Federal Register Vol. 81, No.92,

Background

The 2014 Act reauthorized and amended EQIP. EQIP is implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of CCC.

Through EQIP, NRCS incentivizes agricultural producers to conserve and enhance soil, water, air, plants, animals (including wildlife), energy, and related natural resources on their land. In particular NRCS provides technical and financial assistance to implement conservation practices in a manner that promotes agricultural production, forest management, and environmental quality as compatible goals; optimize conservation benefits; and help agricultural producers meet Federal, State, and local environmental requirements. Conservation benefits are reflected in the differences between anticipated effects of treatment in comparison to existing or benchmark conditions. Differences may be expressed by narrative, quantitative, visual, or other means. Estimated or projected impacts are used as a basis for making informed conservation decisions by applicants and NRCS to help determine which projects to approve for EQIP assistance.

Eligible lands include cropland, grassland, rangeland, pasture, wetlands, nonindustrial private forest land, and other land on which agricultural or forest-related products or livestock are produced and natural resource concerns may be addressed. Participation in the program is voluntary.

On December 12, 2014, the EQIP interim final rule with request for comments was published in the Federal Register (79 FR 73953) that amended the EQIP regulations at 7 CFR part 1466 to implement changes made by the 2014 Act. The changes made to the EQIP regulation by the interim rule include:

• Eliminating the requirement that the program contract remain in place for a minimum of 1 year after the last practice is implemented, but keeping the requirement that the contract term not exceed 10 years;

• Consolidating elements of the Wildlife Habitat Incentive Program (WHIP) in light of the 2014 Act repealing the WHIP authority and incorporating its purposes into EQIP;

• Targeting at least five percent of available EQIP funds for wildlife-related conservation practices for each fiscal year (FY) from 2014 to 2018;

• Replacing the rolling 6-year payment limitation with an established payment limitation for FY 2014 to FY 2018;

• Requiring Conservation Innovation Grants (CIG) to report no later than Dec 31, 2014, and every 2 years thereafter;

• Establishing a $450,000 payment limitation and eliminating payment limit waiver authority.

• Modifying the special rule for foregone income payments for certain associated management practices and resource concern priorities;

• Revising availability of advance payments to up to 50 percent for eligible historically underserved participants to purchase material or contract services instead of the previous 30 percent;

• Providing flexibility for repayment of advance payment if payments are not expended within 90 days;

• Identifying EQIP as a contributing program authorized to accomplish the purposes of the Regional Conservation Partnership Program (RCPP) (Subtitle I of Title XII of the Food Security Act of 1985, as amended) (Seven percent of EQIP's funding is transferred to facilitate implementation of RCPP); and

• Adding provisions to target assistance to veteran farmers and ranchers.

In addition to updating the EQIP regulation to reflect changes made by the 2014 Act, the following administrative changes in the EQIP interim rule were made:

• Incorporating nonindustrial private forest owners and Indian Tribes where appropriate;

• Making reference to Tribal Conservation Advisory Councils when appropriate;

• Clarifying the issues where State Technical Committees and Tribal Conservation Advisory Councils provide input;

• Adjusting definitions to conform to definitions in other NRCS and USDA regulations;

• Clarifying definitions and requirements for development of Comprehensive Nutrient Management Plans (CNMP) associated with Animal Feeding Operations (AFO);

• Clarifying outreach activities and adding language that NRCS will ensure outreach is provided so as to not limit producer participation because of size or type of operation, or production system, including specialty crop and organic production;

• For irrigation and water management practices, allowing an exception to the requirement that land has to have been irrigated 2 of the previous 5 years. The Chief may grant a waiver where there was a loss of access to water due to circumstances beyond the producer's control;

• Changing the contract limitation to correspond with the new payment limitation and clarify that such limitations do not apply to Indian Tribes;

• Revising the rule to clarify when payment rates may be reduced as a result of NRCS entering into a formal agreement with a partner who provides payments to producers participating under general EQIP implementation, i.e. outside of RCPP;

• Revising and adding definitions to reflect EQIP authority to encourage development of wildlife habitat;

• Clarifying terminology and procedures associated with the development of payment schedules documenting practice payment rates;

• Simplifying language throughout to improve the regulation's readability; and

• Removing provisions in the rule that relate solely to internal agency administrative procedures that do not impact any rights or responsibilities of participants in the program;

The interim final rule had a 60-day comment period ending February 10, 2015. There were received 65 timely submitted responses to the rule, constituting 331 comments. This final rule responds to comments received during the public comment period and incorporates changes as appropriate. In this preamble, the comments have been organized alphabetically by topic. The topics include: Acreage cap, administration, advanced payments, allocations, comprehensive nutrient management plan, conservation activity plans, conservation innovation grants, conservation plan, conservation practices, contract length, contract violation and terminations, definitions, EQIP plan of operations, forestry funding, fund management, grouping and selecting applications, irrigation history, national priorities, payment limitations, program requirements, regional conservation partnership program, regional conservationist approval, regulatory certifications, Transparency Act requirements, technical service providers, veteran farmer or ranchers, and wildlife funding. Additionally, NRCS received 34 comments that were general in nature, most of which expressed support for the program or how the program has benefitted particular operations. The topics that generated the greatest response include the irrigation history requirement waiver, wildlife funding, and funding for animal feeding operations.

Comment: NRCS received one comment recommending that NRCS establish a maximum acreage cap for EQIP contracts.

NRCS Response: NRCS implements EQIP in a size-neutral way. The EQIP statute provides a payment limitation and the regulation further provides for a contract limitation. NRCS does not believe any further limitations are necessary to ensure broad participation on farms and ranches of all sizes. No changes were made in response to this comment.

Comment: NRCS received nine comments related to Administration, § 1466.2, most of which were from Conservation Districts. The commenters requested that there be waiver authority for EQIP regulatory provisions for all EQIP implementation, and not limited to RCPP implementation. Several of the comments recommended that NRCS provide greater emphasis to local working groups, identifying that local work groups were removed from the State Technical Committee final rule in 2009. One of the comments also requested that coordination with Indian Tribes be incorporated into the Administration section.

NRCS Response: Local working groups remain an integral component of the operations of the State Technical Committee. They were fully incorporated into the State Technical Committee final rule and operating procedures. The comments about local working groups do not relate to EQIP implementation directly, or to the EQIP final rule, and therefore no changes were made.

NRCS limits the ability to waive EQIP regulatory provisions to the authority provided by statute under RCPP, and believes that it is not appropriate to extend such waiver authority further. With its review of project-wide considerations, RCPP provides a structured format for consideration of waiver requests that helps ensure waivers are not granted in an arbitrary fashion. This safeguard is not available for consideration of waiver requests during a general EQIP sign-up. No changes were made to the regulation in response to the recommendation that the regulatory waiver authority be extended to all EQIP contracts.

NRCS coordinates with Indian Tribes to ensure that program opportunities are available on Tribal lands to Tribal members. NRCS currently identifies this coordination with Indian Tribes, including with the Tribal Conservation Advisory Council (TCAC), the State Technical Committee, and local working groups, in § 1466.2 and throughout the regulation.

NRCS policy related to coordination with Indian Tribes and Tribal members is found at Part 405 of Title 410 of the NRCS General Manual. In its policy, NRCS identifies that an Indian Tribe may designate a TCAC to provide input on NRCS programs and the conservation needs of the Tribe and Tribal producers. The TCAC may:

• Be an existing Tribal committee or department, including a Tribal conservation district;

• Consist of an association of member Tribes that provide direct consultation to NRCS at the State, regional, and national levels; or

• Include a Tribal designee (or designees) from a State Association of Tribal Conservation Districts that represents them and participates as part of the TCAC.

Since coordination with Indian Tribes is established as part of the regulation and NRCS policy, no change was made to the EQIP regulation in response to this comment.

Comment: NRCS received seven comments expressing approval for the additional flexibility available for advanced payments.

NRCS Response: NRCS appreciates the positive feedback. The additional flexibility for advanced payments is provided to assist historically underserved producers meet their responsibilities under the EQIP contract. No changes were necessitated by the comments expressed by the respondents.

Comment: NRCS received five comments requesting more transparency in the method used to allocate EQIP resources between States. These comments recommended against the use of the 2011 State Resource Assessment (SRA).

NRCS Response: The SRA process has been improved significantly since 2011 and now allows States to leverage national, State, and local data to present funding needs and demand in a flexible and transparent manner. At the national level, this process enables NRCS to focus funding on the highest priority resource needs across all States. The resulting annual allocation reflects State-demonstrated need and available funding. In addition, NRCS maintains the flexibility to adjust annual allocations in order to address emerging issues. For example, in FY 2014, NRCS was able to send several States severely impacted by drought an additional $20 million above their annual allocation in order to provide critical assistance to the impacted producers.

Comment: NRCS received nine comments expressing concern about using EQIP funds for new or expanding Confined Animal Feeding Operations (CAFOs). Some comments recommended that NRCS require a CAFO applicant to complete a CNMP as a prerequisite to receiving any EQIP funds to build a waste storage or treatment facility. Other comments recommended that NRCS undertake a full environmental review of the impact of EQIP CAFO funding.

NRCS Response: Section 1240E(a)(3) of the Food Security Act of 1985 (1985 Act), as amended, authorizes payments for AFOs provided the producer submits a plan of operations that provides for development and implementation of a CNMP. In the interim rule, NRCS revised the definition for AFO and CNMP, and revised § 1466.7, EQIP Plan of Operations, to clarify that if an EQIP plan of operations includes an animal waste storage or treatment facility to be implemented on an AFO, the participant must agree to develop and implement a CNMP by the end of the contract period. This requirement is further mirrored at § 1466.21, Contract Requirements, to state that a CNMP should be implemented when an EQIP contract includes an animal waste facility on an AFO. NRCS currently provides EQIP assistance for existing and expanding CAFO's in accordance with statutory regulations that require EQIP to provide assistance in situations where resource concerns currently exists.

As provided by statute and rule, NRCS already requires development of a CNMP as a condition to implement waste facility practices. Since some practices must be implemented prior to others, it is infeasible to require full implementation of a CNMP as a precondition for EQIP assistance for applicable practices.

As identified above and in the regulatory certifications, two respondents recommended that NRCS undertake an environmental analysis of the effects of providing EQIP assistance to CAFOs. NRCS has and will continue to conduct an environmental evaluation before providing EQIP financial assistance to any producer to ensure EQIP financial assistance does not result in significant adverse impacts to the quality of the human environment. The environmental evaluation is used to aid NRCS in compliance with the National Environmental Policy Act (NEPA) and helps NRCS determine the need for an environmental analysis (EA) or environmental impact statement (EIS) when the impacts of the proposed action do not fall within a categorical exclusion or have not already been addressed in the EQIP programmatic EA.

Comment: NRCS received three comments recommending that participants develop a CNMP prior to funding waste storage practices.

NRCS Response: The EQIP regulation at § 1466.7, EQIP Plan of Operations, requires a CNMP to be implemented if an EQIP plan of operations includes an animal waste storage on an AFO. This requirement is further mirrored in § 1466.21, Contract Requirements, to state that a CNMP will be implemented when an EQIP contracts includes an animal waste facility on an AFO. No changes were made to the EQIP regulations in response to these comments.

Comment: NRCS received one comment, disagreeing with the NRCS technical policy determination that Conservation Activity Plan (CAP) 142 on forest land must be approved by a Technical Service Provider (TSP) certified for forestry planning.

NRCS Response: Section 1240E of the EQIP statute requires that EQIP payments for a practice related to forest land must be consistent with the provisions of a “forest management plan that is approved by the Secretary.” This requirement was incorporated into the EQIP interim rule at 7 CFR 1466.7(e).

CAP 142 is a wildlife habitat management plan. Under the TSP provisions at 7 CFR part 652, a TSP hired by a program participant may utilize the services of another TSP to provide specific technical services or expertise needed by the participant. However, it remains the responsibility of the TSP hired by the participant to ensure that any technical services provided to them meets NRCS standards and specifications, and are consistent with the Certification Agreement the TSP entered into with NRCS at the time of Certification. Therefore, on a project-by-project basis, when CAP 142 on forested lands identifies the use of complex forestry conservation practice standards, such as Forest Stand Improvement (FSI), the plan must be approved by a TSP that also has been certified as having the requisite forestry technical skills. Other CAP 142 wildlife habitat management plans may not include forestry practices as complicated as FSI. Depending on the geographic location and the particular practices being planned and implemented, NRCS maintains the flexibility to determine when CAP 142 projects on forested lands need to be approved by TSPs who also have been certified for particular forestry conservation practices. As a result, no changes were made in response to this comment.

Comment: NRCS received six comments concerning CIG, three of which were recommendations. In particular, one commenter recommended that the NRCS State Conservationist, in consultation with the State Technical Committee, should be able to identify other resource concerns for State CIG projects and not be limited to either the national resource concerns or a subset of those concerns. Another commenter recommended that NRCS aggressively promote the on-farm research and development option, including a special focus on and significant funding for projects of this nature in each year's CIG announcement of program funding (APF). A third commenter recommended that NRCS continue to publish the APF in the Federal Register.

NRCS Response: The EQIP regulation currently allows flexibility for NRCS to implement State-level CIGs, with resource priorities identified by the State Conservationist in consultation with the State Technical Committee. In particular, funding availability, application, and submission information for State competition are announced through public notice (Grants.gov) separately from the national notice. The State Conservationist determines the State component categories to be offered annually. The regulation already addresses the comment regarding State identification of CIG priorities and no changes are needed.

For the first time the 2014 Act included language to allow CIG to fund on-farm research and development of technologies and approaches, and this authority was incorporated into the EQIP regulation. NRCS now provides support through CIG to on-farm conservation research, pilot projects, and field demonstrations of promising approaches or technologies. CIG applications should demonstrate the use of innovative approaches and technologies to leverage the Federal investment in environmental enhancement and protection, in conjunction with agricultural production. NRCS appreciates the comment recommending vigorous support for these efforts, but no further change is needed to the regulation in order for NRCS to provide such support.

NRCS supports the broad dissemination of the public announcement of national CIG competition. The CIG APF contains guidance on how to apply for the grants competition. NRCS, at one time, used the Federal Register for CIG announcements, but removed the requirement in the interim rule in order to speed up and simplify the process of making funding announcements. CIG opportunities are now advertised through the NRCS Web site and Grants.gov. No changes were made in response to this recommendation given the wide availability of notice about the CIG APF through other avenues.

Comment: NRCS received one comment recommending that a comprehensive conservation plan should be required prior to obtaining assistance.

NRCS Response: NRCS supports and believes that comprehensive conservation planning is a valuable conservation tool for producers, but does not agree it should make EQIP assistance contingent upon an applicant having obtained a comprehensive conservation plan. Section 1240F of the EQIP statute requires NRCS to assist producers by “providing payments for developing and implementing 1 or more practices, as appropriate” and “providing the producer with information and training to aid in implementation of the plan.” Given that the statute provides the flexibility for NRCS to provide EQIP assistance to implement only one practice, NRCS believes that the intent is for the planning to be similarly flexible to meet the current conservation needs of its participants. No changes were made in response to this comment.

Comment: NRCS received seven comments regarding conservation practices, six of which were recommendations. A couple of the commenters recommended that NRCS allow treatment to be done on the highest priority soils or ecological sites within a Conservation Management Unit, without making the rest of the land unit ineligible for future treatments. One commenter recommended a review and expansion of available conservation practices to better serve historically underserved, veteran, organic, small farmer, and other diverse producers. One commenter recommended adding to the regulation the requirement that financial assistance only be made for conservation practices that address the Priority Natural Resource Concerns identified in the EQIP Plan of Operations. One commenter recommended that NRCS annually consult with the State fish and wildlife agencies and the U.S. Fish and Wildlife Service (FWS).

NRCS Response: NRCS policy authorizes repeated implementation of conservation practices on land where the subsequent implementation of the practice will significantly improve the level of treatment addressing a resource concern. EQIP assistance is provided to the highest priority applications based upon the ranking criteria developed in consultation with the State Technical Committees. FWS and State fish and wildlife agencies are members of the NRCS State Technical Committee and therefore do not need to be identified separately in the EQIP regulation. NRCS continually reviews its conservation practices and whether NRCS assistance is able to address the resource concerns that the diversity of producers may have. No changes were needed in response to these comments.

Comment: NRCS received one comment recommending that the maximum contract length be reduced from 10 years to 5 years.

NRCS Response: Section 1240B of the EQIP statute allows an EQIP contract to have a 10-year duration. Congress has consistently retained this contract term in statute, recognizing the need for variation in contract duration. NRCS believes it must provide the flexibility authorized under the statute and that there are situations where implementation of conservation practices over a longer contract period is needed to address the resource concern. Therefore, no changes were made to the regulation in response to this comment.

In addition, a ranking criterion was added at 7 CFR 1466.20(b) to provide priority to applicants who indicate a willingness to complete all conservation practices in an expedited manner. NRCS identified that the purpose of this ranking criterion was to further statutory intent and to ensure timely and effective conservation improvements. NRCS continues to support the policy behind this regulation. NRCS implements this regulatory provision during the ranking process for applicants that indicate a willingness to implement all conservation practices within 3 years. While the statute authorizes contracts can be for up to 10 years in duration, NRCS implements this criterion for those funding pools where the nature and type of the resource concern to be addressed and practices applied do not require longer term conservation treatment, such as with applications for exclusion fences or other applications with comparatively low application costs. Additionally, NRCS recognizes that this criterion may not be appropriate to implement in funding pools set aside for historically underserved or limited resource producers, or in cases where infrastructure construction is necessary, as financially these producers or projects may need a longer implementation schedule.

Comment: NRCS received seven comments opposed to the removal of the specific reference to conservation districts in EQIP contract termination decisions.

NRCS Response: The EQIP interim rule removed the provision at 7 CFR 1466.26 which identified that NRCS may consult with conservation districts in EQIP contract termination decisions. NRCS removed this section due to the limitations on the disclosure of certain types of information provided by an agricultural producer under Section 1619 of the Food, Conservation, and Energy Act of 2008 (2008 Act). NRCS will continue to work closely with its conservation district partners in the implementation of EQIP and its other conservation programs. No changes were made in response to these comments.

The EQIP contract violation provisions (7 CFR 1466.25) address circumstances in which a participant violates their EQIP contract by losing control of the land under contract. NRCS may allow a participant to transfer the EQIP contract rights to an eligible producer provided the participant notifies NRCS of the loss of control within the time specified in the contract, NRCS determines that the new producer is eligible to participate in the program, and the transfer of the contract rights does not interfere with meeting program objectives.

Given that the new producer is not a party to the EQIP contract until NRCS approves the contract transfer and adds the new producer to the contract, a new producer may not be aware they are not eligible for payment until the contract transfer has been approved by NRCS. In particular, any practices that a new producer implements prior to NRCS approval of the contract transfer is not eligible for payment because they are not a program participant at the time of implementation. Changes to 7 CFR 1466.25 clarify a participant's responsibility to notify NRCS about any loss of control of land, the timing of when a new producer must be identified, the timing of when a new producer becomes eligible for payment, and the circumstances when partial or full termination of the contract may be appropriate. These changes do not affect the substance of the EQIP regulatory and policy framework regarding land transfers.

Comment: NRCS received 27 comments related to the definitions found at 7 CFR 1466.3 of the EQIP interim rule. Amongst these comments, there were a few comments regarding how historic use areas by Indian Tribes should be considered as areas of an agricultural operation.

NRCS Response: Most of the comments were from the same respondent, and related to suggested edits to the wildlife definitions. NRCS recognizes the unique status that Tribal lands and treaties have and will work with Tribal entities to ensure that agricultural operations are properly delineated. These comments did not require any changes to the regulation.

Comment: NRCS received 11 comments related to 7 CFR 1466.7, EQIP Plan of Operations. The comments related to CNMPs have been discussed above. Other comments recommended that the regulation specify that all conservation practices in the EQIP plan of operations must be approved by NRCS or an NRCS-approved TSP with appropriate job approval authority in accordance with the applicable NRCS Conservation Practice Standards in the Field Office Technical Guide. Some comments also recommended that the EQIP plan of operations identify the specific resource concerns to be addressed, which currently is not included.

NRCS Response: NRCS currently requires that the EQIP plan of operations be approved by NRCS or a certified TSP, and these comments do not require any changes be made to the EQIP regulation. The EQIP plan of operations is intended to inform producers what practices are included in the contract, the payment rate for the practice, and when the practice must be installed. Information related to the resource concerns being addressed are included in the conservation plan folder, the environmental evaluation documentation (NRCS-CPA-52), and are the basis for many of the program ranking criteria. As such, it is not necessary to duplicate this information in the EQIP Plan of Operations. No changes were made in response to these comments.

Comment: NRCS received one comment to the EQIP interim rule, recommending that at least 5 percent of EQIP funds be dedicated to forestry practices.

NRCS Response: Greater than 5 percent of EQIP funds have been dedicated to forestry practices following the increased emphasis upon providing assistance to non-industrial private forestlands since the 2008 Act. No changes are needed in order to meet the respondent's recommendations. However, NRCS notes that two of its regulatory provisions may inadvertently hinder participation by forest landowners. Namely, §§ 1466.7(e) and 1466.21(b)(3)(v) require that if an EQIP plan of operations includes conservation practices that address forest-land-related resource concerns, the participant must develop and implement a forest management plan by the end of the contract period. Often, a forestry management plan extends beyond 10 years and thus beyond the maximum duration of an EQIP contract. As such, it may not be feasible for a forestry landowner to implement fully the forestry management plan during the EQIP contract term. Unlike a CNMP that covers a specific type of operation with practices that can be more immediately implemented, a forestry management plan deals with managing a landscape which may require several years for the forest to respond to a treatment before another can be applied. Therefore, the provisions at §§ 1466.7(e) and 1466.21(b)(3)(v) are modified to require a participant to implement conservation practices consistent with an approved forest management plan if the EQIP plan of operations addresses forest-land-related resource concerns.

Comment: NRCS received one recommendation that it dedicate a specific amount of EQIP funding for specific categories (cover crops, CAFOs, etc.) to avoid situations where NRCS and producers are unsure of the level of funding available. The commenter expressed that this creates situations where producers scramble to get their paperwork submitted to meet deadlines only to learn later that they will not be funded.

NRCS Response: NRCS identifies the resource concerns that will receive priority through the posting of its ranking criteria and associated application deadlines, including special announcements of initiative funding. NRCS believes that this provides producers with information necessary to know what activities will receive funding priority. EQIP is only able to fund about 37 percent of the eligible applications it receives. No changes were made in response to these comments.

Comment: NRCS received 15 comments about ranking and 5 comments about grouping applications. The ranking recommendations included that NRCS should:

• Have no ranking;

• Streamline the application process and ranking;

• Not prioritize applications based upon a producer's ability to expedite practice implementation;

• Prioritize grass-based systems over AFOs;

• Encourage transition to more sustainable practices;

• Prioritize greenhouse gas reduction and carbon sequestration; and

• Include consistency with Tribal law as well as State law related to irrigation practice provisions.

As to the grouping of applications, one commenter felt that beginning farmers and ranchers received too much emphasis. One commenter felt that there were too many funding pools, while another recommended that States with at-risk species have more funding pools. One commenter recommended that operations compete against operations of similar sizes, while another commenter recommended prohibiting separate funding pools for CAFOs and instead encourage grazing plans for livestock.

NRCS Response: NRCS accepts EQIP applications on a continuous basis, but establishes application “cut-off” or submission deadline dates for evaluation and ranking of eligible applications. Depending upon annual funding levels, NRCS will allocate specific amounts of EQIP funding to meet legislative requirements, address certain national priorities, and also make funds available for NRCS State Conservationists to help address resource priorities identified by State Technical Committees. These priorities are then incorporated into ranking criteria, based upon the factors identified in statute and in § 1466.20 of the EQIP rule. In response to the request to streamline the application and ranking process, for many years NRCS has utilized screening factors as part of its evaluation and ranking of priority projects. To clarify that these screening factors are part of the ranking process, slight adjustments have been made in § 1466.20(b) to identify how these screening factors are used as part of the evaluation and selection of projects.

In evaluating EQIP applications, NRCS strives to obtain input from Tribes, States, and other affected constituents through seeking advice from the State Technical Committees, TCACs, and local working groups. For water conservation or irrigation-related practices, TCACs routinely have the opportunity to identify issues, including those that raise concerns related to Tribal laws, in order to advise NRCS on more effective ways to deliver programs and on the application process. While not explicitly stated in the regulation, NRCS believes that this advisory process with State Technical Committees and TCACs is considerate of and consistent with applicable State and Tribal laws.

Additionally, in its ranking, NRCS groups applications to the greatest extent possible by similar crop, forestry, or livestock operations for evaluation purposes or otherwise evaluating each application relative to other applications of similar agricultural operations. NRCS establishes a funding pool for beginning farmer and ranchers in accordance with statutory set-aside requirements. Subaccounts may also be developed to address a specific resource concern, geographic area, or type of agricultural operation, such as addressing habitat needs of at-risk species. However, to promote efficient and timely delivery of program assistance, NRCS policy encourages States to limit creating subaccounts in ProTracts to the minimum number needed to effectively rank and approve applications. EQIP policy currently addresses the respondents concerns regarding grouping applications and no changes were made to the regulation.

Comment: NRCS received 73 comments related to the irrigation history requirement and the criteria that NRCS should consider for waiving it. The following summarizes the general content of these comments, recommending:

• Support for the new waiver provision;

• The requirements for the waiver be less restrictive;

• That Indian Tribes be exempt from the irrigation history requirement altogether, or at least not subject to the agricultural history waiver criterion, provided the Tribe has a secured legal water right;

• The irrigation history requirement be completely removed;

• All producers, not just limited resource or socially disadvantaged producers, be eligible for a waiver; and

• Specific recommendations related to the waiver criteria, such as:

○ Removing the proposed acreage limit;

○ Removing the exclusion of land that has been subject to a water shortage;

○ Prohibiting waivers on native prairie and grasslands with no prior cropping history;

○ Clarifying the types of practices that are considered irrigation practices;

○ Clarifying whether the acreage limitation is per operation or per year; and

○ Considering impacts to wildlife when implementing irrigation practices.

NRCS Response: NRCS proposed several criteria and requested public comments on the criteria that will be used to determine whether to waive the irrigation history requirement, including whether:

• The waiver provision should be limited to applicants who are limited resource or socially disadvantaged producers (including Indian Tribal producers). Beginning farmers and ranchers were excluded from this consideration;

• The irrigation practices are necessary for the adoption of a sustainable agricultural production method, such as the adoption of cover crops to improve the soil condition;

• The land has been in active agriculture (cropped, hayed, or grazed) for 4 of the last 6 years;

• The waiver would adversely impact limited surface or groundwater supplies; and

• An acreage limitation should be applied, such as 50 acres per producer or 200 acres per Tribe.

In order to implement the waiver provision, NRCS developed and issued program policy at Title 440 Conservation Programs Manual, Part 515, Section 515.52, reflecting all criteria in the preamble of the EQIP rule except for the acreage limitation. NRCS believes that the criteria incorporated into policy ensure that program participants will be able to obtain access to EQIP to address resource concerns in a manner that does not adversely affect available water supplies. NRCS will continue to evaluate the utility of these criteria as it reviews actual waiver requests and may make adjustments based upon the experience obtained from actual implementation of the waiver provision.

Comment: NRCS received one comment on national priorities, recommending broadening national priority related to threatened and endangered species under the Endangered Species Act.

NRCS Response: As identified in the EQIP regulation, the national priority is not limited to Federally-listed threatened and endangered species, but identifies the promotion of habitat conservation for “at-risk” species habitat conservation. “At-risk” species include any plant or animal listed as threatened or endangered; proposed or a candidate for listing under the Endangered Species Act; a species listed as threatened or endangered under State law or Tribal law on Tribal land; State or Tribal land species of conservation concern; or other plant or animal species or community, as determined by the State Conservationist, with advice from the State Technical Committee or TCAC, that has undergone, or is likely to undergo, population decline and may become imperiled without direct intervention. No changes were made in response to this recommendation.

Comment: NRCS received six comments on outreach, five of which expressed approval for NRCS' current efforts with respect to historically underserved producers and recommending that NRCS maintain and expand outreach to these producers. One commenter recommended increasing participation among forestry landowners.

NRCS Response: NRCS will continue to expand its outreach to historically underserved producers.

NRCS is working in coordination with other USDA and Federal agencies to ensure that we are consistent with our outreach approach to serve historically underserved producers in rural and urban areas. NRCS is collaborating and working cooperatively with a variety of community-based organizations to ensure all customers receive high quality service and the information necessary to fully participate in all of its programs and services. For example, most recently, NRCS initiated a major partnership project in Alabama, North Carolina, and South Carolina to assist African American forest landowners in adopting and applying sustainable forest management practices to improve the value of their forestlands. Due to the success of this partnership, NRCS is looking to expand this project into Arkansas, Georgia, Mississippi, Virginia, and Indian Country.

Comment: NRCS received eight comments concerning payment limitations, five of which recommending a separate payment limitation lower than the current statutory levels.

NRCS Response: Section 1240G of the EQIP statute specifies a $450,000 payment limitation for persons and legal entities. The EQIP statute does not provide authority to mandate a lower payment limitation. No changes were made to the regulation in response to this comment.

Comment: NRCS received 13 comments regarding various program requirements, 11 of which made specific recommendations including:

• Higher payment rates for historically underserved producers with one commenter expressing disagreement for higher payment rates, while another commenter expressed support for veteran farmers or ranchers receiving a higher payment rate;

• Payment schedule scenarios, with two commenters recommending that payment scenarios be published on NRCS State Web sites, one commenter recommending that NRCS address disparities between small or large operations of payments for management practices that are based on number of acres, while another commenter recommending that NRCS have additional organic production scenarios; and

• Initiatives, with the commenter requesting clarification about when NRCS may reduce the level of EQIP assistance provided due to a contribution by a partnering entity.

NRCS Response: NRCS will continue to encourage enrollment by historically underserved producers through statutory tools such as higher payment rates and funding pool set asides, and programmatic policy emphasis and outreach efforts. NRCS will consider the recommendations regarding its payment schedules in its fiscal year 2016 and future payment schedule development efforts. Section 1466.23(b)(4) of the EQIP regulation requires NRCS to adjust program payment percentages to a participant when NRCS enters into a formal agreement with partners who also provide financial support to the participant to help implement program initiatives. This adjustment ensures coordination of conservation investment under formal partnership agreements to encourage the voluntary adoption of practices and not as a windfall to producers. This adjustment does not apply to situations where NRCS and other conservation organizations are independently providing assistance to a producer.

Comment: NRCS received three comments on RCPP. The commenters recommended that RCPP requirements be subject to public comment, that NRCS explain the contribution requirement under RCPP, and identify in the EQIP regulation that EQIP is a covered program under RCPP.

NRCS Response: NRCS has held numerous stakeholder meetings across the country to obtain input concerning RCPP procedures and requirements, and incorporates this feedback into the APF. The RCPP statute requires partners to contribute a significant portion of the overall costs of the project. This contribution of resources is reflected in the partnership agreement entered into between NRCS and a partner. The overall cost includes all direct and indirect costs associated with implementation, from NRCS and partner(s). Partners may include funds they have received from other Federal sources as part of their contribution to the project, provided they submit a written commitment from the Federal agency confirming such funds can be used in conjunction with NRCS funds. NRCS provides greater priority to applicants that are able to contribute at least 50 percent of the resources needed to implement a project. A minor change has been made to the EQIP final rule to clarify that EQIP is a covered program under RCPP.

Comment: NRCS received seven comments on the removal of the requirement that the Regional Conservationist approve contracts obligating funds over $150,000. Three respondents expressed support for the removal, while four recommended that NRCS re-institute the requirement.

NRCS Response: The requirement concerning the approval of contracts by the Regional Conservationist has been removed from the regulation as it is an internal administrative matter. NRCS bases its internal review requirements in a manner that balances ensuring financial integrity with administrative efficiency. NRCS adjusts these requirements based upon findings from its quality assurance reviews. No changes were made to the regulation in response to these recommendations.

Comment: NRCS received 13 comments related to various regulatory certifications that appeared in the preamble of the interim rule. Namely, five commenters stated that consultation was required under Executive Order 13175 since they believe that EQIP imposes substantial costs on Tribal governments associated with environmental and cultural resource compliance; three comments stated that Executive Order 13132 required NRCS to coordinate with Conservation Districts, as well as other State and local governments, prior to publishing the EQIP interim rule; and five commenters stated NRCS failed to meet the requirements of Executive Order 13563 to improve coordination across agencies to reduce costs and simplify rules.

NRCS Response: NRCS met its responsibilities under Executive Orders 13175, 13132, and 13563. Section 5 of Executive Order 13175 provides that an agency should not promulgate any regulation that imposes substantial direct compliance costs on Tribal governments that is not required by statute unless funds necessary to pay the direct costs incurred by the Tribal government or the Tribe in complying with the regulation are provided by the Federal government; or alternatively, the agency, prior to the formal promulgation of the regulation, consulted with Tribal officials early in the process of developing the proposed regulation.

While Indian Tribes and their members are eligible to participate in EQIP, such participation is voluntary and does not mandate compliance costs on the part of the Tribe. Additionally, in response to the 2014 Act enactment, NRCS developed and implemented an outreach plan to obtain meaningful input from Indian Tribes regarding all NRCS conservation programs, including EQIP. NRCS consultation policies related to Executive Order 13175 are currently contained in the NRCS General Manual (GM) at 410 GM Part 405, 180 GM Parts 401 and 404, and 420 GM Part 401. For ongoing NRCS program activities, NRCS State Conservationists have primary responsibility for engaging with Indian Tribes and ensuring that NRCS' Tribal consultation responsibilities have been met.

Executive Order 13132 governs how agencies should develop policies that have federalism implications. Under Executive Order 13132, “policies that have federalism implications” refers to regulations that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EQIP is a voluntary program to provide assistance to producers of eligible lands. As stated in the EQIP interim rule preamble, EQIP does not have a substantial direct effect on States, the relationship between the Federal government and the States, or the distribution of power and responsibilities.

Section 2 of Executive Order 13563 requires that regulations be adopted through a process that involves public participation, and to the extent feasible and consistent with law, the open exchange of information and perspectives among State, local, and Tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole. Section 1246 of the 1985 Act requires publication of the EQIP regulation as an interim rule with an opportunity for public comment. The EQIP interim rule published on December 12, 2014, included a 60-day public comment period, during which the comments regarding Executive Order 13563 were received by NRCS.

Comment: NRCS received five comments expressing concern about the applicability of the Federal Funding Accountability and Transparency Act (Transparency Act) requirements to EQIP contracts and the impact failure to comply with these requirements have upon agricultural producers.

NRCS Response: The Office of Management and Budget (OMB) regulations at 2 CFR parts 25 and 170 implement the Transparency Act and are government-wide requirements. The Transparency Act regulations apply to awards of financial assistance to non-Federal entities. EQIP assistance is financial assistance, thus the Transparency Act requirements apply to its implementation of awards to non-Federal entities. No changes were made in response to these comments.

Comment: NRCS received one comment expressing approval for the utilization of TSPs.

NRCS Response: NRCS appreciates the comment and will continue to encourage the utilization of TSPs in the implementation of EQIP. No changes were necessitated by this comment.

Comment: NRCS received five comments expressing support for the priority provided to veteran farmers and ranchers.

NRCS Response: NRCS appreciates the comment and will continue to encourage participation in EQIP by veteran farmers or ranchers. No changes were necessitated by this comment.

Comment: NRCS received 16 comments expressing concern that 5 percent was the minimum funding available for wildlife-focused activities and that wildlife is not being partitioned clearly to demonstrate an additive effect. Some commenters recommended that wildlife funding be tracked based on ranking of resource concerns and not by targeting specific practices. Others recommended that only those 16 conservation practice standards that have fish and wildlife as a primary purpose should be used to track the wildlife fund requirement.

NRCS Response: The 2014 Act repealed WHIP and incorporated its purposes into EQIP. Under the 2014 Act, at least 5 percent of EQIP assistance must be targeted towards conservation practices with a specific purpose related to wildlife habitat. Since this is an administrative requirement, NRCS did not include it in the EQIP regulation, but discussed in the preamble of the interim rule how it will meet the requirement. In particular, NRCS identified that it will track its compliance with this requirement by identifying those conservation practices where wildlife habitat is the primary purpose. Out of more than 160 existing conservation practice standards, 16 have wildlife habitat as a primary purpose, in addition to approximately 45 standards that are often used to benefit wildlife. The preamble also identified that in certain situations, such as wildlife-focused initiatives, other practices may also be tracked where the practices are designed to achieve specific wildlife objectives.

Given the statutory language, it is appropriate to track both the 16 wildlife-specific practices and, in wildlife-focused initiatives, the 45 standards that are utilized to benefit wildlife. No changes were made to the regulation in response to these comments.

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” directs 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. OMB designated this final rule a significant regulatory action. The administrative record is available for public inspection at NRCS National Headquarters located at 1400 Independence Avenue Southwest, South Building, Room 5831, Washington, DC 20250-2890. Pursuant to Executive Order 12866, NRCS conducted an economic analysis of the potential impacts associated with this program. A summary of the economic analysis can be found at the end of the regulatory certifications section of this preamble, and a copy of the analysis is available upon request from the Director of NRCS' Financial Assistance Programs Division or electronically at: http://www.nrcs.usda.gov/programs/eqip/ under the EQIP Rules and Notices with Supporting Documents title.

The Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute. NRCS did not prepare a regulatory flexibility analysis for this rule because NRCS is not required by 5 U.S.C. 553, or any other provision of law, to publish a notice of proposed rulemaking with respect to the subject matter of this rule. Regardless, NRCS has determined that this action, while mostly affecting small entities, will not have a significant economic impact on a substantial number of these small entities. NRCS made this determination based on the fact that this regulation is incentive-based, and therefore only impacts those who participate voluntarily in the program. Small entity applicants will not be affected to a greater extent than large entity applicants.

Section 1246(c) of the 1985 Act, as amended by section 2608 of the 2014 Act, enables the Secretary of Agriculture to use the authority granted in section 808(2) of Title 5 of the United States Code to forego the Congressional Review Act's 60-day Congressional review, which delays the effective date of major regulations, if the agency finds that there is a good cause to do so. NRCS hereby determines that it has good cause to do so in order to meet the Congressional intent to have the conservation programs, authorized or amended under Title 7 of the 1985 Act, in effect as soon as possible. NRCS also determined it has good cause to forgo delaying the effective date given the critical need to let agricultural producers know what programmatic changes are being made so that they can make financial plans accordingly prior to planting season. For these reasons, this rule is effective upon publication in the Federal Register.

NRCS prepared a programmatic EA in association with the EQIP rulemaking to aid in its compliance with NEPA when expending EQIP funds in implementing site-specific actions (40 CFR 1501.3(b)). As a result of the analysis, the Chief of NRCS determined that there will not be a significant impact to the human environment as a result of the changes implemented by this rule; therefore, an EIS was not required (40 CFR 1508.13). Only one comment was received on the EA. The commenter expressed that EQIP has not allowed for seed producers to adequately respond to programs that are announced after the seed production season and requested communication improvements. This comment did not provide new information that is relevant to environmental concerns or that bears on the proposed action or its impacts that warrants supplementing or revising the EQIP EA and Finding of No Significant Impact.

Two additional letters were received providing comments on the interim final rule recommending that NRCS undertake an EA of the effects of providing EQIP assistance to CAFOs. NRCS considered this input and determined it lacks discretion on whether to provide assistance to existing or expanding CAFOs. NRCS made this determination based on its review of the EQIP legislative history, the purposes of EQIP—which include assisting producers to meet regulatory requirements related to soil and water quality—and the fact that in the Farm Security and Rural Investment Act of 2002, Congress removed the restriction on providing financial assistance to large confined livestock operations to construct animal waste management facilities and required NRCS to direct 60 percent of its EQIP assistance to livestock producers. NRCS has, and will continue to conduct an environmental evaluation before providing EQIP financial assistance to any producer to determine the need for an EA or EIS. NRCS regulations in 7 CFR part 652 define the environmental evaluation as the part of the NRCS planning process that inventories and estimates the potential effects on the human environment of alternative solutions to resource problems. The environmental evaluation is used to determine the need for an EA or EIS, and aids in the consideration of alternatives and in the identification of available resources when an EA or EIS is not required (7 CFR 650.4(c)).

NRCS will also use the environmental evaluation to evaluate the environmental effects of specific requests to grant irrigation waivers. It is not possible to meaningfully analyze the effects of these waivers at a national level because of site-specific factors. NRCS would have to speculate as to the types of requests that might be received and granted, and NEPA does not require analysis of speculative actions. As a result, the programmatic EA prepared to identify the effects of the EQIP rule does not analyze the effects of waiver requests.

A copy of the EA and FONSI may be obtained from the following Web site: http://www.nrcs.usda.gov/ea. A hard copy may also be obtained in any of the following ways: (1) Send an email to [email protected] with “Request for EA” in the subject line, or (2) mail a written request to: National Environmental Coordinator, Natural Resources Conservation Service, Ecological Sciences Division, Post Office Box 2890, Washington, DC 20013-2890.

NRCS conservation programs apply to all persons equally regardless of their race, color, national origin, gender, sex, or disability status. Through its Civil Rights Impact Analysis, NRCS determined that the final rule discloses no disproportionately adverse impacts for minorities, women, or persons with disabilities. The national target of setting aside 5 percent of EQIP funds for socially disadvantaged farmers or ranchers, and an additional 5 percent of EQIP funds for beginning farmers or ranchers, as well as prioritizing veterans that are socially disadvantaged farmers or ranchers and beginning farmer or ranchers is expected to increase participation among these groups.

The Civil Rights Impact Analysis indicates that producers who are members of the protected groups have participated in NRCS conservation programs at the same rates as other producers. Extrapolating from historical participation data, it is reasonable to conclude that EQIP will continue to be administered in a nondiscriminatory manner. Outreach and communication strategies are in place to ensure all producers are provided the same information, enabling them to make informed compliance decisions regarding the use of their lands that will affect their participation in USDA programs. Therefore, this final rule portends no adverse civil rights implications for women, minorities, and persons with disabilities.

Section 1246 of the 1985 Act, as amended by the 2014 Act, requires that implementation of programs authorized by Title 7 of the 1985 Act be made without regard to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Therefore, NRCS is not reporting recordkeeping or estimated paperwork burden associated with this final rule.

NRCS is committed to compliance with the Government Paperwork Elimination Act and the Freedom to E-File Act, which require government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. To better accommodate public access, NRCS has developed an online application and information system for public use.

This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that may have substantial direct effects on one or more Indian Tribes, the relationship between the Federal government and Indian Tribes, or the distribution of power and responsibilities between the Federal government and Indian Tribes. NRCS has assessed the impact of this final rule on Indian Tribes and determined that Tribal consultation under Executive Order 13175 does not apply. However, NRCS believes that consultation with Tribes is critical to ensuring that the program is administered in a fair and equitable manner. Therefore, NRCS has reviewed letters and comments submitted by and on behalf of Tribes during the public comment period leading to an additional public presentation and information gathering on the final rule with Tribes, Tribal representatives, and Tribal members on December 7th in Las Vegas, Nevada. NRCS made several changes to the final rule to address concerns raised by Tribes and Tribal representatives throughout the NRCS outreach and collaboration process. NRCS developed and implemented an outreach and collaboration plan to use while developing its policy regarding the 2014 Act. If a Tribe requests consultation, NRCS will work at the appropriate local, State, or national level, including with the USDA Office of Tribal Relations, to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress.

Title 2 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments or the private sector of $100 million or more in any 1 year. When such a statement is needed for a rule, section 205 of UMRA requires agencies to prepare a written statement, including a cost benefit assessment, for proposed and final rules with “Federal mandates” that may result in such expenditures for State, local, or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule.

This rule contains no Federal mandates, as defined under Title 2 of UMRA, for State, local, and Tribal governments or the private sector. Therefore, a statement under section 202 of UMRA is not required.

NRCS has considered this final rule in accordance with Executive Order 13132, issued August 4, 1999, and has determined that the final rule conforms with the Federalism principles set out in this Executive Order, would not impose any compliance costs on the States, and would not have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, NRCS concludes that this final rule does not have Federalism implications.

Pursuant to section 304 of the Federal Crop Insurance Reform Act of 1994 (Pub. L. 103-354), USDA has estimated that this regulation will not have an annual impact on the economy of $100,000,000 in 1994 dollars, and therefore, is not a major regulation. As such, a risk analysis was not conducted.

This rule is not a significant regulatory action subject to Executive Order 13211, Energy Effects.

OMB published two regulations, codified at 2 CFR part 25 and 2 CFR part 170, to assist agencies and recipients of Federal financial assistance in complying with the Federal Funding Accountability and Transparency Act of 2006 (FFATA) (Pub. L. 109-282, as amended). Both regulations have implementation requirements effective as of October 1, 2010.

The regulations at 2 CFR part 25 require, with some exceptions, recipients of Federal financial assistance to apply for and receive a Dun and Bradstreet Universal Numbering Systems (DUNS) number and register in the Central Contractor Registry (CCR). The regulations at 2 CFR part 170 establish new requirements for Federal financial assistance applicants, recipients, and sub-recipients. The regulation provides standard wording that each agency must include in its awarding of financial assistance that requires recipients to report information about first-tier sub-awards and executive compensation under those awards.

The regulations at 2 CFR part 25 and 2 CFR part 170 apply to EQIP financial assistance provided to entities and, therefore, these registration and reporting requirements will continue to include in the requisite provisions as part of EQIP financial assistance contracts.

Pursuant to Executive Order 12866, Regulatory Planning and Review, NRCS has conducted a Regulatory Impact Analysis (RIA) of EQIP as pursuant to the changes of the 2014 Act. On December 12, 2014, an interim rule and an accompanying RIA, with request for comments, was published which implemented changes to EQIP necessitated by the enactment of the 2014 Act or required to implement administrative clarifications and streamlining improvements. NRCS received 331 comments from 65 respondents to the interim rule. NRCS received no comments on the RIA. The final rule makes permanent the changes proposed in the interim rule along with some minor adjustments based on public comments. NRCS determined that these minor adjustments would not significantly alter the RIA.

In considering alternatives for implementing EQIP, USDA followed the legislative intent to maximize beneficial conservation impacts, address natural resource concerns, establish an open participatory process, and provide flexible assistance to producers who apply appropriate conservation measures to comply with Federal, State, and Tribal environmental requirements. Because EQIP is a voluntary program, the program will not impose any obligation or burden upon agricultural producers who choose not to participate.

EQIP has been authorized by the Congress in the 2014 Farm Bill at $8 billion over the 5-year period beginning in FY 2014 and proceeding through 2018, with annual amounts of $1.35 billion in FY 2014, $1.60 billion in FY 2015, $1.65 billion in FY 2016, $1.65 billion in FY 2017, and $1.75 billion in FY 2018. EQIP and WHIP had been previously authorized under the 2008 Act with annual amounts of $1.32 billion for FY 2008, $1.37 billion in FY 2009, $1.55 billion in FY 2010, $1.66 billion in FY 2011, and $1.75 billion in FY 2012 to FY 2013. Despite this authorization, EQIP and WHIP received only $7.75 billion in funding from FY 2008 through FY 2013. Funds received annually over this period were $1.09 billion in FY 2008, $1.15 billion in FY 2009, $1.27 billion in FY 2010, $1.32 billion in FY 2011, $1.45 billion in FY 2012, and $1.47 billion in FY 2013. Since the enactment of the 2014 Act EQIP received $1.35 billion, the full amount authorized in FY 2014, but only $1.347 billion in FY 2015 rather the $1.60 billion authorized by the 2014 Act.

The 1985 Act, as amended by the 2014 Act, makes several changes to EQIP. The changes include consolidating elements of the former WHIP into EQIP, expanding participation among military veteran farmers or ranchers, requiring that funds provided in advance that are not expended during the 90-day period beginning on the date of receipt of funds be returned, establishing an overall payment limitation over FY 2014 through FY 2018 of $450,000, providing that EQIP funding authorized by the 2014 Act remains available until expended, and requiring that at least 5 percent of available EQIP funds to be targeted for wildlife conservation practices for each fiscal year from 2014 to 2018. This 5 percent for wildlife habitat practices is based upon the total EQIP funding allocated as financial assistance available nationally for producer contracts. Based upon historical expenditures of wildlife-related practices in both WHIP and EQIP, and with emphasis to prioritize funding applications that address wildlife resource concerns, the agency anticipates that the actual funding associated with developing wildlife practices through EQIP will exceed the 5 percent national target. In FY 2014, about 6.5 percent of EQIP funds ($60.8 million) were devoted to wildlife conservation practices. Seven percent of EQIP funds are available for eligible RCPP contracts. Additional explanation regarding funding pools and EQIP program priorities is provided in the Background section of the preamble.

EQIP technical assistance and financial assistance facilitates the adoption of conservation practices that address natural resource concerns. Those practices improve on-site resource conditions and produce offsite environmental benefits for the public. Water erosion conservation practices reduce the flow of pollutants off of fields, thus improving freshwater and marine water quality, including protecting fish habitat, enhancing aquatic recreation opportunities, and reducing sedimentation of reservoirs, streams, and drainage channels. More efficient irrigation practices conserve scarce water, making it available for other uses. Wind erosion control practices improve air quality and some practices increase carbon in the soil profile. Wildlife habitat conservation practices increase wildlife habitat, enhance scenic value, and provide opportunities for recreation. A definition of “habitat development” was added and adopted to encompass the conservation practices that support the wildlife habitat activities authorized by section 1240B(g) of the 2014 Act. The term, as originally defined in the WHIP regulation, is added to EQIP at section 1466.3, “Definitions.” The definition, consistent with EQIP authority to assist with implementation of conservation practices that include the specific technical purpose of habitat development, provides for the conservation of wildlife species.

Other impacts of conservation practices may accrue to the producer. Examples of these impacts include the maintenance of the long-term productivity of the land, improved irrigation efficiency, improved grazing productivity, more efficient crop use of animal waste and fertilizer, and increased profits from energy conservation.

Most of this rule's impacts consist of transfer payments from the Federal government to producers. While those transfers create incentives that very likely cause changes in the way society uses its resources, we lack data with which to quantify the resulting social costs or benefits. Given the existing limitation and lack of data, NRCS will investigate ways to quantify the incremental benefits obtained from this program. Despite the limitations on our ability to quantify and estimate the value of social costs or benefits from the implementation of conservation practices, EQIP, as amended under the 2014 Act, is expected to positively affect natural resources and mitigate environmental degradation. Results from the national Conservation Effects Assessment Project conducted by NRCS demonstrate that implementation of the types of conservation practices funded under EQIP reduce sediment and nutrient loss from agricultural fields and improve water quality nationwide.

The 2014 Act increases EQIP funding over the amount provided by Congress for both EQIP and WHIP from FY 2008 through FY 2013 by 24 percent on an annualized basis to $1.6 billion per year. From FY 2008 through FY 2013, the authorized level for EQIP and WHIP was a total of $9.585 billion, but annual restrictions on EQIP and WHIP obligations enacted in the annual appropriations bills resulted in the actual authority being $7.748 billion, for an annualized amount of $1.291 billion. In contrast, the authorized level for EQIP under the 2014 Act for FY 2014 through FY 2018 is $8 billion, for an annualized amount of $1.6 billion (this assumes future funding caps are set at the authorized amounts). Actual authority for EQIP funding in FY 2014 of $1.350 billion matched the amount authorized in the 2014 Act while restrictions limited actual EQIP funding in FY 2015 to $1.347 million. These changes reduce the authorized level of spending for EQIP for FY 2014 through FY 2018 to $7.747 million. Additionally, the 2014 Act changed the period of availability for EQIP funding from 1-year to no-year funding, which means the funds remain available until expended. Thus, any unobligated balance at the end of a fiscal year could be available for obligation in the subsequent year. It is estimated that the conservation practices implemented with this funding will continue to contribute to reductions of water and wind erosion on cropland, pasture, and rangeland; reduce nutrient losses to streams, rivers, lakes, and estuaries; increase wildlife habitat; and provide other private and public environmental benefits. It is also expected that continued implementation of practices which treat and manage animal waste through EQIP will directly contribute to improvements in water quality and associated improvements in air quality from, for example, reduction in emissions such as methane. NRCS estimates that the cost,1 from both public and private sources, of implementing the conservation practices with EQIP funding will be $11,519 million dollars (FY 2014 through FY 2018). Cost estimates are presented in Table 1 below.

The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to comply with the requirements of Division O, Title 1, Section 101 of Public Law 114-113 (the Consolidated Appropriations Act, 2016) concerning exports of crude oil from the United States. These provisions repeal Section 103 of the Energy Policy and Conservation Act (formerly, 42 U.S.C. 6212), which required that the President promulgate a rule prohibiting the export of crude oil, and mandate, instead, that “notwithstanding any other provision of law, except as provided in subsections (c) and (d) . . . no official of the Federal Government shall impose or enforce any restriction on the export of crude oil.” Consistent with this requirement, this final rule amends part 754 of the EAR by removing and reserving § 754.2, which described the short supply license requirements and licensing policies that applied to exports of crude oil from the United States to all destinations. This rule also amends the Commerce Control List (CCL) in Supplement No. 1 to part 774 of the EAR by removing Export Control Classification Number (ECCN) 1C981, which controlled crude petroleum, including reconstituted crude petroleum, tar sands and crude shale oil listed in Supplement No. 1 to part 754 of the EAR (Crude Petroleum and Petroleum Products). In addition, this rule moves the definition of “crude oil,” which previously appeared in § 754.2(a) of the EAR, to § 772.1 (Definitions of terms as used in the Export Administration Regulations (EAR)), because it continues to have relevance with respect to the end-user/end-use requirements in part 744 of the EAR and the embargoes and other special controls in part 746 of the EAR. The scope of this definition remains unchanged.

The effect of the changes described above is to remove the short supply license requirements previously applicable to crude oil, as controlled under ECCN 1C981, thereby making crude oil an EAR99 item (i.e., subject to the EAR, as described in § 734.3(a), but no longer listed on the CCL). As such, crude oil exports will now be treated similarly to exports of petroleum products listed in Supplement No. 1 to part 754 that have not been produced or derived from the Naval Petroleum Reserves (NPR) or become available for export as a result of an exchange of any NPR produced or derived commodities (such petroleum products are not controlled under ECCN 1C980, 1C982, 1C983, or 1C984 on the CCL, but are designated as EAR99 items, instead). As an EAR99 item, crude oil remains subject to the EAR, as described in § 734.3(a) of the EAR, and exports of crude oil continue to require authorization from BIS to embargoed or sanctioned countries or persons and to persons subject to a denial of export privileges, as described in parts 744, 746, and 764 of the EAR. The continuance of these EAR controls is consistent with the exemptions stated in Division O, Title 1, Section 101, subsections (c) and (d) of Public Law 114-113.

This final rule also amends certain other provisions in the EAR to reflect the removal of the short supply license requirements on crude oil. Specifically, this rule makes additional amendments to part 754 by removing and reserving paragraph (b)(1)(i) in § 754.1 and by removing and reserving Supplement No. 3 to part 754 (Statutory Provisions Dealing with Exports of Crude Oil). This rule also removes references to § 754.2 from Supplement No. 1 to part 730 and § 762.2(b)(39). In addition, this rule amends § 740.15 (License Exception AVS) by removing the parenthetical reference to § 754.2 from § 740.15(b)(3) and by removing the Note to paragraph (c)(3), which also referenced § 754.2. This rule also removes references to ECCN 1C981 from § 742.1(b)(1) and § 746.7(a)(1) of the EAR. In § 744.7 (Restrictions on Certain Exports to and for the use of Certain Foreign Vessels or Aircraft), paragraphs (b)(3)(i) and (ii) are revised to remove the exclusions that previously applied to crude oil and blends of crude oil with other petroleum products, because such items were subject to the short supply controls described in § 754.2 of the EAR.

Finally, this rule removes authority citations for statutory provisions dealing with restrictions on the exports of crude oil, which no longer provide BIS with enforcement authority, based on Division O, Title 1, Section 101, subsection (b) of Public Law 114-113, which prohibits officials of the Federal Government from imposing or enforcing any restriction on the export of crude oil “notwithstanding any other provision of law.” Specifically, this rule removes the authority citations to 30 U.S.C. 185(s), 30 U.S.C. 185(u), and 43 U.S.C. 1354 from parts 730, 754, and 774 of the EAR.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 7, 2015 (80 FR 48233 (Aug. 11, 2015)), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

1. 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, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule contains a collection of information subject to the requirements of the PRA. This collection has been approved by OMB under Control Number 0694-0088 (Multi-Purpose Application), which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget, and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, as indicated in the ADDRESSES section of this rule.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. The provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553) requiring notice of proposed rulemaking and the opportunity for public participation are waived for good cause, because they are “unnecessary” and “contrary to the public interest.” (See 5 U.S.C. 553(b)(B)). This rule brings the Export Administration Regulations (EAR) into conformity with the Congressional mandate in Division O, Title 1, Section 101 of Public Law 114-113, which states that “notwithstanding any other provision of law, except as provided in subsections (c) and (d) . . . no official of the Federal Government shall impose or enforce any restrictions on the export of crude oil.” A delay of this rulemaking to allow for notice and public comment would be “unnecessary,” within the context of the APA, because continuance of the controls in § 754.2 of the EAR would be contrary to the explicit mandate in Public Law 114-113 against the imposition or enforcement of any restriction on the export of crude oil by an official of the Federal Government. Under such circumstances, the public interest would not be served by soliciting comments on the removal of these controls. A delay of this rulemaking to allow for notice and public comment also would be “contrary to the public interest,” within the context of the APA, because continuance of the controls in § 754.2 of the EAR would result in unnecessary confusion due to the obvious contradiction between the short supply license requirements for crude oil, as described in § 754.2 of the EAR prior to the publication of this rule, and the Congressional mandate in Public Law 114-113, which prohibits such license requirements. Furthermore, the confusion resulting from any delay to allow for notice and comment would be contrary to the public interest, as stated in Public Law 114-113, which is “to promote the efficient exploration, production, storage, supply, marketing, pricing, and regulation of energy resources, including fossil fuels.” Specifically, the obvious contradiction between the requirements previously described in § 754.2 of the EAR and the mandate in Public Law 114-113 might discourage some persons from pursuing crude oil export opportunities, thereby resulting in significant economic losses due to lost sales. At best, the confusion caused by this contradiction likely would result in unnecessary delays, which also can involve significant economic costs.

The provision of the Administrative Procedure Act (APA) (5 U.S.C. 553) requiring a 30-day delay in effectiveness is also waived for good cause. (5 U.S.C. 553(d)(3)). The amendments to the EAR contained in this final rule are required to make the EAR conform to the Congressional mandate in Public Law 114-113, which states that “except as provided in subsections (c) and (d) . . . no official of the Federal Government shall impose or enforce any restrictions on the export of crude oil.” A delay of this rulemaking to allow for a 30-day delay in effectiveness would be “unnecessary,” within the context of the APA, because continuance of the controls in § 754.2 of the EAR would be contrary to the explicit mandate in Public Law 114-113 and, as such, would not serve the public interest. A delay of this rulemaking to allow for a 30-day delay in effectiveness, also would be “contrary to the public interest,” within the context of the APA, because such a delay would result in unnecessary confusion caused by the contradiction between the EAR's short supply license requirements for crude oil and the Congressional mandate in Public Law 114-113, as described above. In addition, any delay to allow for notice and comment would be contrary to the public interest, as stated in Public Law 114-113 and reiterated above.

Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore, this regulation is issued in final form.

For the reasons stated in the preamble, parts 730, 740, 742, 744, 746, 754, 762, 772, and 774 of the Export Administration Regulations (15 CFR parts 730-774) are amended 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 DEA using the address information provided above.

The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Under the CSA, controlled substances are classified into one of five schedules based upon their potential for abuse, their currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.

Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he * * * finds that such drug or other substance has a potential for abuse, and * * * makes 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 * * *” The Attorney General has delegated this scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

The CSA provides that scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of Health and Human Services (HHS); or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action imposes the regulatory controls and administrative, civil, and criminal sanctions of schedule V controlled substances for any person who handles or proposes to handle BRV.

The Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89) was signed into law on November 25, 2015. This law amended 21 U.S.C. 811 and states that in cases where a new drug is (1) approved by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an interim final rule scheduling the drug, within 90 days.

The law further states that the 90-day timeframe starts the later of (1) the date DEA receives the HHS scientific and medical evaluation/scheduling recommendation or (2) the date DEA receives notice of drug approval by HHS. In addition, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause therefor.

Specifically, Public Law 114-89 revised section 201 of the CSA (21 U.S.C. 811) by inserting after subsection (i) a new paragraph (j), which requires that with respect to a drug referred to in subsection (f), if the Secretary recommends that the Attorney General control the drug in schedule II, III, IV, or V pursuant to subsections (a) and (b), the Attorney General is required to, within 90 days, issue an interim final rule controlling the drug in accordance with such subsections and 21 U.S.C. 812(b) using the specified procedures. For purposes of calculating the 90 days, Public Law 114-89 states that such date shall be the later of the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the Secretary in accordance with subsection (b), or the date on which the Attorney General receives notification from the Secretary that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act, with respect to the drug described in paragraph (1). Public Law 114-89 further stipulates that a rule issued by the Attorney General under paragraph (1) becomes immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause and requires that the interim final rule give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General must issue a final rule in accordance with the scheduling criteria of subsections 21 U.S.C. 811(b), (c), and (d) of this section and 21 U.S.C. 812(b).

Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) is a new molecular entity with central nervous system (CNS) depressant properties. BRV is known to be a high affinity ligand for the synaptic vesicle protein, SV2A, which is found on excitatory synapses in the brain. On November 22, 2014, UCB Inc. (Sponsor) submitted three New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the tablet, oral, and intravenous formulations of BRV. The FDA accepted the NDA filings for BRV on January 21, 2015.

On March 28, 2016 the DEA received notification that HHS/FDA approved BRV as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or substance to those controlled under the CSA may be initiated by request of the Secretary of the HHS.1 On September 8, 2015, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Place Brivaracetam in Schedule V of the Controlled Substances Act.” Pursuant to 21 U.S.C. 811(b), this document contained an eight-factor analysis of the abuse potential of BRV as a new drug, along with the HHS' recommendation to control BRV under schedule V of the CSA.

In response, in December 2015, the DEA 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 pursuant to 21 U.S.C. 811(c). The DEA concluded that BRV met the 21 U.S.C. 812(b)(5) criteria for placement in schedule V of the CSA. Subsequently, on March 28, 2016, the DEA received notification that HHS/FDA approved three NDAs for BRV (see Background section).

Pursuant to the provisions of the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), and based on the HHS recommendation, NDA approvals by HHS/FDA, and DEA's determination, DEA is issuing this interim final rule to schedule brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (including its salts) as a controlled substance under 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 both the DEA and HHS analyses 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-435.” 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: BRV is a new chemical entity and has not been marketed in the United States or in any other country; information on actual abuse of BRV is not available. The HHS characterized BRV as related in its action to lacasamide and ezogabine, which are both schedule V CNS depressant anti-epileptics (AEDs). Based on data submitted by the Sponsor in their NDAs, the HHS indicated that administration of BRV in mice, rats, and dogs resulted in CNS depressant effects, including decreased locomotor activity and reactivity, motor incoordination, and ataxia.

BRV is not self-administered in animals and, unlike schedule IV benzodiazepines and the schedule III AED perampanel, lacks pentobarbital-like (schedule II) discriminative stimulus and reinforcing effects (HHS review, 2015). In humans, BRV is most similar to the schedule V AEDs lacosamide, ezogabine, and pregabalin in producing positive subjective effects without producing sedation and withdrawal following drug discontinuation that is observed with schedule IV benzodiazepines. Based on this collective evidence, the HHS concluded that BRV has an abuse potential that is most similar to AEDs in schedule V.

2. Scientific Evidence of the Drug's Pharmacological Effects, if Known: BRV selectively binds with high affinity to synaptic vesicle protein 2A (SV2A). It produces reverse inhibition caused by negative modulators of gamma aminobutyric acid (GABA) and glycine and inhibits sodium (Na+) channels. These sites appear to underlie pharmacological activity of BRV.

In rats, BRV at high doses partially generalizes to the schedule IV benzodiazepine chlordiazepoxide. BRV, across a wide range of doses, neither initiates nor maintains self-administration in rats trained to self-administer cocaine. Human studies have reported that healthy individuals may experience euphoria, sedation, and a drunken-like feeling following BRV administration. When treatment-emergent adverse events (TEAEs) 2 were pooled across several clinical BRV studies, the most common TEAEs were dizziness and sedative-related events such as fatigue, extreme drowsiness, and extreme weakness. In a human abuse potential study, the oral abuse potential, safety, tolerability, and pharmacokinetics of BRV (50 mg, 200 mg, and 1000 mg) were compared to 1.5 and 3.0 mg of the schedule IV CNS depressant alprazolam (ALP) and placebo. When surveyed, for all doses of BRV, there was an increase of drug likability, feeling of a high, and taking the drug again in comparison to placebo. The HHS mentioned that individuals who took BRV had fewer sedative, euphoric, stimulant, dizziness, and overall negative subjective effects compared to ALP.

3. The State of Current Scientific Knowledge Regarding Brivaracetam: The chemical name for brivaracetam is (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide. Other names include BRV and UCB-34714. The Chemical Abstract Services number (CAS #) of BRV is: 357336-20-0. BRV is a racetam derivative.3 As the HHS noted, BRV does not have structural similarities to any other scheduled AED or to any major classes of abused sedative drugs with noted euphoric effects. Chemical synthesis of BRV is considered highly complex and includes several steps, reagents and specialized equipment.

BRV is readily soluble in water at up to 700 mg/mL. In an in vitro oral tablet dissolution evaluation, BRV oral tablets were placed in a buffer (pH 6.4) for 16 hours. Approximately 86-96% of BRV was released after 16 hours in the buffer; 14-30% of BRV was released following 1 hour and 40-66% BRV was released after 4 hours.

Following oral ingestion, BRV is rapidly and completely absorbed. In healthy young males, the half-life of BRV was determined to be approximately 9 hours. According to the HHS, the half-life of BRV is decreased to 6 hours when a repeated oral dose of 800 mg/day BRV is administered. The HHS noted that BRV binds weakly to plasma proteins and is extensively metabolized through several pathways. Clearance through the kidneys represents 5-10% of the total clearance and only 3-7% of the parent compound (BRV) was detected in the urine. The three main metabolites of BRV were detected in urine and according to the HHS, these metabolites are relatively inactive. One BRV metabolite was characterized as having a potency that was 20 times less than BRV, and this metabolite was not detected in human plasma and represented less than 3% of the dose in urine.

4. Its History and Current Pattern of Abuse: As noted by the HHS, information on the history and current pattern of abuse of BRV is not available since this drug is currently not marketed in any country. A review of the animal and human data indicates that BRV has an abuse potential similar to other schedule V AEDs. If BRV were to be approved for medical use, the HHS indicated that BRV would be abused for its euphoric properties and other abuse-related TEAEs that were reported in human clinical studies. Based on the available information, the HHS concluded that the history and pattern of abuse of BRV will be similar to other schedule V CNS depressants.

5. The Scope, Duration, and Significance of Abuse: As noted by the HHS, information on the scope, duration, and significance of abuse of BRV is not available since this drug is currently not marketed in any country. Results from animal and human studies suggest that there is abuse potential associated with BRV and if marketed in the United States, it is likely that BRV will be abused similar to other AEDs that are CNS depressants. The HHS stated that it is unlikely that epileptic individuals (the population expected to take this drug) will abuse BRV. The HHS concluded that based on abuse potential similarities between BRV and other schedule V AEDs, it is likely that the scope, duration, and significance of abuse of BRV will be similar to these compounds.

6. What, if any, Risk There is to the Public Health: The HHS characterized BRV's drug abuse potential to be similar to schedule V AEDs. As such, the public health risk with BRV will also be similar to other schedule V AEDs. The HHS noted that if BRV were approved for medical use, it would be abused for its rewarding properties. In healthy volunteers administered 600 mg or higher of BRV, cognitive and motor impairment and sedation were observed. It is unknown how BRV would interact in combination with other CNS depressants and if the sedative effects would be additive or even a lethal combination. In an interaction study with BRV and intravenous ethanol in healthy individuals, it was determined that BRV enhanced the effects of ethanol.

7. Its Psychic or Physiological Dependence Liability: BRV has limited psychological dependence and does not appear to have physical dependence. When rats were administered BRV for 30 days, no signs of physical dependence were noted in comparison to the schedule IV comparator, chlordiazepoxide. Similarly, in human clinical studies with healthy volunteers, there were no reports or adverse events that noted physical dependence or a withdrawal syndrome associated with BRV use. The low potential for physical dependence observed with BRV is consistent with other schedule V AEDs. There is limited evidence for psychological dependence with BRV. Clinical studies have reported individuals experiencing increasing euphoria with increasing doses of BRV. Tolerance does not appear to develop with respect to BRV treatment on epileptic seizure reduction.

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

Conclusion: After considering the scientific and medical evaluation conducted by the HHS, the HHS' recommendation, and its own eight-factor analysis, the DEA has determined that these facts and all relevant data constitute substantial evidence of a potential for abuse of BRV. As such, the DEA hereby schedules BRV as a controlled substance under the CSA.

The CSA outlines 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)(5), finds that:

1. BRV has a low potential for abuse relative to the drugs or other substances in schedule IV. The overall abuse potential of BRV is comparable to schedule V controlled substances such as ezogabalin, pregabalin, and lacosamide;

2. With FDA's approval of the new drug applications, BRV has a currently accepted medical use in the United States as adjunctive treatment of partial onset seizures in epileptic individuals ages 16 and older; and

3. Human and animal studies demonstrate that BRV has limited psychological dependence and does not appear to have physical dependence. There was no evidence of physical dependence associated with BRV in human and animal studies since there have been no reports of withdrawal syndromes or other physical dependence effects. Based on these data, abuse of BRV may lead to limited psychological dependence similar to schedule V AEDs but less than that of drugs in schedule IV.

Based on these findings, the Acting Administrator of the DEA concludes that brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact), including its salts, warrants control in schedule V of the CSA. 21 U.S.C. 812(b)(5).

BRV is subject to the CSA's schedule V 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 V substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) BRV, or who desires to handle BRV, 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. Any person who currently handles BRV, and is not registered with the DEA, must submit an application for registration and may not continue to handle BRV, unless the DEA has approved that application for registration, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule V registration must surrender all quantities of currently held BRV, or may transfer all quantities of currently held BRV to a person registered with the DEA in accordance with 21 CFR part 1317, in additional to all other applicable federal, state, local, and tribal laws.

3. Security. BRV is subject to schedule III-V security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance with 21 CFR 1301.71-1301.93.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of BRV must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

5. Inventory. Every DEA registrant who possesses any quantity of BRV must take an inventory of BRV 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 must take an initial inventory of all stocks of controlled substances (including BRV) 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 BRV) 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.

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

7. Prescriptions. All prescriptions for BRV or products containing BRV must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.

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

9. Liability. Any activity involving BRV 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 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 part 1308:

Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.

Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated her scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into schedule I of the CSA.1 The Administrator transmitted the notice of intent to place butyryl fentanyl and beta-hydroxythiofentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated December 21, 2015. The Assistant Secretary responded to this notice by letter dated January 13, 2016, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for butryl fentanyl or beta-hydroxythiofentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of butryl fentanyl or beta-hydroxythiofentanyl into schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Neither butryl fentanyl nor beta-hydroxythiofentanyl is currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for butryl fentanyl or beta-hydroxythiofentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of butryl fentanyl and beta-hydroxythiofentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule butryl fentanyl and beta-hydroxythiofentanyl was published in the Federal Register on March 23, 2016. 81 FR 15485.

To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for butryl fentanyl and beta-hydroxythiofentanyl, summarized below, indicate that these synthetic opioids have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis, and the Assistant Secretary's January 13, 2016, letter, are available in their entirety under the tab “Supporting Documents” of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2016-0005 (Docket Number DEA-434).

Clandestinely produced substances structurally related to the schedule II opioid analgesic fentanyl were trafficked and abused on the West Coast in the late 1970s and 1980s. These clandestinely produced fentanyl-like substances were commonly known as designer drugs, and recently there has been a reemergence in the trafficking and abuse of designer drug substances, including fentanyl-like substances. Alpha-methylfentanyl, the first fentanyl analogue identified in California, was placed into schedule I of the CSA in September 1981. 46 FR 46799. Following the control of alpha-methylfentanyl, the DEA identified several other fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl, beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl, beta-hydroxyfentanyl, para-fluorofentanyl, and 3-methylfentanyl) in submissions to forensic laboratories. These substances were temporarily controlled 2 in 1985-1987 under schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed in schedule I of the CSA. On July 17, 2015, acetyl fentanyl was temporarily controlled under schedule I of the CSA after a finding by the Administrator that it posed an imminent hazard to public safety. 80 FR 42381.

Prior to October 1, 2014, the System to Retrieve Information from Drug Evidence (STRIDE) collected the results of drug evidence analyzed at DEA laboratories and reflected evidence submitted by the DEA, other federal law enforcement agencies, and some local law enforcement agencies. STRIDE data were queried through September 30, 2014, by date submitted to federal forensic laboratories. Since October 1, 2014, STARLiMS (a web-based, commercial laboratory information management system) has replaced STRIDE as the DEA laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on December 21, 2015. The National Forensic Laboratory Information System (NFLIS) is a program of the DEA that collects drug identification results from drug cases analyzed by other federal, state, and local forensic laboratories. NFLIS reports from other federal, state, and local forensic laboratories were queried on December 22, 2015.3

The first laboratory submission of butyryl fentanyl was recorded in Kansas in March 2014 according to NFLIS. STRIDE, STARLiMS, and NFLIS registered seven reports containing butyryl fentanyl in 2014 in Illinois, Kansas, Minnesota, and Pennsylvania; 81 reports of butyryl fentanyl were recorded in 2015 in California, Connecticut, Florida, Indiana, North Dakota, New York, Ohio, Oregon, Tennessee, Virginia, and Wisconsin. A total of three reports of beta-hydroxythiofentanyl were recorded by STARLiMS, all of which were reported in 2015 from Florida. As of December 22, 2015, beta-hydroxythiofentanyl had not been reported in NFLIS; however, this substance was identified in June 2015 by a forensic laboratory in Oregon.

Evidence also suggests that the pattern of abuse of fentanyl analogues, including butyryl fentanyl and beta-hydroxythiofentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of butyryl fentanyl have been encountered in tablet and powder form. Butyryl fentanyl was identified on bottle caps and spoons and residue was detected within glassine bags, on digital scales, and on sifters which demonstrates the abuse of this substance as a replacement for heroin or other opioids, either knowingly or unknowingly. Butyryl fentanyl has been encountered as a single substance as well as in combination with other illicit substances, such as acetyl fentanyl, heroin, cocaine, or methamphetamine. Like butyryl fentanyl, beta-hydroxythiofentanyl has been encountered in both tablet and powder form. Both butyryl fentanyl and beta-hydroxythiofentanyl have caused fatal overdoses, in which intravenous routes of administration are documented.

The DEA is currently aware of at least 40 confirmed fatalities associated with butyryl fentanyl and 7 confirmed fatalities associated with beta-hydroxythiofentanyl. The information on these deaths occurring in 2015 was collected from toxicology and medical examiner reports and was reported from four states—Florida (7, beta-hydroxythiofentanyl), Maryland (1, butyryl fentanyl), New York (38, butyryl fentanyl), and Oregon (1, butyryl fentanyl). STRIDE, STARLiMS, and NFLIS have a total of 88 drug reports in which butyryl fentanyl was identified in drug exhibits submitted in 2014 and 2015 from California, Connecticut, Florida, Illinois, Indiana, Kansas, Minnesota, North Dakota, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, and Wisconsin. STARLiMS has a total of three drug reports in which beta-hydroxythiofentanyl was identified in drug exhibits submitted in 2015 from Florida. It is likely that the prevalence of butyryl fentanyl and beta-hydroxythiofentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays cannot differentiate these substances from fentanyl.

The population likely to abuse butyryl fentanyl and beta-hydroxythiofentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use history documented in butyryl fentanyl and beta-hydroxythiofentanyl fatal overdose cases. Because abusers of these fentanyl analogues are likely to obtain these substances through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to abusers of butyryl fentanyl and beta-hydroxythiofentanyl. Individuals who initiate (i.e., use an illicit drug for the first time) butyryl fentanyl or beta-hydroxythiofentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.).

Butyryl fentanyl and beta-hydroxythiofentanyl exhibit pharmacological profiles similar to that of fentanyl and other mu-opioid receptor agonists. Due to limited scientific data, their potency and toxicity are not known; however, the toxic effects of both butyryl fentanyl and beta-hydroxythiofentanyl in humans are demonstrated by overdose fatalities involving these substances. Abusers of these fentanyl analogues may not know the origin, identity, or purity of these substances, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.

Based on the documented case reports of overdose fatalities, the abuse of butyryl fentanyl and beta-hydroxythiofentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.

Butyryl fentanyl and beta-hydroxythiofentanyl have been associated with numerous fatalities. At least 40 confirmed overdose deaths involving butyryl fentanyl abuse have been reported in Maryland (1), New York (38), and Oregon (1) in 2015. At least seven confirmed overdose fatalities involving beta-hydroxythiofentanyl have been reported in Florida in 2015. This indicates that both butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent hazard to the public safety.

In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for butyryl fentanyl and beta-hydroxythiofentanyl indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated December 21, 2015, notified the Assistant Secretary of the DEA's intention to temporarily place these substances into schedule I.

In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule butyryl fentanyl and beta-hydroxythiofentanyl into schedule I of the CSA, and finds that placement of these synthetic opioids into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids into schedule I to avoid an imminent hazard to the public safety, this final order temporarily scheduling butyryl fentanyl and beta-hydroxythiofentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).

The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

Upon the effective date of this final order, butyryl fentanyl and beta-hydroxythiofentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, butyryl fentanyl and beta-hydroxythiofentanyl 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, as of May 12, 2016. Any person who currently handles butyryl fentanyl and beta-hydroxythiofentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle butyryl fentanyl or beta-hydroxythiofentanyl as of May 12, 2016, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after May 12, 2016 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle butyryl fentanyl and beta-hydroxythiofentanyl, must surrender all quantities of currently held butyryl fentanyl and beta-hydroxythiofentanyl.

3. Security. Butyryl fentanyl and beta-hydroxythiofentanyl are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of May 12, 2016.

4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of butyryl fentanyl and beta-hydroxythiofentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from May 12, 2016, to comply with all labeling and packaging requirements.

5. Inventory. Every DEA registrant who possesses any quantity of butyryl fentanyl and beta-hydroxythiofentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including butyryl fentanyl and beta-hydroxythiofentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records. All DEA registrants must maintain records with respect to butyryl fentanyl and beta-hydroxythiofentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and § 1307.11. Current DEA registrants authorized to handle butyryl fentanyl and beta-hydroxythiofentanyl shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.

7. Reports. All DEA registrants who manufacture or distribute butyryl fentanyl and beta-hydroxythiofentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 1312 as of May 12, 2016.

8. Order Forms. All DEA registrants who distribute butyryl fentanyl and beta-hydroxythiofentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of May 12, 2016.

9. Importation and Exportation. All importation and exportation of butyryl fentanyl and beta-hydroxythiofentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of May 12, 2016.

10. Quota. Only DEA registered manufacturers may manufacture butyryl fentanyl and beta-hydroxythiofentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of May 12, 2016.

11. Liability. Any activity involving butyryl fentanyl and beta-hydroxythiofentanyl not authorized by, or in violation of the CSA, occurring as of May 12, 2016, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking.

Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).

This action 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. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, “any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to schedule these substances immediately because they pose a public health risk. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place these substances into schedule I because they pose an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule.

For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 7:30 a.m. to 11 a.m. on May 15, 2016, to allow the community to participate in the Capital City Classic Run. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary 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 that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because the specifics associated with the entry and transit of the foreign naval vessels in the harbor were not received in time to publish an NPRM. Publishing an NPRM and delaying the effective date of this rule to await public comments would be impracticable and contrary to the public interest since it would inhibit the Coast Guard's ability to fulfill its statutory missions to protect and secure the ports and waterways of the United States.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to respond to the potential security threats associated with having a foreign nation's Naval Vessels in U.S. Waters.

The Coast Guard is issuing this rule under the authority in 33 U.S.C. 1231. The Captain of the Port of New York (COTP) has determined that potential security risks associated with Canadian Naval Vessels in the Port of New York will be a security concern for vessels within a 100-yard radius of all Canadian Naval Vessels. This rule is needed to protect the vessels and their respective crew in the navigable waters within the security zone while the vessels are within New York Harbor.

This rule establishes a security zone from May 25, 2016 through May 31, 2016. The security zone will cover all navigable waters within 100 yards of all Canadian Naval Vessels. The duration of the zone is intended to protect the vessels and their respective crews in the navigable waters while in port and while transiting New York Harbor. 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 (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

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. 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.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this security zone which will impact a small designated area of the Port of New York South side of Pier 92 for 7 days. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

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 safety 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, 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. This rule involves a security zone lasting less than seven days that will prohibit entry within 100 yards of the Canadian Naval Vessels. 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. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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:

The Coast Guard will enforce the security zone for the Portland Rose Festival detailed in 33 CFR 165.1312 from 11 a.m. on June 9, 2016, through noon on June 13, 2016. This action is necessary to ensure the security of vessels participating in the 2016 Portland Rose Festival on the Willamette River during the event. Under the provisions of 33 CFR 165.1312 and 33 CFR 165 subpart D, no person or vessel may enter or remain in the security zone, consisting of all waters of the Willamette River, from surface to bottom, encompassed by the Hawthorne and Steel Bridges, without permission from the Sector Columbia River Captain of the Port. Persons or vessels wishing to enter the security 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 authority 33 CFR 165.1312 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.

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

On August 17, 2015, EPA proposed to withdraw its May 22, 2014 final action approving California's July 3, 2013 submission to address contingency measure requirements for the 1997 annual and 24-hour PM2.5 NAAQS in the San Joaquin Valley (2013 Contingency Measure Submittal).1 Simultaneously, EPA proposed to disapprove this SIP submission. These proposed actions were in response to a decision issued by the U.S. Court of Appeals for the Ninth Circuit remanding EPA's approval of a related SIP submission and rejecting EPA's rationale for approving SIP submissions that rely on California mobile source control measures not actually part of the EPA-approved SIP in order to meet SIP requirements (Committee for a Better Arvin v. EPA, 786 F.3d 1169 (9th Cir. 2015)), which was a necessary basis for the May 22, 2014 final rule. EPA's May 22, 2014, approval of the 2013 Contingency Measure Submittal likewise relied on the same California mobile source control measures.

EPA proposed to determine that the disapproval of the 2013 Contingency Measure Submittal would not start a mandatory sanctions clock or Federal implementation plan (FIP) clock because the specific type of contingency measure at issue in that submittal was no longer a required attainment plan element for the San Joaquin Valley (SJV) area. The California Air Resources Board (CARB) had submitted the 2013 Contingency Measure Submittal to address the contingency measure requirement in CAA section 172(c)(9) as applied to the 2008 PM2.5 Plan, which provided for attainment of the 1997 PM2.5 NAAQS in the SJV by April 5, 2015, the latest permissible attainment date for this area under subpart 1 of part D, title I of the Act. EPA stated in the proposed rule that, as a consequence of EPA's March 27, 2015 reclassification of the SJV area from “Moderate” to “Serious” nonattainment for the 1997 PM2.5 NAAQS, the specific requirement for contingency measures for failure to attain as a Moderate area plan requirement had been eliminated and superseded by different planning obligations under subpart 4 of part D, title I of the Act.2 Because the State had submitted the 2013 Contingency Measure Submittal to address a contingency measure requirement for failure to attain by a statutory attainment date that no longer applied to the area (April 5, 2015), EPA proposed to find that this SIP submittal no longer addressed an applicable requirement of part D, title I of the Act, and that the disapproval of it therefore would not trigger sanctions. For the same reason, EPA proposed to find that disapproval of the submission would not create any deficiency in a mandatory component of the SIP for the area and, therefore, would not trigger the obligation on EPA to promulgate a FIP under section 110(c) of the Act.3

EPA received one comment on the proposed action, submitted by Earthjustice. EPA summarizes and responds to the comment below.

Comment: Earthjustice argues that EPA has no legal basis for proposing to determine that the disapproval of the 2013 Contingency Measure Submittal would not start a mandatory sanctions clock or FIP clock. According to Earthjustice, section 179(a)(2) of the Clean Air Act provides that sanctions “shall apply” if EPA disapproves a submission based on its failure to meet one or more CAA requirements applicable to nonattainment areas, and section 110(c) provides that EPA “shall promulgate a Federal implementation plan at any time within 2 years after [EPA] . . . disapproves a State implementation plan in whole or in part . . . .” Earthjustice asserts that contingency measures under CAA section 172(c)(9) are required elements for all attainment plans for nonattainment areas and must provide for the implementation of specific measures that will be undertaken if the area fails to attain, regardless of the applicable attainment date. Although EPA has some flexibility to establish a schedule for submitting a plan meeting the requirements of section 172(c), according to Earthjustice, that schedule may not be extended beyond three years from the date of the nonattainment designation, a date that has passed for the San Joaquin Valley. Earthjustice argues that the contingency measure requirement was not a “Moderate area” requirement and is not reset or eliminated with reclassification under subpart 4, and that although reclassification as a “Serious area” may affect the tonnage of reductions that must be achieved, it does not eliminate the section 172(c)(9) requirement that the District was required to meet years ago. For all of these reasons, Earthjustice argues that the disapproval of this submittal triggers a sanctions clock under CAA section 179 and a FIP clock under section 110(c).

Response: Upon further consideration of these issues, EPA agrees with the commenter that the disapproval of the 2013 Contingency Measure Submittal triggers a mandatory sanctions clock under CAA section 179 and a FIP clock under section 110(c).

Section 179(a) of the Act provides that, for any SIP revision required under part D of title I of the Act or required in response to a finding of substantial inadequacy as described in section 110(k), if EPA disapproves a submission for a nonattainment area based on the state's failure to meet one or more of the CAA requirements applicable to the area, mandatory sanctions under section 179(b) shall apply. The 2013 Contingency Measure Submittal was a plan revision required under part D of title I of the Act for the purposes of implementing the 1997 PM2.5 NAAQS in the SJV PM2.5 nonattainment area. As explained in the proposed action, EPA is disapproving the 2013 Contingency Measure Submittal based on the failure to meet the contingency measure requirement in CAA section 172(c)(9) for the area—i.e., because of the reliance on California waiver measures that EPA has not approved into the California SIP. This disapproval triggers a mandatory sanctions clock under section 179.

Section 110(c) of the Act states that EPA “shall promulgate a Federal implementation plan at any time within 2 years after the Administrator—. . . (B) disapproves a State implementation plan submission in whole or in part,” unless the State corrects the deficiency and EPA approves the plan or plan revision before promulgating such FIP. As a consequence of our disapproval of the 2013 Contingency Measure Submittal, the California SIP does not contain any contingency measures to be triggered if the SJV area fails to attain the 1997 PM2.5 NAAQS by the Serious area attainment date, which is currently December 31, 2015. Because this disapproval creates a deficiency in the SIP, the disapproval triggers the obligation on EPA to promulgate a FIP under section 110(c), unless the State submits and EPA approves a SIP revision correcting the deficiency within two years of the disapproval.

As explained in the proposed action, contingency measures for failure to attain by the Moderate area attainment date are no longer required in the SJV as the requirement for such measures has been superseded by the requirement for contingency measures as part of a Serious area plan for the 1997 PM2.5 NAAQS in this area.4 Thus, the State is no longer required to adopt contingency measures for failure to attain by April 5, 2015. Because the SJV area is currently classified as a Serious nonattainment area for the 1997 PM2.5 NAAQS, however, the State must satisfy the contingency measure requirement in section 172(c)(9) as applied to a Serious area attainment plan to provide for attainment of the 1997 PM2.5 NAAQS in the SJV no later than the applicable attainment date, which is currently December 31, 2015.

California submitted a Serious area plan for the 1997 PM2.5 NAAQS in the SJV on June 25, 2015, together with requests for extension of the Serious area attainment date under CAA section 188(e) to December 31, 2018 and December 31, 2020 for the 1997 24-hour and annual standards, respectively, and EPA has proposed to grant these requests for extension of the attainment date.5 If EPA takes final action to extend the Serious area attainment date for the 1997 PM2.5 NAAQS in the SJV, the State will be obligated to adopt and submit contingency measures to be implemented if the SJV area fails to make reasonable further progress or to attain the 1997 PM2.5 NAAQS by the extended attainment date(s) approved by EPA in that action. We encourage the State and District to consult with EPA during their development of a corrective SIP submission to ensure that it fully satisfies the section 172(c)(9) contingency measure requirement for the 1997 PM2.5 NAAQS in the SJV area and thereby corrects the current deficiency in the SIP.

EPA is withdrawing its May 22, 2014 final action approving the 2013 Contingency Measure Submittal. Simultaneously, under section 110(k)(3) of the Act, EPA is disapproving this SIP submission for failure to satisfy the requirements of CAA section 172(c)(9).

Under section 179(a) of the CAA, a final disapproval of a submittal that addresses a requirement of part D of title I of the CAA or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP Call), triggers a sanction clock under CAA section 179(b) that runs from the effective date of the final action. The first sanction, the offset sanction in CAA section 179(b)(2), will apply in the SJV PM2.5 nonattainment area 18 months after June 13, 2016. The second sanction, highway funding sanctions in CAA section 179(b)(1), will apply in the area six months after the offset sanction is imposed. Neither sanction will be imposed under the CAA if California submits and we approve, prior to the implementation of the sanctions, a SIP submission that corrects the deficiencies identified in this final action.

In addition to the sanctions, CAA section 110(c)(1) provides that EPA must promulgate a federal implementation plan (FIP) addressing the deficiency at any time within two years after June 13, 2016, the effective date of this rule, unless the state makes a SIP submission to correct the deficiency and EPA approves such submission before promulgating a FIP.

Because we previously approved the RFP and attainment demonstrations and the motor vehicle emissions budgets,6 we are issuing a protective finding under 40 CFR 93.120(a)(3) to the disapproval of the contingency measures. Without a protective finding, the final disapproval would result in a conformity freeze, under which only projects in the first four years of the most recent conforming Regional Transportation Plan and Transportation Improvement Programs can proceed. During a freeze, no new RTPs, TIPs or RTP/TIP amendments can be found to conform.7 Under this protective finding, the final disapproval of the contingency measures does not result in a transportation conformity freeze in the San Joaquin Valley PM2.5 nonattainment area.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA, because this SIP disapproval does not in-and-of itself create any new information collection burdens, but simply disapproves certain State requirements for inclusion in the SIP.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This SIP disapproval does not in-and-of itself create any new requirements but simply disapproves certain State requirements for inclusion in 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. This action disapproves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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, because the SIP revision that the EPA is disapproving would not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. 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 this SIP disapproval does not in-and-of itself create any new regulations, but simply disapproves certain State requirements for inclusion in the SIP.

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

Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.

The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 11, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: