Federal Register Vol. 83, No.44,

I. Discussion

The Board previously adopted a rule delegating to any member of the Board, as designated by the Chairman, the authority to “review and determine an appeal of denial of access to Board records under the Freedom of Information Act, the Privacy Act, and the Board's rules regarding such access.” 1 The Board has determined that the Secretary of the Board is capable of acting on such requests. Accordingly, the Board is amending its rules regarding delegation of authority to delegate to the Secretary of the Board the authority to review and determine an appeal of denial of access to Board records under the Freedom of Information Act, the Privacy Act, and the Board's rules regarding such access, and to delete the existing delegation of authority to individual Board members.

These amendments relate solely to the agency's organization, procedure, or practice. Accordingly, the provisions of the Administrative Procedure Act regarding notice of proposed rulemaking and opportunity for public participation are not applicable.2

Because no notice of proposed rulemaking is required to be issued, or has been issued, in connection with this rule, it is not a “rule” for purposes of the Regulatory Flexibility Act, and that act, therefore, does not apply.3

These amendments do not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995, as amended.4

Section 722 of the Gramm-Leach-Bliley Act 5 requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The Board has sought to present this rule in a simple and straightforward manner.

The rule is not a “substantive rule” for the purposes of the effective-date provision of the Administrative Procedure Act; as such, the act does not require the Board to delay the effective date of the rule.6 Accordingly, the amendments are effective March 6, 2018.

For the reasons stated in the Supplementary Information, the Board of Governors of the Federal Reserve System amends 12 CFR part 265 as follows:

The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart III, Sections 44701 and 44704. Under section 44701, the FAA is charged with prescribing regulations promoting safe flight of civil aircraft in air commerce by prescribing minimum standards required in the interest of safety for the design and performance of aircraft. Under section 44704, the Administrator issues type certificates for aircraft, aircraft engines, propellers, and specified appliances when the Administrator finds the product is properly designed and manufactured, performs properly, and meets the regulations and minimum standards prescribed under section 44701(a). This regulation is within the scope of these authorities because it promotes safety by updating the existing minimum prescribed standards used during the type certification process to address an equivalent method of showing compliance.

The FAA's rules on airworthiness standards for the pilot compartment in rotorcraft and the requirements for each pilot's view from that compartment are located in parts 27 and 29 of title 14 of the Code of Federal Regulations (14 CFR). Specifically, §§ 27.773(a) and 29.773(a) require that each pilot compartment must be free of glare and reflection that could interfere with the pilot's view. Sections 27.773(b) and 29.773(b) require a flight test to show compliance with paragraph (a) of their respective sections if certification for night operations is requested. While this requirement applies to all applicants for rotorcraft installations that may affect the pilot's ability to see outside the aircraft, the FAA finds that a flight test may not be the only means available to show compliance for some modifications. The purpose of the internal lighting tests is to determine whether the lighting creates glare and reflections within the cockpit that could interfere with the pilot's view outside of the aircraft.

The FAA has conducted rotorcraft ground and flight internal lighting tests over the past 15 years where all external lighting was blocked from entering the cockpit on the ground evaluation and then conducted the follow-on night flight tests. They found that the ground test results were the same as the flight tests. Based on this experience, the FAA concluded that the two tests will provide the same results. The FAA has determined that creating an environment where external light is blocked from entering the cockpit or where the rotorcraft is placed in a darkened hangar or paint booth, provides the same environment as a night flight test would for cockpit lighting evaluations. The FAA has concluded that a ground test provides the same level of safety and that the current requirements in §§ 27.773 and 29.773 for a night flight test are imposing an unnecessary economic burden on applicants for certification for night operations.

On October 17, 2016, the FAA published a notice of proposed rulemaking (NPRM), “Rotorcraft Pilot Compartment View” (81 FR 71412). The FAA proposed to allow a ground test as an alternative to a night flight test in certain cases to show compliance for night operations. The FAA included two Draft Advisory Circulars, (AC) 27-1B, Certification of Normal Category Rotorcraft and AC 29-2C, Certification of Transport Category Rotorcraft, setting forth the conditions under which a ground test would be acceptable and an acceptable means of compliance for the ground test.1

The original comment period closed on November 16, 2016. However, the FAA did not post the associated draft advisory circulars (AC) for public display until November 9, 2016. As a result, the FAA reopened the comment period (81 FR 83744) until December 13, 2016.

The FAA received comments from three aviation companies (Aviation Specialists Unlimited, Inc., Garmin International, and The Boeing Company) and three individuals. Two of the aviation companies and an individual supported the proposed rule. The remaining commenters supported the rule but suggested changes, which are discussed below.

An individual requested the FAA clearly define when a ground test can and cannot be performed and address factors such as the amount of interior light emissions, exterior light emissions, color of light emissions, and focal point of light intensity.

The FAA notes that Advisory Circular (AC) 27-1B, Certification of Normal Category Rotorcraft and AC 29-2C, Certification of Transport Category Rotorcraft address the individual's comments. AC 27-1B and AC 29-2C already provide qualitative general guidance to determine appropriate testing methods.2

An individual requested the FAA conduct tests to analyze specific proficiencies and deficiencies of simulated night ground testing. Alternatively, if there is already empirical and observational evidence that proves the safety factors in ground testing, the commenter requested this be identified in the final rule.

The FAA's determination that a ground test provides the same level of safety is based on the FAA's experience with cockpit lighting evaluations for rotorcraft certification projects. The FAA found the two tests had the same results.

Two individuals requested that night testing account for various lighting scenarios. One of these individuals requested the FAA conduct tests to ensure the accuracy of each ground test simulation using both interior and exterior lighting effects on the rotorcraft windshield and visibility. Another individual requested that testing account for different outside lighting scenarios through multiple ground tests, in both a well-lit airfield and a dark hanger.

The intent of this rule is to allow ground tests, under certain circumstances, to demonstrate compliance for night operations. The FAA notes the request to add additional night testing requirements is beyond the scope of this rulemaking. In light of the comments, the FAA recognizes the material in the AC regarding exterior lighting may create confusion. As a result, we have revised the AC to clarify that exterior lighting is identified as exterior aircraft lighting only.

An aviation company requested that the FAA eliminate the requirement to perform either a ground test or a flight test and require instead that applicants show “compliance.” In support of this request, the commenter stated the FAA and industry are generally in agreement that regulations be performance-based without specifying a means of compliance which, instead, is established through policy, guidance, or industry standards.

The requested change to eliminate testing would compromise the level of safety intended by this rule. Because of the complexity and variables involved in lighting interaction in rotorcraft cockpits, the FAA has determined that either a night flight test or a ground test is required.

The FAA is adopting the rule as proposed.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995).

In conducting these analyses, FAA has determined that this proposed rule: (1) Has regulatory cost savings, (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866, (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) would not have a significant economic impact on a substantial number of small entities; (5) would not create unnecessary obstacles to the foreign commerce of the United States; and (6) would not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

This portion of the preamble summarizes the FAA's analysis of the economic impacts of this rule.

The FAA determined that this action will likely result in regulatory cost savings. The current regulations require night flight testing to demonstrate compliance for night operations. This rule provides a less costly ground test as an alternative to a night flight test for certain interior lighting modifications. Currently, the FAA estimates the total cost for a night flight test to be $37,280. These costs include company costs associated with a ground evaluation ($3,600); company flight test, including flight preparation ($16,240); company preparation of the test report ($800); and FAA flight test, including flight preparation ($16,640). Under this final rule, companies can demonstrate compliance on the ground, thereby avoiding the company and FAA flight test costs and saving an estimated $32,880 per demonstration. Under this rule, the total cost for a ground test is about $4,400, which is substantially less costly than a night flight test of $37,280.

The FAA estimates that 10,506 helicopters in the current fleet will be affected by the final rule. In addition, the FAA receives approximately 120 certification project tests annually. Note that after certification, new helicopters may not need to be upgraded in the next 10 years.3 However, the other helicopters will need at least 1 cockpit illumination upgrade within the next 10 years based on FAA data. In particular, approximately 4,000 rotorcraft will have to upgrade their automatic dependent surveillance-broadcast (ADS-B) in the first 3 years after the rule goes into effect.4 All of the remaining 6,506 are expected to have cockpit lighting night testing due to upgrading communication, surveillance systems, or navigation/electronic indicators in the remaining 7 years.5

As a result, this rule will relieve industry from performing higher cost night flight tests with lower cost ground tests resulting in cost savings. The FAA estimates industry will gain about $384.9 million in total undiscounted cost savings over a 10-year period of analysis [$32,880 × (10,506 tests + 1,200 certification projects)]. The FAA estimates industry's present value cost savings to be about $277.2 million and annualized costs savings to be about $39.5 million using a 7 percent discount rate. The following table provides cost savings to industry over a 10-year period of analysis.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2018-0012-E, dated January 16, 2018 (referred to hereinafter as “the MCAI”), to address an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0084.

We reviewed Safran Helicopter Engines Alert Mandatory Service Bulletin (MSB) No. A319 79 4840, Version A, dated November 27, 2017, and Safran Helicopter Engines Alert MSB No. A319 79 4841, Version A, dated November 20, 2017. The MSBs describe procedures, respectively, for inspecting and replacing the magnetic heads installed on the electrical magnetic plugs. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by France and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This final rule requires inspection and replacement of the magnetic heads installed on oil system electrical magnetic plugs.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the compliance time for the action is less than the time required for public comment. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0084 and Product Identifier 2018-NE-02-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

We estimate that this AD affects 105 engines installed on helicopters of U.S. registry.

We estimate the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

I. Background

The Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA) 1 requires the head of each Federal agency to periodically adjust for inflation the minimum and maximum amount of CMPs provided by law within the jurisdiction of that agency.2 A 2015 amendment to the FCPIAA 3 required agencies to make an initial “catch-up” adjustment to its civil monetary penalties effective no later than August 1, 2016.4 For every year thereafter effective not later than January 15, the FCPIAA, as amended, requires agencies to make annual adjustments for inflation, with guidance from the Director of the Office of Management and Budget.5

The following sections of the CEA provide for CMPs that meet the FCPIAA definition 6 and these CMPs are, therefore, subject to the inflation adjustment: Sections 6(c), 6b, and 6c of the CEA.7

The FCPIAA annual inflation adjustment, in the context of the CFTC's CMPs, is determined by increasing the maximum penalty by a “cost-of-living adjustment”, rounded to the nearest multiple of one dollar.8 Annual inflation adjustments are based on the percent change between the October Consumer Price Index for all Urban Consumers (CPI-U) preceding the date of the adjustment, and the prior year's October CPI-U.9 In this case, October 2017 CPI-U (246.663)/October 2015 CPI-U (241.729) = 1.02041.10 In order to complete the 2018 annual adjustment, the CFTC must multiply each of its most recent CMP amounts by the multiplier, 1.02041, and round to the nearest dollar.11

Applying the FCPIAA annual inflation adjustment methodology results in the following amended CMPs:

The FCPIAA provides that any increase under the FCPIAA in a civil monetary penalty shall apply only to civil monetary penalties, including those whose associated violation predated such increase, which are assessed after the date the increase takes effect.13 Thus, the new CMP amounts established by this rulemaking shall apply to penalties assessed after March 6, 2018, for violations that occurred on or after November 2, 2015, the effective date of the FCPIAA amendment requiring annual adjustments, the 2015 Act.14

The FCPIAA specifically exempted from the Administrative Procedure Act (APA) the rulemakings required to implement annual inflation adjustments.15 “This means that the public procedure the APA generally requires—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.” 16 The Commission further notes that the notice and comment procedures of the APA do not apply to this rulemaking because the Commission is acting herein pursuant to statutory language that mandates that the Commission act in a nondiscretionary matter.17

The Regulatory Flexibility Act 18 requires agencies with rulemaking authority to consider the impact of certain of their rules on small businesses. A regulatory flexibility analysis is only required for rules for which the agency publishes a general notice of proposed rulemaking pursuant to section 553(b) or any other law.19 Because, as discussed above, the Commission is not obligated by section 553(b) or any other law to publish a general notice of proposed rulemaking with respect to the revisions being made to regulation 143.8, the Commission additionally is not obligated to conduct a regulatory flexibility analysis.

The Paperwork Reduction Act of 1995 (PRA),20 which imposes certain requirements on Federal agencies, including the Commission, in connection with their conducting or sponsoring any collection of information as defined by the PRA, does not apply to this rule. This rule amendment does not contain information collection requirements that require the approval of the Office of Management and Budget.

Section 15(a) of the CEA 21 requires the Commission to consider the costs and benefits of its action before issuing a new regulation. Section 15(a) further specifies that costs and benefits shall be evaluated in light of five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness, and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations.

The Commission believes that benefits of this rulemaking greatly outweigh the costs, if any. As the Commission understands, the statutory provisions by which it is making cost-of-living adjustments to the CMPs in regulation 143.8 were enacted to ensure that CMPs do not lose their deterrence value because of inflation. An analysis of the costs and benefits of these adjustments were made before enactment of the statutory provisions under which the Commission is operating, and limit the discretion of the Commission to the extent that there are no regulatory choices the Commission could make that would supersede the pre-enactment analysis with respect to the five factors enumerated in section 15(a), or any other factors.

For the reasons set forth in the preamble, the Commodity Futures Trading Commission amends part 143 of title 17 of the Code of Federal Regulations as follows:

BNSF, bridge owner, requested that the BNSF Swing Bridge across the Columbia River, mile 105.6, remain in the closed-to-navigation position to marine vessel traffic for maintenance and component replacement activities. The BNSF Swing Bridge provides 39 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position. This deviation allows the BNSF Swing Bridge to remain in the closed-to-navigation position, and need not open for maritime traffic as listed in the table below:

The subject bridge operates in accordance with 33 CFR 117.5. The bridge shall operate in accordance to 33 CFR 117.5 at all other times.

Waterway usage on this part of the Columbia River includes vessels ranging from large ships to commercial tug and tow vessels to recreational pleasure craft including cabin cruisers and sailing vessels. Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies during this closure period if a one hour notice is given except on March 6, 2018 and March 8, 2018, and there is no immediate alternate route for vessels to pass. We contacted known river users, and requested objections to reschedule BNSF's maintenance period. We have not received any objections to this deviation. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

I. Background, Purpose and Legal Basis

Due to infrequent drawbridge opening requests between Friday evenings through Monday early mornings, Oregon Department of Transportation (ODOT) (bridge owner), has requested to open the three highway bridges within Youngs Bay and Lewis and Clark River with 2 hours advance notice. The Youngs Bay highway bridge, Old Youngs Bay highway bridge and the Lewis and Clark River highway bridge are within one mile of each other, and currently open on signal for the passage of vessels with one half-hour notice by marine radio, telephone, or other suitable means. These three bridges are operated by the Lewis and Clark River highway bridge operator. The subject bridges operate per 33 CFR 117.899.

Vessels operating on Youngs Bay and the Lewis and Clark River range from small recreational vessels, sailboats, tribal fishing boats and small commercial fishing vessels. No navigational impacts are expected due to few vessels operating on these waterways at the stated hours. Also during roadway maintenance in 2016 and 2017, we approved deviations for the three subject bridges allowing these bridges to open on a three hour notice. No complaints or opening issues were identified at all hours of the day. Vessels able to pass through the subject bridges with the draw in the closed-to-navigation position may do so at any time.

This deviation authorizes ODOT to open the Youngs Bay highway bridge, the Old Youngs Bay highway bridge and the Lewis and Clark River highway bridge, with a two hour advance notice on weekends from 5 p.m. on Friday to 7 a.m. on Monday, including all Federal holidays but Columbus Day, starting 5 p.m. on March 16, 2018 through 7 a.m. on August 10, 2018. The Youngs Bay highway bridge provides a vertical clearance approximately 37 feet above mean high water when in the closed-to-navigation position. The Old Youngs Bay highway bridge provides a vertical clearance approximately 19 feet above mean high water when in the closed-to-navigation position. The Lewis and Clark River highway bridge provides a vertical clearance of 17 feet above mean high water when in the closed-to-navigation position.

The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the subject bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary test deviation. Youngs Bay and the Lewis and Clark River do not have an immediate alternate route for vessels to pass through the subject bridges. The subject bridges will be not be able to open for emergencies.

In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacynotice.

Documents mentioned in this notice as being available in the docket and all public comments, will be in our online docket at http://www.regulations.gov, and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

On August 17, 2017, the Coast Guard published a notice of deviation from drawbridge regulation with request for comments in the Federal Register (82 FR 39019) to test proposed changes. Three comments were received, which were in favor of the regulation changes. Due to unanticipated delays in processing this proposed regulatory change, the Coast Guard finds it necessary to extend the test deviation to allow additional time for public comment. The changes to the operating schedules proposed in this deviation will coincide with the establishment of the proposed Presidential Security Zone (see 82 FR 28036).

When the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago, drawbridge openings have caused traffic backups in the West Palm Beach area. The increase in traffic congestion occurs when the presidential motorcade is in transit, which closes the Southern Boulevard Bridge to vehicle and vessel traffic. This action requires through traffic to use the Flagler Memorial and Royal Park Bridges. The Mayor of Palm Beach has asked the Coast Guard and the bridge owner, Florida Department of Transportation, to test a change to the operating regulations of those bridges.

During this temporary deviation, the Flagler Memorial Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:15 p.m., 3:15 p.m., 4:15 p.m. and 5:15 p.m., weekdays only, if vessels are requesting an opening. The Royal Park Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:30 p.m., 3:30 p.m., 4:30 p.m. and 5:30 p.m., weekdays only, if vessels are requesting an opening. At all other times the bridges will operate per their normal schedules, published in 33 CFR 117.261(u) and (v), respectively.

The operating schedule of the Southern Boulevard Bridge, which is closest to Mar-a-Lago, will be allowed to remain closed to navigation whenever the presidential motorcade is in transit. At all other times the bridge shall operate under the normal operating schedule, published in 33 CFR 117.261(w).

This test deviation will have an impact on marine traffic while alleviating some vehicle traffic backups. Tugs with tows are not exempt from this regulation. Vessels able to pass through the Flagler Memorial and Royal Park Bridges in the closed position may do so at any time. The bridges will be able to open for emergencies. The Southern Boulevard Bridge will be under the control of the on-scene designated representative.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacynotice.

Documents mentioned in this notice as being available in this docket and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

The Washington State Department of Transportation, the bridge owner, has requested that the SR 529 highway bridges, north bound and south bound, across the Snohomish River and Steamboat Slough remain in the closed-to-navigation position. This request is to facilitate safe, uninterrupted roadway passage of participants of the Everett Half Marathon. The SR 529 highway bridges across the Snohomish River, at mile 3.6, provide 37 feet of vertical clearance above mean high water elevation while in the closed-to-navigation position; and these bridges operate in accordance with 33 CFR 117.1059(c). The SR 529 highway bridges across Steamboat Slough, at mile 1.1 and 1.2, provide 10 feet of vertical clearance above mean high water elevation in the closed-to-navigation position; and these bridges operate in accordance with 33 CFR 117.1059(g).

The SR 529 bridges crossing the Snohomish River and Steamboat Slough are authorized to remain in the closed-to navigation position, and need not open for maritime traffic from 7:30 a.m. to 11 a.m. on April 8, 2018. The bridges shall operate in accordance to 33 CFR 117.1059 at all other times. Vessels able to pass under the subject bridges in the closed-to-navigation position may do so at any time, and these bridges will be required to open, if needed, for vessels engaged in emergency response during the closure period.

Waterway usage on this part of the Snohomish River and Steamboat Slough includes vessels ranging from commercial tug and barge to small pleasure craft. An alternate route for vessels to pass is available through Ebey Slough and Union Slough near the entrance of Steamboat Slough at high tide. A request for comment with any objections to this deviation was advertised in the Local Notice to Mariners. We did not receive any comments or objections. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Union Pacific Railroad Company (UPRR) owns and operates the Steel Bridge across the Willamette River, at mile 12.1, in Portland, OR. UPRR requested a temporary deviation from the operating schedule for the Steel Bridge lower lift span. The deviation is necessary to accommodate the Shamrock Stride run/walk event. The Steel Bridge is a double-deck lift bridge, and the lower lift span operates independent of the upper lift span. To facilitate this temporary deviation request, the lower lift span is authorized to remain in the closed-to-navigation position, and need not open to marine vessels from 10:15 a.m. to 11:15 a.m. on March 18, 2018. When the lower span is in the closed-to-navigation position, the bridge provides 26 feet of vertical clearance above Columbia River Datum 0.0. The lower lift span of the Steel Bridge operates in accordance with 33 CFR 117.5.

Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass through the subject bridge with the lower deck in the closed-to-navigation position may do so at any time. The lower lift of the Steel Bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard requested objections be submitted to this deviation in the Local Notice to Mariners. We have not received any objections to this temporary deviation from the operating schedule. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the subject bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

On November 30, 2016 (81 FR 86270), the Postal Service published its revised Freedom of Information Act (FOIA) regulations to comply with the FOIA Improvement Act of 2016 (FOIAIA), effective December 27, 2016. In response to public comments, the Postal Service published an additional change to these regulations on January 10, 2017 (82 FR 2896). After further review, the Postal Service published miscellaneous technical corrections to its regulations on March 8, 2017 (82 FR 12921). The Postal Service is now making two technical corrections to the Change of Address or Boxholder Request Format for process servers found at 39 CFR 265.14. The first revision makes the requirement to provide a copy of the statute or regulation that empowers a requester to serve process optional rather than mandatory. The second revision changes the incorrect citation 39 CFR 265.14(d)(4)(ii) to 39 CFR 265.14(d).

For the reasons stated in the preamble, the Postal Service amends 39 CFR part 265 as follows:

I. Background

On November 2, 2017 (82 FR 50851), EPA published a notice of proposed rulemaking (NPR) for the Lebanon County Area. In the NPR, EPA proposed to determine that the Lebanon County Area attained the 2012 annual PM2.5 NAAQS.

Under EPA's longstanding Clean Data Policy,1 which was codified in EPA's Clean Air Fine Particulate Implementation Rule (72 FR 20586, April 25, 2007), EPA may issue a determination of attainment after notice and comment rulemaking determining that a specific area is attaining the relevant standard. See 40 CFR 51.1004. The effect of a clean data determination is to suspend the requirement for the area to submit an attainment demonstration, RACM, RFP plan, contingency measures, and any other planning State Implementation Plans (SIPs) related to attainment for as long as the area continues to attain the standard. In EPA's Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements final rule (81 FR 58010, August 24, 2016), EPA reaffirmed the Clean Data Policy at 40 CFR 51.1015.

Under EPA regulations at 40 CFR part 50, section 50.18 and appendix N, the annual primary PM2.5 standard is met when the 3-year average of PM2.5 annual mean mass concentrations for each eligible monitoring site is less than or equal to 12.0 micrograms per cubic meter (μg/m3). Three years of valid annual means are required to produce a valid annual PM2.5 NAAQS design value.

Consistent with the requirements of 40 CFR part 50, section 50.18 and appendix N, EPA determined the Lebanon County Area has attained the 2012 annual PM2.5 NAAQS. The certified annual design value for 2014-2016 is 11.2 μg/m3, which is below the 2012 annual primary PM2.5 standard of 12.0 μg/m3.

The specific requirements of this determination of attainment and the rationale for EPA's proposed action, including how the annual design value for 2014-2016 was calculated, are explained in the NPR and will not be restated here. EPA received comments that are addressed in Section III of this rulemaking action.

EPA received adverse comments from one commenter, the Clean Air Council (hereinafter referred to as the “Commenter”). The Commenter expressed concern about EPA's calculations performed for this determination of attainment. The Commenter states, “EPA should perform its calculations again and provide explanations for its conclusions, which were not substantiated by the background documents in the rulemaking docket.” EPA provided its explanations and support for the determination of attainment in the NPR and explained the certified annual design value for 2014-2016 is 11.2 μg/m3, which is below the 2012 annual primary PM2.5 standard of 12.0 μg/m3. The Commenter's specific concerns are summarized and addressed in this section.

Comment 1: For the 2015 annual mean, the Commenter confirmed the annual mean calculation from EPA but had comments regarding data from the second quarter of 2015. The Commenter noted there was only monitored data for 64 of the 91 days in the quarter which led EPA to conduct a “data completeness test.” The Commenter states that “EPA substituted 30.5 micrograms per cubic meter for each of the 27 days of missing data, based on the premise that this figure was the highest daily average in the second quarters of 2014, 2015, and 2016” and stated that this figure was the daily average for June 11, 2015, during the second quarter of 2015. The Commenter states that EPA does not acknowledge that there was actually a higher daily value of 34 μg/m3 on May 11, 2016, during the second quarter of 2016 based on data Commenter obtained from an EPA website.2 The Commenter states that it is possible that EPA excluded this figure under the rationale that there was an “extraordinary event.” The Commenter also notes there was additional monitored data available related to Parameter Occurrence Code 3 (POC 3) from the EPA website for the second quarter of 2015 which EPA did not consider in supporting the determination of attainment. The Commenter notes the design value would still be lower than the NAAQS but notes EPA should provide a legal and technical explanation and should perform the calculations again based on the correct data.

Response 1: In accordance with 40 CFR part 50, appendix N, section 3.0(d)(1), the Pennsylvania Department of Environmental Protection (PADEP) installed a PM2.5 monitor with federal reference method (FRM) code 145, parameter occurrence code 1 (POC 1) at the Lebanon County site (Site ID 42-075-0100) and designated this monitor as the primary monitor in January 2016.3 PADEP also has a collocated monitor with federal equivalent method (FEM) code 170, parameter occurrence code 3 (POC 3). 40 CFR part 50, appendix N, section 3.0(d)(1), states: “The default dataset for PM2.5 mass concentrations for a site shall consist of the measured concentrations recorded from the designated primary monitor(s). All daily values produced by the primary monitor are considered part of the site record; this includes all creditable samples and all extra samples.” Additionally 40 CFR part 58, appendix A, section 3.2.3 states: “For each pair of collocated monitors, designate one sampler as the primary monitor whose concentrations will be used to report air quality for the site, and designate the other as the quality control monitor. There can be only one primary monitor at a monitoring site for a given time period.” As previously mentioned on January 1, 2016, PADEP designated POC 1 as the primary monitor. Therefore, after January 1, 2016, on days where the primary monitor POC 1 produces a daily value, it is considered part of the site record and not the data from collocated monitor POC 3.

Additionally, 40 CFR part 50, appendix N, section 3.0(d)(2), states that, “Data for the primary monitors shall be augmented as much as possible with data from collocated monitors. If a valid daily value is not produced by the primary monitor for a particular day (scheduled or otherwise), but a value is available from a collocated monitor, then that collocated value shall be considered part of the combined site data record (emphasis added). If more than one collocated daily value is available, the average of those valid collocated values shall be used as the daily value. The data record resulting from this procedure is referred to as the `combined site data record.' ”

Pursuant to 40 CFR part 50, appendix N, section 3.0(d)(2), the data from collocated monitor POC 3 is only considered as part of the combined site data record (to be used in determining design value for the 2012 annual PM2.5 NAAQS) when there is no valid daily value from the primary monitor POC 1. For the data substitution test 4 performed by EPA in the second quarter of 2015 due to missing data values, EPA used the highest daily site record for the second quarter substitution value. 40 CFR part 50, appendix N, section 1(c) defines the value used for the maximum data substitution test and provides “[t]he maximum quarterly value data substitution test substitutes actual `high' reported daily PM2.5 values from the same site (specifically, the highest reported non-excluded quarterly value(s) (year non-specific) contained in the combined site record for the evaluated 3-year period) for missing daily values.” The daily site record included data from POC 1 and POC 3 depending on which monitor was primary and which monitor had valid data between April 1 and June 30 in 2014, 2015, and 2016, i.e. the second quarters of 2014, 2015, and 2016. EPA determined that the highest daily site record for the second quarter substitution value was 30.5 μg/m3 recorded on June 11, 2015 from POC 1. The higher daily value of 34 μg/m3 was recorded on May 11, 2016 by the collocated monitor, POC 3. However, because POC 1 produced a valid daily value of 29.1 μg/m3 on this same day, May 11, 2016, the data value from POC 3 was not used in the data substitution test as the highest daily site record and therefore the daily value of 30.5 μg/m3 recorded on June 11, 2015 was the highest daily site record for the second quarter between 2014-2016. EPA's use of 30.5 μg/m3 in the data substitution test for 2015 was therefore correct and in accordance with 40 CFR part 50 appendix N, and no calculations need to be redone for the 2015 annual mean. EPA notes that we did not exclude this data (the 34 μg/m3 recorded on May 11, 2016 by the collocated monitor, POC 3) in our data substitution analysis due to any “exceptional event,” as we did not use this data because data from the primary monitor POC 1 was available on that same day. See 40 CFR part 50, appendix N, section 3.0(d)(2).

Comment 2: For the 2016 annual mean, the Commenter states that it is unclear which monitor is intended to be the primary monitor. The Commenter claims that the 2016 annual mean should be 12.22 μg/m3 instead of EPA's calculated mean of 9.72 μg/m3 and states it was unclear how EPA calculated its annual mean for 2016. Therefore, based on the Commenter's calculations, the annual design value for 2014-2016 should be 12.03 μg/m3 using the higher annual mean for 2016 calculated by the Commenter. The Commenter claims the difference is material because the analysis leads to a determination that Lebanon County is still not attaining the standard of 12.0 μg/m3. Additionally, the Commenter requests that if EPA “has relied primarily on data from POC 1, to the exclusion of data from POC 3, it should provide an explanation of the legal and technical authority for doing so.” The Commenter notes data from POC 1 was generally lower than data from POC 3 when both monitors were operating on the same dates.

Response 2: As discussed in Response 1, POC 1 became the designated primary monitor as of January 2016. See 40 CFR part 50, appendix N, section 3.0(d)(1) and (2) and Docket ID EPA-R03-OAR-2017-0479-0016. When calculating the 2016 annual mean, EPA used the data from primary monitor POC 1 and substituted any missing days from the primary monitor with data from collocated monitor POC 3. Id. This resulted in 2016 quarterly means of 12.18, 8.70, 8.62, 9.37 μg/m3 and an annual mean of 9.72 μg/m3, and not 12.22 μg/m3, which Commenter calculated by inappropriately combining data from POC 1 and POC 3. POC 1 is the primary monitor and thus the primary source of data for determining the mean unless data is missing. Id. Thus, EPA correctly calculated the 2016 annual mean and the 2014-16 design value as explained in the NPR. While EPA disagrees with the Commenter's analysis as stated above, EPA notes that the Commenter's calculated design value of 12.03 μg/m3 (even if correct) would still demonstrate an attaining design value for the 2012 annual PM2.5 NAAQS. 40 CFR part 50, appendix N, section 4.3(a) states, “[a]nnual PM2.5 NAAQS DVs (design values) shall be rounded to the nearest tenth of a µg/m3 (decimals x.x5 and greater are rounded up to the next tenth, and any decimal lower than x.x5 is rounded down to the nearest tenth).” Therefore, based on the rounding conventions established at 40 CFR part 50, appendix N, section 4.3(a), 12.03 μg/m3 would round to 12.0 μg/m3 and still meet the 2012 annual PM2.5 NAAQS.

Comment 3: The Commenter states that an EPA guidance document contemplates supplementing data from a primary monitor with data from a secondary monitor. See AQS Tech Note POC 6-28-13, Technical Note—Guidance on the Use of Parameter Occurrence Codes (POCs) When Using Multiple Instruments at Monitoring Sites, https://www.epa.gov/aqs/aqs-tech-note-poc-6-28-13 (“The regulatory language for particulate matter (PM) and lead (Pb) monitoring allows for the combining of data when the primary monitor at the site does not sample on a particular day either due to it not being a scheduled sampling day or the instrument did not collect a valid sample.”).

Response 3: “AQS (Air Quality System) Tech Note POC 6-28-13” is a technical memo from EPA to states, local, tribal, and other data users who use the Air Quality System5 (AQS) to submit and retrieve air quality data. The memo explains that each individual monitor should be reported to AQS under a specific POC even if the data from these monitors is going to routinely be combined as the site record. Reporting data this way allows data users to properly assess the quality of data from a specific monitor while providing the proper sample completeness at a monitoring site. The memo goes further to explain that in 2008, AQS was enhanced to automatically combine PM2.5 values from collocated data in accordance with 40 CFR part 50, appendix N. As described in Response 1, EPA does allow the data from a collocated monitor to be considered as part of the combined site data record when there is no valid daily value from the primary monitor. EPA thus correctly considered data from the collocated monitor in Lebanon County when appropriate in accordance with 40 CFR part 50, appendix N.

Comment 4: The Commenter states that there is a discrepancy for the third quarter of 2016, as the Commenter found 92 data samples instead of 91 data samples using data downloaded from EPA's website.

Response 4: EPA has reviewed the third quarter data for 2016 and has determined that on August 10, 2016, neither POC 1 nor POC 3 produced a valid daily value. Therefore, 91 data samples were used in calculating the third quarter 2016 mean. Thus, no discrepancy or error exists.

Comment 5: The Commenter claims that EPA relied on data from POC 3 exclusively for 2014 and 2015 and excluded data from POC 3 in the face of lower data from a new POC 1.

Response 5: As previously discussed in Response 1, POC 1 is the designated primary monitor as of January 2016 and POC 3 is a collocated monitor. See 40 CFR part 50, appendix N, section 3.0(d)(1) and (2). Therefore, the data from primary monitor POC 1 is used as the site record, but is augmented with data from collocated monitor POC 3 whenever there is missing data from POC 1. In 2016, POC 3 data was used as the site record 60 days out of the 364 days used to calculate the 2016 annual mean because data from POC 1, the designated primary monitor, was not available. EPA therefore appropriately used data from POC 1 when available in 2016 in calculating the annual mean and used data from POC 3 in 2016 when data from POC 1 was unavailable in accordance with CAA regulations.

EPA is making a final determination that the Lebanon County Area has attained the 2012 annual PM2.5 NAAQS. As provided in 40 CFR 51.1015, finalization of this determination suspends the requirements for this area to submit an attainment demonstration, associated RACM, RFP plan, contingency measures, and any other planning SIP requirements related to the attainment of the 2012 PM2.5 NAAQS, so long as this area continues to meet the standard. This determination of attainment does not constitute a redesignation to attainment. The Lebanon County Area will remain designated nonattainment for the 2012 annual PM2.5 NAAQS until such time as EPA determines that the area meets the CAA requirements for redesignation to attainment, including an approved maintenance plan, pursuant to sections 107 and 175A of the CAA.

This rulemaking action proposes to make a determination of attainment of the 2012 PM2.5 NAAQS based on air quality data and does not impose additional requirements. For that reason, this proposed determination of attainment:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to 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; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the Lebanon County Area does not include any Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

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 May 7, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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 determining that the Lebanon County Area attained the 2012 annual PM2.5 NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On December 5, 2017 (83 FR 57415), EPA published a Notice of Proposed Rulemaking (NPRM) for the Commonwealth of Massachusetts. The NPRM proposed approval of revisions to 310 Code of Massachusetts Regulations (CMR) 7.30 Massachusetts Port Authority (Massport)/Logan Airport Parking Freeze. The formal SIP revision was submitted by Massachusetts on July 13, 2017.

The revised 310 CMR 7.30 increases the total number of commercial spaces in the Logan Parking Freeze area by 5,000 spaces to a total of 26,088. In the event that the remaining 702 park-and-fly spaces in the East Boston Parking Freeze cap were converted to commercial spaces at Logan Airport in the future, the maximum total number of spaces permitted would be 26,790.

In addition, the revision requires Massport to complete the following studies within 24 months of June 30, 2017: (1) Potential improvements to high occupancy vehicle access to Logan Airport; (2) a cost and pricing assessment for different modes of transportation to and from Logan Airport in order to generate revenue for the promotion of high-occupancy vehicle (HOV) use by airport travelers and visitors; and (3) the feasibility and effectiveness of potential operational measures to reduce non-HOV pick-up/drop-off modes of transportation to Logan Airport.

Finally, the revision allows Massport to satisfy its annual reporting requirements through its submission of annual Environmental Data Reports or similar airport-wide documents under the Massachusetts Environmental Policy Act (MEPA).

The rationale for EPA's proposed action is explained in the NPR and will not be restated here. EPA received comments from the Conservation Law Foundation (CLF) in support of the NPRM after the close of the comment period, and they have been included in the docket for this action. Initially, CLF opposed the addition of 5,000 commercial parking spaces. However, with the development of a binding agreement between CLF and Massport, CLF now supports this SIP revision due to the agreed upon addition of substantial transportation mitigation measures and increased HOV targets. The only comment received during the public comment period was not germane or specific to this rulemaking, and did not state how or why the rule should be changed. Therefore, no additional response to the comment will be provided here.

EPA is approving revised 310 CMR 7.30 Massport/Logan Airport Parking Freeze as a revision to the Massachusetts SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of 310 CMR 7.30 Massport/Logan Airport Parking Freeze described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to 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 Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 7, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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. (See section 307(b)(2).)

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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 number EPA-HQ-OPP-2017-0080 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 May 7, 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-2017-0080, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F8520) by Monsanto Company, 1300 I (Eye) St. NW, Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the plant growth regulator LCO SP104 in or on raw agricultural commodities and processed foods. That document referenced a summary of the petition prepared by the petitioner, Monsanto Company, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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.” FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

EPA evaluated the available toxicity and exposure data on LCO SP104 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Lipochitooligosaccharides (LCOs) are signaling molecules produced by bacteria, which are involved in the initiation of plant-microbe endosymbiosis (the scenario when a microbe colonizes a plant) in an estimated 70-80% of terrestrial plants. As a pesticide, LCO SP104, a synthetically produced LCO, is intended for use as a plant growth regulator (PGR) to increase growth and decrease stress in growing crops. Typical of a PGR, LCO SP104 should be applied at low concentrations because use at high concentrations can result in detrimental effects to the plant. LCO SP104 is structurally similar to naturally occurring LCOs. Humans are exposed to naturally occurring LCOs as they are present in the roots of food crops and in the bacteria and fungi that are associated with the roots of these crops. Molecules identical to LCO breakdown products (such as chitin) are also present in insects, crustaceans, fungi, bacteria, and humans, and are regularly consumed by humans as part of a normal diet.

Based on the data submitted in support of this petition (summarized in Unit II. B., below) and the comprehensive risk assessment conducted by the Agency (included in the Docket for this action), EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to LCO SP104, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is not acutely toxic and, based upon a weight of the evidence (WOE) approach, it has been determined not to be a developmental toxicant, a mutagen, or toxic via repeat oral exposure (i.e. not subchronically toxic via the oral route). As such the Agency has not identified any endpoints of concern for LC SP104 and has conducted a qualitative assessment of exposure. The Agency has determined that residues of LCO SP104 in drinking water are not expected when products are used according to label instructions. The active ingredient is applied at low concentrations, is very soluble in water, and will dissociate within minutes once applied. Non-occupational exposures are not expected since LCO SP104 is not intended for residential use. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the January 22, 2018, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Lipochitooligosaccharide (LCO) SP104.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

Based upon its evaluation, EPA concludes that LCO SP104 is of low acute toxicity and no toxicological endpoints have been identified for this compound. Therefore, 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 LCO SP104. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of LCO SP104.

An analytical method is not required for enforcement purposes due to the lack of concern about safety for LCO SP104 at any exposure level.

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 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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 et seq.) do not apply.

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 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, 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 number EPA-HQ-OPP-2016-0519 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 May 7, 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-2016-0519, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8450) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.614 be amended by establishing tolerances for residues of the fungicide kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-α-D-arabino-hexopyranosyl]-D-chiro-inositol, in or on fruit, stone, subgroup 12-12A at 0.6 parts per million (ppm) and walnut at 0.04 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience North America, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

In accordance with EPA's significance figures policy, as discussed in Unit IV.C., the established tolerance for cherry subgroup 12-12A is adjusted slightly from the petition request.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for kasugamycin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with kasugamycin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Kasugamycin is an aminoglycoside antibiotic pesticide with limited activity against some plant bacterial and fungal pathogens. There are no human or veterinary therapeutic applications due to low efficacy, but at one time was used clinically in Japan to treat Pseudomonas kidney infections in humans (Shuwirth et al. (2006) Nat. Struct. Mol. Biol. 13(10):879-886). The mode of action is distinct from other aminoglycosides such as streptomycin, which also has pesticidal uses. Kasugamycin inhibits formation of the 30S ribosomal subunit at initiation of protein synthesis by perturbing the mRNA-tRNA codon/anticodon interaction; other aminoglycoside antibiotics bind to the 30S ribosomal subunit, but disrupt translation of mRNA at later stages of initiation.

The primary target organs identified for kasugamycin were the testes and kidney. These effects were seen at higher dose levels, generally at the highest dose tested (HDT). In the rat combined chronic toxicity/carcinogenicity study, an increased incidence and severity of testicular tubular atrophy was observed at histopathological evaluations at 6, 12 and 24 months. Testicular degeneration and atrophy were also observed in adult F1 males in the rat reproductive toxicity study at the highest dose. Testicular tubular dilatation and degeneration were observed in the subchronic mouse study at a dose that exceeded the limit dose, but not in the mouse carcinogenicity study, which tested at much lower doses. In the dog chronic toxicity study, testicular inflammation was reported at the high dose, but was not accompanied by atrophic or degenerative changes, and was not considered a treatment-related adverse effect.

Kidney toxicity is often associated with exposure to aminoglycoside antibiotics. In the rat reproductive toxicity study, kidney dilatation and increased incidence of chronic progressive nephropathy were observed in F1 males. In the subchronic rat study, increased incidence of eosinophilic bodies (slight severity) in the renal proximal tubular cells was reported in males at several dose levels. These effects were considered treatment-related but not adverse due to the low severity and lack of associated findings. However, in female rats, increased epithelial cells in the urinary sediment, along with decreased urine pH (also seen in males), was considered evidence of possible kidney toxicity. Slight lipofuscin deposition in the rat combined chronic toxicity/carcinogenicity study was not considered adverse due to the lack of other related findings (this study tested up to the NOAEL of the subchronic study). The rat metabolism study indicated higher levels of radioactivity in the kidneys than other tissues. In the subchronic mouse study, minimal to severe basophilia/hyperplasia in the renal pars recta in females was observed. No renal effects were seen in the mouse carcinogenicity study or in the dog.

Kasugamycin caused decreased body weight and/or weight gain in subchronic studies in the rat, mouse and dog. The chronic studies, which tested at lower doses, did not show body weight effects. Decreased body weight was also observed in developmental and reproductive studies in the rat and the range-finding study for the rabbit developmental study. Body weight effects in the mouse immunotoxicity study were observed only at a dose exceeding the limit dose.

Kasugamycin appears to be irritating to the oral and gastrointestinal tract mucosa. Anal lesions and perianal/perigenital staining were observed in the subchronic mouse study. Red and swollen skin around the anal opening, and inflammation and ulceration of the rectum, were noted in male and female rats of both generations in the 2-generation reproduction study. In the rat developmental toxicity study, distention of the large intestine with stool in the cecum, and an increased incidence of loose stool, were reported. Similar findings were seen in the rabbit developmental range-finding study among females that died or were sacrificed in extremis. These effects may be related to the acidity (or other irritant property) of the active ingredient, which is primarily excreted unabsorbed and un-metabolized in the feces. In the dog, tongue and mouth lesions were reported at the highest dose tested in the subchronic toxicity study (but not the chronic study, which tested at a lower dose). Systemic effects were not observed in the rat 21-day dermal study at doses up to the limit dose, but local dermal irritation was observed.

The available studies, including rat acute and subchronic neurobehavioral screening studies, did not show evidence of neurotoxicity. A 28-day mouse immunotoxicity study did not show evidence of immune system effects.

There was no evidence of increased quantitative or qualitative susceptibility in rat or rabbit developmental toxicity studies, or in the rat reproductive study. No developmental effects were seen in the rat developmental study up to doses causing maternal toxicity (decreased body weight gain, food consumption, and feed efficiency). No maternal or developmental toxicity was observed in the main rabbit developmental toxicity study, in the dose range-finding study, but maternal weight loss, reduced food consumption during dosing and abortions (GD 18 or later) were observed at higher doses. Fetal weight was decreased at the maternally toxic dose, but could not be evaluated at higher doses due to maternal death and abortions. In the rat reproductive toxicity study, parental toxicity included decreased body weight/weight gain. No offspring toxicity was observed. Reproductive toxicity at the highest dose tested (above the parental LOAEL) included testicular atrophy, decreased fertility and fecundity in the F1 parents for both litters, and an increased pre-coital interval during the F2b litter mating period.

Kasugamycin is classified as “not likely to be carcinogenic to humans,” based on lack of evidence of carcinogenicity in rat and mouse carcinogenicity studies. There was no evidence of genotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by kasugamycin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Kasugamycin. Human Health Risk Assessment for the Proposed Section 3 Registration of New Uses of the Antibiotic Fungicide on Cherry Subgroup 12-12A and Walnuts” on pages 30-39 in docket ID number EPA-HQ-OPP-2016-0519.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for kasugamycin used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of August 29, 2014 (79 FR 51492) (FRL-9911-57).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to kasugamycin, EPA considered exposure under the petitioned-for tolerances as well as all existing kasugamycin tolerances in 40 CFR 180.614. EPA assessed dietary exposures from kasugamycin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for kasugamycin; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United Stated Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed tolerance level residues and 100% crop treated for all registered and proposed crops.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that kasugamycin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for kasugamycin. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for kasugamycin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of kasugamycin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide Root Zone Model 5/Variable Volume Water Model (VVWM) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of kasugamycin for chronic exposures are estimated to be 1.63 parts per billion (ppb) for surface water and 41.71 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 41.71 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Kasugamycin is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found kasugamycin to share a common mechanism of toxicity with any other substances, and kasugamycin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that kasugamycin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative pre- and/or postnatal susceptibility in developmental toxicity studies in two species, or the rat 2-generation reproductive toxicity study. Abortions and a reduction in fetal body weight in the rabbit developmental toxicity range-finding study were considered secondary to maternal toxicity (weight loss, and decreased food consumption). No toxicity to offspring was observed in the rat reproductive toxicity study.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for kasugamycin is complete.

ii. There is no indication that kasugamycin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that kasugamycin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to kasugamycin in drinking water. These assessments will not underestimate the exposure and risks posed by kasugamycin.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, kasugamycin is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to kasugamycin from food and water will utilize 4.2% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for kasugamycin.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no residential uses, kasugamycin is not expected to pose a short-term risk.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level. Because there are no residential uses, kasugamycin is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, kasugamycin is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to kasugamycin residues.

An approved tolerance enforcement method for crops is available for kasugamycin using a reverse-phase, ion pairing HPLC/UV method (Morse Laboratories Method #Meth-146, Revision #4) for collecting data and enforcing tolerances for kasugamycin in plant commodities. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for kasugamycin.

In establishing the tolerance for cherry subgroup 12-12A, EPA added a significant figure (0.60 ppm rather than the proposed 0.6 ppm). This is in order to avoid the situation where rounding of an observed residue to the level of precision of the tolerance expression would be considered non-violative (such as 0.64 ppm being rounded to 0.6 ppm).

Therefore, tolerances are established for residues of kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-α-D-arabino-hexopyranosyl]-D-chiro-inositol), in or on cherry subgroup 12-12A at 0.60 ppm and walnut at 0.04 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. 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); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or 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 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency 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 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows: