In a final rule  1 that was published in the Federal Register on September 18, 2013 (78 FR 57227-57250, Docket No. APHIS-2011-0003), and effective on November 18, 2013, we amended the regulations concerning the definition of retail pet store and related regulations in order to ensure that the definition of retail pet store in the regulations is consistent with the Animal Welfare Act (AWA), thereby bringing more pet animals sold at retail under the protection of the AWA.

As part of that action, in § 2.1(a)(3) we changed from three to four the maximum number of female breeding dogs or cats that a person can maintain and be exempted from licensing, so long as they sell only the offspring of those animals born and raised on their premises for pets or exhibition and are not otherwise required to obtain a license. In the final rule, we overlooked raising the number of breeding females in § 2.132(d) from three to four with respect to licensing exemption provisions for persons selling cats, dogs, or certain other animals to dealers or exhibitors. This document corrects the oversight.

Accordingly, 9 CFR part 2 is amended as follows:

On January 25, 2011, the Bureau of Industry and Security (BIS) published a final rule, the first in a series of rules, which amended the Export Administration Regulations (EAR) to implement the U.S.-India bilateral understanding (76 FR 4228, January 25, 2011) (January 25 rule). The January 25 rule and the bilateral understanding were the result of the November 8, 2010 Joint Statement issued by President Obama and Prime Minister Singh of India announcing that they had resolved to expand and strengthen the U.S.-India global strategic partnership. (U.S.-India Joint Statement, November 8, 2010). The Joint Statement covered a range of issues, activities, and programs that reflect the vision of the President and of India's Prime Minister. In the Joint Statement, the leaders reaffirmed that the U.S.-India strategic partnership is indispensable for global stability and prosperity and reaffirmed existing assurances regarding procurement and use by India of items subject to the EAR. In the Joint Statement, recognizing that India and the United States should play a leadership role in promoting global nonproliferation objectives and their desire to expand high technology cooperation and trade, the two leaders committed to work together to strengthen the global export control framework and further transform bilateral export control regulations and policies. The two nations decided to take mutual steps to expand U.S.-India cooperation in civil space, defense and other high technology sectors.

The United States' implementation of the commitment included removing Indian defense and space related entities from the Entity List, as well as realigning India in U.S. export control regulations. Additionally, the Joint Statement announced that the United States “intends to support India's full membership in the four multilateral export control regimes (Nuclear Suppliers Group, Missile Technology Control Regime, Australia Group, and Wassenaar Arrangement) in a phased manner, and to consult with regime members to encourage the evolution of regime membership criteria . . . consistent with maintaining the core principles of these regimes, as the Government of India takes steps towards the full adoption of the regimes' export control requirements to reflect its prospective membership, with both processes moving forward together.” The January 25 rule began the implementation of those reforms by revising certain export and reexport controls for India, including the removal of nine Indian entities from the Entity List. In addition, in the January 25 rule, BIS amended the EAR to remove India from Country Groups D:2, D:3, and D:4, and to add India to Country Group A:2 in Supplement No. 1 to Part 740. BIS also made conforming changes in the EAR.

In this rule, BIS amends the EAR to further implement the November 8, 2010 bilateral understanding between the United States and India. Specifically, this rule removes India from Crime Controls (CC) columns 1 and 3, and Regional Stability (RS) column 2 on the Commerce Country Chart in Supplement No. 1 to Part 738 of the EAR because the Government of India has now taken appropriate steps to ensure that the specific U.S.-origin items controlled for CC and RS reasons are not reexported from India without a license. However, a license requirement remains for items controlled under export control classification numbers (ECCNs) 6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India. BIS also makes conforming changes in this rule. These changes, like those in the January 25 rule, are in the national interest of the United States.

BIS amends the EAR to remove the “X” in CC columns 1 and 3 and in RS column 2 for “India” in Supplement No. 1 to Part 738 of the EAR (Commerce Country Chart). These actions remove the license requirement for India for U.S.—origin items controlled under the EAR for CC columns 1 and 3 reasons and for RS column 2 reasons. BIS notes that the elimination of license requirements for RS column 2 items to India does not eliminate license requirements for items classified under ECCNs 6A003.b.4.b and 9A515.e.

In addition, BIS amends the EAR to establish a filing requirement in the Automated Export System (AES) for items exported to India when those items fall under an ECCN on the Commerce Control List in Supplement No. 1 to Part 774, for which CC columns 1 and 3, and RS column 2 are listed as reasons for control. Specifically, BIS amends section 758.1 of the EAR by adding new paragraph (b)(9) that requires exporters file an AES record for items controlled for CC 1 and 3 and RS 2 reasons when such items are for export to India, regardless of value.

BIS amends section 758.6 by adding new paragraph (c) requiring a notation on the invoice, bill of lading, air waybill, or other export control document that accompanies the shipment from its point of origin in the United States to the ultimate consignee or end-user in India. The notation will indicate the ECCNs of items for which CC columns 1 or 3, or RS column 2 reasons for control are listed, that they are destined to India, and that authorization may be required from the U.S. Department of Commerce for reexport of the items.

As a conforming change to removing the license requirement for India for items controlled for CC columns 1 and 3 reasons, BIS also amends section 740.2 of the EAR to add India to paragraph (a)(4)(i). Inclusion in paragraph (a)(4)(i) identifies India as one of the countries or organizations ( i.e., Australia, Japan, New Zealand, or a NATO (North Atlantic Treaty Organization) member state) for which the restrictions on license exceptions due to license requirements described in section 742.7 (crime control and detection) do not apply. This status for India also broadens the availability of license exceptions under the EAR for items exported to India.

BIS also amends the EAR to make a conforming change by adding a seventh footnote to Supplement No. 1 to Part 738 to notify exporters of an AES filing requirement for CC columns 1 and 3 items, and RS column 2 items when they are intended for export to India. That footnote also notifies exporters that the elimination of license requirements for items controlled for RS column 2 reasons to India does not apply to items controlled under ECCNs 6A003.b.4.b and 9A515.e.

Finally, BIS makes conforming changes in paragraph (a)(4)(i) of section 742.6 to add India to the list of countries for which a license is not required for items controlled for RS column 2 reasons for control, while also pointing out that a license requirement remains for items controlled under ECCNs 6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India.

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, 2014, 79 FR 46959 (August 11, 2014), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. 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.

On January 20, 2015, the Under Secretary of Commerce for Industry and Security, pursuant to the authority delegated to him under section 6(n)(2) of the Export Administration Act, designated India as an eligible destination for export and reexport of items controlled for crime control (CC) without a license.

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 (OMB).

2. Notwithstanding any other provisions of law, no person is required to respond to nor 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 OMB Control Number. This rule involves collections of information subject to the PRA. This collection has been approved by OMB under control numbers 0694-0088, “Simplified Network Application Processing System,” which includes among other things license applications and carries a burden hour estimate of 43.8 minutes for a manual or electronic application; and 0694-0122, “Licensing Responsibilities and Enforcement,” which carries a burden hour estimate of 5 seconds to manually or electronically complete each required export clearance document. Total burden hours associated with the PRA and OMB control numbers 0694-0088 and 0694-0122 are not expected to increase as a result of this rule.

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

4. Pursuant to 5 U.S.C. 553(a)(1), the provisions of the Administrative Procedure Act requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States. ( See 5 U.S.C. 553(a)(1)). This rule further implements the phased aspects of the understanding between the United States and India reflected in the November 8, 2010 U.S.-India Joint Statement and is not discretionary. No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no Regulatory Flexibility analysis is required and none has been prepared. Notwithstanding these considerations, BIS welcomes public comments and will review them on a continuing basis.

Accordingly, parts 738, 740, 742, and 758 of the EAR (15 CFR parts 730-774) are amended as follows:

CPSC began investigating drywall in 2009, after reports from homeowners that they were seeing corrosion of metal items inside their homes. According to homeowners' reports, the items primarily involved were electrical fixtures, appliances, plumbing, and air conditioner coils. CPSC used the term “problem drywall” to refer to drywall associated with elevated rates of metal corrosion. After CPSC's initial investigations, CPSC joined with the U.S. Department of Housing and Urban Development (HUD), the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Environmental Protection Agency (EPA) to form the Federal Interagency Task Force on Problem Drywall (Task Force).

In the course of this investigation, samples of problem drywall were analyzed for chemical content and emissions. CPSC staff analysis of chemical content and emissions from problem drywall determined that certain brands of drywall produced around the year 2006 contain elevated levels of elemental sulfur (octahedral sulfur, S 8 ) and have elevated emission factors for hydrogen sulfide (H 2 S) and other reactive sulfur gases known to corrode materials containing copper and silver. CPSC staff's analysis of the technical data also determined that the presence of elemental sulfur in excess of 10 ppm in drywall is associated with elevated emission factors for hydrogen sulfide (H 2 S) and other reactive sulfur gases that are known to cause accelerated corrosion of copper and silver in homes.

CPSC staff and HUD relied on the results of this analysis to develop guidance materials to help homeowners identify homes with problem drywall and to correct the problem by removing and replacing the problem drywall and certain other components of the home. These guidance documents are available on CPSC's Web site. 1

On January 14, 2013, the President signed the Drywall Safety Act of 2012 (DSA) into law. Pub. L. 112-266, 126 Stat. 2437 (2013). The DSA established several requirements related to problem drywall.

The Drywall Labeling Requirement. The DSA states that 180 days after the date of enactment of the DSA, the gypsum board labeling provisions of standard ASTM C1264-11  2 must be treated as a rule promulgated by CPSC under section 14(c) of the CPSA. ASTM uses the more technical term “gypsum board” to refer to the class of products that CPSC refers to as “drywall.” The labeling provisions in ASTM C1264-11 are currently in effect as a CPSC mandatory standard. The DSA provides a process for revision of the CPSC standard if ASTM revises the labeling provisions in the ASTM standard and notifies the Commission of the revision. To date, although ASTM has revised some provisions in ASTM C1264-11, ASTM has not revised the labeling provisions.

Revision of Remediation Guidance for Drywall Disposal Required. The DSA requires the CPSC to revise CPSC's guidance entitled “Remediation Guidance for Homes with Corrosion from Problem Drywall” to specify that problem drywall removed from homes pursuant to the guidance should not be reused or used as a component in the production of new drywall. CPSC revised the Remediation Guidance as directed when CPSC published a new Remediation Guidance on the CPSC Web site on March 15, 2013.

Sulfur Content Standard Requirement. The DSA requires CPSC to promulgate a final rule pertaining to drywall manufactured or imported for use in the United States within two years of the date of enactment of the DSA. The rule must limit sulfur content “to a level not associated with elevated rates of corrosion in the home.” As discussed below, the rulemaking requirement does not apply if the Commission makes certain determinations regarding an ASTM voluntary standard and publishes the determinations in the Federal Register . With this document, the Commission makes the necessary determinations.

Section 4(a) of the DSA requires the Commission to promulgate a final rule limiting sulfur content in drywall manufactured or imported for use in the United States “to a level not associated with elevated rates of corrosion in the home.” The rulemaking requirement does not apply if the Commission determines that:

(a) A voluntary standard pertaining to drywall manufactured or imported for use in the United States limits sulfur content to a level not associated with elevated rates of corrosion in the home;

(b) The voluntary standard is in effect within two years of enactment the DSA; and

(c) The voluntary standard is developed by ASTM International's Subcommittee C11.01 on Specifications and Test Methods for Gypsum Products.

If the Commission makes such determinations, the sulfur content limit in the voluntary standard pertaining to drywall manufactured or imported for use in the United States “shall be treated as a consumer product safety rule under section 9 of the Consumer Product Safety Act.”

The Commission determines that the sulfur limit stated in section 4.7 of ASTM C1396-14a, Standard Specification for Gypsum Board, meets the requirements of section 4(c) of the DSA. CPSC staff worked with the relevant ASTM Subcommittee (ASTM Subcommittee C11.01 on Specifications and Test Methods for Gypsum Products) to develop a test method for elemental sulfur in gypsum products. The test method is stated in ASTM Standard C471M, Test Methods for Chemical Analysis of Gypsum and Gypsum Products (Metric). ASTM Subcommittee C11.01 then worked with CPSC staff to develop a requirement stated in section 4.7 of ASTM C1396-14a limiting the sulfur content of gypsum board. That provision requires that gypsum board must contain not greater than 10 ppm of orthorhombic cylooctasulfur ( i.e., elemental sulfur or “S 8 ”) when tested in accordance with the test methods for Determination of S 8 in Gypsum Panel Products by Liquid Extraction for Analysis by Liquid or Gas Chromatography in sections 55-65 of ASTM C471M.

In accordance with section 4(c) of the DSA, ASTM C1396-14a is a voluntary standard pertaining to drywall manufactured or imported for use in the United States stating that gypsum board (drywall) “shall contain not greater than 10 ppm of orthorhombic cyclooctasulfur (S 8 ).” As discussed in the staff's briefing memorandum, 3 this limit on sulfur content is consistent with CPSC staff's numerous corrosion studies, which showed an association between high levels of elemental sulfur (S 8 ) in drywall and corrosion in the home, but no association between sulfur levels that did not exceed 10 ppm and elevated corrosion.

ASTM C1396-14a was published and became effective October 14, 2014, less than two years after enactment of the DSA. Finally, ASTM C1396-14a was developed by Subcommittee C11.01 on Specifications and Test Methods for Gypsum Products of ASTM International.

Based on these determinations the Commission finds that the requirements of section 4(c) of the DSA have been met. Accordingly, the sulfur content limit requirement stated in section 4.7 of ASTM C1396-14a is a consumer product safety rule under the CPSA.

DSA section 4(d) provides that if the Commission determines that a voluntary standard meets the requirements of section 4(c) of the DSA, the sulfur content limit stated in the voluntary standard shall be treated as a consumer product safety rule beginning on the later of:

• 180 days after publication of the Commission's determination; or

• the effective date stated in the voluntary standard.

ASTM C1396-14a took effect when the standard was published on October 14, 2014. Therefore, the sulfur content limit stated in ASTM C1396-14a shall be treated as a consumer product safety rule effective 180 days after publication of this determination in the Federal Register .

Section 14(a)(1) of the CPSA requires that every manufacturer of a product that is subject to a consumer product safety rule and is imported into or distributed in the United States must certify that the product complies with all applicable CPSC rules, rules, bans, standards, or regulations. 15 U.S.C. 2063(a)(1). As a product subject to a consumer product safety rule, drywall imported into or distributed in the United States will be subject to the certification requirements of section 14(a)(1) of the CPSA (15 U.S.C. 2063(a)(1)) and the Commission's certification regulations at 16 CFR part 1110 once the voluntary standard sulfur limit requirement is in effect as a consumer product safety standard. Drywall manufactured or imported on or after the effective date must comply with the sulfur content limits of ASTM C1396-14a and must be accompanied by a general certification of compliance (GCC).

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, but they are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. 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, each 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 scheduled substances is published at 21 CFR 1308. 21 U.S.C. 812(a).

Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, “remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary of the Department of Health and Human Services (HHS), 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated by a petition from the drug sponsor to remove naloxegol from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and an evaluation of all relevant data by the DEA. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle naloxegol.

Naloxegol, or PEG-naloxol, is a new molecular entity and is a polyethylene glycolyated (PEGylated) derivative of naloxone. Its chemical names are (5α,6α)-17-allyl-6-((20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)-4,5-epoxymorphinon-3,14-diol or alpha-6mPEG7-O-naloxol. Naloxegol is an antagonist predominantly of peripheral mu opioid receptors. The Food and Drug Administration (FDA) approved naloxegol for marketing on September 16, 2014, under the brand name Movantik TM . 2 It is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Gastrointestinal adverse events (AEs) effects are commonly experienced by chronic users of opioid analgesics. Opioids delay gastric emptying and intestinal transport, which over time leads to debilitating constipation. OIC is caused by activation of the mu opioid receptor in the GI tract.

The DEA received a petition from the drug sponsor dated March 22, 2012, requesting that the DEA amend 21 CFR 1308.12(b)(1) to exclude naloxegol as a schedule II controlled substance. The petitioner stated that naloxegol is a mu opioid receptor antagonist without mu opioid agonist or partial agonist properties. The DEA accepted the petition for filing on October 1, 2012.

On February 7, 2013 the DEA forwarded to the HHS the data with the sponsor's petition along with a request for a scientific and medical evaluation and the HHS's recommendation as to whether or not naloxegol should be removed from the list of controlled substances. According to the HHS, the sponsor submitted a New Drug Application (NDA) for naloxegol on September 16, 2013. Based on the NDA, the HHS summarized that naloxegol is an antagonist of peripheral opioid receptors for the treatment of OIC.

On August 8, 2014, the HHS provided to the DEA a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Decontrol Naloxegol and its Salts from Schedule II of the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), including consideration of the substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that naloxegol and its salts be removed from schedule II of the CSA. In response, the DEA conducted its own eight factor analysis of naloxegol pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety in the public docket of this rule (Docket Number DEA-400) at http://www.regulations.gov under “Supporting and Related Material.”

After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol naloxegol from HHS, the Deputy Administrator of the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Removal of Naloxegol from Control” which proposed removal of naloxegol and its salts from the schedules of the CSA. 79 FR 64349, October 29, 2014. The proposed rule provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations by November 28, 2014. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before November 28, 2014.

The DEA received seven comments on the proposed rule to decontrol naloxegol. Five commenters supported decontrol of naloxegol. Two commenters submitted comments not related to the proposed action.

Commenters in support of decontrolling naloxegol included two members of industry, a former intensive care unit (ICU) nurse, and two patient advocacy groups, all of whom expressed agreement with the DEA's findings that naloxegol does not possess abuse or dependence potential.

DEA Response: The DEA appreciates the comments in support of this rulemaking.

Four of the commenters specifically requested that a rule decontrolling naloxegol be issued with an immediate effective date. Commenters stated that an immediate effective date was warranted because naloxegol does not have an abuse potential and is a new therapeutic option for opioid-induced constipation with no alternatives currently on the market. Additionally, a commenter distinguished this particular instance of decontrolling a substance that is not yet commercially available and thus would not result in burdens on the healthcare system or law enforcement from other DEA actions to control a substance which necessitated lead time for registrants to make necessary preparations for compliance.

DEA Response: Generally, DEA scheduling actions are effective 30 days from the date of publication of the final rule in the Federal Register . 21 CFR 1308.45; see also 5 U.S.C. 553(d). In accordance with 21 CFR 1308.45, the DEA finds that the absence of comparative effective therapeutic treatments for OIC with similar or less adverse effects than naloxegol, coupled with the fact that this is an action for decontrol, support the finding that conditions of public health require this action to be effective immediately upon publication in the Federal Register . Due to adverse side effects, the majority of treatment alternatives currently available for OIC have restricted clinical application. By comparison, the side effects of naloxegol have been shown to be generally mild and reversible. The addition of the polyethylene glycol group decreases the capacity of naloxegol from crossing the blood-brain barrier as compared to naloxone and is therefore expected to limit the potential for interference with centrally mediated opioid analgesia.

In making the determination to make this rule immediately effective, the DEA took into consideration the effects of immediate implementation. The DEA agrees that making this rule immediately effective is in the best interest of the public health and will not burden registrants, the healthcare system, or law enforcement. The DEA notes that its decision to make this rule immediately effective aligns with the exceptions to the 30-day effective date requirement of the Administrative Procedure Act (APA). One of the APA's exceptions to the 30-day effective date is for a substantive rule granting or recognizing an exemption or which relieves a restriction. 5 U.S.C. 553(d)(3).

Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and based on the DEA's consideration of its own eight-factor analysis, the Administrator finds that these facts and all relevant data demonstrate that naloxegol does not meet the requirements for inclusion in any schedule, and will be removed from control under the CSA.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “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 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 Civil Justice Reform 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 Federal Government and the States, or 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. This rule 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.

The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove naloxegol from the list of schedules of the CSA. This action removes regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of naloxegol. Accordingly, it has the potential for some economic impact in the form of cost savings.

Naloxegol is a new molecular entity and is not currently available or marketed in any country. According to publicly available information reviewed by the DEA, naloxegol is anticipated to enjoy patent protection for an extended period of time before generic equivalents may be manufactured and marketed in the United States. Although the number of manufacturers of naloxegol may initially be limited, there is potential for numerous handlers in various business activities, e.g., distributors, hospitals/clinics, pharmacies, practitioners, etc.

This rule will affect all persons who would handle, or propose to handle, naloxegol. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the distribution and dispensing rates of new molecular entities, the DEA is unable to determine the number of entities and small entities which might handle naloxegol. However, the DEA estimates that all persons who would handle, or propose to handle, naloxegol are currently registered with the DEA to handle schedule II controlled substances. Therefore, the 1.5 million (1,469,418 as of September 2014) controlled substance registrations, representing approximately 426,714 entities, would be the maximum number of entities affected by this rule. The DEA estimates that 417,302 (97.8%) of 426,714 affected entities are “small entities” in accordance with the RFA and Small Business Administration size standards.

The DEA estimates all controlled substances registrants handle both controlled and non-controlled substances and these registrants are expected to handle naloxegol. Additionally, since prospective naloxegol handlers are likely to handle other schedule II controlled substances, the cost savings they would receive as a result of the de-control of naloxegol would be nominal. As naloxegol handlers are likely to handle other schedule II controlled substances, they will need to maintain their DEA registration and keep the same security, reporting, and recordkeeping processes, equipment, and facilities in place and would experience only a nominal reduction in security, reporting, inventory, recordkeeping, and labeling costs.

While the DEA does not have a basis to estimate the number of affected entities, the DEA estimates that the maximum number of affected entities is 426,714 of which 417,302 are estimated to be small entities. Since the affected entities are expected to handle other schedule II controlled substances and maintain security, reporting, and recordkeeping facilities and processes consistent with schedule II controlled substances handling requirements, the DEA estimates any economic impact (cost savings) will be nominal. Because of these facts, this rule will not result in a significant economic impact on a substantial number of small entities.

On the basis of information contained in the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., 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 provisions of UMRA.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 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 United States-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 final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended to read as follows:

The Coast Guard published a Notice of Proposed Rulemaking (NPRM) on May 10, 2013 (78 FR 27321). Six members of the public submitted comments on the proposed rule. Our responses to these submissions are set out in section V, below.

The purpose of this final rule is to revise and reorganize the regulations governing the Coast Guard Auxiliary. The basis of this action is the Coast Guard's statutory authority to administer the Coast Guard Auxiliary in 14 U.S.C. chapters 23 and 25.

This final rule revises and reorganizes the regulations governing the Coast Guard Auxiliary. The Coast Guard Auxiliary regulations were last updated in 2003 (68 FR 9534, Feb 28, 2003) and 1996 (61 FR 33662, June 28, 1996), but these changes did not address all of the legislative changes being addressed in this final rule. Through this final rule, the Coast Guard updates the regulations in accordance with recent legislation; clarifies Auxiliary powers, duties, and organization; amends provisions regarding Auxiliary membership; and addresses other administrative matters. These changes address several problems common to Auxiliary units. For a more complete list of problems this rulemaking is intended to address, see section III, “Background” in the NPRM, which is located in the docket.

The Coast Guard received six submissions from members of the public about the NPRM. The Coast Guard appreciates the commenters' time and effort to submit comments and will address each comment received. We have incorporated some of the comments into this final rule.

We have divided the comments we received into two groups: Comments from members of the public that resulted in changes to the final rule and comments from members of the public that did not result in changes to the final rule. We have also included a group that discusses administrative changes made to the rule by the Coast Guard.

Three commenters requested that the Coast Guard not use the term “disenrolled” for members who have died. The Coast Guard understands that the term “disenrolled” may have a negative connotation for some people. The Coast Guard respects and appreciates the contributions of every Auxiliary member who has completed their service honorably. We have removed the words “upon death” in § 5.19 of the final rule text relating to reasons for which a member may be disenrolled.

One commenter supported the Coast Guard's proposal to remove the 25 percent minimum ownership interest in a motorboat, yacht, aircraft, or radio station. The Coast Guard agrees that requiring a minimum ownership interest is unnecessary. The 25 percent minimum ownership interest requirement is being removed in this final rule. The remaining criteria for Auxiliary membership are set out in the Auxiliary Manual (COMDTINST M16790.1(series)).

This section addresses comments from the public requesting changes to the proposed regulatory text that the Coast Guard has decided not to adopt. For a number of the comments we received, the Coast Guard's response is that the issue is best handled in Coast Guard policy, for the reasons discussed below.

The Coast Guard received one comment suggesting that the Coast Guard clarify the restriction on Auxiliary participation in direct law enforcement. We agree that “direct law enforcement” should be defined as clearly and unambiguously as possible. However, the dynamic nature of Auxiliary operations and the need to amend operations policy suggest that the Auxiliary manual, not the Code of Federal Regulations (CFR), is the best place to define “law enforcement operations.” The Coast Guard is responsible for ensuring that Auxiliary operations are conducted safely and within the bounds of the Coast Guard and the Auxiliary's authority. The scope and nature of Auxiliary operations are constantly evolving, sometimes rapidly. Missions which would have been unimaginable just a few years ago, such as port security and air intercept training, are now part of everyday Auxiliary operations. In addition, new operational restrictions sometimes come into place very quickly. In 2001, the Auxiliary suffered an aviation mishap with the loss of two lives. To minimize the chance of future mishaps, the Coast Guard and Auxiliary adopted new restrictions for Auxiliary aviation missions within weeks of the mishap. Because of the dynamic nature of Coast Guard and Auxiliary operations and the need for the rules governing operations to be responsive, the proper place to define “direct law enforcement” is the Auxiliary Operations Policy Manual (COMDTINST M16798.3(series)), not the CFR.

We received one comment requesting clarification of the term “personal property of the Auxiliary”, particularly as it relates to licensing and insurance. “Personal property of the Auxiliary” is property that is owned by or under the administrative control of an Auxiliary unit and used for Auxiliary purposes. Coast Guard policy in this area is set out in the Auxiliary Manual, ALCOAST 600/05, and other Coast Guard Directives. The CFR is not the appropriate venue for addressing this matter because the rules about property owned by the Auxiliary are a matter of agency management and not subject to the Administrative Procedure Act. Therefore, we will not be incorporating the relevant Coast Guard policies into this final rule.

Two commenters expressed concern that Auxiliary membership should not be open to persons under the age of 17. Current regulations restrict Auxiliary membership to persons 17 years of age or older. The Coast Guard does not anticipate opening membership in the Auxiliary to persons under the age of 17. We proposed to remove that restriction from the CFR because minimum age for membership is a matter best addressed in Coast Guard policy. Detailed criteria for Auxiliary membership are set out in the Auxiliary Manual. This regulation change will not change the membership requirements in Section 3.A of the Auxiliary Manual.

One commenter encouraged the Coast Guard to reimburse members for travel expenses and per diem. The Coast Guard supports the maximum reimbursement allowed by law and appropriations. This final rule does not change the travel and per diem reimbursement policies of the Coast Guard.

The Coast Guard received two comments about compensation for an Auxiliarist who is injured or dies in the line of duty. One commenter noted that compensation for injury or death in the line of duty should be the same as for active duty members. This final rule continues the Coast Guard policy of providing the maximum compensation allowed by law for Auxiliary members who die or are injured in the line of duty. Another commenter suggested that the final rule specify the grade and step at which auxiliary members are compensated for injuries sustained in the line of duty. Paragraph 5.K.6.a. of the Auxiliary Manual and 14 U.S.C. 707(a) provide that members who are injured or die in the performance of duty are compensated at a rate equal to the minimum rate of basic pay in effect for grade GS-9 of the General Schedule. The Coast Guard believes this policy addresses the commenter's concern without changing the regulation.

We received two comments about membership requirements. One commenter noted that the requirements for Auxiliary membership should not be more stringent than those for membership in the active duty Coast Guard. The Coast Guard agrees. Requirements for Auxiliary membership are driven by operational need and are not more stringent than for membership in the active duty Coast Guard. One commenter requested that the Coast Guard consider admitting members who have a reenlistment code of “RE-4” (not eligible to reenlist). This is a policy set out in paragraph 3.A.6.g of the Auxiliary Manual, and this rulemaking does not change that policy.

One commenter suggested that the regulations on eligibility for membership include a caveat that Auxiliary membership does not entitle a permanent resident alien to expedited naturalization processing. The Coast Guard disagrees that a caveat is necessary. The commenter's concern is already addressed by 14 U.S.C. 893, which provides that Auxiliary membership does not entitle a person to additional rights or benefits except as provided by law.

One commenter expressed support for Auxiliary members acting as docents and tour guides for the Coast Guard and other federal and state property. The Coast Guard agrees. This mission has long been considered an authorized Auxiliary activity.

The Coast Guard is also making a limited number of changes to the proposed regulatory text.

The Coast Guard is making three changes to proposed § 5.40. First, the Coast Guard is amending § 5.40(a) to clarify that the regulations are a restatement of policy already established by Coast Guard directives. Second, the Coast Guard is amending § 5.40(b)(2) to include a description of the markings authorized on vessels, aircraft, motorized vehicles, trailers, and radio stations, which are personal property of the Auxiliary. These markings are already authorized by the U.S. Coast Guard Heraldry Manual (COMDTINST M5200.14 (series)) and paragraph 3.F.1 of the Auxiliary Operations Policy Manual. The third change is to § 5.40(b) (and in §§ 5.45, 5.46, and 5.47, which mirror the language of § 5.40). This change clarifies the rules regarding the required display of the National Ensign, the patrol sign, the patrol ensign, and the Coast Guard ensign on vessels which have been accepted as facilities. The proposed rule required that these markings be displayed when the vessel was “assigned to Coast Guard duty.” The final rule requires these markings be displayed when the vessel is “on patrol.” A strict reading of the Auxiliary Operations Policy Manual could lead a member to believe that a vessel is “assigned to duty” (and must display the national ensign) as soon as written orders are issued, which is not the intent of this rule. The final rule requires display of the required markings when a vessel is on patrol, which is defined in the Auxiliary Operations Policy Manual as the time from getting underway until return to the dock or launch ramp.

The Coast Guard corrected a description in § 5.44 regarding the Auxiliary facility decal, which described the slash as rising toward the hoist. A decal does not usually hang from a hoist, so the Coast Guard changed the description of the Auxiliary facility decal to read “rising toward the viewer's right.” There is no substantive difference in the appearance of the decal and this change will not impact the observer.

The Coast Guard is changing the definition of the term “vessel” in 33 CFR 5.1 to conform to the definition in the Inland Navigation Rules, 33 CFR 83.03(a). Prior to this final rule, 33 CFR 1.05 defined vessel as “a motorboat or yacht.” This final rule expands the definition of vessel to include small craft such as kayaks, canoes, and personal watercraft. These small craft are already being used in support of Auxiliary missions. All vessels under the current regulations will continue to meet the definition of vessel in this final rule.

The Coast Guard is amending the definition of the term “motorboat” in 33 CFR 5.1 to include vessels longer than 65 feet. This change allows (but does not require) the Coast Guard to accept as a facility a motorboat longer than 65 feet. All vessels meeting the definition of motorboat in the current regulations will still be considered vessels under the new rule.

The Coast Guard is amending proposed §§ 5.12 and 5.14. The purpose of this change is to clarify the proposed rule related to Auxiliary organization, including offices, titles, designations, and qualifications as ordered by the Commandant. Auxiliary members may wear the uniforms, uniform insignia, and awards that they are authorized to wear, but Auxiliary uniform insignia are a separate system from the insignia associated with military rank. This change is a clarification of the proposed regulatory text and reflects a long-standing policy.

The Coast Guard is making these changes to §§ 5.01 5.12, 5.14, 5.40, 5.44, 5.45, 5.46, and 5.47 without further notice and opportunity to comment because these changes are within the scope of the NPRM. All of subpart E of the proposed 33 CFR part 5 is a restatement of policy which already exists in the Heraldry Manual and the Auxiliary Operations Policy Manual and was proposed in the NPRM. The changes to the definitions in § 5.1 and the rules for uniforms and insignia in §§ 5.12 and 5.14 are in sections where changes were proposed in the NPRM. Furthermore, these changes do not change the effect of the rule proposed in the NPRM.

In addition to revisions discussed above, this final rule changes two sections of the proposed rule for clarity. Because these changes only clarify existing or proposed text and will have no substantive effect on the public, notice and comment procedures are unnecessary. Therefore, the Coast Guard finds good cause exists under 5 U.S.C. 553 for forgoing an NPRM with respect to these administrative changes. These changes are described below.

In § 5.30(b)(3), the paragraph heading of the proposed rule referred to the status of “Public vessels,” when the section applies to vessels, aircraft, and radio stations which are owned by, in the custody of, or under the administrative jurisdiction of the Auxiliary. This section interprets 14 U.S.C. 827, 828 and 829, which provide protection against third-party damage claims to Auxiliary facilities and equipment. The paragraph heading of the final rule was revised to accurately reflect the scope of the statutory protection.

Section 5.36(a) deals with the loan of vessels, aircraft, radio stations, motorized vehicles, trailers, and other equipment. The words “aircraft, radio station, motorized vehicle, and other equipment” were left out of the fourth sentence and are added in the final rule.

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below, we summarize our analyses based on these statutes or Executive Orders.

Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This final rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the final rule has not been reviewed by the Office of Management and Budget.

The NPRM was published in the Federal Register on May 10, 2013 (78 FR 27321). We received no public comments that change the substance of the requirements or the regulatory analysis embedded in that published NPRM, nor any specifics to that regulatory analysis. Therefore, we adopt the NPRM regulatory analysis as final without any changes. The NPRM regulatory analysis is replicated here for the final rule.

The final rule conforms regulatory language to statutes, codifies many existing practices, clarifies procedures, increases procedural flexibility for the Coast Guard and Auxiliarists, increases overall efficiency in the process, and re-organizes content to improve clarity. There are no costs to either the federal government or the private sector associated with these proposed changes.

This final rule applies to members and prospective members of the Coast Guard Auxiliary and people and companies that interact with the Auxiliary. The Auxiliary is a Congressionally-chartered component of the Coast Guard made up of uniformed volunteers. Auxiliary units (“flotillas”) are neither corporations nor charities and often encounter administrative trouble with banks, insurance companies, and businesses. This rulemaking clarifies for the public the nature, organization, and purpose of the Auxiliary, and conforms the regulatory language to the Auxiliary statutes, as amended by legislative changes. Many of these changes are already reflected in Coast Guard policies and manuals. For example, the financial aspects of these regulations, such as reimbursement of expenses, including the Standard Auxiliary Maintenance Allowance (SAMA), incorporate already existing practices and authorities, as detailed in the Auxiliary Manual, chapter 9 and the Auxiliary Operations Policy Manual, chapter 3 and section B-2.

These changes update our regulations to capture our current practices regarding reimbursement of Auxiliary facility expenses and maintenance costs. The payment of death gratuities to the representatives of Auxiliarists who die in the performance of duty while assigned to duty is currently funded pursuant to legislative authorization and supported by Commandant policy (COMDTINST 12550.21A, CG Death Gratuity Payment), enabling Auxiliarists to be regarded as Coast Guard employees for the purpose of death gratuity payments.

The primary benefit of this final rule is to conform regulatory language to the legislative changes described in section III, Background. This rulemaking makes it easier and more efficient for Auxiliarists to interact with banks, insurance agents, and the Coast Guard. Banks help process reimbursements (via direct deposit) for operations and other missions requiring Auxiliarists to incur an initial expense from their personal funds. Insurance agents' relationships are also important, as Auxiliarists may be reimbursed for damages to their vessels when those vessels are engaged in waterborne or airborne operational patrols.

We have classified the proposed changes into categories, as listed in Table 1. There are no costs associated with the changes.

Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this final rule will have a significant economic impact on a substantial number of small entities. 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. This rule imposes no direct costs; consequently, there are no impacts on small entities to consider. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offered to assist small entities in understanding this rule so that they could better evaluate its effects on them and participate in the rulemaking. 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.

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).

This final rule calls for no 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 Executive Order 13132 and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. This rule revises and reorganizes Coast Guard regulations governing the Coast Guard Auxiliary. The rule is an exercise of authority specifically granted to the Coast Guard in chapters 23 and 25 of Title 14 (Coast Guard), U.S.C., and is a matter of internal administration. It does not prevent states from establishing local law enforcement, public safety, or response capabilities. Therefore, this rule does not have implications for federalism under Executive Order 13132.

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.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (“Governmental Actions and Interference with Constitutionally Protected Property Rights”).

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

We have analyzed this rule under Executive Order 13045 (“Protection of Children from Environmental Health Risks and Safety Risks”). This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”), because it would 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.

We have analyzed this rule under Executive Order 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD (National Environmental Policy Act Implementing Procedures and Policy For Considering Environmental Impacts Manual), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969, 42 U.S.C. 4321-4370f, and have concluded 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 the operation and administration of the Coast Guard Auxiliary and falls under section 2.B.2, figure 2-1, paragraphs (34)(a), (b), (c), and (d) of the Instruction. These paragraphs exempt regulations which are editorial or procedural, concern internal agency functions or organization, concern the training and qualifying of maritime personnel, and concern the inspection of vessels, respectively. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard revises 33 CFR part 5 to read as follows:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0226 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 24, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0226, by one of the following methods:

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

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

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

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

In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8101) by Bayer CropScience LP, 2 T.W. Alexander Dr., P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5 H )-furanone, and its metabolites, difluoro acetic acid (DFA) and 4-[(2,2-difluoroethyl)amino]furan-2(5 H )-one (DFEAF), in or on the following commodities: Aspirated grains fractions at 40 parts per million (ppm); root vegetables except sugar beets (crop subgroup 1B) at 1.5 ppm; tuberous and corm vegetables (crop subgroup 1C) at 0.5 ppm; onion, bulb, subgroup, (crop subgroup 3-07A) at 0.3 ppm; onion, green, subgroup, (crop subgroup 3-07B) at 3 ppm; leafy vegetable, except Brassica vegetables (crop group 4) at 40 ppm; taro leaves at 40 ppm; head and stem Brassica (crop subgroup 5A) at 6 ppm; leafy Brassica greens (crop subgroup 5B) at 40 ppm; turnip greens at 40 ppm; edible-podded legume vegetables (crop subgroup 6A) at 5 ppm; succulent, shelled pea and bean (crop subgroup 6B) at 4 ppm; dried, shelled pea and bean (except soybean) (crop subgroups 6C) at 6 ppm; foliage of legume vegetables, including soybeans (crop group 7), forage, green vines at 40 ppm; foliage of legume vegetables, including soybeans (crop group 7), hay at 50 ppm; soybean, seed at 4 ppm; fruiting vegetables, except cucurbits (crop group 8-10), fruit at 3 ppm; tomato, paste at 4 ppm; cucurbit vegetables (crop group 9), fruit at 2 ppm, citrus fruits (crop group 10-10), fruit at 3 ppm; citrus, pulp, dried at 15 ppm; pome fruits (crop group 11-10), fruit at 1.5 ppm; bushberry subgroup (crop subgroup 13-07B) at 4 ppm; small fruit vine climbing subgroup, except fuzzy kiwifruit (crop subgroup 13-07F) at 3 ppm; grapes, raisin at 6 ppm; low growing berry subgroup (crop subgroup 13-07G) at 1.5 ppm; tree nuts (crop group 14), nutmeat at 0.15 ppm; pistachio at 0.15 ppm; tree nuts (crop group 14), hulls at 15 ppm; grain, cereal, (crop group 15), except rice; grain at 4 ppm; sweet corn, kernels plus cobs with husks removed (k+cwhr) at 0.4 ppm; wheat, bran at 5 ppm; rice, grain (rotational crop) at 4 ppm; grain, cereal, forage, fodder and straw, group 16, forage at 20 ppm; grain, cereal, forage, fodder and straw, group 16, hay at 40 ppm; grain, cereal, forage, fodder and straw, group 16, straw at 30 ppm; grain, cereal, forage, fodder and straw, group 16, stover at 15 ppm; cotton, undelinted seed, (crop subgroup 20C) at 0.9 ppm; cotton, gin by-products at 40 ppm; nongrass animal feeds, forage, (crop group 18) at 20 ppm; nongrass animal feeds, hay, (crop group 18) at 40 ppm; coffee, bean, green at 2 ppm; coffee, bean, roasted; instant at 3 ppm; hops at 20 ppm; peanut, hay at 30 ppm; peanut, nutmeat at 0.15 ppm; prickly pear cactus, fruit; at 0.5 ppm; pitaya, fruit at 0.5 ppm; prickly pear cactus, pads at 0.9 ppm; cattle, goat, hog, horse, sheep fat at 0.5 ppm; cattle, goat, hog, horse, sheep meat at 1 ppm; cattle, goat, hog, horse, sheep, meat byproducts at 2 ppm; milk at 0.3 ppm, poultry, eggs at 0.3 ppm, poultry, meat at 0.5 ppm; poultry, meat byproducts at 0.5 ppm.

That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed commodity definitions and altered tolerance levels for different commodities. EPA has reviewed the available residue data and has determined the appropriate tolerance levels for residues of flupyradifurone. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . ..”

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

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

Flupyradifurone (BYI 02960) is a new butenolide insecticide. The most sensitive effects seen in the flupyradifurone database were skeletal muscle atrophy/degeneration in dogs. With repeated dosing, reductions in body weight and food consumption were commonly seen in various studies and in all species of test animals (rats, mice, dogs, and rabbits). The liver and thyroid were shown to be the common findings of flupyradifurone toxicity. The database appears to suggest that dogs are more sensitive to the effects of flupyradifurone; however, with body weight adjustments (based on a 3/4 scaling factor), the dog and rat are almost equally as sensitive in response to flupyradifurone toxicity. The skeletal muscle atrophy/degeneration seen in the 90-day and 1-year dog studies formed the basis for chronic dietary exposure toxicity endpoints.

The developmental toxicity study in rats demonstrated no evidence of susceptibility in developing animals. In the rabbit developmental toxicity study, there was an increase in the incidence of fetal death at 80 milligram/kilogram/day (mg/kg/day) (the highest dose tested), a dose that did not produce adverse effects in the maternal animals. Therefore, a quantitative increase in susceptibility was demonstrated in the rabbit developmental toxicity study. In the 2-generation reproduction study in rats, decreased parental body weights (≥10%) were seen at the LOAEL of 137 mg/kg/day (parental NOAEL = 37.8 mg/kg/day). In contrast, body weight decreases that were considered adverse were seen in F 2 pups at 37.8 mg/kg/day (the parental NOAEL and the offspring LOAEL; offspring NOAEL = 7.7 mg/kg/day). These findings suggest quantitative susceptibility for developing young animals.

The acute neurotoxicity study (dosing by gavage) showed that at the time of peak-effect, flupyradifurone caused increases in the incidence of piloerection and dilated pupils at 50 mg/kg. At the next higher dose level (200 mg/kg) and above, it produced a large host of clinical signs, which were related to neurotoxicity. The clinical signs included dilated pupils, lower muscle tone, low arousal, tremors, myoclonic jerks, chewing, repetitive licking of lips, gait incoordination, flattened or hunched posture, and impaired righting reflex. In the 90-day neurotoxicity study, no neurotoxicity or other adverse effects were seen at dose levels as high as 174 mg/kg/day. The developmental neurotoxicity study at 102 mg/kg/day yielded an increased incidence of increased amplitude in startle response.

Flupyradifurone is classified as “not likely to be carcinogenic to humans.” Carcinogenicity studies in rats and mice did not yield a compound-related increase in tumor incidence, and the genotoxicity battery did not show flupyradifurone to produce any genotoxicity. Flupyradifurone did not demonstrate any immunotoxic effects.

Specific information on the studies received and the nature of the adverse effects caused by flupyradifurone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Flupyradifurone: Human Health Risk Assessment for The First Food Use” in docket ID number EPA-HQ-OPP-2013-0226.

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

A summary of the toxicological endpoints for flupyradifurone used for human risk assessment is shown in Table 1 of this unit.

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

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for flupyradifurone. Exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID). This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed that flupyradifurone residues were present at recommended tolerance levels in all commodities and that 100% of these crops were treated with flupyradifurone. DEEM default processing factors were used for cranberry juice, dried apple, dried beef, and dried pear; empirical processing factors were used for processed commodities of apple (sauce and juice), citrus oil, coffee, corn (bran, flour, meal, starch, oil), cotton (oil), grape (wine, juice), grapefruit (juice), hops (dried cones), lemons (juice), limes (juice), oranges (juice and peel), peanut (butter, oil), pears (juice), potatoes (chips, flakes, cooked), soybeans (oil, milk, flour), tomatoes (juice, puree, paste), and wheat (bran, germ, flour).

ii. Chronic exposure. Exposure and risk assessments were conducted using the DEEM-FCID. This software uses 2003-2008 food consumption data from the USDA's NHANES/WWEIA. EPA assumed that flupyradifurone residues were present at recommended tolerance levels in all commodities and that 100% of these crops were treated with flupyradifurone. DEEM default processing factors were used for cranberry juice, dried apple, dried beef, and dried pear; empirical processing factors were used for processed commodities of apple (sauce and juice), citrus oil, coffee, corn (bran, flour, meal, starch, oil), cotton (oil), grape (wine, juice), grapefruit (juice), hops (dried cones), lemons (juice), limes (juice), oranges (juice and peel), peanut (butter, oil), pears (juice), potatoes (chips, flakes, cooked), soybeans (oil, milk, flour), tomatoes (juice, puree, paste), and wheat (bran, germ, flour).

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

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

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flupyradifurone, in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flupyradifurone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) the estimated drinking water concentrations (EDWCs) of flupyradifurone for acute exposures is estimated to be 52.5 parts per billion (ppb) for surface water. Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the EDWCs of flupyradifurone for acute exposures are estimated to 352 ppb for ground water.

Based on the PRZM/EXAMS the EDWCs of flupyradifurone for chronic exposures for non-cancer assessments are estimated to be 22.3 ppb for surface water and based on the PRZM GW the EDWCs are estimated to be 307 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 352 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 307 ppb was used to assess the contribution to drinking water.

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

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

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

EPA has not found flupyradifurone to share a common mechanism of toxicity with any other substances, and flupyradifurone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flupyradifurone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The developmental toxicity study in rats demonstrated no evidence of susceptibility in developing animals. In the rabbit developmental toxicity study, there was an increase in the incidence of fetal death at 80 mg/kg/day, a dose that did not produce adverse effects in the maternal animals. Therefore, a quantitative increase in susceptibility was demonstrated in the rabbit developmental toxicity study; however, the deaths occurred only at the highest tested dose. In the 2-generation reproduction study in rats, decreased parental body weights (≥10%) were seen at the LOAEL of 137 mg/kg/day (parental NOAEL = 37.8 mg/kg/day). In contrast, body weight decreases that were considered adverse were seen in F 2 pups at 37.8 mg/kg/day (the parental NOAEL and the offspring LOAEL; offspring NOAEL = 7.7 mg/kg/day). These findings suggest quantitative susceptibility for developing young animals. However, the effects seen in the rabbit developmental study and in the rat reproductive study occurred at doses higher than the toxicity POD for risk assessment, which was selected from the 1-year dog study (28 mg/kg/day, LOAEL) with a NOAEL of 7.8 mg/kg/day. The NOAEL (7.8 mg/kg/day) selected as the POD for chronic dietary risk assessment is protective of the effects seen in the rat F 2 pups and the increased incidence of fetal death in the developmental rabbit study. Therefore, there are no concerns for the observed increased susceptibility.

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

i. The toxicity database for flupyradifurone is complete.

ii. Although there is evidence that flupyradifurone has neurotoxic effects, EPA has a complete set of neurotoxicity studies (acute, subchronic, and developmental). The effects of those studies are well-characterized and indicate neurotoxic effects that occur at levels above the chronic POD that was selected for risk assessment. The NOAEL for the acute neurotoxicity study is being used for the acute POD. Therefore, there is no need to retain the 10X FQPA SF to account for any uncertainty concerning these effects.

iii. There is no evidence that flupyradifurone results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. There is quantitative susceptibility in rabbit developmental study and in the pup of the reproduction study, but the PODs are protective of this increased susceptibility.

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flupyradifurone will occupy 38% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flupyradifurone from food and water will utilize 84% of the cPAD for children 1-2 years old the population group receiving the greatest exposure.

3. Short-term and Intermediate-term risk. Short-term and Intermediate-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term/intermediate-term adverse effect was identified; however, flupyradifurone is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Because there is no short-term or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for flupyradifurone.

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

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

Adequate enforcement methodology (high performance liquid chromatography with tandem mass spectrometry (HPLC/MS-MS)) is available to enforce the tolerance expression. The validated limit of quantification (LOQ) is 0.01 mg/kg for flupyradifurone in most commodities.

An HPLC/MS-MS method, Method RV-004-A11-05 (latest revision of the data collection method RV-004-A11-04), is adequate as the enforcement method for determination of residues of flupyradifurone in livestock commodities. The validated LOQ for flupyradifurone is 0.01 mg/kg in all matrices.

The Food and Drug Administration (FDA) multi-residue methods (MRMs) are suitable for flupyradifurone only in non-fatty matrices. The methods are not suitable for fatty matrices or matrices that require further clean-up. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRLs for flupyradifurone.

The Petitioner requested a definition for enforcement of tolerance as the sum of flupyradifurone and DFA and DFEAF, expressed as flupyradifurone, which significantly inflated the field trial residue values and resulted in higher tolerance values. EPA, consistent with its global review partners, has selected parent flupyradifurone only as the residue definition for tolerance enforcement. Flupyradifurone is the major portion of the residue in plant commodities and in some livestock commodities. In other livestock commodities, it is present at the same approximate concentration as some metabolites. Moreover, the significant metabolite DFA is not suitable for enforcement purposes, as its concentration is erratic with time. The harmonized enforcement definition, flupyradifurone only, will facilitate trade and is predicted to be the residue definition adopted by Codex in the future based on application of their policy. Therefore, EPA is reducing the tolerance values for the petitioned-for tolerances for the following commodity groups/subgroups or commodities: Cattle, goat, hog, horse, and sheep meat and meat byproducts; hog fat; milk; poultry eggs; root vegetables subgroup 1B; tuberous and corm vegetables subgroup 1C; bulb onion subgroup 3-07A; leafy vegetable group 4; legume vegetables subgroups 6A, 6B, 6C; soybean; foliage of legume vegetables group 7; fruiting vegetables group 8-10; cucurbit vegetables group 9; citrus pulp; pome fruits group 11-10; grape raisins; bushberry subgroup 13B except cranberry; tree nut group 14; cereal grain group 15 except rice and except corn; sweet corn, cereal grain forage, fodder, and straw group 16; nongrass animal feeds crop group 18; cotton undelinted seed; coffee bean; hops; peanut hay; peanut; prickly pear cactus fruit and pad.

The petition requested a tolerance for root vegetables, except sugar beets subgroup 1B at 1.5 ppm. The ratio of highest average field trials (HAFTs) of the representative commodities (carrot/radish, 0.603/0.046 ppm) was 13, but the ratio of the median residue value was 1.8. The small median ratio indicates that the central tendency of both carrot and radish residue values are similar and that a single tolerance would be appropriate for the subgroup, represented by carrot and radish. The higher tolerance estimate from carrot (0.90 ppm) will cover all members of the subgroup.

The petition requested a tolerance for the leafy vegetable, except Brassica vegetables, group 4 at 40 ppm. Based on the available residue data, EPA is establishing separate tolerances for each of the subgroups of group 4, instead of a single tolerance for the whole group. For subgroup 4A (leafy greens), EPA is establishing a tolerance at 30 ppm, based on the highest residues, which were found on the representative crop spinach. For subgroup 4B (leafy petioles), EPA is establishing a separate tolerance at 9.0 ppm based on the celery residues. The leafy greens subgroup tolerance was translated to cover taro leaves; therefore, EPA is establishing a tolerance for taro leaves at 30 ppm, rather than the 40 ppm requested.

The petitioned-for tolerance for the shelled pea and bean subgroup 6B at 4 ppm was not possible because the residues on the garden pea and lima bean were substantially different. Residues differ by more than 5X between succulent peas and succulent beans. In accordance with 40 CFR 180.40(g), a subgroup tolerance is not normally appropriate; rather, EPA may establish individual crop tolerances. Therefore, EPA is establishing individual tolerances for succulent peas and succulent beans.

The petition requested a tolerance for cereal grains, grain, group 15 except rice at 4 ppm. The residues on sweet corn and field corn grain were much lower than those on sorghum, wheat, and barley grains; therefore, EPA is excluding corn (field corn, popcorn, and sweet corn) grain from that group 15 tolerance, as well as rice. Based on available residue data, EPA is establishing separate tolerances for popcorn, grain, field corn, grain, and sweet corn (kernels plus cobs with husks removed) at 0.05 ppm. Under 180.40(h), EPA may exclude some commodities from a group tolerance where the residue levels are significantly higher or lower than the other commodities in the group. Corn, unlike the other cereal grains, has a protective husk and this difference is often reflected in lower residues for late season foliar applications. Therefore, EPA is excluding corn grain and rice from the crop group 15 tolerance and establishing separate tolerances for corn. The remaining cereal grains, represented by grain sorghum, barley, and wheat, are quite similar.

The petition requested a tolerance on nongrass animal feeds group 18, forage at 20 ppm and hay at 40 ppm. EPA is unable to establish group 18 tolerances at this time for forage and hay because data from only four field trials on clover (one of the representative crops) was available. Based on the available data, EPA is establishing tolerances for alfafa and regional tolerances for clover (since use on clover is restricted to Washington, Oregon, and Idaho, the area where the field trials were conducted). A group tolerance could be considered if additional field trials for clover from diverse areas of the U.S. were supplied.

The petition requested a tolerance for rice grain at 4 ppm as a rotational crop. EPA cannot establish this tolerance at this time because no data were provided to support this request. Rice field trial data are required to establish a tolerance.

The proposed wheat bran tolerance of 5 ppm is not necessary. The cereal grain group tolerance covers wheat bran. The highest average field trial (HAFT) residue for wheat grain was 0.73 ppm and the experimentally determined processing factor for the conversion of grain to bran was 2.4. Therefore, the tolerance estimate for wheat bran is 1.8 ppm (0.73 × 2.4). As 1.8 ppm is less than the 3 ppm cereal group tolerance, a separate tolerance for wheat bran is not needed.

EPA was petitioned for tolerances on tree nut group 14 and pistachio. In the Federal Register of August 22, 2012 (77 FR 50617) (FRL-9354-3), EPA issued a final rule that revised the crop grouping regulations. As part of this action, EPA expanded and revised the existing tree nut group 14. Changes to crop group 14 included adding the specialty commodities African nut tree, Brazilian pine, bunya, bur oak, cajou nut, candlenut, coconut, coquito nut, dika nut, ginkgo, guiana chestnut, heartnut, Japanese horse-chestnut, mongongo nut, monkey-pot, monkey puzzle nut, okari nut, pachira nut, peach palm nut, pequi, pili nut, pine nut, pistachio, tropical almond and yellowhorn including cultivars, varieties, and/or hybrids of these; and naming the new crop group tree nut group 14-12. EPA indicated in the August 22, 2012 final rule as well as the earlier proposed rule published in the Federal Register of November 9, 2011 (76 FR 69693) (FRL-8887-8) that, for petitions for which a Notice of Filing had been published, the Agency would attempt to conform these petitions to the final rule. Therefore, consistent with this final rule, EPA has assessed exposure to the, insecticide flupyradifurone, assuming use under the revised tree nut group 14-12. Because revising the requested crop group to the updated crop group did not result in a risk of concern, EPA is establishing tolerances for flupyradifurone residues on tree nut group 14-12.

Cranberry was removed from subgroups 13-07B and 13-07G at the request of the petitioner as a modification to the original request.

Tolerances are not needed for the processed commodities instant coffee, roasted coffee, and tomato paste. The recommended tolerances for the raw agricultural commodities, tomato and green coffee bean cover the respective processed commodities. The highest average field trial (HAFT) result for coffee was 0.55 ppm, and the processing factors for instant coffee and roasted coffee were 0.59 and 1.9, respectively. Tolerance estimate (HAFT × processing factor; 0.55 × 0.59 = 0.32 ppm roasted bean; 0.55 × 1.9 = 1.0 ppm instant coffee) are less than the recommended green coffee bean tolerance (1.5 ppm). The HAFT for the tomato field trials was 0.57 ppm and the processing factor for conversion to paste was 2.0, and the product (0.57 × 2.0) is less than the recommended fruiting vegetable group tolerance (1.5 ppm).

Tolerances are not required for poultry meat and poultry meat byproducts, as the projected diet for poultry and the results of the poultry feeding study indicate that residues are not likely in poultry meat and poultry meat byproducts.

Therefore, tolerances are established for residues of flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5 H )-furanone, are: Alfalfa, forage at 9.0 ppm; alfalfa, hay at 20 ppm; almond, hulls at 15 ppm; bean, succulent at 0.2 ppm; berry, low growing, subgroup 13-07G, except cranberry at 1.5 ppm; Brassica, head and stem, subgroup 5A at 6.0 ppm; Brassica, leafy greens, subgroup 5B at 40 ppm; bushberry subgroup 13-07B, except cranberry at 4.0 ppm; cactus, fruit at 0.30 ppm; cactus, pads at 0.70 ppm; cattle, fat at 0.20 ppm; cattle, meat at 0.30 ppm; cattle, meat byproducts at 1.0 ppm; clover, forage at 20 ppm; clover, hay at 30 ppm; coffee, green bean at 1.5 ppm; corn, field, grain at 0.05 ppm; corn, pop, grain at 0.05 ppm; corn, sweet, kernels plus cobs with husks removed at 0.05 ppm; cotton, gin byproducts at 40 ppm; cottonseed subgroup 20C at 0.80 ppm; egg at 0.01 ppm; fruit, citrus, group 10-10 at 3.0 ppm; fruit, citrus, dried pulp, at 10 ppm; fruit, pome, group 11-10 at 0.70 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 3.0 ppm; goat, fat at 0.20 ppm; goat, meat at 0.30 ppm; goat, meat byproducts at 1.0 ppm; grain, aspirated grains fractions at 40 ppm; grain, cereal, except rice and corn, group 15 at 3.0 ppm; grain, cereal, forage, fodder and straw, group 16 at 30 ppm; grape, raisin at 5.0 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.04 ppm; hops, dried cones 10 ppm; horse, fat at 0.20 ppm; horse, meat at 0.30 ppm; horse, meat byproducts at 1.0 ppm; leaf petioles, subgroup 4B at 9.0 ppm; leafy greens, subgroup 4A at 30 ppm; milk at 0.15 ppm; nut, tree, group 14-12 at 0.02 ppm; onion, bulb, subgroup 3-07A at 0.09 ppm; onion, green, subgroup 3-07B at 3.0 ppm; pea and bean, dried, shelled except soybean, subgroup 6C at 3.0 ppm; pea, succulent at 2.0 ppm; peanut at 0.04 ppm; peanut, hay at 20 ppm; pitaya at 0.30 ppm; sheep, fat at 0.2 ppm; sheep, meat at 0.30 ppm; sheep, meat byproducts at 1.0 ppm; soybean, seed at 1.5 ppm; taro leaves at 30 ppm; turnip greens at 40 ppm; vegetable, cucurbit, group 9 at 0.40 ppm; vegetable, fruiting, group 8-10 at 1.5 ppm; vegetable, legume, edible podded, subgroup 6A at 3.0 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.9 ppm; vegetable, tuberous and corm, subgroup 1C at 0.05 ppm; vegetable, foliage of legume, group 7, at 30 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

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

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

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

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

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

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

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

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

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

Accordingly, 44 CFR part 64 is amended as follows:

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

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

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

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

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

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

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

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

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

Accordingly, 44 CFR part 64 is amended as follows:

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

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

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

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

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

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

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

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

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

Accordingly, 44 CFR part 64 is amended as follows:

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, and cobia) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The Gulf migratory group king mackerel is divided into western and eastern zones. The Gulf's eastern zone for king mackerel is further divided into the Florida west coast northern and southern subzones that have separate commercial quotas. The 2014 to 2015 fishing year quota for the hook-and-line component of the commercial sector in the southern Florida west coast subzone is 551,448 lb (250,133 kg) (50 CFR 622.384(b)(1)(i)(B)( 1 )) (76 FR 82058, December 29, 2011).

In accordance with 50 CFR 622.385(a)(2)(ii)(B)( 2 ), from the date that 75 percent of the southern Florida west coast subzone's hook-and-line gear quota has been harvested until a closure of the subzone's commercial sector of the hook-and-line component has been effected or the fishing year ends, king mackerel in or from the EEZ may be possessed on board or landed from a permitted vessel in amounts not exceeding 500 lb (227-kg) per day.

NMFS has projected that 75 percent of the hook-and-line gear quota for Gulf group king mackerel from the southern Florida west coast subzone will be harvested by January 24, 2015. Accordingly, a 500-lb (227-kg) trip limit applies to vessels in the hook-and-line component of the commercial sector for king mackerel in or from the EEZ in the southern Florida west coast subzone effective 12:01 a.m., local time, January 24, 2015. The 500-lb (227-kg) trip limit will remain in effect until the component closes or until the end of the current fishing year (June 30, 2015), whichever occurs first.

From November 1 through March 31, the southern subzone encompasses an area of the EEZ south of a line extending due west of the Lee and Collier County, FL, boundary on the Florida west coast, and south of a line extending due east of the Monroe and Miami-Dade County, FL, boundary on the Florida east coast, which includes the EEZ off Collier and Monroe Counties, FL. From April 1 through October 31, the southern subzone is reduced to the EEZ off Collier County, and the EEZ off Monroe County becomes part of the Atlantic migratory group area.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of Gulf migratory group king mackerel and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.385(a)(2)(ii)(B) and 622.385(a)(2)(iii) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this trip limit reduction for the hook-and-line component of the commercial sector constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary rule is unnecessary and contrary to the public interest. Such procedures are unnecessary because the commercial trip limit for hook-and-line gear at 50 CFR 622.385(a)(2)(ii)(B) has already has been subject to notice and comment, and all that remains is to notify the public of the trip limit reduction. They are contrary to the public interest because there is a need to immediately implement this action to protect the king mackerel resource, since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment on this action would require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in effectiveness of this action under 5 U.S.C. 553(d)(3).

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season apportionment of the 2015 Pacific cod total allowable catch (TAC) specified for vessels using jig gear in the BSAI is 1,871 metric tons (mt) as established by the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014) and inseason adjustment (80 FR 188, January 5, 2015).

The 2015 Pacific cod total allowable catch (TAC) allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI is 4,438 mt as established by the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014), inseason adjustment (80 FR 188, January 5, 2015),

The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that jig vessels will not be able to harvest 1,700 mt of the A season apportionment of the 2015 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)( 1 ). Therefore, in accordance with § 679.20(a)(7)(iv)(C), NMFS apportions 1,700 mt of Pacific cod from the A season jig gear apportionment to the annual amount specified for catcher vessels less than 60 feet (18.3 meters(m)) length overall (LOA) using hook-and-line or pot gear.

The harvest specifications for Pacific cod included in the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014) and inseason adjustment (80 FR 188, January 5, 2015) are revised as follows: 171 mt to the A season apportionment and 1,418 mt to the annual amount for vessels using jig gear, and 6,138 mt to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from jig vessels to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear. Since the fishery is currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 15, 2015.

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

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