
83 FR 46067 - Continuation of the National Emergency With Respect to Certain Terrorist Attacks | |
83 FR 46193 - Sunshine Act Meetings; National Science Board | |
83 FR 46188 - Filing of Plats of Survey: Alaska | |
83 FR 46237 - Community Advantage Pilot Program | |
83 FR 46117 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Old Southington Landfill Superfund Site | |
83 FR 46160 - Certain New Chemicals or Significant New Uses; Statements of Findings for April to July 2018 | |
83 FR 46115 - Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the Requirement of a Tolerance | |
83 FR 46159 - Pesticide Product Registration; Receipt of Applications for New Uses | |
83 FR 46251 - Pilot Program for Expedited Project Delivery | |
83 FR 46199 - Information Collection: NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s) | |
83 FR 46104 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food | |
83 FR 46148 - Energy Conservation Program: Decision and Order Granting a Waiver to ITW Food Equipment Group, LLC From the Department of Energy Commercial Refrigeration Equipment Test Procedure | |
83 FR 46141 - Reorganization and Expansion of Foreign-Trade Zone 135 Under Alternative Site Framework; Palm Beach, Florida | |
83 FR 46141 - Approval of Subzone Status; Driftwood LNG, LLC, Sulphur, Louisiana | |
83 FR 46161 - Regular Meeting; Farm Credit System Insurance Corporation Board | |
83 FR 46196 - FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC, Beaver Valley Power Station, Units 1 and 2, Davis-Besse Nuclear Power Station, Unit No. 1, Perry Nuclear Power Plant, Unit No. 1 | |
83 FR 46258 - Annual Pay Ranges for Physicians, Dentists, and Podiatrists of the Veterans Health Administration (VHA) | |
83 FR 46142 - Reorganization of Foreign-Trade Zone 105 Under Alternative Site Framework Providence, Rhode Island | |
83 FR 46121 - Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation | |
83 FR 46142 - Reorganization of Foreign-Trade Zone 179 Under Alternative Site Framework, Madawaska, Maine | |
83 FR 46142 - Reorganization of Foreign-Trade Zone 158 Under Alternative Site Framework; Vicksburg/Jackson, Mississippi | |
83 FR 46146 - Application To Amend Presidential Permit; Vermont Electric Power Company, Inc., as Agent for the Joint Owners in the Highgate Interconnection Facilities | |
83 FR 46188 - Notice of Public Meetings for the Southeast Oregon Resource Advisory Council | |
83 FR 46223 - Investment Company Act Release No. 33220; 812-14928 Broadstone Real Estate Access Fund and Broadstone Asset Management, LLC | |
83 FR 46253 - Reports, Forms, and Recordkeeping Requirements | |
83 FR 46164 - Board Meeting; 77 K St. NE, Washington, DC; 10th Floor; September 17, 2018; 8:30 a.m. | |
83 FR 46143 - Polyethylene Terephthalate Resin From Canada: Notice of Rescission of Antidumping Duty Administrative Review; 2017-2018 | |
83 FR 46147 - Biological and Environmental Research Advisory Committee | |
83 FR 46152 - Electricity Advisory Committee | |
83 FR 46147 - State Energy Advisory Board; Teleconference | |
83 FR 46136 - Notice of Request for Approval of New Information Collection for Almonds Grown in California (Marketing Order No. 981) | |
83 FR 46163 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
83 FR 46069 - Cranberries Grown in States of Massachusetts, et al.; Establishment of 2018-19 Seasonal Volume Regulation | |
83 FR 46195 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
83 FR 46192 - Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received Under the Antarctic Conservation Act of 1978 | |
83 FR 46193 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
83 FR 46118 - Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole for Vessels Participating in the BSAI Trawl Limited Access Fishery in the Bering Sea and Aleutian Islands Management Area | |
83 FR 46137 - Submission for OMB Review; Comment Request | |
83 FR 46256 - Notice of OFAC Sanctions Actions | |
83 FR 46254 - Notice of OFAC Sanctions Actions | |
83 FR 46254 - Notice of OFAC Sanctions Action | |
83 FR 46170 - Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments | |
83 FR 46153 - Transcontinental Gas Pipe Line Company, LLC; Notice of Revised Schedule for Environmental Review of the Northeast Supply Enhancement Project | |
83 FR 46154 - Midwest Energy Recycling, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
83 FR 46153 - Swan Lake North Hydro LLC; Notice of Anticipated Schedule of Final Order for Swan Lake North Pumped Storage Hydroelectric Project | |
83 FR 46156 - Peterson Machinery Sales; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
83 FR 46173 - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant | |
83 FR 46158 - Enel Green Power Hilltopper Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 46154 - City of Oakland, California v. Pacific Gas and Electric Company; Notice of Complaint | |
83 FR 46157 - Langdon Renewables, LLC, Rush Springs Energy Storage, LLC, Origis Energy, Palmer's Creek Wind Farm, LLC, Meadowlark Wind I LLC, Foard City Wind, LLC, Torrecillas Wind Energy, LLC, Holloman Lessee LLC, Solfuture Gestion, S.L.U., Glicinia Instalaciones Fotovoltaicas, S.L.U.; Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status | |
83 FR 46158 - KO Transmission Company; Notice of Amendment | |
83 FR 46155 - Texas Eastern Transmission, LP; Notice of Intent To Prepare an Environmental Assessment for the Proposed Line 1-N Abandonment Project and Request for Comments on Environmental Issues | |
83 FR 46157 - Combined Notice of Filings #1 | |
83 FR 46255 - Notice of OFAC Sanctions Action | |
83 FR 46192 - NASA Aerospace Safety Advisory Panel; Meeting | |
83 FR 46190 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: Mortality in Correctional Institutions (State Prisons) | |
83 FR 46107 - New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to New Mexico | |
83 FR 46199 - Disposition of Information Related to the Time Period That Safety-Related Structures, Systems, or Components Are Installed | |
83 FR 46164 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees | |
83 FR 46176 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 46178 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings | |
83 FR 46178 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
83 FR 46177 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 46242 - Petition for Exemption; Summary of Petition Received; The Boeing Company | |
83 FR 46189 - Strontium Chromate From Austria and France; Institution of Anti-Dumping Duty Investigations and Scheduling of Preliminary Phase Investigations | |
83 FR 46145 - Consumer Advisory Board Subcommittee Meetings | |
83 FR 46143 - Credit Union Advisory Council Meeting | |
83 FR 46144 - Community Bank Advisory Council Meeting | |
83 FR 46255 - Notice of OFAC Sanctions Actions | |
83 FR 46137 - Announcement of Disaster Assistance Grant Application Deadlines and Funding Levels | |
83 FR 46179 - Wisconsin; Major Disaster and Related Determinations | |
83 FR 46192 - Advisory Committee for Cyberinfrastructure; Notice of Meeting | |
83 FR 46194 - Advisory Committee for Environmental Research and Education Notice of Meeting | |
83 FR 46194 - Proposal Review Panel for Computing and Communication Foundations; Notice of Meeting | |
83 FR 46179 - Hawaii; Amendment No. 1 to Notice of an Emergency Declaration | |
83 FR 46242 - Certification Pursuant to Sections 7045(a)(3)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 | |
83 FR 46200 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Amendment No. 3 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of the Western Asset Total Return ETF | |
83 FR 46230 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Amend Rule 6.2, Interpretation and Policy .01 Concerning Strategy Orders | |
83 FR 46228 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Amendment No. 1 and Order Approving on an Accelerated Basis a Proposed Rule Change, as Modified by Amendment No. 1, Relating to the Continued Listing Criteria Applicable to the Shares of the iShares California AMT Free Muni Bond ETF and iShares New York AMT-Free Muni Bond ETF | |
83 FR 46225 - PIMCO Flexible Credit Income Fund, et al. | |
83 FR 46198 - Guidance About Administrative Licensing Procedures | |
83 FR 46098 - Special Conditions: The Boeing Company (Boeing), Model 787-8, 787-9, and 787-10 Series Airplanes; Dynamic Test Requirements for Single-Occupant, Oblique (Side-Facing) Seats With or Without Airbag Devices or 3-Point Restraints | |
83 FR 46101 - Special Conditions: The Boeing Company (Boeing), Model 777 Series Airplanes; Dynamic Test Requirements for Single Occupant Oblique Seats, With or Without Airbag Devices or 3-Point Restraints | |
83 FR 46241 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Nebraska | |
83 FR 46145 - Agency Information Collection Activities; Comment Request; Grantee Reporting Form-Rehabilitation Services Administration (RSA) Annual Payback Report | |
83 FR 46174 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products | |
83 FR 46166 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program | |
83 FR 46172 - Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 46243 - Notice of Funding Opportunity for Positive Train Control Systems Grants Under the Consolidated Rail Infrastructure and Safety Improvements Program | |
83 FR 46180 - Relief From HUD Requirements Available During Calendar Year (CY) 2018 to Public Housing Agencies To Assist With Recovery and Relief Efforts on Behalf of Families Affected by Presidentially-Declared Major Disasters | |
83 FR 46119 - Pears Grown in Oregon and Washington; Decreased Assessment Rate for Processed Pears | |
83 FR 46162 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority | |
83 FR 46163 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority | |
83 FR 46257 - Members of Senior Executive Service Performance Review Boards | |
83 FR 46126 - Hazardous Waste Management System; Proposed Exclusion for Identifying and Listing Hazardous Waste | |
83 FR 46075 - Disclosure of Records and Information | |
83 FR 46262 - National Emission Standards for Hazardous Air Pollutants: Surface Coating of Large Appliances; Printing, Coating, and Dyeing of Fabrics and Other Textiles; and Surface Coating of Metal Furniture Residual Risk and Technology Reviews |
Agricultural Marketing Service
Rural Utilities Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Food and Drug Administration
National Institutes of Health
Federal Emergency Management Agency
Land Management Bureau
Justice Programs Office
Federal Aviation Administration
Federal Railroad Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
Internal Revenue Service
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Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation to establish a grower allotment percentage for the 2018-19 crop year and allows for the diversion of processed products from that year under the marketing order for cranberries grown in the production area (Order). This action also specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, revises dates by which certain actions are due, and establishes exemptions to the action.
Effective October 12, 2018.
Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 929, as amended (7 CFR part 929), regulating the handling of cranberries grown in the States of Massachusetts, Rhode Island, Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon, Washington, and Long Island in the State of New York. Part 929 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Cranberry Marketing Committee (Committee) locally administers the Order and is comprised of growers of cranberries operating within the production area, and a public member.
The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this final rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Order provisions provide that the Committee may recommend and implement, subject to USDA approval, volume control regulation which would decrease the available supply of cranberries whenever the Secretary of Agriculture (Secretary) finds that “such regulation will tend to effectuate the declared policy of the Act.” Accordingly, this rule establishes a marketable quantity and grower allotment percentage for cranberries produced during the 2018-19 crop year, beginning September 1, 2018, and ending August 31, 2019.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule establishes a marketable quantity and grower allotment percentage for the 2018-19 crop year. This rule is the result of the Committee's recommendations made during its August 4, and August 31, 2017, meetings, and a February 18, 2018, email vote. This rule establishes a marketable quantity of 7.275 million barrels and a grower allotment percentage of 75 percent. This action also allows handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. It also establishes an exemption for organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due.
The Committee also recommended an exemption for organically grown cranberries, and an exemption of 2,500 barrels for each grower. After much consideration, USDA determined the recommended grower exemption of 2,500 barrels should be revised. Consequently, this final rule does not include the exemption of 2,500 barrels for each grower and instead exempts handlers that processed less than 125,000 barrels during the 2017-18 fiscal year, or handlers that did not have carryover inventory at the end of the 2017-18 fiscal year. Accordingly, growers delivering their fruit to exempt handlers are not subject to the allotment.
In addition, in a February 18, 2018, vote by email, the Committee voted unanimously to adjust reporting dates associated with the allotment regulation. These changes were previously discussed and supported by the Committee at a meeting on April 22,
The recommendations included in this rule will adjust supply to more closely meet market demand, improve grower and handler returns, and help reduce inventory.
Sections 929.49 and 929.52 provide, in part, authority to establish a marketable quantity and grower allotment percentage. Section 929.14 defines marketable quantity as the volume of cranberries needed to meet market demand and provide for an adequate carryover into the next season. The allotment percentage is derived by dividing the marketable quantity by the total of all growers' sales histories. Section 929.48 outlines procedures for computing a grower's sales history.
Section 929.49 also prescribes how the grower allotment percentage is calculated and distributed to growers and handlers. Each grower's allotment volume is calculated by multiplying the individual's sales history by the allotment percentage. A grower's allotment is the total volume a handler may purchase from, or handle on behalf of, that grower during a year of volume regulation. Cranberries received by a handler that exceed the sum of their growers' allotments can be used to fill unused allotment. Any remaining cranberries are defined as excess cranberries as defined in § 929.59, which also outlines the procedures and dates by which excess cranberries are to be diverted. Section 929.61 prescribes outlets for excess cranberries, which are further defined in § 929.104.
In addition, § 929.50 provides authority for the transfer of sales history and annual allotment. Section 929.51 requires the Committee to consider market conditions, including supply and demand, prior to recommending an allotment percentage, and that any recommendation be made by March 1. Section 929.58(a) provides the authority to exempt from any or all requirements the handling of cranberries in such minimum quantities as the Committee, with the approval of the Secretary, may prescribe. Section 929.58(b) provides, in part, the authority to exempt from any or all requirements the handling of cranberries of such forms or types, including organic cranberries, as the Committee, with the approval of the Secretary, may prescribe.
Domestic cranberry production has been increasing over the past few years, up from 8.0 million barrels in 2012 to 9.6 million barrels in 2016. During the last few years, demand has remained relatively flat, and has not kept pace with the increases in supply. This has led to increasing levels of inventories. Ending inventory levels increased from 5.8 million barrels in 2012 to 9.7 million barrels in 2016.
Demand for cranberries is inelastic, meaning changes in consumer price have a minimal effect on total sales. However, grower prices are very sensitive to changes in supply. Consequently, higher inventory levels place downward pressure on grower prices for cranberries and reduce grower returns. Data reviewed by the Committee indicates that the price per barrel received by some growers has fallen from $30 a barrel in 2011 to $10 a barrel in 2016. With the cost of production estimated at approximately $35 a barrel, for many growers returns have fallen below the cost of production.
The Committee met on August 4, 2017, and again on August 31, 2017, and discussed the estimated levels of supply and demand and how market conditions were impacting the industry. The Committee discussed the approximate levels of production for the 2017-18 season, forecasting production at approximately 9.1 million barrels. Carryover inventory was estimated at approximately 9.9 million barrels and foreign acquired cranberries were expected to provide an additional 2.1 million barrels, for a total available supply of approximately 21.1 million barrels for the year. After accounting for shrinkage, the Committee agreed on an adjusted supply of 20.4 million barrels for the 2017-18 crop year.
Using these numbers, with estimated sales of 9.5 million barrels for 2017-18, the Committee calculated a potential carryover for the 2018-19 season of 10.9 million barrels. This is an approximately one million barrel increase from the carryover inventory for the 2017-18 crop year. Based on these numbers, carryover inventory for the 2018-19 crop year would be approximately 115 percent of annual sales.
In discussing market conditions, the Committee recognized that sales have been relatively flat. The Committee also noted supply has been exceeding demand by about one million barrels a year. Using crop and sales estimates similar to 2017-18, and the estimated carryover from the 2017-18 season of 10.9 million barrels, the potential carryover supply at the end of the 2018-19 crop year could increase by another one million barrels to 11.9 million if no action is taken to regulate supply.
In reviewing these numbers, the Committee agreed the industry is faced with a large inventory that continues to build. To address the problems associated with oversupply and to try to stabilize grower returns, the Committee discussed the need to establish volume regulation. The Committee considered several options, including establishing free and restricted percentages under a handler withholding for the 2017-18 crop year, establishing a grower allotment for the 2018-19 season, or recommending both regulations.
Considering the levels of inventory and low grower returns, the Committee voted to recommend a handler withholding, setting the free and restricted percentages of 85 percent and 15 percent, respectively, for the 2017-18 season. AMS agreed with the Committee's analysis and recommendation and published the rule establishing these percentages in the
With the handler withholding removing an estimated one million barrels from the market, the industry would still have approximately 10 million barrels remaining in inventory. Given the static demand and anticipated market conditions for the 2018-19 fiscal year, the Committee also recommended establishing a grower allotment percentage for the 2018-19 fiscal year.
The Committee discussed various levels of restriction, being sensitive to the impact volume control could have on small growers and handlers. Some small handlers are able to sell all their production each year and do not maintain an inventory. Several Committee members stated a large restriction would place a hardship on these small handlers. However, the Committee also recognized that volume control measures could help increase grower returns by helping to align supply with demand.
In addition, establishing an allotment regulation can help growers reduce production costs. Growers could choose to take bogs out of production, or reduce inputs such as fertilizer and pesticides in order to reduce their production volume to match their allotment. These and other steps could help growers reduce their costs of production for the 2018-19 crop.
Based on the information available, the Committee recommended
The Committee also recommended that handlers have the option to receive cranberries over their grower allotment and process up to 50 percent of the excess cranberries received rather than divert them in fresh form, as currently required. Handlers that do so need to divert an amount of 2018-19 cranberry processed products equivalent to the volume of excess cranberries processed.
The Committee made this recommendation recognizing that processing fresh fruit to produce one of its top-selling items, sweetened dried cranberries (SDC), results in juice concentrate as a by-product. A significant amount of current inventory is in the form of juice concentrate. By allowing handlers to process a portion of the excess cranberries they receive, more fresh cranberries are available to produce products requiring whole cranberries, such as SDC, and the diversion of concentrate will help prevent additional build-up of inventory. Handlers still have the option to divert fresh berries as excess supply.
To allow for the diversion of processed products, § 929.104(b), which currently prohibits the handling of excess fruit, is removed. To ensure the diversion of processed products in lieu of fresh cranberries is correctly accounted for, the final rule for volume regulation for the 2017-18 season (83 FR 14350) adds guidance under § 929.107 along with a conversion table. The table recognizes different conversion equivalencies of cranberries to processed product based on the volume of Brix concentrate.
Brix is the method for measuring the amount of sugar contained in the cranberry products, and the industry average for concentrate is 50 Brix. The Committee acknowledged that the Brix level can vary depending on the growing region and farming practices. The table helps ensure that the diversion of processed product in lieu of fresh berries is applied equitably among all handlers.
Using the conversion table, handlers can determine the amount of cranberry concentrate they need to divert, in lieu of fresh berries, to cover the fresh cranberry equivalent of any excess cranberries processed. Juice concentrate should comprise the vast majority of processed product used for diversion. Should requests be made to use other processed products for diversion, conversion rates for those products will be provided by the Committee based on information provided by the requesting handler.
For example, a grower with a sales history of 1,000 barrels will have an allotment of 750 barrels (1,000 × .75). If the grower delivered all 1,000 barrels to the handler, the handler will have 250 barrels of excess fruit. Under this final rule, the handler could divert 250 barrels of fresh fruit to approved outlets or divert half (125 barrels of fresh fruit) and process half, diverting a 125 barrel equivalent in 2018-19 processed product.
The Committee also recommended changes to date requirements currently specified in the Order. Section 929.59(b) currently states that “prior to January 1, or such other date as recommended by the committee and approved by the Secretary, handlers holding excess cranberries shall submit to the committee a written plan outlining procedures for the systematic disposal of such cranberries in the outlets prescribed in § 929.61.” The Committee agreed the date for submitting disposal plans should be extended in order to give handlers more time to consider how to divert their excess cranberries. Therefore, the Committee recommended changing the deadline prescribed in § 929.59(b) from January 1 to March 1 of the regulated season.
Section 929.59(c) states that “prior to March 1, or such other date as recommended by the committee and approved by the Secretary, all excess cranberries shall be disposed of pursuant to § 929.61.” Given the change in the due date for the diversion plans, the Committee agreed that this date should also be changed to provide handlers with enough time to comply with this requirement. Therefore, the Committee recommended changing the date by which diversion is to be completed from March 1 to August 31. AMS agrees with the Committee's analysis and recommendation and is issuing this rule to add a new § 929.159 to make these date changes.
Section 929.62(a) requires each grower to file a report with the Committee by January 15 of each year providing the following information: Total acreage harvested and whether owned or leased; total commercial cranberry sales in barrels from such acreage; the amount of acres either in production but not harvested, or taken out of production, and the reason(s) why; the amount of new or replanted acreage coming into production; the name of the handler(s) to whom commercial cranberry sales were made; and such other information as may be needed for implementation and operation of this section. Growers might not have all necessary information to complete the report by the current deadline. Therefore, the Committee recommended changing the grower reporting date from January 15 to March 1.
The Committee also recommended organically grown cranberries be exempt from this regulation as they serve a niche market and represent a very small portion of the total crop. All other cranberry production, including fresh cranberries, are subject to regulation under the grower allotment volume regulation.
To address the burden the volume regulation would have on small growers and handlers, the Committee also recommended providing an exemption of 2,500 barrels for all growers. Under the Committee's recommendation, the exemption would be applied following the calculation of a grower's allotment. However, after much consideration, USDA determined the exemption recommendation should be revised. Rather than provide an exemption of 2,500 barrels for each grower, this action exempts small handlers who processed less than 125,000 barrels from the allotment requirement. Further, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt from the allotment requirement. Accordingly, growers delivering their fruit to exempt handlers are not subject to the allotment.
These changes allow handlers who have matched their production with market demand to continue to serve their customer base and maintain their market share. Small growers also have the option of delivering their fruit to handlers who are not subject to the regulation. Handlers subject to the allotment percentage should be able to meet any market shortfalls by utilizing cranberries or cranberry products available in inventory. The provision allowing handlers to process a portion of their excess cranberries also helps provide some flexibility.
With this action, only those handlers carrying inventory are subject to
Section 929.125 provides authority for a grower to request a review by an appeals subcommittee if the grower is dissatisfied with his or her sales history calculation provided by the Committee. The grower must request the review within 30 days after receipt of the Committee's determination of sales history and must submit documentation showing why he or she believes the calculation is inaccurate. Within 15 days after notification of the appeals subcommittee's decision, if the grower is not satisfied with the decision, the grower may further appeal to the Secretary.
A grower may transfer all or part of their allotment to another grower, provided that the transferred allotment remains assigned to the same handler. Transfers of allotment between growers having different handlers may occur with the consent of both handlers. All such transfers have to be reported to the Committee. After all allotment transfers have occurred, any unused allotment would be transferred to the Committee. The Committee would then redistribute any unused allotment to handlers having excess cranberries in an amount proportionate to each handler's total allotment. These provisions help ensure that excess supply is utilized, to the extent possible, through unfilled allotment.
The Committee considered the estimated level of production and anticipated demand, and determined that without some action on the part of the Committee, inventory levels will continue to increase throughout the 2018-19 season. The Committee believes using the volume control authorities in the Order will help stabilize marketing conditions for cranberries by helping to adjust supply to meet market demand and improve grower returns.
Accordingly, this final rule establishes a grower allotment at 75 percent for the 2018-19 season. It also gives handlers the option to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. This final rule also exempts organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 1,100 cranberry growers in the regulated area and approximately 65 cranberry handlers subject to regulation under the Order. Small agricultural growers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to industry and Committee data, the average grower price for cranberries during the 2016-17 season was $23.50 per barrel and total sales were approximately 9.5 million barrels. The value for cranberries that year totaled $223,250,000 ($23.50 per barrel multiplied by 9.5 million barrels). Taking the total value of production for cranberries and dividing it by the total number of cranberry growers provides an average return per grower of $202,955. Using the average price and utilization information, and assuming a normal distribution, the majority of cranberry growers receive less than $750,000 annually.
According to USDA's Market News report, the average free on board (f.o.b.) price for cranberries was approximately $30.00 per barrel. Multiplying the f.o.b. price by total utilization of 9.5 million barrels results in an estimated handler-level cranberry value of $285 million. Dividing this figure by the number of handlers (65) yields an estimated average annual handler receipt of $4.3 million, which is below the SBA threshold for small agricultural service firms. Therefore, the majority of growers and handlers of cranberries may be classified as small entities.
While cranberry production has continued to rise, demand has failed to keep pace, and inventories have been increasing. In an industry such as cranberries, product can be stored in inventory for long periods of time. Large inventories are costly to maintain, difficult to market, and have a price-depressing effect. When supply outpaces demand and results in high levels of inventories, grower and handler returns can be negatively impacted.
Demand for cranberries is inelastic, meaning changes in price have a minimal effect on total sales volume. However, grower prices are very sensitive to changes in supply. A grower allotment program results in a decrease in supply as handlers can only purchase a portion of a grower's production, which is based on the grower's past sales history. Even a small shift in supply can have a positive effect on grower prices. Therefore, using a grower allotment program to reduce supply should increase grower prices and revenues.
This final rule establishes a grower allotment of 75 percent for the 2018-19 crop year. It also allows handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products. In addition, this rule exempts organically grown cranberries, specifies handlers subject to the regulation, revises the definition of outlets for excess fruit, and revises dates by which certain actions are due. These actions are designed to help stabilize marketing conditions, reduce burdensome inventories, and improve grower and handler returns. This rule revises §§ 929.104 and 929.105 and establishes new §§ 929.159 and 929.253. The authority for these actions is provided for in §§ 929.48, 929.49, 929.51, 929.52, 929.58, 929.59, 929.61, and 929.62. These changes are based on Committee recommendations from meetings on August 4 and August 31, 2017, and a February 18, 2018, email vote.
While these actions could result in some additional costs to the industry, the benefits are expected to outweigh them. The purpose of establishing an allotment percentage is to address oversupply conditions and to stabilize grower prices. The industry has a significant volume in inventory, and this has had a negative impact on grower and handler returns. Without volume control, inventories will likely continue to increase, further lowering returns.
Inventories have significantly increased since 2011. In 2011, existing inventories were around 4.6 million barrels. By the end of the 2016-17 season, inventories were approximately 9.9 million barrels, and by the end of the 2017-18 season, inventories are projected to be approximately 10.9 million barrels. Inventories as a percentage of total sales have also been increasing from approximately 50 percent in 2010 to approximately 103 percent in 2016, and could reach an anticipated 115 percent after the 2017-18 season. These inventories have had a depressing effect on grower prices, which for many growers have fallen below their cost of production.
Retail demand for cranberries is highly inelastic, which indicates changes in consumer prices do not result in significant changes in the quantity demanded. Consumer prices are also not significantly impacted by minor changes in cranberry supplies. Therefore, this action should have little or no effect on consumer prices and should not result in a reduction in retail sales. However, even a small shift in supply could increase grower and handler returns. The use of allotment percentages will likely have a positive impact on grower and handler returns for this crop year.
This rule will result in some fruit being taken off the market. However, a sufficient amount of fruit will still be available to supply all aspects of the market. In addition, allowing handlers the option to process up to 50 percent of the excess cranberries they receive above their growers' allotment, provided they divert an equivalent amount of 2018-19 cranberry processed products, provides handlers some additional flexibility and may help reduce inventories of juice concentrate, one of the largest segments of existing inventory.
There are also secondary outlets available for excess fruit, including foreign markets except Canada, charitable institutions, nonhuman food use, and research and development projects. While these alternatives may provide different levels of return than sales to primary markets, they play an important role for the industry. In addition, if demand is greater than anticipated, there are significant amounts of fruit in inventory that can be utilized to meet demand.
This action also exempts small handlers who processed less than 125,000 barrels in 2017-18 from the allotment percentage. Consequently, small handlers whose acquired volume is 125,000 barrels or less are exempt from the allotment volume restriction. This will reduce the burden the volume restriction has on small handlers and their growers.
In addition, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt from the allotment percentage. This allows handlers that have matched their production with market demand to continue to serve their customer base and maintain their market share. Handlers subject to the restriction should be able to meet any shortfalls by utilizing cranberries or cranberry products they have in inventory.
Further, making the recommendation to regulate the volume handled under a grower allotment program could result in some cost savings for growers depending upon what actions they may take to adjust supply.
As the allotment represents a percentage of the grower's sales history, the costs, when applicable, are proportionate and should not place an extra burden on small entities as compared to large entities. Likewise, growers and handlers, regardless of size, benefit from the stabilizing effects of this action.
One alternative considered by the Committee was not to impose a volume regulation during the 2018-19 crop year. However, Committee members believed that inventory levels were such that some form of volume control was necessary to help stabilize marketing conditions.
The Committee also considered other allotment percentage levels. However, some members were concerned that setting an allotment percentage that was too restrictive could negatively impact small growers. The Committee also considered not recommending a provision to allow a percentage of excess cranberries to be processed into cranberry products. The Committee determined that allowing handlers to process up to 50 percent of the excess cranberries they receive above their growers' allotment would provide additional volumes of fresh cranberries for processing and would provide handlers some flexibility while not adding additional juice concentrate to the existing inventory levels. Therefore, for the reasons mentioned above, these alternatives were rejected by the Committee.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This final rule will not impose any additional reporting or recordkeeping requirements on either small or large cranberry growers or handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
In addition, the Committee's meetings were widely publicized throughout the cranberry industry and all interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the August 4, 2017 and August 31, 2017 meetings were public meetings and all entities, both large and small, were able to express views on these issues.
A proposed rule concerning this action was published in the
During the comment period, 24 comments were received in response to the proposal. Of the comments received, 12 were in support of the regulation, but also requested some changes to the proposal, 11 were opposed to the regulation, and 1 took no position.
The 12 comments also suggested handlers be allowed to divert 100 percent of their excess fruit in processed form, rather than the 50 percent allowed under the proposed rule. They stated
Rather than provide an exemption of 2,500 barrels for each grower, an action which would have exempted nearly 2.75 million barrels, this action exempts small handlers who processed less than 125,000 barrels during the 2017-18 fiscal year from the allotment requirement. Small handlers processing less than 125,000 barrels make up nearly 88 percent of all handlers, yet combined, account for less than 10 percent of the total volume of cranberries processed. Based on Committee data, these small handlers were holding little or no volume in inventory at the end of the 2016-17 season. USDA's revisions to the Committee's proposal therefore exempts these handlers from the allotment requirement. Although focused on handlers, this change is expected to have a positive impact on grower returns by reducing overall supply in the market. Additionally, small growers would have the option of delivering their fruit to handlers who are not subject to the regulation.
In addition, handlers who did not have carryover inventory at the end of the 2017-18 fiscal year are also exempt. USDA believes that this will allow handlers who have matched their production with market demand to continue to serve their customer base and maintain their market share. Only those handlers carrying inventory will be subject to meeting the allotment requirement.
Handlers subject to the allotment percentage should be able to meet any market shortfalls by utilizing cranberries or cranberry products available in inventory. The provision allowing handlers to process a portion of their excess cranberries also helps provide some flexibility.
Further, the benefits are expected to outweigh any additional costs and positively impact all growers and handlers, regardless of size. The industry has a significant volume in inventory, and this has had a negative impact on all grower and handler returns. If steps are not taken to reduce the level of inventory, these downward pressures will persist. The purpose of establishing the allotment percentage is to address the oversupply conditions which are negatively impacting industry returns. Generally, reducing supply levels results in prices increasing for growers and handlers. Therefore, lowering inventory levels is expected to result in positive returns for the entire industry.
For the reasons discussed above, no changes will be made to the rule as proposed, based on the comments received.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant matter presented, including the information and recommendation of the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Cranberries, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 929 is amended as follows:
7 U.S.C. 601-674.
The revision reads as follows:
(a) In accordance with § 929.61, excess cranberries may be diverted only to the following noncommercial or noncompetitive outlets:
(c) Beginning with crop year 2018-19, the due date for the grower report required under § 929.62(a) is changed to March 1.
(a) Beginning with crop year 2018-19, handlers holding excess cranberries shall submit to the Committee a written plan outlining procedures for the systematic disposal of such cranberries as specified in § 929.59(b) by March 1.
(b) Beginning with crop year 2018-19, all excess cranberries shall be diverted as specified in § 929.59(c) prior to August 31.
(a) The marketable quantity for the 2018-19 crop year is set at 7.275 million barrels and the allotment percentage is designated at 75 percent.
(b) Organically grown fruit shall be exempt from the volume regulation requirements of this section. Small handlers who processed less than 125,000 barrels during the 2017-18 fiscal year are exempt from the volume regulation requirements of this section. Any handler who did not have carryover inventory at the end of the 2017-18 fiscal year is also exempt from the volume regulation requirements of this section.
(c) Handlers have the option to process up to 50 percent of the excess cranberries received over their growers' allotments into dehydrated cranberries or other processed products. Handlers utilizing this option shall divert an amount of 2018-19 processed products equivalent to the volume of excess cranberries processed as provided for in § 929.107. The remaining volume of excess cranberries must be diverted as whole fruit.
Bureau of Consumer Financial Protection.
Final rule.
This final rule amends the procedures used by the public to obtain information from the Bureau of Consumer Financial Protection (Bureau) under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings.
This final rule is effective October 12, 2018.
David Snyder, Senior Counsel, Legal Division, at 202-435-7758. If you require this document in an alternative electronic format, please contact
The Bureau first published the procedures used by the public to obtain information from it under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings in an interim final rule on July 28, 2011, 76 FR 45371 (Jul. 28, 2011). This was followed by a final rule on February 15,
The final rule revises subparts A, B, C, and E of section 1070 of title 12 of the Code of Federal Regulations.
The revisions to subpart A address procedures related to the certification of authenticity of Bureau records and the service of summonses or complaints on the Bureau. Subpart A also contains definitions of terms used throughout the remainder of the part, and the final rule revises the definition of “Chief FOIA Officer.”
Subpart B implements the Freedom of Information Act, 5 U.S.C. 552 (the FOIA). The Bureau has revised this subpart to clarify its practices, provide additional flexibility for requesters, and reflect recent changes made to the FOIA by the FOIA Improvement Act of 2016 (Pub. L. 114-185). Additionally, these changes streamline the Bureau's process for assessing FOIA fees and notifying requesters of such fees. These changes will allow the Bureau to process FOIA requests more efficiently and provide records to requesters more quickly. The Bureau has made some minor revisions to its proposal in response to comments.
The final rule does not revise subpart D.
Subpart C (sometimes referred to as
Subpart E contains the Bureau's rule implementing the Privacy Act of 1974, 5 U.S.C. 552a. The Bureau has revised the subpart to clarify the Chief Privacy Officer's authority, to provide additional flexibility for requestors, and to make technical corrections. The Bureau received no comments on this subpart and it finalizes the proposed subpart without modification.
The Bureau received eight comment letters that pertained to its proposal regarding FOIA implementation. These included three comment letters from industry trade associations; and one comment letter each from an individual; an opposition research and communication organization; a financial institution; a consumer advocacy organization; and a Federal agency with responsibilities related to implementation of the FOIA. These comment letters largely proposed minor modifications to the proposed rule in order to clarify it and/or facilitate public access to information. The Bureau also received input from another Federal agency during the comment period. These suggestions primarily focused on procedural and technical changes to the proposed rule. The Bureau made some changes to the final rule based on this input.
The Bureau received no comment letters regarding its proposed revisions to subpart C or subpart E, regarding its
The Bureau proposed the rule pursuant to its authority under (1) Title X of the Dodd-Frank Act, 12 U.S.C. 5481
The Bureau had proposed no change to the defined term, “Chief FOIA Officer.” However, a Federal agency noted that the Bureau's status quo definition permitted a broader delegation of the Chief FOIA Officer's authority than is permitted by the FOIA. The previous definition allowed the Chief Operating Officer to delegate the Chief FOIA Officer's authority to “any employee,” but the FOIA requires that the Chief FOIA Officer be at the assistant secretary level or above. The Bureau agrees that this provision allowed a broader delegation of authority than is permissible under the FOIA and has removed the phrase “or any CFPB employee to whom the Chief Operating Officer has delegated authority to act under this part” from the final rule. The Bureau believes that this provision, in conjunction with § 1070.2(d), provides the Bureau with the necessary flexibility to delegate some of the responsibilities of the Chief FOIA Officer to other CFPB employees without delegating more authority than is permissible under the FOIA.
Section 1070.3(b) authorizes the Bureau's Chief Operating Officer to certify the authenticity of any Bureau record or any copy of such record. The Bureau proposed revising the rule to clarify that the Chief Operating Officer can also certify the absence of a record. Such certification is contemplated in Rule 44 of the Federal Rules of Civil Procedure and Rule 902 of the Federal Rules of Evidence.
The Bureau proposed moving § 1070.31—which provides the process for serving the Bureau with summonses or complaints—to a new section in subpart A for clarity, in order to separate the rule governing service
The Bureau received several general comments concerning its proposed changes to the regulations implementing the FOIA and the Bureau's FOIA process. Some commenters expressed support for the Bureau's proposed changes to the extent that they would expedite the FOIA process. Some of these commenters also raised concerns about the timeliness of the Bureau's FOIA process and its commitment to openness and transparency. The Bureau remains committed to open government and strives to be a leader by being transparent with respect to its own activities. In addition, the Bureau will continue to improve its FOIA process to ensure that all requests are responded to in a timely fashion.
The Bureau also made several technical and typographical revisions to the rule in response to comments, including updating cross-referenced provisions, ensuring consistent spelling of certain terms, and ensuring the consistent use of terminology throughout the rule.
Section 1070.11(a)(2) identifies a category of information and records that the FOIA requires Federal agencies to make publicly available. The Bureau proposed to remove the phrase “and copying” and replace it with “in an electronic format.” The Bureau proposed similar revisions to § 1070.13. These changes are required by the FOIA Improvement Act of 2016. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.11(b) says that, even if a FOIA exemption applies to requested information or records, the Bureau has discretion to disclose it to the extent that the disclosure is not otherwise precluded by law. The paragraph further notes that such disclosures are not precedential. The Bureau proposed no revisions to this paragraph. However, another Federal agency suggested that the phrase “but is merely an indication that, in the processing of the particular request, the CFPB finds no necessity for applying the exemption” is unnecessary. The phrase at issue is contained in the part of § 1070.11(b) noting that the Bureau's decision to discretionarily disclose a record in one case has no precedential value in the processing of another request. The Bureau agrees that this phrase is unnecessary and has removed it from the final rule.
Section 1070.13 addresses the requirement that the Bureau make certain records available on its public website, and paragraph (d) addresses privacy-related redaction of those records. The Bureau proposed no revisions to this paragraph. However, one commenter noted that although § 1070.13(d) discusses redacting records in the Bureau's FOIA reading room for personal privacy, it does not mention any other FOIA exemptions. Although the commenter is correct that § 1070.13(d) does not mention any other FOIA exemptions, the Bureau does not believe any changes to this provision are warranted because § 1070.13(a) already informs requesters that documents published in the Bureau's FOIA reading room are “[s]ubject to the application of the FOIA exemptions and exclusions . . . .” The Bureau finalizes the provision in the final rule without modification.
Section 1070.14(b) specifies the form of FOIA requests, and it previously distinguished between requests made in writing and by electronic means. The Bureau proposed a technical change to this provision, to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposed changes to § 1070.14(b)(1) and (2) to clarify how requesters must submit FOIA requests to the Bureau. The Bureau proposed similar changes to the following sections: 1070.17(b)(1); 1070.21(c); and 1070.22(e)(1)(i). The Bureau received no comments on these proposals and it finalizes them without modification.
Section 1070.14(c) specifies the content of FOIA requests. Although the Bureau did not propose revisions to paragraphs (c)(1), (3), and (6), it received several suggestions from another Federal agency concerning these provisions. First, the agency suggested revising paragraph (c)(1) to say that a “FOIA request must describe the records that the requester seeks in sufficient detail.” The Bureau agrees and will make this edit as it is a core requirement of a perfected FOIA request.
The agency also suggested removing the phrase “[a]s a general rule” from the last sentence of paragraph (c)(1) because it is unnecessary. The Bureau agrees and has removed this text from the final rule.
Next, the agency suggested removing the part of paragraph (c)(3) that concerns requests to inspect records. The Bureau agrees that this provision is unnecessary and that, as a practical matter, requesters do not seek to inspect records prior to production. In response, the Bureau has removed the provision concerning the inspection of records and added a provision directing that the “request should state whether the requester wishes to receive the records in a specific format.”
Finally, the agency suggested changing paragraph (c)(6) to allow requesters to seek expedited processing at any time during the processing. The Bureau's rule previously required requesters to seek expedited processing with their initial requests. The agency noted that this provision could frustrate requesters by requiring them to withdraw and resubmit a request that includes a request for expedited processing. The Bureau agrees with the agency's suggestion, but has instead changed § 1070.17(b)(1) in the final rule to address this concern. As such, revision to § 1070.14(c)(6) is not necessary in response to this suggestion.
Section 1070.14(c)(4) provides that a FOIA requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media or “other” requester, as those terms are defined in § 1070.22(b). The section also informs requesters that they may contact the Bureau's FOIA Public Liaison to seek assistance in determining the appropriate fee
The Bureau received two comment letters regarding this provision. One commenter noted that the section included a fee category, “governmental entity,” which is not recognized under the FOIA and is not defined anywhere in the Bureau's regulations. The Bureau agrees and has removed this fee category from the final rule. Another commenter raised concerns about the removal of language limiting the purposes for which the FOIA Public Liaison could use information provided by a requester. The commenter suggested that the Bureau narrow its proposal to codify certain specified uses for which the FOIA Public Liaison could use the information. The Bureau declines to make this change. The purpose of this proposal was to provide the FOIA Public Liaison with additional flexibilities in using the information to assist requesters in the processing of their requests. The Bureau removed this provision with the goal of maximizing the FOIA Public Liaison's ability to assist requesters with the processing of their requests and it believes that placing restrictions on the FOIA Public Liaison will hamper those efforts. For the aforementioned reasons, the Bureau finalizes the proposal without modification.
Section 1070.14(c)(5) provides that if a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect. The text previously included a statement that any request that does not seek a waiver or reduction of fees constitutes an agreement of the requester to pay all fees up to $25. The Bureau proposed to remove this language in light of other proposed fee-related revisions. Under the Bureau's proposed revisions to § 1070.22(d) and (f), FOIA requesters could still specify an upper limit on the fees that they are willing to pay to process a request and the Bureau would notify a requester of any potential fees beyond that limit before processing the request. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.14(e) directs individuals who wish to inspect or obtain records pertaining to themselves to seek access to the records pursuant to the Bureau's regulations that implement the Privacy Act of 1974, in subpart E of the rule. The Bureau proposed no revisions to this provision. However, another Federal agency suggested that the Bureau directly reference its Privacy Act request identity verification procedures at § 1070.53(c) for first-party FOIA requests. It is the Bureau's practice to use the same identity verification procedures outlined in § 1070.53(c) for both Privacy Act requests and first-party FOIA requests, and such a change would codify the Bureau's current practice in its regulations. As such, the Bureau agrees with the commenter's suggestion and has made this change in the final rule.
Section 1070.14 instructs requesters on how to request records from the Bureau under the FOIA. The Bureau received a suggestion from another Federal agency suggesting that it make the FOIA Public Liaison available more broadly to assist requesters. The Bureau agrees with the commenter's suggestion and has added a new provision to its final rule, § 1070.14(g), which informs requesters that they can contact the FOIA Public Liaison to resolve any problems that arise during the processing of their requests. The Bureau believes that this change renders the reference to the FOIA Public Liaison in § 1070.14(c)(4) unnecessary and has removed it from the final rule.
Section 1070.15 addresses, among other things, the process by which the Bureau consults with other agencies regarding FOIA requests and/or refers FOIA requests to other agencies. The Bureau did not propose any revisions to this provision. However, one commenter noted that the Bureau separately proposed a new definition of “agency” in § 1070.2(a) that included entities that are not subject to the FOIA. Were § 1070.15 to be read in conjunction with this proposed definition, the rule would seem to allow the Bureau to refer FOIA requests to agencies that are not subject to the FOIA. Because the Bureau is not finalizing the proposed definitions in § 1070.2 in this final rule, this comment is moot.
In addition, a Federal agency suggested that the Bureau update and clarify its process for referrals and consultations, and that the Bureau allow for an additional process whereby the Bureau would coordinate with another agency when referral and consultation are not appropriate. The Bureau agrees with this suggestion and has added language to the final rule concerning referrals, consultations, and coordination. The changes to the rule clarify when it is appropriate for the Bureau to refer a request to, consult, or coordinate with another agency when processing a FOIA request. It also clarifies how the Bureau will document referrals and notify requesters when the Bureau has decided to refer a request to another agency.
Section 1070.16(d) addresses circumstances where the Bureau requires an extension to respond to a FOIA request. The Bureau proposed no revisions to this provision. However, one commenter suggested that the Bureau add language to § 1070.16(d) stating that it will notify requesters of the availability of the services provided by the Bureau's FOIA Public Liaison and the National Archives and Records Administration (NARA), Office of Government Information Services (OGIS) when the Bureau requires an extension due to “unusual circumstances” under this provision. The Bureau agrees with this suggestion and has revised the final rule to incorporate this change.
In addition, a Federal agency suggested that the Bureau remove several of the references to FOIA appeals in this paragraph. Although “unusual circumstances” may apply to the processing of a FOIA appeal, the agency pointed out that in such circumstances the Bureau would not give the requester an opportunity to modify the scope of the appeal. The Bureau agrees with this suggestion and has implemented it in the final rule, as this part of the paragraph is intended to apply to requests, not FOIA appeals.
Section 1070.17(b) instructs requesters on how to request expedited processing of a FOIA request. The Bureau proposed no revisions to this section. However, as explained above with respect to § 1070.14(c), in response to a suggestion from another Federal agency, the Bureau has revised § 1070.17(b)(1) of the final rule to state that requesters may request expedited processing at any time during the processing of their requests.
In addition, the Federal agency recommended that the Bureau revise § 1070.17(b)(2)(ii) to clarify what a requester must show to obtain expedited processing of the requested records. The Bureau agrees and has revised the rule accordingly. The FOIA provides for expedited processing of a request upon a showing of a “compelling need,” which includes a request by a “person primarily engaged in disseminating information” where there is an “urgency to inform the public concerning actual or alleged Federal Government activity.” 5 U.S.C. 552(a)(6)(E). The rule did not previously explain what requesters must show to demonstrate that they are persons “primarily engaged in disseminating information.” The revised rule clarifies that a requester who is not a full-time member of the media must establish that the requester is a person “whose primary professional activity or occupation is information dissemination.” The revised rule also informs requesters that the existence of numerous articles on a given subject can be helpful in establishing that there is an “urgency to inform” the public on the topic of the request.
Section 1070.17(c) states that the Bureau will decide requests for expedited processing within ten calendar days of its receipt of the request, and that it will notify the requester of its decision in writing. The Bureau proposed no revisions to this section. However, one commenter suggested that the Bureau revise the provision to require the Bureau to process requests for expedited processing within five business days, and to require the Bureau to provide requested records within three business days of granting a request for expedited processing. The Bureau declines to adopt this recommendation. The current rule requires the Bureau to decide whether to grant a request for expedited processing in ten calendar days, which is what the FOIA requires. Additionally, the Bureau notes that, as reflected in its most recent Annual FOIA Report, the average amount of time it takes the Bureau to adjudicate a request for expedited processing is one day.
The Bureau also declines to commit itself to releasing requested records within three business days of granting a request for expedited processing. When the Bureau grants a request for expedited processing, it processes the request as quickly and efficiently as possible. As noted above, the Bureau, on average, adjudicates requests for expedited processing in one day. Processing a request within three days after expedited processing is granted will not be feasible in many cases, particularly in cases involving a large number of responsive records.
For the aforementioned reasons, the Bureau finalizes the provision without modification.
Section 1070.18(a) requires the Bureau to acknowledge its receipt of FOIA requests. The provision previously created this requirement only for perfected requests. A Federal agency recommended that the Bureau delete the word “perfected,” thus requiring the Bureau to also acknowledge and provide requesters with tracking numbers for requests that have not been perfected. The Bureau agrees with this recommendation. This is the Bureau's current practice, and it has revised the final rule to adopt this suggestion.
Section 1070.18(a)(4) specifies what fee-related information the Bureau will include in acknowledgement letters it sends to requesters. The Bureau proposed to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for the proposed revisions to fee-related provisions in § 1070.22(d) and (f). The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.18(b)(2) addresses the Bureau's response to a request that has been granted in full or in part. The Bureau proposed no revisions to this provision. However, a Federal agency recommended that the Bureau revise § 1070.18(b)(2) to notify requesters that they can seek assistance from the Bureau's FOIA Public Liaison when the Bureau grants a request in full or in part. The Bureau agrees with this recommendation and has revised the final rule to incorporate it.
Section 1070.18(b)(4) addresses the Bureau's response to a request that it determines should be denied in whole or in part. The Bureau proposed to add a new provision at § 1070.18(b)(4)(iv) requiring it to inform requesters of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or OGIS. The Bureau also proposed to renumber the existing provisions under § 1070.18(b)(4) to accommodate this change. The Bureau noted in its proposal that this change is required by the FOIA Improvement Act of 2016. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
The Bureau proposed a new paragraph in § 1070.18 to inform requesters about the resources available to resolve any disputes that may arise during the request process. These resources are the Bureau's FOIA Public Liaison and mediation services provided by OGIS. One commenter suggested that the Bureau remove a provision in § 1070.18(c)(2) stating that the Bureau will not “defer to OGIS mediation decision in particular cases.” The commenter reasoned that this provision is not necessary because OGIS does not issue decisions. The Bureau agrees and it has revised the final rule to incorporate this recommendation.
The Bureau proposed a new paragraph to inform requesters that they may request records in a particular format. Under this proposal, the Bureau would provide records in a requested format when the requested format can readily be reproduced from the original file. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.20(f) provides a submitter of business information with
Section 1070.21(b) provides the time limits for filing administrative appeals. The Bureau proposed to revise this provision to clarify that the time period for filing an appeal begins on the day after the date the initial determination is sent to the requester or the date of the letter transmitting the last records released, whichever is later. The Bureau also proposed to change the time limit for filing an administrative appeal from 45 days to 90 days. This change is required by the FOIA Improvement Act of 2016. The Bureau received no comments on these proposals and it finalizes them without modification.
Section 1070.21(d) specifies how the Bureau will process administrative appeals. The Bureau proposed to remove the requirement that appeals be stamped with the date of their receipt by the FOIA Office. The FOIA Office does not stamp an appeal with the date the Bureau received it, but the date is recorded in the Bureau's system for tracking FOIA requests. This requirement is outmoded and the Bureau proposed to remove it to account for its current practice.
Section 1070.21(d) also previously provided that appeals would be processed in the order in which they are received. Since adopting this provision in 2011, the Bureau has found that it is not always practicable to complete action on appeals in the order in which they are received, and sometimes has chosen to act on a simple later-received appeal rather than delay action pending completion of a more complex earlier-received appeal. In order to better align the regulation with current practice, the Bureau proposed to delete the provision calling for first-in-first-out processing of appeals.
The Bureau received no comments on these proposals and it finalizes them without modification.
Section 1070.21(e) authorizes the General Counsel to decide administrative appeals, and § 1070.21(e)(3) allows for remand of a FOIA determination as one option for the General Counsel's disposition of an appeal. The Bureau proposed to amend the first sentence of § 1070.21(e) to add a reference to remands so that all options for disposition of appeals are listed in that sentence. The Bureau received no comments on its proposed revision and it finalizes the revision without modification. In addition, one commenter recommended that the Bureau also include a provision in § 1070.21(e) committing the Bureau to work as an active partner during the OGIS dispute resolution process when the Bureau agrees to participate in the process concerning a particular request. The Bureau agrees with this recommendation and has revised the final rule to incorporate it.
Section 1070.22(a) directs the Bureau to determine whether and to what extent to charge a requester fees for processing a FOIA request. Among other things, the provision previously stated that the Bureau charges certain fees “unless circumstances exist . . . that render fees inapplicable or inadvisable or unless the requester has requested and the [Bureau] has granted a reduction in or waiver of fees. . . .” The Bureau proposed no revisions to this provision. However, a Federal agency recommended that the Bureau remove the phrase “or inadvisable” from § 1070.22(a) because it is not clear what the phrase means in this context. The Bureau agrees and has removed this phrase from the final rule.
Section 1070.22(b) identifies appropriate fee categories for requesters. One commenter suggested that community-based organizations and non-profits “be added to the category that would obtain the lowest fees” or, alternatively, that the Bureau create a new fee category for such groups where they would pay the lowest processing fees. The Bureau declines to adopt this recommendation. The fee categories are defined by statute and the Office of Management and Budget's fee guidance, and the Bureau does not believe it would be appropriate for it to create a new fee category that was not contemplated by the FOIA. The Bureau also cannot commit to placing all non-profits and community based organizations in the lowest fee categories because not all such organizations will meet the requirements for placement in these fee categories. The Bureau believes that the current FOIA fee categories and the fee waiver provisions in the Bureau's rule are sufficient to address the concerns raised by the commenter.
Section 1070.22(b)(1)(i) defines the “Commercial user” category of requester. The Bureau proposed to amend this provision to clarify that the Bureau's decision to place a requester in the commercial user category will be made on a case-by-case basis based on how the requester will use the information. The Bureau proposed this change to clarify how it will make decisions whether to place a requester in the commercial user category. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.22(b)(1)(ii) defines the “Educational institution” category of requester. Several commenters suggested that the Bureau update the definition to more accurately reflect the text of the FOIA and recent case law expanding the scope of the term “educational institution” to include students at educational institutions who submit a FOIA request in furtherance of coursework or other school-sponsored activities.
Section 1070.22(b)(2) provides that the Bureau will notify a requester of its determination as to the proper fee category to apply to the requester. The provision previously provided that the Bureau make its determination based on a review of the requester's submission and the Bureau's own records. The Bureau proposed to delete this limitation to clarify that it may base its determination on other appropriate information, including phone
Section 1070.22(d) provides certain circumstances where the Bureau may not charge a requester a fee for processing a FOIA request. The Bureau proposed to insert a new paragraph at § 1070.22(d)(2) and to renumber § 1070.22(d) to accommodate the new paragraph. The Bureau explained in its proposal that the new paragraph would provide that it will not charge a requester any fees when the fee, excluding duplication costs, is less than $250. The Bureau proposed this change as part of its larger goal of revising the process for how it assesses FOIA processing fees and how the Bureau notifies requesters of such fees. The Bureau explained that this new provision would streamline its process for assessing FOIA fees. This change would allow the Bureau to process FOIA requests more quickly and efficiently because the Bureau would no longer need to contact a FOIA requester concerning processing fees when the cost to process the request is less than $250. As such, this provision would provide information to these requesters more quickly and at a reduced cost to the requesters.
A Federal agency suggested that the Bureau should remove § 1070.22(d)(1) because it is no longer necessary given other revisions the Bureau has proposed to its FOIA regulations. The agency also recommended that the Bureau clarify § 1070.22(d)(2) because it is not clear from the proposed revisions whether duplication costs would be included in the proposed $250 threshold.
The Bureau intended its proposed $250 fee threshold to only apply to search and review costs, not duplication costs. Under its proposal, the Bureau would not charge any fees if the search and review fees were less than $250, but it did not intend for duplication costs to be subject to this threshold. The Bureau intended to subject duplication costs to § 1070.22(d)(1), which provides that the Bureau will not charge a requester any FOIA processing fee when the cost of collecting the fee is equal to or greater than the fee itself. The Bureau intended to make this distinction because most of its FOIA responses are transmitted to requesters electronically and result in no duplication costs. The Bureau did not intend to offer requesters up to $250 worth of duplication without charge when the Bureau can almost always provide records in an electronic format. The Bureau has made clarifying revisions to its rule to address the agency's comments.
Section 1070.22(d)(4) addresses miscellaneous circumstances where the Bureau may not assess fees. The Bureau proposed to revise this provision to prohibit it from charging search fees, or in certain cases duplication fees, when the Bureau has failed to comply with time limits under § 1070.16 or § 1070.21, unless (1) unusual circumstances apply to the processing of the request; (2) the Bureau has provided timely written notice of the unusual circumstances to the requester; (3) more than 5,000 pages are necessary to respond to the request; and (4) the Bureau has discussed with the requester (or made three good-faith attempts to do so) how the requester could effectively limit the scope of the request. These changes are required by the FOIA Improvement Act of 2016.
A Federal agency recommended that the Bureau revise § 1070.22(d)(4), reasoning that the proposal's exception to when the Bureau can charge FOIA processing fees when it does not meet FOIA timelines was technically broader than the FOIA's requirements. In addition, the Federal agency recommended revising the paragraph to account for a scenario where a court determines that exceptional circumstances apply to a request. The Federal agency also noted a technical error in a cross-reference in the paragraph. The Bureau had intended for proposed § 1070.22(d)(4) to be coextensive with the FOIA. In response to these suggestions, the Bureau has revised the provision to more closely align with the FOIA's requirements, and it has added a paragraph to address a potential court determination that exceptional circumstances apply. It has also fixed the identified cross-reference. The Bureau otherwise finalizes its proposal.
Section 1070.22(e)(5) provides that the Bureau will decide whether to grant or deny a request to reduce or waive fees prior to processing the FOIA request and that the Bureau will notify the requester of such a determination in writing. The Bureau proposed to delete this requirement because it is unnecessary in light of other proposed fee-related revisions. The Bureau explained in its proposal that in many cases involving requests for fee waivers, the Bureau would be able to process the FOIA request without deciding the merits of the fee waiver request because the processing fees would be less than $250. It further reasoned that removing this requirement would allow the Bureau to process FOIA requests more efficiently and provide information to requesters more quickly. Under the Bureau's proposal, the Bureau would notify a requester when it had denied a fee waiver request and processing the request would incur fees. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.22(e)(6) specifies what information the Bureau will include in the letter it sends notifying the requester that the Bureau has denied a request for a waiver or reduction of fees. The Bureau proposed to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for other newly proposed fee-related provisions. The Bureau received no comments on this proposal and it finalizes the proposal without modification.
Section 1070.22(f) describes the Bureau's process for notifying a requester of any processing fees associated with a FOIA request. The Bureau proposed several changes to this provision to clarify and streamline its process for assessing FOIA processing fees and for notifying requesters of such fees. First, the Bureau proposed to revise § 1070.22(f) to provide that the Bureau would notify a requester of the estimated fees to process a FOIA request when the estimated fees are $250 or more and the estimated fees exceed the limit set by the requester, the requester has not specified a limit, or the Bureau has denied a request for a reduction or waiver of fees. Next, the Bureau proposed to revise § 1070.22(f) to raise the fee threshold above which a requester must pre-pay estimated processing fees from $250 to $1000. The Bureau explained in its proposal that this change was necessary because of the Bureau's proposed change to § 1070.22(d): The Bureau proposed raising its previous pre-payment threshold of $250 because it would no longer charge fees for processing a request when the fees are $250 or less. The Bureau further explained that its proposed revisions to § 1070.22(f) would require a requester to agree to
Section 1070.22(a) discusses the role of the Bureau's Chief FOIA Officer. The Bureau proposed inserting two new paragraphs. The first concerns the Chief FOIA Officer's responsibility to offer training to Bureau staff regarding their responsibilities under the FOIA, and the second concerns the Chief FOIA Officer's role as the primary Bureau liaison with the OGIS and the Department of Justice's Office of Information Policy. The Bureau also proposed to renumber the provisions in this section to accommodate these changes. These changes are required by the FOIA Improvement Act of 2016. The Bureau received no comments on these proposals and it finalizes them without modification.
Subpart C addresses the disclosure of Bureau information in connection with legal proceedings. The Bureau proposed several technical corrections throughout the subpart. The Bureau received no comments regarding these technical corrections, and it finalizes them without modification.
Section 1070.30(a) defines the circumstances for which the procedures outlined in subpart C apply. The Bureau proposed to delete paragraph (a)(1) from this provision and to renumber the section accordingly. This was intended as a technical change to account for moving § 1070.31 to subpart A. The Bureau received no comments regarding this proposal, and it finalizes the proposal without modification.
Section 1070.30(e)(2) defines the term “legal proceeding” for subpart C. The Bureau proposed to add the phrase “their agents” to the last sentence of this provision to clarify that this definition applies to formal and informal requests made by both attorneys and their agents. The Bureau received no comments regarding this proposal, and it finalizes the proposal without modification.
Former § 1070.31 provided the process for serving the Bureau with summonses or complaints. As discussed above with respect to proposed § 1070.5, the Bureau proposed to delete § 1070.31 from subpart C and move it to a new § 1070.5 in subpart A. The Bureau also proposed to renumber sections and cross-references in subpart C to account for this change. The Bureau received no comments regarding these proposals, and it finalizes them without modification.
Proposed § 1070.31(d)
Proposed § 1070.31(d) (formerly § 1070.32(d)) provides that the Bureau is not authorized to accept on behalf of its employees any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties. The previous text of the provision implied that it is the Bureau's practice to accept such demands or requests “upon the express, written authorization of the individual CFPB employee to whom such demand or request is directed.” The Bureau proposed to delete this part of the provision because it is not the general practice of the Bureau to accept service on behalf of individual employees. The Bureau further proposed deleting the paragraph's introductory caveat, “[e]xcept as otherwise provided in this subpart,” because the subpart does not otherwise provide for the Bureau to act as an agent for service for subpoenas, orders, or other demands or requests that do not relate to employees' official conduct. The Bureau received no comments regarding these proposals, and it finalizes them without modification.
Section 1070.33(b) provides that the General Counsel may require a party seeking official information through testimony, Bureau records, or other material, to describe all reasonably foreseeable demands for such information. The Bureau proposed to make several technical changes to clarify this provision. The Bureau received no comments regarding these changes, and it finalizes the proposal without modification.
Section 1070.51 specifies the authority and responsibilities of the Bureau's Chief Privacy Officer. The Bureau proposed to add a new paragraph at § 1070.51(a) authorizing the Chief Privacy Officer to “[d]evelop, implement, and maintain an organization-wide privacy program” and to renumber the other paragraphs in § 1070.51 to reflect this change. This change is in accordance with National Institute of Standards and Technology (NIST) Special Publication 800-53 Revision 4, which provides that agencies should “[appoint] a Senior Agency Official for Privacy (SAOP)/Chief Privacy Officer (CPO) accountable for developing, implementing, and maintaining an organization-wide governance and privacy program to ensure compliance with all applicable laws and regulations regarding the collection, use, maintenance, sharing, and disposal of personally identifiable information (PII) by programs and information systems. . . .” The Bureau proposed this change to clarify the authority of its Chief Privacy Officer. The Bureau received no comments on this proposal, and it finalizes the proposal without modification.
Section 1070.53(a) specifies the procedures for making Privacy Act requests for records. The previous text distinguished between requests made in writing and by electronic means. The Bureau proposed a technical change to this provision, to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposed changes to § 1070.53(a)(1) to
Section 1070.56(a)(2)(i) provides that an individual requesting an amendment of a record must identify the system of records containing the record. The Bureau proposed to revise this provision to allow an individual to provide a description of the record in sufficient detail to allow Bureau personnel to locate the system of records containing the record. This revision was intended to provide a requester with more flexibility in the event that the requester does not know the precise name of the applicable system of records. Furthermore, this proposal was consistent with § 1070.53(b)(2), which specifies requirements for requests for access to records. The Bureau received no comments on this proposal, and it finalizes the proposal without modification.
Section 1070.61 addresses, among other things, the Bureau's obligations to conduct privacy-related training and establish rules of conduct related to privacy. The Bureau proposed to replace references to “employees of Government contractors” with the term “contract personnel” to avoid confusion with respect to § 1070.2(k) (proposed § 1070.2(l)), which defines the term “employee.” The Bureau received no comments on this proposal, and it finalizes the proposal without modification.
In developing this final rule, the Bureau has considered the potential benefits, costs, and impacts as required by section 1022(b)(2)(A) of the Dodd-Frank Act.
The Bureau has chosen to consider the benefits, costs, and impacts of the final rule as compared to the status quo, namely the Bureau's regulations as set forth by the Bureau on February 15, 2013, 78 FR 11483 (Feb. 15, 2013).
As relevant, the final rule revises subparts A and C of part 1070 of title 12 of the Code of Federal Regulations: The revisions to Subpart A offer clarifications of procedures related to the certification of authenticity of Bureau records and the service of summonses or complaints on the Bureau; the revisions to Subpart C include organizational and clarifying revisions to the provisions related to the Bureau's
As these revisions mainly include clarifications, corrections and technical changes, they will have limited impacts on consumers and covered persons.
The final rule will not have an appreciable impact on consumers' access to consumer financial products or services, as the scope of the final rule is limited to matters related to access to certain types of information, and does not relate to credit access.
The final rule will not have a unique impact on insured depository institutions or insured credit unions with $10 billion or less in assets as described in section 1026(a) of the Dodd-Frank Act as the rule does not distinguish information regarding such institutions or procedures applicable to such institutions.
The final rule will not have a unique impact on consumers in rural areas as the rule does not distinguish information regarding consumers in rural areas or procedures applicable to such consumers.
The Regulatory Flexibility Act, 5 U.S.C. 601
Finally, the Bureau has determined that this rule does not impose any new recordkeeping, reporting, or disclosure requirements on members of the public that would be collections of information requiring approval under the Paperwork Reduction Act, 44 U.S.C. 3501
Pursuant to the Congressional Review Act (5 U.S.C. 801
Confidential business information, Consumer protection, Freedom of information, Privacy.
For the reasons set forth in the preamble, the Bureau amends 12 CFR part 1070 to read as follows:
12 U.S.C. 5481
(a)
(2) This part establishes mechanisms for carrying out the CFPB's statutory responsibilities under the statutes in paragraph (a)(1) of this section to the extent those responsibilities require the disclosure, production, or withholding of information. In this regard, the CFPB has determined that the CFPB, and its delegates, may disclose information of the CFPB, in accordance with the procedures set forth in this part, whenever it is necessary or appropriate to do so in the exercise of any of the CFPB's authority. The CFPB has determined that all such disclosures, made in accordance with the rules and procedures specified in this part, are authorized by law.
(b)
(1) Subpart A contains general provisions and definitions used in this part.
(2) Subpart B implements the Freedom of Information Act, 5 U.S.C. 552.
(3) Subpart C sets forth the procedures with respect to subpoenas, orders, or other requests for CFPB information in connection with legal proceedings.
(4) Subpart D provides for the protection of confidential information and procedures for sharing confidential information with supervised institutions, government Agencies, and others in certain circumstances.
(5) Subpart E implements the Privacy Act of 1974, 5 U.S.C. 552a.
(c)
(a)
(b)
(c)
Except as provided by this part, employees or former employees of the CFPB, or others in possession of a record of the CFPB that the CFPB has not already made public, are prohibited from disclosing such records, without authorization, to any person who is not an employee of the CFPB.
(a) Only the General Counsel is authorized to receive and accept summonses or complaints sought to be served upon the CFPB or CFPB employees sued in their official capacity. Such documents should be served upon the General Counsel, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. This authorization for receipt shall in no way affect the requirements of service elsewhere provided in applicable rules and regulations.
(b) If, notwithstanding paragraph (a) of this section, any summons or complaint described in that paragraph is delivered to an employee of the CFPB, the employee shall decline to accept the proffered service and may notify the person attempting to make service of the regulations set forth herein. If, notwithstanding this instruction, an employee accepts service of a document described in paragraph (a) of this section, the employee shall immediately notify and deliver a copy of the summons and complaint to the General Counsel.
(c) When a CFPB employee is sued in an individual capacity for an act or omission occurring in connection with duties performed on behalf of the CFPB (whether or not the officer or employee is also sued in an official capacity), the employee by law is to be served personally with process.
(d) The CFPB will only accept service of process for an employee sued in his or her official capacity. Documents for which the General Counsel accepts service in official capacity shall be marked “Service Accepted in Official Capacity Only.” Acceptance of service shall not constitute an admission or waiver with respect to jurisdiction, propriety of service, improper venue, or any other defense in law or equity available under applicable laws or rules.
This subpart contains the regulations of the CFPB implementing the Freedom of Information Act (the FOIA), 5 U.S.C. 552, as amended. These regulations set forth procedures for requesting access to records maintained by the CFPB. These regulations should be read together with the FOIA, the 1987 Office of Management and Budget Guidelines for FOIA Fees, the CFPB's Privacy Act regulations set forth in subpart E of this part, and the FOIA web page on the CFPB's website,
(a)
(1) Information required to be published in the
(2) Information required to be made available for public inspection in an electronic format or, in the alternative, to be published and offered for sale (see § 1070.13); and
(3) Information required to be made available to any member of the public upon specific request (see §§ 1070.14 through 1070.22).
(b)
(c)
(a)
(1) Descriptions of its central and field organization and the established place at which, the persons from whom, and the methods whereby, the public may obtain information, make submissions or requests, or obtain decisions;
(2) Statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(3) Rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(4) Substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the CFPB; and
(5) Each amendment, revision, or repeal of matters referred to in paragraphs (a)(1) through (4) of this section.
(b)
(a)
(1) Final opinions, including concurring and dissenting opinions, and orders made in the adjudication of cases;
(2) Those statements of policy and interpretations which have been adopted by the CFPB but are not published in the
(3) Its administrative staff manuals and instructions to staff that affect a member of the public;
(4) Copies of all records made publicly available pursuant to § 1070.11; and
(5) A general index of the records referred to in paragraph (a)(4) of this section.
(b)
(c)
(d)
(a)
(b)
(1) If a request is submitted by mail or delivery service, it shall be addressed to the Chief FOIA Officer, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. The request shall be labeled “Freedom of Information Act Request.”
(2) If a request is submitted by electronic means, it shall be submitted as set forth on the CFPB's website,
(c)
(2) In order to ensure the CFPB's ability to communicate effectively with the requester, a request should include contact information for the requester, including the name of the requester and, to the extent available, a mailing address, telephone number, and email address at which the CFPB may contact the requester regarding the request;
(3) The request should state whether the requester wishes to receive the records in a specific format;
(4) A requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media, or “other” requester, as those terms are defined in § 1070.22(b), and the basis for claiming that fee category;
(5) If a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect as is required by § 1070.22(e); and
(6) If a requester seeks expedited processing of a request, then the request must include a statement to that effect as is required by § 1070.17.
(d)
(e)
(f)
(g)
(a)
(b)
(c)
(1)
(ii) Whenever the CFPB refers any part of the responsibility for responding to a request to another agency, it must document the referral, maintaining a copy of the record that it refers, and notify the requester of the referral, informing the requester of the name of the agency to which the record was referred, including that agency's FOIA contact information.
(2)
(3)
(a)
(b)
(2) The CFPB may provide a requester in its complex track with an opportunity to limit the scope of the request to qualify for faster processing within the specified limits of the simple track(s).
(c)
(1) Make one reasonable demand to the requester for clarifying information about the request and toll the twenty (20) business day time period while it awaits the clarifying information; or
(2) Toll the twenty (20) business day time period while it awaits clarification from or addresses any dispute with the requester regarding the assessment of fees.
(d)
(2) As used in this paragraph (d), “unusual circumstances” means:
(i) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or
(iii) The need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request, or among two or more CFPB offices having substantial subject matter interest therein.
(a)
(b)
(1) A request for expedited processing shall be made in writing and submitted as part of a request for records in accordance with § 1070.14(b), or at any time during the processing of the request. When a request for records includes a request for expedited processing, the request shall be labeled “Expedited Processing Requested.”
(2) A request for expedited processing shall contain a statement that demonstrates a compelling need for the requester to obtain expedited processing of the requested records. A “compelling need” is defined as follows:
(i) Failure to obtain the requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual. The requester shall fully explain the circumstances warranting such an expected threat so that the CFPB may make a reasoned determination that a delay in obtaining the requested records could pose such a threat; or
(ii) With respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal government activity. A requester who is not a full-time member of the news media must establish that the requester is a person whose primary professional activity or occupation is information dissemination, though it need not be the requester's sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request—one that extends beyond the public's right to know about government activity generally. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on the topic.
(3) The requester shall certify the written statement that purports to demonstrate a compelling need for expedited processing to be true and correct to the best of the requester's knowledge and belief. The certification must be in the form prescribed by 28 U.S.C. 1746: “I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge and belief. Executed on [date].” The requester shall mail or submit electronically a copy of such written certification to the Chief FOIA Officer as set forth in § 1070.14(b). The CFPB may waive this certification requirement in appropriate circumstances.
(c)
(d)
(e)
(a)
(1) The applicable request tracking number;
(2) The date of receipt of the request, as determined in accordance with § 1070.14(d), as well as the date when the requester may expect a response;
(3) A brief statement identifying the subject matter of the request; and
(4) A confirmation, with respect to any fees that may apply to the request pursuant to § 1070.22, that the requester has sought a waiver or reduction in such fees, has agreed to pay any and all applicable fees, or has specified an upper limit that the requester is willing to pay in fees to process the request.
(b)
(2) If the request is granted in full or in part, and if the requester requests a copy of the records requested, then a copy of the records shall be mailed or emailed to the requester in the requested format, to the extent the records are readily producible in the requested format. The CFPB shall also send the requester a statement of the applicable fees, either at the time of the determination or shortly thereafter, and inform the requester of the availability of its FOIA Public Liaison to offer assistance.
(3) In the case of a request for inspection, the requester shall be notified in writing of the determination, when and where the requested records may be inspected, and of the fees incurred in complying with the request. The CFPB shall then promptly make the records available for inspection at the time and place stated, in a manner that will not interfere with CFPB's operations and will not exclude other persons from making inspections. The requester shall not be permitted to remove the records from the room where inspection is made. If, after making inspection, the requester desires copies of all or a portion of the requested records, copies shall be furnished upon payment of the established fees prescribed by § 1070.22. Fees may be charged for search and review time as stated in § 1070.22.
(4) If it is determined that the request for records should be denied in whole or in part, the requester shall be notified by mail or by email. The letter of notification shall:
(i) State the exemptions relied upon in denying the request;
(ii) If technically feasible, indicate the amount of information deleted and the exemptions under which the deletion is made at the place in the record where such deletion is made (unless providing such indication would harm an interest protected by the exemption relied upon to deny such material);
(iii) Set forth the name and title or position of the responsible official;
(iv) Advise the requester of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or the Office of Governmental Information Services;
(v) Advise the requester of the right to administrative appeal in accordance with § 1070.21; and
(vi) Specify the official or office to which such appeal shall be submitted.
(5) If it is determined, after a reasonable search for records, that no responsive records have been found to exist, the requester shall be notified in writing or by email. The notification shall also advise the requester of the right to administratively appeal the CFPB's determination that no responsive records exist (
(c)
(1)
(2)
(d)
(2) The CFPB may charge fees associated with converting records or files into the requested format in accordance with § 1070.22.
Whenever a request is made for a record containing information that another agency has classified, or which may be appropriate for classification by another agency under Executive Order 13526 or any other executive order concerning the classification of information, the CFPB shall refer the responsibility for responding to the request to the classifying or originating agency, as appropriate.
(a)
(b)
(1)
(2)
(c)
(d)
(e)
(i) The information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or
(ii) The CFPB has reason to believe that the information may be protected from disclosure under Exemption 4.
(2) The notice requirements of this paragraph (e) shall not apply if:
(i) The CFPB determines that the information is exempt under the FOIA;
(ii) The information lawfully has been published or otherwise made available to the public;
(iii) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12600 (3 CFR, 1988 Comp., p. 235); or
(iv) The designation made by the submitter under paragraph (e)(1)(i) of this section appears obviously frivolous, except that, in such a case, the CFPB shall, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.
(f)
(2) When notice is given to a submitter under this section, the requester shall be advised that such notice has been given to the submitter. The requester shall be further advised that a delay in responding to the request may be considered a denial of access to records and that the requester may proceed with an administrative appeal or seek judicial review, if appropriate. However, the requester will be invited to agree to a voluntary extension of time so that the CFPB may review the submitter's objection to disclose, if any.
(g)
(1) A statement of the reasons for which the submitter's disclosure objections were not sustained;
(2) A description of the business information to be disclosed; and
(3) A specified disclosure date which is not less than ten (10) business days after the notice of the final decision to release the requested information has been mailed to the submitter. Except as otherwise prohibited by law, a copy of the disclosure notice shall be forwarded to the requester at the same time.
(h)
(i)
(a)
(1) To deny access to records in whole or in part (as provided in § 1070.18(b));
(2) To assign a particular fee category to the requester (as provided in § 1070.22(b));
(3) To deny a request for a reduction or waiver of fees (as provided in § 1070.22(e));
(4) That no records exist that are responsive to the request (as provided in § 1070.18(b)); or
(5) To deny a request for expedited processing (as provided in § 1070.17(e)).
(b)
(c)
(1) If appeal is submitted by mail or delivery service, it shall be addressed to and submitted to the officer specified in paragraph (e) of this section at the address set forth in § 1070.14(b). The appeal shall be labeled “Freedom of Information Act Appeal.”
(2) If an appeal is submitted by electronic means, it shall be addressed to the officer specified in paragraph (e) of this section and submitted as set forth on the CFPB's website,
(3) The appeal shall set forth contact information for the requester, including, to the extent available, a mailing address, telephone number, or email address at which the CFPB may contact the requester regarding the appeal; and
(4) The appeal shall specify the applicable request tracking number, the date of the initial request, and the date of the letter of initial determination, and, where possible, enclose a copy of the initial request and the initial determination being appealed.
(d)
(e)
(1) If it is decided that the appeal is to be denied (in whole or in part) the requester shall be:
(i) Notified in writing of the denial;
(ii) Notified of the reasons for the denial, including which of the FOIA exemptions were relied upon;
(iii) Notified of the name and title or position of the official responsible for the determination on appeal;
(iv) Provided with a statement that judicial review of the denial is available in the United States District Court for the judicial district in which the requester resides or has a principal place of business, the judicial district in which the requested records are located, or the District of Columbia in accordance with 5 U.S.C. 552(a)(4)(B); and
(v) Provided with notification that dispute resolution services are available to the requester as a non-exclusive alternative to litigation through the Office of Government Information Services in accordance with 5 U.S.C. 552(h)(3). Dispute resolution is a voluntary process. If the CFPB agrees to participate in the dispute resolution services provided by the Office of Governmental Information Services, it will actively engage as a partner to the process in an attempt to resolve the dispute.
(2) If the initial determination is reversed on appeal, the requester shall be so notified and the request shall be processed promptly in accordance with the decision on appeal.
(3) If the initial determination is remanded on appeal to the Chief FOIA Officer for further action, the requester shall be so notified and the request shall be processed in accordance with the decision on appeal. The remanded request shall be treated as a new request received by the CFPB as of the date when the General Counsel transmits the remand notification to the requester. The procedures and deadlines set forth in this subpart for processing, deciding, responding to, and filing administrative appeals of new FOIA requests shall apply to the remanded request.
(f)
(a)
(1) The CFPB shall charge a requester fees for the cost of copying or printing records at the rate of $0.10 per page.
(2) The CFPB shall charge a requester for all time spent by its employees searching for records that are responsive to a request. The CFPB shall charge the requester fees for search time as follows:
(i) The CFPB shall charge for search time at the salary rate(s) (basic pay plus sixteen (16) percent) of the employee(s) who conduct the search. However, the CFPB shall charge search fees at the rate of $9.00 per fifteen (15) minutes of search time whenever only administrative/clerical employees conduct a search and at the rate of $23.00 per fifteen (15) minutes of search time whenever only professional/executive employees conduct a search. Search charges shall also include transportation of employees and records necessary to the search at actual cost. Fees may be charged for search time even if the search does not yield any responsive records, or if records are exempt from disclosure.
(ii) The CFPB shall charge the requester for the actual direct costs of conducting an electronic records search, including computer search time, runs, and output. The CFPB shall also charge for time spent by computer operators or programmers (at the rates set forth in paragraph (a)(2)(i) of this section) who conduct or assist in the conduct of an electronic records search.
(3) The CFPB shall charge a requester for time spent by its employees examining responsive records to determine whether any portions of such record are exempt from disclosure, pursuant to the FOIA exemptions of 5 U.S.C. 552(b). The CFPB shall also charge a requester for time spent by its employees redacting any such exempt information from a record and preparing a record for release to the requester. The CFPB shall charge a requester for time spent reviewing records at the salary rate(s) (
(4) Fees for all services provided shall be charged whether or not copies are made available to the requester for inspection. However, no fee shall be charged for monitoring a requester's inspection of records.
(5) Other services and materials requested which are not covered by this part nor required by the FOIA are chargeable at the actual cost to the CFPB. This includes, but is not limited to:
(i) Certifying that records are true copies; or
(ii) Sending records by special methods such as express mail, etc.
(b)
(i)
(ii)
(iii)
(iv)
(v)
(2) Within twenty (20) calendar days of its receipt of a request, the CFPB shall make a determination as to the proper fee category to apply to a requester. The CFPB shall inform the requester of the determination in the request acknowledgment letter, or if no such letter is required, in another writing. Where the CFPB has reasonable cause to doubt the use to which a requester will put the records sought, or where that use is not clear from the request itself, the CFPB should seek additional clarification before assigning the request to a specific category.
(3) If the CFPB assigns to a requester a fee category, then the requester shall have the right to submit an appeal of the CFPB's determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester of an adverse fee category determination. The requester shall label its appeal request “Appeal of Fee Category Determination.”
(c)
(1) Commercial users shall be charged the full direct costs of searching for, reviewing, and duplicating the records they request. Moreover, when a request is received for disclosure that is primarily in the commercial interest of the requester, the CFPB is not required to consider a request for a waiver or reduction of fees based upon the assertion that disclosure would be in the public interest. The CFPB may recover the cost of searching for and reviewing records even if there is ultimately no disclosure of records or no records are located.
(2) Educational and non-commercial scientific institution requesters shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide the first one hundred (100) pages of duplication free of charge.
(3) Representatives of the news media shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide them with the first one hundred (100) pages of duplication free of charge.
(4) Other requesters who do not fit any of the categories described in paragraphs (c)(1) through (3) of this section shall be charged the full direct cost of searching for and duplicating records that are responsive to the request, except that the CFPB shall provide the first one hundred (100) pages of duplication and the first two hours of search time free of charge. The CFPB may recover the cost of searching for records even if there is ultimately no disclosure of records, or no records are located. Requests from persons for records about themselves filed in the CFPB's systems of records shall continue to be treated under the fee provisions of the Privacy Act of 1974, 5 U.S.C. 552a, which permit fees only for duplication, after the first one hundred (100) pages are furnished free of charge.
(d)
(1) If the cost of collecting a fee would be equal to or greater than the total FOIA processing fee, then the CFPB shall not charge a requester any FOIA processing fees.
(2) If the total search and review fees are less than $250, then the CFPB shall not charge a requester any search and review fees.
(3) If the CFPB has waived or reduced FOIA processing fees in accordance with paragraph (e) of this section, then the CFPB shall not charge the portion of the FOIA processing fees that has been waived or reduced.
(4) If the CFPB fails to comply with any time limit under § 1070.15 or § 1070.21, then the CFPB shall not assess search fees or if the requester is a representative of the news media or an educational or noncommercial scientific institution, then the CFPB shall not assess duplication fees, unless:
(i) A court has determined that exceptional circumstances, as defined by the FOIA, exist; or
(ii) The CFPB has determined that unusual circumstances apply to the processing of the request; and
(A) Provided timely written notice to the requester of the unusual circumstances in accordance with § 1070.16(d);
(B) Determined that more than 5,000 pages are necessary to respond to the request; and
(C) Discussed with the requester via mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request.
(5) If the CFPB determines, as a matter of administrative discretion, that waiving or reducing the fees would serve the interest of the United States Government.
(e)
(i) Requests such waiver or reduction of fees in writing as part of the FOIA request;
(ii) Labels the request for waiver or reduction of fees “Fee Waiver or
(iii) Demonstrates that the fee reduction or waiver request that a waiver or reduction of the fees is in the public interest because:
(A) Furnishing the information is likely to contribute significantly to public understanding of the operations or activities of the government; and
(B) Furnishing the information is not primarily in the commercial interest of the requester.
(2) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(A) of this section, the CFPB shall consider the following factors:
(i) The subject of the requested records must concern identifiable operations or activities of the Federal government, with a connection that is direct and clear, and not remote or attenuated.
(ii) The disclosable portions of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either a duplicative or a substantially similar form, is not as likely to contribute to the public's understanding.
(iii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public shall be considered. It shall be presumed that a representative of the news media will satisfy this consideration.
(iv) The public's understanding of the subject in question, as compared to the level of public understanding existing prior to the disclosure, must be enhanced by the disclosure to a significant extent.
(3) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(B) of this section, the CFPB shall consider the following factors:
(i) The CFPB shall consider any commercial interest of the requester (with reference to the definition of “commercial user” in paragraph (b)(1)(i) of this section), or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure. Requesters shall be given an opportunity in the administrative process to provide explanatory information regarding this consideration.
(ii) A fee waiver or reduction is justified where the public interest standard is satisfied and that public interest is greater in magnitude than that of any identified commercial interest in disclosure. The CFPB ordinarily shall presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return shall not be presumed to primarily serve the public interest.
(4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver shall be granted for those records.
(5) If the CFPB denies a request to reduce or waive fees, then the CFPB shall advise the requester, in the denial notification letter, that the requester may incur fees if the CFPB proceeds to process the request. The notification letter shall also advise the requester that the CFPB will not proceed to process the request further unless the requester, in writing, directs the CFPB to do so and either agrees to pay any fees that may apply to processing the request or specifies an upper limit that the requester is willing to pay to process the request. If the CFPB does not receive this written direction and agreement/specification within thirty (30) calendar days of the date of the denial notification letter, then the CFPB shall deem the request to be withdrawn.
(6) If the CFPB denies a request to reduce or waive fees, then the requester shall have the right to submit an appeal of the denial determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester denying the fee reduction or waiver request. The requester should label its appeal request “Appeal for Fee Reduction/Waiver.”
(f)
(i) The fees exceed the limit set by the requester;
(ii) The requester did not specify a limit; or
(iii) The CFPB has denied a request for a reduction or waiver of fees.
(2) The requester must provide an agreement to pay the estimated fees; however, the requester shall also be given an opportunity to reformulate the request in an attempt to reduce fees.
(3) If the fees are estimated to exceed $1000, the requester must pre-pay such amount prior to the processing of the request, or provide satisfactory assurance of full payment if the requester has a history of prompt payment of FOIA fees. The requester shall also be given an opportunity to reformulate the request in such a way as to lower the applicable fees.
(4) The CFPB reserves the right to request prepayment after a request is processed and before documents are released.
(5) If a requester has previously failed to pay a fee within thirty (30) calendar days of the date of the billing, the requester shall be required to pay the full amount owed plus any applicable interest and to make an advance payment of the full amount of the estimated fee before the CFPB begins to process a new request or the pending request.
(6) When the CFPB acts under paragraphs (f)(1) through (5) of this section, the statutory time limits of twenty (20) days (excluding Saturdays, Sundays, and legal public holidays) from receipt of initial requests or appeals, plus extensions of these time limits, shall begin only after fees have been paid, a written agreement to pay fees has been provided, or a request has been reformulated.
(g)
(h)
(i)
(a)
(1) Have CFPB-wide responsibility for efficient and appropriate compliance with the FOIA;
(2) Monitor implementation of the FOIA throughout the CFPB and keep the Director, the General Counsel, and the Attorney General appropriately informed of the CFPB's performance in implementing the FOIA;
(3) Recommend to the Director such adjustments to agency practices, policies, personnel and funding as may be necessary to improve the Chief FOIA Officer's implementation of the FOIA;
(4) Review and report to the Attorney General, through the Director, at such times and in such formats as the Attorney General may direct, on the CFPB's performance in implementing the FOIA;
(5) Facilitate public understanding of the purposes of the statutory exemptions of the FOIA by including concise descriptions of the exemptions in both the CFPB's handbook and the CFPB's annual report on the FOIA, and by providing an overview, where appropriate, of certain general categories of CFPB records to which those exemptions apply;
(6) Designate one or more FOIA Public Liaisons;
(7) Offer Training to Bureau staff regarding their responsibilities under the FOIA;
(8) Serve as the primary Bureau liaison with the Office of Government Information Services and the Office of Information Policy; and
(9) Maintain and update, as necessary and in accordance with the requirements of this subpart, the CFPB's FOIA website, including its e-FOIA Library.
(b)
(a) This subpart sets forth the procedures to be followed with respect to subpoenas, court orders, or other requests or demands for any CFPB information, whether contained in the files of the CFPB or acquired by a CFPB employee as part of the performance of that employee's duties or by virtue of employee's official status.
(b) This subpart does not apply to requests for official information made pursuant to subparts B, D, and E of this part.
(c) This subpart does not apply to requests for information made in the course of adjudicating claims against the CFPB by CFPB employees (present or former) or applicants for CFPB employment for which jurisdiction resides with the U.S. Equal Employment Opportunity Commission, the U.S. Merit Systems Protection Board, the Office of Special Counsel, the Federal Labor Relations Authority, or their successor agencies, or a labor arbitrator operating under a collective bargaining agreement between the CFPB and a labor organization representing CFPB employees.
(d) This subpart is intended only to inform the public about CFPB procedures concerning the service of process and responses to subpoenas, summons, or other demands or requests for official information or action and is not intended to and does not create, and may not be relied upon to create any right or benefit, substantive or procedural, enforceable at law by a party against the CFPB or the United States.
(e) For purposes of this subpart:
(1)
(2)
(3)
(4)
(5)
(a) Except in cases in which the CFPB is represented by legal counsel who have entered an appearance or otherwise given notice of their representation, only the General Counsel is authorized to receive and accept subpoenas or other demands or requests directed to the CFPB or its employees, whether civil or criminal in nature, for:
(1) Records of the CFPB;
(2) Official information including, but not limited to, testimony, affidavits, declarations, admissions, responses to interrogatories, or informal statements, relating to material contained in the files of the CFPB or which any CFPB employee acquired in the course and scope of the performance of his or her official duties;
(3) Garnishment or attachment of compensation of current or former employees; or
(4) The performance or non-performance of any official CFPB duty.
(b) Documents described in paragraph (a) of this section should be served upon
(c) In the event that any demand or request described in paragraph (a) of this section is sought to be delivered to a CFPB employee other than in the manner prescribed in paragraph (b) of this section, such employee shall decline service and direct the server of process to these regulations. If the demand or request is nonetheless delivered to the employee, the employee shall immediately notify, and deliver a copy of that document to, the General Counsel.
(d) The CFPB is not an agent for service for, or otherwise authorized to accept on behalf of its employees, any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties.
(e) Copies of any subpoenas, orders, or other demands or requests that are directed to former employees of the CFPB in connection with the performance of official CFPB duties shall also be served upon the General Counsel. The CFPB shall not, however, serve as an agent for service for the former employee, nor is the CFPB otherwise authorized to accept service on behalf of its former employees. If the demand involves their official duties as CFPB employees, former employees who receive subpoenas, orders, or similar compulsory process should also notify, and deliver a copy of the document to, the General Counsel.
(a) Unless authorized by the General Counsel, no employee or former employee of the CFPB shall, in response to a demand or a request provide oral or written testimony by deposition, declaration, affidavit, or otherwise concerning any official information.
(b) Unless authorized by the General Counsel, no employee or former employee shall, in response to a demand or request, produce any document or any material acquired as part of the performance of that employee's duties or by virtue of that employee's official status.
(a) If, as part of a proceeding in which the United States or the CFPB is not a party, official information is sought through a demand for testimony, CFPB records, or other material, the party seeking such information must (except as otherwise required by Federal law or authorized by the General Counsel) set forth in writing:
(1) The title and forum of the proceeding, if applicable;
(2) A detailed description of the nature and relevance of the official information sought;
(3) A showing that other evidence reasonably suited to the requester's needs is not available from any other source; and
(4) If testimony is requested, the intended use of the testimony, a general summary of the desired testimony, and a showing that no document could be provided and used in lieu of testimony.
(b) To the extent he or she deems necessary or appropriate, the General Counsel may also require from the party seeking such information a plan of all reasonably foreseeable demands, including but not limited to the names of all employees and former employees from whom testimony or discovery will be sought, areas of inquiry, expected duration of proceedings requiring oral testimony, identification of potentially relevant documents, or any other information deemed necessary to make a determination. The purpose of this requirement is to assist the General Counsel in making an informed decision regarding whether testimony, the production of documents, or the provision of other information should be authorized.
(c) The General Counsel may consult or negotiate with an attorney for a party, or the party if not represented by an attorney, to refine or limit a request or demand so that compliance is less burdensome.
(d) The General Counsel will notify the CFPB employee and such other persons as circumstances may warrant of his or her decision regarding compliance with the request or demand.
(a) If a response to a demand described in § 1070.33 is required before the General Counsel renders a decision, the CFPB will request that the appropriate CFPB attorney or an attorney of the Department of Justice, as appropriate, take steps to stay, postpone, or obtain relief from the demand pending decision. If necessary, the attorney will:
(1) Appear with the employee upon whom the demand has been made;
(2) Furnish the court or other authority with a copy of the regulations contained in this subpart;
(3) Inform the court or other authority that the demand has been, or is being, as the case may be, referred for the prompt consideration of the appropriate CFPB official; and
(4) Request the court or authority to stay the demand pending receipt of the requested instructions.
(b) In the event that an immediate demand for production or disclosure is made in circumstances which would preclude the proper designation or appearance of an attorney of the CFPB or the Department of Justice on the employee's behalf, the employee, if necessary, shall request from the demanding court or authority a reasonable stay of proceedings for the purpose of obtaining instructions from the General Counsel.
If a stay of, or other relief from, the effect of a demand made pursuant to §§ 1070.33 and 1070.34 is declined or not obtained, or if the court or other judicial or quasi-judicial authority declines to stay the effect of the demand made pursuant to §§ 1070.33 and 1070.34, or if the court or other authority rules that the demand must be complied with irrespective of the General Counsel's instructions not to produce the material or disclose the information sought, the employee upon whom the demand has been made shall decline to comply with the demand citing this subpart and
(a) In deciding whether to comply with a demand or request, CFPB officials and attorneys shall consider, among other pertinent considerations:
(1) Whether such compliance would be unduly burdensome or otherwise inappropriate under the applicable rules of discovery or the rules of procedure governing the case or matter in which the demand arose;
(2) Whether the number of similar requests would have a cumulative effect on the expenditure of CFPB resources;
(3) Whether compliance is appropriate under the relevant substantive law concerning privilege or disclosure of information;
(4) The public interest;
(5) The need to conserve the time of CFPB employees for the conduct of official business;
(6) The need to avoid spending time and money of the United States for private purposes;
(7) The need to maintain impartiality between private litigants in cases where a substantial government interest is not implicated;
(8) Whether compliance would have an adverse effect on performance by the CFPB of its mission and duties;
(9) The need to avoid involving the CFPB in controversial issues not related to its mission;
(10) Whether compliance would interfere with supervisory examinations, compromise the CFPB's supervisory functions or programs, or undermine public confidence in supervised financial institutions; and
(11) Whether compliance would interfere with the CFPB's ability to monitor for risks to consumers in the offering or provision of consumer financial products and services.
(b) Among those demands and requests in response to which compliance will not ordinarily be authorized are those with respect to which any of the following factors, inter alia, exist:
(1) Compliance would violate a statute or applicable rule of procedure;
(2) Compliance would violate a specific regulation or Executive order;
(3) Compliance would reveal information properly classified in the interest of national security;
(4) Compliance would reveal confidential or privileged commercial or financial information or trade secrets without the owner's consent;
(5) Compliance would compromise the integrity of the deliberative processes of the CFPB;
(6) Compliance would not be appropriate or necessary under the relevant substantive law governing privilege;
(7) Compliance would reveal confidential information; or
(8) Compliance would interfere with ongoing investigations or enforcement proceedings, compromise constitutional rights, or reveal the identity of a confidential informant.
(c) The CFPB may condition disclosure of official information pursuant to a request or demand on the entry of an appropriate protective order.
(a) Except as provided in this section, and subject to 5 CFR 2635.805, CFPB employees or former employees shall not provide opinion or expert testimony based upon information which they acquired in the scope and performance of their official CFPB duties, except on behalf of the CFPB or the United States or a party represented by the CFPB, or the Department of Justice, as appropriate.
(b) Any expert or opinion testimony by a former employee of the CFPB shall be excepted from paragraph (a) of this section where the testimony involves only general expertise gained while employed at the CFPB.
(c) Upon a showing by the requester of exceptional need or unique circumstances and that the anticipated testimony will not be adverse to the interests of the United States, the General Counsel may, consistent with 5 CFR 2635.805, exercise his or her discretion to grant special, written authorization for CFPB employees, or former employees, to appear and testify as expert witnesses at no expense to the United States.
(d) If, despite the final determination of the General Counsel, a court of competent jurisdiction or other appropriate authority orders the appearance and expert or opinion testimony of a current or former CFPB employee, that person shall immediately inform the General Counsel of such order. If the General Counsel determines that no further legal review of or challenge to the court's order will be made, the CFPB employee, or former employee, shall comply with the order. If so directed by the General Counsel, however, the employee, or former employee, shall decline to testify.
(a) This subpart implements the provisions of the Privacy Act of 1974, 5 U.S.C. 552a (the Privacy Act). The regulations apply to all records maintained by the CFPB and which are retrieved by an individual's name or personal identifier. The regulations set forth the procedures for requests for access to, or amendment of, records concerning individuals that are contained in systems of records maintained by the CFPB. These regulations should be read in conjunction with the Privacy Act, which provides additional information about this topic.
(b) For purposes of this subpart, the following definitions apply:
(1) The term
(2) The term
(3)
(4)
(5)
(6)
(7)
(8)
The Chief Privacy Officer is authorized to:
(a) Develop, implement, and maintain an organization-wide privacy program;
(b) Respond to requests for access to, accounting of, or amendment of records contained in a system of records maintained by the CFPB;
(c) Approve the publication of new systems of records and amend existing systems of record; and
(d) File any necessary reports related to the Privacy Act.
(a)
(b)
(1) Total charges associated with a request are less than $5; or
(2) The requester is a CFPB employee or former employee, or an applicant for employment with the CFPB, and the request pertains to that employee, former employee, or applicant.
(a)
(1) If submitted by mail or delivery service, the request shall be labeled “Privacy Act Request” and shall be addressed to the Chief Privacy Officer, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552.
(2) If submitted by electronic means, the request shall be labeled “Privacy Act Request” and the request shall be submitted as set forth at the CFPB's website,
(b)
(1) A statement that the request is made pursuant to the Privacy Act;
(2) The name of the system of records that the requester believes contains the record requested, or a description of the nature of the record sought in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;
(3) Whenever possible, a description of the nature of the record sought, the date of the record or the period in which the requester believes that the record was created, and any other information that might assist the CFPB in identifying the record sought (
(4) Information necessary to verify the requester's identity pursuant to paragraph (c) of this section; and
(5) The mailing or email address where the CFPB's response or further correspondence should be sent.
(c)
(1) In general, the following will be considered adequate proof of a requester's identity:
(i) A photocopy of two forms of identification, including one form of identification that bears the requester's photograph, and one form of identification that bears the requester's signature;
(ii) A photocopy of a single form of identification that bears both the requester's photograph and signature; or
(iii) A statement swearing or affirming the requester's identity and to the fact that the requester understands the penalties provided in 5 U.S.C. 552a(i)(3).
(2) Notwithstanding paragraph (c)(1) of this section, a designated official may require additional proof of the requester's identity before action will be taken on any request, if such official determines that it is necessary to protect against unauthorized disclosure of information in a particular case. In addition, if a requester seeks records pertaining to an individual in the requester's capacity as that individual's guardian, the requester shall be required to provide adequate proof of the requester's legal relationship before action will be taken on any request.
(d)
(a)
(b)
(2) The requester may bring with him or her anyone whom the requester chooses to see the requested material. All visitors to the CFPB's buildings must comply with the applicable security procedures.
(c)
If an individual requests medical or psychological records pursuant to § 1070.53, the CFPB will disclose them directly to the requester unless the CFPB determines that such disclosure could have an adverse effect on the requester. If the CFPB makes that determination, the CFPB shall provide the information to a licensed physician or other appropriate representative that the requester designates, who shall disclose those records to the requester in a manner he or she deems appropriate.
(a)
(2) A request for amendment of a record must:
(i) Identify the name of the system of records that the requester believes contains the record for which the amendment is requested, or a description of the nature of the record in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;
(ii) Specify the portion of that record requested to be amended; and
(iii) Describe the nature and reasons for each requested amendment.
(3) When making a request for amendment of a record, the CFPB will
(b)
(a)
(b)
(1) Why the request (or portion of the request) was denied;
(2) That the requester has a right to appeal; and
(3) How to file an appeal.
(a)
(b)
(1) Specify the background of the request; and
(2) Provide reasons why the requester believes the denial is in error.
(c)
(1) If the General Counsel grants an appeal regarding a request for amendment, he or she will take the necessary steps to amend the record and, when appropriate and possible, notify prior recipients of the record of its action.
(2) If the General Counsel denies an appeal, he or she will inform the requester of such determination in writing, including the reasons for the denial, and the requester's right to file a statement of disagreement and to have a court review its decision.
(d)
(2) When practicable and appropriate, the CFPB will provide a copy of the statement of disagreement to any prior recipients of the record.
The CFPB will not disclose any record about an individual contained in a system of records to any person or agency without the prior written consent of that individual unless the disclosure is authorized by 5 U.S.C. 552a(b). Disclosures authorized by 5 U.S.C. 552a(b) include disclosures that are compatible with one or more routine uses that are contained within the CFPB's Systems of Records Notices, which are available on the CFPB's website, at
(a)
(1) CFPB.002 Depository Institution Supervision Database.
(2) CFPB.003 Non-Depository Institution Supervision Database.
(3) CFPB.004 Enforcement Database.
(4) CFPB.005 Consumer Response System.
(b)
(a)
(b)
(1) The head of each office of the CFPB shall be responsible for assuring that employees subject to such official's supervision are advised of the provisions of the Privacy Act, including the criminal penalties and civil liabilities provided therein, and the regulations in this subpart, and that such employees are made aware of their individual and collective responsibilities to protect the security of personal information, to assure its accuracy, relevance, timeliness and completeness, to avoid unauthorized disclosure either orally or in writing, and to ensure that no system of records is maintained without public notice.
(2) Employees of the CFPB involved in the design, development, operation, or maintenance of any system of records, or in maintaining any record shall:
(i) Collect no information of a personal nature from individuals unless authorized to collect it to achieve a function or carry out a responsibility of the CFPB;
(ii) Collect information, to the extent practicable, directly from the individual to whom it relates;
(iii) Inform each individual asked to supply information, on the form used to collect the information or on a separate form that can be retained by the individual of—
(A) The authority (whether granted by statute, or by executive order of the President) which authorizes the solicitation of the information and whether disclosure of such information is mandatory or voluntary;
(B) The principal purpose or purposes for which the information is intended to be used;
(C) The routine uses which may be made of the information, as published pursuant to 5 U.S.C. 552a(e)(4)(D); and
(D) The effects on the individual, if any, of not providing all or any part of the requested information;
(iv) Not collect, maintain, use or disseminate information concerning an individual's religious or political beliefs or activities or membership in associations or organizations, unless expressly authorized by statute or by the individual about whom the record is maintained or unless pertinent to and within the scope of an authorized law enforcement activity;
(v) Advise their supervisors of the existence or contemplated development of any record system which is capable of retrieving information about individuals by individual identifier;
(vi) Assure that no records maintained in a CFPB system of records are disseminated without the permission of the individual about whom the record pertains, except when authorized by 5 U.S.C. 552a(b);
(vii) Maintain and process information concerning individuals with care in order to ensure that no inadvertent disclosure of the information is made either within or without the CFPB;
(viii) Prior to disseminating any record about an individual to any person other than an agency, unless the dissemination is made pursuant to 5 U.S.C. 552a(b)(2), make reasonable efforts to assure that such records are accurate, complete, timely, and relevant for agency purposes; and
(ix) Assure that an accounting is kept in the prescribed form, of all dissemination of personal information outside the CFPB, whether made orally or in writing, unless disclosed under 5 U.S.C. 552 or subpart B of this part.
(3) The head of each office of the CFPB shall, at least annually, review the record systems subject to their supervision to ensure compliance with the provisions of the Privacy Act of 1974 and the regulations in this subpart.
The CFPB will preserve all correspondence pertaining to the requests that it receives under this part, as well as copies of all requested records, until disposition or destruction is authorized by title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records will not be disposed of or destroyed while they are the subject of a pending request, appeal, proceeding, or lawsuit.
The CFPB will ensure that employees authorized to collect information are aware:
(a) That individuals may not be denied any right, benefit, or privilege as a result of refusing to provide their Social Security numbers, unless the collection is authorized either by a statute or by a regulation issued prior to 1975; and
(b) That individuals requested to provide their Social Security numbers must be informed of:
(1) Whether providing Social Security numbers is mandatory or voluntary;
(2) Any statutory or regulatory authority that authorizes the collection of Social Security numbers; and
(3) The uses that will be made of the numbers.
Federal Aviation Administration (FAA), DOT.
Amended final special conditions; request for comments.
These amended special conditions are issued for the Boeing Model 787-8, 787-9, and 787-10 series airplanes. This amendment states that the Boeing Model 787-8, 787-9, and 787-10 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant seats equipped with airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Boeing on September 12, 2018. Send comments on or before October 29, 2018.
Send comments identified by Docket No. FAA-2016-5909 using any of the following methods:
•
•
•
•
John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email
The substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On November 22, 2017, Boeing applied for a change to Type Certificate No. T00021SE for the installation of oblique (side-facing) passenger seats with or without airbag devices or 3-point restraints in the Boeing Model 787-8, 787-9, and 787-10 series airplanes. The Boeing Model 787-8, 787-9, and 787-10 series airplanes are twin-engine, transport category airplanes with a maximum certified passenger capacity of up to 440, and a maximum takeoff weight of approximately 476,000 lbs.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 787-8, 787-9, and 787-10 series airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. T00021SE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 787-8, 787-9, and 787-10 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.
The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.
The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.
The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.
The proposed Boeing Model 787-8, 787-9, and 787-10 series airplanes business-class seat installation is novel such that the current Boeing Model 787-8, 787-9, and 787-10 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-580-SC for Model 787-9 airplanes on April 14, 2015, and special conditions No. 25-626-SC for certain Model 787-9 airplanes on July 27, 2016. These special conditions contained injury criteria for oblique seats based on the best knowledge the FAA had at the time. These special conditions for oblique seat installations do not adequately address oblique seats, reflecting the current research results, with or without 3-point or airbag restraint systems. Therefore, Boeing's proposed configuration will require amended special conditions.
The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-580-SC and 25-626-SC.
FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and
As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.
Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 787-8, 787-9, and 787-10 series airplanes.
These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Boeing Model 787-8, 787-9, and 787-10 series airplanes. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model airplane. It is not a rule of general applicability.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Boeing Model 787-8, 787-9, and 787-10 series airplanes.
In addition to the requirements of § 25.562:
Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a head-injury criterion (HIC) unlimited score in excess of 1000 is acceptable, provided the HIC15 score (calculated in accordance with 49 CFR 571.208) for that contact is less than 700.
If a seat is installed aft of structure (
The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.
a. The N
b. In addition, peak F
c. Rotation of the head about its vertical axis, relative to the torso, is limited to 105 degrees in either direction from forward-facing.
d. The neck must not impact any surface that would produce concentrated loading on the neck.
a. The lumbar spine tension (F
b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X direction) acceleration exceeding 20g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E filtered in accordance with SAE International (SAE) recommended practice J211/1, “Instrumentation for Impact Test—Part 1-Electronic Instrumentation.”
c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.
Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.
Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.
Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (
Boeing must demonstrate that the installation of seats via plinths or pallets meets all applicable requirements. Compliance with the guidance contained in policy memorandum PS-ANM-100-2000-00123, “Guidance for Demonstrating Compliance with Seat Dynamic Testing for Plinths and Pallets,” dated February 2, 2000, is acceptable to the FAA.
If inflatable airbag restraint systems are installed, the airbag systems must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 787-8, 787-9 and 787-10 series airplanes.
Federal Aviation Administration (FAA), DOT.
Amended final special conditions; request for comments.
These amended special conditions are issued for the Boeing Model 777 series airplanes. This amendment states that the Boeing Model 777 series airplanes oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features are oblique (side-facing) single-occupant passenger seats equipped with or without airbag devices or 3-point restraints. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on The Boeing Company on September 12, 2018. Send comments on or before October 29, 2018.
Send comments identified by Docket No. FAA-2016-4136 using any of the following methods:
•
•
•
•
John Shelden, Airframe and Cabin Safety Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3214; email
The substance of these special conditions has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On November 22, 2017, Boeing applied for an amendment to Type
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777 series airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The business-class seating configuration Boeing proposes is novel or unusual due to the seat installation at 30 degrees to the airplane centerline, the airbag-system installation, and the seat/occupant interface with the surrounding furniture that introduces occupant alignment and loading concerns. The proposed business-class seating configuration is also beyond the limits of current acceptable equivalent-level-of-safety findings. These oblique (side-facing) seats may be installed at an angle of 18 to 45 degrees to the airplane centerline and may include a 3-point or airbag restraint system, or both, for occupant restraint and injury protection.
The existing regulations do not provide adequate or appropriate safety standards for occupants of oblique-angled seats with airbag systems. To provide a level of safety that is equivalent to that afforded occupants of forward- and aft-facing seats, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement part 25 and, more specifically, supplement §§ 25.562 and 25.785.
The requirements contained in these special conditions consist of both test conditions and injury pass/fail criteria.
The FAA has been conducting and sponsoring research on appropriate injury criteria for oblique (side-facing) seat installations. However, the FAA research program is not complete and we may update these criteria as we obtain further research results. To reflect current research findings, the FAA issued policy statement PS-ANM-25-03-R1 to update injury criteria for fully side-facing seats, and policy statement PS-AIR-25-27, to define injury criteria for oblique (side-facing) seats.
The proposed Boeing Model 777 series airplanes business-class seat installation is novel such that the current Boeing Model 777 series airplanes certification basis does not adequately address protection of the occupant's neck and spine for seat configurations that are positioned at an angle greater than 18 degrees from the airplane centerline. The FAA issued special conditions No. 25-569-SC for Model 777-300ER airplanes on September 25, 2014, and special conditions No. 25-621-SC for certain Model 777-300ER airplanes on August 3rd, 2016. These special conditions contained injury criteria for oblique seats based on the best knowledge the FAA had at the time. These special conditions for oblique seat installations do not adequately address oblique seats, reflecting the current research results, with or without 3-point or airbag restraint systems. Therefore, Boeing's proposed configuration will require amended special conditions.
The installation of passenger seats at angles of 18 to 45 degrees to the airplane centerline are unique due to the seat/occupant interface with the surrounding furniture that introduces occupant alignment/loading concerns with or without the installation of a 3-point or airbag restraint system, or both. On-going research has invalidated previously released special conditions for oblique (side-facing) seat installations. These updated special conditions further address potential injuries to the occupant's neck and spine. As a result, these special conditions replace special conditions 25-569-SC and 25-621-SC.
FAA-sponsored research has found that an un-restrained flailing of the upper torso, even when the pelvis and torso are nearly aligned, can produce serious spinal and torso injuries. At lower impact severities, even with significant misalignment between the torso and pelvis, these injuries did not occur. Tests with an FAA H-III anthropomorphic test device (ATD) have identified a level of lumbar spinal tension corresponding to the no-injury impact severity. This level of tension is included as a limit in the special conditions. The spine tension limit selected is conservative with respect to other aviation injury criteria since it corresponds to a no-injury loading condition.
As noted in the special conditions for each airbag restraint system, because an airbag restraint system is essentially a single use device, there is the potential that it could deploy under crash conditions that are not sufficiently severe as to require head injury protection from the airbag restraint system. Since an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the airbag restraint system useless if a larger impact follows the initial impact. This situation does not exist with energy absorbing pads or upper torso restraints, which tend to provide protection according to the severity of the impact. Therefore, the installation of the airbag restraint system should be such that the airbag restraint system will provide protection when it is required, and will not expend its protection when it is not needed.
Because these airbag restraint systems may or may not activate during various crash conditions, the injury criteria listed in these special conditions and in § 25.562 must be met in an event that is slightly below the activation level of the airbag restraint system. If an airbag restraint system is included with the oblique seats, the system must meet the requirements in one of the airbag (inflatable restraint) special conditions applicable to the Boeing Model 777 series airplanes.
These amended special conditions will provide head injury criteria, neck injury criteria, spine injury criteria, and body-to-wall contact criteria. They contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the Boeing Model 777 series airplane. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 777 series airplanes.
In addition to the requirements of § 25.562:
Compliance with § 25.562(c)(5) is required, except that, if the ATD has no apparent contact with the seat/structure but has contact with an airbag, a HIC unlimited score in excess of 1,000 is acceptable, provided the HIC15 score for that contact (calculated in accordance with 49 CFR 571.208) is less than 700.
If a seat is installed aft of structure (
The seating system must protect the occupant from experiencing serious neck injury. The assessment of neck injury must be conducted with the airbag device activated, unless there is a reason to also consider that the neck-injury potential would be higher for impacts below the airbag-device deployment threshold.
a. The N
b. In addition, peak upper-neck F
c. Rotation of the head about its vertical axis, relative to the torso is limited to 105 degrees in either direction from forward-facing.
d. The neck must not impact any surface that would produce concentrated loading on the neck.
a. The lumbar spine tension (F
b. Significant concentrated loading on the occupant's spine, in the area between the pelvis and shoulders during impact, including rebound, is not acceptable. During this type of contact, the interval for any rearward (X direction) acceleration exceeding 20 g must be less than 3 milliseconds as measured by the thoracic instrumentation specified in 49 CFR part 572, subpart E, filtered in accordance with SAE recommended practice J211/1, “Instrumentation for Impact Test-Part 1—Electronic Instrumentation.”
c. The occupant must not interact with the armrest or other seat components in any manner significantly different than would be expected for a forward-facing seat installation.
Any part of the load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of the seat bottom seat-cushion supporting structure.
Axial rotation of the upper leg (about the z-axis of the femur per SAE Recommended Practice J211/1) must be limited to 35 degrees from the nominal seated position. Evaluation during rebound does not need to be considered.
Longitudinal tests conducted to measure the injury criteria above must be performed with the FAA Hybrid III ATD, as described in SAE 1999-01-1609, “A Lumbar Spine Modification to the Hybrid III ATD for Aircraft Seat Tests.” The tests must be conducted with an undeformed floor, at the most-critical yaw cases for injury, and with all lateral structural supports (
In rule document 2018-18766 beginning on page 44821 in the issue of Tuesday, September 4, 2018, make the following correction:
1. On page 44824, in the third column, amendatory instruction number 2e is corrected to read as follows:
“2. * * *
e. Under Russia,
i. By removing the entity “Joint Stock Company Mikron”;
ii. By adding in alphabetical order two entities “Joint Stock Company (JSC) NIIME” and “PJSC Mikron”;
2. On page 44825, in the table, under the country heading for Hong Kong, the Joinus Freight Systems entry should read as follows:
3. On page 44826, in the table, under the country heading for Russia, the PJSC Mikron entry should read as follows:
Food and Drug Administration, HHS.
Final rule; partial withdrawal.
The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the
Effective September 12, 2018, FDA withdraws amendatory instruction 13 on page 56144 of the final rule published at 80 FR 55908 at 56144 on September 17, 2015. Submit either electronic or written comments by October 12, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 12, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
In the
Subsequently, in a final rule published in the
A small business is a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees. A very small business is a business (including any subsidiaries and affiliates) averaging less than $1 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (
After issuing the compliance date final rule, FDA announced that as a matter of enforcement policy it did not intend to enforce certain part 117 requirements for certain facilities, including some of the facilities in table 1 whose compliance dates had been extended by the compliance date final rule. See the January 2018 guidance entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs” (
As mentioned above, in the final rule establishing part 117 we instructed the
When FDA conducts rulemaking, it normally does so using notice-and-comment procedures established under the Administrative Procedure Act (APA) and FDA regulations. These procedures allow the public an opportunity to participate in Agency rulemaking by submitting written comments on proposed rules. FDA considers these comments as it finalizes rules. (5 U.S.C. 553(b) and (c); § 10.40 (21 CFR 10.40.)) The APA, however, does not require an agency to use notice-and-comment procedures in all rulemaking. For example, the APA provides that Agencies shall not use notice-and-comment procedures, and shall proceed with a final rule, when the Agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to public interest, and incorporates the finding and a brief statement of reasons therefor in the rules issued. (5 U.S.C. 553(b)(B).) Likewise, FDA's regulations provide that the requirements of notice and public procedure do not apply when the Commissioner of Food and Drugs determines for good cause that they are impracticable, unnecessary, or contrary to the public interest, in which case, the notice issuing the regulation will state the reasons for the determination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. (§ 10.40(e)(1).) Pursuant to this regulation, FDA requests comments on the timing for the removal of part 110.
In this instance, for several reasons, FDA finds good cause for issuing this final rule without notice and comment.
Notice and comment are unnecessary because this final rule is a minor and technical repair of an obvious oversight in the compliance date final rule, maintains the CGMP regulatory status quo for industry, affirms FDA's plan for transitioning from part 110 to part 117 as outlined in the rule establishing part 117, and is not expected to generate public concern. FDA is addressing the gap in CGMP regulatory coverage from September 17, 2018, to January 27, 2020, by issuing a narrowly tailored amendment to remove instruction 13 from the rule to establish part 117. The result of this amendment will be that the part 110 CGMPs will continue in effect for establishments that have not reached their part 117 compliance date. This action will serve to correct an obvious oversight made in the compliance date final rule. FDA does not anticipate public concern with this action. The Agency previously sought public comment on its proposal to remove part 110 in coordination with the compliance dates for part 117 and received no comments that disagreed. The present continuation and planned eventual removal of part 110 is a repeat of what was previously proposed without public objection. Furthermore, it is clear from the rule establishing part 117 that we intended for facilities to remain subject to part 110 until their part 117 compliance date (80 FR 55908 at 56127). Thus, we do not believe there was ever any reasonable expectation on the part of the establishments listed in table 1 that they would not be continuously subject to CGMPs. For these various reasons, we have determined that notice and comment is unnecessary.
FDA finds further good cause for issuing this final rule without notice and comment because notice and comment are contrary to the public interest and impracticable. There could be negative public health implications if there were a temporal gap in CGMP coverage; for example, there have been outbreaks associated with the types of facilities still subject to part 110 (
To summarize, a gap in CGMP coverage would leave FDA without a primary tool to execute its function of ensuring that food manufacturing establishments follow basic food safety practices, potentially endangering the public health, in order to provide the public an opportunity to comment on a non-controversial technical matter. For these reasons, we are issuing this amendment to the final rule establishing part 117 without prior notice and comment. (5 U.S.C. 553(b)(3)(B)).
In addition, we find good cause for this amendment to the rule establishing part 117 to become effective on the date of publication. The APA allows an effective date less than 30 days after publication as provided by the Agency for good cause found and published within the rule (5 U.S.C. 553(d)(3)). As provided at 80 FR 55908, September 17, 2015, the amendment removing part 110 was to take effect on September 17, 2018. In order to continue part 110 for an interim period, this final rule needs to be effective on or before September 16, 2018, and therefore it is not possible for this rule to take effect 30 days after publication in the
We are issuing this final rule removing instruction number 13 of the rule to establish part 117 under the same authority for which the rule containing instruction number 13 was originally issued. That analysis may be found in section II, “Legal Authority,” of the rule to establish part 117 (80 FR 55908 at 55917 to 55920).
FDA has determined that the removal of instruction 13 will not change the status quo and, therefore, is not a major Federal action significantly affecting the quality of the human environment within the meaning of section 102(2)(C) of the National Environmental Policy
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Food packaging, Foods.
Environmental Protection Agency (EPA).
Final rule; delegation of authority.
The New Mexico Environment Department (NMED) has submitted updated regulations for receiving delegation and approval of a program for the implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA and amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA and amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA and amended between August 30, 2013 and January 15, 2017, as adopted by the NMED. The delegation of authority under this action does not apply to sources located in Bernalillo County, New Mexico, or to sources located in areas defined as Indian Country. The EPA is providing notice that it is updating the delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED.
This rule is effective on October 12, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2016-0091. All documents in the docket are listed on the
Mr. Rick Barrett (6MM-AP), (214) 665-7227; email:
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
On April 13, 2018, EPA published a direct final rule and accompanying proposal approving the updated delegation of authority for implementation and enforcement of NSPS and NESHAPs for all sources (both part 70 and non-part 70 sources) to the NMED. The direct final rule and proposal were published without prior proposal because EPA anticipated no relevant adverse comments.
EPA received an adverse comment on May 14, 2018, and accordingly withdrew the direct final rule on June 5, 2018, pursuant to sections 111 and 112 of the CAA.
The EPA is providing notice that it is approving NMED's request updating the delegation for the implementation and enforcement of certain NSPS. The EPA is also taking final action to approve NMED's request updating the delegation of certain NESHAP. With this delegation, NMED has the primary responsibility to implement and enforce the delegated standards.
Upon the EPA's finding that the procedures submitted by a State for the implementation and enforcement of standards of performance for new sources located in the State are adequate, Section 111(c)(1) of the Clean Air Act (CAA) authorizes the EPA to delegate its authority to implement and enforce such standards. The new source performance standards are codified at 40 CFR part 60.
Section 112(l) of the CAA and 40 CFR part 63, subpart E, authorize the EPA to delegate authority for the implementation and enforcement of emission standards for hazardous air pollutants to a State that satisfies the statutory and regulatory requirements in subpart E. The hazardous air pollutant standards are codified at 40 CFR parts 61 and 63.
In order to receive delegation of NSPS, a State must develop and submit to the EPA a procedure for implementing and enforcing the NSPS in the state, and their regulations and resources must be adequate for the implementation and enforcement of the NSPS. The EPA initially approved New Mexico's program for the delegation of NSPS on June 6, 1986 (51 FR 20648). The EPA reviewed the laws of the State and the rules and regulations of the New Mexico Environmental Improvement Division (now the NMED) and determined the State's procedures, regulations and resources adequate for the implementation and enforcement of the Federal standards. The NSPS delegation was most recently updated on February 2, 2015 (80 FR 5475). This action notifies the public that the EPA is updating NMED's delegation to implement and enforce certain additional NSPS.
Section 112(l)(5) of the CAA requires the EPA to disapprove any program submitted by a State for the delegation of NESHAP standards if the EPA determines that:
(A) The authorities contained in the program are not adequate to assure compliance by the sources within the State with respect to each applicable standard, regulation, or requirement established under section 112;
(B) adequate authority does not exist, or adequate resources are not available, to implement the program;
(C) the schedule for implementing the program and assuring compliance by affected sources is not sufficiently expeditious; or
(D) the program is otherwise not in compliance with the guidance issued by the EPA under section 112(l)(2) or is not likely to satisfy, in whole or in part, the objectives of the CAA.
In carrying out its responsibilities under section 112(l), the EPA promulgated regulations at 40 CFR part 63, subpart E setting forth criteria for the approval of submitted programs. For example, in order to obtain approval of a program to implement and enforce Federal section 112 rules as promulgated without changes (straight delegation), a State must demonstrate that it meets the criteria of 40 CFR 63.91(d). 40 CFR 63.91(d)(3) provides that interim or final title V program approval will satisfy the criteria of 40 CFR 63.91(d).
The NESHAP delegation was most recently approved on February 2, 2015 (80 FR 5475).
As to the NSPS standards in 40 CFR part 60, NMED adopted the Federal standards via incorporation by reference. The NMED regulations are, therefore, at least as stringent as the EPA's rules.
As to the NESHAP standards in 40 CFR parts 61 and 63, as part of its Title V submission NMED stated that it intended to use the mechanism of incorporation by reference to adopt unchanged Federal section 112 standards into its regulations. This commitment applied to both existing and future standards as they applied to part 70 sources. The EPA's final interim approval of New Mexico's Title V operating permits program delegated the authority to implement certain NESHAP, effective December 19, 1994 (59 FR 59656). On November 26, 1996, the EPA promulgated final full approval of the State's operating permits program, effective January 27, 1997 (61 FR 60032). These interim and final title V program approvals satisfy the upfront approval criteria of 40 CFR 63.91(d). Under 40 CFR 63.91(d)(2), once a state has satisfied the up-front approval criteria, it needs only to reference the previous demonstration and reaffirm that it still meets the criteria for any subsequent submittals for delegation of the section 112 standards. NMED has affirmed that it still meets the up-front approval criteria. With respect to non-Title V sources, the EPA has previously approved delegation of NESHAP authorities to NMED after finding adequate authorities to implement and enforce the NESHAP for non-Title V sources.
By letter dated January 22, 2016, the EPA received a request from NMED to update its NSPS delegation and NESHAP delegation. With certain exceptions noted in section VIII below, NMED's request included NSPS in 40 CFR part 60, as amended between September 24, 2013 and September 15, 2015; NESHAP in 40 CFR part 61, as
By letter dated June 9, 2017, the EPA received a request from NMED to update its NSPS delegation and NESHAP delegation. With certain exceptions noted in section VIII below, NMED's request included NSPS in 40 CFR part 60, as amended between September 15, 2015 and January 15, 2017; NESHAP in 40 CFR part 61, as amended between September 15, 2015 and January 15, 2017; and NESHAP in 40 CFR part 63, as amended between September 15, 2015 and January 15, 2017. This action is being taken in response to NMED's requests noted above.
All authorities not affirmatively and expressly delegated by this action are not delegated. These include the following part 60, 61 and 63 authorities listed below:
• 40 CFR part 60, subpart AAA (Standards of Performance for New Residential Wood Heaters);
• 40 CFR part 60, subpart QQQQ (Standards of Performance for New Residential Hydronic Heaters and Forced-Air Furnaces);
• 40 CFR part 61, subpart B (National Emission Standards for Radon Emissions From Underground Uranium Mines);
• 40 CFR part 61, subpart H (National Emission Standards for Emissions of Radionuclides Other Than Radon From Department of Energy Facilities);
• 40 CFR part 61, subpart I (National Emission Standards for Radionuclide Emissions From Federal Facilities Other Than Nuclear Regulatory Commission Licensees and Not Covered by Subpart H);
• 40 CFR part 61, subpart K (National Emission Standards for Radionuclide Emissions From Elemental Phosphorus Plants);
• 40 CFR part 61, subpart Q (National Emission Standards for Radon Emissions From Department of Energy facilities);
• 40 CFR part 61, subpart R (National Emission Standards for Radon Emissions From Phosphogypsum Stacks);
• 40 CFR part 61, subpart T (National Emission Standards for Radon Emissions From the Disposal of Uranium Mill Tailings);
• 40 CFR part 61, subpart W (National Emission Standards for Radon Emissions From Operating Mill Tailings); and
• 40 CFR part 63, subpart J (National Emission Standards for Polyvinyl Chloride and Copolymers Production).
In addition, the EPA regulations provide that we cannot delegate to a State any of the Category II authorities set forth in 40 CFR 63.91(g)(2). These include the following provisions: § 63.6(g), Approval of Alternative Non-Opacity Standards; § 63.6(h)(9), Approval of Alternative Opacity Standards; § 63.7(e)(2)(ii) and (f), Approval of Major Alternatives to Test Methods; § 63.8(f), Approval of Major Alternatives to Monitoring; and § 63.10(f), Approval of Major Alternatives to Recordkeeping and Reporting. Also, some Part 61 and Part 63 standards have certain provisions that cannot be delegated to the States. Furthermore, no authorities are delegated that require rulemaking in the
All inquiries and requests concerning implementation and enforcement of the excluded standards in the State of New Mexico should be directed to the EPA Region 6 Office.
In addition, this delegation to NMED to implement and enforce certain NSPS and NESHAP authorities does not extend to sources or activities located in Indian country, as defined in 18 U.S.C. 1151. Under this definition, the EPA treats as reservations, trust lands validly set aside for the use of a Tribe even if the trust lands have not been formally designated as a reservation. Consistent with previous Federal program approvals or delegations, the EPA will continue to implement the NSPS and NESHAP in Indian country because NMED has not submitted information to demonstrate authority over sources and activities located within the exterior boundaries of Indian reservations and other areas in Indian country.
In approving the NSPS delegation, NMED will obtain concurrence from the EPA on any matter involving the interpretation of section 111 of the CAA or 40 CFR part 60 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.
In approving the NESHAP delegation, NMED will obtain concurrence from the EPA on any matter involving the interpretation of section 112 of the CAA or 40 CFR parts 61 and 63 to the extent that implementation or enforcement of these provisions have not been covered by prior EPA determinations or guidance.
We retain the right, as provided by CAA section 111(c)(2), to enforce any applicable emission standard or requirement under section 111.
We retain the right, as provided by CAA section 112(l)(7) and 40 CFR 63.90(d)(2), to enforce any applicable emission standard or requirement under section 112. In addition, the EPA may enforce any federally approved State rule, requirement, or program under 40 CFR 63.90(e) and 63.91(c)(1)(i). The EPA also has the authority to make decisions under the General Provisions (subpart A) of parts 61 and 63. We are delegating to NMED some of these authorities, and retaining others, as explained in sections V and VI above. In addition, the EPA may review and disapprove State determinations and subsequently require corrections.
Furthermore, we retain any authority in an individual emission standard that may not be delegated according to provisions of the standard. Also, listed in footnote 2 of the part 63 delegation table at the end of this rule are the authorities that cannot be delegated to any State or local agency which we therefore retain.
Finally, we retain the authorities stated in the original delegation agreement.
NMED must provide any additional compliance related information to EPA, Region 6, Office of Enforcement and Compliance Assurance, within 45 days of a request under 40 CFR 63.96(a). In receiving delegation for specific General Provisions authorities, NMED must submit to EPA Region 6, on a semi-annual basis, copies of determinations issued under these authorities.
The EPA oversees NMED's decisions to ensure the delegated authorities are being adequately implemented and enforced. We will integrate oversight of the delegated authorities into the existing mechanisms and resources for oversight currently in place. If, during oversight, we determine that NMED made decisions that decreased the stringency of the delegated standards, then NMED shall be required to take corrective actions and the source(s) affected by the decisions will be notified.
Sources located outside the boundaries of Bernalillo County and outside of Indian country should submit all information required pursuant to the delegated authorities in the Federal NSPS and NESHAP (40 CFR parts 60, 61 and 63) directly to the NMED at the following address: New Mexico Environment Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469. The NMED is the primary point of contact with respect to delegated NSPS and NESHAP authorities. Sources do not need to send a copy to the EPA. The EPA Region 6 waives the requirement that notifications and reports for delegated authorities be submitted to the EPA in addition to NMED in accordance with 40 CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).
In the future, NMED will only need to send a letter of request to update their delegation to EPA, Region 6, for those NSPS which they have adopted by reference. The EPA will amend the relevant portions of the Code of Federal Regulations showing which NSPS standards have been delegated to NMED. Also, in the future, NMED will only need to send a letter of request for approval to EPA, Region 6, for those NESHAP regulations that NMED has adopted by reference. The letter must reference the previous up-front approval demonstration and reaffirm that it still meets the up-front approval criteria. We will respond in writing to the request stating that the request for delegation is either granted or denied. A
We are approving the request by the NMED for the updated delegation of certain NSPS to NMED, and taking final action to approve the delegation of certain NESHAP to NMED, for all sources (both Title V and non-Title V sources). These updated regulations apply to certain NSPS promulgated by the EPA at 40 CFR part 60, as amended between September 24, 2013 and January 15, 2017; certain NESHAP promulgated by the EPA at 40 CFR part 61, as amended between January 1, 2011 and January 15, 2017; and other NESHAP promulgated by the EPA at 40 CFR part 63, as amended between August 30, 2013 and January 15, 2017, as adopted by the NMED (
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
The delegation is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state request to receive delegation of certain Federal standards, and does not alter the relationship or the distribution of power and
In reviewing delegation submissions, EPA's role is to approve submissions, provided that they meet the criteria of the Clean Air Act. This action is not subject to the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Arsenic, Benzene, Beryllium, Hazardous substances, Intergovernmental relations, Mercury, Reporting and recordkeeping requirements, Vinyl chloride.
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
40 CFR parts 60, 61, and 63 are amended as follows:
42 U.S.C. 7401
(b) * * *
(33) State of New Mexico: New Mexico Environment Department, P.O. Box 5469, Santa Fe, New Mexico 87502-5469. Note: For a list of delegated standards for New Mexico (excluding Bernalillo County and Indian country), see paragraph (e)(1) of this section.
(e) * * *
(1)
42 U.S.C. 7401
(b) * * *
(33)
(c) * * *
(6) * * *
(iii)
42 U.S.C. 7401
(a) * * *
(32) * * *
(i) The following table lists the specific part 63 standards that have been delegated unchanged to the New Mexico Environment Department for all sources. The “X” symbol is used to indicate each subpart that has been delegated. The delegations are subject to all of the conditions and limitations set forth in Federal law and regulations. Some authorities cannot be delegated and are retained by the EPA. These include certain General Provisions authorities and specific parts of some standards. Any amendments made to these rules after January 15, 2017 are not delegated.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of
This regulation is effective September 12, 2018. Objections and requests for hearings must be received on or before November 13, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) EPA-HQ-OPP-2017-0705, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID EPA-HQ-OPP-2017-0705 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0705, by one of the following methods:
•
•
•
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.”
EPA evaluated the available toxicological and exposure data on
The available data demonstrated that
Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of
An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR
This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Residues of
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) Region 1 announces the deletion of the Old Southington Landfill Superfund Site (Site) located in Southington, Connecticut, from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Connecticut, through the Connecticut Department of Energy and Environmental Protection (CTDEEP), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.
This action is effective September 12, 2018.
U.S. EPA Region 1—New England, Superfund Records Center, 5 Post Office Square, Suite 100, Boston, MA 02109, Phone: 617-918-1440,
Southington Public Library, 255 Main Street, Southington, CT, Phone: 860-628-0947,
Almerinda Silva, Remedial Project Manager, U.S. Environmental Protection Agency, Region I, OSRR 07-4, 5 Post Office Square, Boston, MA 02109-3912. Telephone (617) 918-1246, Email
The site to be deleted from the NPL is: the Old Southington Landfill Superfund Site located at Old Turnpike Road, Southington, Connecticut. A Notice of Intent to Delete for this Site was published in the
The closing date for comments on the Notice of Intent to Delete was August 20, 2018. No public comments were received. Therefore, a responsiveness summary was not prepared and not placed in the docket, EPA-HQ-SFUND-2005-0011, on
EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.
Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, and Water supply.
For reasons set out in the preamble, 40 CFR part 300 is amended as follows:
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for yellowfin sole in the Bering Sea and Aleutian Islands management area (BSAI) for vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2018 allocation of yellowfin sole total allowable catch for vessels participating in the BSAI trawl limited access fishery in the BSAI.
Effective 1200 hrs, Alaska local time (A.l.t.), September 7, 2018, through 2400 hrs, A.l.t., December 31, 2018.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2018 allocation of yellowfin sole total allowable catch for vessels participating in the BSAI trawl limited access fishery in the BSAI is 18,351 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 allocation of yellowfin sole total allowable catch allocated as a directed fishing allowance for vessels participating in the BSAI trawl limited access fishery in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for yellowfin sole for vessels participating in the BSAI trawl limited access fishery in the BSAI.
While this closure remains in effect, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for yellowfin sole by vessels fishing in the BSAI trawl limited access fishery in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 6, 2018.
The acting AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would implement a recommendation from the Processed Pear Committee (Committee) to decrease the assessment rate established for “summer/fall” varieties of pears for canning for the 2018-2019 and subsequent fiscal periods. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Comments must be received by October 12, 2018.
Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Dale Novotny, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email:
This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927, (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers, handlers, and processors operating within the area of production, and a public member.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This proposed rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled ‘Reducing Regulation and Controlling Regulatory Costs’ ” (February 2, 2017).
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate would be applicable to all assessable “summer/fall” varieties of pears specifically used for canning for the 2018-2019 fiscal period, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The Committee members are familiar with the Committee's needs and with the costs of goods and services in their local area and are in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting where all directly affected persons have an opportunity to participate and provide input.
This proposed rule would decrease the assessment rate from $8.00, the rate that was established for the 2017-2018 and subsequent fiscal periods, to $7.15 per ton of “summer/fall” varieties of pears for canning handled for the 2018-2019 and subsequent fiscal periods. The assessment rate for “winter” and “other” pears for processing would remain unchanged at $0.00. The Committee met on May 30, 2018, and unanimously recommended 2018-2019 fiscal period expenditures of $693,472. In comparison, last year's budgeted expenditures were $800,150. The Committee also unanimously recommended an assessment rate of $7.15 per ton of “summer/fall” varieties
The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850; respectively.
The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments, and the amount of funds available in the authorized reserve. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the proposed $7.15 per ton should provide handler assessments of $715,000. This amount would be adequate to cover budgeted expenses of $693,472, with any excess funds used to make a small contribution to the Committee's monetary reserve. Funds in the reserve (currently $497,565) would be kept within the maximum permitted by § 927.42(a) of approximately one fiscal period's expenses.
The assessment rate proposed in this rule would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee, or other available information.
Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's budget for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 1,500 growers of pears for processing in the production area and approximately 43 handlers of processed pears subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to data from USDA National Agricultural Statistics Service (NASS), the Committee, and the industry for the 2016-2017 season (the most recent complete season of record) the average f.o.b. price for Oregon-Washington processed Bartlett pears (the only variety used for canning in the production area) was approximately $390.50 per ton. Total shipments for that period were approximately 103,020 tons. Using the number of handlers, and assuming a normal distribution, the majority of handlers would have average annual receipts of less than $7,500,000 ($390.50 per ton times 103,020 tons equals $40,229,310 divided by 43 handlers equals $935,565 per handler).
In addition, based on data from the Committee, the industry produced 103,020 tons of processed pears in the production area during the 2016-2017 season, with an average grower price of $360 per ton. Based on the average grower price, production, and the total number of Oregon-Washington processed pear growers reported by the Committee (1,500), and assuming a normal distribution, the average annual grower revenue is below $750,000 ($360 per ton times 103,020 tons equals $37,087,200 divided by 1,500 growers equals $24,725 per grower). Thus, the majority of Oregon and Washington processed pear handlers and growers may be classified as small entities.
This proposal would decrease the assessment rate collected from handlers for the 2018-2019 and subsequent fiscal periods from $8.00 per ton to $7.15 per ton of Oregon and Washington “summer/fall” pears for canning handled. The Committee unanimously recommended 2018-2019 fiscal period expenditures of $693,472 and the $7.15 per ton assessment rate. The proposed assessment rate of $7.15 per ton is $0.85 lower than the rate in effect for the 2017-2018 fiscal period. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the proposed $7.15 per ton rate should provide $715,000 in assessment income. Income derived from handler assessments should be adequate to cover budgeted expenses, with any excess funds to be carried over in the Committee's monetary reserve to be used in subsequent years.
The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850, respectively.
The proposed lower assessment rate is necessary to balance assessment revenue with the Committee's 2018-2019 fiscal period budgeted expenditures and to maintain its monetary reserve at levels authorized in the Order.
Prior to arriving at this budget and assessment rate, the Committee considered the benefits and costs related to maintaining the current assessment rate of $8.00 per ton and establishing other assessment rates. However, leaving the assessment rate unchanged would generate more revenue than required to meet the Committee's 2018-2019 fiscal period budgeted expenses of $693,472, and would add a large amount of excess funds to the Committee's already sufficient monetary reserve. Based on estimated shipments, the recommended assessment rate of $7.15 per ton should provide $715,000 in assessment income. The Committee determined assessment revenue would be adequate to fully cover budgeted expenditures for the 2018-2019 fiscal period, with a small amount of excess funds to be added to the Committee's monetary reserve. Reserve funds would
A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2018-2019 season should be approximately $296 per ton of pears for processing. Therefore, the estimated assessment revenue for the 2018-2019 fiscal period as a percentage of total grower revenue would be about 2.4 percent ($7.15 per ton assessment divided by $296 per ton grower price).
This proposed action would decrease the assessment obligation imposed on handlers for the 2018-2019 and subsequent fiscal periods. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate would reduce the burden on handlers, and may reduce the burden on producers.
The Committee's meetings were widely publicized throughout the Oregon and Washington processed pear industry. All interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the May 30, 2018, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189. No changes in those requirements would be necessary because of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Oregon and Washington processed pear handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
Marketing agreements, Pears, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 927 is proposed to be amended as follows:
7 U.S.C. 601-674.
On and after July 1, 2018, the following base rates of assessment for pears for processing are established for the Processed Pear Committee:
(a) $7.15 per ton for any or all varieties or subvarieties of pears for canning classified as “summer/fall” excluding pears for other methods of processing;
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to repeal a regulation that requires an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation would mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is proposing to take this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation for sterilization of drugs is now well understood, and our regulations require that OTC drugs be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Submit either electronic or written comments on the proposed rule by November 13, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2018. The
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Sudha Shukla, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5198, Silver Spring, MD 20993-0002, 301-796-3345.
This proposed rule would repeal the irradiation regulation, which provides that any drug sterilized by irradiation is a new drug. This action, if finalized, would mean that OTC drugs marketed pursuant to the OTC Drug Review that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an FDA-approved NDA or ANDA, even if the drugs are sterilized by irradiation. FDA is taking this action because the Agency no longer concludes that drugs sterilized by irradiation are necessarily new drugs. The technology of controlled nuclear radiation for sterilization of drugs is now well understood. In addition, drugs that are marketed pursuant to the OTC Drug Review must be manufactured in compliance with CGMPs. Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. Repealing the irradiation regulation would eliminate a requirement that is no longer necessary, and will not diminish public health protections.
The estimated one-time costs of this rule range from $120 to $150. Avoiding the unnecessary preparation and review of a premarket drug application will generate an estimated one-time cost savings that range from about $395,000 to $2,076,000. Over 10 years with a 7 percent discount rate, the annualized net cost savings range from $0.05 million to $0.28 million, with a primary estimate of $0.06 million; with a 3 percent discount rate, the annualized net cost savings range from $0.04 million to $0.24 million, with a primary estimate of $0.05 million. Over an infinite horizon, we assume that one sponsor will benefit from this deregulatory action every 10 years; the present value of the net cost savings over the infinite horizon range from $0.83 million to $4.37 million with a 7 percent discount rate and from $1.58 million to $8.30 million with a 3 percent discount rate.
On February 24, 2017, E.O. 13777, “Enforcing the Regulatory Reform Agenda” (
In addition, in a citizen petition dated August 14, 2014, Richard O. Wood of The Wood Burditt Group LLC requested that the irradiation regulation be revoked. FDA has responded to Mr. Wood's citizen petition. A copy of the response is available at:
In the November 29, 1955, issue of the
In 1996, FDA proposed to revise the statement and consolidate it with similar provisions into a single list of drugs that have been determined by previous rulemaking procedures to be new drugs within the meaning of section 201(p) of the FD&C Act (61 FR 29502 at 29503 to 29504 (June 11, 1996)). The Agency proposed to remove any existing background information describing the Agency's basis for determination of new drug status from the regulatory text.
In 1997, FDA finalized these provisions, now located in 21 CFR 310.502, entitled “Certain drugs accorded new drug status through rulemaking procedures.” (62 FR 12084 at 12084 (March 14, 1997).) Paragraph 310.502(a) sets forth a list of drugs that have been determined by rulemaking procedures to be “new drugs” within the meaning of section 201(p) of the FD&C Act. Included on the list is sterilization of drugs by irradiation (§ 310.502(a)(11) (21 CFR 310.502(a)(11)). Because this regulation reflects an FDA determination that the drugs on the list are “new drugs,” an NDA or ANDA must be submitted and approved by FDA before they can be marketed legally. For a non-prescription drug that could otherwise be legally marketed without an approved NDA or ANDA in effect pursuant to the OTC Drug Review, the effect of § 310.502(a)(11) is that, if the drug is sterilized by irradiation, an approved NDA or ANDA is necessary.
Since the paragraph now reflected at § 310.502(a)(11) was published in 1955, the technology of controlled nuclear radiation for sterilization of drugs has become well understood. Gamma ray irradiation has been recognized as a method of sterilizing drug products for half a century (Refs. 1 and 2). Electron beam and x-ray irradiation are also recognized methods for sterilizing drugs (Ref. 1).
Information and data on whether a particular drug can safely and effectively be sterilized by irradiation are available in the scientific literature (Ref. 1). The United States Pharmacopeial Convention (USP) has provided guidance on irradiation sterilization of drug products since 1965 (Refs. 1 and 3). This includes chapter <1229> on “Sterilization of Compendial Articles,” which sets forth principles that may be applied to the sterilization of compendial and non-compendial drug products, and chapter <1229.10> on “Radiation Sterilization,” which sets forth guidelines on validation of sterilization by irradiation (Refs. 3 and 4). The American National Standards Institute, the Association for the Advancement of Medical Instrumentation, ASTM International, and the International Organization for Standardization (ISO) have also published standards on the irradiation of medical products, including drugs (Ref. 1). ISO standard 11137, which sets forth several methods that can be used to determine the appropriate radiation dose for health care products, was first published in 1984
USP chapter <1229.10> states that the methods set forth in ISO 11137 typically guide the choice of radiation dose (Ref. 3). Relevant factors include a drug's pre-sterilization level of microbial contamination (sometimes referred to as its bioburden) and the desired sterility assurance level (Ref. 1). Once the dose is selected, USP General Chapter <1229.10> states that all materials exposed to radiation, especially the drug product and its primary container, should be evaluated for immediate and long-term effects, and “[p]roduct stability, safety, and functionality should be confirmed over the product's intended use period” (Ref. 3). Among the advantages of sterilizing drug products by irradiation is that due to radiation's high penetrability, drug products can be irradiated after they are placed in their final containers (Ref. 1). Known as terminal sterilization, this provides a greater degree of sterilization assurance than aseptic processing and, where feasible, its use is preferable to relying solely on aseptic processing to ensure sterility (Ref. 5). Other advantages to irradiation sterilization of drugs include low chemical reactivity; the very low rise in temperature associated with radiation, which allows for its use on heat-sensitive products; that irradiation sterilization has fewer process variables than other methods, which translates into fewer sterility rejections; and that radiation does not leave behind any sterilant residuals (Refs. 1 and 6).
The OTC Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. As set forth in 21 CFR 330.10, it is a multiphase public rulemaking process (each phase requiring a
In 1955, when the determination with respect to drugs sterilized by irradiation (now reflected in § 310.502(a)(11)) was made, neither the OTC drug monograph system nor the CGMP requirements existed. The authorizing legislation that the CGMP regulations implement, section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), was enacted in 1962 (
CGMP regulations require manufacturers to take steps to ensure that sterile drug products are free of objectionable microorganisms. (See,
Numerous records relating to the manufacture of the drug product must be maintained and made available for inspection (21 CFR part 211, subpart J). FDA conducts inspections at manufacturing facilities, including irradiation facilities, to ensure that the CGMP regulations are followed. Inspection findings are reviewed and, when appropriate, action may be recommended against manufacturers observed to be out of compliance.
Choosing the sterilization process that is suitable for a particular drug product is the responsibility of the manufacturer and is an important part of pharmaceutical development. To guide them in choosing an appropriate method of sterilization and otherwise complying with the CGMP requirements, manufacturers can turn to voluntary consensus standards that are widely-known by industry and recognized by FDA for the development, validation, and routine control of the sterilization of drugs by irradiation. As noted previously in this document, ISO publishes standards that address the different doses of radiation that are appropriate depending on the type and amount of microbiological contamination and the necessary degree of sterility assurance (Ref. 3). These include the following:
• ISO 11137-1:2006: Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices;
• ISO 11137-2:2013: Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose;
• ISO 11137-3:2006: Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects; and
• ISO/TS 13004:2013: Sterilization of health care products—Substantiation of selected sterilization dose: Method VDmaxSD.
• The USP also provides guidance on irradiation sterilization, including in chapter <1229.10>, which specifically addresses the topic (Ref. 3).
We propose the repeal of § 310.502(a)(11) because the Agency no longer concludes that drugs sterilized by irradiation are necessarily new drugs. The technology of controlled nuclear radiation for sterilization of drugs is now well understood and sterilization is a manufacturing process that is adequately addressed by the regulations governing the OTC drug monograph system and CGMPs.
FDA is issuing this proposed rule under the drugs and general administrative provisions of the FD&C Act (sections 201, 301, 501, 502, 503, 505, 510, 701, 702, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, 372, and 374)) and under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). The FD&C Act gives us the authority to issue and enforce regulations designed to help ensure that drug products are safe, effective, and manufactured according to current good manufacturing practices, while section 361 of the PHS Act gives us the authority to issue and enforce regulations designed to prevent the introduction, transmission, or spread of communicable diseases.
Any final rule that results from this proposed rule will be effective 30 days after the date of the final rule's publication in the
We have examined the impacts of the proposed rule under E.O. 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). E.O. 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this proposed rule is not a significant regulatory action as defined by E.O. 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because few entities will be affected and the net effect will be cost savings to affected firms, we propose to certify that the proposed rule, if finalized, will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after
Table 1 summarizes our estimate of the annualized costs and benefits of the proposed rule.
Because the proposed rule will repeal an outdated regulation and generate net cost savings, we consider this action a deregulatory action under E.O. 13771. Table 2 presents a summary of the E.O. 13771 impacts of the proposed rule over an infinite horizon. For this estimate, we assume that one sponsor will benefit from this deregulatory action every 10 years.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 8) and at:
We have determined under 21 CFR 25.30(h) and 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information resulting from compliance with CGMPs have been
We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the E.O. and, consequently, a federalism summary impact statement is not required.
We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
The following references are on display in the Dockets Management Staff (see
Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 310 be amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-1; 42 U.S.C. 216, 241, 242(a), 262.
(a) The drugs listed in this paragraph have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs:
(11) [Reserved]
Environmental Protection Agency (EPA).
Proposed rule and request for comment.
The Environmental Protection Agency (also, “the Agency” or “we” in this preamble) is proposing to grant a petition submitted by Sandvik Special Metals (Sandvik), in Kennewick, Washington to exclude (or “delist”) up to 1,500 cubic yards of F006 wastewater treatment sludge per year from the list of federal hazardous wastes.
The Agency is proposing to grant the petition based on an evaluation of waste-specific information provided by Sandvik. This proposed decision, if finalized, conditionally excludes the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act.
We conclude that Sandvik's petitioned waste is nonhazardous with respect to the original federal listing criteria and that there are no other factors (including additional constituents) other than those for which the waste was listed that would warrant retaining the waste as a hazardous waste. Subject to state-only requirements within the state of Washington, or federally-authorized or state-only requirements in other states where the subject wastes may be disposed of, Sandvik's petitioned waste may be disposed of in a Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial solid waste.
Comments must be received on or before October 12, 2018. Requests for an informal hearing must reach the EPA by September 27, 2018.
Submit your comments, identified by Docket ID No. EPA-R10-RCRA-2018-0538 by one of the following methods:
•
•
•
Any person may request an informal hearing on this proposed decision by filing a request with Timothy Hamlin, Director, Office of Air and Waste, EPA, Region 10, 1200 6th Ave., Suite 155, OAW-150, Seattle, Washington 98101. The request must contain the information prescribed in 40 Code of Federal Regulations CFR 260.20(d).
Dr. David Bartus, EPA, Region 10, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98070; telephone number: (206) 553-2804; fax number (206) 553-8509; email address:
As discussed in Section V below, the Washington State Department of Ecology is evaluating Sandvik's petition under state authority. Information on Ecology's action may be found at
The information in this section is organized as follows:
The EPA is proposing to grant the petition submitted by Sandvik Special Metals (Sandvik) located in Kennewick, Washington to exclude or delist an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludge from the lists of hazardous waste set forth in 40 Code of Federal Regulations CFR 261.31. Sandvik claims that the petitioned waste does not meet the criteria for which the EPA listed it, and that there are no additional constituents or factors which could cause the waste to be hazardous.
Based on our review described in section III, we agree with the petitioner that the waste is nonhazardous. We reviewed the description of the process which generates the waste and the analytical data submitted by Sandvik. We believe that the petitioned waste does not meet the criteria for which the waste was listed, and that there are no other factors which might cause the waste to be hazardous.
The EPA published an amended list of hazardous wastes from nonspecific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing § 3001 of Resource Conservation and Recovery Act (RCRA). The EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.
We list these wastes as hazardous because: (1) They typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in subpart C of part 261 (that is, ignitability, corrosivity, reactivity, and toxicity) or (2) they meet the criteria for listing contained in § 261.11(a)(2) or (3).
Individual waste streams may vary depending on raw materials, industrial processes, and other factors. Thus, while a waste described in the regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be hazardous.
A procedure to exclude or delist a waste is provided in 40 CFR 260.20 and 260.22 which allows a person or a facility to submit a petition to the EPA or to an authorized state demonstrating
In a delisting petition, the petitioner must show that a waste does not meet any of the criteria for listed wastes in 40 CFR 261.11 and that the waste does not exhibit any of the hazardous waste characteristics of ignitability, reactivity, corrosivity, or toxicity. The petitioner must present sufficient information for us to decide whether any factors in addition to those for which the waste was listed warrant retaining it as a hazardous waste. (See § 260.22, 42 U.S.C. 6921(f) and the background documents for the listed wastes.)
If a delisting petition is granted, the generator remains obligated under RCRA to confirm that the waste remains nonhazardous according to the conditions of the delisting.
In reviewing this petition, we considered the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA). See § 222 of HSWA, 42 U.S.C. 6921(f), and 40 CFR 260.22(d)(2)-(4). We evaluated the petitioned waste against the listing criteria and factors cited in § 261.11(a)(2) and (3).
Besides considering the criteria in 40 CFR 260.22(a), 261.11(a)(2) and (3), 42 U.S.C. 6921(f), and in the background documents for the listed wastes, the EPA must consider any factors (including additional constituents) other than those for which we listed the waste if these additional factors could cause the waste to be hazardous.
Our proposed decision to grant the petition to delist the waste from Sandvik's Kennewick, Washington facility is based on our evaluation of the waste for factors or criteria which could cause the waste to be hazardous. These factors included: (1) Whether the waste is considered acutely toxic; (2) the toxicity of the constituents; (3) the concentration of the constituents in the waste; (4) the tendency of the constituents to migrate and to bioaccumulate; (5) the persistence in the environment of any constituents once released from the waste; (6) plausible and specific types of management of the petitioned waste; (7) the quantity of waste produced; and (8) waste variability.
The EPA must also consider as hazardous wastes mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste. See 40 CFR 261.3(a)(2)(iv) and (c)(2)(i), called the “mixture” and “derived-from” rules, respectively. Mixture and derived-from wastes are also eligible for exclusion but remain hazardous until excluded.
On April 27, 2018, Sandvik petitioned the EPA to exclude an annual volume of up to 1,500 cubic yards of F006 wastewater treatment sludges generated at its facility located in Kennewick, Washington from the list of hazardous wastes contained in 40 CFR 261.31. F006 is defined in § 261.31 as “Wastewater treatment sludges from electroplating operations . . .” Sandvik claims that the petitioned waste does not meet the criteria for which F006 was listed (
Sandvik Special Metals fabricates specialty titanium and zirconium tubing for the aeronautical, medical and nuclear industries. The filter cake waste material that is the subject of this delisting action is the combined end waste from the wastewater treatment facility (WWTF) that manages F006 chemical etching wastes, and a separate coolant process waste stream associated with Sandvik's manufacturing process. A detailed description of the processes which contribute to the filter cake, including the wastewater treatment and the manufacturing processes, associated alloys and process materials, is provided below.
Titanium and zirconium alloys are the main raw materials for the manufacturing process, with titanium being used for most products and zirconium being used only on special orders for the nuclear industry. In recent years, zirconium accounted for less than one percent of the total production, however, zirconium has accounted for up to 10 to 20 percent of the production volume historically. The manufacturing processes meet strict industry standards for Sandvik customers and are consistent at the Kennewick facility.
The standard tube making process for titanium (Ti) and zirconium (Zr) alloyed tubing includes three main steps. See Figure 1 in Sandvik's delisting petition. The alloys used in the process arrive at the Kennewick facility in the form of large diameter rough tubing (either extrusions or Trex [which is an extrusion that has been reduced once]) from one of two suppliers, Sandvik SZ in Sweden or ATI in Oregon. In the first tube-making process, the extrusions or Trex go through multiple cold pilger steps to reduce the diameter size of the tubing into seamless hollow metal tubing. The cold pilgering process uses roll dies (presses) and a tapered mandrel (the rod that supports the inside of the tube during formation) to reduce the size of the tubing cross section. A fatty acid coolant/lubricant is used to manage heat generation during the process. The number of cold pilgering steps is dependent on the available starting materials and final tube size. After each cold pilger step, the interior of the tube is cleaned in a hot alkaline solution to remove the fatty acid coolant/lubricant used in the forming process, resulting in the generation of an alkaline rinsing solution that is discharged to the WWTF and a small amount of used fatty acid coolant/lubricant, which is pumped to an underground storage tank and then batch transferred to the WWTF.
The second step in the tube forming process is a high temperature anneal step performed to relieve stress on the metal that can make it brittle after cold forming. Annealing also improves the homogeneity of the metal and can improve the ductile and toughness properties. No waste is generated during the annealing process.
During the third step, after annealing, the hollows, or final tubes are rotary straightened and cleaned in the hot alkaline solution again to remove the straightening lubrication. The cleaned hollows are open dip etched in an acidic solution to remove a small amount of metal from both the outer diameter (OD) and inner diameter (ID) surfaces. The acidic waste and rinse water from the hollow etch process is discharged to the WWTF. This acid etch step is the basis for application of the F006 listing to Sandvik's WWTF sludge, as discussed in the following section.
If the next pass is to produce a smaller OD or thinner wall hollow, the above three-step process is repeated until the desired sizing is accomplished resulting in a final tube.
The listing definition for F006 waste at 40 CFR 261.31 states that the source definition of F006 wastes include:
Wastewater treatment sludges from electroplating operations except from the following processes: (1) Sulfuric acid anodizing of aluminum; (2) tin plating on carbon steel; (3) zinc plating (segregated basis) on carbon steel; (4) aluminum or zinc-aluminum plating on carbon steel; (5) cleaning/stripping associated with tin, zinc and aluminum plating on carbon steel; and (6) chemical etching and milling of aluminum.
The EPA promulgated an interpretive rule (51 FR 43350 (December 2, 1986)) clarifying the scope of the EPA Hazardous Waste No. F006 contained in the list of hazardous wastes from non-specific sources of Subpart D of Part 261. This interpretive rule established that:
The F006 listing is (and always has been) therefore, inclusive of wastewater treatment sludges from only the following processes: (1) Common and precious metals electroplating, except tin, zinc (segregated basis), aluminum, and zinc-aluminum plating on carbon steel; (2) anodizing, except sulfuric acid anodizing of aluminum; (3) chemical etching and milling, except when performed on aluminum; and (4) cleaning and stripping, except when associated with tin, zinc, and aluminum plating on carbon steel.
Because the Sandvik production process that results in generation of the candidate WWTF sludge includes chemical etching other than that performed on aluminum, Sandvik's WWTF sludge meets the definition of F006 listed waste.
Sandvik conducted a detailed chemical analysis of their WWTF sludge according to a written sampling and analysis plan (SAP), provided as Attachment 2 to the delisting petition. This SAP included the following key elements:
• A description of the manufacturing and wastewater treatment processes relevant to the petitioned waste;
• An initial identification of Constituents of Potential Concern (COPCs) potentially present in the petitioned waste based on manufacturing and wastewater treatment processes;
• Development of sampling strategies to address variations and periodic fluctuations in the manufacturing and wastewater treatment processes, including obtaining representative samples to account for variations of alloys used in the manufacturing process and addition of coolant/lubricant into the filter cake.
• The proposed methodology for evaluating the resulting data with respect to anticipated delisting decision criteria; and
• A Quality Assurance Project Plan (QAPP) documenting the required quality and quantity of the data necessary for decisions based on them to be within an acceptable degree of uncertainty.
Sandvik's SAP identified an initial list of COPCs based on a consideration of constituents included in the F006 hazardous waste listing and present in the manufacturing and wastewater treatment materials and processes. See Section 2 and Table 5 of Attachment 2 in Sandvik's delisting petition. Additionally, the list of COPCs included impurities and other constituents listed in the alloys and in the process and wastewater treatment chemical Safety Data Sheets (SDS).
• Constituent for which F006 was listed (40 CFR part 261 Appendix VII; WAC 173-303-082) or listed as a Land Disposal Restriction (LDR) constituent subject to treatment for F006 or identified as a constituent for which an LDR Universal Treatment Standard has been established (40 CFR 268.40 and 268.48; WAC 173-303-140) with the exception of cyanide. Cyanide was not retained as a COPC because there is no documented use of cyanide at the Kennewick facility and it was not detected in historical filter cake samples.
• Constituent has been historically detected in filter cake and was present on the Toxicity Characteristics List (40 CFR 261.24; WAC 173-303-090 Part 8), Hazardous Constituents List (40 CFR part 261 Appendix VIII; WAC 173-303-9905), and/or Groundwater Monitoring List (40 CFR part 264 Appendix IX; WAC 173-303-110(7)).
• According to the alloy composition, constituent could potentially be present in the filter cake and is listed on the Toxicity Characteristics List (40 CFR 261.24; WAC 173-303-090(8)), Hazardous Constituents List (40 CFR part 261 Appendix VIII; WAC 173-303-9905), and/or the Groundwater Monitoring List (40 CFR part 264 Appendix IX; WAC 173-303-110 Part 7).
A constituent was not retained as a COPC if it was not:
• Listed on potentially relevant regulatory lists; or
• There was no documented Kennewick facility use of the constituent, or it was a minor constituent in wastewater treatment material, not detected in historical filter cake samples, or converted to another COPC in the wastewater treatment process (
Based on this analysis, Sandvik's SAP proposed the following list of COPCs: Arsenic; Barium; Cadmium; Chromium (including hexavalent chromium); Cobalt; Copper; Fluoride;
The objectives of the waste characterization sampling conducted by Sandvik were as follows:
• To supplement the existing historical data set with total and TCLP data for the identified COPCs;
• To collect samples that are representative of process variations that include processing of two different alloy materials (titanium and zirconium) and the periodic addition of the waste coolant/lubricant to the filter cake waste;
• To assess acute toxicity effects of wastes in accordance with the Washington State Department of Ecology's 80-12, Part A protocol,
• To generate a representative data set that can be used in the Delisting Risk Assessment Software (DRAS) modeling.
To achieve these objectives, Sandvik collected six (6) representative samples over three (3) sampling events that included the following scope of work:
• Each event included the collection of one filter cake sample with the used
• Since titanium raw materials are present at higher weight composition percentages than zirconium, four filter cake samples (two with coolant and two without coolant) events were obtained when only titanium alloys were being run in the manufacturing process; and
• To account for the use of zirconium, two samples (one with coolant and one without coolant) were obtained while zirconium alloys were also being run in the manufacturing process in addition to titanium alloys.
All samples were analyzed for total and TCLP COPCs, where applicable. If chromium was detected at a concentration above the laboratory practical quantitation limit (PQL), a sample from the same sampling event was analyzed for hexavalent chromium. If chromium was not detected above the PQL, no additional testing was performed. This approach to sampling for chromium was used for both total and TCLP sampling.
One sample with the coolant/lubricant and one sample without the coolant/lubricant was analyzed to assess acute toxicity via bioassay as part of the first titanium-only sampling events. This combination of the filter cake production characteristics is expected to be the most conservative choice for bioassay testing, given the higher number of impurities in the titanium alloy. Additional details of Sandvik's waste characterization sampling activities are provided in Attachment 2 to the delisting petition.
Sandvik provided results of their waste characterization activities in Attachment 3 to the delisting petition entitled “Sampling Results and Data Evaluation Report.” As part of its overall delisting petition submission, Sandvik submitted a signed statement certifying that information in the petition, including their submission of waste characterization data and description of the associated sampling and analysis activities, is true, accurate and complete, and the responsibilities of the signatory of the delisting petition. See 40 CFR 260.22(i)(12).
Sandvik conducted its first sampling event on July 31, 2017, followed by two additional sampling events on August 31 and September 25, 2017. Two representative samples of the WWTF filter cake were collected during each event, one with the used coolant/lubricant waste stream and one without, for a total of six filter cake samples. Of these six samples, four were collected when only titanium alloys were being run in the manufacturing process, and two when zirconium was also being run. Each sample was a composite sample collected from four separate locations within each filter cake collection bin used to collect the filter cake following the filter press. Sandvik's delisting petition states that according to facility representatives, the filter cake generation durations and resulting volumes within the filter press during each sampling event were typical for facility operations. Additional details of Sandvik's waste characterization sampling activities can be found in Section 3 of the SAP (Attachment 2 of the delisting petition).
Sandvik performed a quality assurance/quality control review of each laboratory report, with complete results of the data validation review detailed in Appendix C of the SAP. While this review identified one constituent (arsenic) from one sampling round where the data do not fully satisfy the data quality objectives set forth in Sandvik's quality control standards, Sandvik concludes that the data are nevertheless generally suitable for their intended decision-making function. This constituent and sampling round are discussed further below.
Based on the results of filter cake characterization sampling, Sandvik concluded that all constituents other than hexavalent chromium should be retained as constituents of concern for further evaluation. Sandvik's deletion of hexavalent chromium from the list of COPCs is based on hexavalent chromium not being detected in any of the filter cake total or TCLP analysis according to the sampling methodology described above.
Sandvik compared their 2017 waste characterization sampling results to historical total and TCLP results available for several of the COPCs. The range of recent COPC results was consistent with historical results except for fluoride. Historical total fluoride concentrations of 67,500 mg/kg and 42,000 mg/kg from 1991 and 1997, respectively, were several orders of magnitude higher than recent concentrations; the highest recent concentration was 907 mg/kg. Sandvik indicates that it has progressively reduced the amount of etching in its process at the Kennewick facility, which would result in a decline in hydrofluoric acid use and fluoride in the filter cake. In addition, the collection method of the historical samples as well as the production and wastewater treatment system operations at the time of historical sampling are unknown. As a result, the 2017 samples are considered to be more representative of typical conditions for fluoride for current and future operations at the Kennewick facility.
Overall, totals concentrations from the three 2017 sampling events were within the range of historical results. In addition to fluoride, as discussed in the previous paragraph, one 2017 maximum nickel sample (425 mg/kg) exceeded the historical maximum nickel sample of 392 mg/kg. The 2017 totals samples also exceeded historical maximum concentrations for arsenic, barium, chromium, and silver, but none of these constituents had a difference of more than one order of magnitude between the 2017 and historic samples. Because most historical concentrations are from 20 or more years ago and production and collection methods are unknown, the 2017 COPC results obtained from implementation of the SAP were considered more reliable and used for the subsequent data evaluation.
Sandvik also compared the 2017 waste characterization sampling result to the toxicity characteristic (TC) regulatory standard for those waste constituents for which regulatory standards have been established. Based on this comparison, Sandvik concluded that the candidate wastes do not exhibit the toxicity characteristic. Although Sandvik did not explicitly evaluate their candidate wastes for the characteristics of ignitability, reactivity or corrosivity, the EPA agrees that process knowledge provides an adequate demonstration that the wastes in question do not exhibit the enumerated characteristics.
For this delisting determination, we assumed that the waste would be disposed in a Subtitle D landfill and we considered transport of waste constituents through ground water, surface water and air. We evaluated Sandvik's analysis of petitioned waste using the Agency's Delisting Risk Assessment Software (DRAS) to predict the concentration of hazardous constituents that might be released from the petitioned waste and to determine if the waste would pose a threat to human health and the environment. The DRAS software and associated documentation can be found at
To predict the potential for release to groundwater from landfilled wastes and subsequent routes of exposure to a receptor, the DRAS uses dilution attenuation factors derived from the EPA's Composite Model for leachate migration with Transformation Products. From a release to ground water, the DRAS considers routes of exposure to a human receptor of ingestion of contaminated groundwater, inhalation from groundwater while showering and dermal contact from groundwater while bathing.
From a release to surface water by erosion of waste from an open landfill into storm water run-off, DRAS evaluates the exposure to a human receptor by fish ingestion and ingestion of drinking water. From a release of waste particles and volatile emissions to air from the surface of an open landfill, DRAS considers routes of exposure of inhalation of volatile constituents, inhalation of particles, and air deposition of particles on residential soil and subsequent ingestion of the contaminated soil by a child. The technical support document and the user's guide to DRAS are included in the docket.
Sandvik documented the input parameters used in their DRAS analysis, as summarized below:
At a target cancer risk of 1×10−
The maximum reported concentrations of the hazardous constituents found in this waste are presented in the table above. The table also presents the maximum allowable concentrations. Except for the groundwater pathway for arsenic, the concentrations of all constituents in both the waste and the leachate are below the allowable concentrations.
For arsenic, the maximum reported concentration was undetected at a value of 0.05 mg/L, a value slightly higher than the maximum allowable TCLP concentration of 0.042 mg/L. The EPA's review of the corresponding laboratory reports indicate that the laboratory reported sample results from the July 31, 2017 characterization sampling round as non-detect based on a practical quantitation limit of 0.05 mg/L. Subsequent laboratory reports for the August 31, 2017 and October 4, 2017 characterization rounds, however, reported TCLP arsenic results as non-detect at a level of 0.001 mg/L, based on a lower method detection limit rather a practical quantitation limit. Since the total arsenic results for all characterization samples are both low and consistent, ranging from 2.02 to 4.77 mg/kg, the EPA believes that the TCLP arsenic results for the July 31, 2017 results are not likely to be materially different than lower non-detect results for the August 31, 2017 and October 4, 2017 sample results. Also, based on the difference in arsenic concentrations from the totals analysis (detected at low levels) and the TCLP samples (non-detect), arsenic appears to be relatively immobile in the filter cake. Therefore, the EPA concludes that even though the TCLP arsenic data from the August 31, 2017, laboratory report does not explicitly document satisfaction of the 0.042 mg/L TCLP arsenic delisting criterion, the overall data set clearly supports a conclusion that the TCLP arsenic results do not exceed the maximum allowable concentration of 0.042 mg/L from any of the characterization sampling rounds, and that this arsenic data quality issue is not a sufficient basis to disqualify Sandvik's waste from being delisted. If the EPA approves Sandvik's delisting petition, Sandvik must ensure that any required periodic verification sampling and analysis meet appropriate data quality standards to address this issue.
We, therefore, conclude that Sandvik's wastewater treatment sludge is not a substantial or potential hazard to human health and the environment when disposed of in a Subtitle D landfill. Further, the data presented by Sandvik in their petition supports the EPA's conclusion that the petitioned waste does not exhibit any hazardous characteristic, and that there are no other factors that would warrant retaining the waste as hazardous. On this basis, we propose to grant the Sandvik's petition to delist this waste. If this exclusion is finalized, and subject to the conditions of the final delisting, Sandvik must dispose of this waste in a Subtitle D landfill permitted or licensed by a state and will remain obligated to verify that the waste continues to meet the allowable concentrations set forth here. Sandvik must also continue to demonstrate that the waste does not exhibit any hazardous characteristics pursuant to 40 CFR part 261 Subpart C.
HSWA specifically requires the EPA to provide notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not make a final decision or grant an exclusion until it has addressed all timely public comments on today's proposal, including any at public hearings.
Since this rule would reduce the existing requirements for persons generating hazardous wastes, the regulated community does not need a six-month period to come into compliance in accordance with § 3010 of RCRA as amended by HSWA.
If the petitioned waste is delisted, Sandvik must dispose of it in a Subtitle D landfill which is permitted, licensed, or registered by a state to manage industrial waste.
Concentrations measured in the waste of the following constituents must not exceed the concentrations in Table 3 below. The EPA notes that for barium, chromium, and silver, the DRAS model output predicts a maximum concentration in an extract of the waste that exceeds the toxicity characteristic regulatory designation level (TC Limit) for that constituent. Since wastes that are a candidate for delisting cannot exhibit a characteristic, the fourth column in Table 3 caps the maximum TCLP concentration of the waste at the toxicity characteristic regulatory level for barium, chromium and silver. These capped levels for the maximum TCLP concentration are the enforceable decision criteria for demonstrating that the waste meets delisting criteria.
The EPA notes that in multiple instances the maximum allowable total constituent concentrations provided by the DRAS model exceed 100% of the waste—these DRAS results are an artifact of the risk calculations that do not have physical meaning. In instances where DRAS predicts a maximum constituent greater than 100 percent of the waste (that is, greater than 1,000,000 mg/kg or mg/L, respectively, for total and TCLP concentrations), the EPA is not requiring Sandvik to perform sampling and analysis for that constituent and sampling type (total or TCLP). In these instances, the corresponding entry in Table 3 above is “N/A.”
Sandvik must analyze a representative sample of the wastewater treatment sludges on an annual basis to demonstrate that the constituents of concern in the petitioned waste do not exceed the concentrations of concern in section IV.C above. Sandvik must use methods with sufficient analytical sensitivity and appropriate quality control procedures. SW-846 Method 1311 must be used for generation of the leachate extract used in the testing of the subject waste. SW-846 Method 1311 is incorporated by reference in 40 CFR 260.11.
A total analysis of the waste (accounting for any filterable liquids and the dilution factor inherent in the TCLP method) may be used to estimate the TCLP concentration as provided for in section 1.2 of Method 1311. The EPA is not requiring Sandvik to use Method 1330 for extraction of wastes, since Method 1330 is applicable to API separator sludges, rag oils, slop oil emulsions, and other oil wastes derived from petroleum refining, which are fundamentally different wastes than those proposed by Sandvik for delisting.
Sandvik must submit the data obtained through annual verification testing to U.S. EPA Region 10, Office of Air and Waste, 1200 6th Avenue, Suite 155, OAW-150, Seattle, Washington 98101 upon each anniversary of the effective date of this exclusion. Sandvik must submit sampling data from both titanium and zirconium manufacturing processes provided both of these materials have been in production and contributed to candidate wastes within the three (3) month period prior to each anniversary of the effective date of this delisting. If both materials are not in production with the specified three-month period, then only data from that material in production need be submitted.
Sandvik must compile, summarize, and maintain on-site for a minimum of five years, records of analytical data required by this rule, and operating conditions relevant to those data analytical data. Sandvik must make those records available for inspection. All data must be accompanied by a signed copy of the certification statement in 40 CFR 260.22(i)(12).
If Sandvik violates the terms and conditions established in the exclusion, the Agency may start procedures to withdraw the exclusion.
If the verification testing of the waste does not demonstrate compliance with the delisting concentrations described in section IV.C above, or other data (including but not limited to leachate data or groundwater monitoring data from the final land disposal facility) relevant to the delisted waste indicates that any constituent is at a concentration in waste above specified delisting verification concentrations in Table 3, Sandvik must notify the Agency within 10 days of first possessing or being made aware of the data. The exclusion will be suspended and the waste managed as hazardous until Sandvik has received written approval from the EPA to continue the exclusion. Sandvik may provide sampling results which support the continuation of the delisting exclusion.
The EPA has the authority under RCRA and the Administrative Procedures Act, 5 U.S.C. 551 (1978
If Sandvik significantly changes the manufacturing or treatment process or the chemicals used in the manufacturing or treatment process, Sandvik may not handle the wastewater treatment sludge generated from the new process under this exclusion until it has demonstrated to the EPA that the waste meets the concentrations set forth in section IV.C and that no new hazardous constituents listed in Appendix VIII of 40 CFR part 261 have been introduced. Sandvik must manage wastes generated after the process change as hazardous waste until Sandvik has received written notice from the EPA that the demonstration has been accepted.
Because the EPA is proposing to issue this exclusion under the federal RCRA delisting regulations, only states subject to federal RCRA delisting provisions will be affected. This exclusion may not be effective in states which have received authorization from the EPA to make their own delisting decisions.
The EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than the EPA's, under § 3009 of RCRA. These more stringent requirements may include a provision that prohibits a federally issued exclusion from taking effect in the state. We urge petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.
The EPA has also authorized some states to administer a delisting program in place of the federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states. If Sandvik manages the waste in any state with delisting authorization, Sandvik must obtain delisting authorization or other determination from the receiving state before it can manage the waste as nonhazardous in that state.
While Washington State has received final authorization to implement most of its dangerous waste program regulations in lieu of the federal program, including the listing and identification of F006 wastes (See 51 FR 3782 (January 30, 1986), it has not been authorized to implement its delisting regulations program in lieu of the federal program. The EPA notes that Washington State has provisions in the Washington Administrative Code (WAC) 173-303-910(3) similar to the federal provisions upon which this delisting is based. These provisions are in effect as a matter of state law. Thus, Sandvik must seek approval from Washington State at the state level in addition to this proposed delisting.
Additional information about these statutes and Executive Orders can be found at
This proposed action is exempt from review by the Office of Management and Budget because it is a rule of particular applicability, not general applicability.
This proposed action is not an Executive Order 13771 regulatory action because actions such as approval of delisting petitions under RCRA are exempted under Executive Order 12866.
This proposed action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This proposed action does not contain any unfunded mandate as described in the Unfunded Mandates Reform Act (2 U.S.C. 1531-1538) and does not significantly or uniquely affect small governments. The action imposes no new enforceable duty on any state, local, or tribal governments or the private sector.
This proposed action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This proposed action does not have tribal implications as specified in Executive Order 13175. This proposed action applies only to a particular facility on non-tribal land. Thus, Executive Order 13175 does not apply to this action.
This proposed action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This proposed action's health and risk assessments using the Agency's Delisting Risk Assessment Software (DRAS), which considers health and safety risks to children, are described in section III.E above. The technical support document and the user's guide for DRAS are included in the docket.
This proposed action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This proposed action does not involve technical standards as described by the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note).
The EPA believes that this proposed action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples. The EPA has determined that this proposed action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment, as described in section III.E above, did not identify risks from management of this material in an authorized, solid waste landfill (
This proposed action is exempt from the Congressional Review Act (5 U.S.C. 801
Environmental protection, Hazardous waste, Recycling, and Reporting and recordkeeping requirements.
For the reasons set out in the preamble, the EPA proposes to amend 40 CFR part 261 as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.
Agricultural Marketing Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request approval for ballots and a petition form used to collect nominations of members and alternates to serve on the Board. Once approved, the forms would be merged with other forms the Board and AMS uses to collect information under Federal Marketing Order No. 981, Almonds Grown in California.
Comments on this notice must be received by November 13, 2018.
Small businesses may request information on this notice by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; telephone (202) 720-2491, Fax: (202) 720-8938, or Email:
The Almond Marketing Order, as amended, (7 CFR part 981), hereinafter referred to as the “Order” regulates the handling of almonds grown in California. The Order authorizes research and promotion activities, as well as quality regulations, and provides for the establishment of the Almond Board of California (Board).
The Board locally administers the Order with USDA oversight. Board members and alternates are appointed by USDA from nominations submitted by industry members to the Board. The Board conducts the nomination process with a petition form completed by individual growers and handlers to nominate themselves or others. Industry members then complete ballots to vote on those individuals whose names would be submitted to USDA for consideration for appointment to the Board. Only authorized employees of the Board, and authorized representatives of the USDA, including AMS, Specialty Crops Program's regional and headquarters staff have access to information provided on the forms.
Requesting public comments on the ballots and petition form described below is part of the process to obtain approval of the forms by the Office of Management and Budget (OMB). These forms have been designated OMB No. 0581-NEW. The forms include Independent Grower Ballot (ABC-15), Independent Handler Ballot (ABC-16), Cooperative Grower Ballot (ABC-17), Cooperative Handler Ballot (ABC-18), and Grower Petition (ABC-19). Once approved by OMB, USDA will request permission to merge the ballots and petition form into OMB No. 0581-0178 Vegetable and Specialty Crops collection that includes other forms related to the Order.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by October 12, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such person are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Rural Utilities Service, USDA.
Notice of funds availability.
As part of the Bipartisan Budget Act of 2018, Public Law 115-123, dated February 9, 2018, the Rural Utilities Service's Water and Environmental Programs (WEP) received $165,475,000 in supplemental grant funding of which $163,475,000 is available for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria. States impacted include: Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.
Unless otherwise specified in this Notice, applications will be accepted on a continual basis until funds are exhausted.
Entities wishing to apply for assistance, or that are in need of further information, should contact the USDA Rural Development State Office in the State where the project is located. A list of the USDA Rural Development State Offices addresses and telephone numbers is as follows:
Telephone numbers are not toll-free.
In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with the Program, as covered in this Notice, have been approved by the Office of Management Budget (OMB) under OMB Control Number 0572-0121.
This program is designed to provide supplemental grant funding for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria in the states of Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.
Details on eligible applicants and projects may be found in the relevant regulations listed in Section B, Eligibility Information below.
The applicable Statutory or Regulatory authority for this action includes:
• Bipartisan Budget Act of 2018, Public Law 115-123, Rural Utilities Service Rural Water and Waste Disposal Program Account.
• 2 CFR parts 200 and 400, uniform Federal grant awards regulations.
The Bipartisan Budget Act of 2018, Public Law 115-123, dated February 9, 2018, enables USDA Rural Development to provide: WEP $165,475,000 in supplemental grant funding of which $163,475,000 is available for repairs to drinking water systems and sewer and solid waste disposal systems impacted by Hurricanes Harvey, Irma, and Maria in the states of Florida, Georgia, South Carolina, Texas, and the territories of Puerto Rico and Virgin Islands.
1.
(i) Be either a Public Body, a Nonprofit Corporation, or an Indian tribe.
(ii) Be eligible to receive a Federal loan or grant under Federal law.
(iii) Certify in writing, and the Agency shall determine and document, that (1) the Applicant is unable to finance the proposed project from their own resources or through commercial credit at reasonable rates and terms, or as applicable, (2) the applicant made repairs by utilizing their own resources or by obtaining commercial credit and as a result is experiencing financial hardship that is impacting its operations and its customers.
(iv) Have the legal authority necessary for owning, constructing, operating, and maintaining the facility or service to be repaired or replaced and for obtaining security for the proposed grant. The Applicant shall be responsible for operating, maintaining, and managing the facility, and providing for its continued availability and use at reasonable user rates and charges. The Applicant shall retain this responsibility even though the facility may be operated, maintained, or managed by a third party under contract or management agreement. Applicants must submit evidence of legal authority before grant approval/obligation
(v) Demonstrate that they possess the technical, managerial, and financial capability necessary to consistently comply with pertinent Federal and State laws and requirements.
(vi) Be current on the repayment of all debts at the time they are due.
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For such repairs and replacements already made to restore service, grants may be awarded to reimburse applicants for expenses incurred by the applicant. These expenses must have been incurred within two years from the date of the covered hurricane. Reimbursement must be justified by a clear demonstration of financial hardship to the system or its customers due to the use of its own funds or commercial credit to make such repairs or replacement. There shall be no reimbursement for repairs or replacements made or financed through the use of other Federal funds such as Federal Emergency Management Agency, Environmental Protection Agency, or other Federal source of assistance used for repairs or replacement, or through insurance proceeds
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i. Form RD 442-7, “Operating Budget” or similar form.
ii. Form RD 1910-11, “Application Certification, Federal Collection Policies for Consumer or Commercial Debts;”
iii. Form RD 400-1, “Equal Opportunity Agreement;”
iv. Form RD 400-4, “Assurance Agreement;”
v. Form AD-1047, “Certification Regarding Debarment, Suspension and other Responsibility Matters;”
vii. Form AD-1049, “Certification regarding Drug-Free Workplace Requirements (Grants) Alternative I For Grantees Other Than Individuals;”
viii. Certifications for Contracts, Grants, and Loans (Regarding Lobbying); and
ix. Certification regarding prohibited tying arrangements. Applicants that provide electric service must provide the Agency a certification that they will not require users of a water or waste facility financed under this Notice to accept electric service as a condition of receiving water assistance.
3.
i. Be registered in SAM before submitting its application;
ii. Provide a valid DUNS number in its application; and
iii. Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency.
The Federal awarding agency may not make a federal award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant. As required by the Office of Management and Budget (OMB), all grant applications must provide a DUNS number when applying for Federal grants, on or after October 1, 2003. Organizations can receive a DUNS number at no cost by calling the dedicated toll-free number at 1-866-705-5711 or via internet at
You will need the following information when requesting a DUNS number:
i. Legal Name of the Applicant;
ii. Headquarters name and address of the Applicant;
iii. The names under which the Applicant is doing business as (dba) or other name by which the organization is commonly recognized;
iv. Physical address of the Applicant;
v. Mailing address (if separate from headquarters and/or physical address) of the Applicant;
vi. Telephone number;
vii. Contact name and title; and
viii. Number of employees at the physical location.
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6.
i. Repairs or replacement of facilities not directly impacted by Hurricanes Harvey, Irma, or Maria;
ii. Facilities which are not modest in size, design, and cost;
iii. Grant finder's fees;
iv. Any portion of the cost of a facility which does not serve a rural area as defined in this Notice;
v. That portion of project costs normally provided by a business or industrial user, such as wastewater pretreatment;
vi. Rental for the use of equipment or machinery owned by the applicant; or
vii. Other purposes not directly related to operating and maintenance of the facility being repaired or replaced.
Within 15 days of receiving your application, RUS will send you a letter of acknowledgment. Your application will be reviewed for completeness to determine if you included all of the items required. If your application is incomplete or ineligible, RUS will return it to you with an explanation. Applicants may resubmit applications deemed incomplete or ineligible after revising them in accordance with RUS explanation.
1.
The RUS Administrator may assign up to 15 additional points that will be considered in the total points. These points will be added to address items such as geographic distribution of funds, the highest priority projects within the jurisdiction, and emergency conditions caused by the hurricanes. The Administrator may delegate the authority to assign these points to National Office staff.
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i. SF-270, “Request for Advance or Reimbursement,” will be completed by the Non-Federal Entity and submitted to either the State or National office no more frequently than monthly.
ii. Upon receipt of a properly completed SF-270, the funds will be requested through the field office terminal system. Ordinarily, payment will be made within 30 days after receipt of a proper request for reimbursement.
iii. Non-Federal Entities may use women- and minority-owned banks (a bank which is owned at least 50 percent by women or minority group members) for the deposit and disbursement of funds.
3.
i. Any change in the scope of the project or any other significant change in the project must be reported to and approved by the approval official by written amendment to the grant agreement. Any change not approved may be cause for termination of the grant.
ii. Non-Federal Entities shall constantly monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. The Non-Federal Entity will provide project reports to the Agency as follows:
iii. SF-425, “Financial Status Report (short form),” and a project performance activity report will be required of all Non-Federal Entities on a quarterly basis, due 30 days after the end of each quarter.
iv. A final project performance report will be required with the last SF-425 due 90 days after the end of the last quarter in which the project is completed.
v. Financial reporting. The Non-Federal Entity will provide an audit report or financial statements to the Agency as follows:
vi. Non-Federal Entities expending $750,000 or more Federal funds per fiscal year will submit an audit conducted in accordance with 2 CFR part 200. The audit will be submitted within nine months after the Non-Federal Entity's fiscal year. Additional audits may be required if the project period covers more than one fiscal year.
vii. Non-Federal Entities expending less than $750,000 will provide annual financial statements covering the grant period, consisting of the organization's statement of income and expense and balance sheet signed by an appropriate official of the organization. Financial statements will be submitted within 90 days after the Non-Federal Entity's fiscal year.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at:
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USDA is an equal opportunity provider, employer, and lender.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
The application to reorganize and expand FTZ 135 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, to an ASF sunset provision for magnet sites that would terminate authority for Sites 4, 5, 6 and 8 if not activated within five years from the month of approval, and to an ASF sunset provision for usage-driven sites that would terminate authority for Sites 2, 3, 7, 9, 10, 11 and 12 if no foreign-status merchandise is admitted for a
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
The application to reorganize FTZ 158 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, and to an ASF sunset provision for magnet sites that would terminate authority for Sites 10, 11, 14, 15, 16, 17 and 18 if not activated within five years from the month of approval.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
The application to reorganize FTZ 105 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, and to an ASF sunset provision for magnet sites that would terminate authority for Sites 2 and 3 if not activated within five years from the month of approval.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
The application to reorganize FTZ 179 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and to the Board's standard 2,000-acre activation limit for the zone.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is rescinding its administrative review of polyethylene terephthalate resin from Canada for the period or review (POR) May 1, 2017, through April 30, 2018.
Applicable September 12, 2018.
Karine Gziryan, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4081.
On May 1, 2018, Commerce published in the
Pursuant to this request and in accordance with 19 CFR 351.221(c)(1)(i), on July 12, 2018, Commerce published a notice of initiation of an administrative review of the antidumping duty order on polyethylene terephthalate resin from Canada.
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review if the party that requested the review withdraws its request within 90 days of the publication date of the notice of initiation of the requested review. Selenis withdrew its review request before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this administrative review in its entirety.
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of polyethylene terephthalate resin from Canada. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period May 1, 2017, through April 30, 2018, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 41 days after the date of publication of this notice in the
This notice also serves as a final reminder to importers for whom this review is being rescinded of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).
Bureau of Consumer Financial Protection.
Notice of public meeting.
Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.
The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4 p.m. eastern daylight time.
The meeting location is the Bureau of Consumer Financial Protection, 1700 G Street NW, Washington, DC 20552.
Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588,
Section 2 of the CUAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Credit Union Advisory Council under agency authority.
Section 3 of the CUAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”
The Credit Union Advisory Council will discuss policy issues related to financial technology.
Persons who need a reasonable accommodation to participate should contact
Written comments will be accepted from interested members of the public and should be sent to
Individuals who wish to join the Credit Union Advisory Council must RSVP via this link
The Council's agenda will be made available to the public on Wednesday September 12, 2018, via
A recording and summary of this meeting will be available after the meeting on the Bureau's website
Bureau of Consumer Financial Protection.
Notice of public meeting.
Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Community Bank Advisory Council (CBAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.
The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4:00 p.m. eastern daylight time.
The meeting location is the Bureau of Consumer Financial Protection, 1700 G Street NW, Washington, DC 20552.
Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588,
Section 2 of the CBAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Community Bank Advisory Council under agency authority.
Section 3 of the CBAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”
The Community Bank Advisory Council will discuss policy issues related to financial technology.
Persons who need a reasonable accommodation to participate should contact
Written comments will be accepted from interested members of the public and should be sent to
Individuals who wish to join the Community Bank Advisory Council must RSVP via this link
The Council's agenda will be made available to the public on Wednesday September 26, 2018, via
A recording and summary of this meeting will be available after the meeting on the Bureau's website
Bureau of Consumer Financial Protection.
Notice of public meeting.
Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Consumer Advisory Board (CAB or Board) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Board.
The meeting date is Thursday, September 27, 2018, from approximately 9:30 a.m. to 4:00 p.m. eastern daylight time.
Crystal Dully, Outreach and Engagement Associate, Advisory Board and Councils Office, External Affairs, at 202-435-9588,
Section 3 of the Charter of the Consumer Advisory Board states that:
The purpose of the Board is outlined in section 1014(a) of the Dodd-Frank Act, which states that the Board shall “advise and consult with the Bureau in the exercise of its functions under the Federal consumer financial laws” and “provide information on emerging practices in the consumer financial products or services industry, including regional trends, concerns, and other relevant information.
To carry out the Board's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The Board will generally serve as a vehicle for market intelligence and expertise for the Bureau. Its objectives will include identifying and assessing the impact on consumers and other market participants of new, emerging, and changing products, practices, or services.
The Consumer Advisory Board will discuss policy issues related to financial technology.
Persons who need a reasonable accommodation to participate should contact
Written comments will be accepted from interested members of the public and should be sent to
Individuals who wish to join the Consumer Advisory Board must RSVP via this link
The Board's agenda will be made available to the public on Wednesday, September 26, 2018, via
A recording and summary of this meeting will be available after the meeting on the Bureau's website
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before November 13, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Karen Holliday, 202-245-7318.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in
Section 302 (b)(2)(C) of the Act requires that data on the employment of scholars are accurate, including tracking of scholars' employment status and location of former scholars supported under the RLTT grants in order to ensure that scholars are meeting the payback requirements.
In addition to meeting the requirement that all scholars be tracked, the data collected will provide performance data relevant to the rehabilitation fields and degrees pursued by RSA scholars, as well as the funds owed and the rehabilitation work completed by them. These data are used to assess program effectiveness and efficiency, and to meet the reporting requirements of the Government Performance and Results Act (GPRA).
RSA is requesting a revision of the currently approved collection for grantees (Institutions of Higher Education) to submit an Annual Payback Report through the online RSA Management Information System (MIS). To collect the needed data, RSA created the revised Payback Information Management System (PIMS). Through the PIMS grantees, scholars and employers report data electronically.
Office of Electricity, DOE.
Notice of application.
Vermont Electric Power Company, Inc. (“VELCO”), as operating-and-management agent for the Joint Owners of the Highgate Interconnection Facilities (the “Highgate Joint Owners”) filed an application to amend PP-82, issued on May 14, 1985 and amended on March 1, 1994, September 3, 2003, February 7, 2005, May 3, 2016 and January 8, 2018. VELCO requested that DOE reflect changes in ownership of the Highgate Interconnection Facilities and transfer the ownership interests in the Highgate Interconnection Facilities from two of the Highgate Joint Owners to the third Highgate Joint Owner.
Comments or motions to intervene must be submitted on or before October 12, 2018.
Comments or motions to intervene should be addressed as follows: Office of Electricity (OE-20), U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585.
Christopher Lawrence (Program Office) at 202-586-5260, or by email to
The construction, operation, maintenance, and connection of facilities at the international border of the United States for the transmission of electric energy between the United States and a foreign country is prohibited in the absence of a Presidential permit issued pursuant to Executive Order (E.O.) 10485, as amended by E.O. 12038.
On August 13, 2018, VELCO filed an application with DOE, as required by 10 CFR 205.322, requesting that DOE amend PP-82-5 to reflect a change in names and ownership interests and authorize, under Article 10 of PP-82-5, the transfer of the Highgate Interconnection Facilities so that Vermont Transco LLC (Transco) will acquire 100% of the ownership interest in the facility from the two other Highgate Joint Owners: the Town of Stowe Electric Department and the City of Burlington Electric Department. Transco would then become sole owner of the Highgate Interconnection Facilities.
The international transmission facilities authorized by Presidential Permit No. PP-82, as amended, include a back-to-back converter station in Highgate, Vermont, and a 345 kilovolt (kV) transmission line extending approximately 7.5 miles from the converter station to the United States-Canada border in Franklin, Vermont. VELCO does not propose to make any physical changes to the Highgate Interconnection Facilities, but rather asks the Department to amend the permit to reflect the change in ownership of the Highgate Transmission Facility.
Additional copies of such motions to intervene also should be filed directly with Mr. Colin Owyang, Vice President, General Counsel & Corporate Secretary, Vermont Electric Power Company, Inc., 366 Pinnacle Ridge Road, Rutland, VT 05701,
Before a Presidential permit may be granted or amended, DOE must determine that the proposed action will not adversely impact the reliability of
Copies of this application will be made available, upon request, for public inspection and copying at the address provided above. In addition, the application may be reviewed or downloaded electronically at
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of open teleconference.
This notice announces a teleconference call of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Thursday, September 20, 2018, from 3 p.m. to 4 p.m. (EDT). To receive the call-in number and passcode, please contact the Board's Designated Federal Officer at the address or phone number listed below.
Michael Li, Senior Policy Advisor, Office of Energy Efficiency and Renewable Energy, US Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585. Phone number 202-287-5718, and email:
Office of Science, Department of Energy.
Notice of Open Meeting.
This notice announces a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Thursday, October 18, 2018; 8:30 a.m.—5:30 p.m. and Friday, October 19, 2018; 8:30 a.m.—12:30 p.m.
Hilton Washington DC/Rockville Hotel & Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.
Dr. Tristram West, Designated Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585-1290. Phone 301-903-5155; fax (301) 903-5051 or email:
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of decision and order.
The U.S. Department of Energy (DOE) gives notice of a Decision and Order (Case No. CR-007) that grants to ITW Food Equipment Group, LLC (ITW) a waiver from specified portions of the DOE test procedure for determining the energy consumption of commercial refrigerators, freezers, and refrigerator-freezers (collectively, “commercial refrigeration equipment”). Under the Decision and Order, ITW is required to test and rate specified basic models of its commercial refrigeration equipment in accordance with a specified method.
The Decision and Order is effective on September 12, 2018. The Decision and Order will terminate in conjunction with any future updates to the test procedure for commercial refrigeration equipment located in 10 CFR part 431, subpart C, appendix B. At such time, ITW must use the relevant test procedure for this equipment for any testing to demonstrate compliance with standards, and any other representations of energy use.
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email:
Ms. Jennifer Tiedeman, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 287-6111. Email:
In accordance with Title 10 of the Code of Federal Regulations (10 CFR 431.401(f)(2)), DOE gives notice of the issuance of its Decision and Order as set forth below. The Decision and Order grants ITW a waiver from the applicable test procedure in 10 CFR part 431, subpart C, appendix B for specified basic models of commercial refrigeration equipment, provided that ITW tests and rates such equipment using the alternate test procedure specified in the Decision and Order. ITW's representations concerning the energy consumption of the specified basic models must be based on testing consistent with the provisions and restrictions in the alternate test procedure set forth in the Decision and Order, and the representations must fairly disclose the test results. Distributors, retailers, and private labelers are held to the same requirements when making representations regarding the energy consumption of this equipment. 42 U.S.C. 6314(d).
Consistent with 10 CFR 431.401(j), not later than November 13, 2018, any manufacturer currently distributing in commerce in the United States equipment employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver. Manufacturers not currently distributing such equipment in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that equipment in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 431.401.
The Energy Policy and Conservation Act of 1975 (EPCA),
Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act include definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).
The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))
Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect energy efficiency, energy use or estimated annual operating cost of covered equipment during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) The test procedure for commercial refrigeration equipment is contained in the Code of Federal Regulations (CFR) at 10 CFR part 431, subpart C, appendix B, “
Under 10 CFR 431.401, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic models for which the waiver was requested contain a design characteristic that prevents testing of the basic models according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic models in a manner so unrepresentative of their true energy or water consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). DOE may grant the
By letter dated December 20, 2016 (and supplemented on May 3, 2017), ITW submitted a petition for waiver and application for interim waiver for certain basic models of commercial refrigeration equipment that are required to be tested according to DOE's test procedure at 10 CFR part 431, subpart C, appendix B. Specifically, ITW requested a waiver for certain Innopod temperature-controlled grocery and general merchandise system (Innopod) basic models of commercial refrigeration equipment. On July 19, 2017, DOE published a notice that announced receipt of ITW's petition for waiver (hereafter “notice of petition for waiver”), and granted an interim waiver to ITW. 82 FR 33081.
DOE's current test procedure references Air-Conditioning and Refrigeration Institute (ARI) Standard 1200-2006 and Air-Conditioning, Heating, and Refrigeration Institute (AHRI) Standard 1200 (I-P)-2010, which further references American National Standards Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers (ANSI/ASHRAE) Standard 72 (incorporated by reference at 10 CFR 431.63(c) and (d)). ITW asserted that the current test procedures do not account for the unique operating characteristics of its Innopod basic models, including floating suction temperatures for individual compartments, different typical door-opening cycles, and a high-temperature “ambient” compartment. ITW asserted that its petition meets both conditions of 10 CFR 431.401(f)(2) for granting waivers, namely that (1) the basic models contain one or more design characteristics that prevent testing according to the prescribed test procedures; and (2) the prescribed test procedures evaluate the basic models in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. ITW submitted to DOE an alternate test procedure that it stated allows for testing its specified Innopod basic models.
ITW's petition recommended an alternate test using an “inverse refrigeration load” test, various calculations to account for refrigeration system and component energy consumption, and adjustments to the door opening requirements based on typical use in the field to accommodate for the basic models' multiple thermally separated, temperature controlled compartments supplied with refrigerant from a single condensing unit. ITW's recommended refrigeration system calculations rely on the current calculations and assumptions used for testing remote condensing commercial refrigeration equipment in accordance with the DOE test procedure.
As noted in the notice of petition for waiver, DOE granted ITW an interim waiver and required that ITW test and rate the specified basic models according to an alternate procedure. The alternate procedure granted by DOE was similar to that requested by ITW, but with minor modifications. Those modifications included clarifications of how ITW should determine the basic models and adjust certain aspects of the requested alternate test procedure regarding ambient test conditions, reference to the current version of the AHRI 1200 industry standard, and clarifications to certain calculations. 82 FR 33081, 33083-33084. DOE received no comments in response to the notice of petition for waiver.
DOE understands that absent a waiver, the basic models identified by ITW in its petition cannot be tested and rated for energy consumption on a basis representative of their true energy consumption characteristics. DOE has reviewed the recommended procedure suggested by ITW and concludes that it will allow for the accurate measurement of the energy use of the equipment, while alleviating the testing problems associated with ITW's implementation of DOE's applicable commercial refrigeration equipment test procedure for the specified Innopod basic models. However, as in the interim test procedure waiver, DOE has clarified how ITW should determine basic models, as discussed in this notice, and adjusted certain aspects of the requested alternate test procedure regarding ambient test conditions, referenced industry standards, and calculations.
In this Decision and Order, DOE requires that ITW test and rate specific basic models of commercial refrigeration equipment according to the alternate test procedure specified in this Decision and Order, which is identical to that provided by DOE in the interim waiver.
In its petition, ITW sought a test procedure waiver for certain basic models. This Decision and Order is applicable only to the basic models listed and does not extend to any other basic models. ITW may request that the scope of this waiver be extended to include additional basic models that employ the same technology as those listed in this waiver. 10 CFR 431.401(g). ITW may also submit another petition for waiver from the test procedure for additional basic models that employ a different technology and meet the criteria for test procedure waivers. 10 CFR 431.401(a)(1).
DOE notes that it may modify the waiver at any time upon DOE's determination that the factual basis underlying the petition for waiver is incorrect, or upon a determination that the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, ITW may request that DOE rescind or modify the waiver if the company discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2). As set forth above, the test procedure specified in this Decision and Order is not the same as the test procedure offered by ITW. If ITW believes that the alternate test method it suggested provides representative results and is less burdensome than the test method required by this Decision and Order, ITW may submit a request for modification under 10 CFR 431.401(k)(2) that addresses the concerns that DOE has specified with that procedure. ITW may also submit another less burdensome alternative test procedure not expressly considered in this notice under the same provision.
After careful consideration of all the material submitted by ITW in this matter, it is
(1) ITW must, as of the date of publication of this Order in the
30-XX-X5-AAAAR, 30-XX-X5-AAARA, 30-XX-X5-AAARR, 30-XX-X5-AAAFA, 30-XX-X5-AAAFR, 30-XX-X5-AARAA, 30-XX-X5-AARAR, 30-XX-X5-AARRA, 30-XX-X5-AARRR, 30-XX-X5-AARFA, 30-XX-X5-AARFR, 30-XX-X5-AAFAA, 30-XX-X5-AAFAR, 30-XX-X5-AAFRA, 30-XX-X5-AAFRR, 30-XX-X5-AAFFA, 30-XX-X5-AAFFR, 30-XX-X5-ARAAA, 30-XX-X5-ARAAR, 30-XX-X5-ARARA, 30-XX-X5-ARARR, 30-XX-X5-ARAFA, 30-XX-X5-ARAFR, 30-XX-X5-ARRAA, 30-XX-X5-ARRAR, 30-XX-X5-ARRRA, 30-XX-X5-ARRRR, 30-XX-X5-ARRFA, 30-XX-X5-ARRFR, 30-XX-X5-ARFAA, 30-XX-X5-ARFAR, 30-XX-X5-ARFRA, 30-XX-X5-ARFRR, 30-XX-X5-ARFFA, 30-XX-X5-ARFFR, 30-XX-X5-AFAAA, 30-XX-X5-
(2) The applicable method of test for the ITW basic models listed in paragraph (1) is the test procedure for commercial refrigeration equipment prescribed by DOE at 10 CFR part 431, subpart C, appendix B, with the following modifications:
For the purpose of testing and rating, the Ambient (75 °F) compartment is treated as a Medium (Refrigerator at 75 °F) compartment. All volume and energy consumption calculations will be included within the Medium (Refrigerator 38 °F) category and summed with other Medium (Refrigerator 38 °F) compartment(s) calculations. Compartments that are convertible between ambient and refrigerator temperature ranges shall be tested at the refrigerator temperature (38 °F). Compartments that are convertible between refrigerator and freezer (0 °F) temperature ranges shall be tested at both temperatures.
(3) Representations. ITW may make representations about the energy use of the specified basic models of its commercial refrigeration equipment for compliance, marketing, or other purposes only to the extent that such equipment has been tested in accordance with the provisions above and such representations fairly disclose the results of such testing in accordance with 10 CFR part 429, subpart B.
(4) This waiver shall remain in effect consistent with the provisions of 10 CFR 431.401.
(5) This waiver is issued on the condition that the statements, representations, and documentation provided by the petitioner are valid. If ITW makes any modifications to the controls or configurations of these basic models, the waiver will no longer be valid and ITW will either be required to use the current Federal test method or submit a new application for a test procedure waiver. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. Likewise, ITW may request that DOE rescind or modify the waiver if ITW discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons.
(6) Granting of this waiver does not release a petitioner from the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on September 6, 2018.
Office of Electricity, Department of Energy.
Notice of Open Meeting.
This notice announces a meeting of the Electricity Advisory Committee. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Wednesday, October 17, 2018, 12:00 p.m.—6:00 p.m. EST; Thursday, October 18, 2018, 8:00 a.m.—12:15 p.m. EST.
The meeting will be held at the National Rural Electric Cooperative Association, 4301 Wilson Blvd., Arlington, VA 22203.
Lawrence Mansueti, Office of Electricity, U.S. Department of Energy, Forrestal Building, Room 8G-017, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (202) 586-2588 or Email:
The meeting agenda may change to accommodate EAC business. For EAC agenda updates, see the EAC website at:
You may submit comments, identified by: “Electricity Advisory Committee Open Meeting,” through any of the following methods:
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The following electronic file formats are acceptable: Microsoft Word (.doc), Corel Word Perfect (.wpd), Adobe Acrobat (.pdf), Rich Text Format (.rtf), plain text (.txt), Microsoft Excel (.xls), and Microsoft PowerPoint (.ppt). If you submit information that you believe to be exempt by law from public disclosure, you must submit one complete copy, as well as one copy from which the information claimed to be exempt by law from public disclosure has been deleted. You must also explain the reasons why you believe the deleted information is exempt from disclosure.
DOE is responsible for the final determination concerning disclosure or nondisclosure of the information and for treating it in accordance with the DOE's Freedom of Information regulations (10 CFR 1004.11).
Delivery of the U.S. Postal Service mail to DOE may be delayed by several weeks due to security screening. DOE, therefore, encourages those wishing to comment to submit comments electronically by email. If comments are submitted by regular mail, the Department requests that they be accompanied by a CD or diskette containing electronic files of the submission.
This notice identifies the Federal Energy Regulatory Commission (FERC or Commission) staff's revised schedule for the completion of the final environmental impact statement (EIS) for Transcontinental Gas Pipe Line Company, LLC's (Transco) Northeast Supply Enhancement Project. The first notice of schedule, issued on January 3, 2018, identified September 17, 2018 as the final EIS issuance date. Staff has revised the schedule for issuance of the final EIS based on the current status of Transco's General Conformity review and feasible mitigation options. The forecasted schedule for the final EIS is also based upon Transco providing complete and timely responses to any future data requests. In addition, the schedule assumes that the cooperating agencies will provide input on their areas of responsibility on a timely basis.
If a schedule change becomes necessary, an additional notice will be provided so that the relevant agencies are kept informed of the project's progress.
In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
On October 28, 2015, Swan Lake North Hydro LLC filed an application requesting authorization to construct and operate the Swan Lake North Pumped Storage Hydroelectric Project. The project would be located 11 miles northeast of Klamath Falls, in Klamath County, Oregon.
In accordance with Title 41 of the Fixing America's Surface Transportation Act, enacted on December 4, 2015, agencies are to publish completion dates for all federal environmental reviews and authorizations. This notice identifies the Commission's anticipated schedule for issuance of the final order for the Project, which is based on the anticipated date of issuance of the final Environmental Impact Statement. Accordingly, we currently anticipate issuing a final order for the Project no later than:
If a schedule change becomes necessary for the final order, an additional notice will be provided so that interested parties and government
Take notice that on September 5, 2018, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e, and Rules 206 and 207 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and 385.207, City of Oakland, California (Complainant) filed a formal complaint against Pacific Gas and Electric Company (Respondent) alleging that the Respondent's provision of power and transmission service to the Complainant failed to comply with the requirements of the Federal Power Act, as more fully explained in the complaint.
The Complainant certifies that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
On July 17, 2018, Midwest Energy Recycling, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Yellow Medicine County Pumped Storage Project to be located near the Minnesota River and the City of Granite Falls, in Yellow Medicine County, Minnesota. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following all new facilities: (1) A circular 100-acre rockfill embankment (upper reservoir) having a total storage capacity of 3,300 acre-feet with a maximum pond elevation level of 1089 feet mean sea level (msl); (2) a 2,400-foot by 1,425-foot rectangular lower reservoir with a total storage capacity of 3,300 acre-feet and water surface elevation between minus (−) 1,320 and minus 1,420 feet msl; (3) a 100-foot outside diameter, 18-foot inside diameter “morning glory” in configuration reinforced concrete intake located in the upper reservoir; (4) a vertical 2,500-foot-long, 18-foot-diameter steel penstock connected to the intake at the upper reservoir and ending in a bifurcation before the powerhouse located at the lower reservoir; (5) a 200-foot-long, 70-foot-wide, 130-foot-high reinforced concrete powerhouse containing two 333-megawatt (MW) reversible pump turbine units with a total plant rating of 666 MW; (6) a 240-foot-long, 50-foot-wide, 40-foot-high transformer gallery; (7); a 200 to 1,000-foot-long, 345-kilovolt transmission line extending from the transformer gallery to an existing substation (the point of interconnection); and (8) appurtenant facilities. The estimated annual generation of the Yellow Medicine County Pumped Storage Project would be 1,450 gigawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 Days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's website at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Line 1-N Abandonment Project involving construction and operation of facilities by Texas Eastern Transmission, LP (Texas Eastern) in Harrison and Marion Counties, Texas. The Commission will use this EA in its decision-making process to determine whether to authorize the project.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies about issues regarding the project. The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from its action whenever it considers the issuance of an authorization. NEPA also requires the Commission to discover concerns the public may have about proposals. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5 p.m. Eastern Time on October 6, 2018.
You can make a difference by submitting your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. Commission staff will consider and address all filed comments during the preparation of the EA.
If you sent comments on this project to the Commission before the opening of this docket on July 24, 2018, you will need to file those comments in Docket No. CP18-533-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law.
Texas Eastern provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-533-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Texas Eastern proposes to abandon a portion of its lateral Line 1-N and related facilities, in Harrison and Marion Counties, Texas. Specifically, Texas Eastern is requesting approval to abandon in place and by removal a total of approximately 30 miles of 8-inch, 10-inch, and 12-inch-diameter lateral pipeline; abandon by removal all of the facilities at Metering and Regulating (M&R) Station 70191; and abandon by removal all aboveground appurtenances on each of the 8-inch, 10-inch and 12-inch-diameter pipeline segments.
According to Texas Eastern, the project would eliminate the need for operating and maintenance expenditures on facilities that have not been used to provide service for over a year and are not necessary to meet Texas Eastern's firm service obligations. The project would not impact the daily design capacity of, or the operating conditions on, Texas Eastern's system, and it would not impact service for Texas Eastern's existing shippers.
The general location of the project facilities is shown in appendix 1.
The project would temporarily affect approximately 6 acres of land within the existing right-of-way. Following abandonment, Texas Eastern would revegetate temporary work areas in accordance with its Erosion and Sedimentation Control Plan. Texas Eastern would retain and continue to maintain the pipeline right-of-way following abandonment activities.
The EA will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• land use;
• water resources, fisheries, and wetlands;
• cultural resources;
• vegetation and wildlife;
• air quality and noise;
• endangered and threatened species;
• public safety; and
• cumulative impacts.
Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present Commission staffs' independent analysis of the issues. The EA will be available in the public record through eLibrary.
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is are using this notice to initiate consultation with the applicable State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that information related to this environmental review is sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
As stated above, the EA will be available in the public record through the Commission's eLibrary, under the Docket Number CP18-533-000.
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public sessions or site visits will be posted on the Commission's calendar located at
On March 19, 2018, Peterson Machinery Sales filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Hubbardston Hydroelectric Project (project) to be located on the Fish Creek, near Hubbardston, in Ionia County, Michigan. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would be located at the site of an existing, non-operational hydroelectric project previously operated by Hope Renewable Energy, LLC without a Commission license. The proposed run-of-river project will involve rehabilitation and upgrade of the following existing facilities: (1) A 60-acre, 600-acre-foot reservoir with normal surface elevation of 850 feet mean sea level; (2) a 350-foot-long, 25 to 30-foot-high combination dam and spillway incorporating a 80-foot-long, 12-foot-wide intake channel; (3) a 30-foot-long, 20-foot-wide, 25-foot-high powerhouse containing two Francis turbines and
Deadline for filing comments, applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's website at
Take notice that during the month of August 2018, the status of the above-captioned entities as Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of the Commission's regulations. 18 CFR 366.7(a)(2018).
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Enel Green Power Hilltopper Wind, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 26, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on August 24, 2018, KO Transmission Company (KOT), 139 East 4th Street, Cincinnati, Ohio, filed an application under section 7(c) of the Natural Gas Act and Part 157 of the Commission's regulations requesting authorization to amend its Certificate of Public Convenience and Necessity issued on April 22, 1998, in Docket No. CP97-720-000
Any questions regarding the proposed amendment should be directed to Lance Stotts, Administrator, KO Transmission Company, 4720 Piedmont Row Drive, Room 864, Charlotte, North Carolina 28210; telephone (704)731-4360; email
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental analysis (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before October 12, 2018.
Submit your comments, identified by the Docket Identification (ID) Number and the File Symbol or EPA Registration Number of interest as shown in the body of this document, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), main telephone number: (703) 305-7090, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
2.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the
This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0097, is available at
This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from April 1, 2018 to July 31, 2018.
TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:
• The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;
• The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;
• The information available to EPA is insufficient to permit a reasoned
• The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or
• The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”
EPA is required under TSCA section 5(g) to publish in the
Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.
The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.
In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:
• EPA case number assigned to the TSCA section 5(a) notice.
• Chemical identity (generic name, if the specific name is claimed as CBI).
• Website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).
15 U.S.C. 2601
Farm Credit System Insurance Corporation.
Notice, regular meeting.
Notice is hereby given of the regular meeting of the Farm Credit System Insurance Corporation Board (Board).
The meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 19, 2018, from 10:00 a.m. until such time as the Board concludes its business.
Dale Aultman, Secretary to the Farm Credit System Insurance Corporation Board, (703) 883-4009, TTY (703) 883-4056,
Farm Credit System Insurance Corporation, 1501 Farm Credit Drive, McLean, Virginia 22102. Submit attendance requests via email to
Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to
• Confidential Report on System Performance
• June 14, 2018 (Open and Closed)
• Quarterly Financial Reports
• Report on Insured and Other Obligations
• Quarterly Report on Annual Performance Plan
• Annual Performance Plan FY 2020-2021
• Proposed 2020 and 2021 Budgets
• Insurance Fund Progress Review and Setting of Premium Range Guidance for 2019
Board of Governors of the Federal Reserve System.
Notice is hereby given of temporary approval of revisions to the mandatory Consolidated Financial Statements for Holding Companies (FR Y-9C; OMB No. 7100-0128) by the Board of Governors of the Federal Reserve System (Board) pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB), per OMB Regulations on Controlling Paperwork Burdens on the Public. The temporary approval is valid until March 31, 2019.
The revisions are applicable as of June 30, 2018.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to temporarily approve a revision to a collection of information without providing opportunity for public comment if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligation.
The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. The Board will publish a notice in the future inviting comment on these actions.
With respect to FR Y-9LP, FR Y-9SP, FR Y-ES, and FR Y-9CS, the information collected would generally not be accorded confidential treatment. If confidential treatment is requested by a respondent, the Board will review the request to determine if confidential treatment is appropriate.
With respect to FR Y-9C, Schedule HI's item 7(g) “FDIC deposit insurance assessments,” Schedule HC-P's item 7(a) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to U.S. government agencies and government sponsored agencies,” and Schedule HC-P's item 7(b) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to other parties” are considered confidential. Such treatment is appropriate because the data is not publicly available and the public release of this data is likely to impair the Board's ability to collect necessary information in the future and could cause substantial harm to the competitive position of the respondent. Thus, this information may be kept confidential under exemptions (b)(4) of the Freedom of Information Act, which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential” (5 U.S.C. 552(b)(4)), and (b)(8) of the Freedom of Information Act, which exempts from disclosure information related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. 552(b)(8)).
In order to avoid the regulatory burden associated with different definitions for HVCRE exposures and brokered deposits within a single organization, the Board has amended the FR Y-9C instructions to permit bank holding companies, savings and loan holding companies, and intermediate holding companies of foreign banks to report HVCRE and brokered deposits on the FR Y-9C report in a manner consistent with their subsidiary depository institution(s).
In order for the FR Y-9C to reflect sections 202 and 214 of EGRRCPA, which became effective immediately when EGRRCPA was signed on May 24, 2018, the Board cannot comply with the normal clearance process and still receive the June 30, 2018, financial data in a timely manner. Therefore, the Board has determined that the revisions to the FR Y-9C described above must be instituted quickly and public participation in the approval process would substantially interfere with the Board's ability to perform its statutory obligations arising from EGRRCPA.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 8, 2018.
1.
Board of Governors of the Federal Reserve System.
Notice is hereby given of temporary approval of revisions to the mandatory Complex Institution Liquidity Monitoring Report (FR 2052a; OMB No. 7100-0361) by the Board of Governors of the Federal Reserve System (Board) pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB), per OMB Regulations on Controlling Paperwork Burdens on the Public. The temporary approval is valid until March 31, 2019.
The revisions are applicable as of June 30, 2018.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to temporarily approve a revision to a collection of information without providing opportunity for public comment if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligation.
The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. The Board will publish a notice in the future inviting comment on these actions.
Final approval under OMB delegated authority of the temporary revision of the following report:
Financial institution information required by the FR 2052a is collected as part of the Board's supervisory process. Therefore, such information is entitled to confidential treatment under Exemption 8 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(8)). In addition, the institution information provided by each respondent would not be otherwise available to the public and its disclosure could cause substantial competitive harm. Accordingly, it is entitled to confidential treatment under the authority of exemption 4 of the FOIA (5 U.S.C. 552(b)(4)), which protects from disclosure trade secrets and commercial or financial information.
Information covered under 5 U.S.C. 552b(c)(4) and (c)(9)(B).
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by October 12, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Sponsors are required to monitor studies evaluating new drugs, biologics, and devices (21 CFR 312.50 and 312.56 for drugs and biologics, and 21 CFR 812.40 and 812.46 for devices). Various individuals and groups play different roles in clinical trial monitoring. One
The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs and describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor.
The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (§ 312.32(c) (21 CFR 312.32(c))) would not apply when the DMC recommendation is related to an excess of events not classifiable as serious. Nevertheless, the Agency recommends in the guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of “serious.”
In the guidance, FDA recommends that sponsors establish procedures to do the following things:
• Assess potential conflicts of interest of proposed DMC members;
• Ensure that those with serious conflicts of interest are not included in the DMC;
• Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC;
• Identify and disclose any concurrent service of any DMC member on other DMCs of the same, related, or competing products;
• Ensure separation, and designate a different statistician to advise on the management of the trial, if the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC; and
• Minimize the risks of bias that are associated with an arrangement under which the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC, if it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management.
The Agency recommends in the guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA with the clinical study report (21 CFR 314.50(d)(5)(ii)).
The sponsor must report to FDA certain serious and unexpected adverse events in drugs and biologics trials (§ 312.32) and unanticipated adverse device effects in the case of device trials (21 CFR 812.150(b)(1)). The Agency recommends in the guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events.
The Agency recommends in the guidance that DMCs should issue a written report to the sponsor based on the DMC meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor. The sponsor may convey the relevant information in this report to other interested parties, such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor.
Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this guidance recommends them, FDA estimates that the majority of sponsors have already prepared SOPs for DMCs, and only a minimum amount of time is necessary to revise or update them for use for other clinical studies. FDA receives very few requests for waivers regarding expedited reporting of certain serious events; therefore, FDA has estimated one respondent per year to account for the rare instance a request may be made. Based on FDA's experience with clinical trials using DMCs, FDA estimates that the sponsor on average would issue two interim reports per clinical trial to the DMC. FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial.
The “Average Burden per Response” and “Average Burden per Recordkeeping” are based on FDA's experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry. The “Average Burden per Response” includes the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The “Average Burden per Recordkeeping” includes the time to record, gather, and maintain the information.
The information collection provisions in the guidance for 21 CFR 312.30,
In the
We estimate the burden of the information collection as follows:
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by October 12, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports FDA's MedWatch safety information and adverse event reporting program. Members of the public use FDA's MedWatch system to report adverse events, product problems, errors with the use of a human medical product, or when evidence of therapeutic failure is suspected or identified in clinical use.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360
Requirements regarding mandatory reporting of adverse events or product problems are codified at parts 310, 314, 600, and 803 (21 CFR parts 310, 314, 600, and 803), specifically §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in sections 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 379aa, and 379aa-1). Mandatory reporting of adverse reactions for human cells, tissues, and cellular- and tissue-based products (HCT/Ps) is codified at § 1271.350 (21 CFR 1271.350).
Voluntary reporting of adverse events is completed using Form FDA 3500 and may be used by healthcare professionals to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the Agency or the manufacturer with the exception of Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Reports for vaccines are not submitted via MedWatch or MedWatch forms, but are submitted to the Vaccines Adverse Event Reporting System, which is jointly administered by FDA and the Centers for Disease Control and Prevention and approved under OMB control number 0910-0308.
Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries. Under Federal law and regulation, section 761(b)(1) of the FD&C Act, a dietary supplement manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA any serious adverse event report it receives regarding use of the dietary supplement in the United States. However, FDA bears the burden to gather and review evidence that a dietary supplement may be adulterated under section 402 of the FD&C Act (21 U.S.C. 342) after that product is marketed. Therefore, the Agency depends on the voluntary reporting by health professionals, and especially by consumers, of suspected serious adverse events and product quality problems associated with the use of dietary supplements. All dietary supplement reports were previously received by the Agency on paper versions of Form FDA 3500 (or Form FDA 3500B) (by mail or Fax). Currently, electronic reports may be sent to the Agency via an online submission route called the Safety Reporting Portal (
Form FDA 3500 may be used to report to the Agency serious adverse events, product problems, and product use errors and therapeutic failures. The form is provided in both paper and electronic formats. Reporters may mail or Fax paper forms to the Agency (a fillable PDF version of the form is available at
In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and (j), 353B, and 374) of the FD&C Act, Congress has required that important safety information relating to all human drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biological products). Mandatory reporting of adverse reactions for HCT/Ps has been codified in § 1271.350.
Section 760 of the FD&C Act provides for mandatory safety reporting for non-prescription human drug products marketed without an approved application as described in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), which became law on December 22, 2006. The law requires manufacturers, packers, and distributors of nonprescription, OTC human drug products marketed without an approved application (OTC monograph drug products) to submit reports of adverse experiences from domestic sources. The law also requires reports of serious adverse events to be submitted to FDA by manufacturers of dietary supplements.
Current requirements specify that postmarketing adverse experience reports must be submitted on paper on Form FDA 3500A (or the CIOMS) (Council for International Organizations of Medical Sciences) I form for serious, unexpected adverse experiences from a foreign source). For the last several years the Agency has accepted electronic submissions in lieu of the paper Form FDA 3500A on the condition they are submitted in a manner that the Agency can process, review, and archive. On June 10, 2014, the Agency issued a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” (79 FR 33072) that requires electronic submission of all mandatory postmarketing safety reports, including individual case safety reports. Entities with mandatory reporting obligations under parts 310 and 314 (drugs) and 600 (biological products) and specified under section 760 of the FD&C Act must implement this rule within 1 year of the issuance date (by June 10, 2015). For more information see:
Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers and importers of devices intended for human use to establish and maintain records, make reports, and provide information, as the Secretary of Health and Human Services may, by regulation, reasonably be required to provide assurance that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. The Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on November 28, 1990, amends section 519 of the FD&C Act. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part 803. Part 803 mandates the use of Form FDA 3500A for reporting to FDA on medical devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), signed into law October 26, 2002, amended section 519 of the FD&C Act. The MDUFMA amendment (section 303) required FDA to revise the MedWatch forms to facilitate the reporting of information relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.
Form FDA 3500B was developed for voluntary reporting by consumers (
FDA supports and encourages direct reporting to the Agency by consumers and healthcare professionals of suspected serious adverse outcomes and other product problems associated with human medical products, (
On March 25, 2008, section 906 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the FD&C Act (21 U.S.C. 352(n)) and mandated that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text (this includes vaccine products): “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
Most private vendors of consumer medication information, the drug product-specific instructions dispensed to consumers at outpatient pharmacies, remind patients to report “side effects” to FDA and provide contact information to permit reporting via the MedWatch process. For this reporting FDA has created Form FDA 3500B, a modified version of Form FDA 3500 tailored for consumers and written in plain language (in conformance with the Plain Writing Act of 2010 (Pub. L. 111-274),
Form FDA 3500B evolved from several iterations of draft versions, with input from human factors experts, from other regulatory agencies, and with extensive input from consumer advocacy groups and the general public. Form FDA 3500B may be used to report to the Agency adverse events, product problems, and product use errors. The form is provided in both paper and electronic formats. Reporters may mail or Fax paper forms to the Agency (a fillable PDF version of the form is available at
The proposed modifications to Form FDA 3500 and Form FDA 3500A reflect changes that will bring the form into conformity, since the previous OMB authorization in 2015, with current regulations, rules, and guidances and fall into three categories: (1) Regulatory driven revisions, (2) work improvements for the Center, and (3) report processing improvements. We also welcome comments about translation of Form FDA 3500B (consumer) into Spanish and other languages. Lastly, formatting modifications are being proposed to several fields to enhance the quality, utility, and clarity of the information.
In section A, we are revising the heading of A3 to “Current Gender” followed by check boxes next to the following options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose.”
In section B, we are revising B1 to “Type of Report (check all that apply)”. In section B2, we are removing “(Devices)” from the last option. We are also splitting section B6 into two
In section C, we are adding question C2 “Do you have a picture of the product?”
In section D1, we are adding the question “Does this report involve cosmetics, dietary supplements or food?” followed by a checkbox for “Yes.” In section D4, we are adding the question “Is therapy still on-going?” This question is important for pharmacovigilance and the current form does not allow the reporter to be specific. The current form does not allow the reporter to be specific. It is proposed to combine boxes D6 and D7 and change the title to “Product Type” (check all that apply).
In section E, we are adding question E9 “Was this device serviced by a third-party servicer?” followed by a checkbox for “Yes” and a checkbox for “No.”
In section A, we are revising the heading of A3 to “Current Gender” followed by check boxes next to the options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose”.
In section B, we are revising the heading for BI to now read “Type of Report (check all that apply)”. In section B2, we are removing “(Devices)” from the last option. Section B6 is being split into two questions: “B6.a. Relevant Test (please include dates)” and “B6.b. Relevant Laboratory Data (please include dates),”
In section C, we are combining boxes C6 and C7 and changing the title to “Product Type” (check all that apply).
In section D, we are adding a new question “Was this device serviced by a third party?” followed by a checkbox for “Yes” and a checkbox for “No.”
In section F, we are changing the revising the heading of F10 to “Adverse Event Problem” and splitting the “Patient Code” box into two fields entitled “Patient Outcome Code” and “Patient Severity Code.” We are also splitting the “Device Code” field into two fields entitled “Device Code” and “Component Code.”
In section G, question G1 will now include “or Compounding Outsourcing Facility” after (and Manufacturing Site for Devices.)” In section G5, we are adding two new options entitled “PreANDA” and “Compounded Product” followed by a check box for “Yes,” and making consistent changes within section G6 by replacing “If IND,” to “Give Protocol #.”
In section H1, we are adding a check box to indicate whether a summary report is included followed by a field in which to indicate “Number of Events Summarized” and an open field in which to add text. We are renaming section H6 to “Adverse Event Problem” and splitting “Patient Code” into two fields entitled “Patient Outcome Code” and “Patient Severity Code.” We are also splitting “Device Code” into two fields entitled “Device Code” and “Component Code.” In section H6, we are renaming the headings as follows: (1) “Method” to “Type of Investigation” (2) “Results” to “Investigation Findings” and (3) “Conclusions” to “Investigation Conclusion.” Finally, H10 is becoming a field entitled “Additional Manufacturer Narrative,” and we are adding field H11 entitled “Corrected Data.”
On page 1, we are removing the text “nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods.” We are also going to number each of the questions included.
In section A, for the question “Did any of the following happen?” we are removing “Devices)” from the last option. We are also revising the question “List any relevant tests or laboratory data if you know them. (Include dates)” as two separate questions: “List any relevant tests (Include dates)”; and “List any relevant laboratory data (Include dates)” with corresponding date fields for “relevant tests” and “laboratory data.”
In section B, we are asking whether respondents have a picture of the product. Also in section B, we are adding the questions “Does this report involve cosmetics, dietary supplements, or food?” and “Is therapy still on-going?” These questions pertain to pharmacovigilance and the current form does not allow for such specificity. We are also adding the question, “Was the product compounded by a pharmacy or an outsourcing facility?” Following the question, “Is the Product Compounded?” we are adding a check box for “Yes” and a checkbox for “No.” We are also adding checkboxes within the field “Product Type (check all that apply)” to correspond with selections for “Over-the-Counter, Generic and Biosimilar.” Finally, we are revising “Name of the . . .” to “Name(s) of the . . .” for clarity.
In section C, we are separating “Other identifying information” into two fields; hoping this improves reporting. New fields will be entitled (1) “Model number” (2) “Catalog number” (3) “Lot number” (4) Serial number” (5) “UDI Number and (6) “Expiration Date.”
In section D we are changing the terminology from “Sex” to “Current Gender” followed by corresponding check boxes next to the options “Female”, “Male”, “Intersex”, “Transgender”, “Prefer not to disclose”.
In section E, we are revising the question “If you do NOT want your identity disclosed to the manufacturer, place an `X' in this box:” to read “If you do NOT want your identity disclosed to the manufacturer/compounder, place an `X' in this box:”
In the
General comments included suggestions that the MedWatch program be better advertised to physicians and other medical healthcare professionals as well as patients. Also, that the forms use terminology more familiar to healthcare providers and consumers. For example, using `Medication error' or `Medication error/product use error' instead of `Product use error' to ensure respondents are aware that MedWatch forms can be used to report medication errors. Other comments suggested revisions that might improve or otherwise clarify instructions. Finally, some comments pertained to the advantages of electronic reporting.
More specific comments included a suggestion to add a question to section A of Form FDA 3500 related to pregnancy. While we agree that documenting pregnancy status is important, we do not plan on adding an additional checkbox for pregnancy at this time. Previously (in 2005), we proposed adding checkboxes for both “Product Used During Pregnancy” and “Product Used During Breast Feeding.” However we received comments expressing concern that these new data fields introduced divergence from International Council on Harmonisation standards and appeared to duplicate information usually provided in the narrative section and in coded adverse event terms. At the same time, we ask readers to note that pregnancy status can be captured in field B7 under “other relevant history.”
Another comment suggested adding “Physician Assistant” to the drop down “Occupation” menu in section G of Form FDA 3500. We appreciate this
We also received comment that some users have experienced “timing out” while completing Form FDA 3500B online and requested that any time limit for completing online forms be extended. We were not aware of this issue and will investigate to see whether it relates to the online functionality of the form. If so, we will make the necessary adjustments.
While we are especially appreciative of the comments received in response to our notice, we continue to welcome feedback at all times regarding ways we might improve the MedWatch Program and the associated forms. In addition to the revisions discussed previously, on our own initiative we are now including burden associated with written submissions under § 329.100(c)(2) (21 CFR 329.100(c)(2)) that request a temporary waiver from the electronic reporting requirements associated with postmarket adverse drug events under section 760 of the FD&C Act. While we expect few such waiver requests, we retain a placeholder for one respondent annually, and we estimate it takes 1 hour to complete the request.
We therefore estimate the burden for the information collection as follows.
While we retain the currently approved estimate for the information collection, as noted previously we have added burden associated with written submissions under § 329.100.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” This public workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients' immunologic risk for organ rejection or tolerance. The public workshop will include discussion of the biomarker qualification process and how it could be used to develop biomarkers for use in clinical trials in transplantation, to develop new drugs to address unmet needs, and in clinical practice to guide patient treatment selection. Speakers will be patients who will provide perspective on the challenges of living with a transplant, managing immunosuppression and perspectives on tolerability, adherence, and risk that may inform patient-reported outcome (PRO) and patient-focused drug development.
The public workshop will be held on September 27, 2018, from 8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m. Submit either electronic or written comments on this public workshop by November 19, 2018. See the
The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 19, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Derek Alberding or Ramou Pratt, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0963,
FDA is announcing a public workshop entitled “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” This public workshop is intended for academic experts, industry, healthcare providers, patients, other U.S. Government Agencies, and other stakeholders.
Presentations and discussions will cover identifying potential candidate biomarkers that could:
• Be considered for the biomarker qualification process
• be used in identifying patients at high immunologic risk or low immunologic risk
• be used in clinical trials to develop drugs to address unmet individual needs in transplantation
• be used to make appropriate immunosuppressive regimen treatment decisions
In addition, patient speakers will provide perspectives on:
• Challenges of living with a transplant,
• managing immunosuppression, and
• tolerability, adherence, and risk of therapy.
The goal of these presentations is to inform PRO and patient-focused drug development.
Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please contact Derek Alberding or Ramou Pratt (see
If you have never attended a Connect Pro event before, test your connection at
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on October 10, 2018, from 8 a.m. to 1 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-3308. The docket will close on October 9, 2018. Submit either electronic or written comments on this public meeting by October 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 9, 2018. The
Comments received on or before October 1, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren D. Tesh (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the
Angela Hoague, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301-348-3915,
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010. The BPCI Act amended the PHS Act and created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference
FDA received notice of the following complaint under section 351(l)(6)(C) of the PHS Act:
FDA has only a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act, and does not perform a substantive review of the complaint.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by November 13, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Amber Sanford, Office of Operations,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) when appropriate. This guidance is intended to assist persons who seek meetings with FDA relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. The original guidance issued in 2012 was revised for updating and clarity in July 2016.
In the guidance, the Agency discusses, among other things:
• What information FDA recommends persons include in a meeting request;
• How and when to submit a request; and
• What information FDA recommends persons submit prior to a meeting.
This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package in advance of the meeting. The purpose of this proposed information collection is to allow FDA to conduct meetings with tobacco manufacturers, importers, researchers, and investigators in an effective and efficient manner. FDA issued this guidance and the revisions consistent with FDA's good guidance practices regulations (21 CFR 10.115).
1. Product name and FDA-assigned Submission Tracking Number (if applicable);
2. Product category (
3. Product use (indicate for consumer use or for further manufacturing);
4. Contact information for the authorized point of contact for the company requesting the meeting;
5. The topic of the meeting being requested (
6. A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans;
7. A preliminary list of the specific objectives/outcomes expected from the meeting;
8. A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item;
9. A preliminary list of specific questions, grouped by discipline (
10. A list of all individuals who will attend the meeting on behalf of the tobacco product manufacturer, importer, researcher, or investigator, including titles and responsibilities;
11. The date on which the meeting information package will be received by FDA; and
12. Suggested format of the meeting (
This information will be used by the Agency to: (1) Determine the utility of the meeting, (2) identify Agency staff necessary to discuss proposed agenda items, and (3) schedule the meeting.
1. Product composition and design data summary;
2. Manufacturing and process control data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data summary;
6. User and nonuser perception data summary; and
7. Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/exclusion criteria, comparison group(s));
e. Human subject protection information, including Institutional Review Board information;
f. Primary and secondary endpoints (definition and success criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline and follow up assessments, and
j. Data analysis plan(s).
The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency's experience, reviewing such information is critical to achieving a productive meeting. If the information package was previously submitted in the meeting request, it should be revised, as applicable, so that the information reflects the most current and accurate information available.
FDA estimates the burden of this collection of information as follows:
FDA's estimate of the number of respondents for meeting requests in table 1 is based on the number of meeting requests received and projected over the next 3 years. FDA estimates that 83 preapplication meetings will be requested.
The hours per response for combining and sending meeting request letters are estimated at 10 hours each, and the total burden hours for meeting requests are expected to be 830 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting.
FDA's estimates that 83 respondents will compile meeting information packages and submit to FDA at 18 hours per response. Based on FDA's experience, the Agency expects that it will take respondents 1,494 hours (83 respondents × 18 hours) to gather, copy, and submit brief statements about the product, a description of the details of the anticipated meeting, and data and information that generally would already have been generated for the planned research and/or product development.
The total number of burden hours for this collection of information is estimated to be 2,324 hours (830 hours to prepare and submit meeting requests and 1,494 hours to prepare and submit information packages).
Our estimated burden for the information collection reflects an overall increase of 16 respondents and 448 hours. We attribute this adjustment to an increase in the number of industry meetings as the premarket tobacco application compliance deadlines will come due in the next 3 years.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4383-DR), dated August 10, 2018, and related determinations.
The declaration was issued August 10, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated August 10, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Wisconsin resulting from severe storms, straight-line winds, and flooding during the period of June 15 to June 19, 2018, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, David G. Samaniego, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Wisconsin have been designated as adversely affected by this major disaster:
Ashland, Bayfield, Burnett, Clark, Douglas, and Iron Counties for Public Assistance.
All areas within the State of Wisconsin are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for State of Hawaii (FEMA-3399-EM), dated August 22, 2018, and related determinations.
This change occurred on August 24, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Willie G. Nunn, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of William Roche as Federal Coordinating Officer for this emergency.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
This Notice advises the public that HUD, in order to more effectively and expeditiously respond to Presidentially-declared Major Disaster Declarations (MDD), is establishing for CY 2018 an expedited process for the review of requests for relief from HUD regulatory and/or administrative requirements (“HUD requirements”) for public housing agencies (PHAs) that are located in counties that are included in MDDs. PHAs located in areas covered by MDDs issued for which a related disaster occurs during 2018 may request waivers of HUD requirements and receive expedited review of such requests utilizing the flexibilities and expedited waiver process set out by this Notice.
Shelia Bethea, Office of Field Operations, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4112, Washington, DC 20410-5000, telephone number 202-402-8120. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at 800-877-8339.
On several occasions in recent years, after Presidential disaster declarations, HUD has published notices to announce waivers and flexibilities available to PHAs, Tribes, and Tribally Designated Housing Entities located in areas covered by MDDs.
• Section II describes the flexibilities that are currently available to MDD PHAs under statutes and/or regulations. MDD PHAs may avail themselves of these flexibilities, following the process described in Section IV of the Notice.
• Section III describes certain HUD requirements that, if waived, may facilitate an MDD PHA's ability to participate in relief and recovery efforts. An MDD PHA may request a waiver of a HUD requirement not listed in Section IV and receive expedited review of the request if the MDD PHA demonstrates that the waiver is needed to assist in its relief and recovery efforts. An MDD PHA may not adopt any requested waiver prior to receiving HUD approval.
• Section V States that a Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).
Waiver requests approved by HUD pursuant to this Notice will be published in the
This Notice applies only during CY 2018.
HUD is exercising discretionary authority consistent with 24 CFR 5.110 to provide relief from the requirements described in this section. Upon notification to HUD and appropriate documentation of good cause, or upon HUD approval, as noted below, relief will be granted to MDD PHAs. Relief from the requirements must benefit families affected by the disasters, for example by enabling MDD PHA staff to focus on relief and recovery efforts. Unless otherwise stated, the deadline for requesting waivers is 4 months after the initial MDD.
For an MDD PHA, HUD will review requests for waivers of HUD requirements on an expedited basis. This section lists requirements for waivers, requests for which HUD anticipates receiving. An MDD PHA may also request a waiver of a HUD requirement not listed in this section and receive expedited review of the request if the MDD PHA documents that the waiver is needed for relief and recovery purposes. This documentation need not be in writing if HUD determines that providing written documentation is impracticable.
PHAs must note that commonly sought waivers such as waiving inspection or income verification requirements entirely cannot be granted. PHAs should go through the hierarchy of verifying income as found in PIH 2017-12 if sources of income are difficult to find. Similarly, while the requirement for HQS inspections cannot be waived, HUD can consider variations to the acceptability criteria to HQS in case of disaster (under the authority of 982.401(a)(4)).
HUD expects that any waiver granted pursuant to this Notice will benefit families affected by disasters by, for example, enabling MDD PHA staff to focus on relief and recovery efforts.
An MDD PHA seeking a waiver of a HUD requirement listed below or of any other HUD requirement needed to assist the MDD PHA in its relief and recovery efforts must submit a waiver request pursuant to the process that will be provided in a further Notice. HUD will not approve an MDD PHA's or other recipient's request to waive a fair housing, civil rights, labor standards, or environmental requirement. The request must be submitted to HUD not later 4 months following the date of the relevant disaster declaration.
For MDD PHAs with a deadline to submit only audited financial information in accordance with 24 CFR 5.801(b) and (d) within 6 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waive the due date. For MDD PHAs with a deadline to submit unaudited financial information in accordance with 24 CFR 5.801(b) and (d) within 4 months before and up to 6 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waiver the due date. For these PHAs, HUD also is willing to consider a request to waive the due date of the audited financial information. For situations beyond a PHA's control, HUD is willing to consider requests from the MDD PHAs with financial submission due dates that fall outside these dates.
The deadline for submission of financial information in accordance with 24 CFR 5.801(b) and the deadline for submission of unaudited financial statement may be extended to 180 calendar days, and the deadline for submission of audited financial statements may be extended to 13 months.
For MDD PHAs with FYE dates within 4 months before and up to 10 months after the date of the disaster related to the MDD, HUD is willing to consider a request to waive the physical inspection and scoring of public housing projects, as required under 24 CFR 902. For situations beyond the PHA's control, HUD is willing to consider requests from MDD PHAs with a FYE date that falls outside these dates.
HUD has developed a checklist (Attachment A to this Notice) that an MDD PHA must complete and submit to take advantage of the provisions identified in this Notice and the expedited review of waiver requests. Each provision on the checklist indicates the documentation that must accompany the MDD PHA's submission. Each request for a waiver (Section 3 of the checklist) must include a good-cause justification stating why the waiver is needed for the PHA's relief and recovery efforts.
To complete the checklist, take the following steps:
1. Download the checklist to your computer, saving the document with the following filename: FR-6050-N-02. Your Agency's HA Code (
2. Complete the section titled Information about Requesting Agency. This section must be complete. An official of the MDD PHA must sign where indicated. If the information about the requesting agency is incomplete or the checklist has not been signed, then the checklist will be returned without review.
3. Complete Sections 1, 2, and/or 3 of the checklist, as applicable, noting the documentation (if any) that accompanies each provision.
4. Address an email to both
5. Attach the completed checklist, letter of justification, and supporting documentation as applicable to your email.
6. Click “Send.”
Checklists and any supporting documentation or information must be submitted not later than 4 months following the MDD. Requests submitted after that time period will not be considered except in special cases outside of the agency's control.
A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the docket file must be scheduled by Calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM), Southeast Oregon Resource Advisory Council (RAC) will meet as indicated below.
The Southeast Oregon RAC will meet Thursday, October 11, and Friday, October 12, 2018 from 8 a.m. to 5 p.m. Pacific Daylight Time each day. A half-hour comment period, during which the public may address the RAC, will begin at 4 p.m. Friday, October 12. The final agenda will be posted online at
This meeting will be held at the Harney County Chamber of Commerce, 484 N Broadway, Burns, OR 97720.
Larisa Bogardus, Public Affairs Officer, 1301 S G Street, Lakeview, Oregon 97630; (541) 947-6811;
The meeting Thursday, October 11, will consist of working sessions that pertain to the Lakeview Resource Management Plan Amendment (RMP-A) and the Southeast Oregon (Vale) RMP-A. The meeting Friday, October 12, will include discussions about potential management approaches for the draft alternatives for the Lakeview District's RMP-A; development of interstate fuel breaks to protect against wildfire; a discussion of potential comments to submit regarding the draft alternatives proposed for the Southeast Oregon RMP-A; a report on the 2018 Fire Season; a presentation by the State of Oregon Department of Fish and Wildlife regarding their wolf management plan and how it applies to Federal lands; and any other business that may reasonably come before the RAC.
The 15-member Southeast Oregon RAC was chartered and appointed by the Secretary of the Interior. Their diverse perspectives are represented in commodity, conservation, and general interests. They provide advice to the BLM and US Forest Service resource managers regarding management plans and proposed resource actions on public land in southeast Oregon. All meetings are open to the public in their entirety. Information to be distributed to the RAC is requested prior to the start of each meeting.
Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee we will be able to do so.
43 CFR 1784.4-2.
Bureau of Land Management, Interior.
Notice of official filing.
The plats of survey of lands described in this notice are scheduled to be officially filed in the Bureau of Land Management (BLM), Alaska State Office, Anchorage, Alaska. The surveys, which were executed at the request of the U.S. Fish and Wildlife Service and the BLM, are necessary for the management of these lands.
The BLM must receive protests by October 12, 2018.
You may obtain a copy of the plats from the Alaska Public Information Center at the BLM Alaska State Office, 222 W. 7th Avenue, Anchorage, AK 99513, upon required payment. You may view the plats at this location at no cost. Please use this address when filing written protests.
Douglas N. Haywood, Chief, Branch of Cadastral Survey, Alaska State Office, Bureau of Land Management, 222 W 7th
The lands surveyed are:
U.S. Survey No. 14489, accepted August 30, 2018.
U.S. Survey No. 14495, accepted August 30, 2018.
A person or party who wishes to protest one or more plats of survey identified above must file a written notice of protest with the State Director for the BLM in Alaska. The notice of protest must identify the plat(s) of survey that the person or party wishes to protest. You must file the notice of protest before the scheduled date of official filing for the plat(s) of survey being protested. The BLM will not consider any notice of protest filed after the scheduled date of official filing. A notice of protest is considered filed on the date it is received by the State Director for the BLM in Alaska during regular business hours; if received after regular business hours, a notice of protest will be considered filed the next business day. A written statement of reasons in support of a protest, if not filed with the notice of protest, must be filed with the State Director for the BLM in Alaska within 30 calendar days after the notice of protest is filed.
If a notice of protest against a plat of survey is received prior to the scheduled date of official filing, the official filing of the plat of survey identified in the notice of protest will be stayed pending consideration of the protest. A plat of survey will not be officially filed until the dismissal or resolution of all protests of the plat.
Before including your address, phone number, email address, or other personal identifiable information in a notice of protest or statement of reasons, you should be aware that the documents you submit, including your personal identifiable information, may be made publicly available in their entirety at any time. While you can ask the BLM to withhold your personal identifiable information from public review, we cannot guarantee that we will be able to do so.
43 U.S.C. Chap. 3.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping duty investigation Nos. 731-TA-1422-1423 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of strontium chromate from Austria and France, provided for in subheadings 2841.50.91 and 3212.90.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value. Unless the Department of Commerce (“Commerce”) extends the time for initiation, the Commission must reach a preliminary determination in antidumping duty investigations in 45 days, or in this case by October 22, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by October 29, 2018.
September 5, 2018.
Kristina Lara (202) 205-3386, Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.
By order of the Commission.
Bureau of Justice Statistics, Department of Justice.
60-day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting an extension to an existing information collection to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until November 13, 2018.
If you have additional comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Mary Cowhig, Statistician, 810 Seventh Street NW, Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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The applicable component within the Department of Justice is the Bureau of Justice Statistics (BJS), in the Office of Justice Programs.
BJS proposes to transfer the MCI-Jails information collection from the currently approved OMB collection under control number 1121-0094, where it was bundled with the Annual Survey of Jails and the Survey of Jails in Indian Country collections in 2015, to this collection (OMB Control Number 1121-0249, expiration 03/31/2019) to form one mortality collection program.
The combined mortality collection would include the 50 state departments of corrections (DOCs) plus approximately 3,000 local jail jurisdictions and would collect data on the number and nature of inmate deaths in the custody of state correctional facilities.
Prior to 2015, BJS collected mortality data from both state prisons and local jails under the OMB Control Number 1121-0249. In 2015, the Mortality in Correctional Institutions (Jails) (MCI-Jails) portion of the collection was bundled with the Annual Survey of Jails (ASJ) and the Survey of Jails in Indian Country (SJIC) in an attempt to consolidate the response burden placed on jails. However, the overlap among these three collections is small, both in terms of jails covered in each and context collected:
• MCI-Jails requests annual data from about 3,000 jail jurisdictions on deaths, the confined population as of December
• The ASJ samples approximately 900 local jails, and provides data to estimate the number and characteristics of local jail inmates nationwide. The ASJ collects population information, including the number of confined inmates, number of individuals supervised in the community by local jails, average daily population, and the number of holds for other authorities as of June 30. The ASJ also obtains data on inmate movements, including the number of admissions and discharges; facility characteristics, including rated and peak capacities and staffing; and inmate characteristics, including race and ethnicity, sex, age group (adult or juvenile), primary offense, and conviction status.
• The SJIC collects data from Indian country jails that are not part of either the ASJ or the MCI-Jails collections. The SJIC collects information from confinement facilities, detention centers, jails, and other facilities operated by tribal authorities or the Bureau of Indian Affairs.
The following forms are proposed to be transferred from OMB Control Number 1121-0094 to OMB Control Number 1121-0249:
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The estimated total burden hours associated with this combined jail and state prison mortality collection for report year 2018 is 3,565. This is a transfer of 1,733 hours from the jail mortality collection to the state prison mortality collection. When the state prison mortality collection was last approved in 2016, the total burden estimate was 1,723 hours. The state prison portion is now estimated at 1,832 burden hours due to an increase in the expected number of individual death reports. Based on the average number of death reports received over the most recent 10-year period, BJS expects to receive about 3,500 state prison and 1,000 jail death reports per year.
If additional information is required, contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
National Aeronautics and Space Administration (NASA).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.
Thursday, October 11, 2018, 10:45 a.m. to 12 p.m., Central Time.
NASA Johnson Space Center, Building 1, Room 966, 2101 NASA Parkway, Houston, TX 77058.
Ms. Evette Whatley, Aerospace Safety Advisory Panel Administrative Officer, NASA Headquarters, Washington, DC 20546, (202) 358-4733, or email at
The Aerospace Safety Advisory Panel (ASAP) will hold its Fourth Quarterly Meeting for 2018. This discussion is pursuant to carrying out its statutory duties for which the Panel reviews, identifies, evaluates, and advises on those program activities, systems, procedures, and management activities that can contribute to program risk. Priority is given to those programs that involve the safety of human flight. The agenda will include:
The meeting will be open to the public up to the seating capacity of the room. Seating will be on a first-come basis. This meeting is also available telephonically. Any interested person may call the USA toll free conference call number (888) 566-6575; pass code 3391926. Attendees will be required to sign a visitor's register and to comply with NASA security requirements, including the presentation of a valid picture ID, before receiving an access badge. Any member of the public desiring to attend the ASAP 2018 Fourth Quarterly Meeting at the Johnson Space Center must provide their full name and company affiliation (if applicable) to Ms. Stephanie Castillo at
At the beginning of the meeting, members of the public may make a verbal presentation to the Panel on the subject of safety in NASA, not to exceed 5-minutes in length. To do so, members of the public must contact Ms. Evette Whatley at
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
National Science Foundation.
Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received.
On March 31, 2003, the National Science Foundation (NSF) issued a final rule that authorized the collection of meteorites in Antarctica for scientific purposes only. In addition, the regulations provide requirements for appropriate collection, handling, documentation, and curation of Antarctic meteorites to preserve their scientific value. These regulations implement the Antarctic Conservation Act of 1978, as amended by the Antarctic Science, Tourism and Conservation Act of 1996, and Article 7 of the Protocol on Environmental Protection to the Antarctic Treaty. The NSF is required to publish notice of the availability of Meteorite Collection, Documentation, and Curation Plans received under the Antarctic Conservation Act of 1978. This is the required notice.
Interested parties are invited to submit written data, comments, or views with respect to this plan by September 27, 2018. This plan may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at
An Antarctic meteorite collection, documentation, and curation plan has been received from Ralph Harvey and James Karner of Case Western University.
The National Science Board, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of RESCHEDULING a meeting for the transaction of National Science Board business.
83 FR 43710, published on August 27, 2018. The teleconference meeting was originally scheduled for Thursday, August 30, 2018, from 3:00-4:00 p.m. EDT.
83 FR 44675, published on August 30, 2018.
This closed teleconference meeting of the National Science Board has been rescheduled and will be held on Tuesday, September 18, 2018, from 4:00-5:00 p.m. EDT.
Brad Gutierrez,
National Science Foundation.
Notice of Permit Modification Request.
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. This is the required notice of a requested permit modification.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 12, 2018. Permit applications may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
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Now the permit holder proposes a modification to the permit to increase the number of takes allocated to certain permitted activities to reflect the same increases authorized earlier this year in NMFS Permit No. 21158-02. The take increases from those allowed under the ACA permit, as originally issued, would be as follows: Increase from 515 to 800 pups, flipper tagged once; increase from 10 to 20 pups, flipper tagged twice; increase from 285 to 385 adults, flipper tagged once; increase from 1325 to 1800 adults, harassment takes (4 per animal); increase from 675 to 910 pups, harassment takes (4 per animal); increase from 10 to 35 adults, salvage parts and vibrissae samples (3 per animal). These proposed changes would set the total number of takes of Weddell seal pups for flipper tagging to 970. The permit holder has also requested that a documentary film crew be allowed to accompany and film the permit holder and agents as they conduct the permitted activities this season.
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Now the applicant proposes a modification to the permit to allow the following: Sedation of all seal pups at all time points using midazolam with or without butorphanol (and continue to have the option of using midazolam in combination with ketamine at 7-8 weeks of age); collection of blood samples from seal pups in the second cohort, at all four time points, while the pups are under sedation; use of a cannulated biopsy needle for muscle tissue sampling of seal pups in the first cohort (rather than a dermal biopsy punch), at all four time points; attachment of a flipper-mounted VHF transmitter tag to seal pups in both cohorts at 3 weeks of age, on the flipper opposite the one with the time/depth tag attached, with removal at the final time point; attachment of accelerometer tags to the dorsal pelage of 1-week-old pups in both cohorts with removal of the tags at 3 weeks of age; administration of antibiotics to treat local or systemic infections in seal pups involved in the study; and increased takes of seal pups and adult females such that a total of 12 pups would be handled for study purposes compared with 10 in the original permit (six pups in each cohort compared with five in the original permit) and a total of 12 adult females, the mothers of the pups, would be disturbed during the handling of the pups (10 in the original permit). The permit holder has also requested a modification of NMFS Permit No. 21006.
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Now the permit holder proposes a modification to the permit to attach a miniature video camera to adult Adelie penguins (n=40) to document activities during diving. The permit holder also proposes to engage the services of experienced pilots to operate remotely piloted aircraft systems (RPAS) to capture video imagery of penguin colonies for the purposes of census and quantifying habitat characteristics. The RPAS operations would occur within the boundaries of ASPA 121, Cape Royds, and ASPA 124, Cape Crozier.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
National Science Foundation.
Notice of permit applications received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 12, 2018. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 671), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
For vessel-supported short overnight stays (camping): Camping would be away from vegetated sites and at least 150m from wildlife concentrations or lakes, protected areas, historical sites, and scientific stations. Tents would be pitched on snow, ice, or bare smooth rock, at least 15m from the high-water line. No food, other than emergency rations, would be brought onshore and all wastes, including human waste, would be collected and returned to the ship for proper disposal. Campers would be limited to 30 passengers plus staff, except at the following sites where campers are limited to 60 passengers plus staff: Damoy Point/Dorian Bay, Danco Island, Pleneau Island, Leith Cove, and Rongé Island. The ratio of staff to passengers would be 1:10. Camping would include overnight stays of any duration, but in accordance with the visitor site guidelines for each site.
For remotely piloted aircraft systems (RPAS) operation: The quadcopter would not be flown over wildlife, or over Antarctic Specially Protected Areas or Historic Sites and Monuments. The RPAS would only be operated by pilots with adequate experience. Several measures would be taken to prevent against loss of the quadcopter including painting the them a highly visible color; only flying when the wind is calm; flying for only 15 minutes at a time to maintain adequate battery charge; having a flotation device for operations over water, and an “auto go home” feature in case of loss of control link or low battery; having an observer on the lookout for wildlife, people, and other hazards; and ensuring that the separation between the operator and quadcopter does not exceed a maximum distance of 300 meters.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a July 19, 2017 request from FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC (collectively, the licensee), as supplemented by letters dated March 16, 2018, and May 2, 2018. The exemption is from the NRC definition for a physical barrier regarding the construction standards for the fence bracket angle. The exemption allows the licensee to apply a fence topper bracket angle of zero degrees (or vertical) at specific locations on the protected area fence at each facility, in lieu of the 30 to 45 degree fence bracket angle required by Commission regulations. All other construction standards contained in the Commission regulations for a physical barrier fence topper remain applicable.
The exemption was issued on September 6, 2018.
Please refer to Docket IDs. NRC-2018-0187, NRC-2018-0192, and NRC-2018-0193 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Bhalchandra K. Vaidya, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3308; email:
The NRC is making the documents identified below available to interested persons through one or more of the following methods, as indicated. To access documents related to this action, see
The text of the exemption is attached.
For the Nuclear Regulatory Commission.
FirstEnergy Nuclear Operating Company (FENOC) and FirstEnergy Nuclear Generation, LLC (collectively, the licensee), are the holders of the following operating licenses: (1) Renewed Facility Operating License No. DPR-66, and No. NPF-73, at Beaver Valley Power Station, Units 1 and 2 (BVPS), issued on November 5, 2009; (2) Renewed Facility Operating License No. NPF-3 at Davis-Besse Nuclear Power Station (DBNPS), Unit No. 1, issued on December 8, 2015; and (3) Facility Operating License No. NPF-58 at Perry Nuclear Power Plant (PNPP), Unit No. 1, issued on November 13, 1986. The licenses provide, among other things, that the facilities are subject to all rules, regulations, and orders of the NRC now or hereafter in effect.
Pursuant to 10 CFR 73.5, “Specific exemptions,” by letter dated July 19, 2017 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17200D139), FENOC requested a specific partial exemption from one physical barrier construction standard described in 10 CFR 73.2, “Definitions” for fences. The Commission requirement for a protected area physical barrier is stated in 10 CFR 73.55(e)(8)(i) which requires, in part, that: “The protected area perimeter must be protected by physical barriers that are designed and constructed to . . . ” to limit access, etc. The construction standards for a physical barrier are defined in 10 CFR 73.2.
The regulation in 10 CFR 73.2 requires, in part, that fences must be constructed of No. 11 American wire gauge, or heavier wire fabric, topped by three strands or more of barbed wire or similar material on brackets angled inward or outward between 30 and 45 degrees from the vertical. Currently, some of the barbed wire bracketing on top of the protected area physical barrier fencing does not meet this design criteria specified in 10 CFR, Section 73.2.
The requested partial exemption would allow the licensees to configure the bracket topper supporting three strands of barbed-wire or similar material at the vertical orientation (or 0 degrees) only at specific
Pursuant to 10 CFR 73.5, “Specific exemptions,” the Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.
In the request dated July 19, 2017, FENOC states, in part, that brackets on the top of physical barrier fencing are currently oriented vertically on gates, near gates, near interfaces with buildings, and on corners. BVPS, DBNPS, and PNPP have similar configurations while DBNPS has vertical brackets on top of fences near the intrusion detection system (lDS). The FENOC exemption request is limited to specific portions of the protected area perimeter fence where the licensee prefers to orient the bracket topper on the protected area fence at a vertical orientation, in lieu of the inward or outward, 45 to 30 degree angular construction standard stated in the 10 CFR 73.2.
In Section 4.0 of the submittal dated July 19, 2017, FENOC states that the basis for this exemption is that the vertical configuration of the brackets on and near gates, near interfaces with buildings, on corners, and near the IDS, of the protected area fence does not have an adverse impact on the site protective strategies and will continue to protect against the design basis threat of radiological sabotage. FENOC further states that because the vertical barbed wire will maintain the plant's physical security, the underlying purpose of the regulation is met. The limited protected area fence sections where the configuration does not meet the current regulatory requirement is a small portion of the entire protected area perimeter fence. Consultation of design drawings and protected area site walk-downs estimates this portion to be approximately 6 percent or less for each of the three sites. Finally, in Chapter 6, Section 6.2, of the BVPS, DBNPS, and PNPP Physical Security Plans, the licensee states that the 45 to 30 degree angular requirement for the fence topping may not be met at locations such as gates and buildings.
In the supplemental submission dated March 16, 2018, to NRC staff Request for Additional Information (RAI) No. 2, the licensee stated that the technical basis for the FENOC request for exemption from this requirement is that the vertical bracket configuration is limited to locations on gates, near gates, near interfaces with buildings, and on corners where the licensee prefers to increase the tension that can be applied to the three strands of barbed-wire. The licensee goes on to state that “DBNPS also has vertical brackets in two locations adjacent to the IDS where physical separation clearance is required.” In the supplemental submission dated May 2, 2018 (ADAMS Accession No. ML18122A133), to NRC staff request for Follow-up RAI No. 1, the licensee stated that the outward angular fence bracket requirement would interfere with the effective operation of the IDS in that it would result in an unacceptable frequency of false alarms and would reduce the sensitivity of the detection capability to an unacceptable level.
The licensee further states in the supplemental response dated March 16, 2018, that “other than the DBNPS locations near the IDS, the vertical bracket configuration at the other locations described in the exemption request is preferred to maintain sufficient tension in the barbed wire strands.” The licensee goes on to state that the vertical bracket configuration is preferred because greater barbed wire tension can be applied when using vertical brackets as opposed to angular brackets on the end of fence runs (which includes on top of gates, adjacent to gates, and adjacent to buildings). Angular corner arms do not provide a good tension point in the barbed wire.
In the supplemental submission dated March 16, 2018, in response to NRC staff RAI No. 3, the licensee stated that the vertical bracket configuration has no impact to adversary or responder timelines in the protective strategies for the FENOC fleet. This is due to site-specific evaluations that determined the limiting perimeter barrier fence scenarios are most similar to a configuration illustrated in Regulatory Issue Summary 2003-06, or the use of mechanical breaching utilizing the same configuration. The licensee also stated that whether or not the fence toppings are vertical or angled makes no difference to the protective strategy limiting timelines.
This exemption would allow the application of a 0 degree (or vertical/upward) fence topper bracket angle at specific locations at BVPS Units 1 and 2, DBNPS, and PNPP. As stated above, 10 CFR 73.5 allows the NRC to grant exemptions from the requirements of 10 CFR part 73. The fence topper bracket angle that will be applied at BVPS, DBNPS, and PNPP does not conform to the fence topper bracket angle of inward or outward, between 30 and 45 degrees that is explicitly defined in 10 CFR 73.2; however, the NRC staff has determined that the construction standard applied at each of the three facilities and as described in the Chapter 6, Section 6.2 of the BVPS, DBNPS, and PNPP Physical Security Plans does not negatively impact the capability of the physical protection program at each facility meet the requirements of 10 CFR 73.55(b). Therefore, granting the licensee's proposed exemption would not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Accordingly, the granting of the partial exemption request from the requirements of 10 CFR 73.2 is authorized by law.
The objectives of 10 CFR 73.55(e) for physical barriers and the construction standards for fences contained in the 10 CFR 73.2 definition are to ensure that licensees provide physical barriers that are adequately designed and constructed to perform their intended physical protection program function. Further, all other construction materials and components required for a fence as defined in 10 CFR 73.2 are currently in place and are maintained at the affected FENOC facilities as stated. In addition, the level of protection offered by the requested bracket configuration has been accounted for by the licensee as part of the facility physical protection program. Finally, based on the above discussion, the NRC staff has concluded that the use of physical barriers as described in the BVPS, DBNPS, and PNPP security plans would provide adequate protection against the design basis threat of radiological sabotage, if effectively implemented. Therefore, the NRC staff has determined that this exemption would not endanger life or property.
The partial exemption would allow the licensee to apply a fence topper bracket angle of 0 degrees (or vertical) at specific locations in lieu of the required inward or outward angle of 30 to 45 degrees. In Section 4.0 of the submittal dated July 19, 2017, the licensee states that the vertical configuration of the brackets on and near gates, near interfaces with buildings, on corners, and near the IDS, of the protected area fence does not have an adverse impact on the site protective strategies and will continue to protect against the design basis threat of radiological sabotage. Because the vertical barbed wire will maintain the plant's physical security, the NRC staff finds that the underlying purpose of the regulation is met. The licensee is required to develop and maintain a physical protection program that maintains the capability to detect, assess, interdict, and neutralize all threats up to and including the design basis threat of radiological sabotage. Therefore, the NRC staff has determined that this exemption would not endanger common defense and security.
Based on its evaluation of licensee's request for an exemption to allow vertical barbed wire fence toppings in limited protected area sections (on and near gates, near interfaces with buildings, on corners, and near the IDS) as described in the licensee's submission dated March 16, 2018, the NRC staff has determined that the partial exemption would maintain the physical security of the sites and would not have an adverse effect on public interest. Therefore, the NRC staff has determined that this exemption is otherwise in the public interest.
In accordance with 10 CFR 51.31(a), the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment as discussed in the NRC staff's Finding of No Significant Impact and associated Environmental Assessment published in
Accordingly, the Commission has determined that pursuant to 10 CFR 73.5, the exemption is authorized by law, will not endanger life or property, is consistent with the common defense and security, and is otherwise in the public interest. Therefore, the Commission hereby grants FENOC a partial exemption from the requirements of 10 CFR 73.2 for a fence bracket to be angled inward or outward between 30 and 45 degrees, to allow the fence bracket angular orientation of 0 degrees (or vertical/upward) at BVPS, DBNPS, and PNPP at only those locations specifically identified by the licensee in the supplemental response dated March 16, 2018, to NRC staff RAI No.1, explicitly, “site layouts with the locations and descriptions of the protected area physical barrier fencing sections topped with vertically-oriented brackets containing barbed wire or similar material are provided in Figures 1, 2, and 3 for BVPS, DBNPS, and PNPP, respectively.” All other construction and design requirements apply to the specified locations as stated in 10 CFR 73.2. Additionally, all construction and design requirements for a physical barrier as stated in 10 CFR 73.2, remain applicable to all other facility locations not specified in Figures 1, 2, and 3, for BVPS, DBNPS, and PNPP, respectively as specified in the supplemental response to NRC staff RAI No. 1, dated March 16, 2018.
Dated at Rockville, Maryland, this 6th day of September, 2018.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft NUREG; request for comments.
The U.S. Nuclear Regulatory Commission (NRC) is revising its guidance about administrative licensing procedures and agency policies for reviewing nuclear materials licensing requests. The NRC is requesting public comment on draft NUREG-1556, Volume 20, “Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures.” The document has been updated from the original version to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by the NRC staff when reviewing NRC materials licensing requests.
Submit comments by October 15, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to assure consideration of comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on accessing information and submitting comments, see “Accessing Information and Submitting Comments” in the
Anthony McMurtray, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2746; email:
Please refer to Docket ID NRC-2018-0093 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods:
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The draft NUREG-1556, Volume 20, Revision 1, is also available on the NRC's public website at
Please include Docket ID NRC-2018-0093 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
NUREG-1556, Volume 20, Revision 1 provides guidance to NRC management and staff regarding administrative licensing procedures and agency policies for reviewing NRC materials licensing requests. The purpose of this notice is to provide the public with an opportunity to review and provide comments on draft NUREG-1556, Volume 20, Revision 1, “Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures.” These comments will be considered in the final version or subsequent revisions.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft regulatory issue summary; withdrawal.
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing draft regulatory issue summary, “Disposition of Information Related to the Time Period that Safety-Related Structures, Systems or Components are Installed,” which was published for public comment in the
The effective date of the withdrawal of the draft regulatory issue summary is September 12, 2018.
Please refer to Docket ID NRC-2016-0098 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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John Thompson, Office of Nuclear Reactor Regulation, telephone: 301-415-1011, email:
On September 14, 2017, NRC's Committee for the Review of Generic Requirements (CRGR) held a public meeting (Meeting No. 447) with industry to discuss this Regulatory Issue Summary (RIS). The meeting minutes are available in ADAMS at ML17276B156. Based on industry concerns expressed during the public meeting, the CRGR recommended that NRC staff cease efforts to further develop and issue the RIS.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s).”
Submit comments by October 12, 2018.
Submit comments directly to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0027), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email:
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2015-0027 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, NRC Form 7, “NRC Form 7, Application for NRC Export/Import License, Amendment, Renewal or Consent Request(s).” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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For the Nuclear Regulatory Commission.
On December 20, 2017, The Nasdaq Stock Market LLC (“Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares of the Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares
Legg Mason Partners Fund Advisor, LLC will be the investment manager (“Manager”)
Paragraph (g) of Rule 5735 provides that if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect and maintain a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company's portfolio.
Rule 5735(g) is similar to Nasdaq Rule 5705(b)(5)(A)(i); however, paragraph (g) in connection with the establishment and maintenance of a “fire wall” between the investment adviser and the broker-dealer reflects the applicable investment company's portfolio, not an underlying benchmark index, as is the case with index-based funds. None of the Manager or any of the Sub-Advisers is a broker-dealer, but each is affiliated with the Distributor, a broker-dealer, and has implemented and will maintain a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the portfolio.
In addition, personnel who make decisions on the Fund's portfolio composition will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding the Fund's portfolio. In the event (a) the Manager or any of the Sub-Advisers registers as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new investment adviser or any new sub-adviser to the Fund is a registered broker-dealer or becomes affiliated with another broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to the Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.
The investment objective of the Fund will be to seek to maximize total return, consistent with prudent investment management and liquidity needs. Although the Fund may invest in securities and Debt (as defined below) of any maturity, the Fund will normally maintain an effective duration as set forth in the prospectus.
Under Normal Market Conditions,
The Manager or Sub-Advisers (as applicable) may select from any of the following types of fixed income securities: (i) U.S. or foreign corporate debt securities, including notes, bonds, debentures, trust preferred securities, and commercial paper issued by corporations, trusts, limited partnerships, limited liability companies and other types of non-governmental legal entities; (ii) U.S. government securities, including obligations of, or guaranteed by, the U.S. government, its agencies or government-sponsored entities (other than MBS described below); (iii) sovereign debt securities, which include fixed income securities issued by governments, agencies or instrumentalities and their political subdivisions, securities issued by government-owned, controlled or sponsored entities, interests in entities organized and operated for the purpose of restructuring the investment instruments issued by such entities, Brady Bonds,
The securities in which the Fund invests may pay fixed, variable or floating rates of interest or, in the case of instruments such as zero coupon bonds, do not pay current interest but are issued at a discount from their face values. Securitized Products in which the Fund will invest make periodic payments of interest and/or principal on underlying pools of mortgages, in the case of MBS; loans, leases and receivables other than real estate, in the case of ABS; and government and corporate bonds or non-real estate related loans, in the case of CDOs. The Fund may also invest in stripped Securitized Products, which represent the right to receive either payments of principal or payments of interest on real estate receivables. Interests in CDOs and ABS will not be stripped so as to provide the right to receive only payments of principal or payments of interest.
Investments by the Fund in loans and similar debt instruments that are not characterized as “securities” under applicable case law (“Debt”)
With respect to fixed income securities, the Fund may invest in restricted instruments which are subject to resale restrictions that limit purchasers to qualified institutional buyers, as defined in Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) or to non-U.S. persons, within the meaning of Regulation S under the Securities Act.
The Fund will use derivatives to (i) provide exposure to U.S. or foreign fixed income securities, Debt and other Principal Investments, (ii) risk manage the Fund's holdings,
The Fund may, without limitation, enter into repurchase arrangements and borrowing and reverse repurchase arrangements, purchase and sale contracts, buybacks
Under Normal Market Conditions, the Fund will seek its investment objective by investing at least 80% of its assets in a portfolio of the Principal Investments. The Fund may invest its remaining assets exclusively in: (i) U.S. or foreign exchange-listed
The types of derivatives in which the Fund may invest and the reference assets for such derivatives are described in greater detail in “Principal Investments” and “Other Investments” above. Exchange-Traded Derivatives will primarily be traded on exchanges that are ISG members or exchanges with which the Exchange has a comprehensive surveillance sharing agreement. The Fund may, however, invest up to 10% of the assets of the Fund in Exchange-Traded Derivatives and exchange-listed securities whose principal market is not a member of ISG or a market with which the Exchange has a comprehensive surveillance sharing agreement. For purposes of this 10% limit, the weight of such Exchange-Traded Derivatives will be calculated based on the mark-to-market value of such Exchange-Traded Derivatives.
The Fund will limit the weight of its investments in OTC Derivatives to 10% of the assets of the Fund, with the exception of Interest Rate Derivatives
Derivatives are subject to trade reporting,
For purposes of the 10% limit applicable generally to OTC Derivatives (other than Interest Rate and Currency Derivatives), the weight of such OTC Derivatives will be calculated based on the mark-to-market value of such OTC Derivatives.
The Fund may choose not to make use of derivatives.
Generally, derivatives are financial contracts whose value depends upon, or is derived from, the value of an underlying asset, reference rate or index, and may relate to stocks, bonds, interest rates, currencies or currency exchange rates, commodities, and related indexes. As described above, the Fund will use derivatives to (i) provide exposure to the Principal Investments, (ii) risk manage the Fund's holdings,
Investments in derivative instruments will be made in accordance with the 1940 Act and consistent with the Fund's investment objective and policies. To limit the potential risk (including leveraging risk) associated with such transactions, the Fund will segregate or “earmark” assets determined to be liquid by the Manager and/or the Sub-Advisers in accordance with procedures established by the Board and in accordance with the 1940 Act (or, as permitted by applicable regulation, enter into offsetting positions) to cover its obligations under derivative instruments. These procedures have been adopted consistent with Section 18 of the 1940 Act and related Commission guidance. In addition, the Fund will include appropriate risk disclosure in its offering documents, including leveraging risk. Leveraging risk is the risk that transactions of the Fund, including the Fund's use of derivatives, may give rise to additional leverage, causing the Fund to be more volatile than it would have if it had not been leveraged. Because the markets for securities or Debt, or the securities or Debt themselves, may be unavailable, cost prohibitive or tax-inefficient as compared to derivative instruments, suitable derivative transactions may be an efficient alternative for the Fund to obtain the desired asset exposure.
The Manager and the Sub-Advisers believe that derivatives can be an economically attractive substitute for an underlying physical security or Debt that the Fund would otherwise purchase. For example, the Fund could purchase futures contracts on Treasury Securities instead of investing directly in Treasury Securities or could sell credit default protection on a corporate bond instead of buying a physical bond. Economic benefits include potentially lower transactions costs, attractive relative valuation of a derivative versus a physical bond (
The Manager and the Sub-Advisers further believe that derivatives can be used as a more liquid means of adjusting portfolio duration, as well as targeting specific areas of yield curve exposure, with potentially lower transaction costs than the underlying securities or Debt (
The Fund also can use derivatives to increase or decrease credit exposure. Index credit default swaps can be used to gain exposure to a basket of credit risk by “selling protection” against default or other credit events, or to hedge broad market credit risk by “buying protection.” Single name credit default swaps can be used to allow the Fund to increase or decrease exposure to specific issuers, saving investor capital through lower trading costs. The Fund can use total return swap contracts to obtain the total return of a reference asset or index in exchange for paying financing costs. A total return swap may be more efficient than buying underlying securities or Debt, potentially lowering transaction costs.
The Fund expects to manage foreign currency exchange rate risk by entering into Currency Derivatives.
The Sub-Advisers may use options strategies to meet the Fund's investment objectives. Option purchases and sales can also be used to hedge specific exposures in the portfolio and can provide access to return streams available to long-term investors such as the persistent difference between implied and realized volatility. Options strategies can generate income or improve execution prices (
The Fund may invest up to 30% of its assets in Non-Convertible Preferred Securities, Equity-Related Warrants and Work Out Securities. The Fund will not invest in equity securities other than Principal Investment Equities.
While the Fund will invest principally in fixed income securities and Debt that are, at the time of purchase, investment grade, the Fund may invest up to 30% of its assets in below investment grade fixed income securities and Debt. For these purposes, “investment grade” is defined as investments with a rating at the time of purchase in one of the four highest rating categories of at least one nationally recognized statistical ratings organization (“NRSRO”) (
The Fund may invest in fixed income or equity securities and Debt issued by both U.S. and non-U.S. issuers (including issuers in emerging markets), but the Fund will not invest more than 30% of its total assets directly in fixed income or equity securities or Debt of non-U.S. issuers or more than 25% of its total assets directly in non-U.S. dollar denominated fixed income or equity securities or Debt. For purposes of these 30% and 25% concentration limits only, derivatives, warrants and ETFs traded on U.S. exchanges that provide indirect exposure to fixed income or equity securities or Debt (as applicable) of non-U.S. issuers or to fixed income or equity securities or Debt (as applicable) denominated in currencies other than U.S. dollars will not be counted by the Fund in calculating its holdings in non-U.S. issuers or in non-U.S. dollar denominated securities or Debt.
The Fund will not invest more than 20% of the fixed income portion of the Fund's portfolio
The Fund may not concentrate its investments (
As noted in “The Fund's Use of Derivatives,” the Fund's investments in derivatives will be consistent with the Fund's investment objective and will not be used for the purpose of seeking leveraged returns or performance that is the multiple or inverse multiple of a benchmark (although derivatives have embedded leverage). Although the Fund will be permitted to borrow as permitted under the 1940 Act, it will not be operated as a “leveraged ETF,” (
Under Normal Market Conditions, the Fund will satisfy the following requirements, on a continuous basis measured at the time of purchase: (i) Component fixed income securities and Debt that in the aggregate account for at least 75% of the fixed income weight of the Fund's portfolio each shall have a minimum original principal amount outstanding of $100 million or more; (ii) no fixed income security held in the portfolio (excluding Treasury Securities and GSE-sponsored securities) will represent more than 30% of the fixed income weight of the Fund's portfolio, and the five most heavily weighted portfolio securities (excluding Treasury Securities and GSE-sponsored securities) will not in the aggregate account for more than 65% of the fixed income weight of the Fund's portfolio; and (iii) the Fund's portfolio of fixed income securities (excluding exempted securities) will include a minimum of 13 non-affiliated issuers.
Those exchange-listed securities and Exchange-Traded Derivatives held by the Fund that are listed and traded on a non-ISG member exchange or an exchange with which the Exchange does not have a comprehensive surveillance sharing agreement are limited to 10% of the Fund's assets.
In addition, the Fund will impose the limits described in the following section, which describes differences between the “generic” listing requirements of Nasdaq Rule 5735(b)(1) and those applicable to the Fund.
The Exchange is submitting this proposed rule change because the Fund will not meet all of the “generic” listing requirements of Nasdaq Rule 5735(b)(1). The Fund will meet all such requirements except the requirements described below,
(i) The Fund will not comply with the requirements in Nasdaq Rule 5735(b)(1) regarding the use of aggregate gross notional value of derivatives when calculating the weight of such derivatives or the exposure that such derivatives provide to underlying reference assets, including the requirements in Rules 5735(b)(1)(D)(i),
(ii) The Fund will not comply with the requirement that securities comprising at least 90% of the fixed income weight of the Fund's portfolio meet one of the criteria in Nasdaq Rule 5735(b)(1)(B)(iv) in respect to its investments in ABS/Private MBS. Instead, ABS/Private MBS will be limited to 20% of the weight of the fixed income portion of the Fund's portfolio.
(iii) The Exchange has classified bank loans as Debt for purposes of this proposed rule change and not as “fixed income securities” as they are classified in Nasdaq Rule 5735(b)(1)(B). As a result, the Fund's investments in bank loans will comply with the limitations or restrictions applicable to the Fund's investments in Debt as set forth herein with respect to such holdings and not with the restrictions for fixed income securities set forth in Nasdaq Rule 5735(b)(1)(B)(i)-(v).
(iv) The Fund will not comply with the equity requirements in Nasdaq Rules 5735(b)(1)(A)(i)
(v) The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(E) that no more than 20% of the assets in the Fund's portfolio may be invested in over-the-counter derivatives. Instead, the Exchange proposes that there shall be no limit on the Fund's investment in Interest Rate and Currency Derivatives, and the weight of all OTC Derivatives other than Interest Rate and Currency Derivatives shall not exceed 10% of the Fund's assets. For purposes of this 10% limit on OTC Derivatives, the weight of such OTC Derivatives will be calculated based on the mark-to-market value of such OTC Derivatives.
(vi) The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(D)(i) that at least 90% of the weight of the Fund's holdings in futures, exchange-traded options, and listed swaps shall, on both an initial and continuing basis, consist of futures, options and swaps for which the Exchange may obtain information via the ISG from other members or affiliates of the ISG, or for which the principal market is a market with which the Exchange has a comprehensive surveillance sharing agreement. Instead, the Exchange proposes that no more than 10% of the assets of the Fund will be invested in Exchange-Traded Derivatives and exchange-listed securities whose principal market is not a member of ISG or is a market with which the Exchange does not have a comprehensive surveillance sharing agreement. For purposes of this 10% limit, the weight of such Exchange-Traded Derivatives will be calculated based on the mark-to-market value of such Exchange-Traded Derivatives.
(vii) The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(D)(ii) that the aggregate gross notional value of listed derivatives, based on any five or fewer underlying reference assets, shall not exceed 65% of the weight of the Fund's portfolio (including gross notional exposures), and the aggregate gross notional value of listed derivatives, based on any single underlying reference asset, shall not exceed 30% of the weight of the Fund's portfolio (including gross notional exposures). Instead, the Exchange proposes that the Fund will comply with the concentration requirements in Nasdaq Rule 5735(b)(1)(D)(ii) except with respect to the Fund's investment in futures and options (including options on futures) referencing eurodollars and sovereign debt issued by the United States (
The Exchange believes that, notwithstanding that the Fund would not meet a limited number of “generic” listing requirements of Nasdaq Rule 5735(b)(1) in order to be able to satisfy its investment objective, the Exchange will be able to appropriately monitor and surveil trading in the underlying investments, including those that do not meet the “generic” listing requirements. The Exchange also notes that the parameters around the Fund's portfolio holdings are generally consistent with the parameters approved by the Commission prior to adoption of “generic” listing requirements for actively-managed ETFs.
As further described in “Statutory Basis,” deviations from the generic requirements are necessary for the Fund to achieve its investment objective and efficiently manage the risks associated with its investments, and any possible risks have been fully mitigated and addressed through the alternative limits proposed by the Exchange. In addition, many of the changes requested are generally consistent with previous filings approved by the Commission.
The Fund's administrator will calculate the Fund's net asset value (“NAV”) per Share as of the close of regular trading (normally 4:00 p.m., Eastern time (“E.T.”)) on each day the New York Stock Exchange is open for business. NAV per Share will be calculated for the Fund by taking the value of the Fund's total assets, including interest or dividends accrued but not yet collected, less all liabilities, and dividing such amount by the total number of Shares outstanding. The result, rounded to the nearest cent, will be the NAV per Share (although creations and redemptions will be processed using a price denominated to the fifth decimal point, meaning that rounding to the nearest cent may result in different prices in certain circumstances).
The Manager and the Sub-Advisers believe there will be minimal, if any, impact on the arbitrage mechanism for the Fund as a result of its use of derivatives. The Manager and the Sub-Advisers understand that market makers and other market participants should be able to value derivatives held by the Fund as long as the Fund's positions are disclosed. The Manager and the Sub-Advisers believe that the price at which Shares trade will continue to be disciplined by arbitrage opportunities created by the ability for authorized participants (“APs”) to purchase or redeem creation Shares at their NAV, which should ensure that Shares will not trade at a material discount or premium in relation to their NAV.
The Manager and the Sub-Advisers do not believe that there will be any significant impact on the settlement or operational aspects of the Fund's arbitrage mechanism due to the use of derivatives. Because derivatives generally are not eligible for in-kind transfer, they will typically be substituted with a “cash in lieu” amount when the Fund processes purchases or redemptions of creation units in-kind.
The Fund will issue Shares of the Fund at NAV only to APs and only in aggregations of at least 50,000 shares (each aggregation is called a “Creation Unit”) or multiples thereof, on a continuous basis through the Distributor, without a sales load, at the NAV next determined after receipt, on any Business Day, of an order in proper form. A “Business Day” is defined as any day that the Trust is open for business, including as required by Section 22(e) of the 1940 Act.
Although the Fund reserves the right to issue Creation Units on a partial or fully “in kind” basis, the Fund expects that it will primarily issue Creation Units solely for cash. As a result, APs seeking to purchase Creation Units will generally be required to transfer to the Fund cash in an amount equal to the value of the Creation Unit(s) purchased and the applicable transaction fee. To the extent that the Fund elects to issue Creation Units on an “in-kind” basis, the applicable AP will be required to deposit with the Fund a designated portfolio of securities and/or instruments (the “Deposit Securities”) that will conform
The Fund also expects to effect redemptions of Creation Units primarily on a cash basis, although it reserves the right to effect redemption on a partial or wholly “in-kind” basis. In connection with a cash redemption, the AP will be required to transfer to the Fund Creation Units and cash equal to the transaction fee. To the extent that the Fund elects to utilize an “in-kind” redemption, it will deliver to the redeeming AP, in exchange for a Creation Unit, securities and/or instruments that will conform
To be eligible to place orders with respect to creations and redemptions of Creation Units, an entity must have executed an agreement with the Distributor, subject to acceptance by the transfer agent, with respect to creations and redemptions of Creation Units. Each
When the Fund permits Creation Units to be issued principally or partially in-kind, the Fund will cause to be published, through the NSCC, on each Business Day, at or before 9:00 a.m. E.T., the identity and the required principal amount or number of each Deposit Security and the amount of the Cash Component (if any) to be included in the current Fund Deposit (based on information at the end of the previous Business Day).
All orders to create Creation Units must be received by the Distributor within a one-hour window from 9:00 a.m. E.T. to 10:00 a.m. E.T. on a given Business Day in order to receive the NAV determined on the Business Day on which the order was placed.
Shares may be redeemed only in Creation Units at their NAV next determined after receipt of a redemption request in proper form on a Business Day and only through an AP. The Fund will not redeem Shares in amounts less than a Creation Unit unless the Fund is being liquidated.
When the Fund permits Creation Units to be redeemed principally or partially in-kind, the Fund will cause to be published, through the NSCC, at or before 9:00 a.m. E.T. on each Business Day, the identity of the Redemption Securities and/or an amount of cash that will be applicable to redemption requests received in proper form on that day. The Redemption Securities will be identical to the Deposit Securities.
In order to redeem Creation Units of the Fund, an AP must submit an order to redeem one or more Creation Units. All such orders must be received by the Distributor within a one-hour window from 9:00 a.m. E.T. to 10:00 a.m. E.T. on a given Business Day in order to receive the NAV determined on the Business Day on which the order was placed.
The Fund's website (
On each Business Day, before commencement of trading in Shares in the Regular Market Session
In addition, for the Fund, an estimated value, defined in Rule 5735(c)(3) as the “Intraday Indicative Value,” that reflects an estimated intraday value of the Fund's Disclosed Portfolio, will be disseminated. Moreover, the Intraday Indicative Value, available on the Nasdaq Information LLC proprietary index data service,
The dissemination of the Intraday Indicative Value, together with the Disclosed Portfolio, will allow investors to determine the value of the underlying portfolio of the Fund on a daily basis and will provide a close estimate of that value throughout the Business Day.
Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the Business Day on brokers' computer screens and other electronic services. Quotation and last sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges and the Consolidated Tape Association (“CTA”) plans for the Shares and for the following U.S. securities, to the extent that they are exchange-listed securities: Work Out Securities, Non-Convertible Preferred Securities, warrants, convertible fixed income securities and ETFs. Price information for U.S. exchange-listed options will be available via the Options Price Reporting Authority and for other U.S. Exchange-Traded Derivatives will be available from the applicable listing exchange and from major market data vendors. Price information for TRACE-Eligible Securities
For other exchange-listed securities (to be comprised primarily of ETFs, warrants and structured notes and which may include exchange-listed securities of both U.S. and non-U.S. issuers), equities traded in the over-the-counter market (including Work Out Securities and Non-Convertible Preferred Securities), Exchange-Traded Derivatives (including U.S. or foreign), OTC Derivatives, Debt and fixed income securities (including convertible fixed income securities), and the small number of Securitized Products that are not reported to TRACE,
Additional information regarding the Fund and the Shares, including investment strategies, risks, creation and redemption procedures, fees, Fund holdings' disclosure policies, distributions and taxes will be included in the Registration Statement. Investors will also be able to obtain the SAI, the Fund's annual and semi-annual reports (together, “Shareholder Reports”), and its Form N-CSR and Form N-SAR, filed twice a year, except the SAI, which is filed at least annually. The Fund's SAI and Shareholder Reports will be available free upon request from the Fund, and those documents and the Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from the Commission's website at
The Shares will be subject to Nasdaq Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares. The Exchange represents that, for initial and continued listing, the Fund must be in compliance with Rule 10A-3
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund. Nasdaq will halt trading in the Shares under the conditions specified in Nasdaq Rules 4120 and 4121, including the trading pauses under Nasdaq Rules 4120(a)(11) and (12). Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and/or the other assets constituting the Disclosed Portfolio of the Fund; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Nasdaq Rule 5735(d)(2)(D), which sets forth circumstances under which Shares of the Fund may be halted.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. Nasdaq will allow trading in the Shares from 4:00 a.m. until 8:00 p.m., E.T. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in Nasdaq Rule 5735(b)(3), the minimum price variation for quoting and entry of orders in Managed Fund Shares traded on the Exchange is $0.01.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and the exchange-listed securities and instruments held by the Fund (including exchange-listed equities and Exchange-Traded Derivatives) with other markets and other entities that are members of ISG
The majority of the Fund's investments in exchange-listed, equity securities (
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (5) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. Members purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
Additionally, the Information Circular will reference that the Fund is subject to various fees and expenses described in the Registration Statement. The Information Circular will also disclose the trading hours of the Shares of the Fund and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares of the Fund will be publicly available on the Fund's website.
All statements and representations made in this filing regarding (a) the description of the portfolio or reference assets, (b) limitations on portfolio holdings or reference assets, (c) dissemination and availability of the reference asset or intraday indicative values, or (d) the applicability of Exchange listing rules shall constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under the Nasdaq 5800 Series.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act in general and Section 6(b)(5) of the Act, in particular, in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and, in general, to protect investors and the public interest.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in Nasdaq Rule 5735. The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both the Exchange and FINRA, on behalf of the Exchange, which are designed to deter and detect violations of Exchange rules and applicable federal securities laws and are adequate to properly monitor trading in the Shares in all trading sessions.
Paragraph (g) of Rule 5735 provides that if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall
Rule 5735(g) is similar to Nasdaq Rule 5705(b)(5)(A)(i); however, paragraph (g) in connection with the establishment and maintenance of a “fire wall” between the investment adviser and the broker-dealer reflects the applicable investment company's portfolio, not an underlying benchmark index, as is the case with index-based funds. None of the Manager or any of the Sub-Advisers is a broker-dealer, but each is affiliated with the Distributor, a broker-dealer, and has implemented and will maintain a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the portfolio.
In addition, personnel who make decisions on the Fund's portfolio composition will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding the Fund's portfolio. In the event (a) the Manager or any of the Sub-Advisers registers as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new investment adviser or any new sub-adviser to the Fund is a registered broker-dealer or becomes affiliated with another broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to the Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.
The Fund's investments, including derivatives, will be consistent with the Fund's investment objectives, applicable legal requirements
The Exchange believes that, notwithstanding that the Fund would not meet all of the “generic” listing requirements of Nasdaq Rule 5735(b)(1), the Fund will not be subject to manipulation, the investments of the Fund will be able to be monitored and surveilled by the Exchange and risks will be mitigated by alternative limits imposed by the Exchange and by the voluntary limits imposed by the Fund (
The Fund will not comply with the requirements in Nasdaq Rule 5735(b)(1) regarding the use of aggregate gross notional value of derivatives when calculating the weight of such derivatives or the exposure that such derivatives provide to underlying reference assets, including the requirements in Rules 5735(b)(1)(D)(i), 5735(b)(1)(D)(ii), 5735(b)(1)(E) and 5735(b)(1)(F). Instead, the Exchange proposes that, except as otherwise provided herein, for the purposes of any applicable requirements under Nasdaq Rule 5735(b)(1), and any alternative requirements proposed by the Exchange, the Fund will use the mark-to-market value of its derivatives in calculating the weight of such derivatives or the exposure that such derivatives provide to their reference assets. The Exchange believes that this alternative requirement is appropriate because the mark-to-market value is a more accurate measurement of the actual exposure incurred by the Fund in connection with a derivatives position.
The Fund will not meet the requirement that at least 90% of the fixed income weight of the Fund's portfolio meet one of the criteria in Nasdaq Rule 5735(b)(1)(B)(iv)
As discussed above, the Exchange has determined to make an exception solely in respect of the Fund such that CDOs will not be deemed to be included in the definition of ABS for purposes of the limitation in Nasdaq Rule 5735(b)(1)(B)(v) and, as a result, will not be subject to the restriction on aggregate holdings of ABS/Private MBS contained in such Rule, which limits such holdings to no more than 20% of the weight of the fixed income portion of the Fund's portfolio. However, the Fund's holdings in CDOs will be limited such that they do not account, in the aggregate, for more than 10% of the total assets of the Fund. The Exchange believes that the 10% limit on the Fund's holdings in CDOs will help to ensure that the Fund maintains a diversified portfolio and will mitigate the risk of manipulation.
The Exchange has classified bank loans as Debt for purposes of this proposed rule change and not as “fixed income securities” as they are classified in Nasdaq Rule 5735(b)(1)(B). As a result, the Fund's investments in bank loans will comply with the limitations or restrictions applicable to the Fund's investments in Debt as set forth herein with respect to such holdings and not with the restrictions for fixed income securities set forth in Nasdaq Rule 5735(b)(1)(B)(i)-(v).
The Fund will not meet the equity requirements in Nasdaq Rule 5735(b)(1)(A) with respect to Non-Convertible Preferred Securities, Work Out Securities and warrants.
The Fund will not meet the requirement in Nasdaq Rule 5735(b)(1)(E) that no more than 20% of the assets in the Fund's portfolio may be invested in over-the-counter derivatives. The Fund proposes that no limit be placed on Interest Rate and Currency Derivatives, which are necessary and appropriate to allow the Manager and Sub-Advisers to risk manage the Fund, but that the weight of all other OTC Derivatives (
The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(D)(i) that at least 90% of the weight of the Fund's holdings in futures, exchange-traded options, and listed swaps shall, on both an initial and continuing basis, consist of futures, options, and swaps for which the Exchange may obtain information via the ISG from other members or affiliates of the ISG, or for which the principal market is a market with which the Exchange has a comprehensive surveillance sharing agreement. Instead, the Exchange proposes that no more than 10% of the assets of the Fund will be invested in Exchange-Traded Derivatives and exchange-listed securities whose principal market is not a member of ISG or is not a market with which the Exchange has a comprehensive surveillance sharing agreement.
The Fund will not meet the requirement in Nasdaq Rule 5735(b)(1)(D)(ii) that the aggregate gross notional value of listed derivatives based on any five or fewer underlying reference assets shall not exceed 65% of the weight of the Fund's portfolio (including gross notional exposures), and the aggregate gross notional value of listed derivatives based on any single underlying reference asset shall not exceed 30% of the weight of the Fund's portfolio (including gross notional exposures) because the Fund may maintain significant positions in Eurodollar and G-7 Sovereign Futures and Options. The Manager has indicated that obtaining exposure to these investments through futures contracts is often the most cost efficient method to achieve such exposure. The Exchange notes that Eurodollar and G-7 Sovereign Futures and Options are highly liquid investments
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily every Business Day that the Fund is traded, and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. In addition, a large amount of information will be publicly available regarding the Fund and the Shares, thereby promoting market transparency.
Moreover, the Intraday Indicative Value, available on the Nasdaq Information LLC proprietary index data service, will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Exchange's Regular Market Session. On each Business Day, before commencement of trading in the Shares in the Regular Market Session on the Exchange, the Fund will disclose on its website the Disclosed Portfolio of the Fund that will form the basis for the Fund's calculation of NAV at the end of the Business Day. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the Business Day on brokers' computer screens and other electronic services. Quotation and last sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges and the CTA plans for the Shares and for the following U.S. securities, to the extent they are exchange-listed: Work Out Securities, Non-Convertible Preferred Securities, warrants, convertible fixed income securities and ETFs. Price information for U.S. exchange-listed options will be available via the Options Price Reporting Authority and for other U.S. Exchange-Traded Derivatives will be available from the applicable listing exchange and from major market data vendors. Price information for restricted securities will be available from major market data vendors, broker-dealers and trading platforms as well as for most fixed income securities sold in transactions under Rule 144A under the Securities Act, from TRACE and EMMA. Money Market Funds are typically priced once each Business Day and their prices will be available through the applicable fund's website or from major market data vendors.
For other exchange-listed securities (to be comprised primarily of ETFs, warrants and structured notes and which may include exchange-listed securities of both U.S. and non-U.S. issuers), equities traded in the over-the-counter market (including Work Out Securities and Non-Convertible Preferred Securities), Exchange-Traded Derivatives (including U.S. or foreign), OTC Derivatives, Debt and fixed income securities (including convertible fixed income securities) and the small number of Securitized Products that are not reported to TRACE, intraday price quotations will generally be available from broker-dealers and trading platforms (as applicable). TRACE will be a source of price information for most of the U.S. dollar denominated corporate bonds,
The Fund's website will include a form of the prospectus for the Fund and additional data relating to NAV and other applicable quantitative information. Moreover, prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Trading in the Shares of the Fund will be halted under the conditions specified in Nasdaq Rules 4120 and 4121 or because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable, and trading in the Shares will be subject to Nasdaq Rule 5735(d)(2)(D), which sets forth circumstances under which Shares of the Fund may be halted. In addition, as noted above, investors will have ready access to information regarding the Fund's holdings, the Intraday Indicative Value, the Disclosed Portfolio, and quotation and last sale information for the Shares.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of actively-managed ETF that will enhance competition among market participants, to the benefit of investors and the marketplace.
For the above reasons, the Exchange believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change will facilitate the listing and trading of an additional type of actively-managed ETF that will enhance competition among market participants, to the benefit of investors and the marketplace.
No written comments were either solicited or received.
After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 3, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
As discussed above, the Fund will not comply with a number of the generic requirements in the initial and continued listing standards for Managed Fund Shares set forth in Nasdaq Rule 5735(b)(1). The Exchange states that it will be able to appropriately monitor and surveil trading in the underlying investments, including those that do not meet the generic listing requirements.
With respect to its investments in derivatives, the Fund will not comply with the requirements in Nasdaq Rule 5735(b)(1) regarding the use of aggregate gross notional value of derivatives when calculating the weight of such derivatives or the exposure that such derivatives provide to underlying reference assets. Instead, the Exchange proposes that, for the purposes of any applicable requirements under Nasdaq Rule 5735(b)(1) and any alternative requirements proposed by the Exchange, the Fund will use the mark-to-market value of derivatives in calculating the weight of such derivatives or the exposure that such derivatives provide to their reference assets. The Exchange states its belief that mark-to-market value is a more accurate measurement of the actual exposure incurred by the Fund in connection with a derivatives position.
With respect to its investments in ABS/Private MBS, the Fund will not meet the generic listing requirement that securities comprising at least 90% of the fixed income weight of the Fund's portfolio meet one of the criteria set forth in Nasdaq Rule 5735(b)(1)(B)(iv).
The Exchange states that the Fund's investments in ABS/Private MBS will, in accordance with Nasdaq Rule 5735(b)(1)(B)(v), be limited to 20% of the fixed income portion of the Fund's portfolio,
For purposes of this Fund, the Exchange proposes to classify bank loans as Debt rather than “fixed income securities” (as they are classified in Nasdaq Rule 5735(b)(1)(B)). As a result, the Fund's investments in bank loans would comply with the proposed limitations applicable to investments in Debt set forth above
The Fund will not comply with the listing requirements related to investments in equities set forth in Nasdaq Rule 5735(b)(1)(A)
The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(E) that no more than 20% of the assets in the Fund's portfolio may be invested in over-the-counter derivatives. Instead, the Exchange proposes that there would be no limit on the Fund's investments in Interest Rate and Currency Derivatives, and that the aggregate weight of all OTC Derivatives other than Interest Rate and Currency Derivatives will not exceed 10% of the Fund's assets.
The Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(D)(i) that at least 90% of the weight of the Fund's holdings in futures, exchange-traded options, and listed swaps shall, on both an initial and continuing basis, consist of futures, options, and swaps for which the Exchange may obtain information via the ISG from other members or affiliates of the ISG, or for which the principal market is a market with which the Exchange has a CSSA. Instead, the Exchange proposes that no more than 10% of the net assets of the Fund will be invested in Exchange-Traded Derivatives and exchange-listed securities whose principal market is not a member of ISG or is not a market with which the Exchange has a CSSA.
Finally, the Exchange states that the Fund may maintain significant positions in Eurodollar and G-7 Sovereign Futures and Options, and that as a result, the Fund will not comply with the requirement in Nasdaq Rule 5735(b)(1)(D)(ii) that the aggregate gross notional value of listed derivatives based on any five or fewer underlying reference assets not exceed 65% of the weight of the Fund's portfolio (including gross notional exposures), and the aggregate gross notional value of listed derivatives based on any single underlying reference asset not exceed 30% of the weight of the Fund's portfolio (including gross notional exposures). The Exchange states that Eurodollar and G-7 Sovereign Futures and Options are highly liquid investments and are not subject to the same concentration risks as Exchange-Traded Derivatives referencing other assets because of such liquidity.
Other than as described above, the Fund will meet all the requirements of Nasdaq Rule 5735. For the reasons articulated by the Exchange above, the Commission believes that these proposed initial and continued listing requirements, including the alternative limitations on the Fund's proposed holdings described above, are designed to mitigate the potential for manipulation of the Shares.
The Commission finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
Quotation and last sale information for exchange-listed Work Out Securities, Non-Convertible Preferred Securities, warrants, convertible fixed income securities, and ETFs will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the UTP and the CTA Plans. Price information for U.S. exchange listed options will be available via the Options Price Reporting Authority and price information for other U.S. Exchange-Traded Derivatives will be available from the applicable listing exchange and from major market data vendors. Price information for TRACE-Eligible Securities sold in transactions under Rule 144A under the Securities Act will generally be available through TRACE and information regarding transactions in non-TRACE-Eligible Securities or transactions not otherwise subject to TRACE reporting will be available from major market data vendors and broker-dealers. For most of the U.S. dollar denominated corporate bonds, GSE-sponsored securities, Securitized Products, and other U.S. dollar denominated fixed income securities in which the Fund invests, price information will be available from TRACE and EMMA.
The Commission also believes that the proposal is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange states that it will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
The Exchange states that it has a general policy prohibiting the distribution of material, non-public information by its employees. The Exchange states that the neither the Manager nor any of the Sub-Advisers is a broker-dealer, but that each is affiliated with a broker-dealer and has implemented, and will maintain, a fire wall with respect to its broker-dealer affiliate regarding access to information concerning proposed changes to the composition and/or changes to the Fund's portfolio prior to implementation. Further, the Commission notes that the Reporting Authority that provides the Disclosed Portfolio must implement and maintain, or be subject to, procedures designed to prevent the use and dissemination of material, non-public information regarding the actual components of the portfolio.
In the OIP, the Commission sought public comment on how the cutoff time for redemption requests and creation orders, as originally proposed, would affect the opportunity for and effective and efficient arbitrage process and whether the proposed cutoff time would be consistent with the maintenance of fair and orderly markets and the requirements of Section 6(b)(5) of the Act.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange represents that:
(1) The Shares will be subject to Nasdaq Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares. Other than as described above, the Fund will meet all requirements of Nasdaq Rule 5735(b)(1). The Fund's investments will be subject to the limitations described in Section II.A above.
(2) A minimum of 100,000 Shares of the Fund will be outstanding at the commencement of trading on the Exchange.
(3) Trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also FINRA on behalf of the Exchange, and these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
(4) FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and the exchange-listed securities and instruments held by the Fund with other markets and other entities that are members of ISG and with which the Exchange has CSSAs, and FINRA and the Exchange both may obtain information regarding trading in the Shares, the exchange-listed securities, derivatives, and other instruments held by the Fund from markets and other entities that are members of ISG, which include securities and futures exchanges and swap execution facilities, or with which the Exchange has in place a CSSA. FINRA, on behalf of the Exchange, will be able to access, as needed, trade information for most of the fixed income securities held by the Fund through reporting on TRACE and, with respect to municipal securities, EMMA.
(5) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss: (i) The procedures for
(6) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(7) For initial and continued listing, the Fund must be in compliance with Rule 10A-3 under the Act.
(8) The Fund's investments, including derivatives, will be consistent with the Fund's investment objectives, and will not be used to seek leveraged returns or performance that is the multiple or inverse multiple of a benchmark (although derivatives may have embedded leverage). Although the Fund will be permitted to borrow as permitted under the 1940 Act, it will not be operated in a manner designed to seek leveraged returns or a multiple or inverse multiple of the performance of an underlying reference index.
The Exchange represents that all statements and representations made in the filing regarding: (1) The description of the portfolio or reference assets; (2) limitations on portfolio holdings or reference assets; (3) dissemination and availability of the reference asset or Intraday Indicative Values; or (4) the applicability of Exchange listing rules specified in the rule filing constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under the Nasdaq 5800 Series.
This approval order is based on all of the Exchange's statements and representations, including those set forth above and in Amendment No. 3.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 3, is consistent with Section 6(b)(5) of the Act
Interested persons are invited to submit written data, views, and arguments concerning whether Amendment No. 3 to the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
The Commission finds good cause to approve the proposed rule change, as modified by Amendment No. 3, prior to the thirtieth day after the date of publication of notice of the filing of Amendment No. 3 in the
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c)(3) of the Act for an exemption from rule23c-3 under the Act, and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain registered closed-end management investment companies to issue multiple classes of shares and to impose asset-based distribution and/or service fees, early withdrawal charges (“Early Withdrawal Charges”), and early repurchase fees.
Broadstone Real Estate Access Fund (the “Initial Fund”), and Broadstone Asset Management, LLC (the “Adviser”).
The application was filed on July 11, 2018. Applicants have agreed to file an amendment during the notice period, the substance of which is reflected in this notice.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on September 27, 2018, and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: Broadstone Asset Management, Inc., 800 Clinton Square, Rochester, NY 14604.
Stephan N. Packs, Senior Counsel, at (202) 551-6853, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. The Initial Fund is a newly-formed Delaware statutory trust that is registered under the Act as a continuously offered, non-diversified, closed-end management investment company.
2. The Adviser, a New York limited liability company, is registered as an investment adviser under the Investment Advisers Act of 1940. The Adviser serves as investment adviser to the Initial Fund.
3. The applicants seek an order to permit the Funds (as defined below) to issue multiple classes of shares, each having its own fee and expense structure and to impose Early Withdrawal Charges, asset-based distribution and/or service fees with respect to certain classes.
4. Applicants request that the order also apply to any continuously-offered registered closed-end management investment company, existing now or in the future, for which the Adviser, or any entity controlling, controlled by, or under common control with the Adviser, or any successor in interest to any such entity,
5. The Initial Fund intends to make a continuous public offering of its shares upon a declaration of effectiveness of its registration statement. Applicants state that additional offerings by any Fund relying on the order may be on a private placement or public offering basis. Shares of the Funds are not expected to be listed on any securities exchange nor quoted on any quotation medium and the Funds do not expect there to be a secondary trading market for their shares.
6. If the requested relief is granted, the Initial Fund intends to continuously offer Class W Shares and Class I Shares, with each class having its own fee and expense structure. Because of the different distribution fees, services, and any other class expenses that may be attributable to the Class W and Class I Shares, the net income attributable to, and the dividends payable on, each class of shares may differ from each other.
7. Applicants state that, from time to time, the Initial Fund may create additional classes of shares, the terms of which may differ from Class W and Class I Shares in the following respects: (i) The amount of fees permitted by different distribution plans or different service fee arrangements; (ii) voting rights with respect to a distribution plan of a class; (iii) different class designations; (iv) the impact of any class expenses directly attributable to a particular class of shares allocated on a class basis as described in the application; (v) any differences in dividends and net asset value resulting from differences in fees under a distribution plan or in class expenses; (vi) any Early Withdrawal Charge or other sales load structure; and (vii) exchange or conversion privileges of the classes as permitted under the Act.
8. Applicants state that the Initial Fund has adopted a fundamental policy to repurchase a specified percentage of its shares (no less than 5% and no more than 25%) at net asset value on a quarterly basis. Such repurchase offers will be conducted pursuant to rule23c-3 under the Act. Each of the other Funds will likewise adopt fundamental investment policies in compliance with rule 23c-3 and make quarterly repurchase offers to its shareholders, or provide periodic liquidity with respect to its shares pursuant to rule 13e-4 under the Exchange Act.
9. Applicants represent that any asset-based service and/or distribution fees for each class of shares of the Funds will comply with the provisions of FINRA Rule 2341 (“FINRA Sales Charge
10. Each of the Funds will comply with any requirements that the Commission or FINRA may adopt regarding disclosure at the point of sale and in transaction confirmations about the costs and conflicts of interest arising out of the distribution of open-end investment company shares, and regarding prospectus disclosure of sales loads and revenue sharing arrangements, as if those requirements applied to the Fund. In addition, each Fund will contractually require that any distributor of the Fund's shares comply with such requirements in connection with the distribution of such Fund's shares.
11. Each Fund will allocate all expenses incurred by it among the various classes of shares based on the net assets of the Fund attributable to each class, except that the net asset value and expenses of each class will reflect the expenses associated with the distribution plan of that class, service fees, and any other incremental expenses of that class. Expenses of a Fund allocated to a particular class of shares will be borne on a pro rata basis by each outstanding share of that class. Applicants state that each Fund will comply with the provisions of rule18f-3 under the Act as if it were an open-end investment company.
12. Applicants state that each Fund may impose an Early Withdrawal Charge on shares submitted for repurchase that have been held less than a specified period and may waive the Early Withdrawal Charge for certain categories of shareholders or transactions to be established from time to time. Applicants state that each Fund will apply the Early Withdrawal Charge (and any waivers or scheduled variations of the Early Withdrawal Charge) uniformly to all shareholders in a given class and consistently with the requirements of rule 22d-1 under the Act as if the Funds were open-end investment companies.
13. Applicants state that shares of a Fund may be subject to an early repurchase fee (“Early Repurchase Fee”) at a rate of no greater than 2% of the aggregate net asset value of a shareholder's shares repurchased by the Fund if the interval between the date of purchase of the shares and the valuation date with respect to the repurchase of those shares is less than 90 days. Any Early Repurchase Fees will apply equally to all classes of shares of a Fund, consistent with section 18 of the Act and rule 18f-3 thereunder. To the extent a Fund determines to waive, impose scheduled variations of, or eliminate any Early Repurchase Fee, it will do so consistently with the requirements of rule 22d-1 under the Act as if the Early Repurchase Fee were a contingent deferred sales load (defined below) and as if the Fund were an open-end investment company and the Fund's waiver of, scheduled variation in, or elimination of, any such Early Repurchase Fee will apply uniformly to all shareholders of the Fund regardless of class. Applicants state that the Initial Funds do not intend to impose an Early Repurchase Fee.
14. Each Fund operating as an interval fund pursuant to rule 23c-3 under the Act may offer its shareholders an exchange feature under which the shareholders of the Fund may, in connection with the Fund's periodic repurchase offers, exchange their shares of the Fund for shares of the same class of (i) registered open-end investment companies or (ii) other registered closed-end investment companies that comply with rule 23c-3 under the Act and continuously offer their shares at net asset value, that are in the Fund's group of investment companies (collectively, “Other Funds”). Shares of a Fund operating pursuant to rule 23c-3 that are exchanged for shares of Other Funds will be included as part of the amount of the repurchase offer amount for such Fund as specified in rule 23c-3 under the Act. Any exchange option will comply with rule 11a-3 under the Act, as if the Fund were an open-end investment company subject to rule 11a-3. In complying with rule 11a-3, each Fund will treat an Early Withdrawal Charge as if it were a contingent deferred sales load.
1. Section 18(a)(2) of the Act provides that a closed-end investment company may not issue or sell a senior security that is a stock unless certain requirements are met. Applicants state that the creation of multiple classes of shares of the Funds may violate section 18(a)(2) because the Funds may not meet such requirements with respect to a class of shares that may be a senior security.
2. Section 18(c) of the Act provides, in relevant part, that a closed-end investment company may not issue or sell any senior security if, immediately thereafter, the company has outstanding more than one class of senior security. Applicants state that the creation of multiple classes of shares of the Funds may be prohibited by section 18(c), as a class may have priority over another class as to payment of dividends because shareholders of different classes would pay different fees and expenses.
3. Section 18(i) of the Act provides that each share of stock issued by a registered management investment company will be a voting stock and have equal voting rights with every other outstanding voting stock. Applicants state that multiple classes of shares of the Funds may violate section 18(i) of the Act because each class would be entitled to exclusive voting rights with respect to matters solely related to that class.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction or any class or classes of persons, securities or transactions from any provision of the Act, or from any rule or regulation under the Act, if and to the extent such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants request an exemption under section 6(c) from sections 18(a)(2), 18(c) and 18(i) to permit the Funds to issue multiple classes of shares.
5. Applicants submit that the proposed allocation of expenses relating to distribution and/or services and voting rights among multiple classes is equitable and will not discriminate
1. Section 23(c) of the Act provides, in relevant part, that no registered closed-end investment company shall purchase securities of which it is the issuer, except: (a) On a securities exchange or other open market; (b) pursuant to tenders, after reasonable opportunity to submit tenders given to all holders of securities of the class to be purchased; or (c) under other circumstances as the Commission may permit by rules and regulations or orders for the protection of investors.
2. Rule 23c-3 under the Act permits a registered closed-end investment company (an “interval fund”) to make repurchase offers of between five and twenty-five percent of its outstanding shares at net asset value at periodic intervals pursuant to a fundamental policy of the interval fund. Rule 23c-3(b)(1) under the Act permits an interval fund to deduct from repurchase proceeds only a repurchase fee, not to exceed two percent of the proceeds, that is paid to the interval fund and is reasonably intended to compensate the fund for expenses directly related to the repurchase. A Fund will not impose a repurchase fee on investors who purchase and tender their shares.
3. Section 23(c)(3) provides that the Commission may issue an order that would permit a closed-end investment company to repurchase its shares in circumstances in which the repurchase is made in a manner or on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased.
4. Applicants request relief under section 6(c), discussed above, and section 23(c)(3) from rule 23c-3 to the extent necessary for the Funds to impose Early Withdrawal Charge on shares of the Funds submitted for repurchase that have been held for less than a specified period.
5. Applicants state that the Early Withdrawal Charges they intend to impose are functionally similar to contingent deferred sales loads imposed by open-end investment companies under rule 6c-10 under the Act. Rule 6c-10 permits open-end investment companies to impose contingent deferred sales loads, subject to certain conditions. Applicants note that rule 6c-10 is grounded in policy considerations supporting the employment of contingent deferred sales loads where there are adequate safeguards for the investor and state that the same policy considerations support imposition of Early Withdrawal Charges in the interval fund context. In addition, applicants state that Early Withdrawal Charges may be necessary for the distributor to recover distribution costs. Applicants represent that any Early Withdrawal Charge imposed by the Funds will comply with rule 6c-10 under the Act as if the rule were applicable to closed-end investment companies. The Funds will disclose Early Withdrawal Charges in accordance with the requirements of Form N-1A concerning contingent deferred sales loads.
1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit an affiliated person of a registered investment company, or an affiliated person of such person, acting as principal, from participating in or effecting any transaction in connection with any joint enterprise or joint arrangement in which the investment company participates unless the Commission issues an order permitting the transaction. In reviewing applications submitted under section 17(d) and rule 17d-1, the Commission considers whether the participation of the investment company in a joint enterprise or joint arrangement is consistent with the provisions, policies and purposes of the Act, and the extent to which the participation is on a basis different from or less advantageous than that of other participants.
2. Rule 17d-3 under the Act provides an exemption from section 17(d) and rule 17d-1 to permit open-end investment companies to enter into distribution arrangements pursuant to rule 12b-1 under the Act. Applicants request an order under section 17(d) and rule 17d-1 under the Act to the extent necessary to permit the Fund to impose asset-based distribution and/or service fees. Applicants have agreed to comply with rules 12b-1 and 17d-3 as if those rules applied to closed-end investment companies, which they believe will resolve any concerns that might arise in connection with a Fund financing the distribution of its shares through asset-based distribution and/or service fees.
For the reasons stated above, applicants submit that the exemptions requested under section 6(c) are necessary and appropriate in the public interest and are consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants further submit that the relief requested pursuant to section 23(c)(3) will be consistent with the protection of investors and will insure that applicants do not unfairly discriminate against any holders of the class of securities to be purchased. Finally, applicants state that the Funds' imposition of asset-based distribution and/or service fees is consistent with the provisions, policies and purposes of the Act and does not involve participation on a basis different from or less advantageous than that of other participants.
Applicants agree that any order granting the requested relief will be subject to the following condition:
Each Fund relying on the order will comply with the provisions of rules6c-10, 12b-1, 17d-3, 18f-3, 22d-1, and, where applicable, 11a-3 under the Act, as amended from time to time, as if those rules applied to closed-end management investment companies, and will comply with the FINRA Sales Charge Rule, as amended from time to time, as if that rule applied to all closed-end management investment companies.
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from
Applicants request an order to permit certain registered closed-end management investment companies to issue multiple classes of shares and to impose asset-based distribution and/or service fees and early withdrawal charges (“EWCs”).
PIMCO Flexible Credit Income Fund (the “Credit Fund”) and PIMCO Flexible Municipal Income Fund (the “Municipal Fund”) (the Credit Fund and the Municipal Fund together the “Initial Funds”), Pacific Investment Management Company LLC (the “Investment Manager”) and PIMCO Investments LLC (the “Distributor”).
The application was filed on April 25, 2017 and amended on December 4, 2017 and August 20, 2018.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on October 1, 2018, and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090; Applicants: PIMCO Flexible Credit Income Fund, PIMCO Flexible Municipal Income Fund, Pacific Investment Management Company LLC and PIMCO Investments LLC, c/o David C. Sullivan, Esq., Ropes & Gray LLP, 800 Boylston St., Boston, MA 02199 .
Rachel Loko, Senior Counsel or Aaron Gilbride, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at or by calling (202) 551-8090.
1. The Credit Fund is a Massachusetts business trust that is registered under the Act as a non-diversified, closed-end management investment company. The Credit Fund seeks to provide attractive risk-adjusted returns and current income. The Credit Fund seeks to achieve its investment objectives by investing, under normal circumstances, at least 80% of its net assets (plus any borrowings for investment purposes) in a portfolio of debt instruments of varying maturities. The Municipal Fund is a Massachusetts business trust registered under the Act as a non-diversified, closed-end management investment company. The Municipal Fund seeks to provide high current income exempt from federal income tax. Capital appreciation is a secondary objective. The Municipal Fund seeks to achieve these objectives by investing at least 80% of its net assets (plus any borrowings for investment purposes) in a portfolio of municipal bonds and other municipal securities, the interest from which, in the opinion of bond counsel for the issuer at the time of issuance (or on the basis of other authority believed by PIMCO to be reliable), is exempt from federal income tax. To a lesser extent, the Municipal Fund also expects to invest in a full range of preferred securities, with an emphasis on preferred securities that, at the time of issuance, are eligible to pay dividends that qualify for certain favorable federal income tax treatment.
2. The Investment Manager is registered as an investment adviser under the Investment Advisers Act of 1940, as amended. The Investment Manager serves as investment adviser to the Initial Funds.
3. The applicants seek an order to permit the Initial Funds to issue multiple classes of shares and to impose asset-based distribution and/or service fees and EWCs.
4. Applicants request that the order also apply to any continuously offered registered closed-end management investment company that has been previously organized or that may be organized in the future for which the Investment Manager or Distributor, or any entity controlling, controlled by, or under common control with the Investment Manager or Distributor, or any successor in interest to any such entity,
5. The Credit Fund continuously offers, and the Municipal Fund will continuously offer, common shares to the public. Applicants state that additional offerings by any Fund relying on the order may be on a private placement or public offering basis. Shares of the Funds will not be listed on any securities exchange nor quoted on any quotation medium. The Funds do not expect there to be a secondary trading market for their shares.
6. If the requested relief is granted, the Credit Fund intends to commence a continuous offering of one or more additional classes of shares. If the relief requested herein is granted, it is currently expected that the Municipal Fund will initially offer two share classes. It is currently expected that one share class will not be subject to a front-end sales load, a distribution fee or a service fee. The other share class may be subject to a front-end sales load, a distribution fee and/or a service fee. The Funds may in the future offer additional classes of shares and/or another sales charges structure. Because of the different distribution fees, services and any other class expenses that may be attributable to the each class of shares, the net income attributable to, and the dividends payable on, each class of shares may differ from each other.
7. Applicants state that, from time to time, the Funds may create additional classes of shares, the terms of which may differ from the initial class in the following respects: (i) The amount of fees permitted by different distribution plans or different service fee arrangements; (ii) voting rights with respect to a distribution plan of a class; (iii) different class designations; (iv) any differences in dividends and net asset value resulting from differences in fees under a distribution or service fee arrangement or in class expenses; (v) any EWC or other sales load structure; and (vi) exchange or conversion privileges of the classes as permitted under the Act.
8. Applicants state that the Initial Funds have each adopted a fundamental policy to repurchase a specified percentage of its shares (no less than 5%) at net asset value on a quarterly basis. Such repurchase offers will be conducted pursuant to rule 23c-3 under the Act. Each of the other Funds will likewise adopt fundamental investment policies and make periodic repurchase offers to its shareholders in compliance with rule 23c-3 or will provide periodic liquidity with respect to its shares pursuant to rule 13e-4 under the Exchange Act.
9. Applicants represent that any asset-based service and/or distribution fees for each class of shares of the Funds will comply with the provisions of FINRA Rule 2341(d) (“FINRA Sales Charge Rule”).
10. Each of the Funds will comply with any requirements that the Commission or FINRA may adopt regarding disclosure at the point of sale and in transaction confirmations about the costs and conflicts of interest arising out of the distribution of open-end investment company shares, and regarding prospectus disclosure of sales loads and revenue sharing arrangements, as if those requirements applied to the Fund. In addition, each Fund will contractually require that any distributor of the Fund's shares comply with such requirements in connection with the distribution of such Fund's shares.
11. Each Fund will allocate all expenses incurred by it among the various classes of shares based on the net assets of that Fund attributable to each class, except that the net asset value and expenses of each class will reflect the expenses associated with the distribution plan of that class, service fees attributable to that class (if any), including transfer agency fees, and any other incremental expenses of that class. Expenses of a Fund allocated to a particular class of shares will be borne on a pro rata basis by each outstanding share of that class. Applicants state that each Fund will comply with the provisions of rule 18f-3 under the Act as if it were an open-end investment company.
12. Applicants state that each Fund may impose an EWC on shares submitted for repurchase that have been held less than a specified period and may waive the EWC for certain categories of shareholders or transactions to be established from time to time. Applicants state that each Fund will apply the EWC (and any waivers or scheduled variations, or elimination of the EWC) uniformly to all shareholders in a given class and consistently with the requirements of rule 22d-1 under the Act as if the Funds were open-end investment companies.
13. Each Fund operating as an interval fund pursuant to rule 23c-3 under the Act may offer its shareholders an exchange feature under which the shareholders of the Fund may, in connection with such Fund's periodic repurchase offers, exchange their shares of the Fund for shares of the same class of (i) registered open-end investment companies or (ii) other registered closed-end investment companies that comply with rule 23c-3 under the Act or Rule 13e-4 under the Exchange Act and continuously offer their shares at net asset value, that are in the Fund's group of investment companies (collectively, “Other Funds”). Shares of a Fund operating pursuant to rule 23c-3 that are exchanged for shares of Other Funds will be included as part of the amount of the repurchase offer amount for such Fund as specified in rule 23c-3 under the Act. Any exchange option will comply with rule 11a-3 under the Act, as if the Fund were an open-end investment company subject to rule 11a-3. In complying with rule 11a-3, each Fund will treat an EWC as if it were a contingent deferred sales load (“CDSL”).
1. Section 18(a)(2) of the Act provides that a closed-end investment company may not issue or sell a senior security that is a stock unless certain requirements are met. Applicants state that the creation of multiple classes of shares of the Funds may violate section 18(a)(2) because the Funds may not meet such requirements with respect to a class of shares that may be a senior security.
2. Section 18(c) of the Act provides, in relevant part, that a closed-end investment company may not issue or sell any senior security if, immediately thereafter, the company has outstanding more than one class of senior security. Applicants state that the creation of multiple classes of shares of the Funds may be prohibited by section 18(c), as a class may have priority over another class as to payment of dividends because shareholders of different classes would pay different fees and expenses.
3. Section 18(i) of the Act provides that each share of stock issued by a registered management investment company will be a voting stock and have equal voting rights with every other outstanding voting stock. Applicants state that multiple classes of shares of the Funds may violate section 18(i) of the Act because each class would be entitled to exclusive voting rights with respect to matters solely related to that class.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction or any class or classes of persons, securities or transactions from any provision of the Act, or from any rule or regulation under the Act, if and to the extent such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants request an exemption under section 6(c) from sections 18(a)(2), 18(c) and 18(i) to permit the Funds to issue multiple classes of shares.
5. Applicants submit that the proposed allocation of expenses relating to distribution and voting rights among multiple classes is equitable and will not discriminate against any group or class of shareholders. Applicants submit that the proposed arrangements would permit a Fund to facilitate the distribution of its securities and provide
1. Section 23(c) of the Act provides, in relevant part, that no registered closed-end investment company shall purchase securities of which it is the issuer, except: (a) On a securities exchange or other open market; (b) pursuant to tenders, after reasonable opportunity to submit tenders given to all holders of securities of the class to be purchased; or (c) under other circumstances as the Commission may permit by rules and regulations or orders for the protection of investors.
2. Rule 23c-3 under the Act permits an “interval fund” to make repurchase offers of between five and twenty-five percent of its outstanding shares at net asset value at periodic intervals pursuant to a fundamental policy of the interval fund. Rule 23c-3(b)(1) under the Act permits an interval fund to deduct from repurchase proceeds only a repurchase fee, not to exceed two percent of the proceeds, that is paid to the interval fund and is reasonably intended to compensate the fund for expenses directly related to the repurchase.
3. Section 23(c)(3) provides that the Commission may issue an order that would permit a closed-end investment company to repurchase its shares in circumstances in which the repurchase is made in a manner or on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased.
4. Applicants request relief under section 6(c), discussed above, and section 23(c)(3) from rule 23c-3 to the extent necessary for the Funds to impose EWCs on shares of the Funds submitted for repurchase that have been held for less than a specified period.
5. Applicants state that the EWCs they intend to impose are functionally similar to CDSLs imposed by open-end investment companies under rule 6c-10 under the Act. Rule 6c-10 permits open-end investment companies to impose CDSLs, subject to certain conditions. Applicants note that rule 6c-10 is grounded in policy considerations supporting the employment of CDSLs where there are adequate safeguards for the investor and state that the same policy considerations support imposition of EWCs in the interval fund context. In addition, applicants state that EWCs may be necessary for the distributor to recover distribution costs. Applicants represent that any EWC imposed by the Funds will comply with rule 6c-10 under the Act as if the rule were applicable to closed-end investment companies. The Funds will disclose EWCs in accordance with the requirements of Form N-1A concerning CDSLs.
1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit an affiliated person of a registered investment company, or an affiliated person of such person, acting as principal, from participating in or effecting any transaction in connection with any joint enterprise or joint arrangement in which the investment company participates unless the Commission issues an order permitting the transaction. In reviewing applications submitted under section 17(d) and rule 17d-1, the Commission considers whether the participation of the investment company in a joint enterprise or joint arrangement is consistent with the provisions, policies and purposes of the Act, and the extent to which the participation is on a basis different from or less advantageous than that of other participants.
2. Rule 17d-3 under the Act provides an exemption from section 17(d) and rule 17d-1 to permit open-end investment companies to enter into distribution arrangements pursuant to rule 12b-1 under the Act. Applicants request an order under section 17(d) and rule 17d-1 under the Act to the extent necessary to permit the Fund to impose asset-based distribution and/or service fees. Applicants have agreed to comply with rules 12b-1 and 17d-3 as if those rules applied to closed-end investment companies, which they believe will resolve any concerns that might arise in connection with a Fund financing the distribution of its shares through asset-based distribution fees.
3. For the reasons stated above, applicants submit that the exemptions requested under section 6(c) are necessary and appropriate in the public interest and are consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants further submit that the relief requested pursuant to section 23(c)(3) will be consistent with the protection of investors and will insure that applicants do not unfairly discriminate against any holders of the class of securities to be purchased. Finally, applicants state that the Funds' imposition of asset-based distribution and/or service fees is consistent with the provisions, policies and purposes of the Act and does not involve participation on a basis different from or less advantageous than that of other participants.
Applicants agree that any order granting the requested relief will be subject to the following condition:
Each Fund relying on the order will comply with the provisions of rules 6c-10, 12b-1, 17d-3, 18f-3, 22d-1, and, where applicable, 11a-3 under the Act, as amended from time to time, as if those rules applied to closed-end management investment companies, and will comply with the FINRA Sales Charge Rule, as amended from time to time, as if that rule applied to all closed-end management investment companies.
For the Commission, by the Division of Investment Management, under delegated authority.
On May 21, 2018, NYSE Arca, Inc. (“Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Blackrock Fund Advisors (“Adviser”) is the investment adviser for the Funds. Under normal market conditions, the CA Fund invests at least 90% of its assets in the component securities of the S&P California AMT-Free Muni Bond Index (“CA Index”), which measures the performance of the investment-grade segment of the California municipal bond market.
Currently, the Exchange lists and trades the Shares under NYSE Arca Rule 5.2-E(j)(3), which governs the listing and trading of Investment Company Units, and pursuant to an order approving the Exchange's proposal to list and trade the Shares.
Currently, for the Exchange to list and trade shares of the CA Fund, each bond in the CA Index must: (1) Be a constituent of an offering where the original offering amount of the constituent bonds in the aggregate was at least $100 million; (2) have a total minimum par amount of $25 million; and (3) maintain a total minimum par amount greater than or equal to $25 million as of the next rebalancing date. Further, the CA Index must include at least 500 component securities.
The Exchange proposes to amend the continued listing requirements for the shares of the CA Fund such that: (1) At least 90% of the weight of the CA Index must consist of securities that have an outstanding par value of at least $15 million and were issued as part of a transaction of at least $100 million; and (2) the CA Index must contain at least 500 component securities.
Currently, for the Exchange to list and trade shares of the NY Fund, each bond in the NY Index must: (1) Be a constituent of an offering where the original offering amount of the constituent bonds in the aggregate was at least $100 million; (2) have a minimum total par amount of $25 million; and (3) maintain a minimum total par amount greater than or equal to $25 million as of the next rebalancing date. Further, the NY Index must include at least 500 component securities.
The Exchange proposes to amend the continued listing requirements for the shares of the NY Fund such that: (1) At least 90% of the weight of the NY Index must consist of securities that have an outstanding par value of at least $5 million and were issued as part of a transaction of at least $20 million; and (2) the NY Index must contain at least 500 component securities.
The Exchange represents that, except for Commentary .02(a)(2) to NYSE Arca Rule 5.2-E(j)(3), the CA Index and NY Index each will continue to satisfy all of the requirements under NYSE Arca Rule 5.2-E(j)(3).
After careful review, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with Sections 6(b)(5) and 11A of the Act and the rules and regulations thereunder applicable to a national securities exchange.
Interested persons are invited to submit written data, views, and arguments concerning Amendment No. 1. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
The Commission finds good cause to approve the proposed rule change, as modified by Amendment No. 1, prior to the 30th day after the date of publication of notice of Amendment No. 1 in the
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Cboe Options proposes a rule change to amend and clarify the definition of a strategy order, clarify other definitions related to the modified HOSS procedure, and permit the entry of orders that offset imbalances after the strategy order cut-off time.
(a)-(h) No change.
.01 Modified Opening Procedure for Series Used to Calculate the Exercise[/]
([a]
[(i) must be received prior to the applicable strategy order cut-off time for the constituent option series (as determined by the Exchange on a class-by-class basis), which may be no earlier than 8:00 a.m. and no later than the opening of trading in the series. The Exchange will announce all determinations regarding changes to the applicable strategy order cut-off time at least one day prior to implementation.
(ii)] may not [be cancelled or changed]
[In general, the Exchange will consider orders to be strategy orders for purposes of this Rule 6.2.01 if the orders possess the following three characteristics:
(A) The orders are for option series with the expiration that will be used to calculate the exercise or final settlement value of the applicable volatility index option or futures contract.
(B) The orders are for option series spanning the full range of strike prices for the appropriate expiration for option series that will be used to calculate the exercise or final settlement value of the applicable volatility index option or futures contract, but not necessarily every available strike price.
(C) The orders are for put options with strike prices less than the “at-the-money” strike price and for call options with strike prices greater than the “at-the-money” strike price. The orders may also be for put and call options with “at-the-money” strike prices.
Whether orders are strategy orders for purposes of this Rule 6.2.01 depends upon specific facts and circumstances. The Exchange may also deem order types other than those provided above as strategy orders if the Exchange determines that to be the case based upon the applicable facts and circumstances.]
([b]
([c]
(i) the Trading Permit Holder with which the Market-Maker is affiliated has established, maintains, and enforces reasonably designed written policies and procedures (including information barriers, as applicable), taking into consideration the nature of the Trading Permit Holder's business and other facts and circumstances, to prevent the misuse of material nonpublic information (including the submission of strategy orders); and
(ii) when submitting these bids and offers, the Market-Maker has no actual knowledge of any previously submitted strategy orders.
(b) Not applicable.
(c) Not applicable.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Cboe Options and Cboe Futures Exchange, LLC (“CFE”) list options and futures, respectively, on different volatility indexes that are calculated using prices of options traded on Cboe Options.
The volatility index settlement process is patterned after the process used to calculate the exercise settlement value of SPX options. On the days SPX options expire, S&P calculates an SOQ of the S&P 500 Index using the opening prices of the component stocks in their primary markets. Market participants can replicate the exposure of their expiring SPX options by entering orders to buy and sell the component stocks of the S&P 500 Index at their opening prices. If they are successful, market participants can effectively construct a portfolio that matches the value of the SOQ. At this point, the derivatives and cash markets converge.
In a very similar way, the exercise settlement value for volatility index derivatives is an SOQ of the volatility index using opening prices of the constituent options used to determine the value of the index. With respect to VIX, the VIX exercise settlement value is calculated using the opening prices of SPX options that expire approximately 30 days later. Analogous to the settlement process for SPX options, market participants can replicate the exposure of their expiring VIX derivatives by entering buy and sell orders in constituent SPX options. If they are successful, market participants can effectively construct a portfolio of SPX options whose value matches the value of the VIX SOQ. By doing so, market participants may make or take delivery of the SPX options that will be used to calculate the exercise settlement value of their VIX derivatives.
A tradable settlement creates the opportunity to convert the exposure of an expiring VIX derivative into the portfolio of SPX options that will be used to calculate the exercise settlement
Since the VIX settlement value converges with the value of the portfolio of SPX options used to calculate that VIX settlement value, trading this SPX option portfolio mitigates settlement risk.
To replicate expiring volatility index derivatives on their expiration dates with portfolios of constituent options, market participants generally submit strategy orders to participate in the modified HOSS procedure on exercise settlement value determination dates. The Exchange understands that the entry of strategy orders may lead to order imbalances in the option series being used to determine the exercise settlement value. To the extent (1) market participants seeking to replicate an expiring VIX derivative position are on one side of the market (
To provide market participants with time to enter additional orders and quotes to offset any such imbalances prior to the opening of these series, the Exchange established a strategy order cut-off time.
The proposed rule change first moves all defined terms in Interpretation and Policy .01 to proposed paragraph (a), adds certain defined terms, and revises and clarifies existing defined terms as each is used in Interpretation and Policy .01. Cboe Options proposes to add and modify the following defined terms in Interpretation and Policy .01 with respect to the modified HOSS procedure:
•
•
•
•
○ Relate to the market participant's positions in expiring volatility index derivatives;
○ are for option series with the expiration that the Exchange will use to calculate the exercise or final settlement value, as applicable, of the applicable volatility index derivative;
○ are for option series with strike prices approximating the range of series that are later determined to constitute the constituent option series for the applicable expiration;
○ are for put (call) options with strike prices equal to or less (greater) than the “at-the-money” strike price; and
○ have quantities approximating the weighting formula used to determine the exercise or final settlement value, as applicable, in accordance with the applicable volatility index methodology.
Current paragraph (a) defines strategy orders as all orders for participation in the modified opening procedure that are related to positions in, or a trading strategy involving, expiring volatility index options or (security) futures. The current rule also says, in general, the Exchange will consider orders to be strategy orders for purposes of Rule 6.2, Interpretation and Policy .01 if the orders possess three characteristics:
• The orders are for option series with the expiration that will be used to calculate the exercise or final settlement value of the applicable volatility index option or futures contract;
• the orders are for option series spanning the full range of strike prices for the appropriate expiration for option series that will be used to calculate the exercise or final settlement value of the applicable volatility index option or futures contract, but not necessarily every available strike; and
• the orders are for put options with strike prices less than the “at-the-money” strike price and for call options with strike prices greater than the “at-the-money” strike price. The orders may also be for put and call options with “at-the-money” strike prices. The current rule also states whether orders are strategy orders for purposes of Rule 6.2, Interpretation and Policy .01 depends upon specific facts and circumstances. Currently, the Exchange may also deem order types other than those provided above as strategy orders if the Exchange determines that to be the case based upon the applicable facts and circumstances.
When the definition of strategy order was adopted, volatility index derivatives had only just begun trading. The Exchange believed some flexibility within the rules regarding what constituted a strategy order was appropriate to permit market participants to submit strategy orders in a manner consistent with their businesses. Additionally, flexibility within the rule provided the Exchange with the ability to gain experience in monitoring trading in these products and evaluating the use of strategy orders.
The proposed definition of strategy order limits strategy orders to strips of orders in constituent options series submitted by a market participant that contain the characteristics of orders that would replicate the exposure of the market participant's expiring volatility index derivatives. This is consistent with how market participants use strategy orders, as discussed above, and is also consistent with the initial purpose of the strategy order cut-off time.
The proposed rule change deletes the provision stating that the Exchange may also deem order types other than those provided in the rule as strategy orders if the Exchange determines it to be the cased based upon the applicable facts and circumstances. Ultimately, based on the Exchange's experience of monitoring trading in volatility index derivatives and the modified opening procedure used on exercise settlement value determination days, orders intending to replicate the vega of expiring volatility index derivatives (or to liquidate a hedge) possess the five specified
•
○ A buy (sell) order in a constituent options series if an expected opening information message (“EOI”)
○ a Market-Maker bid or offer in a constituent option series, as set forth in proposed paragraph (e) (current paragraph (c)).
As discussed above, the Exchange understands the entry of strategy orders may create imbalances in the constituent option series. To provide market participants with time to enter additional orders and quotes to offset any such imbalances prior to the opening of these series, the Exchange established a strategy order cut-off time.
However, if a market participant enters a strategy order prior to the strategy order cut-off time, the Exchange understands such market participant may refrain from entering orders to offset imbalances because of the perceived risk that such an order may be deemed to be a new strategy order or a change to the existing strategy order, which is activity the current rule does not permit. This perceived risk may reduce liquidity at the opening on exercise settlement value determination days and may increase the risk that some series do not open because of an imbalance.
In order to promote a fair and orderly opening process, the Exchange seeks to encourage all market participants to enter orders following the strategy order cut-off time for the purpose of offsetting imbalances in constituent option series until the opening of trading., [sic] Accordingly, the Exchange proposes to add to the definition of non-strategy orders a buy (sell) order in a constituent options series if an EOI disseminated no more than two minutes prior to the time a market participant submitted the order included a sell (buy) imbalance and the size of the order is no larger than the size of the imbalance in the EOI,
The purpose of permitting market participants to enter orders to offset order imbalances is not to permit them to modify strategy orders, but rather to encourage them to respond to EOIs that indicate an imbalance in a series exists. The Exchange believes explicitly permitting market participants to offset order imbalances in response to EOIs, as set forth in the proposed definition of non-strategy orders, may increase liquidity in series, including in constituent option series, which would contribute to a fair and orderly opening in those series. The Exchange disseminates these messages for the purpose of encouraging submission of orders to address order imbalances. Therefore, the Exchange does not believe such orders are “related to” expiring volatility index derivatives, and thus would not constitute a strategy order under the current or proposed definition, as discussed above. The Exchange believes the proposed rule change is consistent with the definition of strategy order because the proposed rule explicitly excludes orders submitted for this imbalance offsetting purpose from falling within the strategy order definition.
The remainder of the proposed definition, including subparagraphs (1) and (3), is consistent with the current definition of non-strategy orders in current paragraph (b), and just clarifies examples of non-strategy orders that exist in the current rule. The proposed definition also makes nonsubstantive changes and incorporates new defined terms.
Proposed paragraph (b) provides that, on exercise settlement value determination days, the Exchange uses the opening procedure described in Rule 6.2, as modified by Interpretation and Policy .01, for constituent option series. This clarifies that the opening procedure the Exchange uses for constituent option series on exercise settlement value determination days is the same as the opening procedure used for all option series on all other days, except as set forth in Interpretation and Policy .01. This proposed provision is consistent with the current introductory paragraph, and makes nonsubstantive changes and incorporates new defined terms.
Proposed paragraph (c) states market participants must submit strategy orders, and changes to or cancellations of strategy orders, prior to the strategy order cut-off time (which the Exchange has currently set as 8:20 a.m. Chicago time). Market participants may not change or cancel strategy orders after the strategy order cut-off time, unless the market participant submits the change or cancellation (1) after the modified opening procedure is concluded; or (2) to correct a legitimate error, in which case the market participant submitting the change or cancellation must prepare and maintain a memorandum setting forth the
Proposed paragraph (d) states market participants must submit non-strategy orders prior to the non-strategy order cut-off time. The Exchange determines the non-strategy order cut-off time on a class-by-class basis, and it may be no earlier than 8:25 a.m. Chicago time and no later than the opening of trading in a series. The Exchange has currently set the non-strategy order cut-off time to be the opening of trading. The Exchange will announce any changes to the non-strategy order cut-off time at least one day prior to implementation. Proposed paragraph (d) is substantively the same as current paragraph (b), and makes nonsubstantive changes and incorporates defined terms. Proposed paragraph (d) also excludes the description of what constitutes a non-strategy order, which is currently included in current paragraph (a) and has been moved to proposed paragraph (a) as a defined term, as discussed above.
The proposed rule change makes additional nonsubstantive changes, including revising the heading for Interpretation and Policy .01 and updating the paragraph lettering.
The Exchange notes the proposed rule change would not impact a Trading Permit Holder's requirements to abide by Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information). The Exchange believes the proposed rule change may contribute to additional liquidity during the modified HOSS procedure, and thus a fair and orderly opening on exercise settlement value determination days. A fair and orderly opening in these series benefits all market participants who trade in the volatility index derivatives and the constituent series. The Exchange will continue to conduct surveillance procedures to monitor trading in the constituent option series, including but not limited to compliance with the strategy order cut-off time (in accordance with the proposed rule change).
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed definition of a strategy order provides market participants with additional clarity regarding what orders constitute strategy orders, and the Exchange believes this added clarity benefits investors and promotes just and equitable principles of trades. The proposed rule change with respect to the definition of strategy orders is consistent with the current definition of strategy orders and the Exchange's view of what orders constitute a strategy order, as well as the legitimate purposes of strategy orders, because orders submitted for the purposes of constituting a strategy order generally possess the five specified characteristics (four of which are in current Rule 6.2, Interpretation and Policy .01(a)).
Additionally, the proposed definition of non-strategy order provides market participants with additional clarity regarding orders that do not constitute strategy orders (and thus that may be submitted after the strategy-order cut-off time and prior to the non-strategy order cut-off time). The Exchange believes explicitly permitting market participants to enter orders to offset order imbalances in response to EOIs that indicate an imbalance in a series exists will encourage entry of orders when there is an imbalance in a series, even if market participants previously submitted strategy orders. This proposed rule change allows the maximum number of participants to address order imbalances during the opening process for the constituent option series while executing their investment and hedging strategies. The Exchange believes these changes may increase liquidity in series, including in constituent option series, to offset imbalances. This result would contribute to a fair and orderly opening process and would benefit all market participants who trade in the volatility index derivatives or the constituent option series. The Exchange also believes these changes are consistent with the original purpose of the strategy order cut-off time. The Exchange believes this additional clarity with respect to what is and is not a strategy order will provide market participants with more certainty with respect to which orders constitute strategy orders, and thus which orders need to be submitted prior to the strategy order cut-off time. It also clarifies for market participants the activity in which they may engage after the strategy order cut-off time. The Exchange believes the proposed reorganization of Interpretation and Policy .01, including defining all relevant terms at the beginning of Interpretation and Policy .01, also benefits market participants by providing additional clarity with respect to all defined terms for the modified HOSS procedure.
The Exchange notes the proposed rule change would not impact a Trading Permit Holder's requirements to abide by Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information). The Exchange believes the proposed rule change may contribute to additional liquidity during the modified HOSS procedure, and thus to a fair and orderly opening in constituent option series on exercise settlement value determination days. A fair and orderly opening in these series benefits all market participants who trade in the volatility index derivatives and the
Cboe Options does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change applies in the same manner to all market participants who submit orders to the Exchange in constituent option series on exercise settlement value determination days. The proposed rule change, and the proposed definition of strategy order in particular, provides market participants with clarity for market participants with respect to what constitutes a strategy order and is generally consistent with the current rules and the Exchange's view of what orders constitute a strategy order. Additionally, the proposed definition of non-strategy order, particularly the explicit permission to enter orders in response to EOIs that indicate an imbalance in a series, is consistent with the original intent of the strategy order cut-off time.
Cboe Options believes that the proposed rule change will relieve any burden on, or otherwise promote, competition. The Exchange believes the proposed rule change may contribute to liquidity in constituent option series during the modified HOSS procedure, and thus a fair and orderly opening on exercise settlement value determination days. A fair and orderly opening in these series benefits all market participants who trade in the volatility index derivatives and the constituent option series.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove such proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice of extension of and changes to Community Advantage Pilot Program; and request for comments.
The Community Advantage (“CA”) Pilot Program is a pilot program to increase SBA-guaranteed loans to small businesses in underserved areas. The Small Business Administration (“SBA”) continues to refine and improve the design of the Community Advantage Pilot Program. To support SBA's commitment to expanding access to capital for small businesses and entrepreneurs in underserved markets, SBA is issuing this Notice to extend the term of the CA Pilot Program, to mitigate risks of the program by placing a moratorium on accepting new CA Lender applications, to limit fees that can be collected from an applicant for a CA loan, and to revise other program requirements.
The moratorium on accepting applications from lenders for participation in the CA Pilot Program and all other changes identified in this Notice will be effective on October 1,
You may submit comments, identified by SBA docket number SBA-2018-0008, by any of the following methods:
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SBA will post all comments on
Daniel Upham, Acting Director, Office of Economic Opportunity, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416, (202) 205-7001,
On February 18, 2011, SBA issued a notice and request for comments introducing the CA Pilot Program (76 FR 9626). The CA Pilot Program was introduced to increase the number of SBA-guaranteed 7(a) loans made to small businesses in underserved markets. The February 18, 2011 notice provided an overview of the CA Pilot Program requirements and, pursuant to the authority provided to SBA under 13 CFR 120.3 to suspend, modify or waive certain regulations in establishing and testing pilot loan initiatives, SBA modified or waived as appropriate certain regulations which otherwise apply to 7(a) loans for the CA Pilot Program.
Subsequent notices have made changes to the CA Pilot Program to improve the program experience for participants, improve their ability to deliver capital to underserved markets, and appropriately manage risk to the Agency. These notices were issued on the following dates: September 12, 2011 (76 FR 56262), February 8, 2012 (77 FR 6619), November 9, 2012 (77 FR 67433), and December 28, 2015 (80 FR 80872). In the December 28, 2015 notice, SBA stated that it would evaluate the CA Pilot Program to refine the program and to determine whether it should be made permanent, with evaluation criteria including, but not limited to, whether the pilot is achieving its objective(s), impact on job creation and retention, impact on business creation and/or business expansion, whether the costs (including losses) of the pilot are within an acceptable range, and portfolio performance as it relates to other 7(a) programs. SBA recently conducted an analysis to compare the performance of CA loans to other relevant groups of 7(a) loans and to the entire 7(a) portfolio, and found that CA loans exhibit more risk than other 7(a) loans. As discussed further below, the analysis found that the CA loan portfolio had a higher early problem loan rate, higher early default rate, and the last 12 month default rate is trending higher than other similar 7(a) loans and the overall 7(a) portfolio. In an effort to mitigate this risk and in order to ensure that SBA's Office of Credit Risk Management (“OCRM”) continues to be able to properly oversee lenders participating in the CA Pilot Program, SBA is issuing this Notice to place a moratorium on the acceptance of new Community Advantage Lender Participation Applications (“CA Lender Applications”) and to further revise program requirements, as described more fully below.
The CA Pilot Program is currently set to expire March 31, 2020. With this Notice, SBA is extending the pilot program until September 30, 2022. This extension will allow for additional time to evaluate the pilot, and if warranted, begin the process for it to be made permanent.
Although the moratorium on accepting applications for new CA Lenders and all other changes are effective October 1, 2018, comments are solicited from interested members of the public on all aspects of the CA Pilot Program. Comments must be submitted on or before the deadline for comments listed in the
As a pilot loan program, the CA Pilot Program is intended to be available to a limited number of lenders to allow the Agency to test new methods for expanding access to capital for small businesses in underserved markets. The limited scope of the program allows SBA to evaluate its effectiveness without unduly increasing risk to the Agency. Since its inception in 2011, the CA Pilot Program has grown to 113 CA Lenders across 39 states, 99 of which are actively making and servicing CA loans. SBA has determined that there is a sufficient number and geographical diversity of CA Lenders to evaluate the pilot; therefore, it is unnecessary to further increase the number of lenders participating in the CA Pilot Program at this time.
In addition, while almost all 7(a) Lenders have a primary Federal financial regulator or a state financial regulator, all CA Lenders are classified as “SBA Supervised Lenders,” as defined in 13 CFR 120.10, and as a result, oversight of CA Lenders is more resource-intensive for SBA than oversight of other 7(a) Lenders.
Furthermore, a recent SBA analysis found that CA loans exhibit more risk than other 7(a) loans. (See
Given the increased risk of CA loans as compared to other 7(a) loans, the need for more resource-intensive oversight of CA Lenders, and the fact that the CA Pilot Program already includes a sufficient number of geographically dispersed CA Lenders, SBA has decided to place a moratorium on acceptance of new CA Lender applications. Effective October 1, 2018, SBA will no longer accept CA Lender Applications (SBA Form 2301). Completed CA Lender Applications that are received before October 1, 2018 will be fully evaluated, and a decision whether to allow the applicant to participate in the CA Pilot Program will be made based on the criteria in Appendix C of Version 4.0 of the Community Advantage Participant Guide, which is the version in effect at the time of receipt of such applications. Any CA Lender Applications that have been submitted to SBA but are incomplete as of October 1, 2018 will not be processed.
The original February 18, 2011 notice introducing the CA Pilot Program defined underserved markets to include: Low-to-moderate income communities (“LMI”); Empowerment Zones and Enterprise Communities; HUBZones; New businesses; Businesses eligible for Patriot Express, including Veteran-owned businesses; and Firms where more than 50% of their full time workforce is low-income or resides in LMI census tracts. In the December 28, 2015 notice, SBA revised this program definition to include designated Promise Zones as an underserved market. In the December 28, 2015 update to the Community Advantage Participant Guide, SBA again updated the definition of underserved market to remove “Businesses eligible for Patriot Express” and replace it with “Businesses eligible for SBA Veterans Advantage,” as the Patriot Express Pilot Initiative expired on December 31, 2013.
SBA is now further revising the definition of underserved markets to include Opportunity Zones and Rural Areas. An Opportunity Zone is an economically distressed community that has been nominated by the state and certified by the Secretary of the U.S. Treasury as a community in which new investments, under certain conditions, may be eligible for preferential tax treatment. More information and a list of Opportunity Zones for all states are available at
Currently, all debt refinancing in the CA Pilot Program must meet the requirements for refinancing set forth in the version of SOP 50 10 in effect at the time of loan approval, with two modifications. First, the CA Lender must demonstrate either (a) a 10 percent improvement in cash flow; or (b) that the CA loan exceeds the amount being refinanced by at least $5,000 or 25 percent, whichever is greater. Second, a CA Lender seeking to refinance non-SBA guaranteed, same institution debt must include a transcript showing the due dates and when payments were received for the most recent six month period. If there are any late payments in the most recent six month period, the debt may not be refinanced with a CA loan. Late payments are defined as any payment made beyond 29 days of the due date.
SBA is modifying the requirements for refinancing non-SBA guaranteed, same institution debt to require a transcript showing the due dates and when payments were received for the most recent 12 month period, rather than six months. If there are any late payments in the most recent 12 month period, the debt may not be refinanced with a CA loan. In addition, debts on the CA Lender's books for less than 12 months may not be refinanced with a CA loan.
OCRM evaluates all CA applicants for delegated authority eligibility at the time of application to become a CA Lender. Currently, if a prospective lender is not determined to be eligible for delegated authority at the time of approval as a CA Lender, it must wait until after it has participated in the CA Pilot Program for six months before it can request another determination. SBA is revising the eligibility requirements applicable to CA Lenders applying for delegated authority by extending the waiting period from six months to 12 months.
In addition, under current requirements, a CA Lender that is determined to be eligible for delegated authority may not process loans using its delegated authority until (i) it closes and makes an initial disbursement on five non-delegated CA loans, and (ii) OCRM determines, in consultation with the Loan Guaranty Processing Center (“LGPC”), that it has satisfactory knowledge of SBA Loan Program Requirements. SBA is increasing the number of CA loans that must be initially disbursed before a CA Lender may receive approval to process
SBA is increasing the minimum acceptable credit score for CA loans. As further described in the Community Advantage Participant Guide, all CA loan applications receive a credit score at the time of submission of the application for guaranty to SBA. A credit score at or above the minimum acceptable credit score satisfies the need to consider several required underwriting criteria, including part of the analysis to determine reasonable assurance of repayment from cash flow. If a CA Lender believes there are mitigating issues to justify a loan, despite an unacceptable credit score, the Lender may contact the LGPC with a full credit write-up for consideration.
SBA recently compared default rates
CA Lenders are required to create a Loan Loss Reserve Account (“LLRA”) to cover potential losses arising from defaulted loans. The reserve fund is to cover both losses from the unguaranteed portion of defaulted loans as well as possible repairs and denials associated with SBA's guaranty on CA loans sold into SBA's secondary market. In the November 9, 2012 notice, SBA reduced the LLRA requirement from 15 percent of the outstanding amount of the unguaranteed portion of a CA Lender's CA loan portfolio to five percent. In that notice, SBA also established an additional reserve requirement for CA Lenders with secondary market authority. The additional reserve requirement was set at three percent of the outstanding amount of the guaranteed portion of each CA loan sold in the secondary market.
Given the increased risk of CA loans as compared to other 7(a) loans, SBA has determined that the current reserve requirements are insufficient with respect to CA loans sold in the secondary market. SBA is at higher risk on defaulted loans in the secondary market because SBA must make payment to the secondary market investor before it can attempt to recover any denials or repairs from the CA Lender. To address this risk, for each CA loan approved on or after October 1, 2018, a reserve of five percent of the outstanding amount of the guaranteed portion must be deposited in the LLRA if the loan is sold in the secondary market. All other requirements regarding the creation and maintenance of the LLRA stated in the February 18, 2011 notice and all subsequent notices remain unchanged, including the five percent reserve requirement on the unguaranteed portion of CA loans. Failure to maintain the LLRA as required may result in removal from the CA Pilot Program, the imposition of additional controls or reserve amounts, and/or other action permitted by SBA regulation or otherwise by law. Based on the risk characteristics or performance of a CA Lender, OCRM in its discretion and in consultation with the Director of the Office of Financial Assistance may require additional amounts to be included in the LLRA.
In the November 9, 2012 notice, SBA also modified its regulation at 13 CFR 120.660 to allow the Director, Office of Credit Risk Management instead of the Director, Office of Financial Assistance to suspend secondary market authority for CA Lenders under that regulation. Effective September 20, 2017, however, SBA amended this regulation with respect to all 7(a) Lenders to provide that suspensions and revocations under 13 CFR 120.660 would be taken by the Director, Office of Financial Assistance together with the Director, Office of Credit Risk Management. Thus, SBA's 2012 modification of 13 CFR 120.660 for purposes of the CA Pilot Program to permit the Director, Office of Credit Risk Management to take action under this regulation is no longer necessary.
Currently, 13 CFR 120.221(a) permits a lender to charge an applicant reasonable fees (customary for similar lenders in the geographic area where the loan is being made) for packaging and other services. Under the current regulation, SBA permits lenders to charge an applicant a reasonable fee to assist the applicant with the preparation of the application and supporting materials. However, SBA does not permit lenders to charge an applicant a commitment, broker, referral, or similar fee.
For purposes of the CA Pilot Program, SBA is modifying 13 CFR 120.221(a) to limit the total fees an applicant can be charged by a CA Lender for assistance in obtaining a CA loan. Regardless of what the fee is called (
SBA considers a fee of no more than $2,500 to be reasonable for the services provided by a CA Lender to an applicant for assistance with obtaining a CA loan. SBA will monitor this fee and, if adjustments are necessary, SBA may revise this amount by publishing a notice with request for comment in the
If the CA Lender charges the applicant a fee for assistance with obtaining a CA loan, the CA Lender must disclose the fee to the applicant and SBA by completing the Compensation Agreement (SBA Form 159) in accordance with the regulation at § 103.5 and the procedures set forth in SOP 50 10.
The remaining sections of 13 CFR 120.221 (sections (b) through (e)) remain unchanged. Thus, in appropriate circumstances as set forth in current §§ 120.221(b) through (e) and further clarified in SOP 50 10, a CA Lender may charge an applicant or borrower extraordinary servicing fees, out of pocket expenses, a late payment fee, and for legal services charged on an hourly basis.
In the February 8, 2012 notice, SBA modified the CA Pilot Program requirements to allow CA Lenders to contract with Lender Service Providers (“LSPs”), as defined at 13 CFR 103.1(d). SBA will continue to allow CA Lenders to contract with LSPs, but is modifying some of the requirements applicable to LSPs, including total fee limits and
SBA is modifying 13 CFR 103.4(g), which permits a limited exception to the “two master” prohibition when an Agent
The regulation at 13 CFR 103.5 sets forth, among other things, the requirement for all Agents to disclose to SBA the compensation received for services provided to an applicant and requires that fees charged must be considered reasonable by SBA. In an effort to clarify what SBA considers reasonable and to prevent applicants from being overcharged by Agents, SBA is modifying this regulation to limit the total fees that an Agent or Agents may charge an applicant in connection with obtaining a CA loan. An Agent or Agents may charge a maximum of up to 2.5% of the CA loan amount, or $7,000, whichever is less.
If an Agent provides more than one service to an applicant (
SBA considers a fee of the lesser of 2.5% of the guaranteed loan amount or $7,000 to be reasonable for the services provided by an Agent or Agents to an applicant in connection with obtaining a CA loan. SBA will monitor this fee and, if adjustments are necessary, SBA may revise this amount from time to time by publishing a notice with request for comments in the
Finally, SBA is also modifying the last sentence in 13 CFR 103.5(c) to remove the word “directly.” This change clarifies that compensation paid by the CA Lender to a Lender Service Provider may not be charged to the applicant, either directly or indirectly.
The changes in this Notice are limited to the CA Pilot Program only. All other SBA guidelines and regulatory waivers or modifications related to the CA Pilot Program remain unchanged. The regulatory waiver and modifications described in this Notice are authorized by 13 CFR 120.3, which provides that the SBA Administrator may suspend, modify or waive rules for a limited period of time to test new programs or ideas. These modifications apply only to loans made under the CA Pilot Program and will last only for the duration of the pilot, which expires September 30, 2022.
SBA has provided more detailed guidance in the form of a Participant Guide which is being updated to reflect these changes and will be available on SBA's website at
15 U.S.C. 636(a)(25) and 13 CFR 120.3.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Nebraska (FEMA-4387-DR), dated 08/27/2018.
Issued on 08/27/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 08/27/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 156766 and for economic injury is 156770.
By virtue of the authority vested in me as the Secretary of State, including pursuant to section 7045(a)(3)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 (Div. K, Pub. L. 115-141) (SFOAA), I hereby certify that the central government of Guatemala is:
• Informing its citizens of the dangers of the journey to the southwest border of the United States;
• combating human smuggling and trafficking;
• improving border security, including preventing illegal migration, human smuggling and trafficking, and trafficking of illicit drugs and other contraband; and
• cooperating with United States Government agencies and other governments in the region to facilitate the return, repatriation, and reintegration of illegal migrants arriving at the southwest border of the United States who do not qualify for asylum, consistent with international law.
This certification shall be published in the
By virtue of the authority vested in me as the Secretary of State, including pursuant to section 7045(a)(3)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 (Div. K, Pub. L. 115-141) (SFOAA), I hereby certify that the central government of El Salvador is:
• Informing its citizens of the dangers of the journey to the southwest border of the United States;
• combatting human smuggling and trafficking;
• improving border security, including preventing illegal migration, human smuggling and trafficking, and trafficking of illicit drugs and other contraband; and
• cooperating with United States Government agencies and other governments in the region to facilitate the return, repatriation, and reintegration of illegal migrants arriving at the southwest border of the United States who do not qualify for asylum, consistent with international law.
This certification shall be published in the
By virtue of the authority vested in me as the Secretary of State, including pursuant to section 7045(a)(3)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 (Div. K, Pub. L. 115-141) (SFOAA), I hereby certify that the central government of Honduras is:
• Informing its citizens of the dangers of the journey to the southwest border of the United States;
• combating human smuggling and trafficking;
• improving border security, including preventing illegal migration, human smuggling and trafficking, and trafficking of illicit drugs and other contraband; and
• cooperating with United States Government agencies and other governments in the region to facilitate the return, repatriation, and reintegration of illegal migrants arriving at the southwest border of the United States who do not qualify for asylum, consistent with international law.
This certification shall be published in the
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before October 2, 2018.
Send comments identified by docket number FAA-2018-0746 using any of the following methods:
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Mark Forseth, AIR-673, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198, phone and fax 206-231-3179, email
This notice is published pursuant to 14 CFR 11.85.
Issued in Renton, Washington.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of Funding Opportunity (NOFO or notice).
This NOFO details the application procedures and requirements to obtain remaining grant funding for eligible positive train control (PTC) system projects of the Consolidated Rail Infrastructure and Safety Improvements (CRISI) Program as provided by the Consolidated Appropriations Act, 2018, (2018 Appropriation). The funding in this NOFO remains from the 2018 Appropriation after DOT selected applications submitted in response to an initial NOFO for PTC systems deployment published on May 18, 2018. The opportunity described in this notice is made available under Catalog of Federal Domestic Assistance (CFDA) number 20.325, “Consolidated Rail Infrastructure and Safety Improvements.”
Applications under this solicitation are due no later than 5 p.m. EDT, October 12, 2018. Applications for funding or supplemental material in support of such an application received after 5 p.m. EDT on October 12, 2018 will not be considered for funding. Incomplete applications will not be considered for funding. See Section D of this notice for additional information on the application process.
Applications must be submitted via
For further information in this notice, please contact Ms. Amy Houser, Office of Program Delivery, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W36-412, Washington, DC 20590; email:
The purpose of this notice is to solicit applications for competitive PTC system project funding authorized under Section 11301 of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94 (2015); 49 U.S.C. 24407 and funded in the 2018 Appropriation. Together with the FAST Act, the 2018 Appropriation provides funding made available under this NOFO to fund the deployment of PTC system technology for Intercity Passenger Rail Transportation, freight rail transportation and/or Commuter Rail Passenger Transportation. Projects selected under this NOFO for Commuter Rail Passenger Transportation may be transferred to the Federal Transit Administration for grant administration. Projects selected for Intercity Passenger Rail Transportation and freight rail transportation will be administered by the FRA.
A railroad must fully implement a PTC system on all required route miles by December 31, 2018, unless a railroad qualifies for and obtains FRA approval
a. “Benefit-Cost Analysis” (“BCA” or “Cost-Benefit Analysis”) is a systematic, data driven, and transparent analysis comparing monetized project benefits and costs, using a no-build baseline and properly discounted present values, including concise documentation of the assumptions and methodology used to produce the analysis; a description of the baseline, data sources used to project outcomes, and values of key input parameters; basis of modeling including spreadsheets, technical memos, etc.; and presentation of the calculations in sufficient detail and transparency to allow the analysis to be reproduced and sensitivity of results evaluated by FRA. Please refer to the Benefit-Cost Analysis Guidance for Discretionary Grant Programs prior to preparing a BCA at
b. “Commuter Rail Passenger Transportation” means short-haul rail passenger transportation in metropolitan and suburban areas usually having reduced fare, multiple ride, and commuter tickets and morning and evening peak period operations. See 49 U.S.C. 24102(3).
c. “Construction” means the production of fixed works and structures or substantial alterations to such structures or land and associated costs.
d. “Final Design” (“FD”) means design activities following Preliminary Engineering, and at a minimum, includes the preparation of final Construction plans, detailed specifications, and estimates sufficiently detailed to inform project stakeholders (designers, reviewers, contractors, suppliers, etc.) of the actions required to advance the project from design through completion of Construction.
e. “Intercity Rail Passenger Transportation” means rail passenger transportation, except Commuter Rail Passenger Transportation. See 49 U.S.C. 24401(3). In this notice, “Intercity Passenger Rail Service” and “Intercity Passenger Rail Transportation” are equivalent terms to “Intercity Rail Passenger Transportation.”
f. “National Environmental Policy Act” (“NEPA”) is a Federal law that requires Federal agencies to assess the environmental impacts of a proposed action in consultation with appropriate federal, state, and local authorities, and with the public. The NEPA class of action depends on the nature of the proposed action, its complexity, and the potential impacts. For purposes of this NOFO, NEPA also includes all related Federal laws and regulations including Section 4(f) of the Department of Transportation Act, Section 7 of the Endangered Species Act, and Section 106 of the National Historic Preservation Act. (See FRA's Environmental Procedures at:
g. “Positive Train Control system” (“PTC system”) is defined by 49 CFR 270.5 to mean a system designed to prevent train-to-train collisions, overspeed derailments, incursions into established work zone limits, and the movement of a train through a switch left in the wrong position, as described in 49 CFR part 236, subpart I.
h. “Preliminary Engineering” (“PE”) means engineering design to: (1) Define a project, including identification of all environmental impacts, design of all critical project elements at a level sufficient to assure reliable cost estimates and schedules, (2) complete project management and financial plans, and (3) identify procurement requirements and strategies. The PE development process starts with specific project design alternatives that allow for the assessment of a range of rail improvements, specific alignments, and project designs—to be used concurrent with NEPA and related analyses. PE occurs prior to FD and Construction.
i. “Rail Carrier” means a person providing common carrier railroad transportation for compensation, but does not include street, suburban, or interurban electric railways not operated as part of the general system of rail transportation. See 49 U.S.C. 10102(5).
j. “Rural Project” means a project in which all or the majority of the project (determined by the geographic location or locations where the majority of the project funds will be spent) is located in a Rural Area.
k. “Rural Area” is defined in 49 U.S.C. 24407(g)(2) to mean any area not in an urbanized area as defined by the Census Bureau. The Census Bureau defines “Urbanized Area” (“UA”) as an area with a population of 50,000 or more people.
The total funding available for awards under this NOFO is $46,301,702 for eligible PTC system projects under 49 U.S.C. 24407(c)(1). Should FRA identify additional funding available under the 2018 Appropriation after the release of this NOFO, FRA may elect to award such additional funds to projects submitted under this NOFO. At least 25 percent of CRISI funding made available in the 2018 Appropriation will be available for Rural Projects as required in 49 U.S.C. 24407(g).
There are no predetermined minimum or maximum dollar thresholds for awards. FRA anticipates making multiple awards with the available funding. FRA may not be able to award grants to all eligible applications, nor even to all applications that meet or exceed the stated evaluation criteria (see Section E, Application Review Information). Projects may require more funding than is available. FRA encourages applicants to propose projects or components of projects that have operational independence that can be completed and implemented with the level of funding available together with other sources.
FRA strongly encourages applicants to identify and include other state, local, public, or private funding or financing to support the proposed project.
FRA will make awards for projects selected under this notice through grant agreements and/or cooperative agreements. Grant agreements are used when FRA does not expect to have
As DOT and FRA are concurrently soliciting applications for transportation infrastructure projects for several financial assistance programs, applicants may submit applications requesting funding for a particular project to one or more of these programs. In the application for PTC system project funding, applicants must indicate the other programs to which they submitted or plan to submit an application for funding the entire project or certain project components, as well as highlight new or revised information in the PTC system project application that differs from the application(s) for other federal financial assistance programs.
This section of the notice explains applicant eligibility, cost sharing and matching requirements, project eligibility, and project component operational independence. Applications that do not meet the requirements in this section will be ineligible for funding. Instructions for submitting eligibility information to FRA are detailed in Section D of this NOFO.
The following entities are eligible applicants:
a. A State;
b. A group of States;
c. An Interstate Compact;
d. A public agency or publicly chartered authority established by one or more States;
e. A political subdivision of a State;
f. Amtrak or another Rail Carrier that provides Intercity Rail Passenger Transportation (as defined in 49 U.S.C. 24102);
g. A Class II railroad or Class III railroad (as those terms are defined in 49 U.S.C. 20102);
h. Any Rail Carrier or rail equipment manufacturer in partnership with at least one of the entities described in paragraph (a) through (e);
i. The Transportation Research Board together with any entity with which it contracts in the development of rail-related research, including cooperative research programs;
j. A University transportation center engaged in rail-related research; or
k. A non-profit labor organization representing a class or craft of employees of Rail Carriers or Rail Carrier contractors.
Applications must identify an eligible applicant as the lead applicant. The lead applicant serves as the primary point of contact for the application, and if selected, as the recipient of the PTC system grant award. Eligible applicants may reference entities that are not eligible applicants in an application as a project partner.
The Federal share of total costs for projects funded under this notice will not exceed 80 percent, though FRA will provide selection preference to applications where the proposed Federal share of total project costs is 50 percent or less. The estimated total cost of a project must be based on the best available information, including engineering studies, studies of economic feasibility, environmental analyses, and information on the expected use of equipment and/or facilities. Additionally, in preparing estimates of total project costs, applicants should refer to FRA's cost estimate guidance documentation, “Capital Cost Estimating: Guidance for Project Sponsors,” which is available at:
The minimum 20 percent non-Federal match may be comprised of public sector (
Amtrak or another Rail Carrier may use ticket and other non-Federal revenues generated from its operations and other sources as matching funds. Applicants must identify the source(s) of its matching and other funds, and must clearly and distinctly reflect these funds as part of the total project cost.
Before applying, applicants should carefully review the principles for cost sharing or matching in 2 CFR 200.306. See Section D(2)(a)(iii) for required application information on non-Federal match and Section E for further discussion of FRA's consideration of matching funds in the review and selection process. FRA may approve pre-award costs for reimbursement and matching contributions consistent with 2 CFR 200.458, as applicable. See Section D(6).
Projects eligible for funding under this NOFO must be used to deploy PTC systems technology for Intercity Passenger Rail Transportation, freight rail transportation, and/or Commuter Rail Passenger Transportation. Eligible projects include: Back office systems; wayside, communications and onboard hardware equipment; software; equipment installation; spectrum; any component, testing and training for the implementation of PTC systems; and interoperability. Maintenance and operating expenses incurred after a PTC system is placed in revenue service are ineligible. Applicants considering more comprehensive projects that include both PTC elements and other passenger/freight improvements are directed to request only the PTC element under this NOFO or submit applications for the more comprehensive project under the subsequent NOFO, which FRA will soon be issuing for the remainder of the 2018 CRISI funding. Applicants are not limited in the number of projects for which they seek funding.
Applicants must complete all necessary Planning, PE and NEPA requirements for projects funded under this NOFO. Projects for FD must:
i. PE is completed for the proposed project, resulting in project designs that are reasonably expected to conform to all regulatory, safety, security, and other design requirements, including those under the Americans with Disabilities Act (ADA);
ii. NEPA is completed for the proposed project;
iii. Signed agreements with key project partners, including infrastructure-owning entities; and
iv. A project management plan is in-place for managing the implementation of the proposed project, including the management and mitigation of project risks.
If an applicant requests funding for a project that is a component or set of components of a larger project, the project component(s) must be attainable with the award amount, together with other funds as necessary, obtain operational independence, and must comply with all eligibility requirements described in Section C.
In addition, the component(s) must be capable of independent analysis and decision making, as determined by FRA, under NEPA (
FRA will consider a project to be in a Rural Area if all or the majority of the project (determined by geographic location(s) where the majority of the project funds will be spent) is located in a Rural Area. However, in the event FRA elects to fund a component of the project, then FRA will reexamine whether the project is in a Rural Area.
Required documents for the application are outlined in the following paragraphs. Applicants must complete and submit all components of the application. See Section D(2) for the application checklist. FRA welcomes the submission of additional relevant supporting documentation, such as planning, engineering and design documentation, and letters of support from partnering organizations that will not count against the Project Narrative 25-page limit.
Applicants must submit all application materials for PTC system projects in their entirety through
For any supporting application materials that an applicant cannot submit via
FRA strongly advises applicants to read this section carefully. Applicants must submit all required information and components of the application package to be considered for funding. Additionally, applicants selected to receive funding must generally satisfy the grant readiness checklist requirements on
Required documents for an application package are outlined in the checklist below.
This section describes the minimum content required in the Project Narrative of the grant application. The Project Narrative must follow the basic outline below to address the program requirements and assist evaluators in locating relevant information.
The above content must be provided in a narrative statement submitted by the applicant. The Project Narrative may not exceed 25 pages in length (excluding cover pages, table of contents, and supporting
i.
ii.
iii.
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vi.
(A) Document submission of a revised Positive Train Control Implementation Plan (PTCIP) to FRA as required by 49 U.S.C. 20157(a);
(B) Document that it is a tenant on one or more host railroads that submitted a revised PTCIP to FRA as required by 49 U.S.C. 20157(a), which states the tenant railroad is equipping its rolling stock with a PTC system and provides all other information required under 49 CFR 236.1011 regarding the tenant railroad; or
(C) Document why the applicant is not required to submit a revised PTCIP as required by 49 U.S.C. 20157(a), and whether the proposed project will assist in the deployment (
For all projects, applicants must provide information about proposed performance measures, as discussed in Section F(3)(c) and required in 2 CFR 200.301 and 49 U.S.C. 24407(f).
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viii.
ix.
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xi.
Applicants must submit:
i. A Statement of Work (SOW) addressing the scope, schedule, and budget for the proposed project if it were selected for award. The SOW must contain sufficient detail so FRA, and the applicant, can understand the expected outcomes of the proposed work to be performed and monitor progress toward completing project tasks and deliverables during a prospective grant's period of performance. Applicants must use FRA's standard SOW template to be considered for award. The SOW template is located at
ii. A Benefit-Cost Analysis (BCA), as an appendix to the Project Narrative for each project submitted by an applicant. The BCA must demonstrate in economic terms the merits of investing in the proposed project. The project narrative should summarize the project's benefits.
Benefits may apply to existing and new rail users, as well as users of other modes of transportation. In some cases, benefits may be applied to populations in the general vicinity of the project area. Improvements to shared-use rail corridors may benefit all users involved. All benefits claimed for the project must be clearly tied to the expected outcomes of the project. Please refer to the Benefit-Cost Analysis Guidance for Discretionary Grant Programs prior to preparing a BCA at
iii. SF 424—Application for Federal Assistance;
iv. SF 424A—Budget Information for Non-Construction or SF 424C—Budget Information for Construction;
v. SF 424B—Assurances for Non-Construction or SF 424D—Assurances for Construction;
vi. FRA's Additional Assurances and Certifications; and
vii. SF LLL—Disclosure of Lobbying Activities.
Forms needed for the electronic application process are at
See subsection F(2) of this notice for post-selection requirements.
To apply for funding through
FRA may not make a grant award to an applicant until the applicant has complied with all applicable Data Universal Numbering System (DUNS) and SAM requirements. (Please note that if a Dun & Bradstreet DUNS number must be obtained or renewed, this may take a significant amount of time to complete.) Late applications that are the result of a failure to register or comply with
A DUNS number is required for
All applicants for Federal financial assistance must maintain current registrations in the SAM database. An applicant must be registered in SAM to successfully register in
Applicants must complete an Authorized Organization Representative (AOR) profile on
The E-Biz POC at the applicant's organization must respond to the registration email from
If an applicant experiences difficulties at any point during this process, please call the
Please use generally accepted formats such as .pdf, .doc, .docx, .xls, .xlsx and .ppt, when uploading attachments. While applicants may embed picture files, such as .jpg, .gif, and .bmp, in document files, applicants should not submit attachments in these formats. Additionally, the following formats will not be accepted: .com, .bat, .exe, .vbs, .cfg, .dat, .db, .dbf, .dll, .ini, .log, .ora, .sys, and .zip.
Applicants must submit complete applications for PTC system projects to
To ensure a fair competition of limited discretionary funds, the following conditions are not valid reasons to permit late submissions: (1) Failure to complete the
Executive Order 12372 requires applicants from State and local units of government or other organizations providing services within a State to submit a copy of the application to the State Single Point of Contact (SPOC), if one exists, and if this program has been selected for review by the State. Applicants must contact their State SPOC to determine if the program has been selected for State review.
Consistent with 2 CFR 200.458, as applicable, FRA will only approve pre-award costs if such costs are incurred pursuant to the negotiation and in anticipation of the grant agreement and if such costs are necessary for efficient and timely performance of the scope of work. Under 2 CFR 200.458, grant recipients must seek written approval from the administering agency for pre-award activities to be eligible for reimbursement under the grant. Activities initiated prior to the execution of a grant or without written approval are not eligible for reimbursement and will not be counted toward a recipient's matching contribution.
If an applicant experiences difficulties at any point during this process, please call the
FRA will first screen each application for applicant and project eligibility (eligibility requirements are outlined in Section C of this notice), completeness (application documentation and submission requirements are outlined in Section D of this notice), and the 20 percent minimum match in determining whether the application is eligible.
FRA will then consider the applicant's past performance in developing and delivering similar projects and previous financial contributions, and previous competitive grant technical evaluation ratings that the proposed project received under previous competitive grant programs administered by the DOT if applicable.
FRA subject-matter experts will evaluate all eligible and complete applications using the evaluation criteria outlined in this section to determine project benefits and technical merit.
i. Project Benefits: FRA will evaluate the Benefit-Cost Analysis of the proposed project for the anticipated private and public benefits relative to the costs of the proposed project and the summary of benefits provided in response to subsection D(2)(a)(ii) including—
(A) Effects on system and service performance;
(B) Effects on safety, competitiveness, reliability, trip or transit time, and resilience;
(C) Efficiencies from improved integration with other modes; and
(D) Ability to meet existing or anticipated demand.
ii. Technical Merit: FRA will evaluate application information for the degree to which—
(A) The tasks and subtasks outlined in the SOW are appropriate to achieve the expected outcomes of the proposed project.
(B) Applications indicate strong project readiness and meet project requirements.
(C) The technical qualifications and experience of key personnel proposed to lead and perform the technical efforts, and the qualifications of the primary and supporting organizations to fully and successfully execute the proposed project within the proposed timeframe and budget are demonstrated.
(D) The proposed project's business plan considers potential private sector participation in the financing, construction, or operation of the proposed project.
(E) The applicant has, or will have the legal, financial, and technical capacity to carry out the proposed project; satisfactory continuing control over the use of the equipment or facilities; and the capability and willingness to maintain the equipment or facilities.
(F) If applicable, the proposed project is consistent with planning guidance and documents set forth by DOT, including those required by law or State rail plans developed under Title 49, United States Code, Chapter 227.
In addition to the eligibility and completeness review and the evaluation criteria outlined in this subsection, the FRA Administrator will select projects applying the following selection criteria:
i. The FRA Administrator will give preference to projects for which the:
(A) Proposed Federal share of total project costs is 50 percent or less; and
(B) Net benefits of the grant funds will be maximized considering the BCA, including anticipated private and public benefits relative to the costs of the proposed project, and factoring in the other considerations in 49 U.S.C. 24407(e).
ii. After applying the above preferences, the FRA Administrator will take into account the following key Departmental objectives:
(A) Supporting economic vitality at the national and regional level;
(B) Leveraging Federal funding to attract other, non-Federal sources of infrastructure investment, as well as accounting for the life-cycle costs of the project;
(C) Using innovative approaches to improve safety and expedite project delivery; and,
(D) Holding grant recipients accountable for their performance and achieving specific, measurable outcomes identified by grant applicants.
FRA will conduct a three-part application review process, as follows:
a. Screen applications for completeness and eligibility;
b. Evaluate eligible applications (completed by technical panels applying the evaluation criteria); and
c. Select projects for funding (completed by the FRA Administrator applying the selection criteria).
Prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, FRA is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313). An applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered and is currently in the designated integrity and performance system accessible through SAM. FRA will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.205.
FRA will announce applications selected for funding in a press release and on the FRA website after the application review periods. FRA will contact applicants with successful applications after announcement with information and instructions about the award process. This notification is not an authorization to begin proposed project activities. A formal cooperative agreement or grant agreement signed by both the recipient and the FRA, including an approved scope, schedule, and budget, is required before the award is obligated and complete.
For all projects, obligation occurs when a selected applicant and FRA enter a written project specific cooperative agreement or grant agreement and is after the applicant has satisfied applicable requirements. For FD/Construction projects, these requirements may include transportation planning, PE and environmental reviews.
Due to funding limitations, projects that are selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate the proposed projects are still viable and can be completed with the amount awarded.
Recipients and entities receiving funding from the recipient, must comply with all applicable laws and regulations. Examples of administrative and national policy requirements include: 2 CFR part 200; procurement standards; compliance with Federal civil rights laws and regulations; requirements for disadvantaged business enterprises, debarment and suspension requirements, and drug-free workplace requirements; FRA's and OMB's Assurances and Certifications; Americans with Disabilities Act; safety requirements including those applicable to PTC projects; NEPA; environmental justice requirements; performance measures under 49 U.S.C. 24407(f); 49 U.S.C. 24405, including the Buy America requirements and the provision deeming operators rail carriers and employers for certain purposes. Grants for PTC system projects selected under 49 U.S.C. 24407(c)(1) for Commuter Rail Passenger Transportation, if transferred to FTA, must comply with the requirements of chapter 53 of Title 49.
See an example of standard terms and conditions for FRA grant awards at
Each applicant selected for a grant will be required to comply with all standard FRA reporting requirements, including quarterly progress reports, quarterly Federal financial reports, and interim and final performance reports, as well as all applicable auditing, monitoring and close out requirements. Reports may be submitted electronically.
Each applicant selected for funding must collect information and report on the project's performance using measures mutually agreed upon by FRA and the recipient to assess progress in achieving strategic goals and objectives.
For further information regarding this notice and the grants program, please contact Ms. Amy Houser, Office of Program Delivery, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W36-412, Washington, DC 20590; email:
All information submitted as part of or in support of any application shall use publicly available data or data that can be made public and methodologies that is accepted by industry practice and standards, to the extent possible. If the application includes information the applicant considers to be a trade secret or confidential commercial or financial information, the applicant should do the following: (1) Note on the front cover that the submission “Contains Confidential Business Information (CBI)”; (2) mark each affected page “CBI”; and (3) highlight or otherwise denote the CBI portions.
DOT protects such information from disclosure to the extent allowed under applicable law. In the event DOT receives a Freedom of Information Act (FOIA) request for the information, DOT will follow the procedures described in its FOIA regulations at 49 CFR 7.17. Only information that is ultimately determined to be confidential under that procedure will be exempt from disclosure under FOIA.
Federal Transit Administration, DOT.
Notice; request for expressions of interest to participate.
The Federal Transit Administration (FTA) is soliciting expressions of interest for the Expedited Project Delivery Pilot Program (Pilot Program) authorized by the Fixing America's Surface Transportation Act (FAST). The Pilot Program is aimed at expediting delivery of new fixed guideway capital projects, small starts projects, or core capacity improvement projects that utilize public-private partnerships, are planned to be operated and maintained by employees of an existing public transportation provider, and have a Federal share not exceeding 25 percent of the project cost. It is also aimed at increasing innovation, improving efficiency and timeliness of project implementation, and encouraging new revenue streams. The law specifies that not more than eight projects can be awarded grants under the Pilot Program. FTA intends to work with selected project sponsors to further define the steps that must be completed before a construction grant can be awarded under the Pilot Program, including expedited FTA reviews of technical capacity, local financial commitment, and project justification. This announcement is available on the FTA's website at:
Expressions of interest to become one of the participants in the Pilot Program for Expedited Project Delivery must be submitted to FTA by mail, email or facsimile by 11:59 p.m. EDT November 13, 2018.
Mail submission must be addressed to the Office of Planning and Environment, Federal Transit Administration, 1200 New Jersey Avenue SE, Room E45-119, Washington, DC 20590 and postmarked no later than November 13, 2018. Email submissions must be sent to
Susan Eddy, FTA Office of Planning and Environment, telephone (202) 366-5499 or email
FTA, together with its transit industry partners, invests billions of dollars in capital projects designed to improve public transportation by reinvesting in existing assets to expand capacity or by increasing the extent and quality of public transportation service by making new investments. These projects take considerable time to plan, develop, design, approve, and deploy. While it is important for FTA to ensure that it selects only well-conceived projects that are implemented in the most efficient and effective manner, a lengthy process delays the delivery of the intended benefits to the riding public.
Section 3005(b) of the FAST Act, Public Law 114-94 (December 4, 2015), authorizes the Pilot Program for FTA to make not more than eight grants for new fixed guideway capital projects, small starts projects, or core capacity improvement projects that have not yet entered a construction grant agreement with the FTA. The law defines these types of eligible projects for the Pilot Program in a manner similar to, but not entirely the same as, the CIG program. Thus, FTA encourages project sponsors to review closely the definitions found in Section 3005(b) to ensure the project's eligibility.
Eligible applicants to the Pilot Program are state or local government authorities. Proposed projects must utilize public-private partnerships; be operated and maintained by employees of an existing provider of fixed guideway or bus rapid transit public transportation in the service area of the project, or if none exists, by employees of an existing public transportation provider in the service area; and have a Federal share not exceeding 25 percent of the net capital project cost. Project sponsors also must have financial advisors providing guidance to them on the terms and structure of the project that are independent from investors in the project. Sponsors must further certify that the existing public transportation system is in a state of good repair as defined by law. (See Pub. L. 114-94, 129 STAT. 1458; 49 U.S.C. 5302; 49 U.S.C. 5326(b)(1); 49 CFR 625.5.)
The Pilot Program requires FTA to use an expedited technical capacity review process for sponsors that have recently and successfully completed at least one new fixed guideway capital project, small start project, or core capacity improvement project, if the sponsor achieved budget, cost, and ridership outcomes for the project that are consistent with or better than projections and the applicant demonstrates that it continues to have staff expertise and other resources to implement a new project.
While not all of the following are required with the expression of interest submission, project sponsors should understand that prior to being considered for a grant agreement, Section 3005(b) requires that project sponsors requesting a construction grant under the Pilot Program must meet all requirements of Section 3005(B) and submit: (1) Information identifying the proposed eligible project; (2) a schedule and finance plan for the construction and operation of the project; (3) an analysis of the efficiencies of the proposed eligible project development and delivery methods and innovative financing arrangement for the eligible project. This submission must include documents related to the public-private partnership and justification of the project based on mobility improvements attributable to the project; environmental benefits associated with the project; congestion relief associated with the project; economic development effects derived as a result of the project; and estimated ridership projections; (4) a certification that the project sponsor's existing public transportation system is in a state of good repair, or, in the event that the applicant does not operate a public transportation system, the public transportation system to which the proposed project will be attached, is in a state of good repair. Alternatively, with respect to the state of good repair certification, for core capacity improvement projects, a sponsor may include a description of how the eligible project will allow it to make substantial progress in achieving a state of good repair. FTA may not award a construction grant agreement until after the project sponsor has completed necessary planning and activities required under the National Environmental Policy Act, 42 U.S.C. 4321,
The law also requires participants in the program to develop a Before and After Study Report that describes and analyzes the impacts of the project on public transportation services and ridership, describes and analyzes the consistency of predicted and actual benefits and costs of the innovative project development and delivery or innovative financing, and identifies reasons for any differences between the predicted and actual outcomes. The law requires the project sponsor to submit the Before and After Study Report to FTA not later than two years after the initiation of revenue service of the project.
All projects that receive a grant through the Pilot Program are expected to be constructed and enter revenue service. Therefore, Section 3005(b) specifies that a sponsor must repay all Federal funds plus interest and penalty charges if the project is not completed. This provision is intended to ensure that all Federal interest is protected if a public-private partnership fails to deliver a project.
At present, $5 million has been appropriated by Congress in Fiscal Year 2016 and $20 million in Fiscal Year 2017 for the Pilot Program. The FY 2018 Consolidated Appropriations Act did not provide funding for the Pilot Program; and the President's FY 2019 budget proposal to Congress did not recommend any funding for the Pilot Program.
If selected for the Pilot Program, project sponsors will be invited to propose alternative ways that FTA might satisfy the requirements established by law for Pilot projects. For example, FTA expects that it will be necessary to establish the cost, scope, and schedule for Pilot projects to a reasonable level of confidence, which could be accomplished in a number of ways, in particular to address the requirement in law for an expedited technical capacity review process for sponsors with successful past performance. Project sponsors selected for the Pilot Program may suggest alternate approaches to any aspect of the statutory evaluation process that the sponsor believes will save time and effort, while still assuring compliance with the Pilot Program requirements outlined in law. FTA is particularly interested in receiving expressions of interest from project sponsors who are considering pursuing Value Capture techniques as part of their innovative project financing arrangements.
Project sponsors must submit the required information by mail, email or facsimile by 11:59 p.m. EDT November 13, 2018, as specified in the
Project sponsors wishing to participate in the Pilot Program must submit an expression of interest to FTA no longer than 10 pages in length including any supporting documentation. While there is no specific format that must be followed for the expression of interest, the narrative provided by the project sponsor to FTA should include the following information:
a. A description of the proposed project that provides sufficient information to demonstrate its eligibility as a new fixed guideway capital project, small starts project, or core capacity improvement project as defined in Section 3005(b);
b. The proposed project schedule and an outline of the proposed financing plan for the project, including the total amount of Federal funding being sought;
c. A description of the public-private partnership included in the project;
d. A description of the advisors providing guidance to the project sponsor on the terms and structure of the project that are independent from investors in the project;
e. How the project sponsor intends to analyze the predicted and actual benefits and costs of the innovative project development and delivery methods or innovative financing for the eligible project in order to complete the Before and After Study required by Section 3005(b);
f. A certification that the project sponsor's existing public transportation system is in a state of good repair, or for core capacity improvement projects, a description of how the eligible project includes elements designed to aid the existing fixed guideway system in making substantial progress towards achieving a state of good repair;
g. Documentation that the project has completed the steps required by the Metropolitan Planning process or the Statewide and Non-Metropolitan Planning process, as applicable. Specifically, provide evidence that the
h. Documentation that the project has completed the NEPA process or a schedule demonstrating the project will complete the NEPA process in the foreseeable future.
FTA will evaluate the proposals to determine which proposed projects best meet the intent of Section 3005(b). FTA will work with the selected project sponsors to further define the steps in law required before a construction grant can be awarded under the program.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice.
The National Highway Traffic Safety Administration (NHTSA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the
Comments must be received on or before November 13, 2018.
You may submit comments using any of the following methods. All comments must have the applicable DOT docket number noted conspicuously on them.
Jason Stammen, Ph.D., Applied Biomechanics Division, Vehicle Research and Test Center, NHTSA, 10820 State Route 347—Bldg. 60, East Liberty, Ohio 43319; Telephone (937) 666-4511; Facsimile: (937) 666-3590; email address:
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), before an agency submits a proposed collection of information to OMB for approval, it must first publish a document in the
(i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(ii) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(iii) how to enhance the quality, utility, and clarity of the information to be collected;
(iv) how to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Historically, child dummy component responses have simply been scaled from adult post-mortem surrogate tests. However, there is a large body of research that has demonstrated that children are not simply small adults when it comes to behavior in a high-speed crash scenario. Developmental anatomy must be considered in addition to mass and anthropometry in the creation of design targets for child dummies.
Because testing of pediatric post-mortem surrogates raises ethical concerns, researchers are compelled to find creative ways to gather biomechanical information from living children. The historical approach for obtaining body region response information is to design a fun, low-intensity activity or game where the participant movement is captured in some manner while resisting forces are collected. The forces generated with respect to the movements are used to develop a “response target” that serves as design guidance for the relevant crash dummy component.
44 U.S.C. Section 3506(c)(2)(A).
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing an update to the identifying information of a person currently included in the list of Specially Designated Nationals and Blocked Persons. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 7, 2018, OFAC updated the Specially Designated Nationals and Blocked Persons List entry for the following person, whose property and interests in property subject to U.S. jurisdiction continue to be blocked.
1. SARRIA DIAZ, Rafael Alfredo (a.k.a. SARRIA, Rafael; a.k.a. SARRIA-DIAZ, Rafael A), Miranda, Venezuela; La Moraleja, Madrid, Spain; 5599 NW 23rd Ave., Boca Raton, FL 33496, United States; 480 Park Avenue, Apt. 10B, New York, NY 10022, United States; Calle de la Pena Pintada, 11, Madrid, Comunidad de Madrid 28034, Spain; Calle Los Malabares, Quinta Anauco, Valle Arriba, Caracas, Miranda 1080, Venezuela; DOB 11 Nov 1965; Gender Male; Cedula No. 6974302 (Venezuela); Passport 114910699 (Venezuela) expires 02 Feb 2020; alt. Passport F0018546 (Venezuela) expires 02 Jul 2014 (individual) [VENEZUELA] (Linked To: CABELLO RONDON, Diosdado).
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On March 19, 2018, OFAC's Director determined that the property and interests in property of the following persons are blocked pursuant to Executive Order 13692 of March 8, 2015, “Blocking Property and Suspending Entry of Certain Persons Contributing to the Situation in Venezuela” (E.O. 13692). The OFAC Director designated each of these persons under section 1(a)(ii)(C) of E.O. 13692 for being a current or former official of the Government of Venezuela.
1. CONTRERAS, Willian Antonio (a.k.a. CONTRERAS, William), Capital District, Venezuela; DOB 17 Aug 1968; citizen Venezuela; Gender Male; Cedula No. 9953939 (Venezuela); Passport 041067710 (Venezuela) expires 12 Jan 2016; Vice Minister of Internal Commerce, within the Ministry of Popular Power of Economy and Finance; National Superintendent for the Defense of Socioeconomic Rights (SUNDDE) (individual) [VENEZUELA]. Designated pursuant to section 1(a)(ii)(C) of E.O. 13692 for being a current or former official of the Government of Venezuela.
2. LEPAJE SALAZAR, Nelson Reinaldo, Aragua, Venezuela; DOB 24
3. MATA GARCIA, Americo Alex (Latin: MATA GARCÍA, Américo Alex) (a.k.a. MATA, Americo (Latin: MATA, Américo)), Miranda, Venezuela; DOB 02 Jan 1976; citizen Venezuela; Gender Male; Cedula No. 12711021 (Venezuela); Passport C1506013 (Venezuela); Alternate Director on the Board of Directors of the National Bank of Housing and Habitat; Former Vice Minister of Agricultural Economics; Former President of the Agricultural Bank of Venezuela (individual) [VENEZUELA]. Designated pursuant to section 1(a)(ii)(C) of E.O. 13692 for being a current or former official of the Government of Venezuela.
4. ROTONDARO COVA, Carlos Alberto (a.k.a. ROTONDARO COVA, Carlos; a.k.a. ROTONDARO, Carlos), Capital District, Venezuela; DOB 11 Sep 1965; citizen Venezuela; Gender Male; Cedula No. 6157070 (Venezuela); Passport 083445280 (Venezuela) expires 29 Jan 2019; alt. Passport 022740782 (Venezuela) expires 24 May 2014; Former President of the Board of Directors of the Venezuelan Institute of Social Security (IVSS) (individual) [VENEZUELA]. Designated pursuant to section 1(a)(ii)(C) of E.O. 13692 for being a current or former official of the Government of Venezuela.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one person that has been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of this person are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 7, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following person are blocked under the relevant sanctions authority listed below.
1. ZEIN, Waleed Ahmed, Mombasa, Kenya; DOB 14 Mar 1991; Passport A120391 (Kenya); National ID No. 33987482 (Kenya) (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
Designated pursuant to section 1(d)(i) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for assisting in, sponsoring, or providing financial, material, or technological support for, or financial or other services to or in support of, the ISLAMIC STATE OF IRAQ AND THE LEVANT, an entity determined to be subject to E.O. 13224.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 6, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked pursuant to the relevant sanctions authority listed below. For a person identified as identified as meeting the definition of the Government of North Korea, dealings in property subject to U.S. jurisdiction in which the person has an interest are prohibited effective as of the date of that status, which may be earlier than the date of OFAC's determination.
1. PARK, Jin Hyok (a.k.a. DAVID, Andoson; a.k.a. HENNY, Watson; a.k.a. KIM, Hyon U; a.k.a. KIM, Hyon Woo; a.k.a. KIM, Hyon Wu; a.k.a. PAK, Ch'in-hyo'k; a.k.a. PAK, Jin Hek; a.k.a. PAK, Jin Hyok); DOB 15 Aug 1984; alt. DOB 18 Oct 1984; Gender Male; Passport
Designated pursuant to section 2(a)(v) of Executive Order 13722 of March 15, 2016, “Blocking Property of the Government of North Korea and the Workers' Party of Korea, and Prohibiting Certain Transactions With Respect to North Korea” (E.O. 13722) for having engaged in significant activities undermining cybersecurity through the use of computer networks or systems against targets outside of North Korea on behalf of the Government of North Korea or the Workers' Party of Korea.
1. KOREA EXPO JOINT VENTURE (a.k.a. CHOSUN EXPO; a.k.a. CHOSUN EXPO JOINT VENTURE; a.k.a. KOREA EXPO JOINT VENTURE CORPORATION), Pyongyang, Korea, North [DPRK3].
Identified as meeting the definition of the Government of North Korea as set forth in section 9(d) of E.O. 13722 and section 510.311 of the North Korean Sanctions Regulations, 31 CFR part 510.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List pursuant to Executive Order 13582 of August 17, 2011, “Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria.” All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The list of Specially Designated Nationals and Blocked Persons (SDN List) and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 5, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. ‘ABBAS, Yasir (a.k.a. ‘ABBAS, Yasir 'Aziz); DOB 22 Aug 1978; nationality Syria; Gender Male (individual) [SYRIA].
Designated pursuant to section 1(b)(i) of Executive Order 13582 of August 17, 2011, “Blocking Property of the Government of Syria and Prohibiting Certain Transactions With Respect to Syria” (E.O. 13582) for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the GOVERNMENT OF SYRIA, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
2. AL-ALI, Adnan (a.k.a. AL ALI, Adnan; a.k.a. AL-‘ALI, 'Adnan), Baniyas, Syria; DOB 17 Jun 1968; POB Lattakia, Syria; nationality Syria; Gender Male; Passport 6066827 (Syria) expires 09 Mar 2017 (individual) [SYRIA] (Linked To: ABAR PETROLEUM SERVICE SAL).
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, ABAR PETROLEUM SERVICE SAL, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
3. AL-QATIRJI, Muhammad (a.k.a. AL-QATIRJI, Bara'; a.k.a. KATARJI, Bara'; a.k.a. KHATARJI, Bara Ahmad; a.k.a. KHATIRJI, Bara Ahmad; a.k.a. QATARJI, Abu al-Bara'; a.k.a. QATIRJI, Muhammad Bara'; a.k.a. QATIRJI, Muhammad Bara; a.k.a. QATIRJI, Muhammad Bara Ahmad Rushdi; a.k.a. QATRJI, Muhammad Nur al-Din; a.k.a. “Abu Bara”); DOB 10 Nov 1976; POB Raqqah; nationality Syria; Gender Male; National ID No. 11010046398 (Syria); Registration Number 11824466 (Syria) (individual) [SYRIA].
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the GOVERNMENT OF SYRIA, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
4. NASSER, Fadi Nabih (a.k.a. NASSER, Fadi), Nasser Building, Menchieh Area, Bourj Brajneh (Baabda), Lebanon; DOB 19 Nov 1963; nationality Lebanon; Gender Male; Passport RL2432659 (Lebanon) issued 22 Jan 2013 expires 22 Jan 2018; alt. Passport RL1239879 (Lebanon) expires 05 Mar 2013; Chairman of Nasco Polymers & Chemicals Co. Sal (Off-shore) (individual) [SYRIA] (Linked To: NASCO POLYMERS & CHEMICALS CO SAL (OFF-SHORE); Linked To: SYRIAN COMPANY FOR OIL TRANSPORT).
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, SYRIAN COMPANY FOR OIL TRANSPORT, an entity identified as meeting the definition of the GOVERNMENT OF SYRIA as set forth in section 8(d) of E.O. 13582 and section 542.305 of the Syrian Sanctions Regulations, 31 CFR part 542.
Also designated pursuant to section 1(b)(ii) of E.O. 13582 for having acted or purported to act for or on behalf of, directly or indirectly, NASCO POLYMERS & CHEMICALS CO SAL (OFF-SHORE), an entity whose property and interests in property are blocked pursuant to E.O. 13582.
1. ABAR PETROLEUM SERVICE SAL (a.k.a. ABAR PETROLEUM SERVICE SAL (OFFSHORE); a.k.a. ABAR PETROLEUM SERVICES LTD SAL (OFFSHORE)), Azarieh Building, Block 03, 5th floor, Azarieh Street, Beirut, Lebanon [SYRIA].
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the GOVERNMENT OF SYRIA, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
2. AL-QATIRJI COMPANY (a.k.a. AL-SHAM AND AL-DARWISH
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the GOVERNMENT OF SYRIA, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
3. INTERNATIONAL PIPELINE CONSTRUCTION FZE, Fujairah, United Arab Emirates [SYRIA] (Linked To: HESCO ENGINEERING & CONSTRUCTION CO).
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, HESCO ENGINEERING & CONSTRUCTION CO, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
Also designated pursuant to section 1(b)(ii) of E.O. 13582 for being owned or controlled by HESCO ENGINEERING & CONSTRUCTION CO, an entity whose property and interests in property are blocked pursuant to E.O. 13582.
4. NASCO POLYMERS & CHEMICALS CO SAL (OFF-SHORE) (a.k.a. NASCO POLYMERS & CHEMICALS; a.k.a. NASCO POLYMERS AND CHEMICALS), 2nd Floor, Nasco Center, Unesco Street, Unesco Sector, Beirut, Lebanon; Postal Box 1800629, Beirut, Lebanon; 2nd Flr, Unesco Center, Verdun Street, Beirut, Lebanon; website
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, SYRIAN COMPANY FOR OIL TRANSPORT, an entity identified as meeting the definition of the GOVERNMENT OF SYRIA as set forth in section 8(d) of E.O. 13582 and section 542.305 of the Syrian Sanctions Regulations, 31 CFR part 542.
5. SONEX INVESTMENTS LTD. (a.k.a. SONEX INVESTMENTS LIMITED; a.k.a. SONNEX INVESTMENTS LTD.), P.O. Box 7191, Dubai, United Arab Emirates [SYRIA] (Linked To: SYRIAN COMPANY FOR OIL TRANSPORT).
Designated pursuant to section 1(b)(i) of E.O. 13582 for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, SYRIAN COMPANY FOR OIL TRANSPORT, an entity identified as meeting the definition of the GOVERNMENT OF SYRIA as set forth in section 8(d) of E.O. 13582 and section 542.305 of the Syrian Sanctions Regulations, 31 CFR part 542.
Internal Revenue Service (IRS), Department of the Treasury (Treasury).
Notice.
The purpose of this notice is to publish the names of those IRS employees who will serve as members on IRS's Fiscal Year 2018 Senior Executive Service (SES) Performance Review Boards.
This notice is applicable September 1, 2018.
Willie Beard, IRS, 1111 Constitution Avenue NW, Room 3518, Washington, DC 20224, (202) 317-3828.
Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members to the IRS's SES Performance Review Boards. The names and titles of the executives serving on the boards are as follows:
This document does not meet the Treasury's criteria for significant regulations.
Department of Veterans Affairs.
Notice.
The Department of Veterans Affairs (VA) Mission Act of 2018 (VA Maintaining Systems and Strengthening Integrated Outside Networks Act), Section 502, provides that podiatrists be paid from the Veterans Health Administration (VHA) physician and dentist pay system.
Annual pay ranges are applicable November 25, 2018.
Farine Cohen, Program Analyst, Policy and Programs, VHA Workforce Management and Consulting Office (10A2A), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7179. This is not a toll-free number.
As required by the “Department of Veterans Affairs Health Care Personnel Enhancement Act of 2004,” (Pub. L. 108-445, dated December 3, 2004) VA is hereby giving notice of annual pay ranges for VHA podiatrists as prescribed by the Secretary for Department-wide applicability. The pay table placement and annual salary rates of podiatrists is intended to enhance the flexibility of the Department to recruit, develop, and retain the most highly-qualified podiatrists to serve our Nation's Veterans and maintain a standard of excellence in the VA health care system. Under 38 United States Code (U.S.C.) 7431(e)(1)(A), not less often than once every 2 years, the Secretary must prescribe for Department-wide applicability the minimum and maximum amounts of annual pay that may be paid to VHA physicians and dentists. Further, 38 U.S.C. 7431(e)(1)(B) allows the Secretary to prescribe separate minimum and maximum amounts of pay for a specialty or assignment. In construction of the annual pay ranges, 38 U.S.C. 7431(c)(4)(A) requires the consultation of two or more national surveys of pay, whether prepared by private, public, or quasi-public entities, in order to make a general assessment of the range of pays payable to physicians and dentists. Lastly, 38 U.S.C. 7431(e)(1)(C) states amounts prescribed under paragraph 7431(e) shall be published in the
The “Department of Veterans Affairs Health Care Personnel Enhancement Act of 2004” (Pub. L. 108-445) was signed by the President on December 3, 2004. The major provisions of the law established a new pay system for VHA physicians and dentists consisting of base pay, market pay, and performance pay. While the base pay component is set by statute, market pay is intended to reflect the recruitment and retention needs for the specialty or assignment of a particular physician or dentist at a facility. Further, performance pay is intended to recognize the achievement of specific goals and performance objectives prescribed annually. These three components create a system of pay that is driven by both market indicators and employee performance, while recognizing employee tenure in VHA.
VA identified and utilized salary survey data sources which most closely represent VA comparability in the areas of practice setting, employment environment, and hospital/health care system. Sullivan Cotter and Associates, Medical Group Management Association, and Korn Ferry Hay Group Healthcare Compensation were collectively utilized as benchmarks from which to prescribe annual pay ranges for podiatrists across the scope of assignments/specialties within the Department. While aggregating the data, a preponderance of weight was given to those surveys which most directly resembled the environment of the Department.
In developing pay table placement and annual salary rates of podiatrists, a few distinctive principles were factored into the compensation analysis of the data. The first principle is to ensure that both the minimum and maximum salary is at a level that accommodates special employment situations, from fellowships and medical research career development awards to Nobel Laureates, high-cost areas, and internationally-renowned clinicians. The second principle is to provide ranges large enough to accommodate career progression, geographic differences, sub-specialization, and other special factors.
Several VA data sources were reviewed against available, relevant private sector data. The podiatry specialties are grouped into one clinical pay range that reflect comparable complexity in salary, recruitment, and retention considerations.
The Secretary of Veterans Affairs approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on September 7, 2018 for publication.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing the results of the residual risk and technology reviews (RTR) for three rules—the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Surface Coating of Large Appliances; the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles; and the NESHAP for the Surface Coating of Metal Furniture. The EPA is proposing to find the risks due to emissions of air toxics from these source categories under the current standards to be acceptable and that the standards provide an ample margin of safety to protect public health. We are proposing no revisions to the numerical emission limits based on these risk analyses or technology reviews. The EPA is proposing no new requirements based on the technology review of the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles. The EPA is proposing to require the use of high efficiency spray application equipment under the technology review for the two rules that employ the use of coating spray application, the NESHAP for the Surface Coating of Large Appliances and the NESHAP for the Surface Coating of Metal Furniture, if the source is not using the emission rate with add-on control compliance option. The EPA is also requesting comment on whether the high efficiency spray equipment technology requirement under the technology review is necessary in light of the risk analyses indicating that there are ample margins of safety. The EPA also is proposing to amend provisions addressing emissions during periods of startup, shutdown, and malfunction; to amend provisions regarding electronic reporting of performance test results; and to make miscellaneous clarifying and technical corrections.
Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. See section I.C of this preamble for instructions on submitting CBI. The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
For questions about this proposed action for the Surface Coating of Large Appliances source category, contact Ms. Kim Teal, Minerals and Manufacturing Group, Sector Policies and Programs Division (Mail Code D243-04), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5580; fax number: (919) 541-4991; and email address:
For questions about this proposed action for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, contact Ms. Paula Hirtz, Minerals and Manufacturing Group, Sector Policies and Programs Division (Mail Code D243-04), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, 109 T.W. Alexander Dr., Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2618; fax number: (919) 541-4991; and email address:
For questions about this proposed action for the Surface Coating of Metal Furniture source category, contact Ms. J. Kaye Whitfield, Minerals and Manufacturing Group, Sector Policies and Programs Division (Mail Code D243-04), Office of Air Quality
For specific information regarding the risk modeling methodology, contact Mr. Chris Sarsony, Health and Environmental Impacts Division (Mail Code C539-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-4843; fax number: (919) 541-0840; and email address:
For information about the applicability of any of these NESHAP to a particular entity, contact Mr. John Cox, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, EPA WJC South Building (Mail Code 2227A), 1200 Pennsylvania Avenue NW, Washington DC 20460; telephone number: (202) 564-1395; and email address:
Table 1 of this preamble lists the NESHAP and associated regulated industrial source categories that are the subject of this proposal. Table 1 is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, once promulgated, will be directly applicable to the affected sources. Federal, state, local, and tribal government entities would not be affected by this proposed action. As defined in the
In addition to being available in the dockets for this action, an electronic copy of this proposed action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at
A redline version of the regulatory language that incorporates the proposed changes in this action is available in the Fabrics and Other Textiles Docket, Metal Furniture Docket, and Large Appliances Docket.
The statutory authority for this action is provided by sections 112 and 301 of the Clean Air Act (CAA), as amended (42 U.S.C. 7401
In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP. All other sources are “area sources.” For major sources, CAA section 112(d) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor.” The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as beyond-the-floor standards. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards where it is not feasible to prescribe or enforce a numerical emission standard. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards.
The second stage in standard-setting focuses on identifying and addressing any remaining (
The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR)
CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less frequently than every eight years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floor.
The NESHAP for the Surface Coating of Large Appliances source category was promulgated on July 23, 2002 (67 FR 48254), and codified at 40 CFR part 63, subpart NNNN. As promulgated in 2002, the Surface Coating of Large Appliances NESHAP applies to the surface coating and related operations at each new and existing affected source of HAP emissions at facilities that are major sources and are engaged in the surface coating of a large appliance part or product. The Surface Coating of Large Appliances NESHAP (40 CFR 63.4081) defines a “large appliance part or product” as “a component of a large appliance product manufactured for household, recreational, institutional, commercial, or industrial use” including, but not limited to, “cooking equipment; refrigerators, freezers, and refrigerated cabinets and cases; laundry equipment; dishwashers, trash compactors, and water heaters; and heating, ventilation, and air-conditioning (HVAC) units, air-conditioning (except motor vehicle) units, air-conditioning and heating combination units, comfort furnaces, and electric heat pumps. Specifically excluded are heat transfer coils and large commercial and industrial chillers.”
Based on our search of the National Emission Inventory (NEI) (
The primary HAP emitted from large appliance surface coating operations are organic HAP and include xylene, glycol ethers, toluene, methanol, ethyl benzene, methylene chloride, and methyl isobutyl ether. Approximately 80 percent of the HAP emissions from the Surface Coating of Large Appliances source category occur from the coating operations and from the mixing and storage areas. At the time of the original rule promulgation in 2002, most large appliance coating was applied either by using a spray gun in a spray booth or by dipping the substrate in a tank. Inorganic HAP emissions were considered in the development of the Surface Coating of Large Appliances NESHAP. Inorganic HAP, including chromium, cobalt, lead, and manganese compounds, are components of some specialty coatings used by this source category. However, most of the inorganic HAP components remain as solids in the dry coating film on the parts being coated or are deposited onto the walls, floor, and grates of the spray booths in which they are applied. The remaining inorganic HAP particles are entrained in the spray booth exhaust air. Spray booths in the large appliance industry typically have either water curtains or dry filters to remove overspray particles from the exhaust air. No inorganic HAP were reported in the cleaning materials in the data collected to develop the Surface Coating of Large Appliances NESHAP. No inorganic HAP were reported in the NEI data used for this RTR for surface coating operations at major source large appliance manufacturing facilities.
We estimated that the Surface Coating of Large Appliances NESHAP requirements would reduce the emissions of organic HAP from the source category by 45 percent or 1,191 tons per year (67 FR 48259, July 23, 2002). The NESHAP specifies numerical emission limits for organic HAP emissions from surface coating application operations. The organic HAP emission limit for existing sources is 0.13 kilogram (kg) organic HAP/liter (1.1 pound/gallon (lb/gal)) of coating solids and for new or reconstructed sources is 0.022 kg organic HAP/liter (0.18 lb/gal) of coating solids.
The Surface Coating of Large Appliances NESHAP provides existing sources three compliance options: (1) Compliant coatings
For any coating operation(s) on which the facility uses the compliant material option or the emission rate without add-on controls option, the facility is not required to meet any work practice standards.
If the facility uses the emission rate with add-on controls option, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, the coating operation(s) using that option. The plan must specify practices and procedures to ensure that a set of minimum work practices specified in the NESHAP are implemented. The facility must also comply with site-specific operating limits for the emission capture and control system.
The NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category was promulgated on May 29, 2003 (68 FR 32172), and codified at 40 CFR part 63, subpart OOOO. As promulgated in 2003, the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP applies to the printing, coating, slashing, dyeing, or finishing of fabrics and other textiles and related operations at each new and existing affected source of HAP emissions at facilities that are major sources and are engaged in the printing, coating, slashing, dyeing, or finishing of fabrics and other textiles. The Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP (40 CFR 63.4371) defines a fabric as any woven, knitted, plaited, braided, felted, or non-woven material made of filaments, fibers, or yarns including thread. This term includes material made of fiberglass, natural fibers, synthetic fibers, or composite. The NESHAP defines textile as any one of the following: (1) Staple fibers and filaments suitable for conversion to or use as yarns, or for the preparation of woven, knit, or nonwoven fabrics; (2) Yarns made from natural or manufactured fibers; (3) Fabrics and other manufactured products made from staple fibers and filaments and from yarn; and (4) Garments and other articles fabricated from fibers, yarns, or fabrics.
Based on our search of the NEI and EPA's ECHO database and a review of active air emission permits, we estimate that 43 facilities are subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. A complete list of facilities we identified as subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP is available in Table 1 of Appendix 10 to the memorandum titled
The Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP also defines a coating material as an elastomer, polymer, or prepolymer material applied as a thin layer to a textile web. Such materials include, but are not limited to, coatings, sealants, inks, and adhesives. Decorative, protective, or functional materials that consist only of acids, bases, or any combination of these substances are not considered coating materials for the purposes of this subpart. Thinning materials also are not included in this
The primary HAP emitted from printing, coating, and dyeing operations are organic HAP and include toluene, phenol, methanol, and N,N-dimethylformamide. The majority of organic HAP emissions (greater than 95 percent) come from the coating and printing subcategories, with the remainder coming from dyeing and finishing.
Inorganic HAP emissions were considered in the development of the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. Based on information reported in survey responses during the development of the 2002 proposed NESHAP, inorganic HAP, including chromium, cobalt, hydrogen chloride (HCl), lead, manganese compounds, and nickel were components of some coatings, dyes, and finishes used by this source category. However, we concluded that inorganic HAP are not likely to be emitted from these sources because of the application techniques used (67 FR 46032, July 11, 2002). No inorganic HAP were reported in the NEI data used for this RTR for printing, coating, and dyeing of fabrics and other textiles operations at major source facilities.
We estimated that the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP requirements would reduce the emissions of organic HAP from the source category by 60 percent or 4,100 tpy (68 FR 32172, May 29, 2003). The NESHAP specifies numerical emission limits for organic HAP emissions from three subcategories of surface coating application operations: Printing and coating; dyeing and finishing; and slashing. The organic HAP emission limit for existing printing or coating affected sources is 0.12 kg organic HAP/kg (lb/lb) of coating solids applied and for new or reconstructed affected sources is 0.08 kg organic HAP/kg (lb/lb) of coating solids applied. Printing or coating affected sources may also demonstrate compliance by achieving at least a 98-percent HAP reduction for new affected sources or a 97-percent HAP reduction for existing sources. New and existing sources using a thermal oxidizer may also comply by achieving a HAP concentration at the oxidizer outlet of no greater than 20 parts per million by volume (ppmv) on a dry basis and having an emission capture system with 100-percent efficiency.
For new, reconstructed, or existing dyeing and finishing operations, the emission limit for conducting dyeing operations is 0.016 kg organic HAP/kg (lb/lb) dyeing materials applied; the limit for conducting finishing operations is 0.0003 kg organic HAP/kg (lb/lb) finishing materials applied; and the limit for conducting both dyeing and finishing operations is 0.016 kg organic HAP/kg (lb/lb) dyeing and finishing materials applied. For new, reconstructed, or existing slashing operations, the slashing materials must contain no organic HAP (each organic HAP that is not an Occupational Safety and Health Administration (OSHA)-defined carcinogen that is measured to be present at less than one percent by weight is counted as zero).
For any coating, printing, or dyeing operation(s) on which the facility uses the compliant material option or the emission rate without add-on controls option, the facility is not required to meet any work practice standards.
If the facility uses an add-on control device to demonstrate compliance, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, the coating operation(s) using that option. The plan must specify practices and procedures to ensure that a set of minimum work practices specified in the NESHAP are implemented. The facility must also comply with site-specific operating limits for the emission capture and control system.
The NESHAP for the Surface Coating of Metal Furniture source category was promulgated on May 23, 2003 (68 FR 28606), and codified at 40 CFR part 63, subpart RRRR. As promulgated in 2003, the Surface Coating of Metal Furniture NESHAP applies to the surface coating and related operations at each new and existing affected source of HAP emissions at facilities that are major sources and are engaged, either in part or in whole, in the surface coating of metal furniture. The Surface Coating of Metal Furniture NESHAP (40 CFR 63.4881) defines metal furniture as furniture or components of furniture constructed either entirely or partially from metal. Metal furniture includes, but is not limited to, components of the following types of products as well as the products themselves: Household, office, institutional, laboratory, hospital, public building, restaurant, barber and beauty shop, and dental furniture; office and store fixtures; partitions; shelving; lockers; lamps and lighting fixtures; and wastebaskets.
Based on our search of the NEI and the EPA's ECHO database and a review of active air emission permits, we estimate that 16 facilities are subject to the Surface Coating of Metal Furniture NESHAP. A complete list of facilities subject to the Surface Coating of Metal Furniture NESHAP is available in Table 1 of Appendix 10 to the memorandum titled
Most of the organic HAP emissions from metal furniture surface coating operations occur from the coating application operations and the drying and curing ovens. In most cases, HAP emissions from surface preparation, storage, and handling are relatively small for this source category. The primary organic HAP emitted from metal furniture surface coating operations are xylene, glycol ethers, ethylbenzene, toluene, and cumene. These compounds account for more than 95 percent of this category's nationwide organic HAP emissions from major sources.
Inorganic HAP emissions, such as chromium, lead, and manganese compounds, were considered in the development of the Surface Coating of Metal Furniture NESHAP, and the EPA determined that inorganic HAP emissions would be very low (67 FR 20206, April 24, 2002). At that time, approximately 680 coatings were reported in the survey responses from the metal furniture industry, and only two coatings were reported as containing inorganic HAP. In the NEI data used for this risk and technology review, only one facility reported inorganic HAP emissions (antimony, 0.015 tpy, and nickel, 0.003 tpy) from metal furniture surface coating operations. According to the reporting facility, the reported emissions in the
We estimated the Surface Coating of Metal Furniture NESHAP requirements would reduce the emissions of organic HAP from the source category by 73 percent or 16,300 tpy (68 FR 28606, May 23, 2003). The NESHAP specifies numerical emission limits for organic HAP emissions from surface coating application operations. The organic HAP emission rate for existing sources is no more than 0.10 kg organic HAP/liter (0.83 lb/gal) of coating solids used during each compliance period. A new or reconstructed affected source can emit no organic HAP during any compliance period unless a source requests approval from the Administrator to use an alternative new source emission limit for specific metal furniture components or types of components.
The Surface Coating of Metal Furniture NESHAP provides existing sources three compliance options: (1) Use only compliant coatings
For any metal furniture coating operation(s) on which the facility uses the compliant material option or the emission rate without add-on controls option, the facility is not required to meet any work practice standards.
If the facility uses an add-on control device to demonstrate compliance, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, the coating operation(s) using that option. The plan must specify practices and procedures to ensure that a set of minimum work practices specified in the NESHAP are implemented. The facility must also comply with site-specific operating limits for the emission capture and control system.
For the risk modeling portion of these RTRs, the EPA used data from the 2011 and 2014 NEI. The NEI is a database that contains information about sources that emit criteria air pollutants, their precursors, and HAP. The database includes estimates of annual air pollutant emissions from point, nonpoint, and mobile sources in the 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands. The EPA collects this information and releases an updated version of the NEI database every three years. The NEI includes data necessary for conducting risk modeling, including annual HAP emissions estimates from individual emission points at facilities and the related emissions release parameters. We used NEI emissions and supporting data as the primary data to develop the model input files for the risk assessments for each of these three source categories. Additional information on the development of the modeling file for each source category can be found in Appendix 1 to the
For both the risk modeling and technology review portion of these RTRs, we also gathered data from facility construction and operating permits, regarding emission points, air pollution control devices, and process operations. We collected permits and supporting documentation from state permitting authorities through state-maintained online databases. The facility permits were also used to confirm that the facilities were major sources of HAP and were subject to the NESHAP that are the subject of these risk assessments. In certain cases, we contacted facility owners or operators to confirm and clarify the sources of emissions that were reported in the NEI. No formal information collection request was performed.
For the technology review portion of these RTRs, we also used information from the EPA's ECHO database as a tool to identify which facilities were potentially subject to the NESHAP. The ECHO database provides integrated compliance and enforcement information for approximately 800,000 regulated facilities nationwide. Using the search feature in ECHO, the EPA identified facilities that could potentially be subject to each of these three NESHAP. We then reviewed operating permits for these facilities, when available, to confirm that they were major sources of HAP with emission sources subject to these NESHAP.
Also for the technology reviews, we collected information from the Reasonably Available Control Technology (RACT), Best Available Control Technology (BACT), and Lowest Achievable Emission Rate (LAER) determinations in the EPA's RACT/BACT/LAER Clearinghouse (RBLC).
Additional information about these data collection activities for the technology reviews is contained in the technology review memoranda titled
For the technology review for each source category, we reviewed the NESHAP for various industries that were promulgated since the MACT standards being reviewed in this action.
In this section, we describe the analyses performed to support the proposed decisions for the RTRs and other issues addressed in this proposal.
As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. As explained in the Benzene NESHAP, “the first step judgment on acceptability cannot be reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” 54 FR 38046, September 14, 1989. Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step. Beyond that information, additional factors relating to the appropriate level of control will also be considered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.”
The Benzene NESHAP approach provides flexibility regarding factors the EPA may consider in making determinations and how the EPA may weigh those factors for each source category. The EPA conducts a risk assessment that provides estimates of the MIR posed by the HAP emissions from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects.
“[t]he policy chosen by the Administrator permits consideration of multiple measures of health risk. Not only can the MIR figure be considered, but also incidence, the presence of noncancer health effects, and the uncertainties of the risk estimates. In this way, the effect on the most exposed individuals can be reviewed as well as the impact on the general public. These factors can then be weighed in each individual case. This approach complies with the Vinyl Chloride mandate that the Administrator ascertain an acceptable level of risk to the public by employing his expertise to assess available data. It also complies with the Congressional intent behind the CAA, which did not exclude the use of any particular measure of public health risk from the EPA's consideration with respect to CAA section 112 regulations, and thereby implicitly permits consideration of any and all measures of health risk which the Administrator, in his judgment, believes are appropriate to determining what will `protect the public health'.” See 54 FR 38057, September 14, 1989.
Thus, the level of the MIR is only one factor to be weighed in determining acceptability of risks. The Benzene NESHAP explained that “an MIR of approximately one in ten thousand should ordinarily be the upper end of the range of acceptability. As risks increase above this benchmark, they become presumptively less acceptable under CAA section 112, and would be weighed with the other health risk measures and information in making an overall judgment on acceptability. Or, the Agency may find, in a particular case, that a risk that includes MIR less than the presumptively acceptable level is unacceptable in the light of other health risk factors.”
The EPA notes that it has not considered certain health information to date in making residual risk determinations. At this time, we do not attempt to quantify those HAP risks that may be associated with emissions from other facilities that do not include the source categories under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the categories.
The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility. We recognize that such consideration may be particularly important when assessing noncancer risks, where pollutant-specific exposure health reference levels (
In response to the SAB recommendations, the EPA is incorporating certain cumulative risk analyses into its RTR risk assessments, including those reflected in this proposal. Specifically, the Agency is (1) conducting facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combining exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzing the ingestion route of exposure. In addition, the RTR risk assessments have always considered aggregate cancer risk from all carcinogens and aggregate noncancer HI from all noncarcinogens affecting the same target organ system.
Although we look at the cumulative risks from all sources at facilities within the category, we do not assess the cumulative risks from facilities outside the category that may be in the vicinity. We are interested in placing source category and facility-wide HAP risks in the context of total HAP risks from all sources of HAP in the vicinity of each source. However, because of the contribution to total HAP risk from emission sources other than those that we have studied, in depth, during this RTR review, such estimates of total HAP risks would have significantly greater associated uncertainties than the source category or facility-wide estimates. Such aggregate or cumulative assessments would compound those uncertainties, making the assessments too unreliable.
Our technology reviews focus on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, in order to inform our decision of whether it is “necessary” to revise the emissions standards, we analyze the technical feasibility of applying these developments and the estimated costs, energy implications, and non-air environmental impacts, and we also consider the emission reductions. In addition, we consider the appropriateness of applying controls to future affected sources versus retrofitting affected sources currently subject to the NESHAP.
For this exercise, we consider any of the following to be a “development”:
• Any add-on control technology or other equipment that was not identified and considered during development of the original MACT standards;
• Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT standards) that could result in additional emissions reduction;
• Any work practice or operational procedure that was not identified or considered during development of the original MACT standards;
• Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT standards; and
• Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT standards).
In addition to reviewing the practices, processes, and control technologies that were considered at the time we originally developed the NESHAP (
The EPA conducted risk assessments that provide estimates of the MIR for cancer posed by the HAP emissions from each source in each source category, the HI for chronic exposures to HAP with the potential to cause noncancer health effects, and the HQ for acute exposures to HAP with the potential to cause noncancer health effects. The assessments also provide estimates of the distribution of cancer risks within the exposed populations, cancer incidence, and an evaluation of the potential for adverse environmental effects. The seven sections that follow this paragraph describe how we estimated emissions and conducted the risk assessments. The Large Appliances Docket, Fabrics and Other Textiles Docket, and Metal Furniture Docket contain, respectively, the
The actual emissions and the emission release characteristics for each facility were obtained primarily from either the 2011 NEI or the 2014 NEI. Most data were obtained from the 2011 NEI, unless the 2014 NEI included HAP data for emission units or processes for which the 2011 NEI included only volatile organic compounds (VOC) or particulate matter. In some cases, the facilities were contacted to confirm emissions that appeared to be outliers, that were otherwise inconsistent with our understanding of the industry, or that were associated with high risk values in our initial risk screening analyses. When appropriate, emission values and release characteristics were corrected based on these facility contacts, and these changes were documented. Additional information on the development of the modeling file for each source category, including the development of the actual emissions and emissions release characteristics, can be found in Appendix 1 to the
The available emissions data in the RTR emissions dataset include estimates of the mass of HAP emitted during a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions level allowed to be emitted under the MACT standards is referred to as the “MACT-allowable” emissions level. We discussed the use of both MACT-allowable and actual emissions in the final Coke Oven Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP RTRs (71 FR 34428, June 14, 2006, and 71 FR 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risks at the MACT-allowable level is inherently reasonable since these risks reflect the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044, September 14, 1989.)
For the Surface Coating of Large Appliances source category, the EPA calculated allowable emissions by developing a source category-specific multiplier of 1.2 that was applied to the current emissions to estimate allowable emissions. The multiplier was calculated using annual coating sales volumes provided in the
For the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, the EPA calculated allowable emissions by developing a source category-specific multiplier of 1.1 that was applied to the current emissions to estimate allowable emissions. We gathered current and historical publicly available category-specific production data from U.S. Census and based the calculation on plant capacity utilization rates for six different NAICS codes related to fabric and textile production for the years 2008 to 2016. We assumed the annual plant capacity utilization rates represented industry annual production rates. The multiplier of 1.1, or the ratio of the peak annual utilization rate in 2013 to the average annual utilization rate for the years 2008 to 2016, was applied to the actual emissions to estimate allowable emissions. For more details on how the EPA calculated the MACT-allowable emissions for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, please see Appendix 1 to the
For the Surface Coating of Metal Furniture source category, the EPA calculated allowable emissions by developing a source category-specific multiplier of 1.8 that was applied to the current emissions to estimate allowable emissions. The multiplier was calculated using annual coating sales volumes from the
Both long-term and short-term inhalation exposure concentrations and health risks from the source categories addressed in this proposal were estimated using the Human Exposure Model (HEM-3). The HEM-3 performs three primary risk assessment activities: (1) Conducting dispersion modeling to estimate the concentrations of HAP in ambient air, (2) estimating long-term and short-term inhalation exposures to individuals residing within 50 kilometers (km) of the modeled sources, and (3) estimating individual and population-level inhalation risks using the exposure estimates and quantitative dose-response information.
The air dispersion model AERMOD, used by the HEM-3 model, is one of the EPA's preferred models for assessing air pollutant concentrations from industrial facilities.
In developing the risk assessment for chronic exposures, we used the estimated annual average ambient air concentrations of each HAP emitted by each source for which we have emissions data in the source categories. The air concentrations at each nearby census block centroid were used as a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. We calculated the MIR for each facility as the cancer risk associated with a continuous lifetime (24 hours per day, seven days per week, 52 weeks per year, for a 70-year period) exposure to the maximum concentration at the centroid of inhabited census blocks. Individual cancer risks were calculated by multiplying the estimated lifetime exposure to the ambient concentration of each HAP (in micrograms per cubic meter) by its unit risk estimate (URE). The URE is an upper bound estimate of an individual's probability of contracting cancer over a lifetime of exposure to a concentration of one microgram of the pollutant per cubic meter of air. For residual risk assessments, we generally use UREs from the EPA's Integrated Risk Information System (IRIS). For carcinogenic pollutants without IRIS values, we look to other reputable sources of cancer dose-response values, often using California EPA (CalEPA) UREs, where available. In cases where new, scientifically credible dose-response values have been developed in a manner consistent with the EPA guidelines and have undergone a peer review process similar to that used by the EPA, we may use such dose-response values in place of, or in addition to, other values, if appropriate.
To estimate incremental individual lifetime cancer risks associated with emissions from the facilities in the source categories, the EPA summed the risks for each of the carcinogenic HAP
To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ system to obtain a TOSHI. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC (
For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. We use the peak hourly emission rate (when available),
To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations), if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs.
An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated
ERPGs are “developed for emergency planning and are intended as health-based guideline concentrations for single exposures to chemicals.”
An acute REL for 1-hour exposure durations is typically lower than its corresponding AEGL-1 and ERPG-1. Even though their definitions are slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1).
For these source categories, we did not have short term emissions data; therefore, we developed source category-specific factors based on information about each industry. We request comment on our assumptions regarding hour-to-hour variation in emissions and our methods of calculating the multiplier for estimating the peak 1-hour emissions for each source category and any additional information that could help refine our approach.
For the Surface Coating of Large Appliances source category, we do not expect to see substantial hour-to-hour variation in emissions during routine operations because the industry employs the use of compliant low HAP coatings in a continuous (non-batch) coating process. Thus, applying the default emission factor of ten to estimate the worst-case hourly emission rate is not reasonable for this category. We expect that minimal variations in emissions could possibly occur due to cleaning of process equipment during routine operations for coating operations using the emission rate without add-on controls compliance option. We calculated worst-case hourly emissions by developing a source category-specific multiplier of 1.2 that was applied to the annual emissions, which were then divided by the total number of hours in a year (8,760 hours). The multiplier was based on historical data on coating sales volumes from the
For the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, we do not expect to see substantial hour-to-hour variation in emissions during routine operations because the industry employs the use of various compliance options, including add-on controls, compliant low HAP coatings, or emission rate without add-on controls option, in a continuous (non-batch) coating process that achieve consistent emission rates. Thus, applying the default emission factor of ten to estimate the worst-case hourly emission rate is not reasonable for this category. We expect that minimal variations in emissions could possibly occur during routine operations due to cleaning of process equipment. We calculated acute emissions by developing a source category-specific multiplier of 1.4 that was applied to the annual emissions, which were then divided by the total number of hours in a year (8,760 hours). The multiplier was based on historical U.S. Census data on plant capacity utilization rates for six different NAICS codes related to fabric and textile production for the years 2008 to 2016. The multiplier was the ratio of the maximum utilization rate (100 percent) to the peak utilization rate of 71.7 percent for the years 2008 to 2016. A further discussion of why this factor was chosen can be found in Appendix 1 to the
For the Surface Coating of Metal Furniture source category, we do not expect to see substantial hour-to-hour variation in emissions during routine operations because the industry employs the use of compliant low HAP
In our acute inhalation screening risk assessment, acute impacts are deemed negligible for HAP where acute HQs are less than or equal to one (even under the conservative assumptions of the screening assessment), and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we consider additional site-specific data to develop a more refined estimate of the potential for acute impacts of concern. For all three source categories, the acute data refinements employed consisted of plotting the HEM-3 polar grid results for each HAP with an acute HQ value greater than one on aerial photographs of the facilities. We then assessed whether the highest acute HQs were off-site and at locations that may be accessible to the public (
The EPA conducted a tiered screening assessment examining the potential for significant human health risks due to exposures via routes other than inhalation (
For the Surface Coating of Large Appliances; the Printing, Coating, and Dyeing of Fabrics and Other Textiles; and Surface Coating of Metal Furniture source categories, we did not identify emissions of any PB-HAP. Because we did not identify PB-HAP emissions, no further evaluation of multipathway risk was conducted for these source categories.
The EPA conducts a screening assessment to examine the potential for adverse environmental effects as required under section 112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines “adverse environmental effect” as “any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”
The EPA focuses on eight HAP, which are referred to as “environmental HAP,” in its screening assessment: Six PB-HAP and two acid gases. The PB-HAP included in the screening assessment are arsenic compounds, cadmium compounds, dioxins/furans, polycyclic organic matter, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are HCl and hydrogen fluoride (HF).
HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, were included due to their well-documented potential to cause direct damage to terrestrial plants. In the environmental risk screening assessment, we evaluate the following four exposure media: Terrestrial soils, surface water bodies (includes water-column and benthic sediments), fish consumed by wildlife, and air. Within these four exposure media, we evaluate nine ecological assessment endpoints, which are defined by the ecological entity and its attributes. For PB-HAP (other than lead), both community-level and population-level endpoints are included. For acid gases, the ecological assessment evaluated is terrestrial plant communities.
An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: Probable effect levels, lowest-observed-adverse-effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread.
For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see Appendix 9 of the
For the environmental risk screening assessment, the EPA first determined whether any facilities in the Surface Coating of Large Appliances; Printing, Coating, and Dyeing of Fabrics and Other Textiles; and Surface Coating of Metal Furniture source categories emitted any of the environmental HAP. For the Surface Coating of Large Appliances source category, we identified emissions of HCl and HF. No environmental HAP were emitted from the other two source categories.
Because one or more of the environmental HAP evaluated are emitted by at least one facility in the Surface Coating of Large Appliances
The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HCl and HF. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify potential adverse environmental effects (as defined in section 112(a)(7) of the CAA) from emissions of HCl and HF, we evaluate the following metrics: The size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and km
To put the source category risks in context, we typically examine the risks from the entire “facility,” where the facility includes all HAP-emitting operations within a contiguous area and under common control. In other words, we examine the HAP emissions not only from the source category emission points of interest, but also emissions of HAP from all other emission sources at the facility for which we have data. For this source category, we conducted the facility-wide assessment using a dataset compiled from the 2014 NEI. The source category records of that NEI dataset were removed, evaluated, and updated as described in section II.C of this preamble: “What data collection activities were conducted to support this action?” Once a quality assured source category dataset was available, it was placed back with the remaining records from the NEI for that facility. The facility-wide file was then used to analyze risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, the modeled source category risks were compared to the facility-wide risks to determine the portion of the facility-wide risks that could be attributed to the source categories addressed in this proposal. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The
Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used conservative tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions datasets, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the
Although the development of the RTR emissions datasets involved quality assurance/quality control processes, the accuracy of emissions values will vary depending on the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the datasets are accurate, errors in emission estimates, and other factors. The emission estimates considered in this analysis generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year. The estimates of peak hourly emission rates for the acute effects screening assessment were based on an emission adjustment factor applied to the average annual hourly emission rates, which are intended to account for emission fluctuations due to normal facility operations.
We recognize there is uncertainty in ambient concentration estimates associated with any model, including the EPA's recommended regulatory dispersion model, AERMOD. In using a model to estimate ambient pollutant concentrations, the user chooses certain options to apply. For RTR assessments, we select some model options that have the potential to overestimate ambient air concentrations (
Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emission inventory likely dominate the uncertainties in the exposure assessment. Some uncertainties in our exposure
There are uncertainties inherent in the development of the dose-response values used in our risk assessments for cancer effects from chronic exposures and noncancer effects from both chronic and acute exposures. Some uncertainties are generally expressed quantitatively, and others are generally expressed in qualitative terms. We note, as a preface to this discussion, a point on dose-response uncertainty that is stated in the EPA's
Cancer UREs used in our risk assessments are those that have been developed to generally provide an upper bound estimate of risk. That is, they represent a “plausible upper limit to the true value of a quantity” (although this is usually not a true statistical confidence limit).
Many of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration (
Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels (
Although every effort is made to identify appropriate human health effect dose-response values for all pollutants emitted by the sources in this risk assessment, some HAP emitted by this source category are lacking dose-response assessments. Accordingly, these pollutants cannot be included in the quantitative risk assessment, which could result in quantitative estimates understating HAP risk. To help to alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for an IRIS assessment for that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazard are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including consideration of HAP reductions achieved by various control options.
For a group of compounds that are unspeciated (
In addition to the uncertainties highlighted above, there are several factors specific to the acute exposure assessment that the EPA conducts as part of the risk review under section 112 of the CAA. The accuracy of an acute inhalation exposure assessment depends on the simultaneous occurrence of independent factors that may vary greatly, such as hourly emissions rates, meteorology, and the presence of humans at the location of the maximum concentration. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and worst-case
For each source category, we generally rely on site-specific levels of PB-HAP or environmental HAP emissions to determine whether a refined assessment of the impacts from multipathway exposures is necessary or whether it is necessary to perform an environmental screening assessment. None of the three source categories in this action emit PB-HAP, therefore, multipathway assessments were not conducted. Since no environmental HAP are emitted from the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category or the Surface Coating of Metal Furniture source category, an environmental risk screen was not conducted for these categories. Small amounts of the environmental HAP, HCl, and HF are emitted from the Surface Coating of Large Appliances source category, therefore, an environmental risk screen was conducted.
The environmental screening assessment relies on the outputs from AERMOD—that estimates environmental pollutant concentrations for two acid gases (HCl and HF). Two important types of uncertainty associated with the use of these models in RTR risk assessments and inherent to any assessment that relies on environmental modeling are model uncertainty and input uncertainty.
Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks.
As described in section III of this preamble, for the Surface Coating of Large Appliances source category, we conducted a risk assessment for all HAP emitted. We present results of the risk assessment briefly below and in more detail in the
Table 2 of this preamble provides a summary of the results of the inhalation risk assessment for the source category. As discussed in section III.C.2 of this preamble, we set MACT-allowable HAP emission levels at large appliance coating facilities equal to 1.2 times actual emissions. For more detail about the MACT-allowable emission levels, see Appendix 1 to the
The results of the inhalation risk modeling using actual emissions data, as shown in Table 2 of this preamble, indicate that the maximum individual cancer risk based on actual emissions (lifetime) could be up to 0.9-in-1 million, the maximum chronic noncancer TOSHI value based on actual emissions could be up to 0.07, and the maximum screening acute noncancer HQ value (off-facility site) could be up to 2. The total estimated annual cancer incidence (national) from these facilities based on actual emission levels is 0.0001 excess cancer cases per year, or one case in every 10,000 years.
Table 2 of this preamble shows the acute risk results for the Surface Coating of Large Appliances source category. The screening analysis for acute impacts was based on an industry specific multiplier of 1.2, to estimate the peak emission rates from the average rates. For more detailed acute risk results,
There are no PB-HAP emitted by facilities in the Surface Coating of Large Appliances source category. Therefore, we do not expect any human health multipathway risks as a result of emissions from this source category.
The emissions data for the Surface Coating of Large Appliances source category indicate that two environmental HAP are emitted by sources within this source category: HCl and HF. Therefore, we conducted a screening-level evaluation of the potential adverse environmental risks associated with emissions of HCl and HF for the Surface Coating of Large Appliances source category. For both HCl and HF, each individual concentration (
One facility has a facility-wide cancer MIR greater than or equal to 1-in-1 million. The maximum facility-wide cancer MIR is 6-in-1 million, driven by chromium (VI) compounds from a cleaning/pretreatment operation. The total estimated cancer incidence from the whole facility is 0.0002 excess cancer cases per year, or one excess case in every 5,000 years. Approximately 600 people were estimated to have cancer risks above 1-in-1 million from exposure to HAP emitted from both MACT and non-MACT sources of the ten facilities in this source category. The maximum facility-wide TOSHI for the source category is estimated to be 0.2, driven by emissions of methylene diphenyl diisocyanate from foam produced as part of plastic products manufacturing.
To examine the potential for any environmental justice issues that might be associated with the source category, we performed a demographic analysis, which is an assessment of risks to individual demographic groups of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risks from the Surface Coating of Large Appliances source category across different demographic groups within the populations living near facilities.
Results of the demographic analysis indicate that, for two of the 11 demographic groups, “African American” and “Below the Poverty Level,” the percentage of the population living within 5 km of facilities in the source category is greater than the corresponding national percentage for the same demographic groups. When examining the risk levels of those exposed to emissions from large appliance coating facilities, we find that no one is exposed to a cancer risk at or above 1-in-1 million or to a chronic noncancer hazard index greater than one based on actual emissions from the source category.
The methodology and the results of the demographic analysis are presented in a technical report titled
As noted in section III.A of this preamble, we weigh all health risk factors in our risk acceptability determination, including the cancer MIR, the number of persons in various cancer and noncancer risk ranges, cancer incidence, the maximum noncancer TOSHI, the maximum acute noncancer HQ, the extent of noncancer risks, the distribution of cancer and noncancer risks in the exposed population, and risk estimation uncertainties (54 FR 38044, September 14, 1989).
For the Surface Coating of Large Appliances source category, the risk analysis indicates that the cancer risks to the individual most exposed could be up to 0.9-in-1 million due to actual emissions and up to 1-in-1 million based on allowable emissions. These risks are considerably less than 100-in-1 million, which is the presumptive upper limit of acceptable risk. The risk analysis also shows very low cancer incidence (0.0001 cases per year for actual emissions and 0.0002 cases per year for allowable emissions), and we did not identify potential for adverse chronic noncancer health effects. The acute noncancer risks based on actual emissions are low at an HQ of 2 for glycol ethers at one facility. Therefore, we find there is little potential concern of acute noncancer health impacts from actual emissions. In addition, the risk assessment indicates no significant potential for multipathway health effects.
Considering all of the health risk information and factors discussed above, including the uncertainties discussed in section III.C.7 of this preamble, we propose to find that the risks from the Surface Coating of Large Appliances source category are acceptable.
Although we are proposing that the risks from the Surface Coating of Large Appliances source category are acceptable, risk estimates for approximately 50 individuals in the exposed population are above 1-in-1 million at the allowable emissions level. Consequently, we further considered whether the MACT standards for the Surface Coating of Large Appliances source category provide an ample margin of safety to protect public health. In this ample margin of safety analysis, we investigated available emissions control options that might reduce the risk from the source category. We considered this information along with all of the health risks and other health information considered in our determination of risk acceptability.
As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Large Appliances source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Large Appliances NESHAP.
The only development identified in the technology review is the use of high-efficiency spray equipment. We estimated no costs or emissions reductions that would be achieved by switching to high efficiency application methods for this source category because we expect that large appliance surface coating facilities are already using high efficiency coating application methods due to state VOC rules and the economic incentives of using more efficient application methods. Because quantifiable
The emissions data for the Surface Coating of Large Appliances source category indicate that two environmental HAP are emitted by sources within this source category: HCl and HF. The screening-level evaluation of the potential for adverse environmental risks associated with emissions of HCl and HF from the Surface Coating of Large Appliances source category indicated that each individual concentration (
Our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Large Appliances source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Large Appliances NESHAP. These emission sources include coating mixing; coating application; coating curing; conveying coatings, thinners and cleaning materials; and waste storage and handling. Based on our review, we identified, as outlined below, one development in technology, the application of high-efficiency spray equipment, for the Surface Coating of Large Appliances source category. A brief summary of the EPA's findings in conducting the technology review of large appliance surface coating operations follows. For a detailed discussion of the EPA's findings, refer to the
The technology basis for the original MACT standards for existing and new or reconstructed sources under the Surface Coating of Large Appliance NESHAP was the use of lower-HAP coatings, thinners, and cleaning materials. Add-on capture and control systems for organic HAP were rarely used by the industry at that time (65 FR 81142, December 22, 2000). During development of that rulemaking, we identified and considered three alternatives more stringent than the MACT floor level of control for organic HAP: (1) Conversion to powder coatings; (2) conversion to liquid coatings that have a very low, or no, organic HAP content; and (3) use of add-on capture systems and control devices (
Using the EPA's NEI and the ECHO databases, we identified ten large appliance surface coating facilities that are currently subject to the Surface Coating of Large Appliances NESHAP. We reviewed their state operating permits to determine whether any are using add-on control technologies to comply with the NESHAP. Two of the ten facilities have add-on controls, but the permits indicate that nine of the ten facilities are using the compliant materials option or the emission rate without add-on controls option to demonstrate compliance with the NESHAP. One facility with an add-on control is using the add-on control to comply with only a VOC emission limitation but not to comply with the NESHAP. The second facility with add-on controls does not have add-on controls on all coating operations, but a 2017 inspection report indicates that the facility is using the emission rate with add-on controls compliance option. This one facility differs from the others complying with subpart NNNN in that it is a contract coating operation that performs surface coating on parts of large appliances, but also performs surface coating on parts for a variety of industries. All of the other facilities are large appliance manufacturers. Therefore, the result from this one facility is not applicable to other facilities dedicated to manufacturing just large appliances. Our search of the RBLC database did not identify any additional large appliance manufacturers using an add-on control device or subject to an emission limit more stringent than in subpart NNNN.
The use of a RTO and permanent total enclosure (PTE) was considered during development of the Large Appliances NESHAP as a control technology capable of achieving an efficiency of 95 percent, but was rejected as not cost effective for the incremental emission reductions that would be achieved relative to the MACT floor level of control. We found no information that any improvements in PTE and add-on control technology have occurred that would affect the cost-effectiveness of a PTE and add-on control or result in additional emission reductions. Therefore, EPA finds there have not been improvements in the RTO/PTE since we promulgated the NESHAP to support requiring this technology for the large appliance source category as part of the technology review.
We have not identified any process change or pollution prevention alternative that could be broadly applied to the large appliance coating industry. We reviewed the
The technology review conducted for the Wood Furniture Manufacturing Operations NESHAP (40 CFR part 63, subpart JJ) identified air-assisted airless spraying, a more efficient coating application technology, as a development in process equipment, and adopted regulations preventing the use of conventional air-atomized coating spray guns. Several other surface coating NESHAP specify that high efficiency spray guns must be used for spray applied coatings (
The Surface Coating of Large Appliances NESHAP does not contain any standards specifying the type of spray equipment that must be used when coatings are spray-applied. However, many facilities complying with the Surface Coating of Large Appliances NESHAP also are required by state VOC regulations in Indiana, Ohio, and Wisconsin to use high-efficiency spray guns for coatings that are spray applied. We expect that large appliance surface coating facilities in other states are also using high-efficiency application equipment for spray applied coatings as a cost saving measure to reduce coating and spray booth filter consumption and to reduce the amount of solid waste generated in the form of used spray booth filters. Although we expect that the high-efficiency application equipment would provide cost savings from an engineering perspective, we are uncertain of other factors that facilities may need to consider if choosing to switch to high-efficiency application equipment. Due to the competitive marketplace and the number of units going through these surface coating facilities, there may be facility specific operational, coating adherence, coating drying time, material compatibility, or other reasons that a facility may not have chosen to switch to high-efficiency spray equipment. We request comment on these and other aspects of facility decision making, as the agency has limited information on the market penetration of this technology and these other factors.
Based on these findings, we are proposing to revise the Surface Coating of Large Appliances NESHAP for coating application operations pursuant to CAA section 112(d)(6) to require that, for each coating operation for which coatings are spray applied, high efficiency spray equipment must be used if the source is not using the emission rate with add-on control compliance option. Specifically, all spray-applied coating operations, where the source is not using the emission rate with add-on control compliance option, must be demonstrated to achieve transfer efficiency equivalent to or better than 65 percent. There are four types of high efficiency spray equipment technologies that have been applied in these applications that could achieve the transfer efficiency equivalent to or better than 65 percent including high volume, low pressure (HVLP) spray equipment, electrostatic application, airless spray equipment, and air assisted airless spray equipment. Alternative spray equipment technologies may also be used with documentation demonstrating at least 65 percent transfer efficiency. Spray application equipment sources not using the emission rate with add-on control compliance option, and/or using alternative spray application equipment technologies other than the four listed, must follow procedures in the California South Coast Air Quality Management District's, “Spray Equipment Transfer Efficiency Test Procedure for Equipment User, May 24, 1989” to demonstrate that their spray application equipment is capable of achieving transfer efficiency equivalent to, or better than, 65 percent. Equivalency documentation may be certified by manufacturers of the spray equipment, on behalf of spray-applied coating operations sources, by following the aforementioned procedure in conjunction with California South Coast Air Quality Management District's “Guidelines for Demonstrating Equivalency with District Approved Transfer Efficient Spray Guns, September 26, 2002.” When using these equivalency procedures and/or guidelines, facilities would not be required to submit an application with the test plan or protocol to the Administrator, conduct the test in the presence of an Administrator's representative, or submit test results to the Administrator for review or approval. Instead, they would be required to maintain records demonstrating the transfer efficiency achieved, including a description of the procedures and/or guidelines used. We are proposing that all spray equipment used for spray-applied coating operations would be required to be operated according to company procedures, local specified operating procedures, or the manufacturer's specifications, whichever is determined to meet the 65 percent transfer efficiency. Further, we are proposing related definitions for “airless and air-assisted airless spray,” “electrostatic application,” “high-volume, low-pressure (HVLP) spray equipment,” “spray-applied coating operations,” “and transfer efficiency.”
Considering just the incremental cost of the high efficiency spray equipment and savings due to using less material consumption, we expect that all facilities have already switched to high efficiency application methods. However, if a large appliance surface coating facility not using the emission rate with add-on control compliance option replaced their existing coating spray guns with a high-efficiency spray gun required by this proposed rule, such as an air-assisted airless spray gun, an estimated cost to do so would be approximately $700 per device, based on vendor information. See the memorandum titled
We have not estimated the emissions reductions achieved by switching to high efficiency application methods for this source category because we expect
Finally, we identified no developments in work practices or procedures for the Surface Coating of Large Appliances source category, including work practices and procedures that are currently prescribed in the NESHAP. The current Surface Coating of Large Appliances NESHAP standards require that, if a facility uses add-on controls to comply with the emission limitations, the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, all coating operations for which emission limits are established. The current work practice requirements address the potential emission sources that are normally located outside of the emission sources that are routed to the control device, and no new measures have been identified to further reduce the emissions from these sources. For further discussion of the technology review results, refer to the
In section III.B. above, we describe our typical approach for conducting technology reviews and the types of information we gather and evaluate as part of these reviews. In addition, we solicit comment on the relationship between the CAA section 112(d)(6) technology review and the CAA section 112(f) risk review. As we described in the preamble of the Coke Ovens RTR Final rule published on April 15, 2005 (70 FR 20009), we believe that the results of a CAA section 112(f) risk determination for a CAA section 112(d) standard should be key factors in any subsequent CAA section 112(d)(6) determination for that standard. In the Coke Ovens RTR final rule, the agency described potential scenarios where it may not be necessary to revise the standards based on developments in technologies, practices or processes if the remaining risks associated with air emissions from a source category have already been reduced to a level where we have determined further reductions under CAA section 112(f) are not necessary. Under one scenario, if the ample margin of safety analysis for the CAA section 112(f) determination was not based on the availability or cost of particular control technologies, then advances in air pollution control technology would not necessarily be a cause to revise the MACT standard pursuant to CAA section 112(d)(6), because the CAA section 112(f) standard (or a CAA section 112(d) standard evaluated pursuant to CAA section 112(f)) would continue to assure an adequate level of safety. Under another scenario, if the ample margin of safety analysis for a CAA section 112(f) standard (or a CAA section 112(d) standard evaluated pursuant to CAA section 112(f)) shows that lifetime excess cancer risks to the individual most exposed to emissions from a source in the category is less than 1-in-1 million, and the remaining risk associated with threshold pollutants falls below a similar threshold of safety, then no further revision under CAA section 112(d)(6) would be necessary, because an ample margin of safety has already been assured.
We solicit comment on whether revisions to the NESHAP are “necessary”, as that term is used in CAA section 112(d)(6), in situations where EPA has determined that CAA section 112(d) standards evaluated pursuant to CAA section 112(f) provide an ample margin of safety to protect public health and prevent an adverse environmental effect. In other words, we solicit comment on our conclusion that, if remaining risks associated with air emissions from a source category have already been reduced to levels where we have determined under CAA section 112(f) that further reductions are not necessary, then it is not “necessary” to revise the standards based on developments in technologies, practices or processes under CAA section 112(d)(6).
Though we believe the results of the ample margin of safety analysis may eliminate the need to revise the emissions standards as based on developments in technologies practices and processes, we conducted a technology review to determine if any developments to further reduce HAP emissions have occurred, and to consider whether the current standards should be revised to reflect any such developments. We believe that the use of high-efficiency spray equipment in the Surface Coating of Large Appliances source category is cost effective, presents minimal or no additional burden and achieves reductions in actual or potential HAP emissions. Therefore, based on our technology review, we are proposing to require the use of high-efficiency spray application equipment for the Surface Coating of Large Appliances source category. Note that the discussion directly above also applies to the Printing, Coating, and Dyeing of Fabrics and Other Textiles and Surface Coating of Metal Furniture source categories.
In the Surface Coating of Large Appliances source category, we are proposing to require electronic submittal of notifications, semi-annual reports and compliance reports (which include performance test reports). In addition, we are proposing revisions to the startup, shutdown, and malfunction (SSM) provisions of the MACT rule in order to ensure that they are consistent with the Court decision in
Though we are not proposing to change reporting frequency currently in the rule, we are requesting comment on changing the reporting frequency for all reports to EPA from semi-annual to annual due to the potential redundancy of these reporting requirements. We recognize that Title V permits have a statutory requirement for semi-annual reports, which are generally reported to state regulatory agencies. However, we are not certain that changing the report frequency for just the reports submitted to EPA in this NESHAP will result in a reporting and recordkeeping burden reduction. We request comment and supporting information on the burden impact of changing the reporting requirement to annual for the reporting to EPA.
The EPA proposes to require owners and operators of Surface Coating of Large Appliances facilities to submit electronic copies of initial notifications required in 40 CFR 63.9(b), notifications of compliance status required in 40 CFR 63.9(h), performance test reports, and semiannual reports through the EPA's Central Data Exchange (CDX), using the Compliance and Emissions Data Reporting Interface (CEDRI).
The EPA proposes that electronic submittal of notifications and reports (initial notifications required in 40 CFR 63.9(b), notifications of compliance status required in 40 CFR 63.9(h), and semiannual reports) be required using electronic reporting forms that the EPA will make available in CEDRI. No specific form is proposed at this time for the initial notifications required in 40 CFR 63.9(b) and notifications of compliance status required in 40 CFR 63.9(h). Until the EPA has completed electronic forms for these notifications, the notifications will be required to be submitted via CEDRI in PDF. For semiannual reports, the EPA proposes that owners or operators use the appropriate spreadsheet template in CEDRI for 40 CFR part 63, subpart NNNN, or an alternate electronic file format consistent with the form's extensible markup language schema. For further information regarding the electronic data submission process, please refer to the spreadsheet attached to the memorandum titled
As noted above, we propose that 40 CFR part 63, subpart NNNN, performance test reports be submitted through the EPA's Electronic Reporting Tool (ERT). The proposal to submit performance test data electronically to the EPA applies only if the EPA has developed an electronic reporting form for the test method as listed on the EPA's ERT website (
We propose to provide owners or operators of facilities with the ability to seek extensions for submitting electronic reports for circumstances beyond the control of the facility,
In 40 CFR 63.4121(d), we propose to address the situation where an extension may be warranted due to outages of the EPA's CDX or CEDRI that may prevent access to the system and submittal of the required reports. If either the CDX or CEDRI is unavailable at any time beginning five business days prior to the date that the submission is due, and the unavailability prevents the submission of a report by the required date, we propose to enable the owner or operator of a facility to assert a claim of EPA system outage. We consider five business days prior to the reporting deadline to be an appropriate timeframe because if the system is down and returns to service prior to this time, facilities will still have 1 week prior to the reporting deadline to complete reporting once the system is back online. However, if the CDX or CEDRI is down during the week a report is due, we realize that this could greatly impact the ability to submit a required report on time. We will notify owners or operators of facilities about known outages as far in advance as possible by notification using the CHIEF Listserv, posting on the CEDRI website, and posting on the CDX website so that owners or operators can plan accordingly and still meet the reporting deadlines. However, if a planned or unplanned outage of the EPA's CDX or CEDRI occurs and an owner or operator of a facility believes that the outage will affect or it has affected compliance with an electronic reporting requirement, the proposed rule provides a process to assert such a claim.
Also in 40 CFR 63.4121(e), we propose to address the situation where an extension may be warranted due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents
While we propose these potential extensions to protect facilities from noncompliance with reporting requirements in cases when a facility cannot successfully submit a report by the reporting deadline for reasons outside of its control as described above, we do not propose an extension for other circumstances. Facility owners or operators should register for CEDRI far in advance of the initial compliance date to ensure that they can complete the identity proofing process prior to the initial compliance date. Additionally, we recommend developing reports early in case any questions arise during the reporting process.
As discussed in the
In its 2008 decision in
We are proposing the elimination of the SSM exemption in this rule. Consistent with
In proposing these rule amendments, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, has not proposed alternate standards for those periods. Startups and shutdowns are part of normal operations for the Surface Coating of Large Appliances source category. As currently specified in 40 CFR 63.4092(b), any coating operation(s) for which you use the emission rate with add-on controls option must meet operating limits “at all times,” except for solvent recovery systems for which you conduct liquid-liquid material balances according to 40 CFR 63.4161(h). Also, as currently specified in 40 CFR 63.4100(a)(2), any coating operation(s) for which you use the emission rate with add-on controls option must be in compliance “at all times” with the emission limit in 40 CFR 63.4090 and work practice standards in 40 CFR 63.4093. This means that during startup and shutdown periods, in order for a facility using add-on controls to meet the emission and operating standards, the control device for a coating operation needs to be turned on and operating at specified levels before the facility begins coating operations, and the control equipment needs to continue to be operated until after the facility ceases coating operations. In some cases, the facility needs to run thermal oxidizers on supplemental fuel before there are enough VOC for the combustion to be (nearly) self-sustaining. The proposed language in 40 CFR 63.4100 requires that the owner or operator operate and maintain the coating operation, including pollution control equipment, at all times to minimize emissions. See section IV.A.4.b.2 of this preamble for further discussion of this proposed revision.
Periods of startup, normal operations, and shutdown are all predictable and routine aspects of a source's operations. Malfunctions, in contrast, are neither predictable nor routine. Instead they are, by definition sudden, infrequent and not reasonably preventable failures of emissions control, process or monitoring equipment. (40 CFR 63.2) (Definition of malfunction). The EPA interprets CAA section 112 as not requiring emissions that occur during periods of malfunction to be factored into development of CAA section 112 standards and this reading has been upheld as reasonable by the Court in U.S.
As the Court recognized in
Although no statutory language compels the EPA to set standards for malfunctions, the EPA has the discretion to do so where feasible. For example, in the Petroleum Refinery Sector Risk and Technology Review, the EPA established a work practice standard for unique types of malfunctions that result in releases from pressure relief devices or emergency flaring events because we had information to determine that such work practices reflected the level of control that applies to the best performing sources (80 FR 75178, 75211-14, December 1, 2015). The EPA will consider whether circumstances warrant setting standards for a particular type of malfunction and, if so, whether the EPA has sufficient information to identify the relevant best performing sources and establish a standard for such malfunctions. We also encourage commenters to provide any such information.
It is unlikely that a malfunction in the application of large appliance surface coatings would result in a violation of the standards. A malfunction would not lead to an increase in the HAP content of the coatings or the amount of HAP emitted from those coatings; therefore, it is unlikely that malfunctions at facilities using the compliant material or emission rate without control option would result in a violation in any case where compliant materials are used. Finally, compliance with the large appliance surface coating emission limits is based on a monthly compliance period, so any malfunction that causes a short-term increase in emissions may not cause a violation of the standard. Similarly, for facilities in the surface coating of metal furniture source category using the emission rate with add-on control compliance option or percent reduction compliance option, the short-term malfunction of an emission capture system or control device is also unlikely to lead to a violation if the owner or operator operates and maintains the affected source in a manner consistent with safety and good air pollution control practices for minimizing emissions during that malfunction. Because compliance is based on a monthly or a rolling 12-month compliance period, a short-term malfunction is likely to represent only a small percent of the total operating time of the affected source. A single malfunction is also not likely to affect all of the emission units and control devices within the affected source. Therefore, a malfunction is not likely to result in a violation of the standards, and we have no information to suggest that it is feasible or necessary to establish any type of standard for malfunctions associated with the Surface Coating of Large Appliances or the Surface Coating of Metal Furniture source categories.
We are requesting comment on the need to establish a standard during periods of malfunction for the Fabric and Other Textiles source category in this action, and we are seeking the specific information described in section IV.B.4 of this preamble to support such a standard. We believe a work practice standard would be appropriate for a malfunction at facilities in this category. We are requesting comment on two alternatives in this preamble. The work practice standard, if included in the final rule, would include the following, or similar, requirements.
In the first alternative if a malfunction of a control device or a capture system that is used to meet the emission limits of this rule occurs, the facility may elect to continue operation without the control device for the period of the malfunction so long as it continues to meet the emission limits for the current compliance period. Each workstation would discontinue its application of coating materials onto the web, and complete drying of any coating materials already applied onto the web as of the start of the malfunction. Draining coating materials from the
A second alternative would require that repairs be immediately initiated and completed as expeditiously as possible, but the line would not have to cease operation. We note that this source category compliance is based on a 12-month rolling average. Therefore, operating a period of time without a control device would not necessarily result in an exceedance of the emissions limit. However, the facility would not be allowed to continue to operate the coating line once it becomes apparent they will be unable to complete repairs before the 12-month rolling average compliance limit will be exceeded. We request comment on both of these approaches for the Fabrics and Other Textiles source category.
In the unlikely event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA will determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. The EPA will also consider whether the source's failure to comply with the CAA section 112(d) standard was, in fact, sudden, infrequent, not reasonably preventable and was not instead caused in part by poor maintenance or careless operation. 40 CFR 63.2 (definition of malfunction).
If the EPA determines in a particular case that an enforcement action against a source for violation of an emission standard is warranted, the source can raise any and all defenses in that enforcement action and the federal district court will determine what, if any, relief is appropriate. The same is true for citizen enforcement actions. Similarly, the presiding officer in an administrative proceeding can consider any defense raised and determine whether administrative penalties are appropriate.
In summary, the EPA interpretation of the CAA and, in particular, CAA section 112 is reasonable and encourages practices that will avoid malfunctions. Administrative and judicial procedures for addressing exceedances of the standards fully recognize that violations may occur despite good faith efforts to comply and can accommodate those situations.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.6(e)(1)(i) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(i) describes the general duty to minimize emissions. Some of the language in that section is no longer necessary or appropriate in light of the elimination of the SSM exemption. We are proposing instead to add general duty regulatory text at 40 CFR 63.4100(b) that reflects the general duty to minimize emissions while eliminating the reference to periods covered by an SSM exemption. The current language in 40 CFR 63.6(e)(1)(i) characterizes what the general duty entails during periods of SSM. With the elimination of the SSM exemption, there is no need to differentiate between normal operations, startup and shutdown, and malfunction events in describing the general duty. Therefore, the language the EPA is proposing for 40 CFR 63.4100(b) does not include that language from 40 CFR 63.6(e)(1).
We are also proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.6(e)(1)(ii) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(ii) imposes requirements that are not necessary with the elimination of the SSM exemption or are redundant with the general duty requirement being added at 40 CFR 63.4100(b).
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.6(e)(3) by changing the “yes” in column 3 to a “no.” Generally, these paragraphs require development of an SSM plan and specify SSM recordkeeping and reporting requirements related to the SSM plan. We are also proposing to remove from 40 CFR part 63, subpart NNNN, the current provisions requiring the SSM plan, including 40 CFR 63.4100(d) and 63.4110(b)(9)(v). As noted, the EPA is proposing to remove the SSM exemptions. Therefore, affected units will be subject to an emission standard during such events. The applicability of a standard during such events will ensure that sources have ample incentive to plan for and achieve compliance, and, thus, the SSM plan requirements are no longer necessary.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.6(f)(1) by changing the “yes” in column 3 to a “no.” The current language of 40 CFR 63.6(f)(1) exempts sources from non-opacity standards during periods of SSM. As discussed above, the Court in
We are also proposing to remove rule text in 40 CFR 63.4161(g) clarifying that, in calculating emissions to demonstrate compliance, deviation periods must include deviations during an SSM period. Since the EPA is removing the SSM exemption, this clarifying text is no longer needed.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.7(e)(1) by changing the “yes” in column 3 to a “no.” Section 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to add a performance testing requirement at 40 CFR 63.4164. The performance testing requirements we are proposing to add differ from the General Provisions performance testing provisions in several respects. The regulatory text does not include the language in 40 CFR 63.7(e)(1) that restated the SSM exemption and language that precluded startup and shutdown periods from being considered “representative” for purposes of performance testing. The proposed performance testing provisions will also not allow performance testing during startup or shutdown. As in 40 CFR 63.7(e)(1), performance tests conducted under this subpart should not be conducted during malfunctions because conditions during malfunctions are often not representative of normal operating conditions. Section 63.7(e) requires that the owner or operator maintain records of the process information necessary to document operating conditions during the test and include in such records an explanation to support that such conditions represent normal operation. The EPA is proposing to add language clarifying that the owner or operator must make such records available to the Administrator upon request.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.8(c)(1)(i) and (iii) by changing the “yes” in column 3 to a “no.” The cross-references to the general duty and SSM plan requirements in those subparagraphs are not necessary in light of other requirements of 40 CFR 63.8 that require good air pollution control practices (40 CFR 63.8(c)(1)) and that set out the requirements of a quality control program for monitoring equipment (40 CFR 63.8(d)). Further, we are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.8(c)(1)(ii) by changing the “yes” in column 3 to a “no.” We have determined that 40 CFR 63.8(c)(1)(ii) is redundant to the current monitoring requirement in 40 CFR 63.4168(a)(4) (
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(b)(2)(i) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(i) describes the recordkeeping requirements during startup and shutdown. These recording provisions are no longer necessary because the EPA is proposing that recordkeeping and reporting applicable to normal operations will apply to startup and shutdown. In the absence of special provisions applicable to startup and shutdown, such as a startup and shutdown plan, there is no reason to retain additional recordkeeping for startup and shutdown periods.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(b)(2)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(ii) describes the recordkeeping requirements during a malfunction, requiring a record of “the occurrence and duration of each malfunction.” A similar record is already required in 40 CFR 63.4130(j), which requires a record of “the date, time, and duration of each deviation,” which the EPA is retaining. The regulatory text in 40 CFR 63.4130(j) differs from the General Provisions in that the General Provisions requires the creation and retention of a record of the occurrence and duration of each malfunction of process, air pollution control, and monitoring equipment; whereas 40 CFR 63.4130(j) applies to any failure to meet an applicable standard and is requiring that the source record the date, time, and duration of the failure rather than the “occurrence.” For this reason, the EPA is proposing to add to 40 CFR 63.4130(j) a requirement that sources also keep records that include a list of the affected source or equipment and actions taken to minimize emissions, an estimate of the quantity of each regulated pollutant emitted over the emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions. Examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters (
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(b)(2)(iv) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events when actions were inconsistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required. The requirement previously applicable under 40 CFR 63.10(b)(2)(iv)(B) to record actions to minimize emissions and record corrective actions is now applicable by reference to 40 CFR 63.4130(j)(4).
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(b)(2)(v) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events to show that actions taken were consistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(c)(15) by changing the “yes” in column 3 to a “no.” The EPA is proposing that 40 CFR 63.10(c)(15) no longer applies. When applicable, the provision allows an owner or operator to use the affected source's SSM plan or records kept to satisfy the recordkeeping requirements of the SSM plan, specified in 40 CFR 63.6(e), to also satisfy the requirements of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate this requirement because SSM plans would no longer be required, and, therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for affected units.
We are proposing to remove the requirement in 40 CFR 63.4130(k)(1) that deviation records specify whether deviations from a standard occurred during a period of SSM. This revision is being proposed due to the proposed removal of the SSM exemption and because, as discussed above in this section, we are proposing that deviation records must specify the cause of each deviation, which could include a malfunction period as a cause. We are also proposing to remove the requirement to report the SSM records in 40 CFR 63.6(e)(3)(iii) through (v) by deleting 40 CFR 63.4130(k)(2).
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(d)(5) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5) describes the reporting requirements for startups, shutdowns, and malfunctions. To replace the General Provisions reporting requirement, the EPA is proposing to add reporting requirements to 40 CFR 63.4120. The replacement language differs from the General Provisions requirement in that it eliminates periodic SSM reports as a stand-alone report. We are proposing language that requires sources that fail to meet an applicable standard at any time to report the information concerning such events in the semi-annual compliance report already required under this rule. Subpart NNNN currently requires reporting of the date, time period, and cause of each deviation. We are clarifying in the rule that, if the cause of a deviation from the standard is unknown, this should be specified in the report. We are also proposing to change “date and time period” to “date, time, and duration” (see proposed revisions to 40 CFR 63.4120(d)(1), (g)(6), (g)(8), and (g)(13)) to use terminology consistent with the recordkeeping section. Further, we are proposing that the report must also contain the number of deviations from the standard, and a list of the affected source or equipment. For deviation reports addressing deviations from an applicable emission limit in 40 CFR
Regarding the proposed new requirement discussed above to estimate the quantity of each regulated pollutant emitted over any emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions, examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters (
We will no longer require owners or operators to determine whether actions taken to correct a malfunction are consistent with an SSM plan, because plans would no longer be required. The proposed amendments, therefore, eliminate 40 CFR 63.4120(j) that requires reporting of whether the source deviated from its SSM plan, including required actions to communicate with the Administrator, and the cross reference to 40 CFR 63.10(d)(5)(i) that contains the description of the previously required SSM report format and submittal schedule from this section. These specifications are no longer necessary because the events will be reported in otherwise required reports with similar format and submittal requirements.
We are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.10(d)(5)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5)(ii) describes an immediate report for startups, shutdown, and malfunctions when a source failed to meet an applicable standard, but did not follow the SSM plan. We will no longer require owners and operators to report when actions taken during a startup, shutdown, or malfunction were not consistent with an SSM plan, because plans would no longer be required.
We are proposing to remove the requirements in 40 CFR 63.4120(g)(8) that deviation reports must specify whether deviation from an operating limit occurred during a period of SSM. We are also proposing to remove the requirements in 40 CFR 63.4120(g)(10) to break down the total duration of deviations into the startup and shutdown categories. As discussed above in this section, we are proposing to require reporting of the cause of each deviation. Further, the startup and shutdown categories no longer apply because these periods are proposed to be considered normal operation, as discussed in section IV.A.4.b.1 of this preamble.
We propose to amend 40 CFR 63.4166(b) to add the option of conducting EPA Method 18 of appendix A to 40 CFR part 60, “Measurement of Gaseous Organic Compound Emissions by Gas Chromatography,” to measure and then subtract methane emissions from measured total gaseous organic mass emissions as carbon. Facilities using the emission rate with add-on control compliance option can use either EPA Method 25 or Method 25A to measure control device destruction efficiency. Unlike EPA Method 25, Method 25A does not exclude methane from the measurement of organic emissions. Because many exhaust streams from coating operations may contain methane from natural gas combustion, we are proposing to allow facilities the option to measure this methane using Method 18 and to subtract this methane from the emissions as part of their compliance calculations. We also propose to revise the format of references to test methods in 40 CFR part 60. The current reference in 40 CFR 63.4166(a) and (b) to Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 25, and 25A specify that each method is in “appendix A” of part 60. Appendix A of part 60 has been divided into appendices A-1 through A-8. We propose to revise each reference to appendix A to indicate which of the eight sections of appendix A applies to the method.
EPA is proposing to amend 40 CFR 63.4141(a)(1)(i) and (4) to remove reference to paragraph (d)(4) of OSHA's Hazard Communication standard, which dealt with OSHA-defined carcinogens. EPA is proposing to replace that reference with its own list of hazardous air pollutants that must be regarded as potentially carcinogenic based on EPA guidelines. Although paragraph (d)(4) of OSHA's standard was deleted when the Agency adopted the Globally Harmonized System of Hazard Communication in 2012, it was replaced by section A.6.4.2 of mandatory Appendix A of that standard, which reads as follows:
“Where OSHA has included cancer as a health hazard to be considered by classifiers for a chemical covered by 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, chemical manufacturers, importers, and employers shall classify the chemical as a carcinogen.” Thus, where OSHA has regulated workplace exposure to a chemical based, at least in part, on carcinogenic risk, OSHA requires the chemical to be classified as a carcinogen. OSHA suggests that EPA should refer to section A.6.4.2 of Appendix A of 29 CFR 1910.1200 in its discussion of section 63.4141 and consider chemicals that meet this requirement be considered “OSHA-defined carcinogens.”
We are proposing to replace these references to carcinogens in 29 CFR 1910.1200(d)(4) with a list (in proposed new Table 5 to subpart NNNN) of those organic HAP that must be included in calculating total organic HAP content of a coating material if they are present at 0.1 percent or greater by mass.
We propose to include organic HAP in proposed Table 5 to subpart NNNN if they were categorized in the EPA's
We propose to revise the monitoring provisions for thermal and catalytic oxidizers to clarify that a thermocouple is part of the temperature sensor referred to in 40 CFR 63.4168(c)(3) for purposes of performing periodic calibration and verification checks.
We propose to renumber 40 CFR 63.4130(k)(8) and (9) to be 40 CFR 63.4130(k)(7) and (8) because current paragraph 40 CFR 63.4130(k) is missing a paragraph (k)(7). This revision will address any confusion over this missing paragraph. We also propose to revise the rule citation “§ 63.4130(k)(9)” in 40 CFR 63.4163(e) to be “§ 63.4130(k)(8),” consistent with the proposed renumbering of 40 CFR 63.4130(k)(9) to (k)(8).
Current 40 CFR 63.4931(a) allows records, “where appropriate,” to be maintained as “electronic spreadsheets” or a “data base.” We propose to add clarification to this provision that the allowance to retain electronic records applies to all records that were submitted as reports electronically via the EPA's CEDRI. We also propose to add text to the same provision clarifying that this ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
We propose to revise various erroneous rule citations. We propose to revise one instance in 40 CFR 63.4160(a)(1) and three instances in 40 CFR 63.4160(b)(1) that an erroneous rule citation “§ 63.4183” is specified. Section 63.4183 does not exist in 40 CFR part 63, subpart NNNN, and 40 CFR 63.4083 is the correct citation, providing the compliance dates referred to in association with the erroneous rule citation. We propose to change the erroneous citation to “§ 63.4083.” We propose to revise one instance in 40 CFR 63.4110(b)(10) of an erroneous rule citation “§ 63.4081(d).” This rule citation is specified in 40 CFR 63.4110(b)(10) as the source for the allowance to comply with the requirements of another subpart in lieu of the requirements of this subpart NNNN. The correct citation for this allowance is 40 CFR 63.4081(e), and we propose to change the erroneous citation to “§ 63.4081(e).” We propose to revise one instance in 40 CFR 63.4130(f) and one instance in 40 CFR 63.4130(g) of an erroneous rule citation of “§ 63.4141(a).” This rule citation is specified in each 40 CFR 63.4130(f) and (g) as the source for the allowance that the volume solids determination is not required for coatings for which the mass fraction of organic HAP of the coating equals zero. However, it is the introductory paragraph to 40 CFR 63.4141, not 40 CFR 63.4141(a), that provides the allowance to not be required to determine the volume solids for zero-HAP coatings. We propose to change the erroneous citation to “§ 63.4141.” We propose to revise one instance in 40 CFR 63.4168(c)(2) that an erroneous rule citation “§ 63.6167(b)(1) and (2)” is specified. Section 40 CFR 63.6167(b)(1) and (2) does not exist in 40 CFR part 63, subpart NNNN. Section 40 CFR 63.4167(b)(1) and (2) is the correct citation, describing how to establish operating limits for catalytic oxidizers as referred to in association with the erroneous rule citation. We propose to change the erroneous citation to “§ 63.4167(b)(1) and (2).” We propose to revise two instances in Table 2 to Subpart NNNN of Part 63 of an erroneous rule citation “§ 63.4120(b).” This rule citation is specified in the fourth column of the table entry for “§ 63.10(d)(2),” as the source for the requirements related to reporting results of performance tests. Section 40 CFR 63.4120(b) does not provide these types of requirements; however, 40 CFR 63.4120(h) provides these requirements. The correct citation for this allowance is 40 CFR 63.4120(h), and we propose to change the erroneous citation to “§ 63.4120(h).” The rule citation “§ 63.4120(b)” is also specified in the fourth column of the table entry for “§ 63.10(e)(3),” as the source for the contents of periodic compliance reports. Section 40 CFR 63.4120(b) does not provide the contents of periodic compliance reports; however, 40 CFR 63.4120(g) provides these requirements. The correct citation for this allowance is 40 CFR 63.4120(g), and we propose to change the erroneous citation to “§ 63.4120(g).” Current 40 CFR 63.4152(c) requires inclusion in the semiannual compliance report of a statement that the source was in compliance with the emission limitations during the reporting period. We propose to add clarification to this provision that the requirement to submit this statement applies only if there were no deviations from the emission limitations.
As part of an ongoing effort to improve compliance with various federal air emission regulations, the EPA reviewed the compliance demonstration requirements in the Surface Coating of Large Appliance NESHAP. Currently, if a source owner or operator chooses to comply with the standards using add-on controls, the results of an initial performance test are used to determine compliance; however, the rule does not require on-going periodic performance testing for these emission capture systems and add-on controls.
As mentioned by the Institute of Clean Air Companies (ICAC) in their comments on proposed revisions to the NESHAP General Provisions (72 FR 69, January 3, 2007), ongoing maintenance and checks of control devices are necessary in order to ensure emissions control technology remains effective.
Given these comments from ICAC, suppliers of air pollution control and monitoring technology, on the need for vigilance in maintaining equipment to stem degradation, the EPA is requesting comment on what steps, in addition to one-time initial emissions and capture efficiency testing, along with ongoing temperature measurement, might better ensure ongoing compliance with the standards.
The EPA specifically is requesting comment on whether performance testing should be required anytime a source plans to undertake an operational change that may adversely affect compliance with an applicable standard, operating limit, or parametric monitoring value. Any such requirement would include provisions to allow a source to make the change, but limit the change to a specific time before a test is required. We anticipate that a reasonable time limit under the new operations change would be approximately 30 days to allow adequate time for testing and developing a test report. The source would submit temperature and flow rate data during the test to establish new operating parameters. We specifically are requesting comment on this potential provision, including the time a source would be allowed to operate under the new parameters before they test, and what would constitute an operational change requiring testing.
This approach on which we are requesting comment could also allow an exception from periodic testing for facilities using instruments to continuously measure emissions. Such continuous emissions monitoring systems (CEMS) would show actual emissions. Use of CEMS to demonstrate compliance would obviate the need for periodic oxidizer testing. Moreover, installation and operation of a CEMS with a timesharing component, such that values from more than one oxidizer exhaust could be tabulated in a recurring frequency, could prove less expensive (estimated to have an annual cost below $15,000) than ongoing oxidizer testing.
The approach on which we are requesting comment would not require periodic testing or CEMS monitoring of facilities using the compliant materials option, or the emission-rate without add-on controls compliance option because these two compliance options do not use any add-on control efficiency measurements in the compliance calculations.
The approach would require air emissions testing to measure organic HAP destruction or removal efficiency at the inlet and outlet of the add-on control device, or measurement of the control device outlet concentration of organic HAP. Emissions would be measured as total gaseous organic mass emissions as carbon using either Method 25 or 25A of appendix A-7 to 40 CFR part 60, which are the methods currently required for the initial compliance demonstration.
We estimate that the cost to perform a control device emissions destruction or removal efficiency test using EPA Method 25 or 25A would be approximately $19,000 per control device. The cost estimate is included in the memorandum titled
The EPA is proposing that affected sources that commenced construction or reconstruction on or before September 12, 2018 must comply with all of the amendments, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than 181 days after the effective date of the final rule. Affected sources that commence construction or reconstruction after September 12, 2018 must comply with all requirements of the subpart, including the amendments being proposed, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than the effective date of the final rule or upon startup, whichever is later. All affected facilities would have to continue to meet the current requirements of 40 CFR part 63, subpart NNNN until the applicable compliance date of the amended rule. The final action is not expected to be a “major rule” as defined by 5 U.S.C. 804(2), so the effective date of the final rule will be the promulgation date as specified in CAA section 112(d)(10).
For existing sources, we are proposing two changes that would impact ongoing compliance requirements for 40 CFR part 63, subpart NNNN. As discussed elsewhere in this preamble, we are proposing to add a requirement that notifications, performance test results, and semiannual compliance reports be submitted electronically using the new template. We are also proposing to change the requirements for SSM by removing the exemption from the requirements to meet the standard during SSM periods and by removing the requirement to develop and implement an SSM plan. Our experience with similar industries that are required to convert reporting mechanisms to install necessary hardware and software, become familiar with the process of submitting performance test results electronically through the EPA's CEDRI, test these new electronic submission capabilities, and reliably employ electronic reporting shows that a time period of a minimum of 90 days, and, more typically, 180 days is generally necessary to successfully accomplish these revisions. Our experience with similar industries further shows that this sort of regulated facility generally requires a time period of 180 days to read and understand the amended rule requirements; to evaluate their operations to ensure that they can meet the standards during periods of startup and shutdown as defined in the rule and make any necessary adjustments; and to update their operation, maintenance, and monitoring plan to reflect the revised requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. From our assessment of the timeframe needed for compliance with the entirety of the revised requirements, the EPA considers a period of 180 days to be the most expeditious compliance period practicable and, thus, is proposing that existing affected sources and new affected sources that commenced construction or reconstruction on or before September 12, 2018 be in compliance with all of this regulation's revised requirements, except for the requirement to use high efficiency spray equipment discussed below, within 181 days of the regulation's effective date.
Under CAA section 112(d), we are proposing compliance dates for the proposed requirement to use high efficiency spray equipment if the source is not using the emission rate with add-on control compliance option. For existing affected sources under this proposed action, we propose to provide sources three years after the effective date of the final rule to comply with the proposed requirement to use high efficiency spray equipment. We are proposing a 3-year compliance date for facilities that have not switched to high efficiency spray equipment because facilities that are not yet using high efficiency spray equipment have multiple alternative equipment types to consider under this proposed rule. The 3-year compliance period will provide all facilities sufficient time to source and purchase the specific type of spray application equipment compatible with their operations. Furthermore, the compliance period provides time for sources to verify that the spray equipment they choose meets the transfer efficiency requirements in this proposed rule. In addition, because a spray gun's useful lifespan is approximately two years, the proposed three-year compliance period will provide enough time for facilities to source and purchase replacement guns on their current equipment purchase cycle, develop any necessary operational procedures, and perform training. Finally, the 3-year compliance period will ensure that a facility is not required to replace a spray gun before it has time to identify and source new guns and develop bid specification and operation procedures. For new affected sources under this proposed action, the proposed compliance date is the effective date of the final rule or upon startup, whichever is later.
We solicit comment on these proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance dates.
As described above in section III of this preamble, for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, we conducted a risk assessment for all HAP emitted. We present results of the risk assessment briefly below and in more detail in the
Table 3 below provides a summary of the results of the inhalation risk assessment for the source category. As discussed in section III.C.2 of this preamble, we determined that MACT-allowable HAP emission levels at fabrics and other textiles printing, coating, and dyeing facilities are equal to 1.1 times the actual emissions. For more detail about the MACT-allowable emission levels, see Appendix 1 to the
The results of the inhalation risk modeling using actual emissions data, as shown in Table 3 above, indicate that the maximum individual cancer risk based on actual emissions (lifetime) could be up to 9-in-1 million, the maximum chronic noncancer TOSHI value based on actual emissions could be up to 0.3, and the maximum screening acute noncancer HQ value (off-facility site) could be up to 0.6. The total estimated annual cancer incidence (national) from these facilities based on actual emission levels is 0.002 excess cancer cases per year, or one case in every 500 years.
Table 3 also shows the acute risk results for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category. The screening analysis for acute impacts was based on an industry-specific multiplier of 1.4, to estimate the peak emission rates from the average emission rates. For more detailed acute risk results refer to the
We did not identify any PB-HAP emitted by facilities in this source category. Therefore, we do not expect any human health multipathway risks as a result of emissions from this source category.
The emissions data for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category indicate that no environmental HAP are emitted by sources within this source category. Therefore, we did not conduct a screening-level evaluation of the potential adverse environmental risks associated with emissions for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category. We do not expect an adverse environmental effect as a result of HAP emissions from this source category.
The results of our facility-wide assessment indicate that 12 facilities have a facility-wide cancer MIR greater than or equal to 1-in-1 million. The maximum facility-wide cancer MIR is 9-in-1 million, driven by ethylene oxide from fabric finishing. The total estimated cancer incidence from the whole facility assessment is 0.003 excess cancer cases per year, or one excess case in every 330 years. Approximately 12,200 people were estimated to have cancer risks above 1-in-1 million from exposure to HAP emitted from both MACT and non-MACT sources collocated at the 43 facilities in this source category. The maximum facility-wide TOSHI for the source category is estimated to be 0.3, driven by emissions of trichloroethylene from adhesive application.
To examine the potential for any environmental justice issues that might be associated with the source category, we performed a demographic analysis, which is an assessment of risks to individual demographic groups of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risks from the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category across different demographic groups within the populations living near facilities.
The results of the demographic analysis are summarized in Table 4 of this preamble. These results, for various demographic groups, are based on the estimated risks from actual emissions levels for the population living within 50 km of the facilities.
The results of the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category demographic analysis indicate that emissions from the source category expose approximately 8,500 people to a cancer risk at or above 1-in-1 million and no one to a chronic noncancer hazard index greater than 1. The percentages of the at-risk population in the following specific demographic groups are higher than their respective nationwide percentages: “African American,” “Over 25 Without a HS Diploma,” and “Below the Poverty Level.”
The methodology and the results of the demographic analysis are presented in a technical report,
As noted in section III.A of this preamble, we weigh all health risk factors in our risk acceptability determination, including the cancer MIR, the number of persons in various cancer and noncancer risk ranges, cancer incidence, the maximum noncancer TOSHI, the maximum acute noncancer HQ, the extent of noncancer risks, the distribution of cancer and noncancer risks in the exposed population, and risk estimation uncertainties (54 FR 38044, September 14, 1989).
For the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, the risk analysis indicates that the cancer risks to the individual most exposed could be up to 9-in-1 million due to actual emissions and up to 10-in-1 million based on allowable emissions. These risks are considerably less than 100-in-1 million, which is the presumptive upper limit of acceptable risk. The risk analysis also shows very low cancer incidence (0.002 cases per year for actual emissions and allowable emissions), and we did not identify potential for adverse chronic noncancer health effects. The acute noncancer risks based on actual emissions is below an HQ of one for all facilities (maximum of 0.6 for formaldehyde). Therefore, we find there is little potential concern of acute noncancer health impacts from actual emissions. In addition, the risk assessment indicates no significant potential for multipathway health effects.
Considering all of the health risk information and factors discussed above, including the uncertainties discussed in section III.C.7 of this preamble, we propose that the risks from the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category are acceptable.
Although we are proposing that the risks from the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category are acceptable, risk estimates for approximately 8,500 individuals in the exposed population are above 1-in-1 million at the actual emissions level and 10,000 individuals in the exposed population are above 1-in-1 million at the allowable emissions level. Consequently, we further considered whether the MACT standards for the Printing, Coating, and
As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, and we reviewed various information sources regarding emission sources that are currently regulated by the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. Based on our review, we did not identify any developments in add-on control technologies, other equipment or work practices and procedures since the promulgation of the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. We note, however, that the only facility that reported ethylene oxide emissions no longer emits this HAP as a result of a process change, as discussed below in the technology review discussion. Therefore, we are proposing that additional emissions controls for this source category are not necessary to provide an ample margin of safety.
The emissions data for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category indicate that no environmental HAP are emitted by sources within this source category and we are unaware of any adverse environmental effects caused by HAP emitted from this source category. Therefore, we do not expect there to be an adverse environmental effect as a result of HAP emissions from this source category and we are proposing that it is not necessary to set a more stringent standard to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by Fabrics and Other Textiles NESHAP. These emission sources include coating and printing, dyeing and finishing, and slashing of fabrics and other textiles. Based on our review, we identified one potential development in technology, a process change that eliminated the use of ethylene oxide at one facility. During a recent site visit to the facility, we learned that the ethylene oxide emissions were, in fact, overstated by the facility. The facility confirmed that it no longer uses the ethylene oxide-containing material due to cost. We note that this was the only facility that reported ethylene oxide emissions, and we conclude that ethylene oxide-containing materials are no longer used in the industry, based on our information. We did not identify any other developments in add-on control technologies, other equipment, or work practices and procedures since the promulgation of the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. A brief summary of the EPA's findings in conducting the technology review of fabric printing, coating, and dyeing operations follows. For a detailed discussion of the EPA's findings, refer to the
The technology basis for coating and printing subcategory operations under the original MACT standards in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP was emission capture and add-on control with an overall control efficiency of 97 percent for existing sources and 98 percent for new or reconstructed sources. During development of that rulemaking, we evaluated the use of alternative coatings (
The technology basis for dyeing and finishing subcategory operations at existing sources and new or reconstructed sources under the original MACT standards in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP was the use of low-HAP materials (
The technology basis for the slashing subcategory operations at existing sources and new or reconstructed sources under original MACT standards in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP was the use of zero organic HAP materials. For these materials, each organic HAP that is not an OSHA-defined carcinogen that is measured to be present at less than one percent by weight is counted as zero. We found that no add-on emission capture and control systems for organic HAP were used by the industry. During development of that rulemaking, we identified no beyond-the-floor technology that could achieve a lower organic HAP content in materials “as purchased” than zero percent HAP (67 FR 46028, July 11, 2002).
Using the RBLC database, we identified seven entries for facilities currently subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. We reviewed the state operating permits for the seven facilities to determine if any are using technologies that exceed MACT. Six of the seven permits included VOC emission limitations issued prior to promulgation of the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. All seven facilities entered in the RBLC database indicated they were meeting their VOC limits using solvent substitution, solvent reformulation, low VOC adhesives, or condensation controls. However, the VOC limits for four facilities were either annual, monthly, or daily VOC emission limits. The remaining limits for three facilities were VOC limits that were at least several times higher than the HAP content limits in 40 CFR part 63, subpart OOOO for the same subcategories. Because none of these limitations were more stringent than the HAP content limits, none of these limitations represented a development in practices, processes, and control technologies for this source category.
Using the EPA's NEI and the ECHO databases, we identified 43 facilities (including the seven facilities mentioned above) that are currently subject to the Printing, Coating, and
For the dyeing and finishing, and slashing subcategories, no facilities are using add-on controls to comply. The technology basis for these subcategories was the use of low-HAP (dyeing and finishing) and non-HAP materials (slashing). We have not identified any other process change or pollution prevention alternatives that could be applied to these two subcategories that would further reduce the emissions from these two subcategories.
Finally, we identified no developments in work practices or procedures for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category. However, we note that the one facility that previously reported ethylene oxide has eliminated its use through a process change, and we solicit comment on whether the agency should ban the use of ethylene oxide in this source category under the technology review. The current Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP requires affected sources using add-on controls as a compliance strategy to develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, all coating operations for which emission limits are established. The current work practice requirements address all of the potential emission sources that are normally located outside of the PTE that is routed to the control device, and no new measures have been identified to further reduce the emissions from these sources.
Based on a finding of no new developments in practices, processes, and control technologies in the technology review for printing, coating, and dyeing operations, we are not proposing to revise the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP emission limit requirements pursuant to CAA section 112(d)(6). For further discussion of the technology review results, refer to the
In the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, we are proposing to require electronic submittal of notifications, semiannual reports, and compliance reports (which include performance test reports). In addition, we are proposing revisions to the SSM provisions of the MACT rule in order to ensure that they are consistent with the Court decision in
Though we are not proposing to change reporting frequency currently in the rule, we are requesting comment on changing the reporting frequency for all reports to EPA from semi-annual to annual due to the potential redundancy of these reporting requirements. We recognize that Title V permits have a statutory requirement for semi-annual reports, which are generally reported to state regulatory agencies. However, we are not certain that changing the report frequency for just the reports submitted to EPA in this NESHAP will result in a reporting and recordkeeping burden reduction. We request comment and supporting information on the burden impact of changing the reporting requirement to annual for the reporting to EPA.
The EPA is proposing that owners and operators of facilities subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP submit electronic copies of initial notifications required in 40 CFR 63.9(b), notifications of compliance status required in 40 CFR 63.9(h), performance test reports, and semiannual reports through the EPA's CDX, using the CEDRI. A description of the EPA's CDX and the EPA's proposed rationale and details on the addition of these electronic reporting requirements for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category is the same as for the Surface Coating of Large Appliances source category as discussed in section IV.A.4.a of this preamble. For further information regarding the electronic data submission process, please refer to the memorandum titled
Regarding submittal of performance test reports via EPA's ERT, as discussed in section IV.A.4.a of this preamble for the Surface Coating of Large Appliances NESHAP, the proposal to submit performance test data electronically to the EPA applies only if the EPA has developed an electronic reporting form for the test method as listed on the EPA's ERT website. For the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP, most of the EPA test methods (including EPA Methods 25 and 25A) listed under 40 CFR part 63, subpart OOOO, are currently supported by the ERT. As discussed in section IV.A.4.a of this preamble, we are proposing that performance test results collected using test methods that are not supported by the ERT as listed on the EPA's ERT website at the time of the test be submitted in PDF using the attachment module of the ERT.
Also, as discussed in section IV.A.4.a of this preamble for the Surface Coating of Large Appliances NESHAP, we are proposing to provide facilities with the ability to seek extensions for submitting electronic reports for circumstances beyond the control of the facility. In proposed 40 CFR 63.4311(f), we address the situation for facilities subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP where an extension may be warranted due to outages of the EPA's CDX or CEDRI, which may prevent access to the system and submittal of the required reports. In proposed 40 CFR 63.4311(g), we address the situation for facilities subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP where an extension may be warranted due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents compliance with the requirement to submit a report electronically as required by this rule.
The EPA is proposing to eliminate the SSM exemption in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. The EPA's proposed rationale for the elimination of the SSM exemption for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category is the same as for the Surface Coating of Large Appliances source category, which is discussed in section IV.A.4.b.1 of this preamble. We are also proposing several revisions to Table 3 to subpart OOOO of 40 CFR part 63 (
In proposing these rule amendments, the EPA has taken into account startup and shutdown periods and, for the same reasons explained in section IV.A.4.b.1 of this preamble for the Surface Coating of Large Appliances source category, has not proposed alternate standards for those periods in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. Although no statutory language compels the EPA to set standards for malfunctions, the EPA has the discretion to do so where feasible, as further discussed in section IV.A.4.b.1 of this preamble for the Surface Coating of Large Appliances source category. It is unlikely that a malfunction of sources in the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category would result in a violation of the standards for those facilities using the compliant material or the emission rate without add-on controls option, since they meet the emission limits without using add-on controls. It also is unlikely that facilities using the add-on control option to meet the emission limits would experience a malfunction that would result in a violation, since compliance with the surface coating emission limits is based on a rolling 12-month compliance period. However, it is not inevitable that a malfunction would result in a violation of the standards for those facilities using add-on controls; therefore, we are considering the need for a work practice for periods of malfunction for these facilities. In fact, the EPA has received information that it is possible that a control device malfunction for sources in the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category could potentially result in an emissions increase and potential violation of the emissions limit. During these periods, it is possible that an immediate line shutdown may not be feasible due to safety concerns, and concerns that an immediate shutdown would result in the unnecessary generation of hazardous wastes. In those cases, it may be appropriate to establish a standard for malfunctions. Given the fact that emissions testing during malfunctions is both economically and technically infeasible, we would anticipate that a separate standard would be in the form of a work practice standard. We are, therefore, soliciting information on industry best practices and the best level of emission control during malfunction events for the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category. We are also soliciting information on the cost savings associated with these practices. In addition, we are soliciting specific supporting data on organic HAP emissions during malfunction events for this category, including the cause of malfunction, the frequency of malfunction, duration of malfunction, and the estimate of organic HAP emitted during each malfunction. We also are asking specifically for comment on the use of CEMS by facilities in this source category as a method to better quantify organic HAP emissions during malfunctions and normal operation.
In the unlikely event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA would determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. Refer to section IV.A.4.b.1 of this preamble for further discussion of the EPA's actions in response to a source failing to comply with the applicable CAA section 112(d) standards as a result of a malfunction
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.6(e)(1)(i) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(i) describes the general duty to minimize emissions. Some of the language in that section is no longer necessary or appropriate in light of the elimination of the SSM exemption. We are proposing instead to add general duty regulatory text at 40 CFR 63.4300(b) that reflects the general duty to minimize emissions while eliminating the reference to periods covered by an SSM exemption. The current language in 40 CFR 63.6(e)(1)(i) characterizes what the general duty entails during periods of SSM. With the elimination of the SSM exemption, there is no need to differentiate between normal operations, startup and shutdown, and malfunction events in describing the general duty. Therefore, the language the EPA is proposing for 40 CFR 63.4300(b) does not include that language from 40 CFR 63.6(e)(1).
We are also proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.6(e)(1)(ii) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(ii) imposes requirements that are not necessary with the elimination of the SSM exemption or are redundant with the general duty requirement being added at 40 CFR 63.4300(b).
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.6(e)(3) by changing the “yes” in column 3 to a “no.” Generally, these paragraphs require development of an SSM plan and specify SSM recordkeeping and reporting requirements related to the SSM plan. We are also proposing to remove from 40 CFR part 63, subpart OOOO, the current provisions requiring the SSM plan in 40 CFR 63.4300(c) and requiring reporting related to the SSM plan in 40 CFR 63.4310(c)(9)(iv). As noted, the EPA is proposing to remove the SSM exemptions. Therefore, affected units will be subject to an emission standard during such events. The applicability of a standard during such events will ensure that sources have ample incentive to plan for and achieve compliance, and, thus, the SSM plan requirements are no longer necessary.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.6(f)(1) by changing the “yes” in column 3 to a “no.” The current language of 40 CFR 63.6(f)(1) exempts sources from non-opacity standards during periods of SSM. As discussed above, the Court in
We are also proposing to remove rule text in 40 CFR 63.4341(e)(4) and (f)(4) and 40 CFR 63.4351(d)(4) clarifying that, in calculating emissions to demonstrate compliance, deviation periods must include deviations during an SSM period. Since the EPA is removing the SSM exemption, this clarifying text is no longer needed.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.7(e)(1) by changing the “yes” in column 3 to a “no.” Section 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to add a performance testing requirement at 40 CFR 63.4360. The performance testing requirements we are proposing to add differ from the General Provisions performance testing provisions in several respects. The regulatory text does not include the language in 40 CFR 63.7(e)(1) that restated the SSM exemption and language that precluded startup and shutdown periods from being considered “representative” for purposes of performance testing. Also, the proposed performance testing provisions will not allow performance testing during startup or shutdown. As in 40 CFR 63.7(e)(1), performance tests conducted under this subpart should not be conducted during malfunctions because conditions during malfunctions are often not representative of normal operating conditions. Section 63.7(e) requires that the owner or operator maintain records of the process information necessary to document operating conditions during the test and include in such records an explanation to support that such conditions represent normal operation. The EPA is proposing to add language clarifying that the owner or operator must make such records available to the Administrator upon request.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.8(c)(1)(i) and (iii) by changing the “yes” in column 3 to a “no.” The cross-references to the general duty and SSM plan requirements in those subparagraphs are not necessary in light of other requirements of 40 CFR 63.8 that require good air pollution control practices (40 CFR 63.8(c)(1)) and that set out the requirements of a quality control program for monitoring equipment (40 CFR 63.8(d)). Further, we are proposing to revise the General Provisions table to subpart NNNN (table 3) entry for 40 CFR 63.8(c)(1)(ii) by changing the “yes” in column 3 to a “no.” We have determined that 40 CFR 63.8(c)(1)(ii) is redundant to the current monitoring requirement in 40 CFR 63.4364(a)(6) (
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(b)(2)(i) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(i) describes the recordkeeping requirements during startup and shutdown. These recording provisions are no longer necessary because the EPA is proposing that recordkeeping and reporting applicable to normal operations will apply to startup and shutdown. In the absence of special provisions applicable to startup and shutdown, such as a startup and shutdown plan, there is no reason to retain additional recordkeeping for startup and shutdown periods.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(b)(2)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(ii) describes the recordkeeping requirements during a malfunction, requiring a record of “the occurrence and duration of each malfunction.” A similar record is already required in 40 CFR 63.4312(i), which requires a record of “the date, time, and duration of each deviation,”
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(b)(2)(iv) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events when actions were inconsistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required. The requirement previously applicable under 40 CFR 63.10(b)(2)(iv)(B) to record actions to minimize emissions and record corrective actions is now applicable by reference to 40 CFR 63.4312(i)(5).
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(b)(2)(v) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events to show that actions taken were consistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(c)(15) by changing the “yes” in column 3 to a “no.” The EPA is proposing that 40 CFR 63.10(c)(15) no longer apply. When applicable, the provision allows an owner or operator to use the affected source's SSM plan or records kept to satisfy the recordkeeping requirements of the SSM plan, specified in 40 CFR 63.6(e), to also satisfy the requirements of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate this requirement because SSM plans would no longer be required, and, therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for affected units.
We are proposing to remove the requirement in 40 CFR 63.4312(j)(1) that deviation records specify whether deviations from a standard occurred during a period of SSM. This revision is being proposed due to the proposed removal of the SSM exemption and because, as discussed above in this section, we are proposing that deviation records must specify the cause of each deviation, which could include a malfunction period as a cause. We are also proposing to remove the requirement to report the SSM records in 40 CFR 63.6(e)(3)(iii) through (v) by deleting 40 CFR 63.4312(j)(2).
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(d)(5) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5) describes the reporting requirements for startups, shutdowns, and malfunctions. To replace the General Provisions reporting requirement, the EPA is proposing to add reporting requirements to 40 CFR 63.4311. The replacement language differs from the General Provisions requirement in that it eliminates periodic SSM reports as a stand-alone report. We are proposing language that requires sources that fail to meet an applicable standard at any time to report the information concerning such events in the semi-annual compliance report already required under this rule. Subpart OOOO currently requires reporting of the date, time period, and cause of each deviation. We are clarifying in the rule that, if the cause of a deviation from a standard is unknown, this should be specified in the report. We are also proposing to change “date and time period” or “date and time” to “date, time, and duration” (see proposed revisions to 40 CFR 63.4311(a)(7)(vii), (a)(7)(ix), and (a)(7)(xiv)) to use terminology consistent with the recordkeeping section. Further, we are proposing that the report must also contain the number of deviations from the standard and a list of the affected sources or equipment. For deviation reports addressing deviations from an applicable emission limit in Table 1 to subpart OOOO or operating limit in Table 2 to subpart OOOO, we are proposing that the report also include an estimate of the quantity of each regulated pollutant emitted over any emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions. For deviation reports addressing deviations from work practice standards associated with the emission rate with add-on controls option (see proposed revisions to 40 CFR 63.4311(a)(7)(xiv)), we are retaining the current requirement (including reporting actions taken to correct the deviation), except that we are revising the rule language to reference the new general duty requirement in 40 CFR 63.4200(b), we are clarifying that the description of the deviation must include a list of the affected sources or equipment and the cause of the deviation, we are clarifying that “time period” includes the “time and duration,” and we are requiring that the report include the number of deviations from the work practice standards in the reporting period.
Regarding the proposed new requirement discussed above to estimate the quantity of each regulated pollutant emitted over any emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions, examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters (
We will no longer require owners or operators to determine whether actions taken to correct a malfunction are consistent with an SSM plan, because plans would no longer be required. The proposed amendments, therefore, eliminate 40 63.4311(c) that requires reporting of whether the source deviated from its SSM plan, including required actions to communicate with the Administrator, and the cross reference to 40 CFR 63.10(d)(5)(i) that contains the description of the previously required SSM report format and submittal schedule from this section. These specifications are no longer necessary because the events will be reported in otherwise required reports with similar format and submittal requirements.
We are proposing to revise the General Provisions table to subpart OOOO (table 3) entry for 40 CFR 63.10(d)(5)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5)(ii) describes an immediate report for startups, shutdown, and malfunctions when a source failed to meet an applicable standard, but did not follow the SSM plan. We will no longer require owners and operators to report when actions taken during a startup, shutdown, or malfunction were not consistent with an SSM plan, because plans would no longer be required.
We are proposing to remove the requirements in 40 CFR 63.4311(a)(7)(ix) that deviation reports must specify whether a deviation from an operating limit occurred during a period of SSM. We are also proposing to remove the requirements in 40 CFR 63.4311(a)(7)(xi) to break down the total duration of deviations into the startup and shutdown categories. As discussed above in this section, we are proposing to require reporting of the cause of each deviation. Further, the startup and shutdown categories no longer apply because these periods are proposed to be considered normal operation, as discussed in section IV.A.4.b.1 of this preamble for the Surface Coating of Large Appliances source category, which also applies to this source category.
We propose to amend 40 CFR 63.4331, Equation 7; 40 CFR 63.4350(a)(3) and (b)(3); and 40 CFR 63.4351(a) and (e) to correct the references to the alternative control device outlet organic HAP concentration limit from 20 parts per million by weight (ppmw) to 20 ppmv. The reference to ppmw was incorrect and inconsistent with the rest of the NESHAP.
We propose to amend 40 CFR 63.4362(b) to add the option of conducting EPA Method 18 of appendix A to 40 CFR part 60 “Measurement of Gaseous Organic Compound Emissions by Gas Chromatography” to measure and then subtract methane emissions from measured total gaseous organic mass emissions as carbon. Facilities using the emission rate with add-on control compliance option can use either EPA Method 25 or Method 25A to measure control device destruction efficiency. Unlike EPA Method 25, Method 25A does not exclude methane from the measurement of organic emissions. Because exhaust streams from coating operations may contain methane from natural gas combustion, we are proposing to allow facilities the option to measure methane using Method 18 and to subtract the methane from the emissions as part of their compliance calculations. We also propose to revise the format of references to test methods in 40 CFR part 60. The current reference in 40 CFR 63.4362(a) and (b) to Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 25, and 25A specify that each method is in “appendix A” of part 60. Appendix A of part 60 has been divided into appendices A-1 through A-8. We propose to revise each reference to appendix A to indicate which of the eight sections of appendix A applies to the method.
EPA is proposing to amend 40 CFR 63.4321(e)(1)(i)(A) and (e)(1)(iv), which describe how to demonstrate initial compliance with the emission limitations using the compliant material option, to remove reference to paragraph (d)(4) of OSHA's Hazard Communication standard, which dealt with OSHA-defined carcinogens. EPA is proposing to replace that reference with its own list of hazardous air pollutants that must be regarded as potentially carcinogenic based on EPA guidelines. Although paragraph (d)(4) of OSHA's standard was deleted when the Agency adopted the Globally Harmonized System of Hazard Communication in 2012, it was replaced by section A.6.4.2 of mandatory Appendix A of that standard, which reads as follows:
“Where OSHA has included cancer as a health hazard to be considered by classifiers for a chemical covered by 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, chemical manufacturers, importers, and employers shall classify the chemical as a carcinogen.” Thus, where OSHA has regulated workplace exposure to a chemical based, at least in part, on carcinogenic risk, OSHA requires the chemical to be classified as a carcinogen. OSHA suggests that EPA should refer to section A.6.4.2 of Appendix A of 29 CFR 1910.1200 in its discussion of section 63.4141 and consider chemicals that meet this requirement be considered “OSHA-defined carcinogens.”
We also propose to remove the same reference in the definition of “No organic HAP” in 40 CFR 63.4371. We propose to replace these references to OSHA-defined carcinogens at 29 CFR 1910.1200(d)(4) with a list (in proposed new Table 6 to subpart OOOO) of those organic HAP that must be included in calculating total organic HAP content of a coating material if they are present at 0.1 percent or greater by mass.
We propose to include organic HAP in proposed Table 6 to subpart OOOO if they were categorized in the EPA's
We propose to revise the monitoring provisions for thermal and catalytic oxidizers to clarify that a thermocouple is part of the temperature indicator referred to in 40 CFR 63.4364(c) for purposes of performing periodic calibration and verification checks.
Current 40 CFR 63.4931(a) allows records, “where appropriate,” to be maintained as “electronic spreadsheets” or a “data base.” We propose to add clarification to this provision that the allowance to retain electronic records applies to all records that were submitted as reports electronically via the EPA's CEDRI. We also propose to add text to the same provision clarifying that this ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a
We propose to revise a reporting requirement in 40 CFR 63.4342(f) to harmonize the requirement with the same reporting requirement in 40 CFR 63.4311(a)(4). Section 40 CFR 63.4342(f) requires “If there were no deviations from the applicable emission limit in Table 1 to this subpart,” then the source (
We propose to revise one instance in 40 CFR 63.4311(a)(7)(i)(B) and one instance in 40 CFR 63.4311(a)(7)(ii)(B) that reference an equation that is missing. Each of these provisions specifies that “Equations 4, 4A, 5, and 7 of § 63.4331” must be used to calculate the organic HAP emission rate for dyeing/finishing operations; however, Equation 6 of § 63.4331 should also be used, together with Equations 4, 4A, 5, and 7 of § 63.4331. We propose to add “6” to the list of equations cited in 40 CFR 63.4311(a)(7)(i)(B) and 63.4311(a)(7)(ii)(B), so that the citation reads “Equations 4, 4A, 5, 6, and 7 of § 63.4331.” We propose to revise one instance in 40 CFR 63.4340(b)(3) in which an erroneous rule citation “§ 63.4561” is specified. Section 63.4561 does not exist in 40 CFR part 63, subpart OOOO, and 40 CFR 63.4341 is the correct citation, providing the calculations for demonstrating initial compliance, referred to in association with the erroneous rule citation. We propose to change the erroneous citation to “§ 63.4341.” We propose to revise one instance in Table 3 to Subpart OOOO of Part 63 of an erroneous rule reference to “sections 63.4342 and 63.4352.” This rule citation is specified in the fourth column of the table entry for “§ 63.8(g)(1)-(5),” as the source for the requirements related to reducing monitoring data. Sections 40 CFR 63.4342 and 63.4352 do not provide requirements related to data reduction; however, 40 CFR 63.4363 and 63.4364 do provide these requirements and should be the correct citation. We propose to change the erroneous citation to “Sections 63.4363 and 63.4364.”
As part of an ongoing effort to improve compliance with various federal air emission regulations, the EPA reviewed the compliance demonstration requirements in the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP. Currently, if a source owner or operator chooses to comply with the standards using add-on controls, the results of an initial performance test are used to determine compliance; however, the rule does not require on-going periodic performance testing for these emission capture systems and add-on controls.
As described more fully in section IV.A.4.d of this preamble for the Surface Coating of Large Appliances source category, the ICAC, in their comments on proposed revisions to the NESHAP General Provisions (72 FR 69, January 3, 2007), commented that ongoing maintenance and checks of control devices are necessary in order to ensure emissions control technology, including both thermal and catalytic oxidizers, remains effective.
Given these comments from ICAC, suppliers of air pollution control and monitoring technology, on the need for vigilance in maintaining equipment to stem degradation, the EPA is requesting comment on what steps, in addition to one-time initial emissions and capture efficiency testing, along with ongoing temperature measurement, might better ensure ongoing compliance with the standards.
EPA specifically requests comment on whether air performance testing should be required anytime a source plans to undertake an operational change that may adversely affect compliance with an applicable standard, operating limit, or parametric monitoring value. This requirement would include provisions to allow a source to make the change, but limit the change to a specific time before a test is required. We anticipate that a reasonable time limit under the new operations change would be approximately 30 days to allow adequate time for testing and developing a test report. The source would submit temperature and flow rate data during the test to establish new operating parameters. We are specifically requesting comment on this potential provision, including the time a source is allowed to operate under the new parameters before they test, and what would constitute an operational change requiring testing.
This approach would require air emissions testing to measure organic HAP destruction or removal efficiency at the inlet and outlet of the add-on control device, or measurement of the control device outlet concentration of organic HAP. Emissions would be measured as total gaseous organic mass emissions as carbon using either Method 25 or 25A of appendix A-7 to 40 CFR part 60, which are the methods currently required for the initial compliance demonstration.
We estimate that the cost to perform a control device emissions destruction or removal efficiency test using EPA Method 25 or 25A would be approximately $19,000 per control device. The cost estimate is included in the memorandum titled
The EPA is proposing that affected sources that commenced construction or reconstruction on or before September 12, 2018 must comply with all of the amendments, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than 181 days after the effective date of the final rule. Affected sources that commence construction or reconstruction after September 12, 2018 must comply with all requirements of the subpart, including the amendments being proposed, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than the effective date of the final rule or upon startup, whichever is later. All affected facilities would have to continue to meet the current requirements of 40 CFR
For existing sources, we are proposing two changes that would impact ongoing compliance requirements for 40 CFR part 63, subpart OOOO. As discussed elsewhere in this preamble, we are proposing to add a requirement that notifications, performance test results, and semiannual compliance reports be submitted electronically using the new template. We are also proposing to change the requirements for SSM by removing the exemption from the requirements to meet the standard during SSM periods and by removing the requirement to develop and implement an SSM plan. Our experience with similar industries that are required to convert reporting mechanisms to install necessary hardware and software, become familiar with the process of submitting performance test results electronically through the EPA's CEDRI, test these new electronic submission capabilities, and reliably employ electronic reporting shows that a time period of a minimum of 90 days, and, more typically, 180 days is generally necessary to successfully accomplish these revisions. Our experience with similar industries further shows that this sort of regulated facility generally requires a time period of 180 days to read and understand the amended rule requirements; to evaluate their operations to ensure that they can meet the standards during periods of startup and shutdown as defined in the rule and make any necessary adjustments; and to update their operation, maintenance, and monitoring plan to reflect the revised requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. From our assessment of the timeframe needed for compliance with the entirety of the revised requirements, the EPA considers a period of 180 days to be the most expeditious compliance period practicable and, thus, is proposing that all affected sources that commenced construction or reconstruction on or before September 12, 2018 be in compliance with all of this regulation's revised requirements within 181 days of the regulation's effective date.
We solicit comment on the proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance dates.
As described in section III of this preamble, for the Surface Coating of Metal Furniture source category, we conducted a risk assessment for all HAP emitted. We present results of the risk assessment briefly below and in more detail in the
Table 5 of this preamble provides a summary of the results of the inhalation risk assessment for the source category. As discussed in section III.C.2 of this preamble, we set MACT-allowable HAP emission levels at metal furniture coating facilities equal to 1.8 times actual emissions. For more detail about the MACT-allowable emission levels, see Appendix 1 to the
The results of the inhalation risk modeling using actual emissions data, as shown in Table 5 of this preamble, indicate that the maximum individual cancer risk based on actual emissions (lifetime) could be up to 7-in-1 million, the maximum chronic noncancer TOSHI value based on actual emissions could be up to 0.2, and the maximum screening acute noncancer HQ value (off-facility site) could be up to 2. The total estimated annual cancer incidence (national) from these facilities based on actual emission levels is 0.0004 excess cancer cases per year or one case in every 2,500 years.
Table 5 of this preamble shows the acute risk results for the Surface Coating of Metal Furniture source category. The screening analysis for acute impacts was based on an industry specific multiplier of 1.8, to estimate the peak emission rates from the average rates. For more detailed acute risk results refer to the
We did not identify any PB-HAP emitted by facilities in this source category. Therefore, we do not expect any human health multipathway risks as a result of emissions from this source category.
The emissions data for the Surface Coating of Metal Furniture source category indicate that no environmental HAP are emitted by sources within this source category. Therefore, we did not conduct a screening-level evaluation of the potential adverse environmental risks associated with emissions for the Surface Coating of Metal Furniture source category. We do not expect an adverse environmental effect as a result
Four facilities have a facility-wide cancer MIR greater than or equal to 1-in-1 million. The maximum facility-wide cancer MIR is 7-in-1 million, driven by ethyl benzene. The total estimated cancer incidence from the whole facility is 0.0005 excess cancer cases per year, or one excess case in every 2,000 years. Approximately 2,200 people were estimated to have cancer risks above 1-in-1 million from exposure to HAP emitted from both MACT and non-MACT sources of the 16 facilities in this source category. The maximum facility-wide TOSHI for the source category is estimated to be 0.1.
To examine the potential for any environmental justice issues that might be associated with the source category, we performed a demographic analysis, which is an assessment of risks to individual demographic groups of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risks from the Surface Coating of Metal Furniture source category across different demographic groups within the populations living near facilities.
The results of the demographic analysis are summarized in Table 6 below. These results, for various demographic groups, are based on the estimated risks from actual emissions levels for the population living within 50 km of the facilities.
The results of the Surface Coating of Metal Furniture source category demographic analysis indicate that emissions from the source category expose approximately 2,100 people to a cancer risk at or above 1-in-1 million and no one to a chronic noncancer HI greater than 1. The percentages of the at-risk population in the following specific demographic groups are higher than their respective nationwide percentages: “Hispanic or Latino,” “Over 25 Without a HS Diploma,” and “Below the Poverty Level.”
The methodology and the results of the demographic analysis are presented in a technical report,
As noted in section III.A of this preamble, we weigh all health risk factors in our risk acceptability determination, including the cancer MIR, the number of persons in various cancer and noncancer risk ranges, cancer incidence, the maximum noncancer TOSHI, the maximum acute noncancer HQ, the extent of noncancer risks, the distribution of cancer and noncancer risks in the exposed population, and risk estimation uncertainties (54 FR 38044, September 14, 1989).
For the Surface Coating of Metal Furniture source category, the risk analysis indicates that the cancer risks to the individual most exposed could be up to 7-in-1 million due to actual emissions and up to 10-in-1 million based on allowable emissions. These risks are considerably less than 100-in-1 million, which is the presumptive upper limit of acceptable risk. The risk analysis also shows very low cancer incidence (0.0004 cases per year for actual emissions, or one case in every
Considering all of the health risk information and factors discussed above, including the uncertainties discussed in section III.C.7 of this preamble, we propose to find that the risks from the Surface Coating of Metal Furniture source category are acceptable.
Although we are proposing that the risks from the Surface Coating of Metal Furniture source category are acceptable, risk estimates for approximately 2,100 individuals in the exposed population are above 1-in-1 million at the actual emissions level and 4,200 individuals in the exposed population are above 1-in-1 million at the allowable emissions level. Consequently, we further considered whether the MACT standards for the Surface Coating of Metal Furniture source category provide an ample margin of safety to protect public health. In this ample margin of safety analysis, we investigated available emissions control options that might further reduce the risk from the source category. This information was considered along with our determination of the health risks acceptability.
As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Metal Furniture source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Metal Furniture NESHAP.
The only development identified in the technology review is the use of high-efficiency spray equipment. We estimated no costs or emissions reductions that would be achieved by switching to high efficiency application methods for this source category because we expect that metal furniture surface coating facilities are already using high efficiency coating application methods due to state VOC rules and the economic incentives of using more efficient application methods. As discussed below, however, we are proposing to require this technology under the technology review. We request comment on this proposed requirement and whether any facilities in this source category do not currently use high efficiency coating application methods.
Based on our review, we did not identify any developments in add-on control technologies, other equipment, or work practices and procedures that would reduce HAP from the industry. Therefore, we are proposing that additional emissions controls for this source category are not necessary to provide an ample margin of safety.
The emissions data for the Surface Coating of Metal Furniture source category indicate that no environmental HAP are emitted by sources within this source category and we are unaware of any adverse environmental effects caused by HAP emitted from this source category. Therefore, we do not expect there to be an adverse environmental effect as a result of HAP emissions from this source category and we are proposing that it is not necessary to set a more stringent standard to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
As described in section III.B of this preamble, our technology review focused on identifying developments in practices, processes, and control technologies for the Surface Coating of Metal Furniture source category, and the EPA reviewed various information sources regarding emission sources that are currently regulated by the Surface Coating of Metal Furniture NESHAP. These emission sources include coating mixing; coating application; coating curing; conveying coatings, thinners and cleaning materials; and waste storage and handling. Based on our review, we identified, as outlined below, one development in technology, the application of high-efficiency spray equipment, for the Surface Coating of Metal Furniture source category. A brief summary of the EPA's findings in conducting the technology review of metal furniture surface coating operations follows. For a detailed discussion of the EPA's findings, refer to the
The technology basis for the original MACT standards for existing sources under the Surface Coating of Metal Furniture NESHAP was a combination of low-HAP liquid (high-solids and waterborne) coatings and cleaning solvents, and powder coatings. During development of that rulemaking, we found that add-on capture and control systems for organic HAP were rarely used by the industry at that time; of the 22 existing sources that were the basis of the MACT analysis, only one source was identified as using an add-on control (a carbon adsorber/oxidizer system).
Using the RBLC database, we identified entries for two facilities currently subject to the Surface Coating of Metal Furniture NESHAP. We reviewed the state operating permits for the two facilities in the RBLC database, and for all other facilities known to be subject to 40 CFR part 63, subpart RRRR to determine if any are using technologies that exceed MACT or that were not considered during the development of the original NESHAP. None of these facilities are using add-on controls to comply with the Surface Coating of Metal Furniture NESHAP, and none of these facilities are using any other technology that exceeds MACT or that was not considered during the development of the original NESHAP.
We have also found no information that any improvements in PTE and add-on control technology have occurred that would affect the cost effectiveness of a PTE and add-on control or result in additional emission reductions. We have not identified any changes that would increase the efficiency of these controls or reduce their cost. Therefore, the EPA does not consider the use of a PTE and add-on control to be a
We have not identified any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original Metal Furniture MACT standard. We reviewed other sources for information on recent trends in coating technology in the metal furniture industry. The
The technology review conducted for the Wood Furniture Manufacturing Operations NESHAP (40 CFR part 63, subpart JJ) identified the use of more efficient spray equipment as a development in process equipment, and adopted regulations preventing the use of conventional air-atomized spray guns. The Wood Furniture Manufacturing MACT identified the use of air-assisted airless spraying as a more efficient coating application technology.
The Surface Coating of Metal Furniture NESHAP does not contain any standards specifying the type of spray equipment that must be used when coatings are spray-applied. Several other surface coating NESHAP specify that high efficiency spray guns must be used for spray applied coatings (
Based on these findings, we are proposing to revise the Surface Coating of Metal Furniture NESHAP for coating application operations pursuant to CAA section 112(d)(6) to require that, for each coating operation for which coatings are spray applied, high efficiency spray equipment must be used if the source is not using the emission rate with add-on control compliance option. Specifically, all spray-applied coating operations, where the source is not using the emission rate with add-on control compliance option, must be demonstrated to achieve transfer efficiency equivalent to or better than 65 percent. There are four types of high efficiency spray equipment technologies that have been applied in these applications that could achieve the transfer efficiency equivalent to or better than 65 percent including high volume, low pressure (HVLP) spray equipment, electrostatic application, airless spray equipment, and air assisted airless spray equipment. Alternative spray equipment technologies may also be used with documentation demonstrating at least 65 percent transfer efficiency. Spray application equipment sources not using the emission rate with add-on control compliance option, and/or using alternative spray application equipment technologies other than the four listed, must follow procedures in the California South Coast Air Quality Management District's, “Spray Equipment Transfer Efficiency Test Procedure for Equipment User, May 24, 1989” to demonstrate that their spray application equipment is capable of achieving transfer efficiency equivalent to, or better than, 65 percent. Equivalency documentation may be certified by manufacturers of the spray equipment, on behalf of spray-applied coating operations sources, by following the aforementioned procedure in conjunction with California South Coast Air Quality Management District's “Guidelines for Demonstrating Equivalency with District Approved Transfer Efficient Spray Guns, September 26, 2002.” When using these equivalency procedures and/or guidelines, facilities would not be required to submit an application with
Considering just the incremental cost of the high efficiency spray equipment and savings due to using less material consumption, we expect that all facilities have already switched to high efficiency application methods for the reasons discussed in the technology review section for surface coating of large appliances. We have not estimated the emissions reductions achieved by switching to high efficiency application methods for this source category because we expect that all large appliance surface coating facilities are using high efficiency coating application methods. However, if any facilities switch to high efficiency application equipment, there would likely be emission reductions of the same magnitude as would occur in the large appliance surface coating source category. For more information on the cost of spray gun equipment and potential HAP emission reductions, see the memorandum titled
Finally, we identified no developments in work practices or procedures for the Surface Coating of Metal Furniture source category, including work practices and procedures that are currently prescribed in the NESHAP. The current Surface Coating of Metal Furniture NESHAP standards require that, if a facility uses add-on controls to comply with the emission limitations (and currently no facilities do this), the facility must develop and implement a work practice plan to minimize organic HAP emissions from the storage, mixing, and conveying of coatings, thinners, and cleaning materials used in, and waste materials generated by, all coating operations for which emission limits are established. The current work practice requirements address all the potential emission sources that are normally located outside of the PTE that is routed to the control device, and no new measures have been identified to further reduce the emissions from these sources.
Refer to section IV.C.5 of this preamble for a discussion of the compliance schedule for using high efficiency spray equipment. For further discussion of the technology review results, refer to the
We are proposing to require electronic submittal of notifications, semiannual reports, and compliance reports (which include performance test reports). In addition, we are proposing revisions to the SSM provisions of the MACT rule in order to ensure that they are consistent with the Court decision in
Though we are not proposing to change reporting frequency currently in the rule, we are requesting comment on changing the reporting frequency for all reports to EPA from semi-annual to annual due to the potential redundancy of these reporting requirements. We recognize that Title V permits have a statutory requirement for semi-annual reports, which are generally reported to state regulatory agencies. However, we are not certain that changing the report frequency for just the reports submitted to EPA in this NESHAP will result in a reporting and recordkeeping burden reduction. We request comment and supporting information on the burden impact of changing the reporting requirement to annual for the reporting to EPA.
The EPA is proposing that owners and operators of facilities subject to the Surface Coating of Metal Furniture NESHAP submit electronic copies of initial notifications required in 40 CFR 63.9(b), notifications of compliance status required in 40 CFR 63.9(h), performance test reports, and semiannual reports through the EPA's CDX, using the CEDRI. A description of the EPA's CDX and the EPA's proposed rationale and details on the addition of these electronic reporting requirements for the Surface Coating of Metal Furniture source category is the same as for the Surface Coating of Large Appliances source category, which is discussed above in section IV.A.4.a of this preamble. For further information regarding the electronic data submission process, please refer to the memorandum titled
Regarding submittal of performance test reports via the EPA's ERT, as discussed in section IV.A.4.a of this preamble for the Surface Coating of Large Appliances NESHAP, the proposal to submit performance test data electronically to the EPA applies only if the EPA has developed an electronic reporting form for the test method as listed on the EPA's ERT website. For the Surface Coating of Metal Furniture NESHAP, most of the current EPA test methods listed under 40 CFR part 63, subpart RRRR, are currently supported by the ERT, including EPA Methods 25 and 25A. EPA Method 18, which is proposed for measuring and subtracting methane from total organic compounds as measured by current EPA Method 25 or 25A, is not supported by ERT. As discussed in section IV.A.4.a of this preamble, we are proposing that performance test results collected using test methods that are not supported by the ERT as listed on the EPA's ERT website at the time of the test be submitted in PDF using the attachment module of the ERT.
Also, as discussed in section IV.A.4.a of this preamble for the Surface Coating of Large Appliances NESHAP, we are proposing to provide facilities with the ability to seek extensions for submitting electronic reports for circumstances beyond the control of the facility. In proposed 40 CFR 63.4921(d), we address the situation for facilities subject to the Surface Coating of Metal Furniture NESHAP where an extension may be warranted due to outages of the EPA's CDX or CEDRI which may prevent access to the system and submittal of the required reports. In 40 CFR 63.4921(e), we address the situation for facilities subject to the Surface Coating of Metal Furniture NESHAP where an extension may be warranted due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents compliance with the requirement to submit a report electronically as required by this rule.
The EPA is proposing to eliminate the SSM exemption in the Surface Coating of Metal Furniture NESHAP. The EPA's proposed rationale for the elimination of the SSM exemption for the Surface Coating of Metal Furniture source category is the same as for the Surface Coating of Large Appliances source category, which is discussed in section IV.A.4.b.1 of this preamble. We are also proposing several revisions to Table 2 to subpart RRRR of 40 CFR part 63 (
In proposing these rule amendments, the EPA has taken into account startup and shutdown periods and, for the same reasons explained in section IV.A.4.b.1 of this preamble for the Surface Coating of Large Appliances source category, has not proposed alternate standards for those periods in the Surface Coating of Metal Furniture NESHAP. Although no statutory language compels the EPA to set standards for malfunctions, the EPA has the discretion to do so where feasible, as further discussed in section IV.A.4.b.1 of this preamble for the Surface Coating of Large Appliances source category. Further, it is unlikely that a malfunction of sources in the Surface Coating of Metal Furniture source category would result in a violation of the standards. Because a malfunction of the coating operation would lead to defective products, it would most likely be corrected by the owner/operator as quickly as possible to minimize economic losses. Furthermore, a malfunction would not lead to an increase in the HAP content of the coatings or the amount of HAP emitted from those coatings; therefore, it is unlikely that malfunctions at facilities using the compliant material or emission rate without control option would result in a violation. Finally, compliance with the surface coating emission limits is based on a monthly compliance period, so any malfunction that causes a short-term increase in emissions may not cause a violation of the standard. We have no information to suggest that it is feasible or necessary to establish any type of standard for malfunctions associated with the Surface Coating of Metal Furniture source category. We encourage commenters to provide any such information, if available.
In the unlikely event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA would determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. Refer to section IV.A.4.b.1 of this preamble for further discussion of the EPA's actions in response to a source failing to comply with the applicable CAA section 112(d) standards as a result of a malfunction event for the Surface Coating of Large Appliances source category, which applies to this source category.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.6(e)(1)(i) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(i) describes the general duty to minimize emissions. Some of the language in that section is no longer necessary or appropriate in light of the elimination of the SSM exemption. We are proposing instead to add general duty regulatory text at 40 CFR 63.4900(b) that reflects the general duty to minimize emissions while eliminating the reference to periods covered by an SSM exemption. The current language in 40 CFR 63.6(e)(1)(i) characterizes what the general duty entails during periods of SSM. With the elimination of the SSM exemption, there is no need to differentiate between normal operations, startup and shutdown, and malfunction events in describing the general duty. Therefore, the language the EPA is proposing for 40 CFR 63.4900(b) does not include that language from 40 CFR 63.6(e)(1).
We are also proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.6(e)(1)(ii) by changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(ii) imposes requirements that are not necessary with the elimination of the SSM exemption or are redundant with the general duty requirement being added at 40 CFR 63.4900(b).
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.6(e)(3) by changing the “yes” in column 3 to a “no.” Generally, these paragraphs require development of an SSM plan and specify SSM recordkeeping and reporting requirements related to the SSM plan. We are also proposing to remove from 40 CFR part 63, subpart RRRR, the current provisions requiring the SSM plan, including 40 CFR 63.4900(c) and 63.4910(c)(9)(v). As noted, the EPA is proposing to remove the SSM exemptions. Therefore, affected units will be subject to an emission standard during such events. The applicability of a standard during such events will ensure that sources have ample incentive to plan for and achieve compliance and thus the SSM plan requirements are no longer necessary.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.6(f)(1) by changing the “yes” in column 3 to a “no.” The current language of 40 CFR 63.6(f)(1) exempts sources from non-opacity standards during periods of SSM. As discussed above, the Court in
We are also proposing to remove rule text in 40 CFR 63.4961(h) clarifying that, in calculating emissions to demonstrate compliance, deviation periods must include deviations during an SSM period. Since the EPA is removing the SSM exemption, this clarifying text is no longer needed.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.7(e)(1) by changing the “yes” in column 3 to a “no.” Section 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to add a performance testing requirement at 40 CFR 63.4963. We are also proposing to remove rule text in 40 CFR 63.4963(a)(1) that states that periods of malfunction do not constitute representative conditions for the purposes of conducting a performance test. The performance testing requirements we are proposing differ from the General Provisions performance testing provisions in several respects. The regulatory text does not include the language in 40 CFR 63.7(e)(1) that restated the SSM exemption and language that precluded startup and shutdown periods from being considered “representative” for purposes of performance testing. Also, the proposed performance testing provisions will not allow performance testing during startup or shutdown. As in 40 CFR 63.7(e)(1), performance tests conducted under this subpart should not be conducted during malfunctions because conditions during malfunctions are often not representative of normal operating conditions. Section 63.7(e) requires that the owner or operator maintain records of the process information necessary to document operating conditions during the test and include in such records an explanation to support that such conditions represent normal operation. The EPA is proposing to add language clarifying that the owner or operator must make such records available to the Administrator upon request.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.8(c)(1)(i) and (iii) by changing the “yes” in column 3 to a “no.” The cross-references to the general duty and SSM plan requirements in those subparagraphs are not necessary in light of other requirements of 40 CFR 63.8 that require good air pollution control practices (40 CFR 63.8(c)(1)) and that set out the requirements of a quality control program for monitoring equipment (40 CFR 63.8(d)). Further, we are proposing to revise the General Provisions table to subpart NNNN (table 2) entry for 40 CFR 63.8(c)(1)(ii) by changing the “yes” in column 3 to a “no.” We have determined that 40 CFR 63.8(c)(1)(ii) is redundant to the current monitoring requirement in 40 CFR 63.4967(a)(4) (
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(b)(2)(i) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(i) describes the recordkeeping requirements during startup and shutdown. These recording provisions are no longer necessary because the EPA is proposing that recordkeeping and reporting applicable to normal operations will apply to startup and shutdown. In the absence of special provisions applicable to startup and shutdown, such as a startup and shutdown plan, there is no reason to retain additional recordkeeping for startup and shutdown periods.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(b)(2)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(ii) describes the recordkeeping requirements during a malfunction, requiring a record of “the occurrence and duration of each malfunction.” A similar record is already required in 40 CFR 63.4930(j), which requires a record of “the date, time, and duration of each deviation,” which the EPA is retaining. The regulatory text in 40 CFR 63.4930(j) differs from the General Provisions in that the General Provisions requires the creation and retention of a record of the occurrence and duration of each malfunction of process, air pollution control, and monitoring equipment; whereas 40 CFR 63.4930(j) applies to any failure to meet an applicable standard and is requiring that the source record the date, time, and duration of the failure rather than the “occurrence.” The EPA is also proposing to add to 40 CFR 63.4930(j) a requirement that sources also keep records that include a list of the affected source or equipment and actions taken to minimize emissions, an estimate of the quantity of each regulated pollutant emitted over the emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions. Examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters (
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(b)(2)(iv) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events when actions were inconsistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required. The requirement previously applicable under 40 CFR 63.10(b)(2)(iv)(B) to record actions to minimize emissions and record corrective actions is now applicable by reference to 40 CFR 63.4930(j)(4).
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(b)(2)(v) by changing the “yes” in column 3 to a “no.” When applicable, the provision requires sources to record actions taken during SSM events to show that actions taken were consistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(c)(15) by changing the “yes” in column 3 to a “no.” The EPA is proposing that 40 CFR 63.10(c)(15) no longer apply. When applicable, the provision allows an owner or operator to use the affected source's SSM plan or records kept to satisfy the recordkeeping requirements of the SSM plan, specified in 40 CFR 63.6(e), to also satisfy the requirements of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate this requirement because SSM plans would no longer be required, and, therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for affected units.
We are proposing to remove the requirement in 40 CFR 63.4930(k)(1) that deviation records specify whether deviations from a standard occurred during a period of SSM. This revision is being proposed due to the proposed removal of the SSM exemption and because, as discussed above in this section, we are proposing that deviation records must specify the cause of each deviation, which could include a malfunction period as a cause. We are also proposing to remove the requirement to report the SSM records in 40 CFR 63.6(e)(3)(iii) through (v) by deleting 40 CFR 63.4930(k)(2).
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(d)(5) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5) describes the reporting requirements for startups, shutdowns, and malfunctions. To replace the General Provisions reporting requirement, the EPA is proposing to add reporting requirements to 40 CFR 63.4920. The replacement language differs from the General Provisions requirement in that it eliminates periodic SSM reports as a stand-alone report. We are proposing language that requires sources that fail to meet an applicable standard at any time to report the information concerning such events in the semi-annual compliance report already required under this rule. Subpart RRRR of 40 CFR subpart 63 currently requires reporting of the date, time period, and cause of each deviation. We are clarifying in the rule that, if the cause of a deviation from the standard is unknown, this should be specified in the report. We are also proposing to change “date and time period” or “date and time” to “date, time, and duration” (see 40 CFR 63.4920(a)(5)(i), (a)(7)(ix), and (a)(7)(xi), (a)(7)(xvi)) to use terminology consistent with the recordkeeping section. Further, we are proposing that the report must also contain the number of deviations from the standard and a list of the affected source or equipment. For deviation reports addressing deviations from an applicable emission limit in 40 CFR 63.4890 or operating limit in Table 1 to subpart RRRR, we are proposing that the report also include an estimate of the quantity of each regulated pollutant emitted over any emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions. For deviation reports addressing deviations from work practice standards associated with the emission rate with add-on controls option (see proposed revisions to 40 CFR 63.4920(a)(7)(xvi)), we are retaining the current requirement (including reporting actions taken to correct the deviation), except that we are revising the rule language to reference the new general duty requirement in 40 CFR 63.4900(b), we are clarifying that the description of the deviation must include a list of the affected sources or equipment and the cause of the deviation, we are clarifying that “time period” includes the “time and duration,” and we are requiring that the report include the number of deviations from the work practice standards in the reporting period. Further, we are proposing to apply these same reporting requirements to deviations from the proposed new equipment standards associated with high efficiency spray equipment (see proposed revisions in 40 CFR 63.4920(a)(5)(ii), (a)(5)(ii)(F), and (a)(5)(ii)(G)).
Regarding the proposed new requirement discussed above to estimate the quantity of each regulated pollutant emitted over any emission limit for which the source failed to meet the standard, and a description of the method used to estimate the emissions, examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters (
We will no longer require owners or operators to determine whether actions taken to correct a malfunction are consistent with an SSM plan, because plans would no longer be required. The proposed amendments, therefore, eliminate 40 CFR 63.4920(c) that requires reporting of whether the source deviated from its SSM plan, including required actions to communicate with the Administrator, and the cross reference to 40 CFR 63.10(d)(5)(i) that contains the description of the previously required SSM report format and submittal schedule from this section. These specifications are no longer necessary because the events will be reported in otherwise required reports with similar format and submittal requirements.
We are proposing to revise the General Provisions table to subpart RRRR (table 2) entry for 40 CFR 63.10(d)(5)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5)(ii) describes an immediate report for startups, shutdown, and malfunctions when a source failed to meet an applicable standard, but did not follow the SSM plan. We will no longer require owners and operators to report when actions taken during a startup, shutdown, or malfunction were not consistent with an SSM plan, because plans would no longer be required.
We are proposing to remove the requirements in 40 CFR 63.4920(a)(7)(xiii) that deviation reports must specify whether a deviation from an operating limit occurred during a period of SSM. We are also proposing to remove the requirements in 40 CFR 63.4920(a)(7)(xi) to break down the total duration of deviations into the startup and shutdown categories. As discussed above in this section, we are proposing to require reporting of the cause of each deviation. Further, the startup and shutdown categories no longer apply because these periods are proposed to be considered normal operation, as discussed in section IV.C.4.b.1 of this preamble for the Surface Coating of Large Appliances source category, which also applies to this source category.
We are proposing to amend 40 CFR 63.4965(b) to add the option of conducting EPA Method 18 of appendix A to 40 CFR part 60, “Measurement of Gaseous Organic Compound Emissions by Gas Chromatography” to measure and then subtract methane emissions from measured total gaseous organic mass emissions as carbon. Facilities using the emission rate with add-on control compliance option can use either EPA Method 25 or Method 25A to measure control device destruction efficiency. Unlike EPA Method 25, Method 25A does not exclude methane from the measurement of organic emissions. Because many exhaust streams from coating operations may contain methane from natural gas combustion, we are proposing to allow facilities the option to measure the methane using Method 18 and to subtract it from the emissions as part of their compliance calculations. We also propose to revise the format of references to test methods in 40 CFR part 60. The current reference in 40 CFR 63.4965(a) and (b) to Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 25, and 25A specify that each method is in “appendix A” of part 60. Appendix A of part 60 has been divided into appendices A-1 through A-8. We propose to revise each reference to appendix A to indicate which of the eight sections of appendix A applies to the method.
EPA is proposing to amend 40 CFR 63.4941(a)(1)(i) and (a)(4), which describe how to demonstrate initial compliance with the emission limitations using the compliant material option, to remove reference to paragraph (d)(4) of OSHA's Hazard Communication standard, which dealt with OSHA-defined carcinogens. EPA is proposing to replace that reference with its own list of hazardous air pollutants that must be regarded as potentially carcinogenic based on EPA guidelines. Although paragraph (d)(4) of OSHA's standard was deleted when the Agency adopted the Globally Harmonized System of Hazard Communication in 2012, it was replaced by section A.6.4.2 of mandatory Appendix A of that standard, which reads as follows:
“Where OSHA has included cancer as a health hazard to be considered by classifiers for a chemical covered by 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, chemical manufacturers, importers, and employers shall classify the chemical as a carcinogen.” Thus, where OSHA has regulated workplace exposure to a chemical based, at least in part, on carcinogenic risk, OSHA requires the chemical to be classified as a carcinogen. OSHA suggests that EPA should refer to section A.6.4.2 of Appendix A of 29 CFR 1910.1200 in its discussion of section 63.4141 and consider chemicals that meet this requirement be considered “OSHA-defined carcinogens.”
We are proposing to replace these references to OSHA-defined carcinogens at 29 CFR 1910.1200(d)(4) with a list (in proposed new Table 5 to 40 CFR part 63, subpart RRRR) of those organic HAP that must be included in calculating total organic HAP content of a coating material if they are present at 0.1 percent or greater by mass.
We are including organic HAP in the proposed Table 5 to 40 CFR part 63, subpart RRRR if they were categorized in the EPA's
We are also proposing to revise the monitoring provisions for thermal and catalytic oxidizers to clarify that a thermocouple is part of the temperature sensor referred to in 40 CFR 63.4967(c)(3) for purposes of performing periodic calibration and verification checks.
Current 40 CFR 63.4931(a) allows records, “where appropriate,” to be maintained as “electronic spreadsheets” or a “data base.” We propose to add clarification to this provision that the allowance to retain electronic records applies to all records that were submitted as reports electronically via the EPA's CEDRI. We also propose to add text to the same provision clarifying that this ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
We propose to revise the second sentence of 40 CFR 63.4920(a)(4) to correct an erroneous reference to “the emission limitations in § 63.4890,” to be “the applicable emission limitations in §§ 63.4890, 63.4892, and 63.4893.” This provision is intended to provide the criteria for all compliance options, for making a statement that there were no deviations in the compliance period. For this provision to apply to the emission rate with add-on control devices option cited later in the sentence in “§ 63.4962(f),” the criteria for making an affirmative statement of no deviations must address all three types of emission limitations (as defined in 40 CFR 63.4981) in 40 CFR 63.4890, 63.4892, and 63.4893. To avoid confusion with the term “emission limitation” as defined in 40 CFR 63.4981, and harmonize the terminology with 40 CFR 63.4890, we also propose to change “emission limitation” in the first sentence of 40 CFR 63.4920(a)(4) to be “emission limit.”
We propose to remove from 40 CFR 63.4951(c) the list of methods that may be used to determine the density of each coating, thinner, and cleaning material, and to retain the reference to 40 CFR 63.4941(c), which provides the same list of methods. This list of methods is being updated in 40 CFR 63.4941(c), including IBR of a new version of a method, and this proposed approach minimizes redundancy in the rule and removes the need to incorporate the revised method into two separate provisions of the subpart.
We propose to revise one instance in Table 2 to Subpart RRRR of Part 63 of an erroneous rule citation of “§ 63.4920(a).” This rule citation is specified in the fourth column of the table entry for “§ 63.10(e)(3),”as the source for the contents of periodic compliance reports. Section 40 CFR 63.4920(a) does not provide the contents of periodic compliance reports; they are provided in 40 CFR 63.4920(b), and we propose to change the erroneous citation to “§ 63.4920(b).”
As part of an ongoing effort to improve compliance with various federal air emission regulations, the EPA reviewed the compliance demonstration requirements in the Surface Coating of Metal Furniture NESHAP. Currently, if a source owner or operator chooses to comply with the standards using add-on controls, the results of an initial performance test are used to determine compliance; however, the rule does not require on-going periodic performance testing for these emission capture systems and add-on controls.
As described more fully in section IV.A.4.d of this preamble for the Surface Coating of Large Appliances source category, the ICAC, in their comments on proposed revisions to the NESHAP General Provisions (72 FR 69, January 3, 2007), commented that ongoing maintenance and checks of control devices are necessary in order to ensure emissions control technology, including both thermal and catalytic oxidizers, remains effective.
Given these comments from ICAC, suppliers of air pollution control and monitoring technology, on the need for vigilance in maintaining equipment to stem degradation, the EPA is requesting comment on what steps, in addition to one-time initial emissions and capture efficiency testing, along with ongoing temperature measurement, might better ensure ongoing compliance with the standards.
One approach on which the EPA is specifically requesting comment, but which is not included in this proposed rule, would be to require air performance testing anytime a source plans to undertake an operational change that may adversely affect compliance with an applicable standard, operating limit, or parametric monitoring value. This requirement would include provisions to allow a source to make the change, but limit the change to a specific time before a test is required. We anticipate that a reasonable time limit under the new operations change would be approximately 30 days to allow adequate time for testing and developing a test report. The source would submit temperature and flow rate data during the test to establish new operating parameters. We are specifically requesting comment on this potential provision, including the time a source is allowed to operate under the new parameters before they test, and what would constitute an operational change requiring testing.
This approach on which we are requesting comment could also allow an exception from periodic testing for facilities using instruments to continuously measure emissions. Such CEMS would show actual emissions. Use of CEMS to demonstrate compliance would obviate the need for periodic oxidizer testing. Moreover, installation and operation of a CEMS with a timesharing component, such that values from more than one oxidizer exhaust could be tabulated in a recurring frequency, could prove less expensive (estimated to have an annual cost below $15,000) than ongoing oxidizer testing.
Of course, this approach on which we are requesting comment would not require periodic testing or CEMS monitoring of facilities using the compliant materials option, or the emission-rate without add-on controls compliance option because these two compliance options do not use any add-on control efficiency measurements in the compliance calculations.
This approach would require air emissions testing to measure organic HAP destruction or removal efficiency at the inlet and outlet of the add-on control device, or measurement of the control device outlet concentration of organic HAP. Emissions would be measured as total gaseous organic mass emissions as carbon using either Method 25 or 25A of appendix A-7 to 40 CFR part 60, which are the methods currently required for the initial compliance demonstration.
We estimate that the cost to perform a control device emissions destruction or removal efficiency test using EPA Method 25 or 25A would be approximately $19,000 per control device. The cost estimate is included in the memorandum titled
The EPA is proposing that affected sources that commenced construction or reconstruction on or before September 12, 2018 must comply with all of the amendments, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than 181 days after the effective date of the final rule. Affected sources that commence construction or reconstruction after September 12, 2018 must comply with all requirements of the subpart, including the amendments being proposed, with the exception of the proposed electronic format for submitting notifications and semiannual compliance reports, no later than the effective date of the final rule or upon startup, whichever is later. All affected facilities would have to continue to meet the current requirements of 40 CFR part 63, subpart RRRR until the applicable compliance date of the amended rule. The final action is not expected to be a “major rule” as defined by 5 U.S.C. 804(2), so the effective date of the final rule will be the promulgation date as specified in CAA section 112(d)(10).
For existing sources, we are proposing two changes that would impact ongoing compliance requirements for 40 CFR part 63, subpart RRRR. As discussed elsewhere in this preamble, we are proposing to add a requirement that notifications, performance test results, and semiannual compliance reports be submitted electronically using the new template. We are also proposing to change the requirements for SSM by removing the exemption from the requirements to meet the standard during SSM periods and by removing the requirement to develop and implement an SSM plan. Our experience with similar industries that are required to convert reporting mechanisms to install necessary hardware and software, become familiar with the process of submitting performance test results electronically through the EPA's CEDRI, test these new electronic submission capabilities, and reliably employ electronic reporting shows that a time period of a minimum of 90 days, and, more typically, 180 days is generally necessary to successfully accomplish these revisions. Our experience with similar industries further shows that this sort of regulated facility generally requires a time period of 180 days to read and understand the amended rule requirements; to evaluate their operations to ensure that they can meet the standards during periods of startup and shutdown as defined in the rule and make any necessary adjustments; and to update their operation, maintenance, and monitoring plan to reflect the revised requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. From
Under CAA section 112(d), we are proposing compliance dates for the proposed requirement to use high efficiency spray equipment if the source is not using the emission rate with add-on control compliance option. For existing affected sources under this proposed action, we propose to provide sources three years after the effective date of the final rule to comply with the proposed requirement to use high efficiency spray equipment. We are proposing a three-year compliance date for facilities that have not switched to high efficiency spray equipment because facilities that are not yet using high efficiency spray equipment have multiple alternative equipment types to consider under this proposed rule. The three-year compliance period will provide all facilities sufficient time to source and purchase the specific type of spray application equipment compatible with their operations. Furthermore, the compliance period provides time for sources to verify that the spray equipment they choose meets the transfer efficiency requirements in this proposed rule. In addition, because a spray gun's useful lifespan is approximately two years, the proposed three-year compliance period will provide enough time for facilities to source and purchase replacement guns on their current equipment purchase cycle, develop any necessary operational procedures, and perform training. Finally, the three-year compliance period will ensure that a facility is not required to replace a spray gun before it has time to identify and source new guns and develop bid specification and operation procedures. For new affected sources under this proposed action, the proposed compliance date is the effective date of the final rule or upon startup, whichever is later. We solicit comment on these proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance dates.
Currently, ten major sources subject to the Surface Coating of Large Appliances NESHAP are operating in the United States. The affected source under the NESHAP is the collection of all coating operations; all storage containers and mixing vessels in which coatings, thinners, and cleaning materials are stored or mixed; all manual and automated equipment and containers used for conveying coatings, thinners, and cleaning materials; and all storage containers and all manual and automated equipment and containers used for conveying waste materials generated by a coating operation. A coating operation is defined as the equipment used to apply cleaning materials to a substrate to prepare it for coating application or to remove dried coating (surface preparation), to apply coating to a substrate (coating application) and to dry or cure the coating after application, or to clean coating operation equipment (equipment cleaning). A single coating operation may include any combination of these types of equipment, but always includes at least the point at which a coating or cleaning material is applied and all subsequent points in the affected source where organic HAP emissions from that coating or cleaning material occur. There may be multiple coating operations in an affected source.
Currently, 43 major sources subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP are operating in the United States. The affected source under the NESHAP includes the following three categories of operations: Web coating and printing operations, slashing operations, and dyeing and finishing operations.
The web coating and printing operations subcategory is the collection of all web coating and printing equipment used to apply cleaning materials to a substrate on the coating or printing line to prepare it for coating or printing material application, to apply coating or printing materials to a substrate and to dry or cure the coating or printing materials, or equipment used to clean web coating/printing operation equipment; all containers used for storage and vessels used for mixing coating, printing, thinning, or cleaning materials; all equipment and containers used for conveying coating, printing, thinning, or cleaning materials; all containers used for storage, and all equipment and containers used for conveying waste materials generated by a coating or printing operation; and all equipment, structures, and/or devices(s) used to convey, treat, or dispose of wastewater streams or residuals generated by a coating or printing operation.
The slashing operations subcategory is the collection of all slashing equipment used to apply and dry the sizing on the warp yarn (the warp yarn are the vertical fibers, and a chemical compound referred to as sizing is used to bind and stiffen the yarn to provide abrasion resistance during weaving); all containers used for storage and vessels used for mixing slashing materials; all equipment and containers used for conveying slashing materials; all containers used for storage and all equipment and containers used for conveying waste materials generated by a slashing operation; and all equipment, structures, and/or devices(s) used to convey, treat, or dispose of wastewater streams or residuals generated by a slashing operation.
The dyeing and finishing subcategory is the collection of all dyeing and finishing equipment used to apply dyeing or finishing materials, to fix dyeing materials to the substrate, to rinse the textile substrate, or to dry or cure the dyeing or finishing materials; all containers used for storage and vessels used for mixing dyeing or finishing materials; all equipment and containers used for conveying dyeing or finishing materials; all containers used for storage, and all equipment and containers used for conveying, waste materials generated by a dyeing or finishing operation; and all equipment, structures, and/or devices(s) used to convey, treat, or dispose of wastewater streams or residuals generated by a dyeing or finishing operation.
Currently, 16 major sources subject to the Surface Coating of Metal Furniture NESHAP are operating in the United States. The affected source under the NESHAP is the collection of all coating operations; all storage containers and mixing vessels in which coatings, thinners, and cleaning materials are stored or mixed; all manual and automated equipment and containers and all pumps and piping within the affected source used for conveying coatings, thinners, and cleaning materials; and all storage containers, all pumps and piping, and all manual and
At the current level of control, estimated emissions of volatile organic HAP from the Surface Coating of Large Appliances source category are approximately 120 tpy. Current estimated emissions of volatile organic HAP from the Printing, Coating, and Dyeing of Fabrics and Other Textiles source category are approximately 737 tpy. Current estimated emissions of volatile organic HAP from the Surface Coating of Metal Furniture source category are approximately 145 tpy.
We do not estimate any volatile organic HAP emission reductions from the proposed requirement to use high-efficiency coating spray application equipment in the large appliance surface coating and the metal furniture surface coating source categories. We did not quantify these reductions; however, if a facility switched from spray guns with 50-percent transfer efficiency to those with 65-percent transfer efficiency, the amount of coating reaching the part during spraying would increase by 30 percent, and the total amount of coating needed to complete the coating operation would be reduced by 23 percent, leading to a corresponding decrease in organic HAP emissions. Due to a combination of economic incentives and state rule requirements to use high-efficiency coating spray application equipment, we expect that facilities in this source category are already using high efficiency coating spray application equipment. However, we are specifically requesting information on any facilities not using high efficiency spray application equipment.
All 69 major sources in the three source categories would be required to comply with the relevant emission standards at all times without the SSM exemption. We were unable to quantify the specific emissions reductions associated with eliminating the SSM exemption. However, eliminating the SSM exemption has the potential to reduce emissions by requiring facilities to meet the applicable standard during SSM periods.
Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices (
We estimate that each facility in the three source categories will experience costs as a result of these proposed amendments for reporting.
Facilities in the large appliances and metal furniture source categories transitioning to high efficiency spray equipment may experience costs to purchase new equipment. We do not have sufficient information on current use of this type of equipment to develop a potential industry-wide cost. However, based the following example from a similar coating operation, we expect the change to result in a net cost savings. Due to the increased transfer efficiency from 45 percent with conventional spray guns to 65 percent with high volume low pressure spray guns, the amount of coating used per part is expected to decrease by approximately 31 percent. See the memorandum titled,
We are specifically soliciting comments on the current use of high efficiency spray equipment, the costs to transition from conventional spray application equipment to high efficiency spray application equipment (including costs for changes to coating delivery systems we may have overlooked), and the actual coating cost savings realized due to the change.
Each facility will experience costs to read and understand the rule amendments. Costs associated with elimination of the SSM exemption were estimated as part of the reporting and recordkeeping costs and include time for re-evaluating previously developed SSM record systems. Costs associated with the requirement to electronically submit notifications and semi-annual compliance reports using CEDRI were estimated as part of the reporting and recordkeeping costs and include time for becoming familiar with CEDRI and the reporting template for semi-annual compliance reports. The recordkeeping and reporting costs are presented in section V.III.C of this preamble.
We estimate that for the large appliances and metal furniture source categories, should a source need to purchase and begin using high efficiency spray equipment, the cost savings associated with less coating material may offset the incremental equipment costs in typical cases.
We are also soliciting comment on whether to require air emissions performance testing in each source category using the emission rate with add-on controls compliance option. We estimate that 15 facilities subject to the Printing, Coating, and Dyeing of Fabrics and Other Textiles NESHAP would incur costs to conduct air emissions performance testing because they are currently using the emission rate with add-on controls compliance option. These 15 facilities have a total of 18 add-on controls. This total does not include other facilities in this source category that have add-on controls and are already required to perform air emissions performance testing as a
The economic impact analysis is designed to inform decision-makers about the potential economic consequences of a regulatory action. For the current proposals, the EPA estimated the cost of becoming familiar with the rule and re-evaluating previously developed SSM record systems. For the proposed revisions to the NESHAP for the Surface Coating of Large Appliances, the total cost is estimated to be $23,000 for the ten affected entities and is expected to range from 0.000002 to 0.02 percent of annual sales revenue per affected entity. For the proposed revisions to the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles, the total cost is estimated to be $90,000 for the 43 affected entities and is expected to range from 0.000005 to 0.42 percent of annual sales revenue per affected entity. For the proposed revisions to the NESHAP for the Surface Coating of Metal Furniture, the total cost is estimated to be $32,000 for the 16 affected entities and is expected to range from 0.00007 to 0.02 percent of annual sales revenue per affected entity. For each of these sectors, the costs are not expected to result in a significant market impact, regardless of whether they are passed on to the purchaser or absorbed by the firms.
The EPA also prepared a small business screening assessment to determine if any of the identified affected entities are small entities, as defined by the U.S. Small Business Administration. One of the facilities potentially affected by the proposed revisions to the NESHAP for the Surface Coating of Large Appliances is a small entity. The annualized costs associated with the proposed requirements for this facility is 0.02 percent of the annual sales revenue for that facility. Eighteen of the facilities potentially affected by the proposed revisions to the NESHAP for the Printing, Coating, and Dyeing of Fabrics and Other Textiles are small entities. The annualized costs associated with the proposed requirements for these 18 affected small entities range from 0.00067 to 0.25 percent of annual sales revenues per affected entity. Six of the facilities potentially affected by the proposed revisions to the NESHAP for the Surface Coating of Metal Furniture are small entities. The annualized costs associated with the proposed requirements for these six affected small entities range from 0.001 to 0.02 percent of annual sales revenues per affected entity. For each of these sectors, there are no significant economic impacts on a substantial number of small entities from the proposed amendments. More information and details of this analysis is provided in the technical documents titled
As stated above in section V.B. of this preamble, we were unable to quantify the specific emissions reductions associated with eliminating the SSM exemption. We also are unable to quantify potential emissions reductions of organic HAP. However, any reduction in HAP emissions would be expected to provide health benefits in the form of improved air quality and less exposure to potentially harmful chemicals.
We solicit comments on all aspects of this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the risk assessments and other analyses. We are specifically interested in receiving any improvements to the data used in the site-specific emissions profiles used for risk modeling, including the data to estimate the acute multipliers. Such data should include supporting documentation in sufficient detail to allow characterization of the quality and representativeness of the data or information. Section VII of this preamble provides more information on submitting data.
We are also specifically soliciting comment on the following:
• Our assumptions regarding hour-to-hour variation in emissions and our methods of calculating the multiplier for estimating the peak 1-hour emissions for each source category and any additional information that could help refine our approach.
• The current use of high efficiency spray equipment, the costs to transition from conventional spray application equipment to high efficiency spray application equipment (including costs for changes to coating delivery systems we may have overlooked), and the actual coating cost savings realized due to the change. We also request information on aspects of facility decision making concerning use of high efficiency coating methods, and facility specific operational, coating adherence, coating drying time, material compatibility, or other reasons that a facility may not have chosen to switch to high-efficiency spray.
• The requirements for submitting electronic reports, including the draft templates developed for report submittal, and whether report frequency should be semiannual (as proposed) or annual for all three source categories. We specifically request comment on the format and usability of the template (
• The need to establish a standard during periods of malfunction for the Fabric and Other Textiles source category in this action, and we are seeking the specific information described in section IV.B.4 of this preamble to support the standard. We also request public comment and information pertaining to malfunction
• The need for ongoing compliance demonstrations, in addition to one-time initial emissions and capture efficiency testing through air emissions testing when a source uses an add-on control to comply with the regulation.
• The proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements.
• Whether the agency should ban the use of ethylene oxide in the Fabric and Other Textiles source category under the technology review.
• The relationship between section 112(d)(6), technology review, and 112(f), residual risk review. Specifically, we solicit comment on the extent to which findings that underlie a section 112(f) determination should be considered in making any determinations under section 112(d)(6).
The site-specific emissions profiles used in the source category risk and demographic analyses and instructions are available for download on the RTR website at
If you believe that the data are not representative or are inaccurate, please identify the data in question, provide your reason for concern, and provide any “improved” data that you have, if available. When you submit data, we request that you provide documentation of the basis for the revised values to support your suggested changes. To submit comments on the data downloaded from the RTR website, complete the following steps:
1. Within this downloaded file, enter suggested revisions to the data fields appropriate for that information.
2. Fill in the commenter information fields for each suggested revision (
3. Gather documentation for any suggested emissions revisions (
4. Send the entire downloaded file with suggested revisions in Microsoft® Access format and all accompanying documentation to Large Appliances Docket, Fabrics and Other Textiles Docket, or Metal Furniture Docket, as applicable (through the method described in the
5. If you are providing comments on a single facility or multiple facilities, you need only submit one file for all facilities. The file should contain all suggested changes for all sources at that facility (or facilities). We request that all data revision comments be submitted in the form of updated Microsoft® Excel files that are generated by the Microsoft® Access file. These files are provided on the RTR website at
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to OMB for review. Any changes made in response to OMB recommendations have been documented in the docket.
This action is expected to be an Executive Order 13771 regulatory action. Details on the estimated costs of this proposed rule can be found in the EPA's analysis of the potential costs and benefits associated with this action.
The information collection activities in this proposed rule have been submitted for approval to OMB under the PRA, as discussed for each source category covered by this proposal in sections VIII.C.1 through 3.
The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 1954.07. You can find a copy of the ICR in the Large Appliances Docket (Docket ID No. EPA-HQ-OAR-2017-0670), and it is briefly summarized here.
As part of the RTR for the Large Appliances NESHAP, the EPA is proposing to require that, for each coating operation for which coatings are spray applied, high efficiency spray equipment must be used, except when the facility is using the emission rate with add-on controls compliance option. In addition, the EPA is proposing revisions to the SSM provisions of the rule and proposing the use of electronic data reporting for future performance test data submittals and semi-annual reporting. This information would be collected to assure compliance with 40 CFR part 63, subpart NNNN.
The ICR document that the EPA prepared has been assigned EPA ICR number 2071.07. You can find a copy of the ICR in the Fabrics and Other Textiles Docket (Docket ID No. EPA-HQ-OAR-2017-0668), and it is briefly summarized here.
The EPA is not proposing to revise the emission limitation requirements for this subpart. The EPA is proposing revisions to the SSM provisions of the rule, and proposing the use of electronic data reporting for future performance test data submittals and semiannual reports. This information is being collected to assure compliance with 40 CFR part 63, subpart OOOO.
The ICR document that the EPA prepared has been assigned EPA ICR number 1952.07. You can find a copy of the ICR in the Metal Furniture Docket (Docket ID No. EPA-HQ-OAR-2017-0669), and it is briefly summarized here.
As part of the RTR for the Metal Furniture NESHAP, the EPA is proposing to require that, for each coating operation for which coatings are spray applied, high efficiency spray equipment must be used, except when the facility is using the emission rate with add-on controls compliance option. In addition, the EPA is proposing revisions to the SSM provisions of the rule and proposing the use of electronic data reporting for future performance test data submittals and semi-annual reporting. This information would be collected to assure compliance with 40 CFR part 63, subpart RRRR.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the dockets identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. No tribal facilities are known to be engaged in any of the industries that would be affected by this action (large appliances surface coating; printing, coating, and dyeing of fabrics and other textiles, surface coating of metal furniture). Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in sections III.A and C, IV.A.1 and 2, IV.B.1 and 2, and IV.C.1 and 2 of this preamble and are further documented in the
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action would not affect producers of energy (
This rulemaking involves technical standards. The EPA is proposing to amend the three NESHAP in this action to provide owners and operators with the option of conducting EPA Method 18 of appendix A to 40 CFR part 60, “Measurement of Gaseous Organic Compound Emissions by Gas Chromatography” to measure and subtract methane emissions from measured total gaseous organic mass emissions as carbon.
We found three voluntary consensus standards (VCS) already allowed in the Surface Coating of Large Appliances NESHAP that have been replaced with newer versions of the methods. The first method, ASTM method Dl475-13, “Standard Test Method for Density of Liquid Coatings, Inks, and Related Products,” has replaced ASTM D1475-90, and it covers the measurement of density of paints, inks, varnishes, lacquers, and components thereof, other than pigments, when in fluid form; secondly, ASTM D2697-03 (2014) “Standard Test Method for Volume Nonvolatile Matter in Clear or Pigmented Coatings” has replaced ASTM D2697-86 (1998), which is applicable to the determination of the volume of nonvolatile matter of a variety of coatings; and finally, ASTM D6093-97 (2016) “Standard Test Method for Percent Volume Nonvolatile Matter in Clear or Pigmented Coatings Using Helium Gas Pycnometer” has replaced ASTM D6093-97(2003) which covers the determination of the percent volume nonvolatile matter of a variety of clear and pigmented coatings.
For the Surface Coating of Metal Furniture NESHAP, the Printing, Coating and Dyeing of Fabrics and Other Textiles NESHAP, and the Surface Coating of Large Appliances NESHAP, the EPA proposes to incorporate by reference ASTM D2369-10 (2015), “Test Method for Volatile Content of Coatings,” which describes a procedure for the determination of the weight percent volatile content of solvent borne and waterborne coatings, as an acceptable alternative to EPA Test Method 24.
The ASTM standards are available from the American Society for Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428-2959. See
The EPA is not proposing CARB Method 310, “Determination of Volatile Organic Compounds in Consumer Products and Reactive Organic Compounds in Aerosol Coating Products,” as an alternative to EPA Method 24 because the EPA has approved the method only for consumer products and aerosol coatings, which do not apply to the rulemakings or source categories addressed in this action.
While the EPA has identified another 21 VCS each for Metal Furniture and Large Appliances, and two VCS for Fabrics Printing and Dyeing, as being potentially applicable to this proposed rule, we have decided not to use these VCS in this rulemaking. The use of these VCS would not be practical due to lack of equivalency, documentation, validation date, and other important technical and policy considerations. See the memoranda titled
Under 40 CFR 63.7(f) and 40 CFR 63.8(f) of subpart A of the General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications, or procedures in the final rule or any amendments.
The EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially applicable VCS and to explain why such standards should be used in this regulation.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is contained in sections IV.A.1 and 2, IV.B.1 and 2, and IV.C.1 and 2 of this preamble and the technical reports titled
As discussed in sections IV.A.1, IV.B.1, and IV.C.1 of this preamble, we performed a demographic analysis for each source category, which is an assessment of risks to individual demographic groups, of the population close to the facilities (within 50 km and within 5 km). In this analysis, we evaluated the distribution of HAP-related cancer risks and noncancer hazards from the Surface Coating of Large Appliances source category, Printing, Coating, and Dyeing of Fabrics and Other Textiles source category, and Surface Coating of Metal Furniture source category across different social, demographic, and economic groups within the populations living near operations identified as having the highest risks.
The results of the Surface Coating of Large Appliances source category demographic analysis indicate that no one is exposed to a cancer risk at or above 1-in-1 million or to a chronic noncancer HI greater than 1. The proximity results (irrespective of risk) indicate that the population within 5 km of facilities in the Surface Coating of Large Appliances source category are greater than the corresponding national percentage for the following demographic percentages: “African American” and “Below the Poverty Level.”
The results of the Printing, Coating and Dyeing of Fabrics and Other Textiles source category demographic analysis indicate that emissions from the source category expose approximately 8,500 people to a cancer risk at or above 1-in-1 million and no one to a chronic noncancer HI greater than 1. The percentages of the at-risk population in the following specific demographic groups are higher than their respective nationwide percentages: “African American,” “Over 25 Without a HS Diploma,” and “Below the Poverty Level.” The proximity results (irrespective of risk) indicate that the population percentages for the below the poverty level demographic category within 5 km of facilities in the Printing, Coating, and Dying of Fabric and Other
The results of the Surface Coating of Metal Furniture source category demographic analysis indicate that emissions from the source category expose approximately 2,100 people to a cancer risk at or above 1-in-1 million and no one to a chronic noncancer HI greater than 1. The percentages of the at-risk population in the following specific demographic groups are higher than their respective nationwide percentages: “Hispanic or Latino,” “Over 25 Without a HS Diploma,” and “Below the Poverty Level.” The proximity results (irrespective of risk) indicate that the population within 5 km of facilities in the Surface Coating of Metal Furniture source category are greater than the corresponding national percentage for the following demographic percentages: “African American,” “Hispanic or Latino,” “Over 25 Without a HS Diploma,” and “Below the Poverty Level.”
We do not expect this proposal to achieve significant reductions in HAP emissions. The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not significantly affect the level of protection provided to human health or the environment. The documentation for this decision is contained in section IV of this preamble and the technical reports,
Environmental protection, Air pollution control, Hazardous substances, Incorporation by reference, Surface Coating of Large Appliances, Surface Coating of Metal Furniture, Printing, Coating, and Dyeing of Fabrics and Other Textiles, Reporting and recordkeeping requirements, Appendix A.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend part 63 of title 40, chapter I, of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
The additions read as follows:
(h) * * *
(13) ASTM Method D1475-13, Standard Test Method for Density of Liquid Coatings, Inks, and Related Products, IBR approved for §§ 63.4141(b) and (c), and 63.4941(b) and (c).
(21) ASTM D2111-10 (2015), Standard Test Methods for Specific Gravity of Halogenated Organic Solvents and Their Admixtures, IBR approved for §§ 63.4141(b) and (c).
(26) ASTM D2369-10 (2015), Test Method for Volatile Content of Coatings, IBR approved for §§ 63.4141(a) and (b), 63.4161(h), 63.4941(a) and (b), and 63.4961(j).
(30) ASTM D2697-03 (2014), Standard Test Method for Volume Nonvolatile Matter in Clear or Pigmented Coatings, IBR approved for §§ 63.4141(b) and 63.4941(b).
(a) For any spray-applied coating operation(s) for which you use the compliant material option or the emission rate without add-on controls option, you are required to meet a transfer efficiency of 65 percent or use the spray coating application method specified in paragraph (b) of this section. For any spray-applied coating operation(s) for which you use the emission rate with add-on controls option, the transfer efficiency requirement does not apply.
(b) As an alternative to the transfer efficiency requirement in paragraph(a), for any spray-applied coating operation(s) for which you use you use the compliant material option or the emission rate without add-on controls option, you may apply all spray-applied coatings using high-volume, low-pressure (HVLP) spray equipment; electrostatic application; airless spray equipment; or air-assisted airless spray equipment, except as specified in paragraphs (b)(1) of this section. You must also meet the requirements in paragraph (b)(2) of this section.
(1) You may apply spray-applied coatings using an alternative coating spray application method if you demonstrate that the alternative method achieves a transfer efficiency equivalent to or better than 65 percent, using procedures equivalent to the California South Coast Air Quality Management District's “Spray Equipment Transfer Efficiency Test Procedure for Equipment User, May 24, 1989” (for availability, see § 63.14) and following guidelines equivalent to “Guidelines for Demonstrating Equivalency with District Approved Transfer Efficient Spray Guns, September 26, 2002” (for availability, see § 63.14). For the purposes of this section, when using these equivalent guidelines or procedures, you are not required to submit an application with the test plan or protocol to the Administrator, conduct the test in the presence of an Administrator, or submit test results to the Administrator for review or approval. Instead you must comply with the recordkeeping requirement in § 63.4130(l).
(2) All spray application equipment must be operated according to company procedures, local specified operating
(b) At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator that may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the affected source.
(b) * * *
(9) For the emission rate with add-on controls option, you must include the information specified in paragraphs (b)(9)(i) through (iv) of this section, except that the requirements in paragraphs (b)(9)(i) through (iii) of this section do not apply to solvent recovery systems for which you conduct liquid-liquid material balances according to § 63.4161(h).
The revisions and additions read as follows:
(b) The semiannual compliance report must contain the information specified in paragraphs (b)(1) through (4) of this section and the information specified in paragraphs (c) through (h) of this section that is applicable to your affected source.
(d) If you use the compliant material option and there was a deviation from the applicable emission limit in § 63.4090, the semiannual compliance report must contain the information in paragraphs (d)(1) through (5) of this section.
(1) Identification of each coating used that deviated from the emission limit, each thinner and cleaning material used that contained organic HAP, and the date, time, and duration each was used.
(4) A statement of the cause of each deviation (including unknown cause, if applicable).
(5) The number of deviations and, for each deviation, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4090, and a description of the method used to estimate the emissions.
(e) If you use the emission rate without add-on controls option and there was a deviation from the applicable emission limit in § 63.4090, the semiannual compliance report must contain the information in paragraphs (e)(1) through (4) of this section.
(3) A statement of the cause of each deviation (including unknown cause, if applicable).
(4) The number of deviations, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4090, and a description of the method used to estimate the emissions.
(g) If you use the emission rate with add-on controls option and there was a deviation from the applicable emission limit in § 63.4090 or the applicable operating limit(s) in Table 1 to this subpart (including any periods when emissions bypassed the add-on control device and were diverted to the atmosphere), the semiannual compliance report must contain the information in paragraphs (g)(1) through (12), (g)(14) and (g)(15) of this section. If you use the emission rate with add-on controls option and there was a deviation from the work practice standards in § 63.4093(b), the semiannual compliance report must contain the information in paragraph (g)(13) of this section.
(3) The date and time that each malfunction of the capture system or add-on control devices started and stopped.
(6) For each instance that the CPMS was inoperative, except for zero (low-level) and high-level checks, the date, time, and duration that the CPMS was inoperative; the cause (including unknown cause) for the CPMS being inoperative; and descriptions of corrective actions taken.
(7) For each instance that the CPMS was out-of-control, as specified in § 63.8(c)(7), the date, time, and duration that the CPMS was out-of-control; the cause (including unknown cause) for the CPMS being out-of-control; and descriptions of corrective actions taken.
(8) The date, time, and duration of each deviation from an operating limit in Table 1 to this subpart; and the date, time, and duration of any bypass of the add-on control device.
(10) A breakdown of the total duration of the deviations from the operating limits in Table 1 to this subpart and bypasses of the add-on control device during the semiannual reporting period into those that were due to control equipment problems, process problems, other known causes, and other unknown causes.
(13) For deviations from the work practice standards in § 63.4093(b):
(i) Number of deviations.
(ii) For each deviation:
(A) A description of the deviation; the date, time, and duration of the deviation; and the actions you took to minimize emissions in accordance with § 63.4100(b).
(B) The description required in paragraph (g)(13)(ii)(A) of this section must include a list of the affected sources or equipment for which a deviation occurred and the cause of the
(14) For deviations from an emission limit in § 63.4090 or operating limit in Table 1 to this subpart, a statement of the cause of each deviation (including unknown cause, if applicable).
(15) For each deviation from an emission limit in § 63.4090 or operating limit in Table 1 to this subpart, a list of the affected sources or equipment for which a deviation occurred, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4090, and a description of the method used to estimate the emissions.
(a) You must submit the results of the performance test required in § 63.4120(h) following the procedure specified in paragraphs (a)(1) through (3) of this section.
(1) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (
(2) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 63.13, unless the Administrator agrees to or specifies an alternate reporting method.
(3) If you claim that some of the performance test information being submitted under paragraph (a)(1) of this section is confidential business information (CBI), you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website, including information claimed to be CBI, on a compact disc, flash drive or other commonly used electronic storage medium to the EPA. The electronic medium must be clearly marked as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Road, Durham, NC 27703. The same ERT or alternate file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraph (a)(1) of this section.
(b) Beginning on [date 2 years after date of publication of final rule in the
(c) Beginning on [date 2 years after date of publication of final rule in the
(d) If you are required to electronically submit a report through the CEDRI in the EPA's Central Data Exchange (CDX), and due to a planned or actual outage of either the EPA's CEDRI or CDX systems within the period of time beginning five business days prior to the date that the submission is due, you will be or are precluded from accessing CEDRI or CDX and submitting a required report within the time prescribed, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or caused a delay in reporting. You must provide to the Administrator a written description identifying the date, time and length of the outage; a rationale for attributing the delay in reporting beyond the regulatory deadline to the EPA system outage; describe the measures taken or to be taken to minimize the delay in reporting; and identify a date by which you propose to report, or if you have
(e) If you are required to electronically submit a report through CEDRI in the EPA's CDX and a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due, the owner or operator may assert a claim of force majeure for failure to timely comply with the reporting requirement. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
The revisions and additions read as follows:
(j) For each deviation from an emission limitation reported under § 63.4120(d), (e), and (g), a record of the information specified in paragraphs (j)(1) through (4) of this section, as applicable.
(1) The date, time, and duration of the deviation, as reported under § 63.4120(d), (e), and (g).
(2) A list of the affected sources or equipment for which the deviation occurred and the cause of the deviation, as reported under § 63.4120(d), (e), and (g).
(3) An estimate of the quantity of each regulated pollutant emitted over any applicable emission limit in § 63.4090 or any applicable operating limit in Table 1 to this subpart, and a description of the method used to calculate the estimate, as reported under § 63.4120(d), (e), and (g).
(4) A record of actions taken to minimize emissions in accordance with § 63.4100(b) and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(k) If you use the emission rate with add-on controls option, you must also keep the records specified in paragraphs (k)(1) through (8) of this section.
(a) Your records must be in a form suitable and readily available for expeditious review, according to § 63.10(b)(1). Where appropriate, the records may be maintained as electronic spreadsheets or as a database. Any records required to be maintained by this subpart that are in reports that were submitted electronically via the EPA's CEDRI may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
(a) * * *
(1) * * *
(i) Count each organic HAP in Table 5 to this subpart that is measured to be present at 0.1 percent by mass or more and at 1.0 percent by mass or more for other organic HAP compounds. For example, if toluene (not listed in Table 5 to this subpart) is measured to be 0.5 percent of the material by mass, you do not have to count it. Express the mass fraction of each organic HAP you count as a value truncated to four places after the decimal point (for example, 0.3791).
(2)
(4)
(b) * * *
(1)
(3) * * *
m
D
(c)
(a) * * *
(1) All emission capture systems, add-on control devices, and CPMS you use to demonstrate compliance must be installed and operating no later than the applicable compliance date specified in § 63.4083. Except for solvent recovery systems for which you conduct liquid-liquid material balances according to § 63.4161(h), you must conduct a performance test of each capture system and add-on control device according to the procedures in §§ 63.4164, 63.4165, and 63.4166, and establish the operating limits required by § 63.4092 no later than the compliance date specified in § 63.4083. For a solvent recovery system for which you conduct liquid-liquid material balances according to § 63.4161(h), you must initiate the first material balance no later than the compliance date specified in § 63.4083.
(b) * * *
(1) All emission capture systems, add-on control devices, and CPMS you use to demonstrate compliance must be installed and operating no later than the applicable compliance date specified in § 63.4083. Except for solvent recovery systems for which you conduct liquid-liquid material balances according to § 63.4161(h), you must conduct a performance test of each capture system and add-on control device according to the procedures in §§ 63.4164, 63.4165, and 63.4166, and establish the operating limits required by § 63.4092 no later than 180 days after the applicable compliance date specified in § 63.4083. For a solvent recovery system for which you conduct liquid-liquid material balances according to § 63.4161(h), you must initiate the first material balance no later than 180 days after the applicable compliance date specified in § 63.4083.
(g)
(h) * * *
(3) Determine the mass fraction of volatile organic matter for each coating used in the coating operation controlled by the solvent recovery system during the compliance period, kilogram, volatile organic matter per kg coating. You may determine the volatile organic matter mass fraction using Method 24 in appendix A-7 of part 60, ASTM D2369-10 (2015), “Test Method for Volatile Content of Coatings” (incorporated by reference,
(e) You must demonstrate continuous compliance with the work practice standards in § 63.4093. If you did not develop a work practice plan, did not implement the plan, or did not keep the records required by § 63.4130(k)(8), this is a deviation from the work practice standards that must be reported as specified in §§ 63.4110(b)(6) and 63.4120(g).
(a) You must conduct each performance test required by § 63.4160 according to the requirements in this section unless you obtain a waiver of the performance test according to the provisions in § 63.7(h).
(1)
(b) Measure total gaseous organic mass emissions as carbon at the inlet and outlet of the add-on control device simultaneously, using either Method 25 or 25A in appendix A-7 of part 60, as specified in paragraphs (b)(1) through (3) of this section. You must use the same method for both the inlet and outlet measurements. You may use Method 18 in appendix A-6 of part 60 to subtract methane emissions from measured total gaseous organic mass emissions as carbon.
(a) * * *
(4) You must maintain the CPMS at all times in accordance with § 63.4100(b) and have readily available necessary parts for routine repairs of the monitoring equipment.
(5) You must operate the CPMS and collect emission capture system and add-on control device parameter data at all times in accordance with § 63.4100(b).
(c) * * *
(3) For each gas temperature monitoring device, you must comply with the requirements in paragraphs (c)(3)(i) through (vii) of this section. For the purposes of this paragraph (c)(3), a thermocouple is part of the temperature sensor.
(1) Fails to meet any requirement or obligation established by this subpart including but not limited to any emission limit, or operating limit, or work practice standard; or
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
You must comply with the applicable General Provisions requirements according to the following table:
(a) * * *
(3) * * *
(i) The web coating/printing or dyeing/finishing operation(s) must be in compliance with the applicable emission limit in Table 1 to this subpart at all times.
(b) At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator that may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the affected source.
(c) * * *
(9) * * *
(iv) A statement of whether or not you developed and implemented the work practice plan required by § 63.4293.
The revisions and additions read as follows:
(a) * * *
(5)
(i) Identification of each coating, printing, slashing, dyeing or finishing material applied that deviated from the emission limit and each thinning or cleaning material applied in web coating/printing operations that contained organic HAP, and the date, time, and duration each was applied.
(iv) A statement of the cause of each deviation (including unknown cause, if applicable).
(v) The number of deviations and, for each deviation, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in Table 1 to this subpart, and a description of the method used to estimate the emissions.
(6)
(iii) A statement of the cause of each deviation (including unknown cause, if applicable).
(iv) The number of deviations, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in Table 1 to this subpart, and a description of the method used to estimate the emissions.
(7)
(iv) The date and time that each malfunction of the capture system or add-on control devices started and stopped.
(vii) For each instance that the CPMS was inoperative, except for zero (low-level) and high-level checks, the date, time, and duration that the CPMS was inoperative; the cause (including
(viii) For each instance that the CPMS was out-of-control, as specified in § 63.8(c)(7), the date, time, and duration that the CPMS was out-of-control; the cause (including unknown cause) for the CPMS being out-of-control; and descriptions of corrective actions taken.
(ix) The date, time, and duration of each deviation from an operating limit in Table 2 to this subpart, and the date, time, and duration of any bypass of the add-on control device.
(xi) A breakdown of the total duration of the deviations from the operating limits in Table 2 to this subpart and bypasses of the add-on control device during the semiannual reporting period into those that were due to control equipment problems, process problems, other known causes, and other unknown causes.
(xiv) For deviations from the work practice standards, the number of deviations, and, for each deviation:
(A) A description of the deviation; the date, time, and duration of the deviation; and the actions you took to minimize emissions in accordance with § 63.4300(b).
(B) The description required in paragraph (a)(7)(xiv)(A) of this section must include a list of the affected sources or equipment for which a deviation occurred and the cause of the deviation (including unknown cause, if applicable.
(xv) For deviations from an emission limit in Table 1 to this subpart or operating limit in Table 2 to this subpart, a statement of the cause of each deviation (including unknown cause, if applicable).
(xvi) For each deviation from an emission limit in Table 1 to this subpart or operating limit in Table 2 to this subpart, a list of the affected sources or equipment for which a deviation occurred, an estimate of the quantity of each regulated pollutant emitted over any emission limit in Table 1 to this subpart, and a description of the method used to estimate the emissions.
(8)
(v) For each deviation, the date, time, and duration of the deviation, a list of the affected sources or equipment, and a statement of the cause of the deviation (including an unknown cause, if applicable).
(c) You must submit the results of the performance test required in paragraph (b) of this section following the procedure specified in paragraphs (c)(1) through (3) of this section.
(1) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (
(2) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 63.13, unless the Administrator agrees to or specifies an alternate reporting method.
(3) If you claim that some of the performance test information being submitted under paragraph (c)(1) of this section is confidential business information (CBI), you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website, including information claimed to be CBI, on a compact disc, flash drive, or other commonly used electronic storage medium to the EPA. The electronic medium must be clearly marked as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same ERT or alternate file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraph (c)(1) of this section.
(d) Beginning on [date 2 years after date of publication of final rule in the
(e) Beginning on [date 2 years after date of publication of final rule in the
(f) If you are required to electronically submit a report through the Compliance and Emissions Data Reporting Interface (CEDRI) in the EPA's Central Data Exchange (CDX), and due to a planned or actual outage of either the EPA's CEDRI or CDX systems within the period of time beginning five business days prior to the date that the submission is due, you will be or are precluded from accessing CEDRI or CDX and submitting a required report within the time prescribed, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or caused a delay in reporting. You must provide to the Administrator a written description identifying the date, time and length of the outage; a rationale for attributing the delay in reporting beyond the regulatory deadline to the EPA system outage; describe the measures taken or to be taken to minimize the delay in reporting; and identify a date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported. In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved. The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(g) If you are required to electronically submit a report through CEDRI in the EPA's CDX and a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due, the owner or operator may assert a claim of force majeure for failure to timely comply with the reporting requirement. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
(i) For each deviation from an emission limitation reported under § 63.4311(a)(5) through (8), a record of the information specified in paragraphs (i)(1) through (4) of this section, as applicable:
(1) The date, time, and duration of the deviation, as reported under § 63.4311(a)(5) through (8).
(2) A list of the affected sources or equipment for which the deviation occurred and the cause of the deviation, as reported under § 63.4311(a)(5) through (8).
(3) An estimate of the quantity of each regulated pollutant emitted over any applicable emission limit in Table 1 to this subpart or any applicable operating limit in Table 2 to this subpart, and a description of the method used to calculate the estimate, as reported under § 63.4311(a)(5) through (8). If you use the equivalent emission rate option to comply with this subpart, a record of the applicable information specified in § 63.4311(a)(8)(ii) through (iv) satisfies this recordkeeping requirement.
(4) A record of actions taken to minimize emissions in accordance with § 63.4300(b) and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(j) If you use the emission rate with add-on controls option, the organic HAP overall control efficiency option, or the oxidizer outlet organic HAP concentration option, you must also keep the records specified in paragraphs (j)(1) through (8) of this section.
(a) Your records must be in a form suitable and readily available for expeditious review, according to § 63.10(b)(1). Where appropriate, the records may be maintained as electronic spreadsheets or as a database. Any records required to be maintained by this subpart that are in reports that were submitted electronically via the EPA's CEDRI may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
(e) * * *
(1) * * *
(i) * * *
(A) Count each organic HAP in Table 6 to this subpart that is measured to be
(iv)
(e) * * *
(4)
(f) * * *
(4)
(f) As part of each semiannual compliance report required in § 63.4311, you must identify the coating/printing and dyeing/finishing operation(s) for which you use the emission rate with add-on controls option. If there were no deviations from the applicable emission limitations in §§ 63.4290, 63.4292, and 63.4293, you must submit a statement that, as appropriate, the web coating/printing operations or the dyeing/finishing operations were in compliance with the emission limitations during the reporting period because the organic HAP emission rate for each compliance period was less than or equal to the applicable emission limit in Table 1 to this subpart, and you achieved the operating limits required by § 63.4292 and the work practice standards required by § 63.4293 during each compliance period.
(d) * * *
(4)
(a) You must conduct each performance test required by §§ 63.4340 or 63.4350 according to the requirements in this section, unless you obtain a waiver of the performance test according to the provisions in § 63.7(h).
(1)
(b) Measure the volatile organic matter concentration as carbon at the inlet and outlet of the add-on control device simultaneously, using Method 25 or 25A in appendix A-7 of part 60. If you are demonstrating compliance with the oxidizer outlet organic HAP concentration limit, only the outlet volatile organic matter concentration must be determined. The outlet volatile organic matter concentration is determined as the average of the three test runs. You may use Method 18 in appendix A-6 of part 60 to subtract methane emissions from measured volatile organic matter concentration as carbon.
(a) * * *
(6) At all times, you must maintain the monitoring system in accordance with § 63.4300(b) and in proper working order including, but not limited to, keeping readily available necessary parts for routine repairs of the monitoring equipment.
(7) You must operate the CPMS and collect emission capture system and add-on control device parameter data at all times in accordance with § 63.4300(b). Data recorded during monitoring malfunctions, associated repairs, out-of-control periods, or required quality assurance or control activities shall not be used for purposes of calculating the emissions concentrations and percent reductions specified in Table 1 to this subpart. You must use all the data collected during all other periods in assessing compliance of the control device and associated control system. A monitoring malfunction is any sudden, infrequent, not reasonably preventable failure of the monitoring system to provide valid data. Monitoring failures that are caused in part by poor maintenance or careless operation are not malfunctions.
(8) Except for periods of required quality assurance or control activities, any averaging period during which the CPMS fails to operate and record data continuously as required by paragraph (a)(1) of this section, or which generates data that cannot be included in calculating averages as specified in paragraph (a)(7) of this section, constitutes a deviation, and you must notify the Administrator in accordance with § 63.4311(a).
(1) Fails to meet any requirement or obligation established by this subpart, including but not limited to any emission limit, or operating limit, or work practice standard; or
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
You must comply with the applicable General Provisions requirements according to the following table:
(a) For any spray-applied coating operation(s) for which you use the compliant material option or the emission rate without add-on controls option, you are required to meet a transfer efficiency of 65 percent or use the spray coating application method specified in paragraph (b) of this section. For any spray-applied coating operation(s) for which you use the emission rate with add-on controls option, the transfer efficiency requirement does not apply.
(b) As an alternative to the transfer efficiency requirement in paragraph (a) of this section, for any spray-applied coating operation(s) for which you use the compliant material option or the emission rate without add-on controls option, you may apply all spray-applied coatings using high-volume, low-pressure (HVLP) spray equipment; electrostatic application; airless spray equipment; or air-assisted airless spray equipment, except as specified in paragraphs (b)(1) of this section. You must also meet the requirements in paragraph (b)(2) of this section.
(1) You may apply spray-applied coatings using an alternative coating spray application method if you demonstrate that the alternative method achieves a transfer efficiency equivalent to or better than 65 percent, using a procedure equivalent to the California South Coast Air Quality Management District's “Spray Equipment Transfer Efficiency Test Procedure for Equipment User, May 24, 1989” (incorporated by reference, see § 63.14 of subpart A of this part) and following guidelines equivalent to “Guidelines for Demonstrating Equivalency with District Approved Transfer Efficient Spray Guns, September 26, 2002” (incorporated by reference, see § 63.14 of subpart A of this part). For the purposes of this section, when using these equivalent guidelines or procedures, you are not required to submit an application with the test plan or protocol to the Administrator, conduct the test in the presence of an Administrator, or submit test results to the Administrator for review or approval. Instead you must comply with the recordkeeping requirement in § 63.4130(l).
(2) All spray application equipment must be operated according to company procedures, local specified operating procedures, and/or the manufacturer's specifications, whichever is most stringent, at all times. If you modify spray application equipment, you must maintain emission reductions or a transfer efficiency equivalent to HVLP spray equipment, electrostatic application, airless spray equipment, or air-assisted airless spray equipment, and you must demonstrate equivalency according to paragraph (b)(1) of this section and comply with the recordkeeping requirement in § 63.4130(l).
(a) The affected source must be in compliance at all times with the applicable emission limitations specified in §§ 63.4890, 63.4892, and 63.4893.
(b) At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator that may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the affected source.
(c) Reserved.
(c) * * *
(9) For the emission rate with add-on controls option, you must include the information specified in paragraphs (c)(9)(i) through (iv) of this section. However, the requirements in paragraphs (c)(9)(i) through (iii) of this section do not apply to solvent recovery systems for which you conduct liquid-liquid material balances according to § 63.4961(j).
The revisions and additions read as follows:
(a) * * *
(3)
(4)
(5) * * *
(i) Identification of each coating used that deviated from the emission limit, and of each thinner and cleaning material used that contained organic HAP, and the date, time, and duration each was used.
(iv) A statement of the cause of each deviation (including unknown cause, if applicable).
(v) The number of deviations and, for each deviation, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4890, and a description of the method used to estimate the emissions.
(6)
(v) A statement of the cause of each deviation (including unknown cause, if applicable).
(vi) The number of deviations, a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4890, and a description of the method used to estimate the emissions.
(7)
(vi) The date and time that each malfunction of the capture system or add-on control devices started and stopped.
(ix) For each instance that the CPMS was inoperative, except for zero (low-level) and high-level checks, the date, time, and duration that the CPMS was inoperative; the cause (including unknown cause) for the CPMS being inoperative, and descriptions of corrective actions taken.
(x) For each instance that the CPMS was out-of-control, as specified in § 63.8(c)(7), the date, time, and duration that the CPMS was out-of-control; the cause (including unknown cause) for the CPMS being out-of-control; and descriptions of corrective actions taken.
(xi) The date, time, and duration of each deviation from an operating limit in Table 1 to this subpart; and the date,
(xiii) A breakdown of the total duration of the deviations from the operating limits in Table 1 to this subpart and bypasses of the add-on control device during the semiannual reporting period into those that were due to control equipment problems, process problems, other known causes, and other unknown causes.
(xvi) For deviations from the work practice standards in § 63.4893(b), the number of deviations, and, for each deviation:
(A) A description of the deviation; the date, time, and duration of the deviation; and the actions you took to minimize emissions in accordance with § 63.4900(b).
(B) The description required in paragraph (a)(7)(xvi)(A) of this section must include a list of the affected sources or equipment for which a deviation occurred and the cause of the deviation (including unknown cause, if applicable).
(xvii) For deviations from an emission limit in § 63.4890 or operating limit in Table 1 to this subpart, a statement of the cause of each deviation (including unknown cause, if applicable).
(xviii) For each deviation from an emission limit in § 63.4890 or operating limit in Table 1 to this subpart, a list of the affected sources or equipment for which a deviation occurred, an estimate of the quantity of each regulated pollutant emitted over any emission limit in § 63.4890, and a description of the method used to estimate the emissions.
(a) You must submit the results of the performance test required § 63.4920(b) following the procedure specified in paragraphs (a)(1) through (3) of this section:
(1) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (
(2) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 63.13, unless the Administrator agrees to or specifies an alternate reporting method.
(3) If you claim that some of the performance test information being submitted under paragraph (a)(1) of this section is confidential business information (CBI), you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website, including information claimed to be CBI, on a compact disc, flash drive or other commonly used electronic storage medium to the EPA. The electronic medium must be clearly marked as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Road, Durham, NC 27703. The same ERT or alternate file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraph (a)(1) of this section.
(b) Beginning on [date 2 years after date of publication of final rule in the
(c) Beginning on [date 2 years after date of publication of final rule in the
(d) If you are required to electronically submit a report through the CEDRI in the EPA's Central Data Exchange (CDX), and due to a planned or actual outage of either the EPA's CEDRI or CDX systems within the period of time beginning five business
(e) If you are required to electronically submit a report through CEDRI in the EPA's CDX and a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due, the owner or operator may assert a claim of force majeure for failure to timely comply with the reporting requirement. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
(j) For each deviation from an emission limitation reported under § 63.4920(a)(5), (a)(6), and (a)(7), a record of the information specified in paragraphs (j)(1) through (4) of this section, as applicable.
(1) The date, time, and duration of each deviation, as reported under § 63.4920(a)(5), (a)(6), and (a)(7).
(2) A list of the affected sources or equipment for which the deviation occurred and the cause of the deviation, as reported under § 63.4920(a)(5), (a)(6), and (a)(7).
(3) An estimate of the quantity of each regulated pollutant emitted over any applicable emission limit in § 63.4890 or any applicable operating limit(s) in Table 1 to this subpart, and a description of the method used to calculate the estimate, as reported under § 63.4920(a)(5), (a)(6), and (a)(7).
(4) A record of actions taken to minimize emissions in accordance with § 63.4900(b) and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(k) If you use the emission rate with add-on controls option, you must also keep the records specified in paragraphs (k)(3) through (8) of this section.
(a) Your records must be in a form suitable and readily available for expeditious review, according to § 63.10(b)(1). Where appropriate, the records may be maintained as electronic spreadsheets or as a database. Any records required to be maintained by this subpart that are in reports that were submitted electronically via the EPA's CEDRI may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
(a) * * *
(1) * * *
(i) Count each organic HAP in Table 5 to this subpart that is measured to be present at 0.1 percent by mass or more and at 1.0 percent by mass or more for other organic HAP compounds. For example, if toluene (not listed in Table 5 to this subpart) is measured to be 0.5 percent of the material by mass, you do not have to count it. Express the mass fraction of each organic HAP you count as a value truncated to four places after the decimal point (for example, 0.3791).
(2)
(4)
(b) * * *
(1)
(3) * * *
M
D
(c)
(c)
(h)
(j) * * *
(3) Determine the mass fraction of volatile organic matter for each coating, thinner, and cleaning material used in the coating operation controlled by the solvent recovery system during the compliance period. You may determine the volatile organic matter mass fraction using Method 24 in appendix A-7 of part 60, ASTM D2369-10 (2015), “Test Method for Volatile Content of Coatings” (incorporated by reference, see § 63.14), or an EPA-approved alternative method. Alternatively, you may use information provided by the manufacturer or supplier of the coating. In the event of any inconsistency between information provided by the manufacturer or supplier and the results of Method 24, ASTM D2369-10 (2015), or an approved alternative method, the test method results will govern.
(a) You must conduct each performance test required by § 63.4960 according to the requirements in this section unless you obtain a waiver of the performance test according to the provisions in § 63.7(h).
(1)
(b) Measure total gaseous organic mass emissions as carbon at the inlet and outlet of the add-on control device simultaneously, using either Method 25 or 25A in appendix A-7 of part 60, as specified in paragraphs (b)(1) through (3) of this section. You must use the same method for both the inlet and outlet measurements. You may use Method 18 in appendix A-6 of part 60 to subtract methane emissions from measured total gaseous organic mass emissions as carbon.
(a) * * *
(4) You must maintain the CPMS at all times in accordance with § 63.4900(b) and have readily available necessary parts for routine repairs of the monitoring equipment.
(5) You must operate the CPMS and collect emission capture system and add-on control device parameter data at
(c) * * *
(3) For each gas temperature monitoring device, you must meet the requirements in paragraphs (a) and (c)(3)(i) through (vi) of this section for each gas temperature monitoring device. For the purposes of this paragraph (c)(3), a thermocouple is part of the temperature sensor.
(1) Fails to meet any requirement or obligation established by this subpart including, but not limited to, any emission limit, or operating limit, or work practice standard; or
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
You must comply with the applicable General Provisions requirements according to the following table:
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |