In FR Doc. 2012-19973 appearing on page 49991 in the Federal Register issue of Monday, August 20, 2012, the following corrections are made:

1. On page 50008, in the second column, instruction `y' is corrected to read as follows: “y. Remove entries 315111, 315119, 315191, 315912, 315211, 315212, 315221 through 315225, 315228, 315231 through 315234, 315239, 315291, 315292, 315299, 315991, 315992, 315993 and 315999;”.

2. On page 50008, in the third column, instruction `ll' is corrected to read as follows: “ll. Add entries for 325130, 325180, and 325194;”.

3. On page 50008, in the third column, instruction `ddd' is corrected to read as follows: “ddd. Add an entry for 332119;”.

4. On page 50008, in the third column, instruction `eee' is corrected to read as follows: “eee. Remove the entries for 332211, 332212, 332213, and 332214;”.

5. On page 50008, in the third column, instruction `jjj' is corrected to read as follows: “jjj. Remove the entries for 332995, 332997, and 332998;”.

On March 29, 2012, at 77 FR 18965, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 to include an AD that would apply to Eurocopter France Model SA341G helicopters, with rotating star, part number (P/N) 341A31.4116.21 installed. That NPRM proposed to require replacing any rotating star with 12,000 or more hours TIS with an airworthy rotating star with less than 12,000 hours TIS. The NPRM also proposed to revise the Airworthiness Limitations section of the Instructions for Continued Airworthiness by reducing the service life of the main rotor rotating star from unlimited hours to 12,000 hours TIS. The proposed requirements were intended to prevent failure of the rotating star and subsequent loss of control of the helicopter.

The Direction Generale de l'Aviation Civile (DGAC), which is the aviation authority for France, has issued DGAC AD No. F-2004-070, dated May 26, 2004, to correct an unsafe condition for Eurocopter France Model SA 341/342 helicopters. The DGAC advises that they issued the AD to require a new service life limit of 12,000 flight hours for the rotating star, part number (P/N) 341A31.4116.21, installed on Model SA341G helicopters.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, DGAC, its technical representative, has notified us of the unsafe condition described in the DGAC AD. We are issuing this AD because we evaluated all information provided by DGAC and determined the unsafe condition exists and is likely to exist or develop on other helicopters of the same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

We estimate that this AD will affect 21 helicopters of U.S. registry and the actions will take approximately 6 work hours per helicopter to accomplish at an average labor rate of $85 per work hour. Required parts will cost approximately $6,000. Based on these figures, we estimate the total cost impact of this AD on U.S. operators to be $6,510 to replace the rotating star on each helicopter, or $136,710 for the entire U.S. fleet.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on February 24, 2012 (77 FR 11019). That NPRM proposed to correct an unsafe condition for the specified products. European Aviation Safety Agency (EASA) AD 2011-0232 states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

Based on the service information, we estimate that this AD affects about 96 engines installed on airplanes of U.S. registry. We also estimate that it will take about 5 work-hours per engine to perform one inspection and about 8 work-hours per engine to perform the rework. The average labor rate is $85 per work-hour. Based on these figures, if all engines are reworked, we estimate the cost of the AD on U.S. operators to perform one inspection and to perform the rework to be $106,080.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (phone: (800) 647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2012-0120, dated July 4, 2012 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

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

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because no affected IP turbine discs are installed in engines that are used on U.S.-registered airplanes. Therefore, we determined that notice and opportunity for public comment before issuing this AD are unnecessary and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2012-0848; Directorate Identifier 2012-NE-20-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of the Web site, anyone can find and read the comments in any of our dockets, including, if provided, the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

On May 21, 2012, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class E airspace for the Kerrville, TX, area, creating additional controlled airspace at Kerrville Municipal Airport/Louis Schreiner Field (77 FR 29921) Docket No. FAA-2011-1399. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Subsequent to publication, it was discovered that the Shein LOM/NDB had been decommissioned. This action removes the Shein LOM/NDB from the regulatory text,

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Kerrville Municipal Airport/Louis Schreiner Field, Kerrville, TX. This action is necessary for the safety and management of IFR operations at the airport. Geographic coordinates are updated to coincide with the FAA's aeronautical database. This action also removes the decommissioned Shein LOM/NDB from the regulatory text.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Kerrville Municipal Airport/Louis Schreiner Field, Kerrville, TX.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule ” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:

Background

Since the Export Administration Act of 1979, as amended (50 U.S.C. app. sections 2401-2420 (2000)), expired in August 2001, parts 730—744 and 746—774 of the EAR (15 CFR Parts 730-774) have been continued in force pursuant to Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), and the annual notices continuing the international emergency declared in that executive order. This rule revises 25 authority citations paragraphs in the Code of Federal Regulations (CFR) to include the President's Notice of August 15, 2012—Continuation of Emergency Regarding Export Control Regulations, 77 FR 49699 (August 16, 2012), which is the most recent such annual notice. In addition, the authority for parts 730, 736 and 746 of the EAR with respect to Syria is based in part on Executive Order 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 168, and the annual notices continuing the international emergency declared in that executive order. This rule revises the authority citation paragraphs for parts 730 and 736 of the EAR to include the President's Notice of May 9, 2012—Continuation of the National Emergency With Respect to the Actions of the Government of Syria, 77 FR 27559 (May 10, 2012), which is the most recent such annual notice. Finally, this rule adds a citation to Executive Order 13338 and the President's Notice of May 9, 2012 to the authority citations paragraph of EAR part 746 because that executive order is the authority for certain license requirements and license application review policies pertaining to Syria that are now located in part 746.

This rule is purely procedural, and makes no changes other than to revise CFR authority citations paragraphs. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.

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). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule does not involve any collection of information.

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

4. The Department finds that there is good cause under 5 U.S.C. 553(b)(3)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746, 747, 748, 750, 752, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774 of the EAR (15 CFR parts 730-774) are amended as follows:

Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-258 for Sulfadimethoxine Soluble Powder, ANADA 200-344 for Tiamulin Soluble Antibiotic, and ANADA 200-345 for Lincomycin-Spectinomycin Soluble Powder to Phibro Animal Health Corp., 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660.

In addition, Phibro Animal Health Corp. has informed FDA of a change of address to GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062 has informed FDA of a change of address to 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067. Accordingly, the Agency is amending the regulations in 21 CFR 510.600 to reflect these changes.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as follows:

PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR Part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR Part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site ( http://www.pbgc.gov ).

The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for October 2012 and updates the asset allocation interest assumptions for the fourth quarter (October through December) of 2012.

The fourth quarter 2012 interest assumptions under the allocation regulation will be 3.07 percent for the first 20 years following the valuation date and 3.00 percent thereafter. In comparison with the interest assumptions in effect for the third quarter of 2012, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), an increase of 0.12 percent in the select rate, and a decrease of 0.66 percent in the ultimate rate (the final rate).

The October 2012 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for September 2011, these interest assumptions are unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during October 2012, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

Direct Final Rule and Significant Adverse Comments

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves nonsubstantive changes dealing with DoD's management of its Privacy Programs. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register . A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

It has been determined that Privacy Act rules for the Department of Defense impose no additional information collection requirements on the public under the Paperwork Reduction Act of 1995.

It has been determined that Privacy Act rules for the Department of Defense do not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

It has been determined that Privacy Act rules for the Department of Defense do not have federalism implications. The rules do not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Accordingly, 32 CFR part 701 is amended as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking GICW Gulf Intracoastal Waterway COTP Captain of the Port LLNR Light List Number A. Regulatory History and Information

The Coast Guard published a NPRM in the Federal Register on July 10, 2012 (77 FR 40541), providing proper notice and opportunity to comment on this rule. No comments were received nor were there any requests for a public meeting.

The Coast Guard is making this rule effective less than 30 days after publication in the Federal Register pursuant to authority the Administrative Procedure Act (APA) (5 U.S.C. 533(d)). This provision authorizes an agency to make a rule effective less than 30 days after publication in the Federal Register when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . This action is necessary for the protection of persons and vessels, on navigable waters, during the construction of a subaqueous water main that begun in June 2012. It would be contrary to public interest to delay the effective date of the rule.

A 36″ subaqueous water main is being constructed across the Choctawhatchee Bay to improve water system delivery. The water main will cross the GICW, a federally maintained navigable channel. Construction of the water main and the required use of turbidity silt curtains pose significant safety hazards to both vessels and mariners operating in or near the GICW. The COTP Mobile is establishing a temporary safety zone for a portion of GICW in Choctawhatchee Bay, Santa Rosa Beach, FL. This temporary safety zone is deemed necessary to protect persons and vessels during construction of the water main across the GICW. The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory safety zones.

The COTP anticipates some impact on vessel traffic due to this regulation. However, the temporary safety zone is deemed necessary for the protection of life and property within the COTP Mobile zone.

There were no comments received by the Coast Guard during the NPRM process; however the regulatory text for this rule has been amended reflecting an updated effective period and anticipated closure times for the safety zone. The original effective date of August 1, 2012 to September 30, 2012 has been amended to read; September 14, 2012 to October 14, 2012. This amendment is necessary to reflect changes in the project's timeline. Also the regulatory text “during daylight hours” is being removed and amended to reflect more accurate closure times for the safety zone.

The Coast Guard is establishing a temporary safety zone for a portion of the GICW in Choctawhatchee Bay from the Highway 331 fixed bridge west to the Red Nun Buoy “26” (LLNR 31510), to include the entire width of the channel. This rule will protect the safety of life and property in this area. Entry into or transiting in this zone will be prohibited to all vessels, mariners, and persons unless specifically authorized by the COTP Mobile or a designated representative. The COTP may be contacted by telephone at (251) 441-5976.

This rule will be effective and enforceable with actual notice from September 14, 2012 to October 14, 2012. The COTP Mobile anticipates that this rule will be enforced for approximately three (3) days, to include a complete Twenty-Four (24) hour closure of the GICW. The COTP Mobile or a designated representative will inform the public through Broadcast Notices to Mariners of the specific enforcement periods throughout the water main construction project as well as any changes in the safety zone.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The temporary safety zone listed in this rule will only restrict vessel traffic from entering or transiting a small portion of the GICW. The effect of this regulation will not be significant for several reasons: (1) The COTP Mobile will issue maritime advisories widely available to users of the waterway; (2) this rule will only affect vessel traffic that are subject to transiting the GICW due to draft restrictions; and (3) the impacts on routine navigation are expected to be minimal. Notifications to the marine community will be made through Local Notices to Mariners and Broadcast Notices to Mariners. These notifications will allow the public to plan operations around the affected area.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612), as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit the affected portion of the GICW during construction of the water main. This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This safety zone is limited in size, is of short duration and shallow draft vessel traffic may pass safely around the temporary safety zone.

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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 would not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule would 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 does not create an environmental risk to health or risk to safety that may 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.

This rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone for a portion of the GICW in Choctawhatchee Bay, Santa Rosa Beach, FL, for the safety of the public and is not expected to result in any significant adverse environmental impact as described in NEPA. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES .

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

Throughout this document, wherever “we”, “us” or “our” are used, we mean EPA. We are providing the following outline to aid in locating information in this rule.

EPA is making several separate and independent types of determinations with respect to a number of 1997 8-hour ozone nonattainment areas in California. First, pursuant to section 181(b)(2) of the Clean Air Act (CAA), EPA is determining that the Amador and Calaveras Counties (Central Mountain Counties), Chico (Butte County), Kern County (Eastern Kern), Mariposa and Tuolumne Counties (Southern Mountain Counties), Nevada County (Western Nevada County), and Sutter County (Sutter Buttes) 8-hour ozone nonattainment areas in California (herein referred to as the “six CA areas”) attained the 1997 8-hour ozone NAAQS by their respective applicable attainment dates. Second, in connection with this determination, EPA is also granting, pursuant to section 181(a)(5) and 40 CFR 51.907, applications submitted by the California Air Resources Board (CARB) for extensions to the applicable attainment dates for the Southern Mountain Counties and Western Nevada County nonattainment areas.

The applicable attainment dates vary among the six CA areas. For Butte County and Sutter Buttes, EPA is determining that these areas attained the 1997 8-hour ozone standard by their applicable attainment deadline of June 15, 2007, based on complete, quality-assured, and certified ambient air quality monitoring data for 2004-2006. For the Central Mountain Counties and Eastern Kern ozone nonattainment areas, EPA is determining that they attained the 1997 8-hour ozone standard by their applicable attainment deadline of June 15, 2010, based on complete, quality-assured and certified air quality data for 2007-2009. For the Southern Mountain Counties and Western Nevada County, whose original attainment date was June 15, 2010, EPA is granting a one-year attainment date extension until June 15, 2011 and determining that these areas attained the 1997 8-hour ozone NAAQS by that extended attainment date, based on complete, quality-assured data for 2008-2010.

In addition, for all the areas listed above and for Ventura County, 1 EPA is determining, based on complete, quality-assured and certified air quality monitoring data for 2009-2011, that these areas have attained and continue to attain the 1997 8-hour ozone NAAQS. Preliminary data for 2012 indicate that these areas continue to attain the NAAQS. Under the provisions of 40 CFR 51.918, these latter determinations suspend the obligation of the State to submit certain planning requirements related to attainment for as long as the areas continue to attain the standard.

In 1997, EPA revised the health-based NAAQS for ozone, setting it at 0.08 parts per million (ppm) averaged over an 8-hour time frame. EPA set the 8-hour ozone standard based on scientific evidence demonstrating that ozone causes adverse health effects at lower ozone concentrations and over longer periods of time than was understood when the pre-existing 1-hour ozone standard was set. EPA determined that the 8-hour standard would be more protective of human health, especially for children and adults who are active outdoors, and individuals with a pre-existing respiratory disease, such as asthma.

On March 27, 2008 (73 FR 16436), EPA promulgated a revised 8-hour ozone NAAQS of 0.075 ppm. On April 30, 2012 (77 FR 30088 and 77 FR 30160), EPA issued final rules addressing air quality designations and implementation of the 2008 8-hour ozone NAAQS. The rulemakings that are the subject of this notice concern only the 1997 8-hour ozone NAAQS and are not affected by the 2008 8-hour ozone NAAQS.

On April 30, 2004 (69 FR 23858), EPA finalized its attainment/nonattainment designations for areas across the country with respect to the 8-hour ozone standard. In that action EPA designated Butte County, the Central Mountain Counties, Eastern Kern, the Southern Mountain Counties, Sutter Buttes, and Western Nevada County as nonattainment under title I, part D, subpart 1 of the CAA (subpart 1) and provided that these designations would become effective on June 15, 2004. Also in EPA's April 30, 2004 action, Ventura County was designated nonattainment under title I, part D, subpart 2 of the CAA (subpart 2) and classified as “moderate”. 2

In June 2007, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit Court) vacated the portion of the 1997 ozone implementation rule that allowed areas to be designated under subpart 1. 3 On January 16, 2009 (74 FR 2936), EPA published a proposed rule to address, among other issues, the D.C. Circuit Court vacatur of the classification system that EPA used to designate a subset of initial 1997 8-hour ozone nonattainment areas under subpart 1. In that rulemaking, EPA proposed that all areas designated nonattainment for the 1997 8-hour ozone NAAQS under subpart 1 would be classified as subpart 2 areas (hereafter referred to as the “Subpart 1/Subpart 2 1997 8-Hour Ozone Rulemaking”). The Butte County, Central Mountain Counties, Eastern Kern, Southern Mountain Counties, Sutter Buttes, and Western Nevada County ozone nonattainment areas were among those areas that would be classified under subpart 2. On May 14, 2012 (77 FR 28424), EPA finalized the Subpart 1/Subpart 2 1997 8-Hour Ozone Rulemaking. The boundaries, resulting classifications and attainment dates for the six new subpart 2 California nonattainment areas and Ventura County are provided in Table 1.

The 8-hour ozone implementation rule gives EPA discretion to grant up to two one-year extensions of the attainment date upon application by the state. The criteria for such a request are found in CAA section 181(a)(5) and 40 CFR 51.907. The state must show that (1) the state has complied with all requirements and commitments pertaining to the area in the applicable State Implementation Plan (SIP); and (2) no more than one exceedance of the NAAQS has occurred in the area in the year preceding the extension year.

Under the provisions of EPA's ozone implementation rule for the 1997 ozone NAAQS ( see 40 CFR 51.918), if EPA issues a determination that an area is attaining the standard (through a rulemaking that includes public notice and comment), it will suspend the area's obligations to submit an attainment demonstration and associated reasonable available control measures (RACM), a reasonable further progress (RFP) plan, contingency measures and other planning requirements related to attainment for as long as the area continues to attain. The determination of attainment is not equivalent to a redesignation. The state must still meet the statutory requirements for redesignation in order for an area to be redesignated to attainment.

A determination of whether an area's air quality meets the ozone NAAQS is generally based upon the most recent three years of complete, quality-assured data gathered at established State and Local Air Monitoring Stations (SLAMS) in the nonattainment area and entered into the EPA Air Quality System (AQS) database. Data from air monitors operated by state/local agencies in compliance with EPA monitoring requirements must be submitted to AQS. Heads of monitoring agencies annually certify that these data are accurate to the best of their knowledge. Accordingly, EPA relies primarily on data in AQS when determining the attainment status of areas. See 40 CFR 50.10; 40 CFR part 50, appendix I; 40 CFR part 53; 40 CFR part 58, appendices A, C, D and E. All data are reviewed to determine the area's air quality status in accordance with 40 CFR part 50, appendix I.

Under EPA regulations at 40 CFR part 50, the 1997 8-hour ozone standard is attained at a site when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentrations at an ozone monitor is less than or equal to 0.08 ppm. See 40 CFR 50.10. This 3-year average is referred to as the design value. When the design value is less than or equal to 0.084 ppm (based on the rounding convention in 40 CFR part 50, appendix I) at each monitoring site within the area, then the area is meeting the NAAQS. The data completeness requirement is met when the three-year average percent of days with valid ambient monitoring data is at least 90%, and no single year has less than 75% data completeness as determined in Appendix I of 40 CFR part 50.

Pursuant to CAA section 181(a)(5) and 40 CFR 51.907, the State has requested, and EPA is approving one-year attainment date extensions for the Southern Mountain Counties and Western Nevada County nonattainment areas. The effect of granting the attainment date extensions is to allow the State an additional year to demonstrate that the Southern Mountain Counties and Western Nevada County nonattainment areas have attained the 1997 8-hour ozone NAAQS pursuant to section 181(b)(2) of the CAA. Without the one-year extension, the State cannot demonstrate that the two areas attained 1997 8-hour ozone NAAQS by the attainment dates in 77 FR 28424.

Pursuant to section 181(b)(2) of the CAA, EPA is determining that the Butte County, Central Mountain Counties, Eastern Kern, Southern Mountain Counties, Sutter Buttes, and Western Nevada County ozone nonattainment areas attained the 1997 8-hour ozone NAAQS by their applicable attainment dates.

These determinations discharge EPA's obligations under section 181(b)(2) with respect to determining whether these areas attained by their respective attainment deadlines, and establish that these areas are not subject to reclassification for failure to attain by these deadlines.

In addition, EPA is separately determining that the six CA areas and Ventura County have attained the standard based upon the most recent three years of data (without reference to their attainment deadlines). Under the provisions of 40 CFR 51.918, these determinations of attainment suspend the obligation for the State to submit certain planning requirements described above; however, they do not constitute redesignations to attainment under section 107(d)(3) of the CAA. The designation status of the six CA areas and Ventura County remains nonattainment for the 1997 8-hour ozone NAAQS until such time as EPA determines that each area meets the CAA requirements for redesignation to attainment, including an approved maintenance plan.

In accordance with 40 CFR 51.918, based on these determinations, the obligation under the CAA for the State of California to submit an attainment demonstration and RACM, RFP plan, contingency measures, and any other planning requirements related to attainment of the 1997 8-hour ozone NAAQS for these seven ozone nonattainment areas is suspended for so long as the areas continue to attain the 1997 8-hour ozone NAAQS. Although these requirements are suspended, EPA is not precluded from acting upon these elements, if California submits them for EPA review and approval.

The suspension continues until such time, if any, that EPA (i) redesignates the area to attainment at which time those requirements no longer apply, or (ii) subsequently determines that the area has violated the 1997 8-hour ozone NAAQS. It is separate from, and does not influence or otherwise affect, any future designation determination or requirements for the area based on any new or revised ozone NAAQS. It remains in effect regardless of whether EPA designates the area as a nonattainment area for purposes of any new or revised ozone NAAQS.

If EPA subsequently determines, after notice-and-comment rulemaking, that any one of these nonattainment areas has violated the 1997 8-hour ozone NAAQS, the basis for the suspension of the requirements for that area, provided by 40 CFR 51.918, would no longer exist, and the violating ozone nonattainment area would thereafter have to address those requirements.

CARB is the governmental agency delegated under State law with the authority and responsibility for collecting ambient air quality data as directed by the CAA of 1977 and CAA Amendments of 1990. CARB and local Air Pollution Control Districts and Air Quality Management Districts (“Districts”) operate ambient monitoring stations throughout the State. CARB is the lead monitoring agency in the Primary Quality Assurance Organization  10 (PQAO) that includes all the monitoring agencies in the State with a few exceptions. 11 CARB, Butte County Air Pollution Control District (APCD), Northern Sierra Air Quality Management District (AQMD), and Ventura County APCD are the agencies responsible for monitoring ambient air quality within the seven nonattainment areas affected by today's final action. In addition, CARB oversees the quality assurance of all data collected within the CARB PQAO. CARB submits annual monitoring network plans to EPA that describe the monitoring sites CARB operates, in addition to monitoring sites operated by many smaller air districts, including Butte County APCD and Northern Sierra AQMD. Ventura County APCD submits the annual monitoring network plan for all sites in Ventura County. These plans discuss the status of the air monitoring network, as required under 40 CFR part 58.10.

Since 2007, EPA has regularly reviewed these annual plans for compliance with the applicable reporting requirements in 40 CFR part 58. With respect to ozone, EPA has found that the areas' network plans meet the applicable requirements under 40 CFR part 58. See EPA letters to CARB approving its annual network plans for years 2007, 2009, 2010, and 2011. 12 CARB did not propose modifications to their network in 2008 and therefore was not required to submit a network plan to EPA for approval. 13 EPA also concluded  14 from its Technical System Audit of the CARB PQAO (conducted during Summer 2007), that the combined ambient air monitoring network operated by CARB and the local air districts in their PQAO (which includes Butte County APCD, Northern Sierra AQMD, and Ventura County APCD) currently meets or exceeds the requirements for the minimum number of SLAMS for all criteria pollutants for the areas addressed in this action, and that all of the monitoring sites are reviewed with respect to monitoring objectives, spatial scales and other site criteria as required by 40 CFR part 58, appendix D. Also, CARB annually certifies that the data it submits to AQS are complete and quality-assured. This includes data from all CARB sites, along with some data for local district sites. 15 Northern Sierra AQMD annually certifies that the data it submits for its Grass Valley site to AQS are complete and quality-assured. 16 Ventura County APCD annually certifies that the data it submits for Ventura County to AQS are complete and quality-assured. 17 Data for National Park Service sites, which includes the Yosemite—Turtleback Dome site, are certified by the National Park Service. 18

There were 16 ozone SLAMS monitoring sites operating during the 2004-2011 period within the seven ozone nonattainment areas addressed in today's action. These 16 sites monitored ozone concentrations on a continuous basis  19 using ultraviolet absorption monitors. For most sites, the spatial scale and monitoring objectives are “regional” and “high concentrations.”  20 Consistent with the requirements contained in 40 CFR part 50, EPA has reviewed the complete, quality-assured, and certified 8-hour ozone ambient air monitoring data as recorded in AQS for the applicable monitoring period collected at the monitoring sites in the seven nonattainment areas.

Based on our review of the monitoring data, and taking into account the reliability of the ozone monitoring network in the relevant CA nonattainment areas and the reliability of the data collected by the network, EPA makes the determinations presented in the following paragraphs.

Table 2 shows the ozone design values for the Butte County and Sutter Buttes ozone nonattainment area monitors, based on ambient air quality monitoring data for the three-year period (2004-2006) prior to the applicable attainment date (June 15, 2007) and for the most recent three-year period (2009-2011). The data show that the design value for the 2004-2006 period was equal to or less than 0.084 ppm at all of the monitors. Therefore, pursuant to CAA section 181(b)(2), we are determining that the Butte County and Sutter Buttes marginal nonattainment areas attained the 1997 8-hour ozone NAAQS by their applicable attainment date of June 15, 2007, based on complete, quality-assured data for the 2004-2006 ozone seasons. In addition, the data show that the design value for the 2009-2011 period was also equal to or less than 0.084 ppm at all of the monitors. Therefore, we are determining, based on the complete, quality-assured data for 2009-2011, that the Butte County and Sutter Buttes areas have attained the standard. Preliminary data available for 2012 indicate that the areas continue to attain the standard.

Table 3 shows the ozone design values for the Eastern Kern and Central Mountain Counties ozone nonattainment area monitors based on ambient air quality monitoring data for the three-year period (2007-2009) prior to the applicable attainment date (June 15, 2010) and the most recent three-year period (2009-2011). The data show that the design value for the 2007-2009 period was equal to or less than 0.084 ppm at all of the monitors. Therefore, pursuant to section 181(b)(2), we are determining that the Eastern Kern and Central Mountain Counties moderate nonattainment areas attained the 1997 8-hour ozone NAAQS by their applicable attainment deadline of June 15, 2010, based on the complete, quality-assured data for the 2007-2009 ozone seasons. In addition, the data show that the design value for the 2009-2011 period was also equal to or less than 0.084 ppm at all of the monitors. Therefore, we are determining, based on the complete, quality-assured data for 2009-2011, that the Eastern Kern and Central Mountain Counties areas have attained the 1997 8-hour ozone standard. Preliminary data available for 2012 indicate that the areas continue to attain the standard.

Table 4 shows the fourth-highest daily maximum recorded for 2009, the ozone design values for the Southern Mountain Counties and Western Nevada County nonattainment area monitors based on 2008-2010 ambient air quality monitoring data, and the ozone design values for the most recent three-year period (2009-2011). Because the Southern Mountain Counties and Western Nevada County are classified as “moderate” nonattainment areas, the applicable attainment date for both areas was set as June 15, 2010. However, the air quality and other factors in these areas showed the areas were eligible, pursuant to CAA section 181(a)(5) and 40 CFR 51.907, for extensions of the applicable attainment date for these two areas from June 15, 2010 to June 15, 2011. CARB applied to EPA for these extensions by letters dated March 23, 2010 and May 24, 2010 for Southern Mountain Counties and Western Nevada County, respectively (see also footnotes 5 and 9 in table 1 of this direct final rule).

As noted previously, under CAA section 181(a)(5) and 40 CFR 51.907, upon application of a State, EPA may extend for one additional year (“extension year”) the applicable attainment date if (1) the State has complied with all requirements and commitments pertaining to the area in the applicable State Implementation Plan (SIP); and (2) no more than one exceedance of the NAAQS has occurred in the area in the year preceding the extension year. No more than two one-year extensions are allowed. We have reviewed the requests using the criteria set forth at CAA section 181(a)(5) and are approving the extensions in today's action. The basis for our approval is set forth below.

First, the fourth-highest value recorded at the monitors in each of these areas did not exceed the NAAQS during 2009, the year preceding the extension year, thereby meeting one of the two criteria. Second, EPA interprets the requirement that the State is complying with the commitments and requirements in the applicable implementation plan, as referenced in section 181(a)(5) of the CAA, to mean the State is implementing the EPA-approved SIP. 21 EPA has determined that the State is implementing the requirements in the EPA-approved SIP as applicable to these two nonattainment areas, thereby meeting the other criterion under section 181(a)(5). Therefore, because both criteria under CAA section 181(a)(5) are met in both areas, we are granting the one-year extensions for these two areas, and with the granting of one-year extensions under section 181(a)(5) for these areas, the applicable attainment date for the Southern Mountain Counties and Western Nevada County becomes June 15, 2011. With respect to this extended applicable attainment date, the data in table 4 show that the design value for the 2008-2010 period was equal to or less than 0.084 ppm at all of the monitors. Therefore, pursuant to section 181(b)(2), we are determining that the Southern Mountain Counties and Western Nevada County moderate nonattainment areas attained the 1997 8-hour ozone NAAQS by their applicable attainment deadlines of June 15, 2011, based on the complete, quality-assured data for the 2008-2010 ozone seasons. In addition, the data show that the design value for the 2009-2011 period was also equal to or less than 0.084 ppm at all of the monitors. Therefore, we are also determining, based on the most recent three years of complete, quality-assured data for 2009-2011, that the Southern Mountain Counties and Western Nevada County areas have attained the standard. Preliminary data available for 2012 indicate that the areas continue to attain the standard.

Table 5 shows the ozone design values for the Ventura County ozone nonattainment area monitors, based on ambient air quality monitoring data for the most recent three-year period (2009-2011). 22 The data show that the design value for the 2009-2011 period was equal to or less than 0.084 ppm at all of the monitors. Therefore, we are determining, based on the complete, quality-assured data for 2009-2011, that the Ventura County serious ozone nonattainment area has attained the 1997 8-hour ozone standard. Preliminary data available for 2012 indicate that the area continues to attain the standard.

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, but are not limited to those engaged in the following activities:

• 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://ecfr.gpoaccess.gov/cgi/t/text/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-2009-1008 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 November 13, 2012. 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-2009-1008, 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.htm.

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

In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7652) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The petition requested that 40 CFR 180.442 be amended by establishing tolerances for residues of the insecticide bifenthrin, (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on tea (import tolerance) at 25 parts per million (ppm); and tolerances with regional registrations in or on grass, forage at 2.5 ppm and grass, hay at 4.5 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerances for several commodities and revised the commodity definition for tea to tea, dried. The Agency has also revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reasons for these changes are explained in Unit IV.D.

To control the brown marmorated stink bug, EPA is also establishing time-limited tolerances for the use of bifenthrin in or on apple, nectarine, and peach at 0.5 ppm. These tolerances expire and are revoked on December 31, 2015. The Agency is establishing the time-limited tolerances in response to an informal crisis exemption request under FIFRA section 18 on behalf of the states of Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, Virginia, and West Virginia for the emergency use of bifenthrin to control the brown marmorated stink bug on these commodities.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of bifenthrin in or on apple, nectarine, and peach. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and the Agency decided that the necessary tolerances under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2015, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on apple, nectarine, and peach after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions whether bifenthrin meets FIFRA's registration requirements for use in or on apple, nectarine, and peach, or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerances serve as a basis for registration of bifenthrin by a State for Special Local Needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than those listed to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for bifenthrin, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 assessment 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 bifenthrin including exposure resulting from the tolerances, including the time-limited tolerances, established by this action. EPA's assessment of exposures and risks associated with bifenthrin 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.

Bifenthrin has a low order of acute toxicity via the dermal and inhalation routes of exposure and has moderate acute toxicity via the oral route. It is neither an eye nor skin irritant, and it is not a dermal sensitizer. Behavioral changes characteristic of Type I pyrethroids, such as muscle tremors, were noted in most of the bifenthrin experimental toxicology studies, consistent with its mode of action of delaying the inactivatation of voltage gated sodium channels. Additional effects seen in one or more toxicity studies for bifenthrin included muscle twitching, decreased grip strength, altered landing foot splay, depressed respiration, increased grooming counts, loss of muscle coordination, staggered gait, exaggerated hind limb flexion, and convulsions at high doses. Decreased body weight, body weight gains and food consumption were also noted in repeat-dosing dietary studies. Evidence of increased qualitative or quantitative susceptibility of offspring was not observed in any of the available guideline toxicity studies for bifenthrin.

Bifenthrin is classified as a “possible human carcinogen” based on an increased incidence of urinary bladder tumors in mice. However, EPA concluded that the bladder tumors may not be uncommon in mice and are not likely to be malignant. Additionally, these tumors were observed only in male mice at the highest dose tested and the incidence was of borderline significance. No evidence of carcinogenicity was observed in bifenthrin carcinogenicity studies in rats, and bifenthrin was negative in five different tests for mutagenicity but was marginally active in a forward mutation test in mouse lymphoma cells. Overall, based on the available information, there is a low concern for mutagenicity. Taking into account all of this information, the Agency has determined that quantification of risk using a non-linear approach (i.e., acute population-adjusted dose (aPAD)) will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to bifenthrin. While the Agency would typically use a chronic population-adjusted dose (cPAD) to protect for cancer concerns, use of the aPAD is protective for bifenthrin because increasing toxicity with increasing duration of exposure is not seen for bifenthrin. The no observed adverse effect level (NOAEL) observed in the mouse chronic study, in which tumors were observed, is 6.7 mg/kg/day, 2-fold higher than the points of departure (POD) used for acute risk assessment.

Specific information on the studies received and the nature of the adverse effects caused by bifenthrin as well as the dose at which the motor activity change is equal to one standard deviation (SD) from the control value (BMD 1SD ), and the lower 95% confidence limit of the BMD value (the BMDL 1SD ), resulting from the benchmark data (BMD) analysis of the toxicity studies can be found at http://www.regulations.gov in document, “Bifenthrin: Human Health Risk Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use on Apple, Nectarine, and Peach” at pages 62-70 in docket ID number EPA-HQ-OPP-2009-1008.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. Typically, 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 bifenthrin 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 bifenthrin, EPA considered exposure under the petitioned-for tolerances and those being established in response to the Agency issuing section 18 emergency exemptions, as well as all existing bifenthrin tolerances in 40 CFR 180.442. EPA assessed dietary exposures from bifenthrin 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 bifenthrin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a highly-refined, acute probabilistic dietary exposure and risk assessment for all established food uses as well as the petitioned for tolerances and the section 18 time-limited tolerances. Anticipated residues (ARs) were developed based on the following: USDA's Pesticide Data Program (PDP) monitoring data from 1998-2010 for bell pepper, blueberry, broccoli, cabbage, cauliflower, cilantro, cranberry, cucumber, egg, eggplant, grape, grapefruit, orange, orange juice, lettuce, pear, cantaloupe, winter squash, spinach—canned, succulent bean, strawberry, sweet corn, sweet peas, tomato, watermelon and milk; the Food and Drug Administration (FDA) 2002 data for blackberry and raspberry; and field trial data for bifenthrin. ARs were further refined using percent crop treated (PCT) data and processing factors, where appropriate.

Additionally, the uses proposed under the section 18 emergency exemption program have use patterns that are similar to the registered use on pear. Therefore, the Agency relied on PDP data for pears, including for baby food and canned products, when assessing anticipated residues on peach, nectarine, and apple. EPA believes the use of PDP data for pears is appropriate, as bifenthrin residues are found mainly on the fruit surface and residues on peach, nectarine, and apple are expected to be similar to those found on pear.

ii. Chronic exposure. Based on the data summarized in Unit III.A., there is no increase in hazard from repeated exposures to bifenthrin; the acute dietary exposure assessment is protective for chronic dietary exposures because acute exposure levels are higher than chronic exposure levels. Accordingly, a dietary exposure assessment for the purpose of assessing chronic dietary risk was not conducted.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., the Agency has determined that quantification of risk using a non-linear approach (i.e., aPAD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to bifenthrin. Additionally, since the cancer dietary assessment assumed average residue levels and the acute assessment used high-end residue levels, the acute dietary assessment will be protective of any cancer effects resulting from consumption of bifenthrin residues in foods.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

The Agency estimated the PCT for existing uses as follows:

Alfalfa, 1%; almond, 25%; artichoke, 30%; beans, green, 50%; broccoli, 6%; cabbage, 30%; caneberries, 45%; canola/rapeseed, 3%; cantaloupe, 60%; carrots 10%; cauliflower, 10%; celery, 1%; corn, 5%; cotton, 10%; cucumbers, 15%; dry beans and peas, 1%; grape, table, 1%; grape, wine, 5%; honeydew, 75%; hazelnut (filberts), 5%; lettuce, 15%; onion, 1%; lima bean, 35%; peanut, 5%; pea, green, 25%; pear, 4%; pecan, 5%; pepper, 20%; pistachio, 40%; potato, 5%; pumpkin, 40%; sorghum, 1%; soybean, 5%; squash, 20%; strawberry, 55%; sweet corn, 50%; tomato, 20%; walnut, 25%; watermelon, 15%; wheat, spring, 1%; and wheat, winter, 1%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency estimated the PCT for the new uses associated with the time-limited tolerances as follows:

Apple, 10%; nectarine, 3%; and peach, 7%.

Bifenthrin is being considered for use on apple, nectarine, and peach in Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, Virginia, and West Virginia to control the brown marmorated stink bug under FIFRA section 18, which allows for the emergency use of a pesticide on a site for which it is not registered.

The Agency conservatively estimated that 100 percent of the crops in these states will be treated with bifenthrin and calculated the national PCT given the share of utilized production or grown acreage from the seven states likely to seek the use of bifenthrin.

EPA used data from 2010 USDA/NASS for apples and peaches. Data on the most recent survey years, 2007-2009, were used to derive the needed PCT estimates. The sum of the utilized production in these states was divided by the total domestic utilized production and multiplied by 100 to determine the PCT for each of the crops for each of the named years.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations, including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which bifenthrin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for bifenthrin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of bifenthrin. 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 First Index Reservoir Screening Tool (FIRST), Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of bifenthrin for acute exposures are estimated to be 0.0140 parts per billion (ppb) for surface water and 0.0030 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 0.0140 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). Bifenthrin is currently registered for several uses that could result in residential exposures: In indoor residential/household premises as a crack and crevice spray, paint additive and as a dust, in or on automobiles/recreational vehicles, and for termite treatments. Residential exposure is also anticipated from a pending registration for bed bug treatment use, including surface-directed application to indoor surfaces. Outdoor residential uses of bifenthrin include broadcast and spot treatments to residential lawns and turf; golf course turf and outdoor premises by means of liquid spray and granular products; and ornamental uses (turf, shrubs, vines, trees, ground cover). EPA assessed residential handler and post-application exposures for the existing and proposed bed bug uses of bifenthrin.

The Agency combines risk values resulting from separate routes of exposure when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population, and if the hazard associated with the points of departure is similar across routes. A common toxicological endpoint, neurotoxicity, exists for dermal, incidental oral, and inhalation routes of exposure to bifenthrin. Therefore, these were combined for all residential exposure scenarios assessed.

Of the proposed and established uses with potential residential handler and post-application exposure, the following high-end risk estimates were selected for use in the bifenthrin short-term aggregate assessment: Combined dermal and inhalation exposures to adults from the outdoor ornamental use and combined dermal and incidental oral exposures to children from contact with treated turf.

Residential handler and post-application exposure scenarios are generally not combined. Although the potential exists for the same individual (i.e., adult) to apply a pesticide around the home and be exposed by re-entering a treated area in the same day, this is an unlikely exposure scenario. Combining these exposure scenarios would also be inappropriate because of the conservative nature of each individual assessment.

EPA did not assess intermediate-term and chronic residential exposures because bifenthrin is acutely toxic and does not increase in potency with repeated dosing. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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.”

The Agency is required to consider the cumulative risks of chemicals sharing a common mechanism of toxicity. The Agency has determined that the pyrethroids and pyrethrins, including bifenthrin, share a common mechanism of toxicity. The members of this group share the ability to interact with voltage-gated sodium channels, ultimately leading to neurotoxicity. The cumulative risk assessment for the pyrethroids/pyrethrins was published in the Federal Register on November 9, 2011 (76 FR 69726) (FRL-8888-9), and is available at http://www.regulations.gov in the public docket, EPA-HQ-OPP-2011-0746. Further information about the determination that pyrethroids and pyrethrins share a common mechanism of toxicity may be found in document ID number: EPA-HQ-OPP-2008-0489-0006.

The Agency has conducted a quantitative analysis of the proposed bifenthrin bed bug use and has determined that it will not contribute significantly or change the overall findings presented in the pyrethroid cumulative risk assessment. This analysis is summarized in the document: “Bifenthrin: Human Health Risk Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use on Apple, Nectarine, and Peach” at pages 78-81 in docket ID number EPA-HQ-OPP-2009-1008. Further, the proposed food uses of bifenthrin will not contribute significantly or change the overall findings in the pyrethroid cumulative risk assessment, as the dietary risks are a minor component of total pyrethroid cumulative risk. For information regarding EPA's efforts to evaluate the risk of exposure to pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

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

2. Prenatal and postnatal sensitivity. The bifenthrin toxicity database includes developmental toxicity studies in rats and rabbits, a 2-generation reproduction study in rats, and a developmental neurotoxicity (DNT) study in rats. Bifenthrin is neither a developmental nor a reproductive toxicant. In the developmental toxicity studies in rat and rabbit, no developmental effects of biological significance were noted in either species in the presence of maternal toxicity. In a 2-generation reproduction study in the rat, tremors were noted only in females of both generations with one parental generation rat observed to have clonic convulsions.

There are several in vitro and in vivo studies that indicate pharmacodynamic contributions to pyrethroid toxicity are not age-dependent. A study of the toxicity database for pyrethroid chemicals also noted no residual uncertainties regarding age-related sensitivities for the young, based on the absence of prenatal sensitivity observed in 76 guideline studies for 24 pyrethroids and the scientific literature. However, high-dose studies at LD 50 doses noted that younger animals were more susceptible to the toxicity of pyrethroids. These age-related differences in toxicity are principally due to age-dependent pharmacokinetics; the activity of enzymes associated with the metabolism of pyrethroids increases with age. Nonetheless, the typical environmental exposures to pyrethroids are not expected to overwhelm the clearance capacity in juveniles. In support, at a dose of 4.0 mg/kg deltamethrin (near the Wolansky study LOAEL value of 3.0 mg/kg for deltamethrin), the change in the acoustic startle response was similar between adult and young rats.

3. Conclusion. Given different levels of uncertainty for various risk assessment scenarios, EPA is applying different FQPA safety factors for the protection of fetuses, infants, and children depending on the route of exposure and the population exposed. For non-inhalation exposure scenarios for adults (including women of child-bearing age) and children greater than 6 years of age, EPA is reducing the FQPA safety factor to 1X. For non-inhalation exposure scenarios for infants and children less than six years of age, EPA is reducing the FQPA safety factor to 3X. Finally, for inhalation exposure scenarios for all population groups, EPA is also retaining a 10X FQPA safety factor. Because the 3X factor for infants and children less than six years of age and the 10X factor for inhalation exposure scenarios are in response to different uncertainties, these safety factors have been combined for inhalation exposure scenarios for infants and children less than six years of age resulting in a FQPA safety factor of 30X. That decision on the various levels of the FQPA safety factor is based on the following considerations:

i. The toxicity database for bifenthrin is not complete. EPA lacks additional data on immunotoxicity, inhalation toxicity, and adult-juvenile sensitivity. Recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OCSPP Guideline 870.7800) for pesticide registration. The toxicology database for bifenthrin does not show any evidence of treatment-related effects on the immune system, and the overall weight-of-evidence suggests that this chemical does not directly target the immune system. Therefore, the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently in use for overall risk assessment, and additional safety factors are not needed to account for a lack of this study. EPA is requiring an inhalation toxicity study for bifenthrin because inhalation data for other pyrethroids show the potential for the inhalation route to be more potent than the oral route. Currently, the POD for inhalation risk assessment scenarios is based on an oral toxicity study. Reliance on an oral study raises uncertainty as to whether the standard safety factors are protective of infants and children. Finally, in light of the literature studies indicating a possibility of increased sensitivity to bifenthrin in juvenile rats at high doses, EPA has also requested proposals for study protocols which could identify and quantify bifenthrin's potential juvenile sensitivity. For the reasons discussed in Unit III.D.3.ii., the uncertainty regarding the protectiveness of the intraspecies uncertainty factor raised by the literature studies and the absence of the requested data warrant application of an additional 3X for risk assessments for infants and children under six years of age.

ii. There is no evidence that bifenthrin 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. This is consistent with the results of the guideline pre- and post-natal testing for other pyrethroid pesticides. There are, however, high dose LD 50 studies (studies assessing what dose results in lethality to 50 percent of the tested population) in the scientific literature indicating that pyrethroids can result in increased quantitative sensitivity in the young. Examination of pharmacokinetic and pharmacodynamic data indicates that the sensitivity observed at high doses is related to pyrethroid age-dependent pharmacokinetics—the activity of enzymes associated with the metabolism of pyrethroids. Predictive pharmacokinetic models indicate that the differential adult-juvenile pharmacokinetics will result in otherwise equivalent administered doses for adults and juveniles producing a 3X greater dose at the target organ in juveniles compared to adults. No evidence of increased quantitative or qualitative susceptibility was seen in the pyrethroid scientific literature related to pharmacodynamics (the effect of pyrethroids at the target tissue) both with regard to inter-species differences between rats and humans and to differences between juveniles and adults. Specifically, there are in vitro pharmacodynamic data and in vivo data indicating similar responses between adult and juvenile rats at low doses and data indicating that the rat is a conservative model compared to the human based on species-specific pharmacodynamics of homologous sodium channel isoforms in rats and humans.

In light of the high dose literature studies showing juvenile sensitivity to pyrethroids and the absence of the requested data on juvenile sensitivity to pyrethroids, EPA is retaining a 3X additional safety factor as estimated by pharmacokinetic modeling. For several reasons, EPA concludes there are reliable data showing that a 3X factor is protective of the safety of infants and children. First, the high doses that produced juvenile sensitivity in the literature studies are well above normal dietary or residential exposure levels of pyrethroids to juveniles and these lower levels of exposure are not expected to overwhelm the ability metabolize pyrethroids as occurred with the high doses used in the literature studies. This is confirmed by the lack of a finding of increased sensitivity in pre- and post-natal guideline studies in any pyrethroid, including bifenthrin, despite the relatively high doses used in those studies. Second, the portions of both the inter- and intraspecies uncertainty factors that account for potential pharmacodynamic differences (generally considered to be approximately 3X for each factor) are likely to overstate the risk of inter- and intraspecies pharmacodynamic differences given the data showing similarities in pharmacodynamics between juveniles and adults and between humans and rats. Finally, as indicated, pharmacokinetic modeling only predicts a 3X difference between juveniles and adults.

iii. There are no residual uncertainties identified in the bifenthrin databases with regard to dietary (food and drinking water), and residential exposures. Although the acute dietary exposure estimates are refined, as described in Unit III.C.1.i., the exposure estimates will not underestimate risk for the established and proposed uses of bifenthrin since the residue levels used are based on either monitoring data reflecting actual residues found in the food supply, or on high-end residues from field trials which reflect the use patterns which would result in highest residues in foods. Furthermore, processing factors used were either those measured in processing studies, or default high-end factors representing the maximum concentration of residue into a processed commodity. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to bifenthrin in drinking water. Further, postapplication exposure of children and incidental oral exposure of toddlers are based on conservative, health-protective assumptions that also ensure exposures are not underestimated. These assessments will not underestimate the exposure and risks posed by bifenthrin.

Further information about the reevaluation of the FQPA safety factor for pyrethroids may be found in document ID number: EPA-HQ-OPP-2011-0746-0011.

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 assumptions discussed in this unit for acute exposure, at the 99.9th percentile of exposure the acute dietary exposure from food and water to bifenthrin will occupy 5% of the aPAD for the general U.S. population and 29% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Based on the data summarized in Unit III.A., there is no increase in hazard with increasing dosing duration. Furthermore, chronic dietary exposures will be lower than acute exposures. Therefore, the acute aggregate assessment is protective of potential chronic aggregate exposures.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Bifenthrin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to bifenthrin.

For children 1-2 years old, the most highly exposed children's subgroup, using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposures result in an aggregate MOE of 330. Because EPA's level of concern for bifenthrin is a MOE of 300 or below, this MOE is not of concern.

For adults, although the short-term dermal and inhalation risks were estimated using the same oral POD, these exposure estimates could not be directly combined for the adult short-term exposure assessment because the LOCs for dermal and inhalation routes of exposure are not the same (an MOE of < 100 defines the LOC for dermal exposure while inhalation risk is defined by an MOE of < 1,000). Accordingly an aggregate risk index (ARI) was required to estimate aggregate risk for adults. EPA identifies an ARI at or below one as a risk estimate of concern. The short-term aggregate ARI for adults is 2.0. An ARI greater than 1 indicates risks that are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term aggregate risk assessment was not conducted because bifenthrin is acutely toxic and does not increase in potency with repeated dosing. Because the neurotoxicity POD used for acute risk assessment is lower (more protective) than PODs for longer durations of exposure and acute and short-term exposure levels are higher than longer term exposure levels, the acute and short-term aggregate assessments are protective for intermediate-term aggregate risks anticipated from bifenthrin exposure.

5. Aggregate cancer risk for U.S. population. For the reasons discussed in Unit III.A. (cancer effects are non-linear and appear at higher doses than acute effects) and Unit III.E.2. (chronic exposures are lower than acute exposures), the acute aggregate assessment is protective of potential cancer risk.

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

An adequate method, utilizing gas chromatography with electron capture detection (GC/ECD), is available to enforce the proposed tolerances for plant commodities.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 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 an MRL for bifenthrin. However, Codex has proposed a 30 ppm MRL for green and black tea (fermented and dried). The United States has recommended a tolerance on tea, dried at 30 ppm in order to harmonize with the proposed Codex MRL.

EPA received one comment to the notice of filing that stated, in part, that no residue should be allowed for bifenthrin. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

Based on the data supporting the petitions, EPA revised the proposed tolerance on grass, forage from 2.5 ppm to 4.0 ppm; and grass, hay from 4.5 ppm to 15 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. Additionally, EPA revised the proposed tolerance on tea from 25 ppm to 30 ppm, in order to harmonize with the proposed Codex MRL associated with the commodity. EPA also revised the proposed commodity definition for tea to tea, dried in order to reflect the correct commodity nomenclature.

Finally, the Agency has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of bifenthrin not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Therefore, tolerances are established for residues of bifenthrin, (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass, forage at 4.0 ppm; grass, hay at 15 ppm; and tea, dried at 30 ppm. This regulation additionally establishes time-limited tolerances for residues of bifenthrin in or on apple, nectarine, and peach at 0.5 ppm. Finally, this regulation removes time-limited tolerances in or on orchardgrass, forage at 2.5 ppm; and orchardgrass, hay at 4.5 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. 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 part 180 is amended as follows:

On August 2, 2012, NMFS published proposed specifications that are finalized here, and a request for public comments (77 FR 46014). Additional background information on this action is found in the preamble to the proposed specifications, and is not repeated here.

Through this action, NMFS is specifying a quota (annual catch target, ACT) of 325,000 lb of Deep 7 bottomfish in the main Hawaiian Islands (MHI) for the 2012-13 fishing year, based on an annual catch limit (ACL) of 346,000 lb. The MHI Management Subarea is the portion of U.S. Exclusive Economic Zone around the Hawaiian Archipelago lying to the east of 161° 20′ W. longitude. The Deep 7 bottomfish are onaga ( Etelis coruscans ), ehu ( E. carbunculus ), gindai ( Pristipomoides zonatus ), kalekale ( P. sieboldii ), opakapaka ( P. filamentosus ), lehi ( Aphareus rutilans ), and hapuupuu ( Epinephelus quernus ). The Council recommended the quota and ACL based on the best available scientific, commercial, and other information, taking into account the associated risk of overfishing.

The MHI bottomfish fishing year starts September 1, 2012. NMFS will monitor the fishery, and if the is quota is projected to be reached before August 31, 2013, NMFS will close the non-commercial and commercial fisheries for Deep 7 bottomfish in Federal waters through August 31, 2013. During a fishery closure for Deep 7 bottomfish, no person may fish for, possess, or sell any of these fish in the MHI, except as otherwise authorized by law (specifically, vessels with valid Pacific Remote Island Areas bottomfish fishing permits are not affected by the closure). There is no prohibition on fishing for or selling other non-Deep 7 bottomfish species throughout the year. All other management measures continue to apply in the MHI bottomfish fishery.

The comment period for the proposed specifications ended on August 17, 2012. NMFS received comments and responds as follows:

Comment 1: The annual catch limit is a management tool that will ensure fish stocks for future generations to come.

Response: NMFS agrees. Federal law requires NMFS and the Council to manage fisheries using annual catch limits. NMFS and the Council developed the annual catch limit using the best available scientific and commercial information and in consideration of scientific uncertainty and social and economic factors. The use of an annual catch limit, annual catch target and accountability measure will help prevent overfishing and ensure sustainable, long-term catches for fishermen.

Comment 2: The combination of measures to prevent overfishing by the Federal government (through ACL and AM), and by the State of Hawaii (through spatial restrictions, or bottomfish restricted fishing areas) are duplicative, disadvantaging certain fishing communities, and NMFS should remove the bottomfish restricted fishing areas, or at least those in Federal waters.

Response: While the State and Federal bottomfish regulations may appear to be duplicative, they are not. In 1998, the State of Hawaii established by administrative rule the bottomfish restricted fishing areas. At that time, in the absence of Federal regulations these areas were intended specifically to prevent overfishing. Some of the restricted areas were located in Federal waters. The Council and NMFS recognized that the administration and enforcement of these areas were and continue to be, the responsibility of the State, and any change to the management of the bottomfish restricted fishing areas is the purview of the State.

The Council subsequently (in 2008) developed, and NMFS implemented, the first Hawaii bottomfish quota system. The Federal quota measures complement, but do not duplicate, State restricted area measures. The combined State and Federal bottomfish management programs include a mix of minimum fish sizes, non-commercial bag limits, restricted fishing areas, catch limits, gear restrictions, permits and logbooks reporting, and other measures, none of which duplicates the others.

The Council may review its management program, as recommended to and implemented by NMFS, to gauge the overall effectiveness in achieving the objectives of the Hawaii fishery ecosystem plan, including whether or not the two programs working in concert are preventing overfishing and achieving optimum yield on a continuing basis. Mindful that the Magnuson-Stevens Act requires that all federally-managed U.S. fisheries be governed under a system of annual catch limits, if the Council finds that other parts of its Federal management program are superfluous in light of existing State measures, or that Federal programs are disadvantaging fishermen, it may recommend changes to the Federal requirements. Any changes to the Federal program would be coordinated with the State of Hawaii.

Comment 3: NMFS must consider the State's bottomfish restricted fishing areas and affiliated bottomfish resources when conducting bottomfish stock assessments and specifying annual catch limits.

Response: NMFS agrees, but information is not currently available about the conservation effects of the State's bottomfish restricted areas. The analyses in the most recent (2010) MHI Deep 7 bottomfish stock assessment, on which the annual catch limit and catch target are based, do not consider the impacts of the restricted areas. Rather, the assessment treats the main Hawaiian Islands as a single fishing area with no spatial restrictions. Until the State and NMFS can quantify the benefits of the bottomfish restricted fishing areas, stock assessments will likely continue to treat the main Hawaiian Islands as a single fishing area with no spatial restrictions. NMFS and the Council will continue to work with the State to obtain accurate information needed for stock assessments, including data on bottomfish distribution, relative abundance, stock structure, size and age composition, and other biological characteristics, both within and outside the bottomfish restricted fishing areas.

Comment 4: Bottomfish camera bait stations (“BotCam”) may not provide a true picture of the bottomfish stock because, while bottomfish may be attracted initially to the BotCam, once predators such as amberjacks and sharks arrive, bottomfish leave the area.

Response: A wide range of survey and sampling methods provide scientists and managers with multiple sources of information on which to base stock assessments. NMFS developed the BotCam as a cost-effective and non-fishing method to assess and monitor bottomfish (and other commercially important deepwater species). NMFS recognizes that this technology has both advantages and shortcomings compared to other data collection methods, and because BotCam surveys are still being conducted, NMFS has not fully evaluated the data obtained from these surveys for use in bottomfish stock assessments.

Comment 5: The most accurate way to get a true picture of the bottomfish stock is to open the bottomfish restricted fishing areas, and analyze the fish catch reports.

Response: The State of Hawaii, which governs and administers the bottomfish restricted fishing areas, has begun fishery-dependent studies in some bottomfish restricted fishing areas that may provide information, as suggested by the commenter.

Comment 6: Another option to help perpetuate the various Deep 7 bottomfish species is to increase the weight minimum for legal sale.

Response: Generally, minimum sizes (length or weight) are set at the level associated with the onset of maturity and are intended to provide individual fish with an opportunity to reproduce before being caught and kept. Current Federal regulations do not contain minimum sizes for sale of Deep 7 bottomfish. However, the State has implemented a minimum sales weight of one pound for onaga ( Etelis carbunculus ) and opakapaka ( Pristipomoides filamentosus ); changes to these limits would be the purview of the State. NMFS will continue to work with the Council to review available scientific information and evaluate whether additional conservation and management measures, including size limits, are needed to meet the objectives of the plan.

There are no changes in the final specifications.

The Regional Administrator, NMFS PIR, determined that this action is necessary for the conservation and management of MHI bottomfish, and that it is consistent with the Magnuson-Stevens Act and other applicable laws.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed specification stage that this action would not have a significant economic impact on a substantial number of small entities. NMFS published the factual basis for certification in the proposed specifications, and does not repeat it here. NMFS did not receive comments regarding this certification. As a result, a final regulatory flexibility analysis is not required, and none was prepared.

This action is exempt from review under Executive Order 12866.