Federal Register Vol. 83, No.233,

This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927, (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers, handlers, and processors operating within the area of production, and a public member.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. The assessment rate established by this rule will be applicable to all “summer/fall” varieties of pears specifically used for canning for the 2018-2019 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The Order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The Committee members are familiar with the Committee's needs and with the costs of goods and services in their local area and can formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting where all directly affected persons have an opportunity to participate and provide input.

This final rule decreases the assessment rate from $8.00 per ton, the rate that was established for the 2017-2018 and subsequent fiscal periods, to $7.15 per ton of “summer/fall” varieties of pears for canning handled for the 2018-2019 and subsequent fiscal periods. The assessment rate for “winter” and “other” pears for processing will remain unchanged at $0.00. The Committee met on May 30, 2018, and unanimously recommended 2018-2019 fiscal period expenditures of $693,472. In comparison, last year's budgeted expenditures were $800,150. The Committee also unanimously recommended an assessment rate of $7.15 per ton of “summer/fall” varieties of pears for canning handled. The new assessment rate of $7.15 per ton is $0.85 lower than the previous $8.00 per ton rate. The Committee recommended the lower assessment rate to balance assessment revenue with its budgeted expenditures and to maintain its monetary reserve at levels authorized by the Order.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850; respectively.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments, and the amount of funds available in the authorized reserve. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the recommended $7.15 per ton assessment rate is expected to provide handler assessments of $715,000. This amount will be adequate to cover budgeted expenses of $693,472, with any excess funds used to make a small contribution to the Committee's monetary reserve. Funds in the reserve (currently $497,565) will be kept within the maximum permitted by § 927.42(a) of approximately one fiscal period's expenses.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee, or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's budget for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 1,500 growers of pears for processing in the production area and approximately 43 handlers of processed pears subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to data from USDA National Agricultural Statistics Service (NASS), the Committee, and the industry for the 2016-2017 season (the most recent complete season of record) the average f.o.b. price for Oregon-Washington processed Bartlett pears (the only variety used for canning in the production area) was approximately $390.50 per ton. Total shipments for that period were approximately 103,020 tons. Using the number of handlers, and assuming a normal distribution, the majority of handlers may have average annual receipts of less than $7,500,000 ($390.50 per ton times 103,020 tons equals $40,229,310 divided by 43 handlers equals $935,565 per handler).

In addition, based on data from the Committee, the industry produced 103,020 tons of processed pears in the production area during the 2016-2017 season, with an average grower price of $360 per ton. Based on the average grower price, production, and the total number of Oregon-Washington processed pear growers reported by the Committee (1,500), and assuming a normal distribution, the average annual grower revenue is below $750,000 ($360 per ton times 103,020 tons equals $37,087,200 divided by 1,500 growers equals $24,725 per grower). Thus, the majority of Oregon and Washington processed pear handlers and growers may be classified as small entities.

This rule decreases the assessment rate collected from handlers for the 2018-2019 and subsequent fiscal periods from $8.00 per ton to $7.15 per ton of Oregon and Washington “summer/fall” pears for canning handled. The Committee unanimously recommended 2018-2019 fiscal period expenditures of $693,472 and the $7.15 per ton assessment rate. The assessment rate of $7.15 per ton is $0.85 lower than the previous rate in effect for the 2017-2018 fiscal period. The quantity of assessable “summer/fall” pears for canning for the 2018-2019 fiscal period is estimated at 100,000 tons. Thus, the $7.15 per ton rate should provide $715,000 in assessment income. Income derived from handler assessments should be adequate to cover budgeted expenses, with any excess funds to be carried over in the Committee's monetary reserve to be used in subsequent years.

The major expenditures recommended by the Committee for the 2018-2019 fiscal period include $495,000 for promotion and paid advertising, $136,172 for research, $15,000 for market access programs, $25,000 for administrative and management services, and $22,300 for Committee expenses. In comparison, these major expense categories for the 2017-2018 fiscal period were budgeted at $591,030, $147,694, $14,576, $25,000, and $21,850, respectively.

The new, lower assessment rate is necessary to balance assessment revenue with the Committee's 2018-2019 fiscal period budgeted expenditures and to maintain its monetary reserve at levels authorized in the Order.

Prior to arriving at this budget and assessment rate, the Committee considered the benefits and costs related to maintaining the previous assessment rate of $8.00 per ton and establishing other assessment rates. However, leaving the assessment rate unchanged would have generated more revenue than required to meet the Committee's 2018-2019 fiscal period budgeted expenses of $693,472, and would have added a large amount of excess funds to the Committee's already sufficient monetary reserve. Based on estimated shipments, the assessment rate of $7.15 per ton is expected to provide $715,000 in assessment income. The Committee determined assessment revenue will be adequate to fully cover budgeted expenditures for the 2018-2019 fiscal period, with a small amount of excess funds to be added to the Committee's monetary reserve. Reserve funds will be kept within the amount authorized by the Order.

A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2018-2019 season should be approximately $296 per ton of pears for processing. Therefore, the estimated assessment revenue for the 2018-2019 fiscal period as a percentage of total grower revenue is about 2.4 percent ($7.15 per ton assessment divided by $296 per ton grower price).

This action decreases the assessment obligation imposed on handlers for the 2018-2019 and subsequent fiscal periods. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate will reduce the burden on handlers, and may reduce the burden on producers.

The Committee's meetings were widely publicized throughout the Oregon and Washington processed pear industry. All interested persons were invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the May 30, 2018, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements are necessary because of this action. Should any changes become necessary, they will be submitted to OMB for approval.

This rule does not impose any additional reporting or recordkeeping requirements on either small or large Oregon and Washington processed pear handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

A proposed rule concerning this action was published in the Federal Register on September 12, 2018 (83 FR 46119). Copies of the proposed rule were also mailed or sent via facsimile to all Oregon and Washington fresh pear handlers. The proposal was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending October 12, 2018, was provided for interested persons to respond to the proposal. Two comments were received during the comment period. The first comment was in support of the action. The second comment was a negative opinion on marketing orders in general and did not address the specific proposed rulemaking action. Accordingly, no changes will be made to the rule as proposed, based on the comments received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, will tend to effectuate the declared policy of the Act.

For the reasons set forth in the preamble, 7 CFR part 927 is amended as follows:

The FAA's authority to issue rules regarding 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 I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Kemmerer Municipal Airport, Kemmerer, WY, to accommodate airspace redesign in support of IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 21970; May 11, 2018) for Docket No. FAA-2018-0034 to amend Class E airspace at Kemmerer Municipal Airport, Kemmerer, WY, to accommodate airspace redesign in support of IFR operations at the airport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying the north extension of the Class E surface area airspace at Kemmerer Municipal Airport, Kemmerer, WY, to within 1.8 miles (from 1 mile) each side of the 354° bearing (from the 360° bearing) from the airport extending from the 4.3-mile radius of the airport to 7.7 miles (from 7 miles) north of the airport. Also, the NOTAM part-time status for the airspace would be removed to make the airspace effective continuously.

The FAA also amends the Class E airspace extending upward from 700 feet above the surface to within a 4.3-mile radius of Kemmerer Municipal Airport from the airport 035° bearing clockwise to the airport 006° bearing, and within a 9.5 mile radius of the airport from the airport 006° bearing clockwise to the airport 035° bearing, and within 2.2 miles each side of the 354° bearing from the airport extending from the 4.3-mile radius of the airport to 15.9 miles north of the airport, and within 2.2 miles each side of the 172° bearing from the airport extending from the 4.3-mile radius of the airport to 7.4 miles south of the airport (from within the 8-mile radius of Kemmerer Municipal Airport, and within 4 miles each side of the 174° bearing from the airport extending from the airport 11 miles south of the airport, and within 3.6 miles each side of the 354° bearing from the airport extending from the airport to 16.1 miles northwest of the airport). Additionally, the Class E airspace extending upward from 1,200 feet above the surface is removed because sufficient airspace exists (Wasatch and Jackson Class E airspace areas) and duplication is not necessary. This airspace redesign is necessary for the safety and management of IFR operations at the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding 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 I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it clarifies airspace designations by eliminating the redundancy.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 7432; February 21, 2018) for Docket No. FAA-2017-1147 to remove Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 removes Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. This airspace is wholly contained within the Sacramento en route airspace area and duplication is not necessary.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

We are making a technical amendment to Item 27 of Form N-1A under 17 CFR 239.15A and 274.11A.

For the reasons set out above, title 17, chapter II of the Code of Federal Regulations is amended as follows:

We are removing our Alternate Participant Program rules in accordance with E.O. 13777 (“Enforcing the Regulatory Reform Agenda”).1 The E.O. requires agencies to identify rules that, among other things, are outdated or unnecessary, and repeal, replace, or modify them, consistent with applicable law. These rules, found in 20 CFR Chapter III Part 411, Subpart J, describe how the Alternate Participant Program was affected by the Ticket to Work and Self-Sufficiency Program (Ticket Program),2 and procedures related to phasing it out.

Under the Social Security Act (Act), the Commissioner of Social Security is authorized to reimburse States for reasonable and necessary costs of vocational rehabilitation (VR) services furnished to certain disabled individuals under a State VR plan that meets specific requirements.3 If a State is unwilling to participate or does not have a plan meeting the specified requirements, we can enter into agreements or contracts with alternative VR service providers under the same conditions that apply to a State VR agency.4 In 1994, we created the Alternate Participant Program, which was intended to provide more VR service options to beneficiaries.5 These alternate VR service providers, referred to as “alternate participants,” could be organizations, institutions, individuals, or other public or private agencies.

Our procedures changed when we published final rules implementing the Ticket Program 6 in 2001. The Ticket Program, authorized by the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA),7 expanded the universe of service providers available to beneficiaries with disabilities who are seeking employment services, VR services, and other support services. Under the Ticket Program, beneficiaries have the option of obtaining services from providers known as employment networks (ENs). As we implemented the Ticket Program and began using ENs, we phased out the use of alternate participants, as authorized by section 101(d)(5) of the TWWIIA.8

Under current rules, we cannot pay an alternate participant for services provided after December 31, 2003. There are no outstanding Alternate Participant Program payments and no entity could become eligible for these payments in the future. Because we no longer use the Alternate Participant Program, the rules associated with that program are obsolete and no longer necessary. In alignment with this rule removal, we are also removing references to the program found in Subparts A and E of 20 CFR part 411, sections in Subparts A and V of 20 CFR part 404, and sections in Subpart A and V of 20 CFR part 416.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when we develop regulations. Generally, the APA requires that an agency provide prior notice and opportunity for public comment before issuing a final rule. The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest.

We find that there is good cause under 5 U.S.C. 553(b)(B) to issue this regulatory change as a final rule without prior notice or public comment. We find that prior notice and public comment are unnecessary because this final rule only removes from the CFR obsolete and unnecessary rules that do not affect any current beneficiaries.

In addition, we find good cause for dispensing with the 30-day delay in the effective date of this rule provided for in 5 U.S.C. 553(d)(3). For the reasons stated above, we find it unnecessary to delay the effective date of the changes we are making in this final rule. Accordingly, we are making them effective upon publication.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under E.O. 12866, as supplemented by E.O. 13563. Thus, OMB did not review the final rule.

We analyzed this final rule in accordance with the principles and criteria established by Executive Order 13132 and determined that the rule will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. We also determined that this rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions.

This regulation codifies legislative changes that already took place. Accordingly, the regulation does not have any financial impact on the public, and as such is an exempt regulatory action under E.O. 13771.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because there are no current participants of the Alternate Participant Program. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This rule does not create any new or affect any existing collections and, therefore, does not require Office of Management and Budget approval under the Paperwork Reduction Act.

For the reasons set out in the preamble, we amend 20 CFR parts 404, 411, and 416 as set forth below:

I. Does this action apply to me?

A list of potentially affected entities is provided in the Federal Register of October 3, 2018 (83 FR 49806) (FRL-9983-82). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

In the Federal Register of October 3, 2018 (83 FR 49806) (FRL-9983-82), EPA issued direct final SNURs for 26 chemical substances that are identified in the document. Because the Agency received adverse comments regarding the SNURs identified in the document, EPA is withdrawing the direct final SNURs issued for these 26 chemical substances, which were the subject of PMNs. In addition to the Direct Final SNURs, elsewhere in the same issue of the Federal Register of October 3, 2018 (83 FR 49903) (FRL-9983-81), EPA issued proposed SNURs covering these 26 chemical substances. EPA will address all adverse public comments in a subsequent final rule, based on the proposed rule.

EPA determined that this document is not subject to the 30-day delay of effective date generally required by the Administrative Procedure Act (APA) (5 U.S.C. 553(d)) because of the time limitations for publication in the Federal Register. This document must publish on or before the effective date of the direct final rule containing the direct final SNURs being withdrawn.

This action withdraws regulatory requirements that have not gone into effect and which contain no new or amended requirements and reopens a comment period. As such, the Agency has determined that this action will not have any adverse impacts, economic or otherwise. The statutory and Executive Order review requirements applicable to the direct final rules were discussed in the October 3, 2018 Federal Register (83 FR 49806). Those review requirements do not apply to this action because it is a withdrawal and does not contain any new or amended requirements.

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). Section 808 of the CRA allows the issuing agency to make a rule effective sooner than otherwise provided by CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. As required by 5 U.S.C. 808(2), this determination is supported by a brief statement in Unit III.

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

On April 10, 2018 (83 FR 15343), EPA published a Notice of Proposed Rulemaking (NPRM) for the State of New Hampshire. The NPRM proposed approval of two SIP submissions from the New Hampshire Department of Environmental Services (NHDES), which included an infrastructure SIP submission for the 2012 fine particle (PM2.5 1 ) National Ambient Air Quality Standard (NAAQS) submitted by the state on December 22, 2015, and a separate SIP submission addressing the “Good Neighbor” (or “transport”) provisions for the 2012 PM2.5 NAAQS (Section 110(a)(2)(D)(i)(I) of the CAA) submitted by the state on June 8, 2016.

This rulemaking does not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources (“SSM” emissions) that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP-approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); and, (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each of these substantive areas separately. A detailed history, interpretation, and rationale for EPA's approach to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” See 79 FR 27241 at 27242-45.

The rationale for EPA's proposed action is explained in the NPRM and will not be restated here.

EPA received six sets of comments during the comment period. Only one set includes significant, adverse comment, and it relates solely to section 110(a)(2)(K) of the Act (regarding air quality modeling and data). In the NPRM, EPA proposed to approve NHDES' submissions for the 2012 PM2.5 NAAQS for the infrastructure requirements of Section 110(a)(2)(A) through (M), including (K). In this rulemaking, EPA is finalizing the approval of New Hampshire's submissions for the infrastructure requirements of section 110(a)(2)(A) through (M), except (K). EPA will take separate action at a later date addressing these comments and the section 110(a)(2)(K) requirements for New Hampshire's infrastructure SIP submissions for the 2012 PM2.5 NAAQS.

The other five sets of comments we received all discuss subjects outside the scope of an infrastructure SIP action, do not explain (or provide a legal basis for) how the proposed action should differ in any way, and, indeed, make no specific mention of the proposed action. Consequently, those five sets of comments are not germane to this rulemaking and require no further response.

EPA is approving New Hampshire's December 2015 and June 2016 infrastructure SIP submissions for the 2012 PM2.5 NAAQS, except for Section 110(a)(2)(K) (regarding air quality modeling and data), which EPA will address in a later rulemaking.

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);

• This action 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 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 February 4, 2019. 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:

The EPA issued a final rule in the Federal Register on November 19, 2018 (83 FR 58188). An error occurred in the DATES section where it erroneously stated that “Written comments must be received on or before December 19, 2018.” The EPA previously provided an opportunity for written comments, on our proposed approval of Connecticut's SIP revision, in a proposed rule issued in the Federal Register on June 4, 2018 (83 FR 25615). Therefore, this corrective action merely designates the Final rule as being effective on December 19, 2018.

In FR Doc. 2018-24895 appearing on page 58188 in the Federal Register of Monday, November 19, 2018, the following correction is made:

On page 58188, in the second column, under the heading entitled DATES remove the text “Written comments must be received on or before December 19, 2018.” and add in its place the text “This final rule is effective on December 19, 2018.”.

On July 17, 2018 (83 FR 33168), EPA proposed to approve into the Georgia SIP changes to Georgia's air quality rule 391-3-1-.01, “Definitions” and rule 391-3-1-.02(4), “Ambient Air Standards” submitted by the State of Georgia through the Georgia EPD on November 13, 2017. EPA's July 17, 2018, rulemaking did not propose action on Georgia's air quality rules 391-3-1-.03(6), “Exemption” under permits and rule 391-3-1-.0(7)(a)(1), “General Requirements” under Prevention of Significant Deterioration (PSD). EPA will address these changes in a separate notice. Additionally, EPA's July 17, 2018, rulemaking did not propose action on Georgia's air quality rule 391-3-1-.02(7)(a)2(ix), “Regulated NSR pollutant” under PSD, and rule 391-3-1-.03(8)(c)(16), “Additional Provisions for PM2.5 Non-attainment Areas” under permits.1

The November 13, 2017, SIP revision changes Rule 391-3-1-.01, “Definitions” by adding t-Butyl acetate (also known as tertiary butyl acetate or TBAC) and 1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of organic compounds having negligible photochemical reactivity. The definition of VOC is also being updated by removing the recordkeeping requirements for t-Butyl acetate. Additionally, the definition of VOC is being revised to include chemical names to clarify previous exemptions. Lastly, the submission revises Rule 391-3-1-.02(4), “Ambient Air Standards” by updating Georgia's air quality standard to be consistent with the NAAQS. The details of the Georgia submission and the rationale for EPA's action are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before August 20, 2018. EPA did not receive any adverse comments on the proposed action. EPA is now taking final action to approve the above-referenced revisions.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Georgia Rule 391-3-1-.01 entitled “Definitions,” effective July 20, 2017, which revises the VOC definition and removes the recordkeeping requirements for t-Butyl acetate. Rule 391-3-1-.02(4) entitled “Ambient Air Standards,” effective July 20, 2017, updates Georgia's air quality standard to be consistent with the NAAQS. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.2

EPA is taking final action to approve Georgia's November 13, 2017, SIP revision which amends the VOC definition in rule 391-3-1-.01, and updates Georgia's air quality standards to be consistent with the NAAQS in rule 391-3-1-.02(4). EPA has evaluated the relevant portions of Georgia's November 13, 2017, SIP revision and has determined that it meets the applicable requirements of the CAA and EPA regulations.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 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 CAA. 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted 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).

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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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 February 4, 2019. 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).

40 CFR part 52 is amended as follows:

Throughout this document “we,” “us,” and “our” means the EPA.

Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets the NAAQS. These ambient standards currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA approved SIP regulations and control strategies are federally enforceable.

In 2008, we revised the 8-hour ozone primary and secondary NAAQS to a level of 0.075 parts per million (ppm) to provide increased protection of public health and the environment (73 FR 16436, March 27, 2008). The 2008 8-hour ozone NAAQS revised the 1997 8-hour ozone NAAQS of 0.08 ppm. The DFW area was classified as a “Moderate” ozone nonattainment area for the 2008 8-hour ozone NAAQS (77 FR 30088, May 21, 2012). The DFW 2008 ozone nonattainment area consists of Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall, Tarrant, and Wise counties.

On August 21, 2018, Texas submitted a SIP revision addressing oxides of nitrogen (NOx) reasonably available control technology (RACT) for a cement manufacturing plant in Ellis County as a part of its DFW 2008 8-hour ozone NAAQS SIP update. That SIP revision also included a description of how the CAA Section 182(a)(3)(B) requirement for emission statements from stationary point sources are met in the DFW area for the 2008 ozone NAAQS, using already-existing measures previously approved by EPA.1 EPA is only evaluating the emission statements portion of the August 21, 2018 SIP submittal in this action.2 A copy of the SIP revision submittal that includes the emission statement requirement is included in the docket to this rulemaking and is available online at www.regulations.gov, Docket number EPA-R06-OAR-2018-0676. In the SIP revision submittal, Texas noted that the SIP revision pertaining to emissions inventory requirements approved by EPA on August 26, 1994 (59 FR 44036) meets the CAA requirement for emission statements. The codification of the Texas SIP approved by EPA can be found at 40 CFR 52.2270(c).

CAA section 182(a)(3)(B) calls for SIPs for all ozone nonattainment areas to require that the owner or operator of each stationary source of nitrogen oxides or volatile organic compounds (ozone precursors) provide the State with an annual statement of emissions along with a certification that this information is accurate to the best knowledge of the individual certifying the statement.

The Texas SIP includes 30 TAC Section 101.10 (Emissions Inventory Requirements). The certification for emission statements is found at 30 TAC Section 101.10(d) (Certifying statement). We initially approved this certification as meeting the CAA emission statement requirement on August 26, 1994 (59 FR 44036).3 Most recently we approved revisions to 30 TAC Section 101.10 (Emissions Inventory Requirements) on June 8, 2017 (82 FR 26598). The most recently EPA approved Texas regulation continues to include appropriate provisions so that the owner or operator of each stationary source must provide the State with a statement with each emissions inventory attesting that the information contained in the inventory is true and accurate to the best knowledge of the certifying official (30 TAC Section 101.10(d)(1)). We find that the SIP revision submittal that is the subject of this action continues to be consistent with those requirements. Therefore, since the Texas SIP already includes an approved CAA emission statement requirement, we are approving this portion of the SIP revision as it pertains to the 2008 ozone standard.

We are approving the revision to the Texas SIP submitted on August 21, 2018, that pertains to the 2008 ozone NAAQS requirement for emission statements for large stationary sources in the DFW area.

The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on March 4, 2019 without further notice unless we receive relevant adverse comment by January 3, 2019. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the CAA, 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, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted 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, 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. The 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. 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 February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

I. Background

On August 28, 2018 (82 FR 43836), EPA published a notice of proposed rulemaking (NPRM) which proposed approval of the SIP revisions submitted by the State of West Virginia for revisions to Regulation 45CSR40. The first formal SIP revision was submitted by West Virginia through the West Virginia Department of Environmental Protection (WVDEP) on July 13, 2016. On October 10, 2017, WVDEP provided a supplemental SIP submission comprised of a demonstration showing that NOX emissions from applicable non-EGUs do not exceed the West Virginia NOX budget under EPA's NOX SIP Call.1 The NOX SIP Call, issued pursuant to Section 110 of the CAA and codified at 40 CFR 51.121 and 51.122, was designed to mitigate significant transport of NOX, one of the precursors of ozone. At the same time, EPA developed the NOX Budget Trading Program, an EPA-administered allowance trading program that states could adopt to meet their obligations under the NOX SIP Call. The NOX Budget Trading Program allowed EGUs greater than 25 megawatts and industrial non-EGUs, such as boilers and turbines, with a rated heat input greater than 250 million British thermal units per hour (MMBtu/hr), referred to as “large non-EGUs,” to participate in a regional NOX cap and trade program. West Virginia complied with the NOX SIP Call by participation of its large EGUs and large non-EGUs in the NOX Budget Trading Program. EPA discontinued administration of the NOX Budget Trading Program in 2009 upon the start of the CAIR trading programs (70 FR 25162, May 12, 2005). The NOX SIP Call requirements continued to apply, however, and EGUs in most states (including West Virginia) that formerly participated in the NOX Budget Trading Program continued to meet their NOX SIP Call requirements under the generally more stringent requirements of the CAIR NOX Ozone Season Trading Program, either pursuant to CAIR FIPs (71 FR 25328, April 28, 2006) or pursuant to approved CAIR SIP revisions.2 For the large non-EGUs, states needed to take regulatory action to ensure that their obligations under the NOX SIP Call continued to be met, either through an option to submit a CAIR SIP revision that allowed the non-EGUs to participate in the CAIR NOX Ozone Season Trading Program or through adoption of other replacement regulations. West Virginia chose to include the large non-EGUs as CAIR trading sources, and submitted, for inclusion in the SIP, Regulation 40CSR40 which implemented the CAIR NOX Ozone Season Trading Program and included the non-EGUs as trading sources. EPA approved Regulation 45CSR40 into the West Virginia SIP on August 4, 2009 (74 FR 38536). 45CSR40 also included requirements for stationary internal combustion engines and cement manufacturing kilns that are subject to the NOX SIP Call.

When CSAPR replaced CAIR starting on January 1, 2015,3 the CSAPR FIP trading programs for annual NOX, ozone season NOX and annual SO2 were applicable in West Virginia. Thus, since January 1, 2015, the provisions related to implementation of the CAIR Ozone Season Trading Program in West Virginia regulation 45CSR40 were obsolete. Initially, the CSAPR FIP trading programs applied only to EGUs and, unlike CAIR, did not provide for expansion of the ozone season trading program to include the NOX SIP Call large non-EGUs. States, like West Virginia, whose large non-EGUs had previously traded in the CAIR NOX Ozone Season Trading Program, were therefore required to address the non-EGU reduction requirements of the NOX SIP Call outside of a regional trading program.4

The CSAPR FIPs which replaced CAIR only applied to EGUs, and, at the time West Virginia developed its SIP submittal, states did not have an option under CSAPR to bring their non-EGUs into the CSAPR NOX Ozone Season Trading Program. So, while EGU compliance with CSAPR satisfied the EGUs' NOX SIP Call requirements, West Virginia needed to modify its ozone season NOX regulation to address the NOX SIP Call requirements for the non-EGUs that were formerly trading in the CAIR NOX ozone season trading program. 40 CFR 51.121(f) sets forth alternatives for states to address NOX SIP Call reduction obligations for large non-EGUs including (1) imposing a NOX mass emissions cap on each source, (2) imposing a NOX emissions rate limit on each source and assuming maximum operating capacity for every such source for purposes of estimating NOX mass emissions, or (3) imposing other regulatory requirements that the state has demonstrated to EPA provide equivalent or greater assurance that the state will comply with its ozone season NOX budget.

Former Regulation 45CSR40 (effective in West Virginia on July 1, 2016), which was approved into the West Virginia SIP, was originally adopted by WVDEP to implement the ozone season trading program under CAIR and to address NOX SIP Call requirements. The July 13, 2016 West Virginia SIP submittal is comprised of a revised 45CSR40 which removed the CAIR Ozone Season Trading Program provisions, retained the definitions, applicability, and other provisions responding to the NOX SIP Call (including monitoring under 40 CFR part 75), added new requirements to address its NOX SIP Call obligations for sources that were trading under CAIR but are no longer part of a trading program, and retained and recodified the limits on NOX emissions that applied to stationary internal combustion engines and cement kilns previously in the former version of 45CSR40 (with a State effective date of May 1, 2008) which EPA had approved into the West Virginia SIP. As the CAIR trading program has been replaced by the trading programs under CSAPR, as described previously, these revisions removing references to CAIR are consistent with the requirements for CAA 110(l) as CAIR was replaced by CSAPR and thus no longer yielded reductions in pollutants nor presently applied to any sources.

On February 8, 2018, WVDEP provided a letter clarifying an applicability exclusion specified in section 4 of 45CSR40 of the July 13, 2016 SIP submittal. The letter clarifies that the West Virginia regulation was intended to refer to current provisions of CSAPR, and thus is intended to refer to updated CSAPR provisions. The letter states that West Virginia will work towards revising 45CSR40 as expeditiously as possible to conform the regulation to refer to currently enforceable CSAPR provisions and will submit the revised 45CSR40 as a SIP revision to EPA for approval once the regulation correctly refers to 40 CFR part 97, subpart EEEEE.

Other specific requirements of revised West Virginia regulation 45CSR40 and the rationale for EPA's proposed approval are explained in the NPRM and will not be restated here. However, EPA provides two clarifications on the NPRM—one pertains to an aspect of EPA's summary of the new sections in 45CSR40 that address ozone season NOX emissions, and the second pertains to the date of West Virginia's supplemental SIP submission.

EPA's summary of section 4 (Applicability) explained that any unit that is already subject to the CSAPR NOX Ozone Season Trading Program FIP established under 40 CFR part 97, subpart BBBBB is exempt from the ozone season NOX emission limits, monitoring, recordkeeping, and reporting requirements established in sections 5 and 6 of 45CSR40.5 Section 4 of 45CSR40 also exempts from applicability any units subject to a CSAPR-equivalent trading program established under regulations approved as a SIP revision pursuant to 40 CFR 52.38(b)(5).6 Thus, while West Virginia presently does not have a CSAPR-equivalent program in its SIP, if West Virginia submits a SIP revision for a CSAPR-equivalent trading program in the future, and EPA approves the submittal into the State's SIP, sections 5 and 6 of 45CSR40-4 would not apply to such units. EPA's intent, as stated in the NPRM, is to approve the State submission in full, including the entirety of section 4. Thus, our approval of 45CSR40 is not affected; we are providing this clarification to explain the breadth of 45CSR40.

Also, EPA clarifies that the October 10, 2017 SIP submission, which West Virginia submitted to demonstrate compliance with its NOX SIP Call non-EGU NOX emissions budget, was the only supplemental submission from West Virginia. The references to an October 11, 2017 and an October 13, 2017 supplemental submission were in error and should have instead referred to the October 10, 2017 submittal, which is included in the docket for this rulemaking action.

EPA received three anonymous comments on the NPRM, all of which are in the docket for this rulemaking at www.regulations.gov. One of the comments did not concern any of the specific issues raised in the NPRM, nor did they address EPA's rationale for the proposed approval of WVDEP's submittal. Therefore, EPA is not responding to this comment. The remaining two comments are addressed as follows:

Comment 1: A commenter noted that the NPRM made reference to an October 11, 2017 and an October 13, 2017 supplemental submission from West Virginia, and asked where these submissions were as the docket only included a supplemental submission dated October 10, 2017.

EPA Response: The references to the October 11, 2017 and October 13, 2017 submittals were in error as EPA intended to refer instead to the October 10, 2017 supplemental submission. There was only one supplemental submission from West Virginia—the October 10, 2017 submittal, which provided the demonstration that West Virginia's NOX budget was being met. The docket included this submittal, and the preamble to this final rulemaking notice explains that the NPRM inadvertently cited the two incorrect dates that were both intended to refer to the October 10, 2017 submittal.

Comment 2: A commenter made a general comment that, because of the large coal mining industry in West Virginia, air pollution should be taken seriously to ensure good air quality.

EPA Response: As explained in this document and in the NPRM, this action establishes new requirements for large non-EGUs to meet West Virginia's obligations under the NOX SIP Call. Total NOX emissions from all affected units may not exceed West Virginia's statewide NOX budget, or cap, established by EPA under the NOX SIP Call. Continuous emissions monitoring, recordkeeping, and reporting are required to assure NOX emissions do not exceed the State cap. Thus, the 45CSR40 in the West Virginia SIP will not interfere with the air quality or CAA requirements, as EPA explained in the NPRM.

EPA is approving West Virginia's July 13, 2016 SIP revision submittal as supplemented on October 10, 2017 and clarified on February 8, 2018. Amended regulation 45CSR40 removes the obsolete provisions that implemented the CAIR NOX Ozone Season Trading Program, establishes new requirements to address the NOX SIP Call obligations for large non-EGUs in the State that were trading under CAIR but are no longer part of a trading program, establishes an enforceable statewide cap on ozone season NOX emissions for these non-EGUs in accordance with West Virginia's state budget under the NOX SIP Call, and recodifies previously SIP-approved provisions that apply to internal combustion engines and cement kilns. The October 10, 2017 supplemental submission demonstrates that the total NOX emissions from all affected large non-EGUs in West Virginia do not exceed the State cap previously established for West Virginia under the NOX SIP Call. The February 8, 2018 letter clarified West Virginia's intent to refer specifically to provisions of CSAPR presently enforceable and its intent to address the minor citation cross reference expeditiously with a future SIP revision submittal. The revisions are in accordance with section 110 of the CAA as the SIP submittal meets requirements in the CAA and in 40 CFR 51.121 related to the NOX SIP Call requirements.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of West Virginia regulation 45CSR40—Control of Ozone Season Nitrogen Oxides Emissions. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.7

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because

SIP approvals are exempted 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 SIP is not approved to apply in 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 February 4, 2019. 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 approving West Virginia revised regulation 45CSR40 into the West Virginia SIP may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 52 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:

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. 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-2018-0091 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 February 4, 2019. 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-2018-0091, 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 April 11, 2018 (83 FR 15528) (FRL-9975-57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11075) by ADAMA Agan, Ltd. c/o Makhteshim Agan of North America, Inc., 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. That document referenced a summary of the petition prepared by ADAMA Agan, LTD, the petitioner, which is available in the docket, http://www.regulations.gov.

This is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document: Calcium Formate; Human Health Risk Assessment in docket ID number EPA-HQ-OPP-2018-0091. No comments were received in response to the notice published by EPA.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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 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 . . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 calcium formate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with calcium formate follows.

EPA has evaluated the available toxicity data and considered their 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.

The toxicity database on calcium formate is somewhat limited. Consequently, studies on appropriate surrogates were used to supplement the database on calcium formate. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid.

Calcium formate is not expected to be acutely toxic based on acute toxicity data. There are no subchronic or chronic studies on calcium formate, although there are studies on potassium formate. These studies show effects based on reduced body weight gain. A two-year study with potassium formate indicates the compound is not carcinogenic to Wistar rats.

In mutagenicity studies with calcium formate, sodium formate and methyl formate, results of the test were negative for all chemicals. The weight-of-evidence suggests that calcium is not expected to be mutagenic.

There are no available developmental toxicity studies on calcium formate; however, both a rat and rabbit developmental toxicity study have been conducted on sodium formate. In the rat study, the maternal and developmental no-observed-adverse-effect-level (NOAEL) was considered the highest dose tested at 945 milligram/kilogram/day (mg/kg/day). In the rabbit study, the maternal and developmental toxicity NOAEL was also the highest dose tested at 1,000 mg/kg/day. A five-generation rat reproductive toxicity study on calcium formate has been conducted with a NOAEL of >200 mg/kg/day (only dose tested). In a three-generation reproduction study in rats via drinking water, no treatment related effects were observed in the parental animals and off springs at doses up to 200 mg/kg/day.

No studies were submitted for immunotoxicity. However, the toxicity studies available did not show any signs of immunotoxicity up to limit doses. Therefore, immunotoxicity is not of concern.

There are no available studies for neurotoxicity. However, the functional observation battery performed in the 90-day oral toxicity study did not show any signs of neurotoxicity up to limit doses. Therefore, neurotoxicity is not of concern.

A metabolism study is available in the toxicity database. Calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard. Formate ions are readily converted to carbon dioxide in the environment by biodegradation or photooxidation.

Specific information on the studies received and the nature of the adverse effects caused by calcium formate as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Calcium Formate Risk Assessment at page 7 in docket ID number EPA-HQ-OPP-2018-0091.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.

No toxicological endpoints of concern were identified for calcium formate based on available toxicity studies on surrogate chemicals. Formic acid, sodium formate, potassium formate and ammonium formate were selected as appropriate surrogates since they are either the acid form of calcium formate or other salts of formic acid. Most of the available studies on these substances were not conducted up to the limit dose. The highest dose of 200 mg/kg/day in a lifelong study in rats via drinking water did not produce any systemic toxicity (IUCLID, Calcium formate, 2001). Therefore, a conservative risk assessment was conducted using a NOAEL of 200 mg/kg/day for chronic dietary and short- and intermediate-term dermal exposure risk estimates. An uncertainty/safety factor of 100X (10X for interspecies variability and 10X for interspecies extrapolation) was used. The Food Quality Protection Act (FQPA) factor of 10X was reduced to 1X, therefore, the chronic Reference Dose (cRfD) of 2 mg/kg/day is equal to the chronic Population Adjusted Dose (cPAD). A 100% dermal absorption factor is assumed for converting oral to dermal equivalent doses in the absence of dermal toxicity or dermal absorption studies.

For short and intermediate term inhalation exposure, the route specific study was used. The NOAEL of 0.62 mg/l (32 parts per million (ppm)) was observed in a 90-day inhalation toxicity study in rats (IUCLID, Formic acid, 2000). The uncertainty factor is 100X (10X for interspecies variability and IOX for interspecies extrapolation). The FQPA factor of 10 X was reduced to 1X.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to calcium formate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from calcium formate in food as follows:

Because no endpoint was identified for acute exposure, an acute exposure assessment was not conducted.

In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, what we eat in America, (NHANES/WWEIA). This dietary survey was conducted from 1994-98. As to residue levels in food, no residue data were submitted. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentration of active ingredients in agricultural products is generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.

Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient.

In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, and then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for calcium formate, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

There are no known or anticipated residential uses for calcium formate and therefore, residential exposure is not expected.

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 calcium formate to share a common mechanism of toxicity with any other substances, and calcium formate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that calcium formate 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://www.epa.gov/pesticides/cumulative.

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 pre-natal and post-natal 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 is available to EPA to support the choice of a different factor.

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:

1. Toxicological studies were identified for calcium formate in the publicly available databases. However, calcium formate breaks down into calcium and formate ions. Calcium ions are ubiquitous in the natural environment and can be considered as having little toxicity or hazard risk. The toxicological database for calcium formate is limited. There is available data on formic acid and related formate compounds (such as ammonium, sodium and methyl formate), which can serve as suitable surrogates for calcium formate. Studies conducted with methanol are also applicable to formate compounds, since methanol is metabolized into formic acid. Therefore, the database is considered adequate for FQPA assessment.

2. There is no evidence of increased susceptibility of infants and children in the available reproduction and developmental toxicity studies with calcium formate and/or sodium formate. No developmental or maternal systemic toxicity was observed in rats at doses up to 200 mg/kg/day when calcium format was administered via drinking water. No developmental or maternal toxicity was observed in mice at doses up to 750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence of increased susceptibility was observed following pre- and post-natal exposure to calcium formate. In a multigeneration reproduction study (three to five generations), no parental, reproductive or offspring toxicity was observed at doses up to 200 mg/kg/day.

3. No neurotoxicity studies are available in the database. However, there is no evidence of clinical signs of neurotoxicity in the database, nor evidence of susceptibility in the young in the database. Therefore, EPA concluded that the developmental neurotoxicity study is not required. There is no evidence of immunotoxicity in the available database.

4. The dietary food exposure assessment utilizes highly conservative default assumptions that would not under estimate the dietary risk to all populations. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ammonium formate, a value of 100 ppb for drinking water based on screening level modeling was used for the chronic dietary risk assessment. The value of 100 ppb is considered to be a high end, conservative assumption that is not likely to underestimate drinking water risks.

Taking into consideration the available information, EPA concludes the additional 10X FQPA safety factor can be reduced to 1X. These assessments will not underestimate the exposure and risks posed by calcium formate.

Taking into consideration all available information on calcium. EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to calcium formate under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of calcium formate when used as an inert ingredient in pesticide formulations applied is safe under FFDCA section 408.

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, calcium formate is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure analysis, EPA has concluded that risk estimates for chronic exposure to calcium formate from food and water are not of concern (<100% cPAD with a risk estimate at 31.2% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for calcuim formate.

3. Short-and intermediate term risk. Short- and intermediate-term toxicological endpoints were established; however, calcium formate is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for calcium formate.

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

5. 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 calcium formate residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for calcium formate (CAS Reg. No. 544-17-2) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only.

This action establishes an exemption from the requirement of a tolerance 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) or 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 exemption 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:

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.

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-2016-0538 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 February 4, 2019. 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-2016-0538, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), 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 6F8475) by FMC Corporation. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide bixafen, N-(3′,4′-dichloro-5-fluoro[1,1′-biphenyl]-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, in or on cattle, fat at 0.5 parts per million (ppm); cattle, kidney at 0.3 ppm; cattle, liver at 1.5 ppm; cattle, muscle at 0.15 ppm; grain, aspirated fractions at 80 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), forage at 4.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), hay at 5.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), stover at 6.0 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice), straw at 7.0 ppm; grain, cereal, group 15 (except rice and sorghum) at 0.15 ppm; milk at 0.1 ppm; oilseed, rapeseed subgroup 20A at 0.15 ppm; peanut, hay at 10.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 0.04 ppm; poultry, eggs at 0.02 ppm; poultry, fat at 0.02 ppm; poultry, liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sorghum, grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.06 ppm; sugar beet, dried pulp at 1.0 ppm; vegetable, root subgroup 1A at 0.2 ppm and vegetable, tuberous and corm subgroup 1C at 0.02 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from those proposed. The reason for these changes are explained in Unit IV.D.

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 bixafen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with bixafen 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.

Following repeated oral administration of bixafen, the liver was the primary target organ in mice, rats and dogs. Increased liver weights and hepatocellular hypertrophy were observed in all species tested and were considered to reflect hepatic microsomal enzyme induction. Also, in several studies, there was evidence for liver toxicity based on clinical chemistry changes (increased serum alkaline phosphatase and cholesterol, decreased serum albumin) and histopathological changes (hepatocellular pigmentation, degeneration and necrosis). In mice and rats, the thyroid was an additional target in the subchronic and chronic studies, with effects such as increased thyroid weight, follicular cell hypertrophy and follicular cell hyperplasia observed. Thyroid toxicity was seen only in the presence of liver effects, either adverse effects (such as hepatocellular single-cell degeneration/necrosis) or adaptive effects (such as increased liver weights with enzyme changes, hepatocellular hypertrophy). This correlation suggested they thyroid effects are secondary to the liver effects via enhanced hepatic clearance of thyroid hormones. This suggestion was supported by a 14-day mechanistic study in rats in which a marked induction of phase I and II hepatic enzymes, a slight reduction of thyroid hormone (T3, T4) levels and a significant increase of TSH levels were observed at 150 mg/kg bodyweight per day, the only dose tested. Since thyroid toxicity was seen in the absence of adverse liver effects in studies such as the subchronic and chronic rat studies, a primary adverse effect on the thyroid cannot be ruled out. However, no studies are available to address potential susceptibility in the young to potential thyroid toxicity. As a result, the need for a Comparative Thyroid Assay (CTA) was considered. However, given risk estimates are well below the Agency's level of concern (LOC) even when using conservative exposure assumptions, the Agency concluded that a CTA is not required at this time. This conclusion, however, may be revisited should the use pattern change or if updated risk estimates reach a point where the PODs used in the risk assessment are no longer protective of potential life-stage susceptibility.

From the prenatal developmental studies, it is apparent that evidence of increased quantitative susceptibility in offspring was observed in the database. The prenatal developmental study in the rat showed decreased fetal body weights at a dose that produced no adverse effects in the dam. Similarly, the prenatal developmental study in the rabbit showed decreased fetal body weight in the absence of maternal toxicity. In the rat 2-generation reproduction study, however, parental toxicity (decreased body weight and increased liver weight with centrilobular and diffuse hypertrophy) and offspring toxicity (decreased F1 and F2 pup body weights) occurred at the same dose level.

An acute neurotoxicity study in the adult rat indicated decreased motor activity in both sexes and decreased rearing counts in females at a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study was not available, and no evidence of neurotoxicity was observed in other studies in the database.

Bixafen did not produce evidence of mutagenicity or clastogenicity in the required battery of studies. The available mouse carcinogenicity study produced no treatment-related tumors in the presence of other toxicity such as organ weight changes with histopathology in both the liver and thyroid. Thus, bixafen is classified as “not likely to be carcinogenic to humans.”

Bixafen has low acute oral, dermal, and inhalation toxicity. Bixafen is not an acute eye irritant and is neither a dermal irritant nor a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by bixafen 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 Bixafen. Human Health Risk Assessment for Section 3 Registration and Tolerance Requests for a New Active Ingredient Proposed for Use on Cereal Grains, Group 15 (Except Rice); Forage, Fodder and Straw of Cereal Grains, Group 16 (Except Rice); Peanut; Soybean; Root Vegetable Subgroup 1A; and Tuberous and Corm Vegetable Subgroup 1C at pages 14—23 in docket ID number EPA-HQ-OPP-2016-0538.

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 bixafen used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to bixafen, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from bixafen 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.

Such effects were identified for bixafen. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the acute dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on tolerance-level residues and 100% crop treated (100 PCT) estimates for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA conducted from 2003-2008. As to residue levels in food, the chronic dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on tolerance-level residues and 100 PCT estimates for all commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that bixafen 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 and/or PCT information in the dietary assessment for bixafen. 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 bixafen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of bixafen. 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.

The Tier II Pesticide in Water Calculator (PWC version 1.52) and Tier I Pesticide Root Zone Model Ground Water (PRZM GW) was used for calculating surface water and ground water EDWCs respectively. The driver for drinking water exposure is from surface water and the EDWC of bixafen for acute exposure is estimated to be 16.3 parts per billion (ppb). For chronic exposure for non-cancer assessment, it is estimated to be 15.2 ppb for surface water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 16.3 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 15.2 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).

Bixafen is not proposed nor is it 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 bixafen to share a common mechanism of toxicity with any other substances, and bixafen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that bixafen 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. The prenatal developmental toxicity studies showed effects in the fetus (decreased body weights) at dose levels that were lower than that of the observed maternal toxicity (decreased body weights). However, concerns for potential pre- and postnatal susceptibility from the developmental and reproduction studies are low because clear NOAELs and LOAELs exist for these developmental effects, and the PODs and endpoints selected for risk assessment are protective of potential toxicity in offspring.

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 bixafen is considered complete at this time. The following acceptable studies are available to support this determination: A prenatal developmental toxicity study in rabbits, a prenatal developmental toxicity study in rats, a two-generation reproduction study in rats and an acute neurotoxicity study. The following study waivers were accepted, and it was determined that these studies are not required at this time: subchronic inhalation, subchronic neurotoxicity, and an immunotoxicity study. As summarized in Unit III.A., EPA determined that the CTA study is not required at this time.

ii. An acute neurotoxicity study in the adult rat indicated decreased motor activity in both sexes and decreased rearing counts in females at a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study was not available, and no evidence of neurotoxicity was observed in other studies in the database. Concern for neurotoxicity is low, and thus no developmental neurotoxicity study or FQPA 10X SF is necessary, because (1) signs of neurotoxicity in the database occur only at a high dose level, do not include neuropathology; (2) a clear and well-defined NOAEL has been established; and (3) the PODs used for risk assessment are protective of neurotoxicity seen in the database.

iii. There is evidence of increased prenatal quantitative susceptibility of the developing offspring in the toxicology database for bixafen. Developmental toxicity (reduced fetal body weight) was seen at doses that caused no maternal toxicity in both rats and rabbits. However, clear NOAELs and LOAELs exist for these developmental effects, and the endpoints and PODs selected for risk assessment are protective of these effects. In the 2-generation reproduction toxicity study, toxicity in the offspring (decreased F1 and F2 pup body weights) occurred at the same level where parental toxicity (decreased body weight) was observed, and susceptibility was not demonstrated. The subchronic and chronic rat studies in the database indicate thyroid toxicity (epithelial cell hypertrophy) at the LOAELs, and no studies are available to address potential susceptibility in the young to potential thyroid toxicity. As a result, the need for a CTA was considered. However, given risk estimates are well below the Agency's level of concern even when using conservative exposure assumptions and that further refinement of exposure estimates would yield even greater margins of safety, the Agency concluded that a CTA is not required at this time.

iv. There are no residual uncertainties identified in the exposure databases. The unrefined dietary risk assessments are based on high-end assumptions such as tolerance-level residues, 100PCT assumptions, and modeled, high-end estimates of residues in drinking water. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to bixafen in drinking water. These assessments will not underestimate the exposure and risks posed by bixafen.

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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to bixafen will occupy <1% of the aPAD for children 1-2 years of age, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to bixafen from food and water will utilize 20% of the cPAD for children 1-2 years of age the population group receiving the greatest exposure.

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). A short-term adverse effect was identified; however, bixafen is not proposed for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for bixafen.

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).

An intermediate-term adverse effect was identified; however, bixafen is not proposed for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for bixafen.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, bixafen 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 bixafen residues.

Adequate enforcement methodology (Analytical Methods 00983 and 01063, high- performance liquid chromatography methods with tandem mass spectrometry detection (LC/MS/MS)) is available as an enforcement method for determination of residues of bixafen and its metabolite bixafen-desmethyl.

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 established MRLs for bixafen in or on barley and oats at 0.4 ppm; the U.S. tolerance for grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm is harmonized with those MRLs. Codex has also established MRLs for rye, wheat, and wheat bran at 0.05 ppm, which is not harmonized with the U.S. tolerances for group 15 because use consistent with approved labeling could result in exceedances. Codex has also established MRLs for barley straw and fodder, dry at 20 ppm; oat straw and fodder, dry at 20 ppm; rye straw and fodder, dry at 20 ppm; and wheat straw and fodder, dry at 20 ppm. The U.S. tolerance for grain, cereal, forage, fodder and straw, group 16, except rice at 20 ppm is harmonized with those Codex MRLs.

Additionally, the Codex has established MRLs for bixafen in or on cattle, fat at 2 ppm; cattle, meat byproducts at 4 ppm; cattle, muscle at 2 ppm; goat, fat at 2 ppm; goat, meat byproducts at 4 ppm; goat, muscle at 2 ppm; horse, fat at 2 ppm; horse, meat byproducts at 4 ppm; horse, muscle at 2 ppm; milk at 0.2 ppm; sheep, fat at 2 ppm; sheep, meat byproducts at 4 ppm; and sheep, muscle at 2 ppm. These MRLs are significantly higher than the tolerances being established for bixafen on the same commodities in the United States. The U.S. tolerances are based on calculated dietary burden that supports a lower residue level in fat, muscle, and meat byproducts commodities. Therefore, these tolerances are not harmonized because such high tolerances could mask instances of misuse by U.S. growers. As noted in the next section, the Agency is not establishing tolerances for milk fats and poultry commodities in harmony with Codex MRLs for milk fats, poultry, edible offal, poultry fats, and poultry meat because the Agency has determined that use consistent with the approved pesticide will not result in residues in milk fats and poultry commodities.

Several proposed tolerances requested by the petitioner are different from those being established by EPA. For soybean seed; peanut; peanut, hay; vegetable, tuberous and corm (subgroup 1C); and vegetable, root, subgroup 1A, tolerance values were calculated using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures and field trial residue data. The combination provided a different tolerance value than the proposed values. EPA is establishing a tolerance for grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm instead of 0.15 ppm and for grain, cereal, forage, fodder and straw, group 16, except rice at 20 ppm, rather than the requested tolerances for forage at 4.0 ppm, hay at 5.0 ppm, stover at 6.0 ppm, straw at 7.0 ppm in order to harmonize with Codex MRLs. Since the tolerance of 20 ppm for group 16 covers the residues on forage, hay, stover, and straw forms of the group 16 commodities, EPA has determined that separate tolerances are unnecessary.

Additionally, while tolerances were proposed on liver and kidney for livestock commodities, EPA is establishing tolerances on meat byproducts, which are inclusive of kidney and liver. EPA is further establishing lower tolerances for residues in fat, muscle and meat byproducts in cattle, based on the calculated dietary burdens paired with low residue transfer rates into ruminant commodities. The tolerance on milk is also established at a lower level (0.04 ppm versus the 0.10 ppm proposed tolerance). This recommendation is also based on the calculated dietary burdens paired with low residue transfer rates into ruminant commodities.

Under EPA's regulations (40 CFR 180.6), EPA assessed whether residues on raw agricultural commodities would result in possible residues entering the diet of man through the ingestion of milk, eggs, meat, and/or poultry produced by animals fed agricultural products bearing such residues. As a result of that assessment, EPA determined that quantifiable residues are expected in commodities from cattle, horses, goats, and sheep and is establishing tolerances for residues in fat, muscle and meat byproducts in horse, goat and sheep. EPA also determined that there is no reasonable expectation of residues in or on milk fats and poultry products; therefore, no tolerances on milk fats and poultry commodities are needed.

Additionally, the proposed use and associated tolerance on Rapeseed subgroup 20A (canola) was subsequently withdrawn by the petitioner; therefore, the Agency is not establishing a tolerance on that subgroup because it is not needed.

The Agency is not establishing a tolerance for peanut, refined oil as requested because the residue data indicate that anticipated residues in the peanut, refined oil are lower than, and will be covered by, the tolerance for peanut.

Finally, the Agency is establishing a tolerance for radish, tops, even though it was not requested by the petitioner. Under EPA's regulations (40 CFR 180.40(f)(1)(i)(B)), EPA will not establish a crop group tolerance unless all necessary tolerances are established, including tolerances for raw commodities not covered by the crop group and derivative of commodities in the group. In this case, EPA is establishing a tolerance for root vegetables, subgroup 1A, which includes radish. Due to the presence of residues on radish tops, EPA is establishing a necessary tolerance on radish tops to facilitate the establishment of the subgroup 1A tolerance.

Therefore, tolerances are established for residues of bixafen in or on beet, sugar, dried pulp at 1.0 ppm; cattle, fat at 0.08 ppm; cattle, meat byproducts at 0.40 ppm; cattle, muscle at 0.08 ppm; goat, fat at 0.08 ppm; goat, meat byproducts at 0.40 ppm; goat, muscle at 0.08 ppm; grain, aspirated grain fractions at 80 ppm; grain, cereal, forage, fodder, and straw, group 16, except rice at 20 ppm; grain, cereal, group 15, except rice and grain sorghum at 0.40 ppm; horse, fat at 0.08 ppm; horse, meat byproducts at 0.40 ppm; horse, muscle at 0.08 ppm; milk at 0.04 ppm; peanut at 0.01 ppm; peanut, hay at 8.0 ppm; radish, tops at 3.0 ppm; sheep, fat at 0.08 ppm; sheep, meat byproducts at 0.40 ppm; sheep, muscle at 0.08 ppm; sorghum, grain, grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.04 ppm; vegetable, root subgroup 1A at 0.30 ppm; and vegetable, tuberous and corm subgroup 1C at 0.01 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) 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 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:

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 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, 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-2018-0290 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 February 4, 2019. 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-2018-0290, 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 14, 2018 (83 FR 27743) (FRL-9978-41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11148) filed by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 277709-3528. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01-0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. Reg. No. 35641-59-9). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request.

There were no comments received in response to the notice of filling.

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 use 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 an exemption from the requirement of 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 . . . ” and specifies factors EPA is to consider in establishing an exemption.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer both conform to the definition of a polymer given in 40 CFR 723.250(b) and meet the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

8. The polymer's number average MW of 14,000 is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer meet the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on their conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

For the purposes of assessing potential exposure under this exemption, EPA considered that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer are greater than 14,000 daltons. Generally, polymers of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer to share a common mechanism of toxicity with any other substances, and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do 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://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt or 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer.

Accordingly, EPA finds that exempting residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer from the requirement of a tolerance will be safe.

This action establishes a tolerance 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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 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:

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.

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-2015-0820 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 February 4, 2019. 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-2015-0820, 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 March 16, 2016 (81 FR 14030) (FRL-9942-86), 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 5F8415) by Geo Logic Corporation, P.O. Box 3091, Tequesta, FL 33469. The petition requested that 40 CFR 180.337 be amended by establishing tolerances for residues of the bactericide oxytetracycline, (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, in or on fruit, citrus, crop group 10-10 at 0.01 parts per million (ppm).

That document referenced a summary of the petition prepared by Geo Logic Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

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 oxytetracycline including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with oxytetracycline 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.

At high doses, the target organ of tetracycline toxicity is the liver. The most common effect in intermediate- or long-term oral exposures in rats and mice was a decrease in body weight. In the prenatal developmental study in rats, clinical signs included increased incidences of respiratory signs and rough hair coat in the dams, in addition to increased mortality and a decreased percentage of dams found pregnant. Also identified was a decrease in fetal body weight. In the mouse prenatal developmental study, there was no toxicity identified in the dams or fetuses. In all of the above animal studies, adverse effects were seen at doses that exceed the limit dose. There is no adequate reproductive toxicity study available in the database, however, the data requirement was waived based on the lack of reproductive effects reported during the history of use as a drug. No evidence of neurotoxicity was observed in any guideline study. A rat immunotoxicity study demonstrated immunosuppression at doses lower than those for systemic toxicity. Tetracyclines are known to inhibit bone growth in developing tissue. When oxytetracycline was administered orally as a single dose to two female infant rhesus monkeys, zygomatic arch bone (lateral surface of temporal bone) growth was inhibited for ~12.5 days with no recovery observed by 21 days. Effects on bone growth are consistent with oxytetracycline's ability to chelate calcium, and so are not unexpected. Bone developmental effects were also observed after administration of chlortetracycline and demethylchlortetracycline in adult rhesus monkeys highlighting the consistency of tetracycline treatment across this class of chemicals.

The Agency has classified oxytetracycline as “Group D: Not Classifiable as to Human Carcinogenicity”. Oxytetracycline has low acute toxicity, being Toxicity Category IV for oral toxicity, the only acute lethality study available in the database.

Specific information on the studies received and the nature of the adverse effects caused by oxytetracycline 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 document “Oxytetracycline/Oxytetracycline Hydrochloride/Oxytetracycline Calcium: Draft Human Health Risk Assessment in Support of Registration Review and Tolerance Establishment in/on Citrus Fruit Crop Group 10-10” in docket ID number EPA-HQ-OPP-2015-0820.

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.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to oxytetracycline, EPA considered exposure under the petitioned-for tolerances as well as all existing oxytetracycline tolerances in 40 CFR 180.337. EPA assessed dietary exposures from oxytetracycline 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 oxytetracycline; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA 2003-2008 food consumption data from the USDA's National Health and Nutrition Examination Survey/What We Eat in America. As to residue levels in food, EPA used tolerance-level residues, default processing factors (PFs), and assumed 100 percent crop treated (PCT).

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that oxytetracycline 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 PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for oxytetracycline. Tolerance-level residues and/or 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 oxytetracycline in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of oxytetracycline. 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 version 5.02/Variable Volume Water Body Model (VVWM V1.02) and Pesticide Root Zone Model Ground Water (PRZM GW), EDWCs of oxytetracycline for chronic exposures for non-cancer assessments are estimated to be 2.85 ppb for surface water and 0.323 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 of value 2.85 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). Oxytetracycline is not registered for any specific use patterns that would result in residential exposure.

Tetracycline hydrochloride (97% chemical similarity to oxytetracycline) is approved by FDA for use as an oral antibiotic to treat certain bacterial and parasitic infections. EPA examined the impact that additional pesticide exposures to oxytetracycline would have on a person who has been prescribed the antibiotic. EPA determined that the additional pesticide exposure would not have more than a minimal impact on the total dose to the pharmaceutical patient, and thus concludes that there is a reasonable certainty that the additional exposure from pesticide uses of oxytetracycline would result in no harm finding to a user being treated therapeutically.

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 assessed the potential for oxytetracycline to share a common mechanism of toxicity with any other substances. Based on its assessment of the available toxicological data, EPA has determined that oxytetracycline does not share a similar toxicological profile with other pesticides, and no further cumulative evaluation is necessary for oxytetracycline.

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. Considering the toxicity database for oxytetracycline, the mouse prenatal development study did not identify adverse effects up to the highest dose tested (HDT), 2,100 mg/kg/day. In addition, the effects seen in the rat prenatal development study occurred only at levels above the limit dose. Although guideline toxicity studies do not suggest an increased lifestage sensitivity/susceptibility (effects above the limit dose or no effects at the highest doses tested), data from the literature suggests that developing infants and children may be more susceptible to oxytetracycline side-effects than adults. When oxytetracycline was administered orally, as a single dose, to two female infant rhesus monkeys, zygomatic arch bone (lateral surface of temporal bone) growth was inhibited for ~12.5 days with no recovery observed by 21 days. The delayed bone growth occurs as a result of chelation of calcium, the mineral needed for bone growth. When the monkeys are treated with a very high dose of oxytetracycline (80 mg/kg), the calcium can be bound up for several days, leading to a delay in bone growth during that short time frame. However, once the oxytetracycline levels diminish, bone growth continues resulting in normal bones at maturity.

3. Conclusion. The existing database, together with the extensive literature and study reports available on oxytetracycline, including studies submitted to and reviewed by the EPA, the National Toxicology Program, and World Health Organization, the FDA and open literature studies, is adequate for characterizing toxicity and quantification of risk from the proposed and existing uses of oxytetracycline. EPA is retaining the 10X FQPA SF because of the potential for pre-natal toxicity. The Agency concludes that this safety factor will be protective of potential toxicity to infants and children based on the following findings:

i. The toxicity database for oxytetracycline is complete.

ii. There is no indication that oxytetracycline 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 oxytetracycline results in increased susceptibility in in utero rats in the prenatal developmental studies. Within the toxicity database, the mouse prenatal developmental study did not identify adverse effects up to the highest does tested (HDT), 2,100 mg/kg/day. Based on the adverse effects seen in infant rhesus monkeys after oral administration of oxytetracycline, the Food Quality Protection Act (FQPA) Safety Factor (SF) is being retained at 10X.

iv. There are no residual uncertainties identified in the exposure databases. The dietary assessment overestimates actual exposures to oxytetracycline as it incorporated tolerance-level residues, default PFs, assumed that 100% of the proposed and existing crops are treated with oxytetracycline, and included high-end ground and surface drinking water modeling estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to oxytetracycline in drinking water. These assessments will not underestimate the exposure and risks posed by oxytetracycline.

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, oxytetracycline 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 oxytetracycline from food and water will utilize 33% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential pesticide uses for oxytetracycline.

3. Short-term risk and Intermediate-term risk. Short-term and intermediate-term aggregate exposures take into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level) and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level), respectively. Short and intermediate-term adverse effects were identified; however, oxytetracycline is not registered for any residential pesticide uses that would result in short or intermediate-term residential exposures. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure and intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there are no short-term or intermediate-term residential exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for oxytetracycline.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in adequate carcinogenicity studies in two animals, oxytetracycline is not expected to pose a cancer risk to humans and no cancer risk assessment was necessary.

5. Pharmaceutical aggregate risk for U.S. population. Section 408 of the FFDCA requires EPA to consider potential sources of exposure to a pesticide and related substances in addition to the dietary sources expected to result from a pesticide use subject to the tolerance and determine that “there is a reasonable certainty of no harm” from those exposures. Because the Food and Drug Administration (FDA) may approve pharmaceutical drugs under FFDCA section 505, notwithstanding the possibility that some users may experience adverse side effects. EPA examines the impact that the additional pesticide exposures would have to a pharmaceutical user exposed to a related (or, in some cases, the same) compound in assessing the potential of harm to the pharmaceutical user. Where the additional pesticide exposure has no more than a minimal impact on the pharmaceutical user, EPA has concluded that it can make a reasonable certainty of no harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA.

For oxytetracycline, EPA's pesticide exposure assessment has taken into consideration the appropriate population, exposure route, and exposure duration for comparison with pharmaceutical exposure to oxytetracycline. EPA estimates that the pharmaceutical exposure a person is expected to receive from a typical therapeutic dose (25 mg/kg/day for children) is 750 to 2,800 times greater than the estimated dietary exposure from the pesticidal sources of oxytetracycline (0.0089334 mg/kg/day). Therefore, because the pesticide exposure has no more than a minimal impact on the total dose to a pharmaceutical user, EPA concludes that there is a reasonable certainty that the potential pesticide exposure will result in no harm to a person being treated therapeutically with oxytetracycline.

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 oxytetracycline residues.

Adequate enforcement methods are available for determining oxytetracycline residues in/on plant commodities. A high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) has been proposed for tolerance enforcement.

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 oxytetracycline.

One comment was received generally opposing the use of any pesticides in or on food. The Agency recognizes that some individuals oppose the use of pesticides in or on food, but the FFDCA authorizes the Agency to establish tolerances for residues of pesticides in or on food if the Agency determines that the tolerance is safe. EPA has examined all the available data and determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. The commenter has provided no information to support a finding that the tolerances would not be safe.

Therefore, tolerances are established for residues of oxytetracycline, in or on fruit, citrus, group 10-10 at 0.01 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 tolerance 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:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

The U.S. Department of Health and Human Services (HHS) is publishing this final rule without previously publishing a proposed rule because HHS has determined that the rule qualifies for exemption from notice-and-comment rulemaking under section 553 of the Administrative Procedures Act (Pub. L. 79-404, enacted June 11, 1946) (APA), both because it is a “matter relating to agency management” under section 553(a)(2) 1 and a “rule of agency organization, procedure or practice” under section 553(b)(3)(A). This rule eliminates an unnecessary reference to an internal inter-agency process, but makes no changes to the policy or operational processes set forth for participating FFE issuers or third parties subject to 45 CFR 156.50(d), and will have no effect on these entities or the other individuals and entities that were subjects of the July 2, 2013 final rule “Coverage of Certain Preventive Services Under the Affordable Care Act” (78 FR 39870), namely eligible organizations, self-insured plans of eligible organizations, and participants and beneficiaries of those plans.

The Patient Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23, 2010) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted March 30, 2010) are collectively referred to as “PPACA” in this final rule. Section 1321(a) of the PPACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, qualified health plans (QHPs), and other components of title I of the PPACA. When operating an FFE under section 1321(c)(1) of the PPACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the PPACA to collect and spend user fees. OMB Circular A-25 Revised (OMB Circular A-25R) establishes federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from federal activities beyond those received by the general public.

Section 2713(a)(4) of the Public Health Service Act, as added by the PPACA and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code, requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide certain women's preventive health services as a benefit without cost sharing, as provided for in comprehensive guidelines supported by the Health Resources and Services Administration. On July 2, 2013, the final rule “Coverage of Certain Preventive Services Under the Affordable Care Act” (78 FR 39870) published by HHS, the Department of the Treasury, and the Department of Labor, set forth regulations allowing eligible organizations to receive an accommodation relating to coverage of contraceptive services, so that they are not required to provide, arrange, or pay for these services. Those regulations at 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A were amended, but largely left in place, by interim final rules with requests for comments published in the Federal Register on October 13, 2017, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (82 FR 47792) and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (82 FR 47838) and final rules published in the Federal Register on November 15, 2018,with an effective date of January 14, 2019, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (83 FR 57536) and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (83 FR 57592). The 2013 final regulation also set forth processes and standards at § 156.50(c) and (d) to take into account the payments for the contraceptive services that are provided for participants and beneficiaries in self-insured plans of eligible organizations under the accommodation described in that final rule through an adjustment in the FFE user fee payable by an issuer participating in an FFE, at no cost to plan participants or beneficiaries, eligible organizations, third party administrators, or issuers.

This final rule amends the regulations for adjustments of FFE user fees set forth at § 156.50, as established in the final rule published in the July 2, 2013 Federal Register. HHS is amending § 156.50(d)(3), to remove the current language providing that an authorizing exception under OMB Circular No. A-25R must be in effect in order for HHS to provide a participating issuer a reduction in its obligation to pay the FFE user fee. HHS will calculate the user fee reduction as the sum of the total dollar amount of the payments for contraceptive services submitted by applicable third party administrators, as described in paragraph (d)(2)(iii)(D), and an allowance, specified by HHS, for administrative costs and margin.

HHS is also amending § 156.50(d)(4) to remove a corresponding requirement that an authorizing exception under OMB Circular No. A-25R be in effect. If the amount of the reduction under § 156.50(d)(3) is greater than the amount of the obligation to pay the FFE user fee in a particular month, the participating issuer will be provided a credit in succeeding months in the amount of the excess.

HHS has determined that an exception to OMB Circular No. A-25R is not required to be in effect to effectuate the FFE user fee adjustment for participating issuers. HHS has implemented an adjustment to FFE user fee collections for each benefit year beginning with the 2014 benefit year, and the adjustment has accounted for less than 2 percent of total FFE user fee collections for each benefit year. Therefore, HHS continues to believe that the adjustment to FFE user fee collections will not materially undermine FFE operations. HHS believes that the reduced user fee collections resulting from the adjustment will not necessitate an exception to OMB Circular No. A-25R. Subject to HHS's standing financial management procedures, HHS will continue to monitor user fee collections and expenditures to ensure compliance under OMB Circular No. A-25R going forward. Additionally, HHS notes that it has not raised the FFE user fee finalized in the annual notice of benefit and payment parameters to offset the FFE user fee adjustments for any applicable benefit year. HHS estimates that payments for contraceptive services will continue to represent only a small portion of total FFE user fees in future benefit years, and it does not anticipate that it will need to increase the FFE user fee rate to offset the FFE user fee adjustment available to participating issuers.

This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

HHS has examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, enacted September 19, 1980) (RFA), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, enacted March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year).

This final rule is not “economically significant” within the meaning of section 3(f)(1) of Executive Order 12866 because it is unlikely to have an annual effect of $100 million in any single year. In addition, for the reasons noted in this final rule, HHS does not believe that this final rule is a major rule under the Congressional Review Act.

The RFA requires agencies to analyze options for regulatory relief of small businesses. This rule would not have a significant impact on small businesses.

In addition, section 1102(b) of the Act requires HHS to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This rule would not have a significant impact on small rural hospitals because the amendments contained in this final rule do not pertain to hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by state, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. HHS anticipates this rule would not impact state governments or the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. HHS does not anticipate this rule would impose direct requirement costs on state or local governments, preempt state law, or otherwise have federalism implications.

For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR part 156 as set forth below:

I. Background

DoD published a proposed rule in the Federal Register at 83 FR 42822 on August 24, 2018, to implement section 813(b) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018 (Pub. L. 115-91). Section 813(b) repeals section 858 of the NDAA for FY 2015 (Pub. L. 113-291), but does not repeal section 846 of the NDAA for FY 2011 (Pub. L. 111-383), with regard to sources of photovoltaic devises purchased by contractors that become property of DoD. There were no public comments submitted in response to the proposed rule. There are no changes from the proposed rule in the final rule.

This rule does not affect the applicability of DFARS clause 252.225-7017, Photovoltaic Devices, and DFARS provision 252.225-7018, Photovoltaic Devices—Certification. A determination was signed by the Director, Defense Procurement and Acquisition Policy, on October 13, 2011, to not apply the requirements of section 846 of the NDAA for FY 2011 to contracts at or below the simplified acquisition threshold, but to apply the rule to contracts for the acquisition of commercial items, including commercially available off-the-shelf items.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This rule is not an E.O. 13771 regulatory action, because this final rule is not significant under E.O. 12866.

A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

This rule implements section 813(b) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2018 (Pub. L. 115-91), which repealed of section 858 of the National Defense Authorization Act (NDAA) for FY 2015 (Pub. L. 113-291), while retaining the requirements of section 846 of the NDAA for FY 2011 (Pub. L. 111-383), with regard to sources of photovoltaic devices purchased by contractors that become the property of DoD.

The objective of this rule is to revert to the regulations on photovoltaic devices that were in effect prior to superimposing the additional regulations required by section 858 on November 20, 2015 (80 FR 72599). By restoring the tie to the Buy American statute, this rule reinstates the Buy American exceptions for acquisitions of photovoltaic devices below the micro-purchase threshold, nonavailability, unreasonable cost, and public interest, including the DoD class determinations that exempt U.S.-made and qualifying country photovoltaic devices from the requirements of the Buy American statute, as well as the Governmentwide determination that removes the component test for commercially available off-the-shelf items.

No significant issues were raised by the public comments in response to the initial regulatory flexibility analysis. No public comments were received.

This rule generally applies at the prime contract level to other than small entities. When purchasing renewable power generated via onsite photovoltaic devices, DoD can either purchase the photovoltaic devices and thereby own, operate, and maintain the devices for their full economic life (already covered in DFARS part 225 under standard Buy American statute/Trade Agreements regulations) or, for example, may do some variation of the following:

a. Enter into an energy savings performance contract, which is a contracting method in which the contractor provides capital to facilitate energy conservation measures and maintains them in exchange for a portion of the energy savings generated. Under this arrangement, the Government would take title to the devices during contract performance or at the conclusion of the contract. For example, DoD uses either the master indefinite delivery-indefinite quantity contract of the Department of Energy or the Army Corps of Engineers and awards task orders off one of those contracts. Generally, the same approved contractors are on each contract. Of the approved contractors, all but one are large businesses. There are subcontracting goals that each contractor has to meet, but the ultimate task order award is most often made to a large business.

b. Enter into a power purchase agreement, also referred to as a utility service contract, for the purchase of the power output of photovoltaic devices that are installed on DoD land or buildings, but owned, operated, and maintained by the contractor. At the conclusion of the contract, DoD would either require the contractor to dismantle and remove the photovoltaic equipment or abandon the equipment in place. Prime contractors for this type of contract would generally be large businesses, based on the capital costs involved in these projects. However, many developers tend to subcontract out the majority of the work to smaller companies.

There are approximately 80 manufacturers of photovoltaic devices. We do not currently have data available on whether any of the manufacturers of photovoltaic devices are small entities, because the Federal Procurement Data System does not collect such data on subcontractors.

There are no new reporting burdens under this rule. In fact, there is a de minimis reduction in burden, because no certification will be required if the value of the photovoltaic devices does not exceed the micro-purchase threshold, and identification of country of origin will no longer be required if the photovoltaic devices are domestic or U.S.-made. Furthermore, since the prime contractors subject to this rule are other than small businesses, the existing reporting requirements do not impact small entities.

DoD did not identify any significant alternatives that meet the requirements of the statute and would have less impact on small entities. The overall effect of this rule is deregulatory and it does not have significant impact on small entities.

The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C chapter 35); however, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 0704-0229, entitled “Defense Federal Acquisition Regulation Supplement (DFARS) Part 225, Foreign Acquisition, and related clauses at DFARS 252.225.”

Therefore, 48 CFR parts 212, 225, and 252 are amended as follows:

I. Background

DoD is amending the DFARS to implement section 875 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232). Section 875 amends section 865 of the NDAA for FY 2009 (Pub. L. 110-417) by removing the requirement for agencies, prior to requesting another agency to conduct an acquisition on its behalf, to make a determination that the use of an interagency acquisition represents the best procurement approach. The requirement for a best procurement approach determination is implemented at Federal Acquisition Regulations (FAR) 17.502-1(a). Removal of the requirement from the FAR, in accordance with section 875, is being accomplished under FAR case 2018-015. This rule removes supplemental text from DFARS 217.502-1 that advises contracting officers, when providing acquisition assistance to deployed DoD units or personnel from another DoD Component, to obtain the determination from the requiring DoD unit or personnel.

This rule only impacts the internal operating procedures of the agency. As such, the rule does not impose any new requirements on contracts at or below the simplified acquisition threshold or for commercial items, including commercially available off-the-shelf items.

Executive Order (E.O.) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).

This final rule is not an E.O. 13771 regulatory action, because this rule is not significant under E.O. 12866.

The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is Office of Federal Procurement Policy statute (codified at title 41 of the United States Code). Specifically, 41 U.S.C. 1707(a)(1) requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because it only impacts determination and documentation processes that are internal to the agency.

Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 41 U.S.C. 1707(a)(1) (see section V. of this preamble), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR part 217 is amended as follows:

I. Background

DoD published a proposed rule in the Federal Register at 83 FR 30659 on June 29, 2018, to modify DFARS clause 252.217-7001, Surge Option, to replace the term “Production Surge Plan (DI-MGMT-80969)” with “Capabilities Analysis Plan (CAP)” and add text to permit the option increase of supplies or services called for under the clause to be expressed as a specific number. The associated clause prescription at DFARS 217.208-70(b) is amended to reflect that the option increase of supplies or services may also be expressed as a specific number. This rule supports a recommendation from the DoD Regulatory Reform Task Force under Executive Order (E.O.) 13777, Enforcing the Regulatory Reform Agenda.

One respondent submitted a public comment in response to the proposed rule. The comment is outside the scope of this case and no changes are made in the final rule.

This rule does not propose to create any new provisions or clauses. The proposed changes to DFARS clause 252.217-7001, Surge Option, are minimal and reflect only updates required to mirror current industry terminology and practice for support that may be required for industrial planning for selected essential military items in the event of an emergency. The rule continues to apply to contracts below the simplified acquisition threshold, however, the rule does not apply to commercial items, including commercially available off-the-shelf items.

E.O. 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).

This final rule is not subject to E.O. 13771, because this rule is not significant under E.O. 12866.

A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

The Department of Defense is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices. The objective of this rule is to improve the flexibility offered to contractors submitting pricing for surge options by giving them the option to quote prices by percentage or quantity increases, and to update the terminology used from “Production Surge Plan” to “Capability Analysis Plan” (CAP), since this is the most current and accurate term for this type of plan. The modification of this DFARS text supports a recommendation from the DoD Regulatory Reform Task Force under E.O. 13777, Enforcing the Regulatory Reform Agenda.

No public comments were received in response to the initial regulatory flexibility analysis.

This rule is not expected to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the scope of the rule limits the application of the reporting requirement to a small number of service contracts. Based on fiscal year 2017 data from the Federal Procurement Data System, the Government issued approximately 78 contract actions that used mobilization or essential research and development as the reason for other than full and open competition. Of the 78 contract actions, approximately 33 awards were made to 24 unique small entities.

This rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses.

There are no known significant alternative approaches to the rule that would meet the proposed objectives.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Government procurement.

Therefore, 48 CFR parts 217 and 252 are amended as follows: 1. The authority citation for parts 217 and 252 continues to read as follows:

I. Public Participation and Request for Comments A. Submitting Comments

If you submit a comment, please include the docket number for this IFR (FMCSA-2001-11117), indicate the specific section of the document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2001-11117, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

FMCSA will consider all comments and material received during the comment period and may change this IFR based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.

To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2001-11117, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.transportation.gov/privacy.

On May 5, 2003, FMCSA published an IFR titled “Limitations on the Issuance of Commercial Driver's Licenses with a Hazardous Materials Endorsement” (68 FR 23844). It revised its regulations to require State licensing agencies to issue or renew a hazardous materials endorsement for a CDL only if the Transportation Security Administration (TSA) has determined that the applicant does not pose a security risk warranting denial of such endorsement. To determine applicability, a CDL renewal, transfer, or upgrade was also considered a new issuance and fell within the scope of these requirements if it involved a hazardous materials endorsement. The IFR implemented FMCSA's part of the requirements of section 1012 of the USA PATRIOT Act, which limited the issuance of hazardous materials licenses. Because FMCSA shares with TSA the responsibility for implementing section 1012, TSA concurrently published an IFR containing regulations governing the security risk determination process in 49 CFR parts 1570 and 1572 (May 5, 2003, 68 FR 23852). No public meeting was requested and none was held. The IFR became effective upon publication on May 5, 2003.

On April 29, 2005, FMCSA published an IFR titled “Limitations on the Issuance of Commercial Driver's Licenses with a Hazardous Materials Endorsement” (70 FR 22268). That rule was issued as an IFR because it related to the 2003 IFR. In the preamble, FMCSA wrote that the 2005 IFR would be subsumed into the 2003 IFR when that rulemaking was finalized. FMCSA's 2003 IFR provided a specific date on which States became subject to the new requirement. The 2005 IFR amended the FMCSRs to cross-reference the TSA's compliance date as the date when FMCSA's companion requirements also became applicable (70 FR 22268). Consistent with the TSA regulations, FMCSA also reduced the amount of advance notice that States must provide to drivers that a security threat assessment will be performed when they renew a hazardous materials endorsement.

FMCSA solicited comments to the 2003 IFR. The Agency received over 50 comments. No comment period was included with the 2005 IFR.

On October 5, 2018, Congress enacted the FAA Reauthorization Act of 2018 (Pub. L. 115-254). Under Sec. 1977, a CMV driver who wants to obtain a hazardous materials endorsement on a commercial driver's license is an “applicable individual who is subject to credentialing or background investigation”. Section 1978 exempted individuals who hold a valid transportation security card (TSC, or TWIC as implemented by TSA) issued under section 70105 of Title 46. FMCSA intends to incorporate this exemption when finalizing the IFRs, subject to TSA requirements on the issuance of the HME.

Considering the passage of time since the publication of the IFRs, and because some items may not have been touched on during the initial notice and comment, FMCSA is re-opening the comment period. At the end of the comment period, FMCSA will consider all issues under its authority and may change the IFR based on the comments. FMCSA may issue a final rule at any time after the close of the comment period.

I. Background A. History

On May 27, 2015, FMCSA published a final rule titled “Lease and Interchange of Vehicles; Motor Carriers of Passengers” (80 FR 30164). The American Bus Association (ABA) and United Motorcoach Association (UMA) filed a joint request for an extension of the June 26, 2015, deadline to submit petitions for reconsideration of the final rule (80 FR 37553). On July 1, 2015, the Agency extended the deadline for such petitions until August 25, 2015 (80 FR 37553).

The Agency received 37 petitions for reconsideration, all of which were filed in the public docket referenced above. After the initial review of the petitions, FMCSA held a meeting on October 28, 2015, with a cross section of the petitioners. Attending were representatives from small and large bus companies, charter and regular-route operations, and diverse geographic areas of the nation. Additionally, two insurance company representatives were invited due to litigation and financial liability concerns. The purpose of the meeting was to have an open discussion and to gather additional details about petitioners' specific operations and concerns.

Based on these discussions, and after further analysis, FMCSA concluded that some aspects of the petitions for reconsideration have merit. The Agency therefore extended the compliance date to January 1, 2018, to allay stakeholder concerns that there would not be sufficient time to adjust passenger carrier operations before compliance with the regulations was required (81 FR 13998, March 16, 2016). After further review of the petitions, the Agency announced on August 31, 2016, that it intended to consider changes to four aspects of the 2015 final rule, but it also denied requests to reconsider other issues raised by petitioners (81 FR 59951). The August 31 document announced that a public roundtable would be held to discuss the four issues. The roundtable was held on October 31, 2016.

On June 16, 2017, FMCSA published a final rule (2017 final rule) and a proposal in the Federal Register (82 FR 27766, and 27768). The 2017 final rule extended the compliance date of the 2015 final rule from January 1, 2018, to January 1, 2019. The proposal provided information about FMCSA's planned revisions to the 2015 final rule and requested public comment on those revisions.

To address the concerns in the petitions, FMCSA published an NPRM on September 20, 2018 (83 FR 47764). This NPRM (RIN 2126-AC07) proposed to extend the compliance date of the 2015 final rule from January 1, 2019, to January 1, 2021. It also included proposed revisions to the 2015 final rule and requested public comment by November 19, 2018.

In October 2018, several passenger carriers petitioned FMCSA to extend the compliance date immediately in accordance with the Agency's prior commitments and provide sufficient time to finalize the NPRM, to avoid an uncertain operating environment, confusion, and disruption in industry operations. ABA wrote that the outcome of an uncertain business environment is entirely avoidable. The Agency should take the same action it has taken on two prior occasions, and simply publish a final rule to extend the compliance date of the current rule. ABA argued that extending the compliance date would not affect safety, as the current rule has never been in force; nor would an extension interfere with the rulemaking process to finalize revisions to the current rule. Further, the Agency has committed to extending the compliance date on several occasions for the stated purpose of allowing sufficient time to complete revisions to the current rule.

FMCSA received 15 comments supporting the extension of the compliance date of the 2015 final rule to January 1, 2021. The extension is necessary to provide time to consider all the issues and to publish a final rule, while giving motor carriers sufficient time to comply with the revised requirements. FMCSA therefore extends the 2019 compliance date until January 1, 2021.

The Agency is extending the compliance date by 2 years, to January 1, 2021. The temporary section added to subpart F of 49 CFR part 390 when a previous extension of the compliance date was issued, is being updated to include the new compliance date. The temporary section continues to be in effect only from December 4, 2018 through January 1, 2021.

FMCSA performed an analysis of the impacts of this final rule and determined it is not a significant regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, October 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), Improving Regulation and Regulatory Review. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order. It is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.5 dated May 22, 1980; 44 FR 11034 (February 26, 1979)). This final rule provides regulatory relief from January 1, 2019, through December 31, 2020, from all compliance costs associated with the 2015 final rule. The Agency's estimates of the cost of the 2015 final rule are thoroughly explained in that rule's Regulatory Evaluation (available in docket FMCSA-2012-0103) and were updated to reflect more recently available data for the NPRM. The analysis of today's final rule utilizes the same data and methodology as the NPRM.

To estimate the costs that will result from the final rule, the Agency calculated the total compliance costs from 2019 through 2028, albeit with no costs incurred in years 2019 and 2020. These costs are compared to a baseline in which the compliance costs of the 2015 final rule are incurred beginning in 2019, as shown in Table 1.

The Agency estimates that the final rule will result in a cost savings of $13.4 million discounted at 3 percent and $14.6 million discounted at 7 percent over the 10-year analysis period. Expressed on an annualized basis, this equates to a cost savings of $1.6 million at a 3 percent discount rate and $2.1 million at a 7 percent discount rate. All values are in 2016 dollars.

This rule is an E.O. 13771 deregulatory action.1 The present value of the cost savings of this rule, measured on an infinite horizon at a 7 percent discount rate, is approximately $11.9 million. Expressed on an annualized basis, the cost savings are $0.8 million. These values are expressed in 2016 dollars.

Section 603 of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, March 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, September 27, 2010), requires FMCSA to perform a detailed analysis of the potential impact of the final rule on small entities. Accordingly, DOT policy requires that agencies shall strive to lessen any adverse effects on these businesses and other entities. The Final Regulatory Flexibility Analysis conducted as part of the May 27, 2015, rule continues to be applicable to this final rule.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this rule so that they can better evaluate its effects on themselves. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Loretta Bitner, listed in the FOR FURTHER INFORMATION CONTACT section of this rule.

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the SBA's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy ensuring the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.

A rule has federalism implications if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on the States. FMCSA analyzed this rule under E.O. 13132 and has determined that it has no federalism implications.

This final rule does not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532 et seq.), that would result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $161 million (which is the value of $100 million in 2017 after adjusting for inflation) or more in any 1 year.

This final rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

FMCSA analyzed this action under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. The Agency has determined that this rule does not create an environmental risk to health or safety that would disproportionately affect children.

FMCSA reviewed this final rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it would not effect a taking of private property or otherwise have taking implications.

Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This final rule does not require the collection of any personally identifiable information.

The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency which receives records contained in a system of records from a Federal agency for use in a matching program. FMCSA has determined this final rule does not result in a new or revised Privacy Act System of Records for FMCSA.

The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), Federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations. On August 5, 2015, OMB approved the May 27, 2015, final rule's two information collections titled “Commercial Motor Vehicle Marking Requirements,” OMB No. 2126-0054, and “Lease and Interchange of Motor Vehicles,” OMB No. 2126-0056. OMB renewed these collections of information in October 2018, and they will both expire on October 31, 2021.

FMCSA analyzed this final rule in accordance with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.). The Agency has determined under its environmental procedures Order 5610.1, published March 1, 2004, in the Federal Register (69 FR 9680), that this action is categorically excluded from further environmental documentation under Appendix 2, Paragraphs 6.y(2) and 6.y(7) of the Order (69 FR 9702). These categorical exclusions relate to:

• 6.y(2) Regulations implementing motor carrier identification and registration reports; and

• 6.y(7) Regulations implementing prohibitions on motor carriers, agents, officers, representatives, and employees from making fraudulent or intentionally false statements on any application, certificate, report, or record required by FMCSA.

Thus, this final action does not require an environmental assessment or an environmental impact statement.

FMCSA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that Executive Order because it is not economically significant and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

For the reasons stated in the preamble, FMCSA amends 49 CFR part 390 in title 49, Code of Federal Regulations, chapter III, subchapter B, as follows:

The snapper-grouper fishery of the South Atlantic is managed under the FMP, and includes golden tilefish along with other snapper-grouper species. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

NMFS issued a temporary rule to implement interim measures to reduce the total annual catch limit (ACL), commercial and recreational sector ACLs, and quotas for the hook-and-line and longline components of the commercial sector on January 2, 2018 (83 FR 65). On June 19, 2018, NMFS extended the interim measures for an additional 186 days, through January 3, 2019 (83 FR 28387). On September 27, 2018, NMFS published a proposed rule for Regulatory Amendment 28 and requested public comment (83 FR 48788). Regulatory Amendment 28 and the proposed rule outline the rationale for the actions contained in this final rule. A summary of the actions implemented by Regulatory Amendment 28 and this final rule is provided below.

The Magnuson-Stevens Act requires that NMFS and regional fishery management councils prevent overfishing and achieve, on a continuing basis, the OY from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems.

Golden tilefish are harvested by both commercial and recreational fishermen throughout the South Atlantic, although the majority of landings are attributed to the bottom longline component of the commercial sector. Using data through 2010, the golden tilefish stock was assessed in 2011 through the Southeast Data, Assessment, and Review (SEDAR) stock assessment process (SEDAR 25). SEDAR 25 results indicated that the golden tilefish stock was not subject to overfishing and was not overfished. Based upon the results of SEDAR 25, the final rule for Amendment 18B to the FMP specified ACL based upon the acceptable biological catch (ABC) recommendation from the Council's Scientific and Statistical Committee (SSC). The total ACL was distributed among the sectors and commercial gear components (i.e., bottom longline and hook and line) based on allocations specified in Amendment 18B (78 FR 23858; April 23, 2013). For golden tilefish, 97 percent of the combined (commercial and recreational sectors together) ACL is allocated to the commercial sector, with 25 percent of the commercial ACL available for harvest by the hook-and-line component and 75 percent of the commercial ACL available for the longline component. The recreational sector is allocated 3 percent of the combined ACL.

In April 2016, an update to the SEDAR 25 stock assessment was completed for golden tilefish using data through 2014 (SEDAR 25 Update 2016). In May 2016, the Council's SSC reviewed the updated assessment, determined the assessment was based on the best scientific information available, and provided an ABC recommendation. In a letter dated January 4, 2017, NMFS notified the Council of the updated golden tilefish stock status (SEDAR 25 Update 2016) determination that the stock is undergoing overfishing but is not overfished. As mandated by the Magnuson-Stevens Act, NMFS and the Council must prepare and implement a plan amendment and regulations to end overfishing of golden tilefish. Therefore, the Council began development of an amendment to end overfishing of golden tilefish. Because the ABC recommendation from the Council's SSC was not available until late October 2017, there was insufficient time for the Council and NMFS to develop and implement management measures to end overfishing of golden tilefish by the start of the 2018 fishing year on January 1, 2018. Consequently, in a letter to NMFS dated June 27, 2017, the Council requested that NMFS implement interim measures to immediately reduce overfishing of golden tilefish while long-term measures could be developed through Regulatory Amendment 28. A temporary rule, published in the Federal Register on January 2, 2018 (83 FR 65), reduced the combined ACL based on a projected yield at 75 percent of the yield produced by the fishing mortality rate at maximum sustainable yield (F = 75%FMSY), which was 362,000 lb (164,654 kg), whole weight. Converting this value to gutted weight using a conversion factor of 1.12 provided a value of 323,000 lb (146,510 kg), gutted weight. On June 19, 2018 (83 FR 28387), the temporary rule was extended for an additional 186 days, through January 3, 2019.

This final rule revises the combined ACL for golden tilefish to be 342,000 lb (155,129 kg), gutted weight. In May 2016, the Council's SSC reviewed the SEDAR 25 assessment update and provided fishing level recommendations based on a P* (probability of overfishing) value of 30 percent derived from the Council's ABC control rule. However, at their March 2018 meeting, the Council determined that they were willing to accept a risk of overfishing at the level implemented through the temporary interim rule (F = 75%FMSY) when the population is at equilibrium. Thus, the Council requested the SSC recommend an ABC based on F = 75%FMSY, which represented a level closer to a P* value of 40 percent. At their May 2018 meeting, the SSC reviewed the Council's request to revise the ABC recommendation and agreed to change the ABC to the value at F = 75%FMSY. Therefore, the SSC's most recent ABC recommendation was 362,000 lb (164,654 kg), whole weight.

This combined ACL specified in Regulatory Amendment 28 is equal to the Council's SSC ABC recommendation of 362,000 lb (164,654 kg), whole weight, when converted to gutted weight. The SEDAR 25 Update (2016) for golden tilefish used a whole weight to gutted weight conversion factor of 1.059, but the interim rule used a conversion value of 1.12. At their June 2018 meeting, the Council indicated that a conversion factor of 1.059 rather than a 1.12 was more appropriate to convert the ABC recommendation from whole weight to gutted weight. Both SEDAR 25 Update 2016 and the 1.059 conversion factor constitute the best scientific information available for golden tilefish. The SSC's ABC recommendation forms the basis for the actions in Regulatory Amendment 28 and this final rule, which is expected to end overfishing of golden tilefish in the South Atlantic.

This final rule also specifies the commercial and recreational sector ACLs and component commercial quotas using the existing sector allocations of 97 percent commercial and 3 percent recreational, as well as allocating 25 percent of the commercial ACL to the hook-and-line component and 75 percent of the commercial ACL to the longline component. Therefore, through this final rule, the commercial ACL (equivalent to the commercial quota) is 331,740 lb (150,475 kg), gutted weight. The commercial ACL for the hook-and-line component is 82,935 lb (37,619 kg), gutted weight, and the commercial ACL for the longline component is 248,805 lb (112,856 kg), gutted weight. The recreational ACL is 2,316 fish.

The reduction in the ACLs in this final rule is expected to end overfishing of golden tilefish and minimize future adverse socio-economic effects. Adhering to sustainable harvest through an ACL based on information from the most recent stock assessment (Southeast Data Assessment and Review (SEDAR) 25 2016 Update) is expected to be more beneficial to fishers and fishing communities in the long term because catch limits are based on the current conditions. The reduction in the ACLs in this final rule is expected to provide biological benefits (such as protections against recruitment failure) to the golden tilefish stock by reducing the levels of fishing mortality. The revised ACL values in Regulatory Amendment 28 and implemented through this final rule are based on the best scientific information available.

The measures in Regulatory Amendment 28, as described in this final rule, replace the current interim measures outlined in the temporary rule. Failure to implement Regulatory Amendment 28 by the expiration of the temporary rule (January 4, 2019) may risk overfishing of golden tilefish because ACLs will revert to higher levels in place prior to implementation of the temporary rule, and those levels exceed the SSC's most recent ABC recommendation. In addition, implementing Regulatory Amendment 28 by the expiration date of the temporary rule will avoid confusion among fishers and law enforcement with changing catch levels.

During the public comment period, NMFS received a total of 10 comments on Regulatory Amendment 28 and the proposed rule from individuals and fishing organizations. Of these, three comments supported the need for protection of golden tilefish, with which NMFS agrees. Two comments generally expressed support for golden tilefish harvest by the recreational sector and complained of increasing costs, but those comments were not directed to the ACL changes contained in the proposed rule; thus, they are considered to be outside the scope of Regulatory Amendment 28. Two additional comments were entirely unrelated to golden tilefish harvest and were, therefore, also outside the scope of Regulatory Amendment 28. Comments that were beyond the scope of Regulatory Amendment 28 and the proposed rule, are not addressed further in this final rule. Comments that specifically relate to the actions contained in the Regulatory Amendment 28 and the proposed rule, as well as NMFS' respective responses, are summarized below.

Comment 1: Regulatory Amendment 28 does not adequately consider the socio-economic impacts that will disproportionately impact the small fishing communities that are affected by the South Atlantic fishing industry.

Response: As described in the EA and the for Regulatory Amendment 28 and the proposed rule, the ACL reductions are necessary to end overfishing of golden tilefish in the South Atlantic. The Council and NMFS have adequately considered the socio-economic impacts through the socio-economic impact analysis developed in Regulatory Amendment 28 for implementing this final rule. NMFS conducted a RIR, an Initial Regulatory Flexibility Analysis (IRFA), and a Final Regulatory Flexibility Analysis (FRFA) that analyze the expected impacts of the actions in the regulatory amendment on the commercial and recreational sectors engaged in fishing for South Atlantic golden tilefish.

NMFS expects the reductions to the ACLs and quotas will result in adverse, short-term economic effects. These effects will apply directly on the participants of the golden tilefish commercial and recreational sectors and indirectly on the supporting industries, such as dealers, tackle and bait shops, and fishing communities. However, Regulatory Amendment 28 and this final rule will likely minimize future adverse socio-economic effects by ending overfishing of South Atlantic golden tilefish and preventing the stock from being overfished.

NMFS has determined that all entities directly affected by the management measures outlined in Regulatory Amendment 28 and this final rule are small entities as this term is defined in the Classification section of this rule, so that disproportionate impacts on small versus large entities are not expected to occur. However, effects on affected entities will not be uniform. In general, the larger the sector (e.g., commercial sector) or commercial component's (e.g., longline fishermen) percentage of the allocation, the greater the short-term adverse economic impacts will be. In addition, the more dependent a location or fishing community is on fishing for golden tilefish, the greater the adverse impacts will be on an area's fishing participants and supporting industries.

Comment 2: Why is the commercial ACL, listed in weight, significantly greater than the recreational ACL, which is given in numbers of fish?

Response: The commercial ACL is greater than the recreational ACL because 97 percent of the total ACL is allocated to the commercial sector and 3 percent to the recreational sector. The sector allocations were specified in 2010 (75 FR 82280; December 30, 2010). Regulatory Amendment 28 and this final rule revise the ACL for golden tilefish based on the ABC recommendation from the Council's SSC, but do not change the allocation of the ACL among the commercial and recreational sectors. This allocation was previously determined by the Council and NMFS to be fair and equitable, based on landings data, and considered the least disruptive to economic and social environments. The commercial ACL is further allocated into commercial quotas with 75 percent to the commercial longline sector and 25 percent to the commercial hook-and-line sector, as established in 2013 through Amendment 18B to the FMP (78 FR 23858; April 23, 2013). These quota allocations were also based on commercial landings data, as more of the commercial harvest is from the commercial longline component than the hook-and-line component.

The commercial allocation is listed in pounds (lb) of gutted weight (gw) and the recreational allocation is in numbers of fish. To convert the recreational ACL into numbers of fish, the recreational landings data collected through the Marine Recreational Information Program and Southeast Region Headboat Survey were used to calculate the average weight of South Atlantic golden tilefish. From 2012-2016, the average weights of recreational golden tilefish have ranged annually from 4.21 lb, gw to 5.11 lb, gw. Using these 5 years of data (2012-2016) provides an average weight of 4.43 lb, gw. Therefore, a conversion factor of 4.43 lb, gw per fish is used for converting the South Atlantic golden tilefish recreational ACL into numbers of fish.

Comment 3: There needs to be better data collected on golden tilefish instead of continuing to use limited existing data applied in inconsistent methods because it is irresponsible with the goal of achieving MSY.

Response: NMFS determined that the data used in Regulatory Amendment 28 represents the best scientific information available and that the data used in SEDAR 25 2016 Update is applied neither inconsistently nor irresponsibly. NMFS notes that Regulatory Amendment 28 and the final rule respond to the latest stock assessment for golden tilefish in the South Atlantic (SEDAR 25 Update 2016). The SEDAR 25 Update 2016 concluded that the stock is undergoing overfishing, but is not overfished.

The SEDAR 25 participants outlined the research needs for the golden tilefish stock assessment and these are contained in the SEDAR 25 Assessment Report. The next golden tilefish stock assessment, which will include a review of all existing data, is scheduled to begin in 2019.

The golden tilefish stock of the South Atlantic was assessed through the SEDAR process, which is a peer-reviewed cooperative effort to assess the status of stocks in the jurisdictions of the South Atlantic, Caribbean, and Gulf of Mexico Fishery Management Councils; as well as NMFS' Southeast Fisheries Science Center and Southeast Regional Office, and the NMFS Highly Migratory Species Division; and the Atlantic and Gulf States Marine Fisheries Commissions. SEDAR also relies on state agencies and universities throughout the region for research, data collection, and stock assessment expertise. Fishery-dependent and independent data were utilized in the stock assessment. All of the data sources used are further described in the SEDAR 25 Update 2016, which is available on the SEDAR website at http://sedarweb.org. The SEDAR website also provides supporting documentation that describes data collection programs and research findings.

The Council received the results of the assessment update from their SSC in June 2016, and Council members expressed concern over the large differences in biological benchmarks and fishing level recommendations between SEDAR 25 Update 2016 and SEDAR 25. Subsequently, the Council requested an updated stock assessment for golden tilefish.

To address the Council's concerns, in May 2017, the SEDAR Steering Committee agreed to revise the SEDAR 25 Update 2016, because a new golden tilefish stock assessment could not be completed in 2017. The SSC reviewed the 2017 revision to the SEDAR 25 Update 2016 at their October 2017 meeting and determined that it was unsuitable for management. Therefore, the best scientific information available for golden tilefish remains the SEDAR 25 Update 2016.

The Regional Administrator for the NMFS Southeast Region has determined that this final rule is consistent with Regulatory Amendment 28, the Magnuson-Stevens Act, and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866. This final rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

In compliance with section 604 of the RFA, NMFS prepared a Final Regulatory Flexibility Analysis (FRFA) for this final rule. The FRFA incorporates the IRFA, a summary of the significant economic issues raised by public comments, NMFS' responses to those comments, and a summary of the analyses completed to support the action. The FRFA follows.

A description of this final rule, and its rationale, objectives, and legal basis are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. The Magnuson-Stevens Act provides the statutory basis for this final rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule. Accordingly, this final rule does not implicate the Paperwork Reduction Act.

No comments specific to the IRFA were received from the public or from the Chief Counsel for the Advocacy of the Small Business Administration; however, there are comments that have socio-economic implications, and they are addressed in the Comments and Responses section, specifically in Comment 1.

No changes to the proposed rule were made in response to public comments. NMFS agrees that the Council's recommendation for the action will best achieve their objectives for this final rule while minimizing, to the extent practicable, the adverse effects on fishermen, support industries, and associated communities.

NMFS expects this final rule will directly affect all commercial vessels that harvest South Atlantic golden tilefish under the FMP. The change in the recreational ACL in this final rule will not directly affect or regulate for-hire businesses. Any impact to the profitability or competitiveness of for-hire fishing businesses will be the result of changes in for-hire angler demand and will therefore be indirect in nature. Under the RFA, recreational anglers who will be directly affected by this final rule, are not considered small entities, so they are outside the scope of this analysis and only the effects on commercial vessels were analyzed. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.

From 2012 through 2016, an average of 23 longline vessels per year landed golden tilefish from the South Atlantic. The Federal golden tilefish longline endorsement to the snapper-grouper permit started in 2013 upon implementation of the final rule for Amendment 18B to the snapper-grouper FMP (78 FR 23858; April 23, 2013). Endorsed vessels, combined, averaged 255 trips per year in the South Atlantic on which golden tilefish were landed, and 182 other trips that took place either in the South Atlantic (but no golden tilefish were caught) or in other areas (Gulf of Mexico or Mid-Atlantic) that caught any species including golden tilefish. The average annual total dockside revenue (2016 dollars) for these vessels combined was approximately $1.56 million from golden tilefish, approximately $0.10 million from other species co-harvested with golden tilefish (on the same trips), and approximately $0.43 million from other trips by these vessels on trips in the South Atlantic on which no golden tilefish were harvested or on trips which occurred in other areas. Total average annual revenue from all species harvested by longline vessels landing golden tilefish in the South Atlantic was approximately $2.10 million, or approximately $92,000 per vessel. Longline vessels generated approximately 74 percent of their total revenues from golden tilefish. For the same period, an average of 82 vessels per year landed golden tilefish using other gear types (mostly hook-and-line) in the South Atlantic. These vessels, combined, averaged 483 trips per year in the South Atlantic on which golden tilefish were landed and 2,862 trips taken in the South Atlantic on which golden tilefish were not harvested or trips that took place in other areas and caught any species including golden tilefish. The average annual total dockside revenue (2016 dollars) for these 82 vessels was approximately $0.36 million from golden tilefish, approximately $0.66 million from other species co-harvested with golden tilefish (on the same trips in the South Atlantic), and approximately $4.13 million from the other trips taken by these vessels. The total average annual revenue from all species harvested by these 82 vessels was approximately $5.16 million, or approximately $62,000 per vessel. Approximately 7 percent of these vessels' total revenues came from golden tilefish.

Based on the foregoing revenue information, all commercial vessels using longlines or hook-and-line gear affected by this final rule may be considered to be small entities. Because all entities expected to be directly affected by this final rule are assumed to be small entities, NMFS has determined that this final rule will affect a substantial number of small entities. However, since all affected entities are small entities, the issue of disproportionate effects on small versus large entities does not arise in the present case.

This final rule will reduce the combined stock ACL, and consequently the ACLs for the commercial and recreational sectors as well as the longline and hook-and-line component ACLs of the commercial sector. The longline and hook-and-line components of the commercial sector will be expected to lose approximately $592,000 ($25,739 per vessel) and $217,000 ($2,646 per vessel) respectively, in annual ex-vessel revenues. This will very likely translate to profit reductions for both the longline and hook-and-line components, particularly for longline vessels, as they are more dependent on golden tilefish. As noted above, golden tilefish account for about 74 percent of longline vessel revenues and 7 percent of hook-and-line vessel revenues. The ACLs may be changed in the future if this final rule is successful in addressing the overfishing condition for the South Atlantic golden tilefish. Economic benefits would ensue if the ACLs are subsequently increased based on an improved stock status.

The following discussion analyzes the alternatives that were considered by the Council, including those that were not selected as preferred by the Council. Unlike the preferred alternative, six of the other alternatives would provide for varying ACLs over 6 years, at least. For this reason, a 6-year period is considered for comparing alternatives. To carry out a 6-year comparison, the ACL under the preferred alternative is kept constant for 6 years. It is noted that a stock assessment for golden tilefish would be completed in 2019, so the Council may opt to revise the ACL in 2020 or later. Over a 6-year period with constant ACL, the preferred alternative will be expected to reduce revenues by approximately $3.02 million for the longline component and $1.11 million for the hook-and-line component of the commercial sector, using a 7 percent discount rate.

Ten alternatives, including the preferred alternative as described above, were considered for reducing the South Atlantic golden tilefish ACLs. The first alternative, the no action alternative, would maintain the current economic benefits to all participants in the South Atlantic golden tilefish component of the snapper-grouper fishery. This alternative, however, would not address the need to end overfishing of the stock, thereby increasing the likelihood that more stringent measures would need to be implemented in the near future.

With one exception, all the other alternatives would result in larger revenue losses to the longline and hook-and-line vessels than the preferred alternative. Alternatives that would result in larger revenue losses than the preferred alternative would provide for lower ACLs over a 6-year period. Total losses over 6 years from these alternatives would range from $3.17 million to $4.29 million for longline vessels and from $1.16 million to $1.83 million for hook-and-line vessels. The alternative with lower attendant revenue losses than the preferred alternative would be expected to reduce total ex-vessel revenues by approximately $2.65 million for longline vessels and $0.97 million for hook-and-line vessels over 6 years. Relative to the preferred alternative, this alternative would result in larger ex-vessel revenue losses initially but lower revenue losses in subsequent years, because the ACLs in subsequent years would be greater than those of the preferred alternative. Both alternatives would be expected to result in early harvest closures as a result of reaching the ACL during the fishing year, and in the first fishing year, harvest closure under the preferred alternative would occur later than that of the other alternative. The reverse may be expected for the subsequent years. The Council considered the preferred alternative as affording the best means to end overfishing of golden tilefish in the South Atlantic, because it is based on the best scientific information available.

For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014). NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

NMFS published a final rule (i.e., the “quota rule” (83 FR 51391, October 11, 2018)) that increased the baseline U.S. BFT quota from 1,058.79 mt to 1,247.86 mt consistent with a 2017 ICCAT recommendation and accordingly increased the category quotas for 2018. Within the General category quota, each time period (January, June through August, September, October through November, and December) is further allocated a subquota or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward from one time period to the next and is available for use in subsequent time periods within the fishing year, which coincides with the calendar year.

For the January 2018 subquota period, NMFS transferred 14.3 mt of BFT quota from the December 2018 subquota period, and transferred 10 mt from the Reserve category, resulting in an adjusted subquota of 53.8 mt for the January 2018 period and a subquota of 14.6 mt for the December 2018 period (82 FR 60680, December 22, 2017, and 83 FR 9232, March 5, 2018, respectively). For 2018, NMFS also transferred a total of 75 mt from the Reserve and 40 mt from the Harpoon category to the General category through two inseason actions in September and October, resulting in an adjusted 2018 General category quota of 680.8 mt and adjusted 2018 Harpoon category of 36 mt (83 FR 47843, September 21, 2018, and 83 FR 50857, October 10, 2018, respectively). NMFS closed the October through November General category fishery after multiple reopenings when the subquota (127.2 mt) was met, effective November 16, 2018 (83 FR 57340, November 15, 2018). The 2018 General category fishery reopens December 1, 2018, and will remain open until December 31, 2018, or until the General category quota is reached, whichever comes first. Prior to this action, the adjusted Reserve category quota was 142.9 mt, and was most recently adjusted in the October 11, 2018 quota rule, which augmented the 2018 BFT Reserve category quota with available underharvest of the 2017 adjusted U.S. BFT quota. The Harpoon category fishery automatically closed for the year on November 15, 2018.

Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria at § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to the General category fishery. These considerations include, but are not limited to, the following:

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT over the longest time-period allowable would support the collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS considered the catches of the General category quota to date (including during the summer/fall and winter fisheries in the last several years), and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Preliminary landings data as of November 26, 2018, indicate that the Harpoon category landed 26.1 mt of the 36 mt adjusted Harpoon quota before closing. They also indicate that the General category has landed 770 mt this year, which exceeds the overall General category adjusted quota of 680.8 mt. For all commercial categories, however, approximately 23 percent (267.9 mt) of the total of the BFT category quotas remains available as of November 26, 2018 (i.e., 881 mt of 1148.9 mt has been harvested), and NMFS anticipates that some amount of quota may remain unused by the end of the year even with the transfer. Absent a transfer, the December General category fishery would remain closed, even though quota remains available within the overall quota for the year and NMFS anticipates that commercial-sized BFT will be readily available on the fishing grounds when the fishery is otherwise scheduled to re-open December 1, 2018. Transferring 129.2 mt of BFT quota from the Reserve category, and 9.9 mt from the Harpoon category would allow the General category fishery to resume as scheduled and would result in a total of 50.0 mt being available to the General category in December after accounting for quota exceedances. It would also leave 13.7 mt in the Reserve category to account for any BFT mortalities associated with research and/or any overharvests that may occur in December. In analyzing the criteria for transfer, NMFS also considered the fact that BFT quota management throughout the year had been informed, in part, by anticipated upward adjustments to the overall quota. Such adjustments, while not certain, were anticipated as a result of the 2017 ICCAT recommendation increasing the overall BFT quota and upward adjustments for last year's underharvests, although any such adjustments would only take effect after appropriate rulemaking procedures and actions (i.e., the 2018 quota rule).

Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered General category landings over the last several years and landings to date this year. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. A portion of the transferred quota covers overharvests in the category to date, and NMFS anticipates that General category participants will be able to harvest the remaining 50 mt of transferred BFT quota by the end of the fishing year.

NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2018 landings and dead discards. In the last several years, total U.S. BFT landings have been below the total available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2018 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and NMFS anticipates having sufficient quota to do that, even with this 139.1 mt transfer to the General category.

This transfer would be consistent with the current U.S. quota, which was established and analyzed in the 2018 BFT quota final rule, and with objectives of the 2006 Consolidated HMS FMP and amendments. (§ 635.27(a)(8)(v) and (vi)). Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

Based on the considerations above, NMFS is transferring 129.2 mt from the Reserve category to the General category. Therefore, NMFS adjusts the General category December subquota quota to 50.0 mt for the 2018 General category fishing season and adjusts the Reserve category quota to 13.7 mt. The 2018 General category fishery reopens December 1, 2018, and will remain open until December 31, 2018, or until the adjusted General category quota is reached, whichever comes first.

NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov or by using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action (e.g., quota adjustment or closure) is necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register. In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

NMFS reminds General category participants that when the fishery reopens December 1, 2018, the BFT General category daily retention limit will be one large medium or giant BFT (measuring 73” or greater) per vessel per day/trip.

The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2018 is impracticable and contrary to the public interest as such a delay would result in continued closure of the General category fishery (because the available quota has been exceeded) and the need to re-open the fishery later in the December time period, rather than the fishery automatically re-opening on December 1. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

This action is being taken under § 635.27(a)(9) (Inseason adjustments) and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The 2018 Pacific cod total allowable catch (TAC) apportioned to catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA is 880 metric tons (mt), as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the 2018 Pacific cod TAC apportioned to catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 870 mt and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA. While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod by catcher vessels less than 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 28, 2018.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.