Federal Register Vol. 81, No.166,

I. Background and Summary Authority

This rulemaking is authorized by section 2(b) of the Competitive, Special, and Faculties Research Grant Act 7 U.S.C. 450i(b).

A primary function of NIFA is the fair, effective, and efficient administration of Federal assistance programs implementing agricultural research, education, and extension programs. The awards made under the above authority are subject to the NIFA assistance regulations at 7 CFR part 3430, Competitive and Noncompetitive Non-formula Federal Assistance Programs—General Award Administrative Provisions. NIFA's development and publication of this regulation for its non-formula Federal assistance programs enhances its accountability and standardizes procedures across the Federal assistance programs it administers while providing transparency to the public. NIFA published 7 CFR part 3430 with subparts A through F as a final rule on September 4, 2009 [74 FR 45736-45752]. These regulations apply to all Federal assistance programs administered by NIFA except for the formula grant programs identified in 7 CFR 3430.1(f), the Small Business Innovation Research programs with implementing regulations at 7 CFR part 3403, and the Veterinary Medicine Loan Repayment Program (VMLRP), with implementing regulations at 7 CFR part 3431.

NIFA organized the regulation as follows: Subparts A through E provide administrative provisions for all competitive and noncompetitive non-formula Federal assistance programs. Subparts F and thereafter apply to specific NIFA programs.

NIFA is, to the extent practical, using the following subpart template for each program authority: (1) Applicability of regulations, (2) purpose, (3) definitions (those in addition to or different from § 3430.2), (4) eligibility, (5) project types and priorities, (6) funding restrictions, (7) matching requirements, and (8) duration of grant. Subparts F and thereafter contain the above seven components in this order. Additional sections may be added for a specific program if there are additional requirements or a need for additional rules for the program (e.g., additional reporting requirements).

Through this rulemaking, NIFA is making minor additions to Subpart G—Agriculture and Food Research Initiative (AFRI) in order to implement the AFRI commodity board provision from section 7404 of the Agricultural Act of 2014 (Pub. L. 113-79).

Subpart G contains the administrative provisions for the Agriculture and Food Research Initiative (AFRI). The purpose of AFRI is to make competitive grants for fundamental and applied research, extension, and education to address food and agricultural sciences, as defined under section 1404 of the National Agriculture Research, Extension, and Teaching Policy Act of 1977, as amended (7 U.S.C. 3103).

Section 7404 of the Agricultural Act of 2014 amended the general administration, special considerations, and eligible entities subsections for the Agriculture and Food Research Initiative (AFRI) program, and added a special contributions requirement making it necessary to modify the program's administrative provisions.

With this rule, NIFA makes clear that it will solicit funding ideas under this subpart from statutorily defined national and state commodity boards for research topics that the commodity boards are willing to co-fund equally with NIFA under the AFRI competitive grant program. If the ideas are evaluated and found to be consistent with the AFRI statutory priorities and priorities noted in the President's budget request related to NIFA, the topics will be incorporated in existing program areas in the relevant AFRI Request for Applications (RFA(s)). Researchers wishing to submit a proposal on a topic suggested by a commodity board will be required to obtain a letter of support from the co-funding commodity board. The applications submitted in response to a commodity board co-funded topic will compete against all proposals submitted in the same RFA program area. Supported applications will receive no preference regarding the evaluation of their scientific merit. Letters of commodity board support will be used by NIFA solely to determine that the application fits within the commodity board co-funded topic and the commodity board is willing to co-fund that application, if it is evaluated by the review panel as being meritorious and recommended for award.

While the Administrative Procedure Act (APA), 5 U.S.C. 553(a)(2), specifically exempts rules that involve public property, loans, grants, benefits, or contracts from notice-and-comment requirements, NIFA is issuing this rule as final with request for comments. Accordingly, NIFA is allowing 30 days for the submission of comments.

If upon consideration of the comments received in response to this notice NIFA decides to amend the AFRI final rule, NIFA will issue a subsequent final rule that includes an explanation of any changes made in response to the comments.

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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant.

This final rule has been reviewed in accordance with the Regulatory Flexibility Act of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, (5 U.S.C. 601-612). The Director certifies that this final regulation will not have a significant economic impact on a substantial number of small entities. This final regulation will affect institutions of higher education receiving Federal funds under this program. The U.S. Small Business Administration Size Standards define institutions as “small entities” if they are for-profit or nonprofit institutions with total annual revenue below $5,000,000 or if they are institutions controlled by governmental entities with populations below 50,000. The rule does not involve regulatory and informational requirements regarding businesses, organizations, and governmental jurisdictions subject to regulation.

The Department certifies that this final rule has been assessed in accordance with the requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (PRA). The Department concludes that this final rule does not impose any new information requirements or increase the burden hours. In addition to the SF-424 form families (i.e., Research and Related and Mandatory) and the SF-425 Federal Financial Report (FFR) No. 0348-0061, NIFA has three currently approved OMB information collections associated with this rulemaking: OMB Information Collection No. 0524-0042, NIFA REEport; No. 0524-0041, NIFA Application Review Process; and No. 0524-0026, Organizational Information.

This final regulation applies to the following Federal financial assistance programs administered by NIFA including CFDA No. 10.310, Agriculture and Food Research Initiative (AFRI).

The Department has reviewed this final rule in accordance with the requirements of Executive Order No. 13132 and the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq., and has found no potential or substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. As there is no Federal mandate contained herein that could result in increased expenditures by State, local, or tribal governments, or by the private sector, the Department has not prepared a budgetary impact statement.

Executive Order 12866 and the President's Memorandum of June 1, 1998, require each agency to write all rules in plain language. The Department invites comments on how to make this final rule easier to understand.

Accordingly, the Department of Agriculture, National Institute of Food and Agriculture, adopts the final rule amending 7 CFR part 3430 which was published at 75 FR 54759 on September 9, 2010, and amends 7 CFR part 3430 as set forth below:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to PILATUS Aircraft Ltd. Model PC-7 airplanes. The NPRM was published in the Federal Register on June 9, 2016 (81 FR 37166). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 37166, June 9, 2016) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

We reviewed PILATUS Aircraft Ltd. PC-7 Service Bulletin No: 53-013; and PILATUS Aircraft Ltd. PC-7 Service Bulletin No: 53-014, both dated February 25, 2016. PILATUS Aircraft Ltd. PC-7 Service Bulletin No: 53-013, dated February 25, 2016, describes procedures for initial and repetitive inspection of the main frame FR11 left and right fittings for stress corrosion cracking; and PILATUS Aircraft Ltd. PC-7 Service Bulletin No: 53-014, dated February 25, 2016, describes procedures for replacement of the main frame FR11 left and right fittings when necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of the AD.

We estimate that this AD will affect 19 products of U.S. registry. We also estimate that it would take about 3 work-hours per product to check the material specification of the fittings and 11 work-hours per product to inspect the 2014-T351 fittings as required in order to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $17,765, or $935 per product.

In addition, we estimate that any necessary follow-on actions would take about 19 work-hours and require parts costing $5,000 for a cost of $6,615 per product. We have no way of determining the number of products that may need these actions.

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7026; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

On March 30, 2016, we issued AD 2016-07-24, Amendment 39-18469 (81 FR 21250, April 11, 2016), (“AD 2016-07-24”), for all Textron Aviation, Inc. Models 310 through 310R, E310H, E310J, T310P through T310R, 310J-1, 320 through 320F, 320-1, 335, 340, 340A, 401 through 401B, 402 through 402C, 411, 411A, 414, 414A, and 421 through 421C airplanes (type certificates 3A10, 3A25, and A7CE previously held by Cessna Aircraft Company). AD 2016-07-24 required replacing the hardware connecting the elevator trim tab push-pull rod to the elevator trim tab actuator and elevator trim tab. AD 2016-07-24 resulted from accident reports on Textron Aviation, Inc. Models T310Q, 310Q, and 402B airplanes; lessons learned in accident investigation support; and analysis of past accidents. The analysis of National Transportation Safety Board (NTSB) determination of probable cause indicated that following the loss of the attachment hardware connecting the elevator trim tab actuator to the elevator trim tab push-pull rod, the elevator trim tab may jam in a position outside the normal limits of travel. We issued AD 2016-07-24 to require replacement and repetitive inspections of the hardware securing the elevator trim tab push-pull rod.

Since we issued AD 2016-07-24, we have received reports of difficulties in installing the required bolt, part number (P/N) NAS464P3-8, because it was found in some cases to be too short to properly fasten with a cotter pin as required by the AD. It was also determined beneficial to revise the repetitive inspection intervals to better coincide with the standard established inspection intervals for these airplanes. We are issuing this AD to correct the unsafe condition on these products.

We reviewed Textron Aviation, Inc. (Cessna Aircraft Company) Multi-engine Service Bulletin No. MEB-27-02, Revision 1, dated June 15, 2016. The service information describes procedures for replacing the hardware connecting the elevator trim tab push-pull rod to the elevator trim tab actuator and elevator trim tab. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires replacement and repetitive inspection of the elevator trim tab push-pull rod connecting hardware.

Due to the immediate safety of flight condition of this AD action, we are requiring replacement of the hardware within 90 days after the effective date of this AD rather than the potential of up to a year as allowed in the service information.

The kit referenced in the service bulletin contains only standard parts that may be procured from other sources.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the loss of the attachment hardware connecting the elevator trim tab actuator to the elevator trim tab push-pull rod may result in jamming of the elevator trim tab beyond normal limits, which could result in loss of ability to control the airplane. Therefore, we find that notice and opportunity for prior public comment are impracticable and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2016-8992 and directorate identifier 2016-CE-021-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

We estimate that this AD affects 5,066 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. This is the same replacement that is initially required by this AD. We have no way of determining the number of aircraft that might need this repetitive on-condition replacement:

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(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),

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

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 767-200 and -300 series airplanes. The NPRM published in the Federal Register on March 8, 2016 (81 FR 12047) (“the NPRM”). The NPRM was prompted by an evaluation by the DAH indicating that the aft pressure bulkhead web to pressure chord joint is subject to WFD. The NPRM proposed to require repetitive HFEC inspections of the aft pressure bulkhead web at fasteners common to the bulkhead web and pressure chord, around the entire circumference of the pressure chord, for any crack, and repair of cracks. We are issuing this AD to detect and correct cracks in the aft pressure bulkhead web. Such cracking could result in the loss of structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response. Boeing and United Airlines supported the NPRM.

Aviation Partners Boeing stated that accomplishing supplemental type certificate (STC) ST01920SE does not affect the actions specified in the proposed AD.

We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1), and added new paragraph (c)(2) to this AD to state that installation of STC ST01920SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01920SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed Boeing Alert Service Bulletin 767-53A0268, dated April 1, 2015. The service information describes procedures for HFEC inspections of the aft pressure bulkhead web at fasteners common to the bulkhead web and pressure chord, around the entire circumference of the pressure chord, for any crack, and repair of cracks. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 296 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

The size of any repair area needs to be determined before material and work-hour costs can be calculated, so we cannot provide cost estimates for the on-condition actions specified in this AD.

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(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),

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 777 airplanes. The NPRM published in the Federal Register on February 18, 2016 (81 FR 8164) (“the NPRM”). The NPRM was prompted by a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the MLG aft trunnion pin was later found to be fractured. The NPRM proposed to require identification and replacement of certain MLG aft trunnion pins. We are issuing this AD to prevent a fractured MLG aft trunnion pin, which could result in collapse of the MLG and consequent loss of control of the airplane during landing.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Three commenters indicated their support for the NPRM.

One commenter, Gilles Oriot, asked that we update the cost estimate to reflect the costs shown in Boeing Information Notice 777-32A0103 IN 03, dated February 2, 2015.

We agree with the commenter and have updated the Costs of Compliance to reflect the updated information.

The Boeing Company, American Airlines, Air France, Korean Air, Etihad Airways, and All Nippon Airways requested that we allow installation of pins with serial numbers beginning with “EGL” or “MAL” that have been inspected previously but were not marked “BASE METAL INSPECTED” to fulfill the requirements of the proposed AD. The commenters stated that the previous inspection may have been done as part of a previous overhaul or required inspection using other service information that did not specify to mark “BASE METAL INSPECTED.” The commenters also stated that the actions specified in the service information are consistent with the requirements of the proposed AD. The commenters suggested various changes in order to allow installation of these parts.

We acknowledge that previous inspections may have been done as part of an overhaul or previous service requests, but we do not agree with the suggested changes. We disagree because providing credit for the inspections required by this AD undermines the level of record review required by this AD for compliance, cannot ensure that the various actions taken for each pin are the same actions required by this AD, and may not provide an acceptable level of safety equivalent to this AD. Operators that would like credit for the actions performed before the effective date of this AD may request approval of an alternative method of compliance (AMOC). The request should include a list of affected pin serial numbers, the airplane on which each pin is currently installed (if applicable), and the actions that were performed for each pin with applicable service information. We have not changed this final rule regarding this issue.

FedEx requested that we allow the suffix “BMI” to be allowed for marking the pins. FedEx stated that its record keeping system can only track unique part number and serial number combinations; it is not capable of tracking the additional “BASE METAL INSPECTED” marking.

We disagree with the commenter's request. We disagree because pins can be rotated among other airplanes and operators. Operators need to be consistent with how the pins are identified to comply with this AD and ensure the safety of passengers and crew. We recommend that the commenter work with the manufacturer to identify a suitable method of compliance for future revision of the service information. We have not changed this final rule regarding this issue.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015. The service information describes procedures for identifying and replacing certain MLG aft trunnion pins. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 123 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this repair:

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(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),

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

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

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

We received a report indicating that the engine pylon wiring bracket on certain airplanes is missing a corner relief fillet, because the engineering graphics for the engine pylon wiring bracket located on the left wing did not contain the corner relief fillet. A missing corner relief fillet could result in stress concentration and cracking in the bracket. The engineering graphics were subsequently revised to add the corner relief fillet, but the engine pylon wiring bracket part number was not changed. Therefore, brackets with and without an existing corner relief fillet have the same bracket part number. We are issuing this AD to prevent cracking in the engine pylon wiring bracket. Such cracking could result in damage to adjacent power feeders, subsequent electrical arcing in a flammable leakage zone, and consequent uncontrollable fire.

We reviewed Boeing Alert Service Bulletin B787-81205-SB570012-00, Issue 001, dated March 14, 2013. The service information describes procedures for a one-time inspection of the engine pylon wiring bracket on the left wing for the presence of existing corner relief fillets, re-identification of any bracket with an existing corner relief fillet, and replacement of any bracket without an existing corner relief fillet. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires accomplishing the actions specified in the service information described previously.

Currently, there are no domestic operators of the affected airplanes on the U.S. Register. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number and Directorate Identifier 2016-NM-046-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

Currently, there are no affected airplanes on the U.S. Register. However, if an affected airplane is imported and placed on the U.S. Register in the future, we estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary re-identification or replacement that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need re-identification or replacement:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(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),

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A318 and A319 series airplanes, Model A320-211, -212, -214, -231, -232, and -233 airplanes, and Model A321 series airplanes. The NPRM published in the Federal Register on February 17, 2016 (81 FR 8023) (“the NPRM”).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0080, dated May 7, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318 and A319 series airplanes, Model A320-211, -212, -214, -231, -232, and -233 airplanes, and Model A321 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3696.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Airbus requested that we refer to the latest service information: Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4, 2016 (we referred to Airbus Service Bulletin A320-27-1242, dated February 9, 2015, as the appropriate source of service information for accomplishing the replacement specified in the NPRM). Airbus also requested that we provide credit for previous actions done per Airbus Service Bulletin A320-27-1242, dated February 9, 2015.

We agree with the request to refer to the latest service information. Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4, 2016, includes updated information and specifies that no additional work is necessary for airplanes modified by the previous issue. We have revised paragraphs (h)(1) and (h)(2) of this AD to refer to Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4, 2016. We have also added new paragraph (k) to this AD (and redesignated subsequent paragraphs accordingly) to provide credit for actions done as specified in Airbus Service Bulletin A320-27-1242, dated February 9, 2015.

United Airlines (UAL) requested that we extend the compliance times proposed in the NPRM. UAL stated that U.S. operators receive less time to prepare and plan compared to their counterparts in Europe who follow EASA AD 2015-0080, dated May 7, 2015. UAL noted that the large amount of THSAs that need to be replaced will cause cancellations, spare shortages, and interruptions to its operation. UAL recommended a later compliance time than proposed in paragraph (g)(2) of the proposed AD.

We disagree with the request to extend the compliance time. UAL did not provide data to substantiate that an extension to the compliance time will provide an acceptable level of safety. We determine AD compliance times primarily on our assessment of the safety risk. Some safety issues are more time-sensitive than others, so we consider the overall risk to the fleet, including the severity of the failure and the likelihood of the failure's occurrence.

We and our colleagues in the foreign civil airworthiness authorities (in this case, EASA) work closely with manufacturers to ensure that all appropriate actions are taken at appropriate times to mitigate risks to the fleet and address identified unsafe conditions. In addition, U.S. operators have the same opportunity as their European counterparts to prepare and plan by reviewing and providing comments to EASA's proposed airworthiness directives (PADs). An EASA PAD is a rulemaking document similar to the FAA's NPRM. In most cases, the FAA follows the intent of the AD issued by the state of design; therefore, we encourage U.S. operators to provide feedback to EASA PADs, which are accessible at the following link: http://ad.easa.europa.eu.

For this AD, we determined that accomplishing the replacements before specific dates, as stated in the MCAI, are necessary in order to address the identified unsafe condition in a timely manner. Therefore, we have not changed this AD in this regard. However, under the provisions of paragraph (l)(1) of this AD, we may approve requests for adjustments to the compliance time if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety.

UAL requested that we remove the replacement requirement specified by paragraph (h)(2) of the proposed AD. UAL stated that the requirements in paragraphs (h)(1) and (h)(2) of the proposed AD are contradictory. UAL noted that operators will not be able to predict the future number of flight cycles. UAL stated, as an example, that a THSA having accumulated 38,000 total flight cycles on the effective date would be out of compliance with paragraph (h)(2) of the proposed AD when the AD becomes effective, since the THSA has exceeded 36,000 total flight cycles.

We disagree with the request to remove paragraph (h)(2) of this AD. However, we do find it necessary to clarify the requirements. After accomplishing each inspection required by paragraph (g) of this AD, operators must comply with paragraph (h)(1) of this AD, which mandates the first requirement for THSA replacement after each inspection of the THSAs if any part number 47145-(XXX) is found and the THSA has exceeded the corresponding flight-cycle limits specified in paragraphs (g)(1) through (g)(5) of this AD.

Paragraph (h)(2) of this AD establishes the life limit of the THSA as of each date specified in paragraphs (g)(1) through (g)(5) of this AD and mandates replacement before the corresponding flight-cycle limit. The flight-cycle limit varies on each date specified in paragraphs (g)(1) through (g)(5) of this AD. Paragraphs (h)(1) and (h)(2) of this AD are separate requirements that do not conflict.

For example, if the THSA has accumulated 38,000 total flight cycles as of the effective date of this AD, then paragraph (h)(1) of this AD does not require replacement immediately (on the effective date of this AD) since the THSA has fewer than 40,000 total flight cycles (which is the flight-cycle limit specified in paragraph (g)(1) of this AD). That THSA would be subject to the compliance time of paragraph (h)(2) of this AD, which requires that, as of the effective date of this AD, the THSA must be replaced before exceeding 40,000 total flight cycles until the next inspection is done before December 31, 2016. The new flight-cycle limit as of that date is 36,000 total flight cycles (which is the flight-cycle limit specified in paragraph (g)(2) of this AD).

Each U.S. operator has unique fleet utilization data that can assist in predicting the number of flight cycles accumulated on the THSA and therefore can estimate when a THSA must be replaced. However, under the provisions of paragraph (l)(1) of this AD, we may approve requests for adjustments to the compliance time for replacing the THSA if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety. We have not changed this AD in this regard.

We made minor changes to the language in paragraph (j) of this AD to clarify the parts installation limitation.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed Airbus Service Bulletin A320-27-1242, Revision 01, dated February 4, 2016. The service information describes procedures for replacing the THSA with a serviceable THSA. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 959 airplanes of U.S. registry.

We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $81,515, or $85 per product.

In addition, we estimate that any necessary follow-on actions would take about 21 work-hours and require parts costing $26,500, for a cost of $28,285 per product. We have no way of determining the number of aircraft that might need this action.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705) and CL-600-2D24 (Regional Jet Series 900) airplanes. The NPRM published in the Federal Register on March 4, 2016 (81 FR 11467) (“the NPRM”). The NPRM was prompted by two in-service incidents reported on Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes regarding a loss of all air data information in the flight deck. The NPRM proposed to require revision of the airplane flight manual (AFM) to provide procedures to guide the crew to stabilize the airplane's airspeed and attitude for continued safe flight. We are issuing this AD to prevent loss of air data information that may affect continued safe flight.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2015-08, dated April 28, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705) and CL-600-2D24 (Regional Jet Series 900) airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3990.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

The Air Line Pilots Association stated that the AFM revision will not address the root cause of the high-altitude icing (ice crystal contamination), and requested that further investigation be done for the ice crystal contamination issue and remedies be provided in addition to the AFM amendments.

We agree that the AFM revision will not address the root cause of the high-altitude icing (ice crystal contamination). The manufacturer is investigating the issue, but there is no timetable for a final resolution. Should the manufacturer develop modifications to prevent this problem, the FAA will consider further rulemaking. The incorporation of the AFM procedures is meant to be used to guide the crew on how to stabilize the airplane airspeed and altitude for continued safe flight in icing conditions. However, further investigation into this matter extends beyond the scope of this AD.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Bombardier, Inc. has issued Emergency Procedure 1., Unreliable Airspeed, of Section 03-19, Emergency Procedures—Unreliable Airspeed, of Chapter 3, Emergency Procedures, in Volume 1 of the Bombardier CRJ Series Regional Jet CL-600-2D15 and CL-600-2D24 Airplane Flight Manual CSP C-012, Revision 11A, dated May 25, 2015. The service information describes procedures to guide the crew to stabilize the airplane's airspeed and attitude for continued safe flight. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Required actions in this AD apply only to Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705) and CL-600-2D24 (Regional Jet Series 900) airplanes. We may consider issuing further rulemaking on the other Bombardier airplane models identified previously.

We estimate that this AD affects 230 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to RUAG Aerospace Services GmbH Models 228-100, 228-101, 228-200, 228-201, 228-202, and 228-212 airplanes. That NPRM was published in the Federal Register on June 1, 2016 (81 FR 34927), and proposed to supersede AD 2009-13-04, Amendment 39-15943 (74 FR 29116; June 19, 2009) (“AD 2009-13-04”).

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI (EASA AD No.: 2009-0031R1) states that:

EASA revised the MCAI (EASA AD No.: 2009-0031R2) to incorporate changes to the applicability. The FAA had already incorporated these changes in the NPRM so no changes to the final rule are necessary.

The MCAI can be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6983.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (74 FR 29116; June 19, 2009) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (74 FR 29116; June 19, 2009) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (74 FR 29116; June 19, 2009).

We reviewed the RUAG Aerospace Services GmbH Dornier 228 Alert Service Bulletin No. ASB-228-279, revision 1, dated September 22, 2015. The service information describes procedures for repetitive inspections of the guide pins of the power and condition levers and replacement of those pins if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of the AD.

We estimate that this AD will affect 18 products of U.S. registry. We also estimate that it would take about 20 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $10 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $30,780, or $1,710 per product.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6983; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Public Participation

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the interim rule. U.S. Customs and Border Protection (CBP) also invites comments that relate to the economic, environmental, or federalism effects that might result from this interim rule. Comments that will provide the most assistance to CBP in finalizing these regulations will reference a specific portion of the interim rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. CBP is also interested in receiving comments regarding the collection of data on behalf of Partner Government Agencies (PGAs) for shipments valued below $800. See ADDRESSES above for information on how to submit comments.

On February 24, 2016, President Obama signed into law the Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA) (Pub. L. 114-125). Prior to enactment of the TFTEA, section 321(a)(2)(C) of the Tariff Act of 1930 (19 U.S.C. 1321(a)(2)(C)) authorized CBP to provide an administrative exemption to admit free from duty and tax shipments of merchandise (other than bona fide gifts and certain personal and household goods) imported by one person on one day having an aggregate fair retail value in the country of shipment not less than $200. Section 901(c) of the TFTEA amended section 1321(a)(2)(C) by increasing the value of this administrative exemption from $200 to $800. Pursuant to section 901(d) of TFTEA, the effective date of this amendment was the 15th day after the date of enactment, i.e., effective as of March 10, 2016. Section 901 did not change the administrative exemption for bona fide gifts and personal or household articles accompanying travelers under 19 U.S.C. 1321(a)(2)(A) and 1321(a)(2)(B).

CBP implements the administrative exemption provided for in 19 U.S.C. 1321 in its regulations at 19 CFR 10.151 and 10.153. The administrative exemption amount is also referenced in various other sections in the CBP regulations: §§ 128.21(a)(4)(ii); 128.24(d) and (e); 143.21(l)(1); 143.23(j); 143.26; and 145.31. In all of the previously listed sections that currently provide that the 19 U.S.C. 1321(a)(2)(C) administrative exemption amount is $200, CBP is amending the regulations to reflect that the new amount is $800.

Under 19 U.S.C. 1321(b), the Secretary of the U.S. Department of the Treasury is authorized to promulgate regulations to prescribe exceptions to any exemption provided for in section 1321(a) whenever the Secretary finds that such action is necessary for any reason to protect the revenue or to prevent unlawful importations.

This rule also amends the scope of alcohol and tobacco products covered by the limitation in paragraph (e) of section 10.153, to conform to other past statutory changes. Perfume is removed from the list of products excluded from the administrative exemption because the excise tax on such products was eliminated in 1995 pursuant to section 136 of the Uruguay Round Agreements Act, Public Law 103-465. Paragraph (e) of section 10.153 is also amended pursuant to amendments to the Internal Revenue Code, Section 5701, which increased excise taxes for smokeless tobacco, pipe tobacco, roll-your-own tobacco, and cigarette tubes and papers. 26 U.S.C. 5701, as amended by the Children's Health Insurance Program Reauthorization Act of 2009 (Pub. L. 111-3).

This rule also adds a new paragraph (h) in section 10.153 to clarify that regarding shipments that qualify for the 19 U.S.C. 1321 administrative exemption, the importing party is not exempt from having to pay any applicable excise taxes collected by other agencies on imported goods. It is also noted that pursuant to 19 CFR 24.24(d)(3), the harbor maintenance tax will not be assessed on loadings or unloadings of cargo in which the shipment would be entitled to be entered under informal entry procedures.

This document also revises paragraph (j) of § 143.23 to clarify that different dollar amounts apply to articles that are bona fide gifts and articles that are shipped from the Virgin Islands, Guam, and American Samoa. This document also revises paragraph (j) of § 143.23 to reflect that the increase in the value of shipments from $200 to $800 only applies to shipments that qualify for the administrative exemption under sections 10.151 and 128.24(e).

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the interim rule. In particular, CBP is seeking comments on how CBP can maintain the collection of data required by Partner Government Agencies (PGAs) for imported merchandise to prevent unlawful importations when shipments of merchandise valued below $800 that qualify for an administrative exemption are admitted through “release from manifest.” (Generally, such shipments are entered by the carrier and released by CBP based on information contained on the manifest or bill of lading provided by the carrier.) CBP is aware that the manifest information may not contain all the necessary information required by PGAs for admissibility purposes.

The Administrative Procedure Act (APA) requirements in 5 U.S.C. 553 govern agency rulemaking procedures. Section 553(b) of the APA generally requires notice and public comment before issuance of a final rule. In addition, section 553(d) of the APA requires that a final rule have a 30-day delayed effective date. The APA, however, provides exceptions from the prior notice and public comment requirement and the delayed effective date requirements, when an agency for good cause finds that such procedures are impracticable, unnecessary, or contrary to the public interest.

Treasury and CBP find that prior notice and comment procedures are unnecessary and that good cause exists to issue these regulations effective upon publication. By immediately effectuating this interim rule, CBP can avoid inconsistent application of the exemption and eliminate confusion that may arise among importers with regard to the scope of the exemption and with regard to payment of excise taxes.

Pursuant to section 901(d) of the TFTEA, Congress established March 10, 2016, as the effective date of the increase in the administrative exemption under 19 U.S.C. 1321(a)(2)(C). The clear intent of Congress is that this amendment be rapidly implemented; therefore the regulations must be changed to conform to TFTEA's statutory amendment.

In addition, pursuant to the authority of the Secretary of the Treasury under 26 U.S.C. 7805(b)(3), regulations implementing the internal revenue laws can be made immediately effective to prevent abuse. Under that authority, these regulations reflect intervening statutory changes to section 5701 of the Internal Revenue Code, which increased excise taxes for smokeless tobacco, pipe tobacco, roll-your-own tobacco, and cigarette tubes and papers.

Accordingly, pursuant to 5 U.S.C. 553(b) and (d) and the Secretary of the Treasury's authority under 19 U.S.C. 1321(b) and 26 U.S.C. 7805, the requirements for prior notice and comment and a delay in effective date are inapplicable; however, CBP is soliciting comments on this interim rule and will consider all comments received before issuing a final rule.

Executive Orders 13563 and 12866 direct agencies to assess the 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866.

This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people). The Regulatory Flexibility Act applies when agencies are required to publish a general notice of proposed rulemaking for a proposed rule. Since a general notice of proposed rulemaking is not necessary in this rulemaking, a regulatory flexibility analysis is not required by the Regulatory Flexibility Act.

As there is no new collection of information required in this document, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.

This document is being issued in accordance with § 0.1(a)(1) of the CBP Regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain customs revenue functions.

For the reasons stated above in the preamble, CBP amends parts 10, 12, 128, 143, and 145 of title 19 of the Code of Federal Regulations (19 CFR parts 10, 12, 128, 143, and 145) as follows:

Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and supplemental information, including the complete Department of Health and Human Services and Drug Enforcement Administration eight-factor analyses, to this interim final rule are available at http://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44(a)-(c), requests for a hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” 21 CFR 1300.01. Requests for a hearing and notices of participation must conform to the requirements of 21 CFR 1308.44(a) or (b), as applicable, and include a statement of the interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver of an opportunity for a hearing must conform to the requirements of 21 CFR 1308.44(c), including a written statement regarding the interested person's position on the matters of fact and law involved in any hearing.

Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of the hearing are restricted to “(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . . .” Requests for a hearing and waivers of participation in the hearing should be submitted to the DEA on or before the deadline specified above, using the address information provided therein.

Thiafentanil, known chemically as 4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidine, a potent opioid, is an analogue of fentanyl. The product Thianil (thiafentanil oxalate, a salt form of thiafentanil) was reviewed by the Food and Drug Administration (FDA) to determine whether it meets the requirements for addition to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) (21 U.S.C. 360ccc-1) as set forth by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act, 2004). The MUMS Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to allow for the legal marketing of unapproved new animal drugs intended for use in minor species. In a letter from the Department of Health and Human Services (HHS) dated June 20, 2016, the DEA received notification that HHS/FDA added Thianil (thiafentanil oxalate) to the Index under section 572 of the FDCA. In this same notification, HHS/FDA stated that on June 16, 2016, HHS/FDA granted the request for the addition of Thianil to the Index under Minor Species Index File (MIF) 900000. Thianil is indicated for use in the immobilization of non-domestic, non-food-producing minor species hoofstock.

Thiafentanil will be marketed as thiafentanil oxalate, 4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidinium oxalate. Thiafentanil should not be confused with thiofentanyl (N-phenyl-N-(1-(2-(thiophen-2-yl)ethyl)piperidin-4-yl)propionamide), which is currently listed as a controlled schedule I substance.

Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), where the DEA receives notification from HHS that the Secretary has indexed a drug under section 572 of the FDCA, the DEA is required to issue an interim final rule controlling the drug not later than 90 days after receiving such notification from HHS. 21 U.S.C. 811(j). Accordingly, the DEA is issuing this interim final rule controlling thiafentanil.

When controlling a drug pursuant to section 811(j), the DEA must apply the scheduling criteria of subsections 811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3). In accordance with these criteria, the DEA has reviewed the scientific and medical evaluation and scheduling recommendation provided by the HHS, along with all other relevant data, and completed its own eight-factor review document on thiafentanil pursuant to 21 U.S.C. 811(c). As explained below, based on these considerations, the DEA concludes that thiafentanil meets the criteria for placement in schedule II of the CSA.

On November 28, 2011, the HHS provided the DEA with its initial scientific and medical evaluation and scheduling recommendation regarding thiafentanil. Pursuant to 21 U.S.C. 811(b), this document contained an eight-factor analysis of the abuse potential of thiafentanil as a new drug, along with the HHS' recommendation to control thiafentanil and its salts under schedule II of the CSA. Subsequently, on March 23, 2016, the HHS provided the DEA with a supplement to its 2011 analysis, which indicated that the HHS/FDA planned to add Thianil (thiafentanil oxalate) to the Index for use in the immobilization of non-domestic, non-food-producing minor species hoofstock and reiterated their recommendation that thiafentanil be placed in schedule II of the CSA. By letter dated June 20, 2016, the DEA received notification from the HHS that the FDA had granted the request on June 16, 2016, for Thianil (thiafentanil oxalate) to be added to the Index.

Pursuant to 21 U.S.C. 811(j), and based on the HHS recommendation, MUMS Act indication by the HHS/FDA, and the DEA's determination, the DEA finds that thiafentanil has a high potential for abuse, a currently accepted medical use with severe restrictions, and that abuse of thiafentanil may lead to severe psychological or physical dependence. Accordingly, the DEA is issuing this interim final rule to add thiafentanil (4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidine) and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, whenever the existence of such, to schedule II of the CSA.

Included below is a brief summary of each factor as analyzed by the HHS and the DEA, and as considered by the DEA in its scheduling action. Please note that the DEA and HHS analyses, along with the HHS supplement, are available in their entirety under “Supporting Documents” in the public docket for this interim final rule at http://www.regulations.gov, under Docket Number “DEA-375.” Full analysis of, and citations to, the information referenced in the summary may also be found in the supporting and related material.

1. The Drug's Actual or Relative Potential for Abuse: Thiafentanil is a chemical substance that has not been marketed in the United States, however, it is approved and marketed in the Republic of South Africa as a salt form under the brand name Thianil (thiafentanil oxalate). There is no information available which details actual abuse of thiafentanil.

According to the HHS, thiafentanil is a synthetic analogue of fentanyl and is structurally related to other fentanyl-like opioids such as sufentanil (schedule II) and carfentanil (schedule II). It acts as a potent µ-opioid receptor agonist and produces strong morphine-like effects in animals. It is only intended for the immobilization of non-domestic, non-food-producing minor species hoofstock. Thiafentanil has been used in a manner similar to other opioid immobilizing agents such as etorphine hydrochloride (schedule II) and carfentanil (schedule II), which are approved only for veterinary use as animal immobilization agents. The abuse potential of thiafentanil has not been evaluated in humans or in animal behavioral models that are predictors of abuse by humans. Because thiafentanil shares chemical and pharmacological similarities with schedule II fentanyl and its analogues, the abuse potential of thiafentanil is considered similar to that of schedule II opioid substances such as sufentanil and carfentanil.

Pharmacologically, as a potent µ opioid receptor agonist, thiafentanil is slightly less potent than carfentanil, which is 100 times more potent than fentanyl and 10,000 times more potent than morphine. Thiafentanil is a potent fentanyl analogue. Thus, it is reasonable to assume that there will be potentially significant diversion of thiafentanil from legitimate channels by people who have access to it, and that thiafentanil would be used without medical advice, therefore causing substantial hazards to the users or to the safety of the community if not controlled. The chemical and potent opioid-like pharmacological properties of thiafentanil predict that its risk to the public health is likely to be similar to fentanyl (schedule II) and its analogues such as carfentanil (schedule II), sufentanil (schedule II) and alpha-methylfentanyl (schedule I).

2. Scientific Evidence of the Drug's Pharmacological Effects, if Known: According to HHS' scientific and medical review, there are no data on the effects of thiafentanil in humans. Thiafentanil's effects in humans are predicted from its effects in animals and its chemical and pharmacological similarity to other schedule II potent opioids such as fentanyl and carfentanil.

The HHS eight-factor review document described a study directly comparing the immobilizing effects of thiafentanil (15 mg) and carfentanil (2 or 4 mg) in elk in which thiafentanil produced a faster immobilization effect (0.7 to 2.2 minutes) than carfentanil. In addition, the elk returned to standing 0.9 to 1.4 minutes faster under the thiafentanil condition. This study appears to support a faster immobilization and recovery time with thiafentanil relative to carfentanil. However, the authors stated that the role of the increased dose of thiafentanil is unknown.

Animal studies described by the HHS demonstrated that the effects of thiafentanil and carfentanil are completely reversed by naltrexone. As a µ-opioid receptor antagonist, naltrexone can reverse the effects of a variety of opioid drugs including thiafentanil and carfentanil. Those studies suggest that thiafentanil possesses a neuro-pharmacological mechanism of action similar to other schedule II opioid drugs with a high abuse potential.

According to HHS' review, Thianil (thiafentanil) is currently approved and registered for use in the Republic of South Africa. Thiafentanil oxalate is suggested as a drug of choice in the capture of exotic and ungulate wildlife species.

3. The State of Current Scientific Knowledge Regarding Thiafentanil: The chemical name of free base thiafentanil is 4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidine. It has a molecular formula of C22H28N2O4S and a molecular weight of 416.52 g/mol with a Chemical Abstract Registry Number (CAS) of 101345-60-2. Thiafentanil oxalate is also known as A3080 with a CAS number of 101365-73-5 and has a molecular formula of C24H30N2O8S with a molecular weight of 506.57 g/mol. Thiafentanil oxalate is a white crystalline powder with a melting point of 190-192 °C and its salt crystalizes from absolute alcohol. Thiafentanil should not be confused with thiofentanyl (N-phenyl-N-(1-(2-(thiophen-2-yl)ethyl)piperidin-4-yl)propionamide), which is currently listed as a schedule I substance.

4. Its History and Current Pattern of Abuse: According to the HHS' review, there are no reports of actual abuse and misuse of thiafentanil. This may be due to the limited use of thiafentanil as an immobilizing agent by trained veterinarians.

Current data from the National Forensic Laboratory System (NFLIS),1 the System to Retrieve Information from Drug Evidence (STRIDE),2 and the STARLiMS databases show that there is no evidence of law enforcement encounters of thiafentanil in the United States. However, thiafentanil's pharmacological and structural properties suggest that its pattern of abuse would be similar to other potent schedule II µ-opioid receptor agonists such as fentanyl and carfentanil.

5. The Scope, Duration, and Significance of Abuse: An assessment of the scope, duration, and significance of thiafentanil abuse is not available since it has only been used in a limited market. However, as stated in the HHS review, the structural and pharmacological properties of thiafentanil suggest that it could lead to an abuse pattern with a scope, duration, and significance of abuse similar to that observed with other opioid drugs and opioid analogues if it were marketed in a non-controlled status or were the subject of clandestine synthesis. The HHS and DEA note that thiafentanil is not known to be or to have been the subject of abuse in the United States.

6. What, if any, Risk There is to the Public Health: The HHS review indicates that thiafentanil presents a significant risk to the public health and, in this vein, that thiafentanil should only be used in certain animals for very limited purposes and with extreme caution. Based on the review of the structural and pharmacological properties of thiafentanil, the HHS concluded that the abuse of thiafentanil is likely to pose a similar risk to public health as that of other potent opioid drugs such as sufentanil (schedule II), fentanyl (schedule II), carfentanil (schedule II) and clandestinely synthesized alpha-methylfentanyl (schedule I). Thus, inappropriate use of thiafentanil poses a high risk to the public health. Among other things, HHS noted that as a fentanyl derivative, and assuming that thiafentanil can be aerosolized, the use of thiafentanil presents a significant risk to the public health.

HHS described that thiafentanil's labeling indicates that it is solely intended for use by zoologic, wildlife, or exotic animal veterinarians or field biologists who have received training and are supervised by veterinarians. The sponsor recommends the use of handling protocols similar to those in place for other scheduled potent opioids such as carfentanil. HHS further indicated that thiafentanil should be handled in teams consisting of at least two individuals knowledgeable about the hazards of working with potent μ-opioid agonist substances. Personal protective equipment such as latex gloves and protective eyewear should be used and syringes must be disposed of properly. If exposure to thiafentanil occurs in a remote or distant environment, veterinary naltrexone is recommended for use as a reversal agent. The label information will further state that thiafentanil must never be used unless an adequate amount of reversal agent (naltrexone hydrochloride) is immediately available.

HHS also describes the risk of thiafentanil intoxication upon ingestion of animals immobilized with thiafentanil. The label information states that thiafentanil is not intended for human or animal consumption or in non-food producing minor species that become eligible for consumption by humans or food-producing animals. Because thiafentanil, similar to carfentanil, etorphine hydrochloride and diprenorphine, is a potent μ-opioid receptor agonist, it will be subject to specialized handling, distribution and storage procedures similar to those applicable for carfentanil, etorphine hydrochloride and diprenorphine as set forth in 21 CFR parts 1301 and 1305. As a result, this interim final rule revises 21 CFR 1301.74(g), 1301.75(e), 1305.07 introductory text and paragraph (a), and 1305.17(d) to include “thiafentanil.”

7. Its Psychic or Physiological Dependence Liability: HHS' review states that the structural and pharmacological properties of thiafentanil suggest that it possesses a psychic and physiological dependence liability that is similar to other schedule II related µ-opioid receptor agonist drugs such as sufentanil, fentanyl and carfentanil.

As cited by the HHS review, a double-blind abuse liability study examining intravenous fentanyl, buprenorphine, heroin, morphine, and oxycodone in methadone-maintained patients reported that fentanyl produced subjective effects similar to heroin (schedule I) on several outcome measures indicating that the two drugs produce similar subjective effects. It also demonstrates the psychic dependence liability of fentanyl, and thiafentanil is expected to produce effects similar to fentanyl and to present a similar risk of psychic and physiological dependence. There has been a major increase in abuse of opioids analgesics in the United States (HHS review document, 2011; Compton and Volkow, 2006). Thiafentanil, similar to these opioid analgesics, presents a risk of severe psychic and physiological dependence.

8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled under the CSA: Thiafentanil is not considered an immediate precursor of any controlled substance.

The CSA lists the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of the HHS and review of all available data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(2), finds that:

1. Thiafentanil has a high potential for abuse. Based on its structural and pharmacological properties, thiafentanil has an abuse potential that is comparable to other schedule II opioid drugs such as fentanyl, carfentanil, and sufentanil;

2. FDA determined that Thianil (thiafentanil oxalate) meets the requirements for addition to the Index as set forth by the MUMS Act, 2004 and accordingly added Thianil (thiafentanil oxalate) to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) under section 572 of the Federal Food, Drug, and Cosmetic Act. Thianil (thiafentanil oxalate) will be legally marketed in the United States and will have an accepted medical use with severe restrictions; 3 and

3. Due to the chemical and pharmacological similarities of thiafentanil to other schedule II fentanyl derivatives, abuse of thiafentanil may lead to severe psychological or physical dependence.

Based on these findings, the Acting Administrator of the DEA concludes that thiafentanil, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existences of such isomers, esters, ethers, and salts is possible warrants control in schedule II of the CSA. 21 U.S.C. 812(b)(2).

Thiafentanil is subject to the CSA's schedule II regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule II substances, including the following:

1. Registration. Any person who desires to handle thiafentanil (manufacture, distribute, reverse distribute, dispense, import, export, engage in research, or conduct instructional activities or chemical analysis with, or possess), must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Quota. Only registered manufacturers are permitted to manufacture thiafentanil in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

3. Disposal of stocks. Upon obtaining a schedule II registration to handle thiafentanil, and if subsequently, any person who does not desire or is not able to maintain a schedule II registration must surrender all quantities of currently held thiafentanil, or may transfer all quantities of currently held thiafentanil to a person registered with the DEA in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws.

4. Security. Thiafentanil is subject to schedule II security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71-1301.93.

5. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of thiafentanil must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. In addition, thiafentanil is subject to additional labeling requirements provided by FDA. Thiafentanil must be labeled, distributed, and promoted in accordance with the Index entry of the new animal drug and the FDA may remove a new animal drug from the Index if the conditions and limitations of use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G); (f)(l)(F). The labeling of an indexed new animal drug must prominently state that the extra-label use of the product is prohibited. 21 U.S.C. 360ccc-l(h).

6. Inventory. Every DEA registrant who desires to possess any quantity of thiafentanil must take an inventory of thiafentanil on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

Any person who becomes registered with the DEA to handle thiafentanil must take an initial inventory of all stocks of controlled substances (including thiafentanil) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

7. Records and Reports. Every DEA registrant must maintain records and submit reports for thiafentanil, or products containing thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317.

8. Orders for thiafentanil. Every DEA registrant who distributes thiafentanil is required to comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.

9. Prescriptions and other dispensing. All prescriptions for thiafentanil or products containing thiafentanil must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C. Moreover, given that thiafentanil is not the subject of an approved new drug application under the FDCA, and that it is only allowed under the MUMS Act amendments to the FDCA to be marketed for extremely limited use in minor species, DEA would not consider any dispensing of thiafentanil for human use to be for a legitimate medical purpose within the meaning of the CSA. Likewise, DEA would not consider any dispensing of thiafentanil for animal use beyond the scope of the drug's labeling authorized under the MUMS Act amendments to the FDCA to be for a legitimate medical purpose within the meaning of the CSA.

10. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule II controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of thiafentanil may only be for the legitimate purposes consistent with the drug's labeling authorized under the MUMS Act, or for research activities authorized by the FDCA and CSA.

11. Importation and Exportation. All importation and exportation of thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

12. Liability. Any activity involving thiafentanil not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This amendment provides that in cases where a new drug is (1) approved or indexed by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II-V, the DEA shall issue an interim final rule scheduling the drug within 90 days. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause. Therefore, the DEA has determined that the notice and comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action.

In accordance with Public Law 114-89, this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects 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.

In accordance with 5 U.S.C. 603(a), “[w]henever an agency is required by [5 U.S.C. 553], or any other law, to publish general notice of proposed rulemaking for any proposed rule, or publishes a notice of proposed rulemaking for an interpretive rule involving the internal revenue laws of the United States, the agency shall prepare and make available for public comment an initial regulatory flexibility analysis.” As noted in the above discussion regarding applicability of the Administrative Procedure Act, the DEA has determined that the notice and comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action. Consequently, the RFA does not apply to this interim final rule.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this interim final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, the DEA amends 21 CFR parts 1301, 1305 and 1308 as follows:

I. Background and Purpose

In July, 2015, the Department of Defense (Department) issued a final rule 1 (the July 2015 Final Rule) amending its regulation implementing the Military Lending Act (MLA) 2 primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products, rather than the limited credit products that had been defined as “consumer credit.” 3 Moreover, among other amendments, the July 2015 Final Rule modified provisions relating to the optional mechanism a creditor may use when assessing whether a consumer is a “covered borrower,” modified the disclosures that a creditor must provide to a covered borrower, and implemented the enforcement provisions of the MLA.

Subsequently, the Department received requests to clarify its interpretation of points raised in the July 2015 Final Rule. The Department is issuing this interpretive rule to inform the public of its views. The Department has chosen to provide this guidance in the form of a question and answer document to assist industry in complying with the July 2015 Final Rule. This interpretive rule does not substantively change the regulation implementing the MLA, but rather merely states the Department's preexisting interpretations of an existing regulation. Therefore, under 5 U.S.C. 553(b)(A), this rulemaking is exempt from the notice and comment requirements of the Administrative Procedure Act, and, pursuant to 5 U.S.C. 553(d)(2), this rule is effective immediately upon publication in the Federal Register.

The following questions and answers represent official interpretations of the Department on issues related to 32 CFR part 232. For ease of reference, the following terms are used throughout this document: MLA refers to the Military Lending Act (codified at 10 U.S.C. 987); MAPR refers to the military annual percentage rate, as defined in 32 CFR 232.3(p); TILA refers to the Truth in Lending Act (codified at 15 U.S.C. 1601 et seq.); Regulation Z refers to the regulation, and interpretations thereof, issued by the Consumer Financial Protection Bureau (or the Board of Governors of the Federal Reserve System, as applicable) to implement TILA, as defined in 32 CFR 232.3(s); DMDC refers to the Defense Manpower Data Center.

Answer: The MLA regulation generally directs creditors to look to provisions of TILA and its implementing regulation, Regulation Z, in determining whether a product or service is considered “consumer credit” for purposes of the MLA.4 Also, the supplementary information to the July 2015 Final Rule discusses coverage of overdraft products.

The MLA regulation defines “consumer credit” as credit offered or extended to a covered borrower primarily for personal, family or household purposes that is either subject to a finance charge or payable by a written agreement in more than four installments, with some exceptions. The exceptions include: Residential mortgage transactions; purchase money credit for a vehicle or personal property that is secured by the purchased vehicle or personal property; certain transactions exempt from Regulation Z (not including transactions exempt under 12 CFR 1026.29); and credit extended to non-covered borrowers consistent with 32 CFR 232.5(b). Although coverage by the MLA and the MLA regulation is not completely identical to that of TILA and Regulation Z, the July 2015 Final Rule amends the definition of consumer credit under the MLA to be more consistent with how credit is defined under TILA. The supplementary information to the July 2015 Final Rule states:

The MLA regulation also defines “closed-end credit” and “open-end credit” with express references to the definitions of the same terms in Regulation Z.

The supplementary information to the July 2015 Final Rule illustrates how to apply these standards specifically with respect to overdraft products and services.6 It states that consistent with Regulation Z, an overdraft line of credit with a finance charge is a covered consumer credit product when: It is offered to a covered borrower; the credit extended by the creditor is primarily for personal, family, or household purposes; it is used to pay an item that overdraws an asset account and results in a fee or charge to the covered borrower; and, the extension of credit for the item and the imposition of a fee were previously agreed upon in writing. The supplementary information further states that other types of overdraft products not pursuant to a written agreement typically are not covered consumer credit “because Regulation Z excludes from `finance charge' any charge imposed by a creditor for credit extended to pay an item that overdraws an asset account and for which the borrower pays any fee or charge, unless the payment of such an item and the imposition of the fee or charge were previously agreed upon in writing.” 7

Thus, whether or not a particular overdraft product or service is “consumer credit” under the MLA regulation depends on whether the product or service meets each element of the definition of “consumer credit” and whether an exception applies.

Answer: No. Section 232.3(f)(1) defines “consumer credit” as credit extended to a covered borrower primarily for personal, family, or household purposes that is subject to a finance charge or payable by written agreement in more than four installments. Section 232.3(f)(2) provides a list of exceptions to paragraph (f)(1), including an exception for any credit transaction that is expressly intended to finance the purchase of personal property when the credit is secured by the property being purchased. A hybrid purchase money and cash advance loan is not expressly intended to finance the purchase of personal property, because the loan provides additional financing that is unrelated to the purchase. To qualify for the purchase money exception from the definition of consumer credit, a loan must finance only the acquisition of personal property. Any credit transaction that provides purchase money secured financing of personal property along with additional “cash-out” financing is not eligible for the exception under § 232.3(f)(2)(iii) and must comply with the provisions set forth in the MLA regulation.

Answer: Yes. Section 232.4(b) requires that a creditor may not impose an MAPR greater than 36 percent in connection with an extension of consumer credit that is closed-end credit or in any billing cycle for open-end credit. In an open-end credit account, a covered borrower's use of a line of credit might, under certain circumstances, give rise to the imposition of a combination of fees and/or periodic charges that would cause the MAPR to exceed the limit in § 232.4(b). A creditor can comply with § 232.4(b) by designing a combination of periodic rates and fees that cannot possibly result in an MAPR greater than 36 percent. Nevertheless, nothing in 32 CFR part 232 prohibits a creditor from complying by waiving fees or finance charges, either in whole or in part, in order to reduce the MAPR to 36 percent or below in a given billing cycle. Thus, a creditor could alternatively comply by not imposing charges in excess of 36 percent MAPR that would otherwise be permitted under the credit agreement.

Answer: 32 CFR 232.4(c)(1) details the charges that must be included in the calculation of the MAPR. Among the charges that must be included are finance charges associated with the consumer credit. Finance charges are defined by § 232.3(n) to mean a “finance charge” in Regulation Z. If such fees are considered “finance charges” under Regulation Z, then such fees must be included in the calculation of the MAPR, unless they are bona fide fees charged to a credit card account that are excludable under § 232.4(d). However, if the fees are not “finance charges” under Regulation Z, then they may be excluded from the calculation of the MAPR, provided they do not qualify for any of the other categories of charges listed under § 232.4(c)(1).

Answer: Section 232.4(c)(2)(ii)(B) specifically provides that for open-end credit, if the MAPR cannot be calculated in a billing cycle because there is “no balance” in the billing cycle, a creditor may not impose any fee or charge during that billing cycle, except for a participation fee that complies with the limitations set forth in § 232.4(c)(2)(ii)(B). Because the provision is tied to whether the MAPR can be calculated based on whether there is a balance in the billing cycle, creditors that impose fees or charges that are excluded from the calculation of the MAPR during a particular billing cycle are not subject to the limitations in § 232.4(c)(2)(ii)(B) for that billing cycle, as there would be no MAPR to calculate whether or not there was a balance during the billing cycle. For example, if a creditor charged a late fee for a late payment in accordance with its credit agreement with the covered borrower and in compliance with Regulation Z, the creditor may charge the fee, regardless of whether there is a balance in the billing cycle, because a late fee is not among the charges that are included in the calculation of the MAPR.

Furthermore, § 232.4(c)(2)(ii)(A) states that the MAPR shall be calculated following the rules set forth in 12 CFR 1026.14(c) and (d) of Regulation Z. Thus, the reference in § 232.4(c)(2)(ii)(B) to a situation in which the MAPR cannot be calculated in a billing cycle, because there is no balance, relates solely to the situation like the one described in 12 CFR 1026.14(c)(2), which is the only provision in 12 CFR 1026.14(c) and (d) that describes the inability to calculate an effective annual percentage rate when there is no balance in the billing cycle. 12 CFR 1026.14(c)(2) discusses how to compute an effective annual percentage rate when the charge imposed during the billing cycle is or includes a minimum, fixed, or other charge not due to the application of a periodic rate, other than a charge with respect to any specific transaction during the billing cycle. Under 12 CFR 1026.14(c)(2), if there is no balance to which the charge is applicable, an effective annual percentage rate cannot be determined under the section. Similarly, § 232.4(c)(2)(ii)(B) relates to when finance charge imposed during the billing cycle is or includes a minimum, fixed or other charge not due to the application of a periodic rate, other than a charge with respect to a specific transaction charge, and there is no balance to which the charge is applicable.

Answer: Yes. 32 CFR 232.4(d)(1) provides that for consumer credit extended in a credit card account under an open-end (not home-secured) consumer credit plan, a bona fide fee, other than a periodic rate, is not a charge required to be included in the MAPR, provided it is a bona fide fee and reasonable for that type of fee. A minimum interest charge that a creditor will charge a covered borrower if the creditor charges interest during a particular billing cycle for a credit card account under an open-end (not home-secured) consumer credit plan is generally required to be disclosed in the account-opening table under 12 CFR 1026.6(b)(2)(iii). Such a charge is not a periodic rate. Furthermore, neither of the categories of fees that are ineligible for the exclusion for bona fide fees (credit insurance premiums and fees for a credit-related ancillary product) applies to this type of charge. Consequently, a minimum interest charge that is generally disclosed in the account-opening table under 12 CFR 1026.6(b)(2)(iii) (even if it does not exceed the threshold for required disclosure in the account-opening table under 12 CFR 1026.6(b)(2)(iii)) may be a bona fide fee excludable from the calculation of the MAPR if it meets the conditions for exclusion.

Answer: Generally, yes. The July 2015 Final Rule intends to provide a firm, yet flexible, adaptable standard allowing credit card issuers to exclude bona fide and reasonable credit card fees from the calculation of the MAPR. Under the safe harbor set forth in § 232.4(d)(3)(ii), creditors are allowed to exclude a reasonable bona fide fee charged to a credit card account from the calculation of the MAPR, where that fee is less than or equal to an average amount of a fee for the same or a substantially similar product or service charged by 5 or more creditors, each of whose U.S. credit cards in force is at least $3 billion in an outstanding balance (or at least $3 billion in loans on U.S. credit card accounts initially extended by the creditor) at any time during the 3-year period preceding the time such average is computed. As the Department stated in the supplementary information to the July 2015 Final Rule, the Department believes that information on credit card fees imposed by large credit card issuers is widely available. Moreover, the Department stated in the supplementary information to the July 2015 Final Rule that the amount of outstanding credit card loans is available in both Securities and Exchange Commission filings as well as Call Reports. Nevertheless, nothing in 32 CFR part 232 prohibits a credit card issuer from relying on information sources compiled in commercially available databases or other industry sources in making safe harbor calculations. However, the safe harbor under § 232.4(d)(3)(ii) is available only if the amount of the fee is actually less than or equal to an average amount of a fee for the same or a substantially similar product or service charge by 5 or more creditors each, of whose U.S. credit cards in force is at least $3 billion in an outstanding balance (or at least $3 billion in loans on U.S. credit card accounts initially extended by the creditor) at any time during the 3-year period preceding the time such average is computed.

Answer: Generally, yes. Section 232.4(d)(1) provides that for a credit card account under an open-end (not home-secured) consumer credit plan, a bona fide fee, other than a periodic rate, is not a charge required to be included in the MAPR, provided it is a bona fide fee and reasonable for that type of fee. Under § 232.4(d)(3)(i), whether a fee is reasonable is determined by comparison to fees typically imposed by other creditors for the same or a substantially similar product or service. Under § 232.4(d)(3)(iii), whether a fee is reasonable depends on other factors relating to the credit card account. Section 232.4(d)(3)(iv) further clarifies that whether a participation fee is reasonable may be determined in reference to whether a credit card offers additional services or other benefits. Moreover, the supplementary information to the July 2015 Final Rule explains that “the `reasonable' condition for a bona fide fee is intended to be applied flexibly so that, in general, creditors may continue to offer a wide range of credit card products that carry reasonable costs expressly tied to specific products or services and which vary depending upon the covered borrower's own choices regarding the use of the card.” 8

Under the Department's flexibly applied conditional exclusion, creditors may use any reasonable approach in identifying whether a fee is substantially similar for purposes of comparison and reasonable overall. Thus, the Department's policy, in this regard, permits a creditor to consider whether the benefits provided by a rewards program in determining whether a fee is reasonable overall. Moreover, creditors may consider rewards program benefits in determining whether the amount of a fee is less than or equal to an average amount of a fee for a substantially similar product or service for purposes of the safe harbor in § 232.4(d)(3)(ii).

Answer: Yes. Under § 232.5(b) a creditor may conclusively determine whether credit is offered or extended to a covered borrower by assessing the status of a credit applicant, in accordance with the methods for checking the status of consumers discussed in § 232.5(b)(2). A creditor's timely covered borrower check is legally conclusive, so long as the creditor creates and thereafter maintains a record of the consumer's covered borrower status. Under § 232.3(i)(2) a creditor, by definition, includes the creditor's assignee. Thus, the Department's policy is to extend the covered borrower check safe harbor to a creditor's assignee, provided that the assignee continues to maintain the record created by the creditor that initially extended the credit.

Answer: No. Section 232.5 explains the methods available to creditors when determining a consumer's covered borrower status prior to or at the time the parties enter into a transaction or an account is created. The provision permits a creditor to use its own method to assess covered borrower status, and it provides a safe harbor to a creditor that employs either of two available methods: Using information obtained directly or indirectly from the DMDC database; or obtaining a consumer report from a nationwide consumer reporting agency (or a reseller of the same) containing a statement, code, or similar indicator describing that status. To benefit from the safe harbor provision, a creditor must determine a consumer's covered borrower status at or before the time of the transaction or the time an account is established and make a record of the determination. Section 232.5(b)(2)(B) prohibits a creditor from accessing the DMDC database after the time a consumer entered into a transaction or established an account for a specific purpose, namely “to ascertain whether a consumer had been a covered borrower as of the date of that transaction or as of the date that account was established.” Therefore, the plain language of the regulation does not prohibit a creditor or assignee from accessing the DMDC database for other purposes, such as determining whether a previously covered borrower retains that status. However, as stated in § 232.7, other State or Federal laws providing greater protections to covered borrowers may apply to covered transactions under the MLA. Creditors should ensure compliance with any such laws that may apply to them and these transactions.

Answer: No. Under the safe harbor provided in § 232.5(b)(1), a creditor may conclusively determine whether credit is offered to a covered borrower by assessing the status of a consumer using information related to that consumer obtained from the database, maintained by the DMDC, for that purpose. Section 232.5(b)(2) references a uniform resource locator (URL), more commonly known as an Internet address, as a convenience to assist the public in locating the DMDC MLA database. However, that particular URL address itself does not serve as a restriction on the method through which the DMDC MLA database is accessed. For technological reasons, the Department may from time to time revise the DMDC MLA URL through providing notice on the DMDC MLA Web page. Therefore, a creditor who makes a determination regarding the status of a consumer by accessing the database maintained by the DMDC through a URL provided by the DMDC that is different from the one specifically referenced in § 232.5(b)(2) may still take advantage of the safe harbor in § 232.5(b)(1), so long as the creditor timely creates and thereafter maintains a record of the information so obtained as provided in § 232.5(b)(3).

Furthermore, the Department is currently developing a pilot project in collaboration with several financial service providers that anticipate a large volume of covered borrower checks. In this pilot project, the Department is experimenting with a direct connection that may improve access to the DMDC database for the financial services industry. This direct connection pilot project accesses the same DMDC database available through an internet query. A creditor may verify the status of a consumer by using the database maintained by the Department for that purpose, even though the creditor uses a method of accessing that database provided by the Department other than the particular URL listed in § 232.5(b)(2). Thus, a creditor who makes a determination regarding the status of a consumer under § 232.5(b)(2) by participating in the Department's direct connection pilot project (or a similar form of access should it be provided by the Department at a future date) is deemed conclusive with respect to that transaction or account involving consumer credit between the creditor and that consumer, so long as that creditor timely creates and thereafter maintains a record of the information so obtained as provided in § 232.5(b)(3).

Answer: Section 232.6(a)(3) requires a creditor to provide to a covered borrower, before or at the time the borrower becomes obligated on the transaction or establishes an account for the consumer credit, a clear description of the payment obligation of the covered borrower, as applicable. A payment schedule (in the case of closed-end credit) or an account-opening disclosure (in the case of open-end credit) provided pursuant to the requirement to provide Regulation Z disclosures satisfies this obligation. Therefore, a creditor may orally provide the information in a payment schedule or an account-opening disclosure to a covered borrower. However, an oral recitation of the payment schedule or the account-opening disclosure is not the only way a creditor may comply with § 232.6(a)(3). A creditor may also orally provide a clear description of the payment obligation of the covered borrower by providing a general description of how the payment obligation is calculated or a description of what the borrower's payment obligation would be based on an estimate of the amount the borrower may borrow. For example, a creditor could generally describe how minimum payments are calculated on open-end credit plans issued by the creditor and then refer the covered borrower to the written materials the borrower will receive in connection with opening the plan. Alternatively, a creditor could choose to generally describe borrowers' obligations to make a monthly, bi-monthly, or weekly payment as the case may be under the borrowers' agreements.

Neither the MLA nor the MLA regulation specifies particular content or format for the requirement of a clear, oral description of the payment obligation. Also, nothing in the MLA or the MLA regulation requires that the clear description of the payment obligation provided in writing must be the same as the oral disclosure, provided that both disclosures are clear and accurate. As explained in the supplementary information to the Department's July 2015 Final Rule, the Department's approach has been to interpret the MLA's oral disclosure requirement in a manner that provides creditors “straightforward mechanisms” that afford “latitude to develop the same (or consistent) systems to orally provide the required disclosures—regardless of the particular context . . .” 9 The requirement of a clear, oral payment obligation disclosure has sufficient breadth that creditors may choose a variety of acceptable oral disclosure compliance strategies. Thus, under the Department's approach, a generic oral description of the payment obligation may be provided, even though the disclosure is the same for borrowers with a variety of consumer credit transactions or accounts.

Answer: Section 232.6(d)(2) requires a statement of the MAPR and a clear description of the covered borrower's payment obligation to be provided to the covered borrower orally. Creditors may satisfy this requirement by providing the information to the covered borrower in person or through a toll-free telephone number. If the creditor decides to provide the borrower with a toll-free telephone number, the toll-free telephone number must be provided on i) a form the creditor directs the consumer to use to apply for the transaction or account, or ii) the written disclosure of the information that is required under § 232.6(d)(1). Since § 232.6(d)(2) permits creditors to provide oral disclosures by providing a toll-free telephone number, such information must be available from the time the creditor provides the toll-free telephone number. The difficulty of providing this information in a timely way through a toll-free telephone system is mitigated by the Department's interpretation of mandatory oral disclosures as allowing for a nonnumeric statement of the MAPR and a generic, clear description of the payment obligation. See § 232.6(c) and Question and Answer #12 of these Interpretations. Oral disclosures provided through a toll-free telephone system need only be available under § 232.6(d)(2)(ii)(B) for a duration of time reasonably necessary to allow a covered borrower to contact the creditor for the purpose of listening to the disclosure.

Answer: Yes. 32 CFR 232.6(a) states that a creditor shall provide mandatory loan disclosures, including “any disclosure required by Regulation Z,” to a covered borrower “before or at the time the borrower becomes obligated on the transaction or establishes an account for the consumer credit. . .” Section 232.6(a)(2) further states that “any disclosure required by Regulation Z . . . shall be provided only in accordance with the requirements of Regulation Z that apply to that disclosure...” In certain instances Regulation Z allows a creditor to provide a disclosure after the borrower has become obligated on a transaction, as in the case of purchase orders or requests for credit made by mail, telephone, or fax under 12 CFR 1026.17(g). The MLA regulation's general timing requirement does not override more specific disclosure timing provisions in Regulation Z. The requirement in § 232.6(a) that any disclosure required by Regulation Z be provided only in accordance with the requirements of Regulation Z does not amount to a requirement that MLA-specific disclosures be separately provided to borrowers in advance of TILA disclosures. Thus, the disclosures required in § 232.6(a) may be provided at the time prescribed in Regulation Z.

Answer: Yes. Section 232.8 makes it unlawful for any creditor to extend consumer credit in which the credit agreement imposes on a covered borrower a proscribed term or provision listed in § 232.8. However, nothing in the MLA regulation restricts the ability of creditors to impose on non-covered borrowers those provisions proscribed under § 232.8 for covered borrowers. Along these lines, the supplementary information in the July 2015 Final Rule explains that the Department “recognizes that many creditors likely would adopt disclosures and contract documents that would be designed to be provided to both consumers who are not entitled to the protections under the MLA and to covered borrowers.” 10 Under the MLA, a creditor may include a proscribed term under § 232.8, such as a mandatory arbitration clause, within a standard written credit agreement with a covered borrower, provided that the agreement includes a contractual “savings” clause limiting the application of the proscribed term to only non-covered borrowers, consistent with any other applicable law.

Answer: No. As a general proposition the prohibition of a creditor's use of a check or other method of access in § 232.8(e) does not in any way imply that a creditor cannot be paid. In no case does paragraph (e) prevent covered borrowers from tendering a check or authorizing access to a deposit, savings, or other financial account to repay a creditor. Section 232.8(e) also does not prohibit a covered borrower from authorizing automatically recurring payments, provided that such recurring payments comply with other laws, such as the Electronic Fund Transfer Act and its implementing regulations, including 12 CFR 1005.10, as applicable.

In contrast, § 232.8(e) prohibits a creditor from using the borrower's account information to create a remotely created check or remotely created payment order in order to collect payments on consumer credit from a covered borrower. Similarly, a creditor may not use a post-dated check provided at or around the time credit is extended that deprives the borrower of control over payment decisions, as is common in certain payday lending transactions.

Section 232.8(e)(1) and (2) further clarify that covered borrowers may tender checks and authorize electronic fund transfers by specifying permissible actions creditors may take to secure repayment by covered borrowers. The exceptions address cases where a creditor requires a covered borrower to provide repayment in a certain way. Specifically, under § 232.8(e)(1), a creditor may require an electronic fund transfer to repay a consumer credit transaction, unless otherwise prohibited by law. The Department notes that 12 CFR 1005.10(e)(1) prohibits anyone from conditioning an extension of credit to a consumer on the consumer's repayment by preauthorized electronic fund transfers (except for credit extended under an overdraft credit plan or extended to maintain a specified minimum balance in the consumer's account). However, a preauthorized electronic fund transfer is defined under 12 CFR 1005.2(k) as an electronic fund transfer authorized in advance to recur at substantially regular intervals.

In addition, § 232.8(e)(2) clarifies that a creditor is permitted to require direct deposit of the consumer's salary as a condition of eligibility for consumer credit, unless otherwise prohibited by law. While § 232.8(g) prohibits a creditor from requiring as a condition for the extension of consumer credit that the covered borrower establish an allotment to repay an obligation, the regulation does not apply this restriction to a “military welfare society” or a “service relief society” as defined in 37 U.S.C. 1007(h)(4).

Answer: No. The prohibition in § 232.8(e) does not prohibit covered borrowers from granting a security interest to a creditor in the covered borrower's checking, savings, or other financial account, provided that it is not otherwise prohibited by applicable law and the creditor complies with the MLA regulation including the limitation on the MAPR to 36 percent. As discussed in Question and Answer #16 of these Interpretations, § 232.8(e) prohibits a creditor from using the borrower's account information to create a remotely created check or remotely created payment order in order to collect payments on consumer credit from a covered borrower or using a post-dated check provided at or around the time credit is extended.

Section 232.8(e)(3) further clarifies that covered borrowers may convey security interests in checking, savings, or other financial accounts by describing a permissible security interest granted by covered borrowers. Thus, for example, a covered borrower may grant a security interest in funds deposited in a checking, savings, or other financial account after the extension of credit in an account established in connection with the consumer credit transaction.

Answer: No. Under certain circumstances federal or state statutes may grant creditors statutory liens on funds deposited within covered borrowers' asset accounts. For example, under 12 U.S.C. 1757(11) federal credit unions may “enforce a lien upon the shares and dividends of any member, to the extent of any loan made to him and any dues or charges payable by him.” As discussed in Question and Answer #16 of these Interpretations, § 232.8(e) serves to prohibit a creditor from using the borrower's account information to create a remotely created check or remotely created payment order in order to collect payments on consumer credit from a covered borrower or using a post-dated check provided at or around the time credit is extended. Section 232.8(e)(3) describes a permissible activity under § 232.8(e). However, the fact that § 232.8(e)(3) specifies a particular time when a creditor may take a security interest in funds deposited in an account does not change the general effect of the prohibition in § 232.8(e). Therefore, § 232.8(e) does not impede a creditor from exercising a statutory right to take a security interest in funds deposited in an account at any time, provided that the security interest is not otherwise prohibited by applicable law and the creditor complies with the MLA regulation, including the limitation on the MAPR to 36 percent.

Answer: For purposes of the MLA, the term “vehicle” means any self-propelled vehicle primarily used for personal, family, or household purposes for on-road transportation. The term does not include motor homes, recreational vehicles (RVs), golf carts, or motor scooters.

Executive Orders 13563 and 12866 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. It has been determined that this is not a significant rule. This interpretive rule will not have an annual effect of $100 million or more on the economy, or adversely affect productivity, competition, jobs, the environment, public health or safety, or State or local governments. This rulemaking will not interfere with an action taken or planned by another agency, or raise new legal or policy issues. Finally, this rulemaking will not alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients of such programs. Accordingly, this rulemaking is not subject to Office of Management and Budget (OMB) review under Executive Order 12866.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

The Department of Defense certifies that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This rule does not impose reporting and record keeping requirements under the Paperwork Reduction Act of 1995.

This rule was analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). It has been determined that it does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. This rule has no substantial effect on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials. Nothing in this rule preempts any State law or regulation. Therefore, Department did not consult with State and local officials because it was not necessary.

The Maryland State Highway Administration, who owns and operates the S213 (MD 213) Bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.551, to facilitate painting of the bridge.

Under this temporary deviation, the bridge will be in the closed-to-navigation position from 8 p.m. September 6, 2016 to 6 a.m. October 30, 2016. The bridge is a double bascule drawbridge and has a vertical clearance in the closed-to-navigation position of 12 feet above mean high water.

The Chester River is used by recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

For the duration of the bridge maintenance, vessels will not be allowed to pass through the bridge due to placement of barges and equipment in the main navigation span. The bridge will open for vessels on signal during the scheduled closure periods, if at least 24 hours notice is given. The bridge will not be able to open for emergencies and there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

The Coast Guard will enforce the safety zone for the Portland Dragon Boat Races detailed in 33 CFR 165.1341 from 8 a.m. to 6 p.m., on both Saturday, September 10, 2016, and Sunday, September 11, 2016. This action is necessary to ensure the safety of maritime traffic, including public vessels present, on the Willamette River during the Portland Dragon Boat Races. Our regulations for the Portland Dragon Boat Races in § 165.1341 specify the location of the regulated area for this event. Under the provisions of 33 CFR 165.1341 and 33 CFR part 165, subpart C, no person or vessel may enter or remain in the safety zone without permission from the Sector Columbia River Captain of the Port. Persons or vessels wishing to enter the safety zone may request permission to do so from the on-scene Captain of the Port representative via VHF Channel 16 or 13. The Coast Guard may be assisted by other Federal, State, or local enforcement agencies in enforcing this regulation.

This notice of enforcement is issued under the authority of 33 CFR 165.1341 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) [5 U.S.C. 553(b)]. This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds those procedures are “impractical, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this rule effective less than 30 days after publication in the Federal Register. The Coast Guard further finds that it would be impractical to issue an NPRM with respect to this rule because details of the VIP's travel to Hawaii were not provided to the Coast Guard until August 9, 2016, preventing the Coast Guard from completing full notice-and-comment rulemaking procedures. Publishing an NPRM and delaying the effective date would be contrary to the security zone's intended objectives, including but not limited to protection of the VIP, mitigation of potential terrorist risks, and enhancing public and maritime security. Publishing a Notice of Proposed Rulemaking (NPRM) and delaying the effective date would be contrary to the public interest since the occasion would occur before a notice-and-comment rulemaking could be completed, thereby jeopardizing the safety of the VIP. The COTP finds this temporary security zone must be effective by August 30, 2016 to ensure the safety of the VIP during his visit to the Kailua Bay area on the eastern coast of Oahu, Hawaii.

The Coast Guard is issuing this rule under the authority in 33 U.S.C. 1231. From August 30, 2016 through September 2, 2016, a VIP of the United States of America plans to visit the Kailua Bay area on Oahu, Hawaii. The security zone encompasses two primary areas from the surface of the water to the ocean floor: (1) The navigable waters of the Kawainui Canal, beginning 150 yards south of the N. Kalaheo Avenue Road Bridge and continuing into Kailua Bay; and (2) the navigable waters of Kailua Bay beginning at Kapoho Point and extending in a southwesterly direction to the shore boundary of a property located at 123 Kailuana Loop, Kailua, HI 96734. The Captain of the Port of Honolulu (COTP) has determined the potential risks associated with the VIP's visit to the Kailua Bay area render a security zone necessary to ensure the VIP's safety. Entry of persons or vessels into the security zone is prohibited unless authorized by the Captain of the Port (COTP) Honolulu or a designated representative.

This temporary final rule establishes a security zone from 4:00 p.m. (HST) on August 30, 2016, through 11:30 p.m. (HST) on September 2, 2016. The security zone encompasses two primary areas from the surface of the water to the ocean floor: (1) The navigable waters of the Kawainui Canal, beginning 150 yards south of the N. Kalaheo Avenue Road Bridge and continuing into Kailua Bay; and (2) the navigable waters of Kailua Bay beginning at Kapoho Point and extending in a southwesterly direction to the shore boundary of a property located at 123 Kailuana Loop, Kailua, HI 96734.

Two (2) shore-side markers will be placed in proximity of the security zone along the security zone boundary and one (1) orange boom will be placed at the canal boundary south of the N. Kalaheo Avenue Road Bridge as visual aids for mariners and public to approximate the zone. An illustration of the security zone will be made available on www.regulations.gov in the docket for this rulemaking, USCG-2015-1030. No vessel or person will be permitted to enter the security zone without obtaining permission from the COTP or a designated representative.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Coast Guard expects the economical impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the limited duration of the zone, the limited geographic area affected by it, and the lack of commercial vessel traffic affected by the zone. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the 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 the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

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

This rulemaking addresses CAA section 110(a)(2)(D)(i) requirements in New York's infrastructure SIP submitted on April 4, 2013 to address applicable infrastructure requirements with respect to the 2008 ozone NAAQS.

The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address. EPA commonly refers to such state plans as “infrastructure SIPs.” In particular, section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS (commonly referred to as prong 1), or interfering with maintenance of the NAAQS (prong 2), in any another state. Section 110(a)(2)(D)(i)(II) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration (PSD) of air quality (prong 3) and to protect visibility (prong 4) in another state. This rulemaking addresses prongs 1, 2, and 4 of CAA section 110(a)(2)(D)(i). EPA will address the other portions of the April 4, 2013 infrastructure SIP submittal, including prong 3 pertaining to CAA section 110(a)(2)(D)(i)(II), in another action.

The proposed rulemaking associated with this final action was published on June 21, 2016 (81 FR 40229). In that action, EPA proposed to disapprove the portions of New York's April 4, 2013 SIP submission addressing prongs 1 and 2, and proposed to approve prong 4 regarding CAA section 110(a)(2)(D)(i) requirements.

In proposing to disapprove the SIP submission as to prongs 1 and 2, EPA noted several deficiencies in New York's submission: (1) New York's own modeling showed “predicted” nonattainment in the bordering states of Connecticut, New Jersey, and Pennsylvania, but did not adequately explain its conclusion that New York emissions will not significantly contribute to those predicted exceedances; (2) the emissions reductions cited in New York's submission were based on preliminary emissions estimates, and were below the assumed emissions reductions that were used in New York's cited preliminary screening modeling performed for the Ozone Transport Commission; (3) the submission used a projection year (2020) to model downwind air quality that is two years beyond the July 11, 2018 moderate area attainment date for the 2008 ozone NAAQS; (4) the submission failed to address prong 2, the State's potential interference with maintenance of the 2008 ozone NAAQS in other states; (5) the submission did not demonstrate that the emission rates at which Electric Generating Units (EGUs) in the state operated were the result of enforceable emission limits or other mandatory programs such that the emission rate would not increase; (6) New York's submission relied on the state's implementation of the Clean Air Interstate Rule (CAIR), which was not designed to address interstate transport with respect to the 2008 ozone standard and is no longer being implemented by the states and EPA; and (7) EPA recently released technical data that contradicts the State's conclusion that its SIP already contains adequate provisions to meet interstate transport requirements with respect to the 2008 ozone NAAQS.

In proposing to approve the New York SIP submission with respect to the prong 4 visibility transport requirements under CAA section 110(a)(2)(i)(II), EPA explained that New York's SIP submission relied on the State's approved Regional Haze SIP to ensure that emissions from sources within the State were not interfering with measures to protect visibility in other states.

We received comments during the public comment period on our proposed action from the New York State Department of Environmental Conservation (NYSDEC), the State of Connecticut Department of Energy and Environmental Protection (DEEP), and the Environmental Energy Alliance of New York, LLC (the Alliance). A synopsis of the comments and our responses are below.

Comment 1: The NYSDEC stated that EPA is proposing to replace New York's “supposedly deficient” plan with a partial remedy that controls fewer units at less stringency. NYSDEC further states that EPA is proposing to disapprove a plan based in part on a NOX regulation that covers EGUs as well as non-EGU source categories at a $5,000 per ton control cost threshold, and replace it with a program that covers only EGUs at a $1,300 per ton control cost threshold. NYSDEC also states that EPA should explain how its proposed transport rule addresses transport more effectively than New York's plan.

Response 1: As noted above, we identified a number of deficiencies with New York's SIP submission to support the proposed disapproval of the plan as to prongs 1 and 2 with respect to the 2008 ozone NAAQS. While EPA cited the modeling conducted for EPA's proposed Cross State Air Pollution Rule Update for the 2008 ozone standard (CSAPR Update), 80 FR 75706 (December 3, 2015), as additional evidence that emissions from New York may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in other states, this action did not propose and does not finalize any remedy to address the deficiency identified in New York's SIP submission. This action does not itself replace New York's plan with the proposed remedy that was included in the CSAPR Update proposal or any other remedy. Rather, with respect to prongs 1 and 2, this action disapproves New York's submission for its failure to provide sufficient analysis to support its conclusion that the state's SIP contains adequate provisions prohibiting emissions which interfere with air quality in other states.

NYSDEC misstates the burden imposed upon the EPA in reviewing this action. In submitting an infrastructure SIP, the state's burden is to demonstrate to EPA's satisfaction that it has complied with the statutory requirements of CAA section 110(a)(2). EPA's role in reviewing infrastructure SIP submissions is to ensure that the state's plan complies with the statute. With respect to prongs 1 and 2, the EPA has reviewed New York's demonstration and determined, for the reasons summarized above, that it does not adequately demonstrate that the state's plan is sufficient to ensure that emissions from the state will not significantly contribute to nonattainment or interfere with maintenance. As noted below, this disapproval will trigger a federal implementation plan (FIP) clock which will require the EPA to promulgate a plan to prohibit those levels of emissions that impact downwind air quality in violation of the statute. However, the EPA is not required to provide that metric at the time it reviews the state's demonstration.

Moreover, EPA's 2011 modeling baseline used for evaluating interstate transport with respect to the 2008 ozone NAAQS accounted for the emission reductions from controls listed in the SIP—including New York's Reasonably Available Control Technology (RACT) rules—and nonetheless continued to show that New York would contribute to downwind air quality problems. Despite the considerable emission reductions achieved by New York, EPA's technical analysis for the CSAPR Update proposal demonstrates that New York's emissions still have an impact on other states.

Comment 2: The NYSDEC agreed that emissions in New York contribute significantly to nonattainment or interfere with maintenance in downwind areas. However, NYSDEC states that EPA should review New York's control program relative to what EPA might determine to be an approvable remedy rather than basing its disapproval on NYSDEC's emission reduction estimates and the fact that New York did not quantify its significant contribution.

Response 2: In this action, EPA is rightly focused on the discrete question of whether New York has demonstrated that its SIP contains adequate provisions to prohibit significant contribution to nonattainment and interference with maintenance of the 2008 ozone NAAQS in downwind states. New York acknowledges in its comment, and EPA agrees, that New York's SIP submission does not currently satisfy those requirements. As such, EPA must disapprove New York's SIP submission for failing to satisfy the statutory requirements of CAA section 110(a)(2)(D)(i)(I). As explained in our June 21, 2016 proposal, and summarized above, New York has not demonstrated that its SIP contains adequate provisions to address interstate transport as to the 2008 ozone standard. Furthermore, despite recent emission reductions achieved by New York, in EPA's technical analysis for the proposed CSAPR Update, our modeling shows that New York contributes well above the air quality threshold of 1 percent of the 2008 ozone NAAQS (0.75 parts per billion) to several projected downwind nonattainment or maintenance receptors. As indicated in our proposal, EPA's modeling shows that New York contributes 16.96 ppb to downwind receptors in Connecticut, and 17.21 ppb to downwind maintenance receptors in Connecticut and New Jersey, both of which greatly exceed the threshold contribution levels.

Comment 3: The NYSDEC stated that EPA did not provide states with a clear indication of what was required for their respective transport SIPs at the time they were due. Without this information about cross-state contributions, NYSDEC relied on control measures already in place within the state.

Response 3: States have an independent responsibility to demonstrate that their plans contain adequate provisions to address the statutory interstate transport provisions, specifically to demonstrate that the plan properly prohibits emissions that will significantly contribute to nonattainment or interfere with maintenance of the NAAQS in downwind states. As the Supreme Court clearly held in EPA v. EME Homer City Generation, L.P., “nothing in the statute places the EPA under an obligation to provide specific metrics to States before they undertake to fulfill their good neighbor obligations.” 134 S. Ct. 1584, 1601 (2014).1 Simply put, the CAA does not require EPA to quantify states' good neighbor obligations before acting on their SIP submissions. Nevertheless, EPA did provide information to assist states with developing or supplementing their SIP submittal for the 2008 ozone NAAQS. On January 22, 2015, we issued a memorandum providing preliminary modeling information regarding potential downwind air quality problems and levels of upwind state contributions. See Memorandum from Stephen D. Page to Regional Air Division Directors, Regions 1-10, “Information on the Interstate Transport `Good Neighbor' Provision for the 2008 Ozone [NAAQS] under [CAA] Section 110(a)(2)(D)(i)(I)”, January 22, 2015.” 2 As we noted in our CSAPR Update proposal, the EPA also provided updated modeling and contribution information in its August 4, 2015 NODA. (80 FR 46271). All of these documents consistently indicated that the EPA's technical analysis showed that New York emissions contribute to downwind air quality problems with respect to the 2008 ozone NAAQS, yet New York did not revise or supplement its SIP submittal with additional data demonstrating that the state had satisfied its statutory obligation.

Comment 4: NYSDEC states that EPA's failure to implement a full remedy leaves states unsure how to satisfy their transport obligations in regard to the 2008 ozone NAAQS. NYSDEC asserts that EPA should propose a subsequent update to CSAPR by June 2017 that encompasses a full remedy. NYSDEC states that the update should include requirements for large non-EGU sources and utilize a control cost threshold that is more equitable to states.

Response 4: For the reasons stated above, this comment is outside of the scope of this action. EPA will address comments regarding the adequacy of the proposed FIP in the final CSAPR Update rule.

Comment 5: Connecticut DEEP is supportive of the proposed disapproval of New York's SIP submission regarding prongs 1 and 2. DEEP notes that New York and Connecticut have partnered for over 40 years to provide clean air, especially in the southwest portion of Connecticut and the New York City metropolitan region, and will continue this collaboration. DEEP encourages EPA to describe, with as much specificity as possible, the steps states should take to meet their good neighbor responsibilities under the Clean Air Act. DEEP also urges EPA to immediately propose and finalize a full transport remedy for the 2008 ozone NAAQS rather than allowing compliance efforts for the 2015 NAAQS to drive compliance with the 2008 NAAQS.

Response 5: EPA is supportive of the states' collaborative efforts to improve air quality. This action is focused on EPA's review of New York's infrastructure SIP submission addressing prongs 1 and 2 of CAA section 110(a)(2)(D)(i) submitted for the 2008 ozone NAAQS. As noted earlier, while the EPA is not obligated to quantify state's emission reduction obligations prior to or as part of reviewing a state's SIP submission, we have provided data informative to the state's development and EPA's review of SIPs addressing these requirements with respect to the 2008 ozone NAAQS. EPA will further address state's emission reduction obligations in the rulemaking to finalize the CSAPR Update rule.

Comment 6: The Alliance requested extension of the public comment period for the proposal to coincide with the comment period for a proposed consent decree “requiring the EPA to reject the SIP” to address a lawsuit filed by the Sierra Club in the United States District Court for the Northern District of California.3

Response 6: We disagree that an extension of the public comment period is warranted for this action. The commenter does not provide an adequate justification why an extension is necessary. The proposed consent decree only concerns a proposed deadline by which EPA would have to act on the state's SIP submissions under CAA section 110(k)—not the substance of that action. See 81 FR 42351 (June 29, 2016). In contrast, the June 21, 2016 proposed disapproval sought comment on a substantive action—i.e., whether to approve or disapprove New York's submission, and on what basis.

Comment 7: The Alliance asserts that the proposed disapproval of New York's transport SIP, the proposed consent decree mentioned in comment 6, and the CSAPR Update rule are all related and should be resolved at the same time. The Alliance states that they are concerned that one of the actions may be settled without consideration of comments associated with the other actions, and that the resulting plans for attainment may not be as cost effective, “reduction efficient” or may not significantly impact attainment. By way of example, the Alliance notes that it provided comments on the proposed CSAPR Update rule regarding errors in EPA's supporting modeling. The Alliance contends that without finalizing the CSAPR Update rule, neither the EPA nor the commenting public is able to fully evaluate the legitimacy of the SIP disapproval. The Alliance further states that in as much as the proposed consent decree is intended to effectuate SIP disapproval, finalization of the consent decree is unwarranted until the full assessment of public input to the CSAPR Update rule is completed and finalized.

Response 7: EPA disagrees that the proposed disapproval of New York's transport SIP, the proposed consent decree mentioned in comment 6, or the CSAPR Update rule should be resolved at the same time. CAA section 110(k)(2) requires EPA to act on a state's SIP submission within one year after the submission is determined to be complete. As indicated in the response to comment 6, the proposed consent decree with the Sierra Club governs only the timetable on which EPA would be required to act on the state's SIP submissions under CAA section 110(k)(2)—not the substance of EPA's action.

As described in the proposal and earlier in this document, EPA has identified several ways in which New York's SIP submission was deficient for purposes of addressing the state's obligation pursuant to CAA section 110(a)(2)(D)(i)(I). In particular, EPA proposed to disapprove New York's SIP submission because the State's modeling showed “predicted” nonattainment in other nearby states with existing measures; the submission did not demonstrate that the emission rates at which EGUs operated were the result of enforceable emission limits; the submission failed to address the State's potential interference with maintenance (or prong 2 of section 110(a)(2)(D)(i)); and the submission relied on the state's implementation of CAIR, a rule that is no longer being implemented by the states and EPA and that was declared invalid by the D.C. Circuit.

While EPA cited the modeling conducted for the proposed CSAPR Update rule as additional evidence that New York may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in downwind states, we did not propose to make a specific finding of contribution or to quantify any specific emissions reduction obligations. Rather, the evaluation of whether emissions from the State significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS downwind, and if so what reductions are necessary to address that contribution, is being conducted in the context of the CSAPR Update rulemaking. Accordingly, EPA is considering submitted comments regarding EPA's air quality modeling and various associated legal and policy decisions in finalizing that rulemaking.

EPA notes that the technical data discussed at proposal with respect to New York's potential contribution to downwind air quality problems is consistent with modeling previously conducted for trading programs addressing interstate ozone transport such as CSAPR (76 FR 48208), CAIR (70 FR 25162), and the NOX SIP Call (63 FR 57356), indicating that New York is frequently linked to downwind receptors. The modeling conducted to support the proposed CSAPR Update is the most recent technical information available to the Agency which still shows such linkages to downwind receptors. Even absent this modeling data, New York's SIP submission is inadequate to demonstrate compliance with prongs 1 and 2 of CAA section 110(a)(2)(D)(i) with respect to the 2008 ozone NAAQS.

Comment 8: The Alliance commented that, under 110(a)(2)(D)(i)(I), SIP control requirements should apply to a source category or a reasonable aggregation of emissions. The Alliance further stated that under the CSAPR Update rule, EPA unreasonably concluded that the New York electric generating unit sector budget—and only that budget—had to be revised to address significant nonattainment. The Alliance contends that the New York EGU sector emissions are not a significant contributor to neighboring state nonattainment or maintenance issues, and if EPA finalizes the SIP disapproval and finalizes the CSAPR Update rule as proposed, another round of emission reductions from the New York EGU sector will not provide any significant improvement in air quality. The Alliance concludes that it is not appropriate to consider additional reductions from EGUs until reductions are found in other sectors.

Response 8: As described in the proposal and earlier in this document, EPA has identified several ways in which New York's SIP fails to address the prongs 1 and 2 requirements of CAA section 110(a)(2)(D)(i)(I). This action did not propose and does not finalize any remedy to address the deficiency identified in New York's SIP submission. Rather, with respect to prongs 1 and 2, this action disapproves New York's submission for its failure to provide sufficient analysis to support its conclusion that the state's SIP contains adequate provisions to meet interstate transport requirements with respect to the 2008 ozone NAAQS. The evaluation of the emission reductions necessary to address the State's significant contribution, including from which sectors such reductions might be achieved, is outside the scope of this rulemaking, and is being conducted in the context of the CSAPR Update rulemaking.

Comment 9: The Alliance cited comments submitted to the docket of the CSAPR Update rulemaking that identified alleged technical deficiencies in EPA's modeling. The Alliance states that EPA should run its modeling using the Integrated Planning Model (IPM) 5.15 base case, and correct for other technical errors in CSAPR modeling. The Alliance questioned the CSAPR Update rule's conclusion of state linkages to downwind nonattainment (and therefore the validity of EPA's proposed disapproval), and the expenditure of significant state and EGU resources on developing revised SIPs and modifying controls based on an outdated modeling platform. The Alliance also states that regulated entities are not being given appropriate notice and opportunity to comment on the SIP disapproval when EPA has not yet completed modeling for the final CSAPR Update rule. The Alliance concludes that the correction of errors will demonstrate that the CSAPR Update rule, which EPA is relying on to disapprove New York's SIP, results in over-control.

Response 9: As noted earlier in this document, EPA will consider timely submitted comments regarding EPA's air quality modeling, the modeling platform, and state linkages to downwind nonattainment for the CSAPR Update in the context of that rulemaking, not this one.

With respect to this rulemaking, EPA disagrees with the commenter that we are only relying on CSAPR modeling to disapprove the State's SIP. As we have previously noted, EPA has identified several ways in which New York's SIP submission is deficient for purposes of addressing the State's obligations under CAA section 110(a)(2)(D)(i)(I). While EPA cited the modeling conducted for the CSAPR Update as additional evidence that New York may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in downwind states, we did not propose to make a specific finding of contribution or to quantify any specific emissions reduction obligations. Rather, EPA is conducting its evaluation of whether emissions from the State significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS downwind and, if so, what reductions are necessary to address that contribution, in the context of the CSAPR Update rulemaking.

EPA therefore disagrees with the commenter that appropriate notice and comment to regulated entities on the proposed SIP disapproval has not been provided since the CSAPR Update modeling has not been finalized. EPA provided a 30 day comment period on the proposed disapproval (see 81 FR 40229). EPA has also provided appropriate public notice and comment for the CSAPR Update rule (see 80 FR 75706). Moreover, there are no regulated entities under this action as this action merely disapproves the portion of New York's SIP addressing CAA section 110(a)(2)(D)(i)(I), and does not itself create any new requirements.

Comment 10: The Alliance commented that EPA should have performed refined screening modeling to determine all the factors driving ozone exceedances in New York and Connecticut. The Alliance further states that failure to do so could unnecessarily require further reductions in New York, not resolve the ozone nonattainment problem, and unnecessarily lead to the disapproval of New York's SIP.

Response 10: As discussed above, this action did not propose and does not finalize any remedy to address the deficiency identified in New York's SIP submission. Rather, with respect to prongs 1 and 2, this action disapproves New York's submission for its failure to provide sufficient analysis to support its conclusion that the state's SIP contains adequate provisions to meet interstate transport requirements with respect to the 2008 ozone NAAQS. The degree to which additional emission reductions may be necessary to address the requirements of section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone NAAQS will be evaluated in a separate rulemaking.

Comment 11: The Alliance submitted analyses regarding NOX emission trends in New York showing declining NOX emissions and emission rates, and operational data from 2007 to 2015 for annual NOX emissions, NOX ozone season emissions, NOX peak day emissions, and NOX emissions on ozone exceedance days. The Alliance commented that New York's “higher level of assumed reductions” is more conservative than the actual data reveal and that New York's modeling assumptions should be honored by EPA. The Alliance indicates that EPA's SIP disapproval is based on New York's modeling using higher levels of assumed emission reductions, assuming 48% NOX reductions and 30% VOC reductions without demonstrating how it will achieve those higher levels of emission reductions. The Alliance further indicated that the data they submitted shows that between 2007 and 2015, two years before the New York modeling year, annual NOX emissions decreased 64%, ozone season NOX emissions decreased 56%, peak ozone season emission day NOX emissions decreased 40%, and the average NOX emission reduction on those days when ozone exceedances were observed at eight New York ozone monitoring sites ranged from 47% to 63% and the NOX emission reduction at the Fairfield, Connecticut ozone monitoring site was 38%. The Alliance further stated that both the EPA and NYSDEC modeling used annual or ozone season emissions for their projections and in both instances the observed reductions from 2007 to 2015 are greater than the reductions used by NYSDEC. The Alliance concludes that the EPA basis for the SIP disapproval is incorrect.

The Alliance also notes that EPA claimed that New York did not demonstrate that the emission rates at which EGUs operated in the state are the result of enforceable emission limits or other mandatory programs such that the emission rate will not increase. The Alliance notes that the NOX emission trends show a marked decrease in 2014 when New York's revised RACT limits become effective, resulting in an annual NOX rate decrease of 52% and an ozone season rate decrease of 42%. The Alliance states that the comparison of daily NOX emissions from 2007 to 2015 shows that New York's revised NOX RACT limits did have an enforceable impact. The Alliance also notes that coupled with the number of recent retirements at other New York facilities, it is extremely unlikely that NOX emission rates could increase substantially.

Response 11: EPA agrees with the commenter that NOX emissions and emission rates in New York have been trending downward since 2007. EPA also agrees that due to New York's stringent 2014 RACT emission limits—which EPA approved into the SIP and, as such, are federally enforceable—there are enforceable limits on NOX emissions from EGUs and other large boilers regulated under New York's RACT rules. New York's RACT rules also make it unlikely that emission rates from those sources will increase above the levels permitted by the emissions limits.

As an initial matter, EPA notes that the Alliance based its analysis only on a subset of New York's emissions data (from EPA's Clean Air Markets database), whereas New York's modeling was based on a much larger emission inventory (projected 328,457 tons of NOX emissions, and 368,784 tons of VOC emissions from overall state emissions in 2020).

Most importantly, EPA notes that New York's RACT rules were factored into New York's modeling as well as EPA's base case modeling. Despite emission reductions from New York's RACT regulations, as noted previously in this document, EPA modeling still shows a very large contribution to downwind nonattainment and maintenance receptors from New York (i.e., over twenty times the threshold contribution). New York's modeling also showed nonattainment problems in nearby states. Thus, New York has not demonstrated that its RACT rules are sufficient to address the state's significant contribution to nonattainment and interference with maintenance of the 2008 ozone NAAQS in other states.

Comment 12: The Alliance submitted analyses showing the correlation between New York NOX emissions and observed daily maximum ozone concentrations on ozone exceedance days. The Alliance commented, “While these analyses confirm that there is a relationship [between ozone concentrations in Fairfield, Connecticut and New York EGU NOX emissions] they also indicate that EPA and NYSDEC should address the trend toward a weaker relationship noted in the difference between 2007 and 2015.” The Alliance further stated, “[I]t is obvious that the relationship between [New York] emissions and downwind ozone is complicated, not solely related to [New York] EGU emissions and must be evaluated in better detail before the EPA unilaterally rejects the New York's [sic] SIP.”

Response 12: EPA agrees that there is a relationship between New York EGU NOX emissions and ozone concentrations in Fairfield, Connecticut. This relationship supports EPA's finding that reductions in New York EGU NOX emissions are needed to help lower ozone concentrations in Fairfield, Connecticut and at other downwind nonattainment and maintenance sites in Connecticut to which New York is linked. Ozone concentrations in Fairfield, Connecticut are dependent upon a number of factors including NOX emissions from EGUs and other upwind sources of NOX and VOC emissions, as well as local emissions in Connecticut. Inter-annual variability in meteorology is a principal factor in determining year-to-year differences in the magnitude of ozone concentrations. In this respect, the fact that the relationship between New York EGU NOX emissions and ozone in Fairfield, Connecticut is different in 2007 compared to 2015 does not disprove the contributions of New York EGU NOX emissions to high ozone concentrations in Fairfield, Connecticut.

EPA is disapproving a portion of the April 4, 2013 SIP submittal from New York pertaining to the requirements of CAA section 110(a)(2)(D)(i)(I) regarding interstate transport of air pollution that will significantly contribute to nonattainment or interference with maintenance of the 2008 ozone NAAQS in other states, known as prongs 1 and 2 of the good neighbor provision.

EPA is approving the portion of the April 4, 2013 SIP submittal from New York pertaining to the requirements of CAA section 110(a)(2)(D)(i)(II) requirement for visibility (or prong 4).

We expect to take action on the other portions of New York's infrastructure SIP at a later date.

Pursuant to CAA section 110(c)(1), this disapproval establishes a 2-year deadline for the EPA to promulgate a FIP for New York addressing the requirements of CAA section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone NAAQS unless New York submits and we approve a SIP that meets these requirements. Disapproval does not start a mandatory sanctions clock for New York pursuant to CAA section 179 because this action does not pertain to a part D plan for nonattainment areas required under CAA section 110(a)(2)(I) or a SIP call pursuant to CAA section 110(k)(5).

This final action is not a “significant regulatory action” under the terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993) and was therefore not submitted to the Office of Management and Budget for review.

This final action does not impose an information collection burden under the PRA because it does not contain any information collection activities.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This rule does not impose any requirements or create impacts on small entities. This partial SIP approval and partial SIP disapproval under CAA section 110 will not in-and-of itself create any new requirements but simply approves and disapproves certain state requirements for inclusion into the SIP.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This action does not apply on any Indian reservation land, any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, or non-reservation areas of Indian country. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it merely partially approves and partially disapproves a SIP submittal from the State of New York.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. This action merely partially approves and partially disapproves a SIP submittal from the State of New York.

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to 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 October 25, 2016. 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 CAA section 307(b)(2)).

40 CFR part 52 is amended as follows:

I. Background

On October 26, 2015, the Commonwealth of Virginia through the Virginia Department of Environmental Quality (VADEQ) submitted a revision to its SIP. The SIP revision submittal seeks to include state operating permit conditions and terms for the control of emissions of VOCs from Reynolds' plant located in Chesterfield, Virginia, in the Richmond Area, in order to address VOC RACT requirements for Reynolds. Previously, VOC RACT requirements for Reynolds were addressed via inclusion in the Virginia SIP of a Consent Order between VADEQ and Reynolds. This SIP revision submittal seeks to remove the prior Reynolds' consent order included in the SIP and replace it with nearly identical VOC RACT requirements now contained for the Reynolds' plant in a state operating permit. The SIP revision submittal also contains minor administrative and technical changes related to VOCs compared to the Reynolds' consent order; however, the substantive provision of VOC RACT remains the same for the Reynolds' plant, thus the minor administrative and technical changes have no effect on facility operation, VOC emissions, or air quality.

The Virginia SIP provides that the Commonwealth of Virginia's State Air Pollution Control Board must, on case-by-case basis, determine RACT for VOCs from major sources for which EPA has not issued a control technology guideline (CTG). EPA defines RACT as “the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” 44 FR 53761 (September 17, 1979). The Richmond Area was originally designated as a “moderate” ozone nonattainment area under the 1-hour ozone national ambient air quality standard (NAAQS), and thereby had to meet the non-CTGs RACT requirements under section 182 of the CAA (56 FR 56694, November 6, 1991). Reynolds' printing plant was identified as being subject to non-CTG RACT. The facility underwent a RACT analysis, and a federally-enforceable consent order was issued to the facility on October 30, 1986. The order was then submitted to EPA as a SIP revision, and approved into the Commonwealth's SIP on June 6, 1996 (61 FR 29963).

The SIP revision removes the prior Reynolds' consent order included in the SIP and replaces it with nearly identical VOC RACT requirements now contained for the Reynolds' plant in a state operating permit. Including the permit in the SIP will continue to implement RACT requirements for the plant, a major source of VOCs, as required by sections 172 and 182(b) of the CAA. The permit established control technology and other requirements for the control of VOC emissions from the Reynolds' plant in the Richmond Area. The permit incorporates only the conditions of the consent order, along with general permit conditions relating to testing, right of entry, and change of ownership. All operational requirements are limited in scope to those required by the consent order approved into the Commonwealth's SIP on June 6, 1996 (61 FR 29963). This includes process requirements to control VOC emissions, process emission limits, and on-site records.

The Commonwealth of Virginia's SIP revision also corrects two typographical errors in the formula used to calculate the estimated percent reduction in VOC emissions at Reynolds' plant for X14 (total actual solvent usage for time period) and X15 (total estimated solvents the plant is capable of using if water based materials were not used). The formula with the typographical errors was approved into the Commonwealth's SIP on June 6, 1996 (61 FR 29963). The revised formula for the state operating permit merely corrects a typographical mistake made within the consent order but does not alter how VOCs are or were calculated nor affect VOC emissions from the plant. A more detailed description of the state submittal and EPA's evaluation is included in a technical support document (TSD) prepared in support of this rulemaking action.

EPA is approving the October 26, 2015 submittal for the purpose of removing a consent order previously included in the Virginia SIP to address RACT requirements for VOC control at the Reynolds' plant and including Reynolds' state operating permit in the SIP to continue to address RACT requirements for Reynolds. EPA also approves the minor administrative and technical changes in the formula used to calculate the estimated percent reduction in VOC emissions. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on October 25, 2016 without further notice unless EPA receives adverse comment by September 26, 2016. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

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 a revision removing the prior Reynolds' consent order included in the SIP and replacing it with nearly identical VOC RACT requirements now contained for the Reynolds' plant in a state operating permit. 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 by the Director of the Federal Register in the next update of the SIP compilation.1 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

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);

• 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 as defined in 18 U.S.C. 1151 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).

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. section 804, however, exempts from section 801 the following types of rules: Rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). Because this is a rule of particular applicability, EPA is not required to submit a rule report regarding this action under section 801.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 25, 2016. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action.

This action removing a consent order previously included in the Virginia SIP to address RACT requirements for VOCs control at Reynolds plant and including Reynolds' state operating permit in the SIP to continue to address RACT requirements for Reynolds; as well as, making minor administrative and technical changes in the formula used to calculate the estimated percent reduction in VOC emissions, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Pursuant to sections 331(a) and 307(b) of the Communications Act, this is a synopsis of the Commission's Memorandum Opinion and Order, MB Docket No. 09-230, adopted August 3, 2016, and released August 4, 2016. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. This document will also be available via ECFS (http://fjallfoss.fcc.gov/ecfs/). To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

The Commission has before it for consideration an Application for Review filed by PMCM TV, LLC (“PMCM”), seeking review of three decisions by the Video Division of the Media Bureau (the “Division”): (1) The Seaford Report and Order that allotted very high frequency (“VHF”) television channel 5 to Seaford, Delaware; (2) the Seaford MO&O on Reconsideration rejecting a petition for reconsideration of the Seaford Report and Order and (3) the Seaford MO&O on Further Reconsideration dismissing PMCM's petition for reconsideration of the prior Seaford decisions as untimely. For the reasons set forth below, we deny the AFR and affirm the Division's dismissal of the PMCM Petition.1

In ordering the Seaford allotment, the Commission concluded that the outcome of PMCM's Reallocation Request was not relevant. PMCM did not seek reconsideration of that finding until nearly three years later when, for the first time, it opposed the new Seaford allotment that it had previously “strongly” supported. In hindsight, PMCM now argues that the Commission should have postponed allocating a new channel to Delaware while its efforts to reallocate channel 2 played out at the Commission and in court, even though the pendency of that litigation did not prevent PMCM from raising other concerns premised on a favorable outcome regarding its Reallocation Request, and the Seaford allotment is consistent with that request.2 In short, it appears that PMCM simply changed its strategy as developments unfolded.

The staff was correct in determining that PMCM's Petition for Reconsideration of the Seaford Report and Order was untimely. Section 405 of the Act provides that “petitions for reconsideration must be filed within thirty days from the date upon which public notice is given of the action . . . complained of.” Public notice of the Seaford Report and Order was given on May 7, 2010. The Petition for Reconsideration was filed on March 15, 2013, on the basis that allotment of a new channel to Seaford was improper. PMCM's claim that its Petition was timely because it was filed within 30 days after issuance of the Seaford MO&O on Further Reconsideration is entirely without merit. PMCM's Petition challenged the allocation adopted in the Seaford Report and Order, not the Commission's rejection of BMC's argument that the Commission should have placed the new allocation at channel 2 or 3. As to its request for reconsideration of the Seaford MO&O on Reconsideration, the Petition therefore was an impermissible collateral challenge to the Seaford Report and Order. The deadline for filing the Petition therefore was 30 days after public notice of the Seaford Report and Order, not 30 days after public notice of the Seaford MO&O on Reconsideration. Accordingly, PMCM filed its Petition for Reconsideration approximately three years late.

The Commission can only accept late-filed petitions for reconsideration if the petitioner shows that extraordinary circumstances warrant overriding the statutory filing deadline. As the D.C. Circuit has explained, “[a]lthough section 405 does not absolutely prohibit FCC consideration of untimely petitions for reconsideration, we have discouraged the Commission from accepting such petitions in the absence of extremely unusual circumstances.” Consistent with the D.C. Circuit's decisions, the Commission in applying that standard has focused on whether the Commission has failed to adhere to its procedural rules for providing notice of its decisions. PMCM has not even attempted to show that it has met this standard, much less demonstrated that the extraordinary circumstances required under this precedent are present here.

The assertion that the Court's decision in PMCM TV constituted “changed circumstances” warranting an extension of the deadline for reconsideration of the Seaford Report and Order is also without merit. This contention presumes incorrectly that a showing of “changed circumstances” under section 1.429(b) warrants an extension of the statutory deadline for the filing of petitions for reconsideration. Thus, PMCM claims that “[i]t is hornbook law that `changed circumstances' provide an adequate legal basis for reconsideration” and that the “relevant test is whether the petitioner has raised the changed circumstance at the first opportunity to do so.” Rather than supporting its theory that changed circumstances can support a request for reconsideration filed after the applicable statutory deadline, the single case PMCM cites, a 1979 Commission order, relates not to the filing of petitions for reconsideration after the statutory deadline but instead to the circumstances under which parties may seek reconsideration of a Commission order denying an application for review. Section 1.429(b)(1) sets forth the limited circumstances in which new matter raised in a timely petition for reconsideration will be considered. It does not and cannot supersede the statutorily established deadline for the filing of petitions for reconsideration, which is set forth in Section 405 of the Act and reflected in Section 1.429(d) of the Commission's rules.3

For the foregoing reasons, PMCM's argument that the Petition was timely filed because of its submission within 30 days of the release of the Seaford MO&O on Further Reconsideration is without merit. We therefore affirm the Bureau's dismissal of the Petition and deny the AFR. In light of our denial of the AFR, the Motion to Dismiss and associated pleadings are moot. We therefore dismiss these filings.

Accordingly, it is ordered That, pursuant to section 5(c)(5) of the Communications Act of 1934, as amended, 47 U.S.C. 155(c)(5), and § 1.115(g) of the Commission's rules, 47 CFR 1.115(g), the Application for Review IS DENIED.

It is further ordered That, pursuant to section 4(i)-(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i)-(j), and § 1.41 of the Commission's rules, 47 CFR 1.41, the Motion to Dismiss, Request for Leave to File Motion to Dismiss, and Reply to Opposition to Motion to Dismiss of Western Pacific Broadcast, LLC, and the Opposition to Motion to Dismiss, Comments in Response to Reply to Opposition to Motion to Dismiss, and Request for Leave to File Comments in Response to Reply to Opposition to Motion to Dismiss of PMCM TV, LLC, ARE DISMISSED as moot.

Notice is hereby given that the Office of Inspector General (OIG) adopts the Health and Human Services Acquisition Regulations (HHSAR) as issued in the Code of Federal Regulations (CFR) as chapter 3 of title 48; as promulgated by the Assistant Secretary for Financial Resources (ASFR) under the authority of 5 U.S.C. 301 and section 205(c) of the Federal Property and Administrative Services Act of 1949, as amended (40 U.S.C. 121(c)(2)), and as delegated by the Secretary.

In addition, by the authority vested in the Senior Procurement Executive (SPE) in accordance with 48 CFR chapter 3, section 301.401 of the HHSAR, and 48 CFR chapter 1, section 1.401 of the Federal Acquisition Regulations (FAR), I execute three class deviations from the HHSAR to ensure compliance with section 3(g) of the Inspector General Act. These deviations establish the OIG shall make use of the Office of Counsel to the Inspector General (OCIG), and not Office of the General Counsel (OGC), for the purposes of HHSAR sections 301.602-3; 303.203; & 333.102(g)(1); and further reaffirm the requirement that OCIG be consulted when the HHSAR and/or FAR require consultation with legal counsel.

Background

The monkfish fishery is jointly managed by the New England and the Mid-Atlantic Fishery Management Councils under the Monkfish Fishery Management Plan (FMP). The fishery extends from Maine to North Carolina from the coast out to the end of the continental shelf. The Councils manage the fishery as two management units, with the Northern Fishery Management Area (NFMA) covering the Gulf of Maine and northern part of Georges Bank (GB), and the Southern Fishery Management Area (SFMA) extending from the southern flank of GB through Southern New England (SNE) and into the Mid-Atlantic (MA) Bight to North Carolina.

The monkfish fishery has not fully harvested the available annual catch target since fishing year 2011, particularly in the NFMA where the under-harvest has been more substantial. As a result, the fishery has not been achieving optimum yield in either area. The Councils developed Framework 9 to enhance the operational efficiency of existing management measures in an effort to better achieve optimum yield. Because this action modifies some requirements for Northeast (NE) multispecies sector vessels, it is also considered Framework Adjustment 54 to the NE Multispecies FMP.

On June 23, 2016, we published a rule (81 FR 40838) proposing the measures included in Framework 9, and solicited comment through July 8, 2016. The Councils took final action on Framework 9 during summer 2015 and formally submitted it to us in February 2016. The proposed rule included three measures. This rule approves two measures and disapproves one measure. For more information on these measures, and the rationale for approval or disapproval, please refer to Approved Measures and Disapproved Measures below.

This rule eliminates the monkfish possession limit for monkfish Category C and D permitted vessels (referred to as Category C and D vessels in this section) fishing under both a NE multispecies and monkfish day-at-sea (DAS) in the NFMA. This measure is designed to help increase monkfish landings and better achieve the annual catch target caught in the NFMA.

Possession limits differ based on the type of DAS being used by a vessel. By eliminating the trip limit for a vessel fishing under both a NE multispecies and monkfish DAS, we are adding another tier to the possession limit system without changing the existing possession limits for a vessel fishing on a NE multispecies DAS or a monkfish DAS. A Category C or D vessel that is fishing under both a NE multispecies and a monkfish DAS in the NFMA may now retain an unlimited amount of monkfish. Table 2 includes a summary of the existing and new monkfish tail weight possession limits for a vessel fishing under the various DAS available in the NFMA.

A Category C or D vessel is still required to declare a trip at the dock under a NE multispecies A DAS with the option to declare a monkfish DAS while at sea, but can then declare a monkfish DAS while at sea in order or to be exempt from the monkfish possession limits. Alternately, a Category C or D vessel can declare a concurrent NE Multispecies A DAS and a monkfish DAS at the dock prior to starting a trip in order or to be exempt from the monkfish possession limits.

We are revising minimum mesh size and possession restrictions in different parts of SFMA (see Figure 1) to increase operational flexibility.

This rule implements a measure that allows a Category C or D vessel fishing under both a NE multispecies and a monkfish DAS in the SFMA to use 6.5-inch (16.5-cm) roundfish gillnets. This rule also allows any monkfish-permitted vessel fishing on a monkfish-only DAS in the Mid-Atlantic Exemption Area to use 5-inch (12.7-cm) roundfish gillnets in the Mid-Atlantic Exemption Area. Finally, monkfish-permitted vessels fishing on a monkfish-only DAS in either the SNE Dogfish Gillnet Exemption Area or the SNE Monkfish and Skate Gillnet Exemption Area may retain both monkfish and dogfish on the same trip when declared into either area. This measure also limits a vessel to using 50 roundfish gillnets in the SNE Dogfish and the Mid-Atlantic Exemption Areas. Table 3 summarizes the approved measures (highlighted in bold) and also includes existing seasonal, gear, and DAS requirements.

A vessel taking advantage of these smaller minimum mesh size requirements must still comply with all other requirements of fishing in the SFMA or in the Exemption Areas. Existing monkfish possession limits for vessels issued a limited access monkfish permit and fishing in the SFMA would remain the same.

We are disapproving the Framework 9 measure that would have allowed a Monkfish Category C and D vessel enrolled in a NE multispecies sector, fishing exclusively in the NFMA under either a NE multispecies non-DAS sector trip or a monkfish-only DAS, to declare a NE multispecies A DAS while at sea through the vessel monitoring system (VMS). We are disapproving this measure because it is inconsistent with National Standards 5 and 7 and the NE Multispecies FMP. Specifically, our disapproval is based on this measure's limited utility for fishery participants, poor cost-to-benefit ratio, enforcement concerns, and inconsistency with the NE multispecies FMP at-sea monitoring program. A full description of our rationale is provided below.

This measure was intended to help increase operational flexibility and potentially increase monkfish landings in the NFMA. However, as proposed by the Councils, it would create a loophole that would allow a vessel to circumvent existing groundfish sector at-sea monitoring requirements, which would be inconsistent with the NE Multispecies FMP. We have determined that the measure itself and the proposed remedy to the monitoring loophole described in the proposed rule are not consistent with National Standards 5 and 7 of the Magnuson-Stevens Fishery Conservation and Management Act because administrative costs and burdens are not offset by meaningful benefits to the industry.

We raised several concerns with this measure in the proposed rule (see 81 FR 40838, 40839) and noted that we intended to further evaluate the potential cost/benefit of providing this at-sea declaration flexibility, as well as review comments, when considering the approvability of this measure. We specifically requested comments on this measure and our concerns in the proposed rule and received two comments generally supporting this measure from industry members. These comments provided no specific feedback on the monitoring loophole, justifications for the cost/benefits, or our request to address concerns related to approvability. In addition, we had extensive conversations about this measure with the New England Council during the regulatory deeming process. The New England Council did not comment in support of the measure, nor did the New England Council address the multiple concerns we raised.

We are disapproving this DAS flexibility measure for the following reasons:

1. Allowing a vessel to declare a NE multispecies A DAS after starting a trip on a monkfish-only DAS is inconsistent with the NE Multispecies FMP. This measure would have allowed a groundfish sector vessel to circumvent existing NE multispecies pre-trip notification requirements for deploying industry-funded at-sea monitors. Monitoring is a fundamental requirement of the NE multispecies sector system because it allows the sectors and NMFS to adequately monitor the catching and discards made by participating vessels.

2. It is inconsistent with National Standards 5 and 7 of the Magnuson-Stevens Act. If approved, the costs of this measure and potential remedies to the monitoring loophole far outweigh any potential benefits to the industry. This measure would have required VMS changes that were estimated by the agency to cost approximately $100,000 based on comparisons of other similar programmatic changes that required VMS vendors to reprogram for additional declaration codes. Other database changes in the pre-trip notification system and to accommodate bycatch moderating would also have been needed to address the loophole created in the NE multispecies monitoring program. These changes are not reflected in the $100,000 VMS change estimate.

Further, this measure would not have provided as many benefits as first anticipated. Framework 9 estimated that only a small percent (1.6 percent) of vessels approached applicable trip limits for non-DAS sector trips and monkfish-only trips in recent fishing years, indicating that few vessels would realize a benefit from this measure. During its development, this measure underwent several iterative changes wherein the universe of vessels that could potentially use the provision was reduced. Many of these changes were designed to address the concern raised in the proposed rule. Presently, sector vessels may only use monkfish-only DAS in an exempted fishery. The only exempted fishery that overlaps with the NFMA is in the Gulf of Maine/Georges Bank Dogfish and Monkfish Gillnet Exemption Area, as described in § 648.80(a)(13). Given that the majority of the fleet in the NFMA fishes with trawl gear and cannot take advantage of this opportunity because they are excluded from this exempted fishery, we were concerned that only a small number of vessels that use gillnet gear would benefit from this flexibility. In fact, additional agency analysis indicates that, in the last three years, only three vessels took four trips that would have been eligible to use the monkfish-only flexibility. These four trips resulted in landings worth approximately $12,000. National Standard 5 and 7 require that management measures consider efficiency in the utilization of fishery resources and minimize costs and avoid unnecessary duplication. Given this limited benefit and the costs associated with this DAS declaration flexibility, we have determined that this measure is inconsistent with National Standards 5 and 7.

In addition, we also raised concern in the proposed rule that allowing this measure would create enforcement concerns with regulatory discard requirements. A vessel declared out of the NE multispecies fishery and fishing in an exempted fishery is prohibited from retaining NE multispecies (must discard all groundfish); whereas a vessel fishing under a NE multispecies DAS is required to retain all legal size NE multispecies. If we had approved this measure, a vessel would have begun a trip discarding all NE multispecies, only to then be required to retain all legal-sized NE multispecies after declaring a NE multispecies DAS. There would be no way to monitor these discard requirements unless each trip making use of this provision was monitored.

This final rule corrects a number of inadvertent errors, omissions, and ambiguities in existing regulations in order to ensure consistency with, and accurately reflect the intent of, previous actions under the FMP, or to more effectively administer and enforce existing and new provisions. These clarifications are being taken under the authority provided to the Secretary of Commerce in section 305(d) of the Magnuson-Stevens Act. The following measures are listed in the order in which they appear in the regulations.

In § 648.10, paragraphs (b)(3), (g)(1), (g)(3), and (g)(3)(i) through (ii) are revised to enhance readability and more clearly state the regulatory requirements.

In § 648.92, paragraph (b)(1)(i) is revised to enhance readability and more clearly state the regulatory requirements. A reference to the DAS requirements in the SFMA and adjustment for gear conflicts has also been removed, as these references are unnecessary. The reference to DAS requirement in the SFMA in § 648.92(b)(1)(ii) is not needed because that referenced section further explains how the overall DAS allocation may be used. The reference to adjustment for gear conflicts in § 648.96(b)(3) states that the Councils may develop recommendations to address gear conflicts. This reference is unnecessary because those measures would be captured in the regulations and appropriately cross-referenced.

In § 648.94, paragraph (b)(3)(i) is be revised to enhance readability and more clearly state the regulatory requirements. A reference to Category F permits has also been deleted for clarity because it may cause confusion with regard to the possession limits for Category F permits. Possession limit requirements for Category F permits are more clearly outlined in § 648.95.

Our proposed rule solicited comments for 15 days through July 8, 2016. We received nine comments from fishing industry members. A summary of the comments and our responses is provided below.

Comment 1: Six letters supported eliminating the trip limit for Category C and D vessels fishing under both a NE multispecies and monkfish DAS in the NFMA. One stated that this measure was needed to help more fully harvest the quota. Another stated that this measure will help increase efficiency, decrease discards, and will promote the conservation of other stocks by promoting harvest of monkfish.

Response: We agree and are approving this measure. The Councils specifically designed this measure to “increase monkfish landings to more fully utilize the annual catch target in the NFMA.” The Councils were also optimistic that this measure could benefit other fisheries by noting that it “could provide additional fishing revenue for groundfish vessels to help offset expected fishing revenue reductions associated with reduced groundfish quotas in NFMA in the near future . . .” While we cannot be certain that this measure will decrease discards, we recognize the potential benefit and encourage the Council to continue developing measures that reduce discards and discard mortality, as required by National Standard 9.

Comment 2: Three letters opposed removing the trip limit for Category C and D vessels fishing under both a NE multispecies and monkfish DAS in the NFMA. These letters based this recommendation on overall questions about the stock assessment and uncertainty about growth rates, stock definition, and stock distribution.

Response: The Northeast Fisheries Science Center is in the process of completing a monkfish operational assessment update. This assessment process has raised questions about the validity of monkfish aging information included in previous stock assessments. These important issues could change the results of the ongoing or future assessments. The Councils will need to evaluate these future results, set catch advice, and adjust management measure taking this new information into account. Still, the best available scientific information indicates that the monkfish stock is not overfished, nor subject to overfishing. Further, the fishery has been under-harvested the past several years. We believe that eliminating the trip limit for Category C and D vessels fishing under both a NE multispecies and monkfish DAS in the NFMA is warranted and presents little to no risk to the northern stock. Moreover, should this measure increase catch to levels above the annual catch target, the FMP has accountability measures designed to prevent recurring overages.

Comment 3: Three letters supported revising minimum mesh size and possession requirements in the SFMA, two of which also noted support for the 50-net limit in certain exemption areas. These letters noted that these changes help align the regulations with historic practices of the fishery. Two letters also spoke to timing: One letter requested the regulations be approved by October when dogfish become available, while the other requested that these administrative changes be made as soon as possible.

Response: We are approving the suite of SFMA mesh and possession measures, sharing the Council's rationale that this measure “increases operational flexibility of monkfish operations by allowing vessels to target both monkfish and dogfish using different gear types when on a monkfish DAS.” Monkfish are not overfished, nor subject to overfishing, and removing these administrative burdens to better align current regulations with historic practices will help the fishery better achieve optimum yield. To expedite the effective date of these measures, we are waiving the 30-day delay in effectiveness because this rule relieves restrictions. For more information on this waiver, please refer to the Classification section below.

Comment 4: Two letters generally supported the measure that would have allowed a Monkfish Category C and D vessel enrolled in a NE multispecies sector fishing exclusively in the NFMA under either a NE multispecies non-DAS sector trip or a monkfish-only DAS to declare a NE multispecies A DAS while at sea.

Response: As discussed above, we have disapproved this measure. We raised several concerns with the measure, noting that we would evaluate available data on potential use, the costs of implementation, and any public comments when considering the approvability of the measure. These two comments were very general and provided no additional information to address our noted concerns including the monitoring loophole, cost/benefits, or our request to address concerns related to approvability or justification in support of the measure. As discussed in Disapproved Measure, we have determined that this measure is inconsistent with the NE Multispecies FMP and National Standards 5 and 7, and have disapproved it.

The Administrator, Greater Atlantic Region, NMFS, determined that Framework 9 is necessary for the conservation and management of the monkfish fishery and that it is consistent with the Magnuson-Stevens Act and other applicable laws.

Because this rule relieves a restriction by increasing the trip limit in the NMFA and liberalizing gear and possession restrictions in the SFMA, it is not subject to the 30-day delayed effectiveness provision of the Administrative Procedure Act pursuant to 5 U.S.C. 553(d)(1). The Councils developed these measures to increase monkfish landings and associated fishing revenue to more effectively achieve optimum yield in the fishery. Accordingly, delaying this action for 30-days is contrary to the public interest, because it would unnecessarily delay the industry's ability to take advantage of increased opportunities to catch and land monkfish and benefit from the associated economic benefits of higher monkfish landings. Further, since this rule imposes no further restrictions on the monkfish fishery that would alter existing fishing practices or require affected entities to acquire additional equipment, there is no need to delay implementation of this action to provide affected entities sufficient time to prepare or comply with the measures of this rule. Thus, there is good cause under 5 U.S.C. 553(d)(3) to waive the delay in effectiveness for this action.

This rule has been determined to be not significant for purposes of Executive Order 12866.

On December 29, 2015, the National Marine Fisheries Service (NMFS) issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016. Id. at 81194.

Pursuant to the Regulatory Flexibility Act, and prior to July 1, 2016, a certification was developed for this regulatory action using SBA's former size standards. NMFS has reviewed the analyses prepared for this regulatory action in light of the new size standard. Under the SBA's size standards, 16 shellfish businesses were determined not to be small. The new standard could result in a few more commercial shellfish businesses being considered small. In addition, the new standard could result in fewer commercial finfish businesses being considered small. Previously, all finfish businesses (206 businesses) were classified as small businesses. Based on analysis in the environmental assessment, we do not expect any of these finfish businesses to be classified as large under the new size standards. However, NMFS has determined that the new size standard does not affect its decision to certify this regulatory action. The action results in minimal, potentially slightly positive impacts on all regulated entities regardless of size.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: