Background

USDA regulations specifying the conditions that may make a producer ineligible for certain USDA benefits, such as disaster assistance payments from FSA, in certain cases in which agricultural commodities are planted on highly erodible land or a converted wetland, or production of agricultural commodities on acreage is made possible by the conversion of a wetland, are in 7 CFR part 12, “Highly Erodible Land and Wetland Conservation.” The regulations have been in place since the implementation of the requirements in the Food Security Act of 1985 (Pub. L. 99-198, commonly known as the 1985 Farm Bill). The 1985 Farm Bill provides restrictions applicable to participants in certain USDA programs on the use of highly erodible land and wetlands. Participants are ineligible for certain loans, payments, and benefits for the production of an agricultural commodity on highly erodible land unless the land is farmed according to a conservation system approved by USDA's Natural Resources Conservation Service (NRCS). Participants are similarly ineligible for benefits if they convert a wetland to make possible the production of an agricultural commodity or plant an agricultural commodity on a converted wetland. Under the HELC and WC provisions of the 1985 Farm Bill, persons determined to be in violation of HELC or WC provisions are ineligible for certain loans, payments, and benefits in the year that the violation occurred. Persons who violate HELC or WC provisions remain ineligible for certain loans, payments, and benefits until corrective actions have been implemented on the highly erodible land or the converted wetland has been restored. This rule is not changing these HELC and WC provisions.

The 1985 Farm Bill and the current regulations provide some exemptions to the requirements of the HELC and WC provisions and allow USDA flexibility in helping producers achieve compliance. Eligibility for loans, payments, and benefits may be reinstated if one of the exemptions authorized by the 1985 Farm Bill and implemented in the current regulations applies. One of those exemptions applies to persons who failed to apply a conservation system on highly erodible land, or who converted wetlands or planted an agricultural commodity on a converted wetland but who acted in good faith and without intent to violate HELC or WC provisions. These exemptions are specified in § 12.5, “Exemptions.”

Prior to the 2008 Farm Bill, the HELC and WC provisions in 16 U.S.C. 3812 and 3822 allow for a good faith exemption to the program ineligibility that would otherwise apply in the case of a violation. Section 2002 of the 2008 Farm Bill amends the “good faith” provisions by requiring additional review for determinations for both HELC and WC matters and by changing the HELC provisions to provide that in all cases the Secretary can impose a payment reduction commensurate with the seriousness of the violation. Under prior law in some cases the Secretary was required to automatically fully allow program benefits. With respect to review, the 2008 Farm Bill specifies that local HELC and WC good faith determinations must be reviewed within the agency. Specifically, under the new process, the good faith determinations made by a local FSA county committee must be reviewed at the FSA State or district level, with the technical concurrence of the NRCS State or area level conservationist, before benefits are restored.

These new provisions have been implemented administratively to be in compliance with the 2008 Farm Bill requirements, and this rule changes the regulations accordingly.

In addition to making these changes, this rule revises several paragraphs in the regulation to simplify the structure and to clarify the language, without changing the substantive provisions. Additionally, this rule makes a minor, technical change by adding the word “acreage” in the paragraphs on wetland mitigation, so that the rule will nowrequire that wetland values, acreage, and functions are adequately mitigated. (Note:The remaining uses of the term “functions and values” in 7 CFR part 12 are correct and do not need to be changed.) That change is made to be consistent with section 1222(f)(2) of the 1985 Farm Bill, (16 U.S.C. 3822(f)). The change is being made in the following paragraphs:

• Section 12.1(b)(4),

• Section 12.4(c),

• Section 12.5(b)(1)(iii)(D), (b)(1)(vi)(A), (b)(1)(vi)(B), and (b)(4)(i), (b)(4)(i)(E), (b)(4)(i)(F), (b)(4)(ii), and(b)(4)(iii),

• Section 12.31(d) (in the final sentence only), and

• Section 12.33(a).

These regulations are exempt from the notice and comment requirements of the Administrative Procedures Act (5 U.S.C. 553) as specified in section 2904 of the 2008 Farm Bill, which requires that the regulations be promulgated and administered without regard to the Statement of Policy of the Secretary of Agriculture effective July 24, 1971 (36 FR 13804), relating to notices of proposed rulemaking and public participation in rulemaking.

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

The Office of Management and Budget (OMB) designated this rule as not significant according to Executive Order 12866, and, therefore, this rule has not been reviewed by OMB.

It has been determined that the Regulatory Flexibility Act is not applicable to this rule because the Secretary of Agriculture, FSA, and CCC are not required to publish a notice of proposed rulemaking for this rule.

The environmental impacts of this rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and FSA regulations for compliance with NEPA (7 CFR part 799). The specific changes required by the 2008 Farm Bill that are identified in this rule are considered administrative in nature, solely amending those provisions in the USDA regulations dealing with HELC and WC violators and the retention of USDA program benefits. Therefore, FSA has determined that NEPA does not apply to this final rule, and no environmental assessment or environmental impact statement will be prepared.

This program is not subject to Executive Order 12372, which requires consultation with State and local officials. See the notice related to 7 CFR part 3015, subpart V, published in theFederal Registeron June 24, 1983 (48 FR 29115).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not retroactive and does not preempt State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. Before any judicial action may be brought regarding the provisions of this rule, appeal provisions of 7 CFR parts 11 and 780 must be exhausted.

The policies contained in this rule do not have any substantial direct effect on States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. This rule does not impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.

This rule has been reviewed for compliance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” The Executive Order imposes requirements on the development of regulatory policies that have Tribal implications or preempt Tribal laws. The policies contained in this rule do not preempt Tribal law. This rule was included in the October through December, 2010, Joint Regional Consultation Strategy facilitated by USDA that consolidated consultation efforts of 70 rules from the 2008 Farm Bill. USDA sent senior level agency staff to seven regional locations and consulted with Tribal leadership in each region on the rules. When the consultation process is complete, USDA will analyze the feedback and then incorporate any required changes into the regulations.

This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4). In addition, the Secretary of Agriculture is not required to publish a notice of proposed rulemaking for this rule. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

This rule has a potential impact on participants in most programs listed in the Catalog of Federal Domestic Assistance in the Agency Program Index under the Department of Agriculture.

The regulations in this rule are exempt from the requirements of the Paperwork Reduction Act (44 U.S.C. Chapter 35), as specified in section 2904 of the 2008 Farm Bill, which provides that these regulations be promulgated and the programs administered without regard to the Paperwork Reduction Act.

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

For the reasons explained above, 7 CFR part 12 is amended as follows:

The regulations that are the subject of these technical amendments were published on December 23, 1999, in a final rule titled “Food Ingredients and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products” (64 FR 72168). Among other things, this final rule consolidated various existing regulations on food ingredients and sources of radiation into a single new part, 9 CFR part 424, applicable to both meat and poultry establishments. Specifically, it combined the separate listings of food ingredients approved for use in meat and poultry products contained in 9 CFR 318.7 and 9 CFR 381.147 into a single table (9 CFR 424.21(c)). FSIS then removed §§ 318.7 and 381.147 from the meat and poultry products inspection regulations. The Agency did not, however, replace all of the references to §§ 318.7 and 381.147 contained in the meat and poultry product inspection regulations with a reference to § 424.21(c), the correct citation.

As published, the final regulations contain this error in several locations and thus needs to be corrected. Therefore, FSIS is replacing all references to §§ 318.7 and 381.147 contained in the meat and poultry product inspection regulations with a reference to the correct section, § 424.21(c).

Accordingly, 9 CFR parts 303, 317, 319, and 381 are corrected by making the following correcting amendments:

Title 10 of the Code of Federal Regulations (10 CFR), Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” Subpart B, presents the process for obtaining standard design certifications. Section 52.63, “Finality of standard design certifications,” provides criteria for determining when the Commission may amend the certification information for a previously certified standard design in response to a request for amendment from any person.

The NRC originally approved the AP1000 design certification in a final rule in 2006 (71 FR 4464; January 27, 2006). The final AP1000 DCR incorporates by reference Revision 15 of the design control document (DCD) (ADAMS Accession No. ML053460400), which describes the AP1000 certified design. During its initial certification of the AP1000 design, the NRC issued a final safety evaluation report (FSER) for the AP1000 as NUREG-1793, “Final Safety Evaluation Report Related to Certification of the AP1000 Standard Design,” in September 2004 (ADAMS Accession No. ML043570339) and Supplement No. 1 to NUREG-1793 (ADAMS Accession No. ML053410203).

From March 2006 through May 2007, NuStart Energy Development, LLC (NuStart)1 and Westinghouse provided the NRC with a number of technical reports (TRs) for pre-application review of a possible amendment to the approved AP1000 certified design, in order to: (1) close specific, generically applicable COL information items (information to be supplied by COLapplicants/holders) in the AP1000 certified standard design; (2) identify standard design changes resulting from the AP1000 detailed design efforts; and (3) provide specific standard design information in areas or for topics where the AP1000 DCD was focused on the design process and acceptance criteria. TRs typically addressed a topical area (e.g.,redesign of a component, structure or process) and included the technical details of a proposed change, design standards, analyses and justifications as needed, proposed changes to the DCD, and Westinghouse's assessment of the applicable regulatory criteria (e.g.,the assessment of the criteria in 10 CFR part 52, Appendix D, Section VIII, “Processes for Changes and Departures”). The NRC identified issues associated with the TRs and engaged Westinghouse in requests for additional information and meetings during the pre-application phase to resolve them.

On May 26, 2007, Westinghouse submitted, via transmittal letter (ADAMS Accession No. ML071580757), an application to amend the AP1000 DCR. The application included Revision 16 of the DCD (ADAMS Accession No. ML071580939). This application was supplemented by letters dated October 26 (ADAMS Accession No. ML073120415), November 2 (ADAMS Accession No. ML073090471), and December 12, 2007 (ADAMS Accession No. ML073610541), and January 11 (ADAMS Accession No. ML080150513) and January 14, 2008 (ADAMS Accession No. ML080220389). The application noted, in part, that:

(1) Generic amendments to the design certification, including additional design information to resolve DAC and design-related COL information items, as well as design information to make corrections and changes, would result in further standardization and improved licensing efficiency for the multiple COL applications referencing the AP1000 DCR that were planned for submittal in late 2007 and early 2008.

(2) Westinghouse, in conjunction with NuStart, has been preparing TRs since late 2005. These TRs were developed with input, review, comment, and other technical oversight provided by NuStart members, including the prospective AP1000 COL applicants. Submittal of these TRs to the NRC was initiated in March 2006. The TRs contain discussion of the technical changes and supplemental information that is used to support the detailed information contained in the DCD.

In Attachment 2 to the May 26, 2007, application, Westinghouse identified the criteria of 10 CFR 52.63(a)(1) that apply to the changes described in each TR and associated COL information items, if applicable.

On January 18, 2008, the NRC notified Westinghouse that it accepted the May 26, 2007, application, as supplemented, for docketing (Docket No. 52-006) and published a notice of acceptance (ADAMS Accession No. ML073600743) in theFederal Register(73 FR 4926; January 28, 2008). On September 22, 2008, Westinghouse submitted Revision 17 to the AP1000 DCD. Revision 17 contained changes to the DCD that had been previously accepted by the NRC in the course of its review of Revision 16 of the DCD. In addition, Revision 17 proposed changes to DAC in the areas of piping design (Chapter 3), instrumentation and control (I&C) systems (Chapter 7) and human factors engineering (HFE) (Chapter 18).

The NRC issued guidance on the finalization of design changes in Interim Staff Guidance (ISG) DC/COL-ISG-011, “Finalizing Licensing-basis Information,” (ADAMS Accession No. ML092890623), which describes various categories of design changes that should not be deferred and those that should be included in the DCR.

By letter dated January 20, 2010, Westinghouse submitted a list of design change packages that would be included in Revision 18 of the AP1000 DCD (ADAMS Accession No. ML100250873). A number of subsequent submittals were made by Westinghouse to narrow the focus of those design changes to the categories of changes that should not be deferred, as recommended by DC/COL-ISG-011.

Revision 18 to the AP1000 DCD (ADAMS Accession Nos. ML103480059 and ML103480572) was submitted on December 1, 2010, and contains both proposed changes previously described in the design change packages and changes already accepted by the NRC in the review process of Revision 17 to the AP1000 DCD.

In the course of its ongoing review of the amendment application, the NRC determined that changes from information in Revision 15 to the DCD were needed. In response to NRC questions, Westinghouse proposed such changes. Once the NRC was satisfied with these DCD markups, they were documented in the advance safety evaluation report (SER) as confirmatory items (CIs). The use of CIs is restricted to cases where the NRC has reviewed and approved specific DCD proposals. With the review of Revision 18, the NRC has confirmed that Westinghouse has made those changes to the DCD accepted by the NRC that were not addressed in Revision 17 to the AP1000 DCD. For the final rule, the NRC has completed the review of the CIs and prepared a FSER reflecting that action. The CIs were closed based upon an acceptable comparison between the revised DCD text and the text required by the CI. As further discussed later, Revision 19 is the version being certified in the final rule.

In order to simplify the NRC's review of the design change documentation, and to simplify subsequent review by the NRC's Advisory Committee on Reactor Safeguards (ACRS), the design changes pursuant to DC/COL-ISG-011 are reviewed in a separate chapter (Chapter 23) of the FSER. This chapter indicates which areas of the DCD are affected by each design change and the letters from Westinghouse that submitted them. In some cases, the NRC's review of the design changes reviewed in Chapter 23 may be incorporated into the chapters of the FSER where this material would normally be addressed because of the relationship between individual design changes and the review of prior DCD changes from Revisions 16 and 17 of the DCD.

The Westinghouse Revision 18 DCD includes an enclosure providing a cross-reference to the DCD changes and the applicable 10 CFR 52.63(a)(1) criteria. Revision 17 provides a similar cross-reference within the September 22, 2008, Westinghouse letter for those changes associated with the revised DCD. Revision 16, on the other hand, uses TRs to identify the DCD changes and lists the corresponding applicable 10 CFR 52.63(a)(1) criteria via Westinghouse letter, dated May 26, 2007 (Table 1). Revision 19 has a cross-reference similar to Revisions 17 and 18.

As of the date of this document, the application for amendment of the AP1000 design certification has been referenced in the following COL applications:

The NRC published the proposed rule amending the AP1000 DCR in theFederal Registeron February 24, 2011 (76 FR 10269). The public comment period for the proposed rule closed on May 10, 2011. The NRC received a large number of comment submissions for the proposed rule (AP1000 rulemaking) from members of the public, non-governmental organizations, and the nuclear industry. A comment submission means a communication or document submitted to the NRC by an individual or entity, with one or more distinct comments addressing a subject or an issue. A comment, on the other hand, refers to statements made in the submission addressing a subject or issue.

The NRC received more than 13,500 comment submissions, which appear to be variations of two letters with largely similar content. These comment submissions also contained approximately 100 separate comments. The NRC also received 66 additional comment submissions containing over 100 comments. Finally, the NRC received four “petitions” to suspend or terminate this rulemaking, which are being treated as public comments. The petitions set forth approximately 39 comments. As stated in the proposed rule, “Comments received after May 10, 2011 will be considered if it is practical to do so, but assurance of consideration of comments received after this date cannot be given.” The NRC determined that it was practical to consider comment submissions received on or before June 30, 2011. Five of the comment submissions were received after the 75-day comment period closed, and the NRC has addressed these late-filed comment submissions as part of this final rule (the numbers above reflect those late-filed comments, which were deemed practical to consider). These late comment submissions consisted of one petition, two submissions requesting the NRC to reconsider comments made during the initial AP1000 DC rulemaking, and two submissions with supplemental information to support suspending this rulemaking. The NRC also received several comment submissions after June 30, 2011. The NRC deemed that it was not practical to consider, in this rulemaking, comments received after June 30, 2011 and, therefore, does not provide responses to those comments. The NRC has briefly reviewed them to ensure that they contain no health and safety matters.

There were several commenters in favor of completing the AP1000 rulemaking, while some were unconditionally opposed to completing the proposed amendment to the AP1000 design. The vast majority of commenters favored delaying (in some fashion) the AP1000 amendment rulemaking until lessons are learned from the Fukushima Daiichi Nuclear Power Plant (Fukushima) accident that occurred on March 11, 2011, and the NRC applies the lessons learned to U.S. nuclear power plants, including the AP1000 design.

Before responding to specific comments based upon the Fukushima Daiichi Nuclear Power Plant Event, the NRC is providing this discussion about the ongoing actions underway in response to this event. The Commission created a Near-Term Task Force (NTTF) to conduct an analysis of the lessons that can be learned from the event. The task force was established to conduct a systematic and methodical review of NRC processes and regulations to determine whether the NRC should make additional improvements to its regulatory system. The NTTF issued a report (ADAMS Accession No. ML111861807) evaluating currently available technical and operational information from the event, and presented a set of recommendations to the Commission. The task force concluded that continued operation and continued licensing activities do not pose an imminent risk to public health and safety. Among other recommendations, the NTTF supports completing the AP1000 design certification rulemaking activity without delay (see pages 71-72 of the report).

In an August 19, 2011, Staff Requirements Memoranda (SRM) (ADAMS Accession No. ML112310021), the Commission set forth actions related to the NTTF report together with a schedule for the conduct of those actions. Two of those actions have been completed and are documented in the following reports: “Recommended Actions to Be Taken Without Delay from the Near-Term Task Force Report,” September 9, 2011 (SECY-11-0124) (ADAMS Accession No. ML11245A127) and “Prioritization of Recommended Actions To Be Taken In Response to Fukushima Lessons Learned,” October 3, 2011 (SECY-11-0137) (ADAMS Accession No. ML11269A204).

The NTTF recommendations relevant to the AP1000 design certification are limited to: Seismic and flooding protection (Recommendation 2); mitigation of prolonged station blackout (Recommendation 4); and enhanced instrumentation and makeup capability for spent fuel pools (Recommendation 7). The task force concluded that, by the nature of its passive design and inherent 72-hour coping capability, the AP1000 design has many of the features and attributes necessary to address the Task Force recommendations, and the NRC concludes that no changes to the AP1000 DCR are required at this time. Moreover, even if the Commission concludes at a later time that some additional action is needed for the AP1000, the NRC has ample opportunity and legal authority to modify the AP1000 DCR to implement NRC-required design changes, as well as to take any necessary action to ensure that holders of COLs referencing the AP1000 also make the necessary design changes.

The NRC organized the comments on the AP1000 amendment into the following subject areas: Fukushima-related, shield building, containment, severe accident mitigation design alternative (SAMDA), spent fuel, environmental, other AP1000 topics, and general concerns. Some comments opposed the AP1000 rulemaking until purported shield building flaws are corrected. Many comments opposed completing the AP1000 rulemaking for reasons outside the scope of this rulemaking. For example, many comments opposed the completion of the AP1000 rulemaking until there is resolution of high level radioactive waste storage issues.

Due to the large number of comments received and the length of the NRC responses provided, this section of the statement of considerations (SOC) for the final rule amending the AP1000 design certification only provides a summary of the categories of comments with a general description of the resolution of those comments. A detailed description of comments and the NRC's response is contained in a comment response document, which is available electronically through ADAMS Accession No. ML113480018.

This section is provided to help readers understand the issues and the NRC's responses. The following is a brief description of the three design features that were commented on, and a summary of the design changes that are being approved by the AP1000 amendment.

The containment vessel is a single steel pressure vessel, inside which is located the reactor vessel with the nuclear fuel, the steam generators, the refueling water storage tank, and various equipment for power generation, refueling, and emergency response, and supporting electric power, control, and communications equipment.

The steel containment building stands independently inside the shield building. The containment's primary purpose is to retain pressure up to the maximum “design pressure” should an accident occur in which the reactor vessel or associated equipment releases reactor coolant into the containment atmosphere. The containment also acts as the passive safety-grade interface to the ultimate heat sink.

The primary containment vessel prevents the uncontrolled release of radioactivity to the environment. The AP1000 primary containment consists of a cylindrical steel shell with ellipsoidal upper and lower heads. The steel thickness is increased in the transition region where the cylindrical shell enters the foundation concrete to provide additional margin in consideration of corrosion.

Safety-related coatings are applied to both the interior and exterior surfaces of the containment vessel. These coatings have several functions. For the exterior surface, the corrosion-resistant paint or coating for the containment vessel is specified to enhance surface wetability and film formation, as well as for corrosion protection. Wetability and film formation are important to the passive cooling function. For the interior containment surfaces, the coatings are designed to remain intact within the zone-of-influence of any postulated pipe break (or to result in settling of any resultant debris) to facilitate heat transfer to the containment vessel and for corrosion protection. Periodic inspections are required of the containment internal and external surfaces and of the coatings on those surfaces.

As the interface to the ultimate heat sink (the surrounding atmosphere), the primary containment is an integral component of the passive containment cooling system. The exterior of the containment vessel provides a surface for evaporative film cooling and works in conjunction with the natural draft airflow created by the shield building baffle and chimney arrangement to reduce the pressure and temperature of the containment atmosphere following a design-basis accident (DBA). The source of water for the evaporative cooling is the passive containment cooling water storage tank, located at the top of the shield building.

Design changes within the scope of the amendment with respect to the containment vessel are certain details about coatings with respect to long-term core cooling capability and the calculated peak accident pressure (from correction of errors). Other changes included addition of a vacuum relief system to provide protection for external pressure events.

The shield building performs multiple functions (e.g.,to provide a biological shield to high-energy radiation, to support the primary containment cooling water storage tank on the roof, to shield the steel containment from high-velocity debris that may be generated by tornadoes or other natural phenomena, to protect the containment from aircraft impact, and to function as a “chimney” to enhance airflow over the primary steel containment to remove heat from the containment and reduce containment pressure in the event that post-accident cooling of the containment would be necessary). While other designs have included shield buildings of reinforced concrete, with the exception of the AP600 design, they did not perform cooling functions. The shield building is not intended to be a pressure retaining structure or to mitigate the effects of a containment failure. The shield building construction is primarily a steel-concrete composite module wall, with a reinforced concrete roof and reinforced concrete where the wall meets the foundation. The wall is appropriately reinforced and sized where the composite wall module joins the reinforced concrete sections and as appropriate to accommodate seismic loads and aircraft loads. This design is new to the amendment; previously the structure was all reinforced concrete.

The shield building and the containment are designed with a gap, or annulus, that ensures that both the shield building and steel containment are physically separate, excluding their foundation, and are considered to be “freestanding.” In the shield building, air flows from the environment through openings in the shield building wall. The air then flows down along an interior baffle, turns toward the steel containment vessel, and then rises alongside the steel containment vessel where it absorbs heat. This heated air naturally rises and is then exhausted through the chimney located in the center of the primary containment cooling water storage tank.

Design changes to the passive containment cooling system and shield building principally involve the redesign of the shield building to a steel-composite design, with related changes to air inlet sizing, height of the building, and gratings above the chimney opening. Revised safety analyses were performed to confirm adequate containment pressure control, capability of the shield building to withstand external events (tornado, seismic), as well as aircraft impact assessment. The shield building functions to protect the containment and facilitate passive containment cooling were not changed in the current amendment.

The spent fuel pool (SFP) is a safety-related structure that is housed in the auxiliary building, which provides protection from aircraft impact or other external hazards.

For the first 72 hours after loss of normal SFP cooling, including response to a station blackout (SBO) event, the SFP relies upon the natural heat capacity of the water in the pool to absorb the heat from spent fuel elements, and boil the water in the pool. Thus, the safety-related means of heat removal for 72 hours is by heat-up of the volume of water in the pool and in safety-related water sources such as the cask washdown pit. The AP1000 design (as initially certified) included safety-related water level indication with readout and alarm in the main control room. A nonsafety-related spent fuel pool cooling system is also installed. Onsite, protected sources of water are available for up to 7 days, controlled from areas away from the pool. During high heat load conditions in the pool, two sources of alternating current (ac) power are required to be available. Water can be sprayed into the pool from two nozzle headers on opposite sides of the pool. A cross-connection also exists to the residual heat removal system. Those design features needed to provide make-up water after 72 hours and up to 7 days, such as the passive containment cooling water ancillary storage tank, and ancillary diesel generators, are protected from external hazards including thesafe-shutdown earthquake (SSE), tornado, and flooding.

Design changes within the scope of the current amendment are the number of fuel assemblies stored, the rack designs for new and spent fuel storage, the criticality analysis for spent fuel in the pool (including use of boron material attached to the storage cells), installation of spray headers, and credit for additional water sources for pool makeup.

Comment:Many comments noted the NRC staff nonconcurrence on the shield building design and requested that the NRC should reconsider the views expressed in the nonconcurrence.

NRC Response:The NRC disagrees with these comments. Professional opinions may vary, and the NRC has mechanisms in place for making differing views known.

NRC employees can choose to exercise the nonconcurrence process as a way of communicating their views and ensuring their opinions are heard by NRC management. The NRC staff individual who authored the nonconcurrence used this open process to express concerns regarding the safety of the AP1000 shield building design. The specific concerns and staff response to the nonconcurrence are publically available (ADAMS Accession No. ML103370648).

The NRC concluded that the AP1000 shield building design is safe, meets the Commission's regulations, and provides reasonable assurance that the building will remain functional under design-basis loads. The comments did not offer new information on the matters related to the nonconcurrence nor did they include a rationale showing the NRC's resolution of the technical matters raised in the nonconcurrence to be incorrect. No change was made to the final rule, DCD, or environmental assessment (EA) as a result of these comments.

Comment:One comment noted that the spent fuel racks' design in Revision 18 increased the density. The higher density fuel pools require boron shields between stored assemblies to reduce the risk of criticality. The comment stated that such re-racking introduces potential partial loss of cooling water, possible fire of spent fuel assemblies, and release of large inventories of cesium-137 and other radionuclides.

NRC Response:The NRC agrees that, under the proposed amendment of the AP1000 DCR, the capacity of the spent fuel pool racks would be increased from 619 to 889 (rather than 884 as asserted by the comment) fuel assemblies, and that the increased density of fuel assemblies being stored in the spent fuel pool requires the use of boron shields as part of the amendment.

However, the NRC disagrees with this comment's assertion that the increased capacity and density would introduce potential loss of cooling water, resulting in a possible fire of spent fuel assemblies and large releases of radionuclides. The comment did not explain how increased fuel capacity and concomitant increase in density of the spent fuel pool would “introduce” potential loss of cooling water as compared with the capacity and density described in DCD Revision 15. The NRC does not believe that the increased capacity and density leads to a new (previously un-described or unconsidered) way of losing spent fuel pool cooling water. The NRC evaluated the proposed increase in fuel assembly capacity and density, and the effectiveness of the Westinghouse-proposed boron shields to ensure against re-criticality of the spent fuel stored in the spent fuel pool. The AP1000 DCD Revision 18 SFP criticality analysis was reviewed following the guidance found in NUREG-0800 Section 9.1.1, Revision 3, “Criticality Safety of Fresh and Spent Fuel Storage and Handling,” to ensure that the applicant is in compliance with the applicable regulations (General Design Criterion 62, “Prevention of Criticality in Fuel Storage and Handling,” and 10 CFR 50.68, “Criticality Accident Requirements”). These requirements are generally performance-based with limitations on the reactivity values, and as such, there are no specific physical design requirements such as minimum geometric spacing which must be met. The AP1000 SFP criticality analysis demonstrates that, with the proposed storage arrangement of the SFP, the reactivity requirements are met, and no regulations are violated. Therefore, the NRC determined that that the AP1000 spent fuel pool storage arrangement is acceptable. No change was made to the rule, the DCD, or the EA as a result of this comment.

Comment:Several comments stated that given the recent event at the Fukushima plant in Japan, the 75-day comment period is not adequate and should be extended.

NRC Response:The NRC disagrees with this comment, and believes that the 75-day public comment period, which is consistent with most other NRC technical rulemakings, is adequate. The Commission established a NTTF to review relevant NRC regulatory requirements, programs, and processes, and their implementation, and to recommend whether the agency should make near-term improvements to its regulatory system. The public comment period for the proposed rule on the AP1000 design certification amendment closed on May 10, 2011, and the NTTF issued its report (ML111861807) on July 12, 2011. The NTTF considered the AP1000 design certification amendment in its report and noted that it has passive safety systems. By nature of their passive designs and inherent 72-hour coping capability for core, containment, and spent fuel pool cooling, the AP1000 designs have many of the design features and attributes necessary to address the NTTF recommendations. The NTTF supports completing the AP1000 design certification rulemaking activities without delay.

The NRC believes that the AP1000 final rulemaking can and should proceed without extending the public comment period because: (i) The NRC has determined that the AP1000 design certification amendment meets current regulations; (ii) the NRC will provide an opportunity for the public to provide input on NTTF recommendations, and (iii) if the NRC imposes additional requirements on the AP1000 design, existing regulations already define the process for doing so. No change was made to the rule, the DCD, or the EA as a result of this comment.

Comment:One comment questioned whether the NRC endorsed NQA-1-1994 for work performed for the AP1000 project, where the NRC documented that NQA-1-1994 adequately meets the NRC requirements in the Code of Federal Regulations, and whether the Westinghouse's AP1000 design meets the requirements of 10 CFR Part 50, Appendix B.

NRC Response:The NRC has, in application-specific requests for NRC approval of quality assurance programs, approved the use of NQA-1-1994 as an acceptable method to meet the requirements of Appendix B to 10 CFR Part 50. The NRC's approvals of NQA-1-1994 have been documented in NRC SERs on those requests.

The NRC believes that the AP1000 design meets the requirements of 10 CFR Part 50, Appendix B. By letter dated February 23, 1996 (ADAMS Accession No. ML11280A309), the NRC issued a safety evaluation report approving Revision 1 of the Westinghouse Quality Systems Manual (Westinghouse Quality Assurance (QA) Manual). The Westinghouse QA Manual is based upon the guidance in NQA-1-1994. The NRC found that the Westinghouse QA Manual meets all therequirements of Appendix B. In addition, the NRC concluded in its FSER for the amendment that Revision 5 of the Westinghouse Quality Systems Manual, as described in the AP1000 Design Control Document, Revision 17, meets the criteria of Appendix B with respect to AP1000 quality assurance. No change was made to the final rule, the DCD, or the EA as a result of this comment.

Comment:Several comments claimed the containment design was flawed because the containment cooling method includes convective air flow and because the steel containment could be subject to corrosion. As a result, they state that Westinghouse has not satisfactorily proved that the thin steel containment shell over the reactor would be effective during severe accidents.

NRC Response:The NRC considers these comments to be outside the scope of the rulemaking amending the AP1000 DCR. These features of the AP1000 design that demonstrate that the containment shell would be effective during severe accident conditions, as well as resistant to corrosion have already been certified with Revision 15. The proposed amendment to the AP1000 design does not propose any modification to these features and, therefore, the comment is outside the scope of this rulemaking.

The NRC considers a single metal containment vessel to be acceptable if it meets the requirements of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section III, Subsection NE. This part of the ASME Code contains requirements for the material, design, fabrication, examination, inspection, testing, and overpressure protection of metal containment vessels. Many such vessels are in use at operating nuclear power plants. The AP1000 containment is designed to meet ASME requirements for a pressure of 6.9 kPa (59 psi) and a temperature of 149 degrees C (300 degrees F). Its thickness includes an allowance for corrosion that may occur over the 60-year design life of the plant.

The AP1000 containment building has an additional function—transferring heat from containment to the atmosphere. The staff has reviewed the applicant's analysis, which shows that the containment building and the shield building, working as a system, would transfer heat to the atmosphere during severe accidents as well as design-basis earthquakes. Experiments were conducted to demonstrate that these predictions are based upon physical phenomena that can be relied upon to work even when there is no ac power. In short, Westinghouse has demonstrated that the containment building is robust and will perform its safety functions effectively if a severe accident occurs at an AP1000 plant.

The commenters did not offer any basis for Westinghouse to revise its design or for the NRC to revise its evaluation. No change was made to the final rule, the DCD, or the EA as a result of these comments.

Comment:Many comments stated that Westinghouse has not proven that the reactor could be properly cooled in conditions similar to those at Fukushima.

NRC Response:The NRC considers these comments to be outside the scope of the rulemaking amending the AP1000 DCR. The Fukushima event involved an extended SBO (loss of offsite and onsite ac power). Westinghouse has shown that the AP1000 includes design features that keep the reactor properly cooled under these conditions. The features of the AP1000 design ensuring that the reactor can be properly cooled in an extended SBO are already part of the certified design for the AP1000, and are not being changed or modified by this final rule amending the AP1000 design. Therefore, these comments are out of scope for this rulemaking.

In addition, even if these comments are assumed to be within the scope of the rulemaking, the NRC disagrees with the comment. If a severe accident occurs, seriously damaging the core, the AP1000 containment can be adequately cooled for 3 days—even if a loss-of-coolant accident (LOCA) occurred and without any ac power—because the AP1000 containment is cooled by gravity-fed water from a tank located at the top of the containment. After 3 days with no ac power, only a small “ancillary” generator is needed. This generator is used to power a small pump that re-fills the tank that supplies water to the outside surface of the containment. The generator could be brought to the site; however, in an AP1000 design, two such generators are installed in a seismically qualified structure (along with fuel and supporting equipment). After 1 week, the containment can be cooled indefinitely as long as fuel for at least one ancillary generator is provided and there is water to replenish the water tank above the shield building, as discussed in the DCD.

These comments did not present any basis that would support an NRC determination that the AP1000 design is deficient in this regard. No change was made to the final rule, the DCD, or the EA as a result of these comments.

Comment:Some comments stated that there are significant unresolved technical issues related to Revision 19 changes and that the NRC has not fully disclosed its analysis of these weaknesses, and the existence of such weaknesses is evidenced by the concerns identified by Dr. Susan Sterrett, Mr. Arnie Gundersen of Fairewinds Associates, and Dr. John Ma.

NRC Response:The NRC disagrees with this comment. As discussed in more detail in the comment response document, the NRC concludes these issues were either resolved as part of the initial AP1000 rulemaking, or are resolved as part of this rulemaking. Elsewhere in this notice, NRC discusses the Revision 19 changes and summarizes the response to the other technical issues.

Comment:Many comments expressed views that nuclear power plants are too expensive or too dangerous, or that alternative energy sources should be pursued.

NRC Response:The NRC considers these comments to be outside the scope of the rulemaking amendment the AP1000 DCR. The NRC has concluded that the AP1000 design meets its regulatory requirements, and the comments do not offer any basis that this is not supported. Other issues about expense or alternative energy sources are outside the scope of the rulemaking amending the AP1000 DCR. A design certification rule is not an NRC license or authorization for construction or operation. No change was made to the final rule, the DCD, or the EA as a result of these comments.

Comment:Many comments expressed concerns about nuclear waste.

NRC Response:These comments address matters that are outside the scope of the rulemaking amending the AP1000 DCR. These comments do not address whether the AP1000 design changes, as reflected in the amendment application and evaluated in the NRC's SER and EA, meet the applicable NRC requirements. No change was made to the final rule, the DCD, or the EA as a result of these comments.

Westinghouse's request to amend the AP1000 design contained several classes of changes. Each class is discussed below:

Westinghouse requested changes to the AP1000 DCD to correct spelling,punctuation, grammar, designations, and references. None of these changes make substantive changes to the certified design, and NUREG-1793, “Final Safety Evaluation Report Related to Certification of the AP1000 Standard Design,” Supplement 2 (SER) does not address these changes.

Westinghouse requested changes to the currently-approved AP1000 DCD (Revision 15) to achieve consistency and uniformity in the description of the certified design throughout the DCD. For example, a change to the type of reactor coolant pump (RCP) motor is evaluated in Chapter 5 of the SER on the application for the AP1000 amendment; Westinghouse requested that wherever this RCP motor is described in the DCD, the new description of the changed motor be used. The NRC reviewed the proposed change (to be used consistently throughout the DCD) to ensure that the proposed changes needed for uniformity and consistency are technically acceptable and do not adversely affect the previously approved design description. The NRC's bases for approval of these changes are set forth in the SER for the AP1000 amendment.

Substantive Technical Changes to the AP1000 Design(other than those needed for compliance with the AIA rule)

Among the many technical changes to the currently-approved DCD Revision 15 that are proposed by Westinghouse for inclusion in Revision 19 of the AP1000 DCD, the NRC selected 15 substantive changes for specific discussion in this final rule document, based on their safety significance:

• Removal of HFE DAC from the DCD.

• Change to I&C DAC and Inspections, Tests, Analyses, and Acceptance Criteria (ITAACs).

• Minimization of Contamination.

• Extension of Seismic Spectra to Soil Sites and Changes to Stability and Uniformity of Subsurface Materials and Foundations.

• Long-Term Cooling.

• Control Room Emergency Habitability System.

• Changes to the Component Cooling Water System (CCWS).

• Changes to I&C Systems.

• Changes to the Passive Core Cooling System (PCCS)—Gas Intrusion.

• Integrated Head Package (IHP)—Use of the QuickLoc Mechanism.

• Reactor Coolant Pump Design.

• Reactor Pressure Vessel (RPV) Support System.

• SFP Decay Heat Analysis and Associated Design Changes.

• Spent Fuel Rack Design and Criticality Analysis.

• Vacuum Relief System.

The NRC evaluated each of the proposed changes and concluded that they are acceptable. The NRC's bases for approval of these changes are set forth in the FSER for the AP1000 amendment and are summarized in Section XII, “Backfitting and Issue Finality,” of this document, as part of the discussion as to how each of the 15 changes satisfy the criteria in 10 CFR 52.63(a).

Westinghouse requested changes to the AP1000 design in order to comply with the requirements of the AIA rule, 10 CFR 50.150. The NRC confirmed that Westinghouse has adequately described key AIA design features and functional capabilities in accordance with the AIA rule and conducted an assessment reasonably formulated to identify design features and functional capabilities to show, with reduced use of operator action, that the facility can withstand the effects of an aircraft impact. In addition, the NRC determined that there will be no adverse impacts from complying with the requirements for consideration of aircraft impacts on conclusions reached by the NRC in its review of the original AP1000 design certification. The NRC's bases for approval of these changes are set forth in the FSER for the AP1000 amendment. As a result of these changes, the AP1000 design will achieve the Commission's objectives of enhanced public health and safety and enhanced common defense and security through improvement of the facility's inherent robustness to the impact of a large commercial aircraft at the design stage.

The NRC staff's (staff's) review of DCD Revision 18 (ADAMS Accession No. ML103260072) identified a few areas where the DCD wording should be revised for clarity, to resolve internal inconsistencies, or to provide updated versions of referenced technical reports. In addition, three technical issues were noted: a load combination for the shield building, the method used to evaluate tank sloshing, and containment peak pressure analysis error correction. As a result of these activities, Westinghouse submitted Revision 19 of the DCD on June 13, 2011 (ADAMS Accession No. ML11171A315), and this is the version of the DCD that is being certified by this final rule. The NRC has determined that none of the changes from Revision 18 to Revision 19 of the DCD require an additional opportunity for public comment. These changes, which are organized into five subject areas, are discussed below.

The NRC has also determined, in its review of Revision 19, that three of the five subject areas must be identified as Tier 2* matters in the Section VIII of the final rule. The NRC has determined that none of the three new Tier 2* designations in Section VIII.B.6 of the rule require an additional opportunity for public comment. The bases for the NRC's determinations are set forth below.

Revision 18 of the DCD moved some design details regarding structures, including the shield building, from supporting Westinghouse documents into the DCD itself. Some of the details were marked as Tier 2*, based upon initial NRC staff comments. For example, information about penetrations was brought out of TR-9 into the DCD, and the shield building structural description was added to Section 3.8.4 in Revision 18.

The advanced final safety evaluation report (AFSER) included a confirmatory item to verify that the DCD appropriately reflected all necessary details regarding the structural design and shield building, and clearly showed which design details were to be Tier 2* (see AFSER Section 3.8.4 under ADAMS Accession No. ML103430502). The staff was able to close the confirmatory item after Westinghouse submitted Revision 19 of the DCD by verifying the appropriate structural details were in the DCD and the design details were identified as Tier 2*. These DCD revisions enhanced the description of the design and were not a result of changes to the design itself. Westinghouse report GLR-603, submitted on March 28, 2011 (ADAMS Accession No. ML110910541), was the nonproprietary version of the report that presented shield building information to be made Tier 2*, in addition to the DCD information separately added to Section 3.8 and Appendix 3H. The scope of the report was materials, connection details, and tie bar spacing.

Use of steel composite modules was the heart of the revised shield building design, including the NRC's determination that existing consensus standards are not techinically applicable in all respects to the analysis for such modules. This was a key factor in the NRC conclusion that design details about the shield building are Tier 2* sothat any future changes to that information by the COL would receive prior staff review and approval. The staff considered the existing rule language as it relates to Tier 2* designation for structural information. For example, the existing rule includes use of ACI-349, definition of critical locations and thicknesses, nuclear island structural dimensions, and design summary of critical sections. Some of the critical sections are within the shield building, and ACI-349 was part of the design criteria. However, the staff concluded, during the course of final rule preparation, that the rule would be more clear if the use of steel composite module details that are designated in the DCD as Tier 2* was explicitly stated in the final rule (at Section VIII.B.6.c) and requested that Westinghouse designate this information at Tier 2* in Revision 19 of the DCD. Westinghouse included this change in Revision 19. As a result of the Tier 2* markings, a conforming change is being made to the final rule language to Section VIII.B.6.c about the categories of Tier 2* information that would expire at fuel load.

The NRC does not believe that the DCD changes or the designation of this information as Tier 2* in the final rule require re-noticing. The material was publicly available in referenced reports, the staff's intention that the composite steel module design be designated Tier 2* was clear at the time of the public comment period, and there were no comments regarding the extent of Tier 2* inclusion in Revision 18.

In the NRC staff's follow-up to an apparent editorial error in a table in the Westinghouse shield building report, the staff determined that Westinghouse had not documented in its calculations the numerical combination of the loads for external temperature conditions (minus 40 degrees F) and a safe-shutdown earthquake (SSE). On April 12, 2011, the staff requested Westinghouse to document in the shield building report the numerical combination of loads for extreme ambient thermal loads and SSE loads, as specified in DCD Table 3.8.4-1 for steel structures and Table 3.8.4-2 for concrete structures. See meeting summary dated May 17, 2011 (ADAMS Accession No. ML111440298). By letter dated June 15, 2011, Westinghouse responded to this request (ADAMS Accession No. ML111950098), and concluded that the current design is acceptable when the load combinations are explicitly analyzed. The analysis results are discussed in detail in Revision 4 of the shield building report. Changes were made to the DCD to reflect the results of this load combination analysis, but the changes did not involve any changes to the methodology or the design of the shield building. The specific DCD changes were the addition of Section 3.8.4.5.5 to discuss the load combination analysis, and updating of tables of results in Appendix 3H. No change to the language of the AP1000 DCR in 10 CFR part 52, Appendix D was made as a result of the DCD changes.

The NRC does not believe these DCD changes require re-noticing because Revision 18 of the DCD stated that the design would be verified using the required load combinations, and these load combinations had previously been approved by the NRC for use in AP1000 analyses similar to those for the shield building elements requiring reanalysis. There was no change to the methodology or the actual design of the shield building was needed, and there was no change to the language of the AP1000 DCR. The also NRC notes that the June 16, 2011 “petition” (filed by John Runkle) that requested the NRC terminate the rulemaking specifically raised the three technical issues in Revision 19, including the load combination topic.

During the analysis of the thermal plus earthquake load combination for the passive containment cooling water storage tank (located on top of the shield building), Westinghouse determined that it had not performed an analysis of hydrodynamic loads using an equivalent static analysis as stated in Westinghouse's response (ADAMS Accession No. ML102650098) to an action item from the NRC's shield building report review (documented in AFSER Chapter 3, ADAMS Accession No. ML103430502). Instead, the analysis had been done by response spectrum analysis. Both the equivalent static method and the response spectrum method had previously been approved by the NRC for use in the AP1000 design for structural analyses as described in Revision 18 of the DCD. This issue was discussed in a May 17, 2011, public meeting (see meeting summary dated May 26, 2011 (ADAMS Accession No. ML111430775)). In response, Westinghouse performed the analysis with the equivalent static method and presented the results in the revised shield building report and in DCD Revision 19 as follows. The use of the equivalent static method for the tank is discussed in Section 3.7 and Appendix 3G, and a table and figure were added to Appendix 3H. The revised shield building report included the results of the load combination for the containment cooling water storage tank using the equivalent static analytical method, which demonstrated that the design remained adequate when evaluated using the equivalent static analytical method. No change to the language of the AP1000 DCR in 10 CFR Part 52, Appendix D was made as a result of the DCD changes.

The NRC does not believe these DCD changes require renoticing. Revision 18 of the DCD stated that the design would be verified through the use of the equivalent static method, and that method had been previously approved by the NRC for AP1000 analyses equivalent to that peformed for the containment cooling water tank. No change to the actual design of the tank was needed, and there was no change to the language of the AP1000 DCR. The NRC also notes that one of the petitions (dated June 16, 2011) that the NRC is responding to in the comment response document specifically raised this issue and the NRC has provided an answer similar to that described above.

In its December 20, 2010, letter on long-term core cooling (ADAMS Accession No. ML103410348), the ACRS concluded that the regulatory requirements for long-term core cooling for design-basis accidents have been adequately met, based on cleanliness requirements specified in the amendment. In particular, the amount of latent debris that might be present in the containment is an important parameter. The ACRS further stated that any future proposed relaxation of the cleanliness requirements will require substantial additional data and analysis. In their January 24, 2011, (ADAMS Accession No. ML110170006) report on the Vogtle COL application, which references the AP1000 design, the ACRS recommended that the containment interior cleanliness limits on latent debris should be included in the Technical Specifications (TSs) for the Vogtle plant.

In a letter dated February 23, 2011 (ADAMS Accession No. ML110590455), Westinghouse proposed DCD markups to designate information in Section 6.3 including debris sources such as latent debris (and the amount of fiber) as Tier 2*. Revision 19 of the DCD includes changes to mark selected information as Tier 2*.

The NRC made a conforming change to the final rule language to provide a new item as Section VIII.B.6.b(7), “Screen design criteria,” for this new type of Tier 2* information. The NRC believes that inclusion of debris limits in the AP1000 DCD as Tier 2* information, rather than including such limits in each plant referencing the AP1000, represents a better regulatory approach for achieving the intent of the ACRS. Inclusion of debris limits in the AP1000 and its designation as Tier 2* would ensure that there is consistency across all referencing plants with repect to debris control, and ensures NRC regulatory control of any future relaxations of the limits, as discussed in the staff's March 3, 2011, response to the ACRS (ADAMS Accession No. ML110350198).

The NRC does not believe that this change to the DCD marking or to the final rule language requires renoticing because the ACRS letter, the staff response, and the Westinghouse letter, were all publicly available during the comment period, and the public had a fair opportunity to comment on this matter. In this regard, the staff notes that the April 6, 2011, “petition” (filed by John Runkle) that requested the NRC to suspend the AP1000 amendment rulemaking, included discussion about this topic with specific reference to the ACRS letter (ADAMS Accession No. ML11108A077). Numerous other comment submissions pointed to this petition as part of their comments. This lends support to the NRC's view that the public had adequate notice and an opportunity to comment on this matter. In addition, the inclusion of debris limits as Tier 2* represents a new limitation, not present in the prior revisions of the AP1000 DCD, which will require a referencing COL holder to use debris limits as specified in the AP1000 DCD. Given that the designation of the debris limits as Tier 2* represents a new restriction agreed to by Westinghouse, a matter on which the NRC received public comment, the staff does not believe that an additional opportunity for public comment need be provided on the inclusion of debris limits in Revision 19 of the DCD and the designation of those limits as Tier 2*.

In its December 13, 2010, letter on the AP1000 design certification, the ACRS identified an error in the previously certified Revision 15 of the DCD (ADAMS Accession No. ML103410351) concerning the containment cooling analysis. The error affected the time at which steady-state film coverage is achieved on the exterior of the containment vessel. In a February 5, 2011, letter, the NRC staff agreed with the ACRS, and indicated that Westinghouse agreed that the error existed and should be corrected. The letter also indicated that the NRC staff would monitor Westinghouse's corrective actions and review any needed revisions to the DCD (ADAMS Accession No. ML103560411).

In the course of correcting the steady-state film coverage error, after the proposed rule was published, Westinghouse identified other errors and modeling updates in supporting analyses that affected the calculated post-accident peak containment pressure (the highest peak pressure in the event of a large break loss-of-coolant accident). The net impact of correcting the steady-state film error and the subsequent Westinghouse-identified errors and modeling updates was an increase in calculated peak containment pressure from 57.8 psig to 59.2 psig, which would have exceeded the 59 psig post-accident peak containment pressure acceptance criterion in the existing AP1000 DCR.

Therefore, as part of the revised analysis to account for all the identified errors, Westinghouse relied upon a limited number of existing structural elements (gratings) within the containment as heat sinks, in order to remain within the 59 psig post-accident peak containment pressure acceptance criterion. Westinghouse's revised analysis used the NRC-approved methodology in the existing AP1000 DCR containment pressure calculation, and the method for crediting heat sink capacity as described in Westinghouse documents WCAP-15846 (proprietary) and WCAP-15862 (nonproprietary) “WGOTHIC Application to AP600 and AP1000,” Revision 1, March 2004, which are incorporated by reference in the previously certified Revision 15 of the DCD. In addition, the Westinghouse-revised analysis used the NRC-approved 59 psig post-accident peak containment pressure acceptance criterion in the existing AP1000 DCD, Revision 15.

The staff safety evaluation of the Westinghouse revised analysis is included in Sections 23.X and 23.Y of the FSER (ADAMS Accession No. ML112061231). Table 6.2.1.1-10 of Revision 19 of the DCD includes the credited elements. The ACRS reviewed the Westinghouse corrections, and agreed that Westinghouse's revised analysis continues to demonstrate that the containment will be able to withstand the post-accident peak containment pressure (ADAMS Accession No. ML11256A180), and that the reevaluated pressure is based on a sufficiently conservative methodology. The final AP1000 rule language designates this “heat sink data for containment analysis” by adding it as a new Tier 2* item in Section VIII.B.6.b(8). The NRC decided to control any future changes to the credited elements by designating the material as Tier 2* because the geometry and location of the heat sinks could impact their effectiveness.

The NRC does not believe that the revisions to Table 6.2.1.1-10 of Revision 19 of the DCD require renoticing for several reasons. The gratings to be credited as heat sinks were already part of the approved AP1000 design and were not part of the proposed amendment to the AP1000 DCR described design. Thus, the actual DCD did not involve any new design elements being added. The use of heat sinks as part of the containment pressure calculation and the method for crediting heat sink capacity were described in the DCD Revision 15. The criterion for evaluating the acceptability of the change continues to be the calculated post-accident peak containment pressure of 59 psig. Therefore, the revised Westinghouse analysis did not involve the use of any previously unapproved design methodologies or acceptance criteria; the methodology used and the acceptance criterion (59 psig post-accident peak containment pressure) is in the already-approved AP1000 DCR. Finally, crediting of the gratings as heat sinks in the revised analysis did not introduce any new safety issues not previously addressed. Therefore, the NRC does not believe that opportunity for public comment need be provided on the rule language change.

The NRC does not believe that the designation of the heat sink as Tier 2* requires renoticing. As discussed above, the Tier 2* change is a direct result of the Westinghouse revised analysis that does not warrant an additional opportunity for public comment. The designation of this information as Tier 2* adds a new limitation, not present in the prior revisions of the AP1000 DCD, which limits a referencing combined license applicant/holder to alter the heat sink information for the grating and all other heat sinks credited in the containment peak pressure analysis. Given that the designation of the heat sink information as Tier 2* represents a new restriction agreed to by Westinghouse, the staff does not believe that opportunity for public comment need be provided on the Westinghouse revised analysis and the designation of the heat sink information as Tier 2*.

The purpose of Section III is to describe and define the scope and contents of this design certification and to set forth how documentation discrepancies or inconsistencies are to be resolved. Paragraph A is the required statement of the Office of the Federal Register (OFR) for approval of the incorporation by reference of Tier 1, Tier 2, and the generic TSs into this appendix. The NRC is updating the revision number of the DCD that is incorporated by reference to the revision Westinghouse provided to the NRC in its application for amendment to this DCR. In this final rule, the revision of the DCD that is incorporated by reference is Revision 19.

The effect of this incorporation by reference is that the incorporated material has the same legal status as if it were published in theFederal Registerand in NRC's regulations at 10 CFR part 52. This material, like any other properly issued regulation, has the force and effect of law. The AP1000 DCD was prepared to meet the technical information contents of application requirements for design certifications under 10 CFR 52.47(a) and the requirements of the OFR for incorporation by reference under 1 CFR part 51. One requirement of the OFR for incorporation by reference is that the applicant for the design certification (or amendment to the design certification) makes the generic DCD available upon request after the final rule becomes effective. Therefore, paragraph A identifies a Westinghouse representative to be contacted to obtain a copy of the AP1000 DCD.

The AP1000 DCD is electronically accessible under ADAMS Accession No. ML11171A500, at the OFR, and atwww.regulations.govby searching under Docket ID NRC-2010-0131. Copies of the generic DCD are also available at the NRC's PDR. Questions concerning the accuracy of information in an application that references Appendix D will be resolved by checking the master copy of the generic DCD in ADAMS. If a generic change (rulemaking) is made to the DCD by the revision process provided in Section VIII of Appendix D, then, at the completion of the rulemaking process, the NRC would request approval of the Director, OFR, for the revised incorporation by reference and revise its copies of the generic DCD, provide a revised copy to the OFR, and notify the design certification applicant to change its copy. The Commission requires that the design certification applicant maintain an up-to-date copy of the master DCD under Section X.A.1 of Appendix D because it is likely that most applicants intending to reference the standard design will obtain the generic DCD from the design certification applicant. Plant-specific changes to and departures from the generic DCD will be maintained by the applicant or licensee that references Appendix D in a plant-specific DCD under Section X.A.2 of Appendix D.

The NRC is also making a change to paragraph D. Paragraph D establishes the generic DCD as the controlling document in the event of an inconsistency between the DCD and the design certification application or the FSER for the certified standard design. The revision renumbers paragraph D as paragraph D.1, clarifies this requirement as applying to the initial design certification, and adds a similar paragraph D.2 to indicate that this is also the case for an inconsistency between the generic DCD and the amendment application and the NRC's associated FSER for the amendment.

Section IV of this appendix sets forth additional requirements and restrictions imposed upon an applicant who references this appendix. Paragraph A sets forth the information requirements for these applicants. Paragraph A.3 requires the applicant to physically include, not simply reference, the proprietary information (PI) and safeguards information (SGI) referenced in the AP1000 DCD, or its equivalent, to ensure that the applicant has actual notice of these requirements. The NRC revised paragraph A.3 to indicate that a COL applicant must include, in the plant-specific DCD, the sensitive unclassified non-safeguards information (SUNSI) (including PI) and SGI referenced in AP1000 DCD. This revision addresses a wider class of information (SUNSI) to be included in the plant-specific DCD, rather than limiting the required information to PI. The requirement to include SGI in the plant-specific DCD would not change.

The NRC also added a new paragraph A.4 to indicate requirements that must be met in cases where the COL applicant is not using the entity that was the original applicant for the design certification (or amendment) to supply the design for the applicant's use. Paragraph A.4 requires that a COL applicant referencing Appendix D to 10 CFR Part 52 include, as part of its application, a demonstration that an entity other than Westinghouse is qualified to supply the AP1000 certified design unless Westinghouse supplies the design for the applicant's use. In cases where a COL applicant is not using Westinghouse to supply the AP1000 certified design, this information is necessary to support any NRC finding under 10 CFR 52.73(a) that the entity is qualified to supply the certified design.

The purpose of Section V is to specify the regulations applicable and in effect when the design certification is approved (i.e.,as of the date specified in paragraph A, which is the date of publication of this rule in theFederal Register). The NRC is redesignating paragraph A as paragraph A.1 to indicate that this paragraph applies to that portion of the design that was certified under the initial design certification. The NRC is further adding a new paragraph A.2, similar to paragraph A.1, to indicate the regulations that would apply to that portion of the design within the scope of this amendment, as approved by the Commission and signed by the Secretary of the Commission.

The purpose of Section VI is to identify the scope of issues that were resolved by the Commission in the original certification rulemaking and, therefore, are “matters resolved” within the meaning and intent of 10 CFR 52.63(a)(5).

Paragraph B presents the scope of issues that may not be challenged as a matter of right in subsequent proceedings and describes the categories of information for which there is issue resolution. Paragraph B.1 provides that all nuclear safety issues arising from the Atomic Energy Act of 1954 (the Act), as amended, that are associated with the information in the NRC's FSER related to certification of the AP1000 standard design (ADAMS Accession No. ML112061231) and the Tier 1 and Tier 2 information and the rulemaking record for Appendix D to 10 CFR part 52, are resolved within the meaning of 10 CFR 52.63(a)(5). These issues include the information referenced in the DCD that are requirements (i.e.,“secondary references”), as well as all issues arising from PI and SGI, which are intended to be requirements. Paragraph B.2 provides for issue preclusion of PI and SGI.

The NRC revised paragraph B.1 to extend issue resolution to the information contained in the NRC's FSER (Supplement No. 2), Appendix 1B of Revision 19 of the generic DCD, and the rulemaking record for this amendment. In addition, the NRC revised paragraph B.2 to extend issueresolution to the broader category of SUNSI, including PI, referenced in the generic DCD.

The NRC also revised paragraph B.7, which identifies as resolved all environmental issues concerning severe accident mitigation design alternatives (SAMDAs) arising under the National Environmental Policy Act of 1969 (NEPA) associated with the information in the NRC's final EA for the AP1000 design and Appendix 1B of the generic DCD (Revision 15) for plants referencing Appendix D to 10 CFR part 52 whose site parameters are within those specified in the SAMDA evaluation. The NRC revised this paragraph to identify all resolved environmental issues concerning SAMDA associated with the information in the NRC's final EA for this amendment and Appendix 1B of Revision 19 of the generic DCD for plants referencing Appendix D to 10 CFR part 52 whose site parameters are within those specified in the SAMDA evaluation.

Finally, the NRC is revising paragraph E, which provides the procedure for an interested member of the public to obtain access to SUNSI (including PI) and SGI for the AP1000 design in order to request and participate in proceedings, as identified in paragraph B, involving licenses and applications that reference Appendix D to 10 CFR part 52. The NRC is replacing the current information in this paragraph with a statement that the NRC will specify at an appropriate time the procedure for interested persons to review SGI or SUNSI (including PI) for the purpose of participating in the hearing required by 10 CFR 52.85, the hearing provided under 10 CFR 52.103, or in any other proceeding relating to Appendix D to 10 CFR part 52 in which interested persons have a right to request an adjudicatory hearing. The NRC will follow its current practice of establishing the procedures by order when the notice of hearing is published in theFederal Register(e.g.,Florida Power and Light Co., Combined License Application for the Turkey Point Units 6 and 7, Notice of Hearing, Opportunity To Petition for Leave To Intervene and Associated Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information and Safeguards Information for Contention Preparation (75 FR 34777; June 18, 2010); Notice of Receipt of Application for License; Notice of Consideration of Issuance of License; Notice of Hearing and Commission Order and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information and Safeguards Information for Contention Preparation; In the Matter of AREVA Enrichment Services, LLC (Eagle Rock Enrichment Facility) (74 FR 38052; July 30, 2009)).

In the four currently approved design certifications (10 CFR part 52, Appendices A through D), paragraph E presents specific directions on how to obtain access to PI and SGI on the design certification in connection with a license application proceeding referencing that DCR. The NRC is changing this because these provisions were developed before the terrorist events of September 11, 2001. After September 11, 2001, Congress changed the statutory requirements governing access to SGI, and the NRC revised its rules, procedures, and practices governing control and access to SUNSI and SGI. The NRC now believes that generic direction on obtaining access to SUNSI and SGI is no longer appropriate for newly approved DCRs. Accordingly, the specific requirements governing access to SUNSI and SGI contained in paragraph E of the four currently approved DCRs will not be included in the DCR for the AP1000. Instead, the NRC will specify the procedures to be used for obtaining access at an appropriate time in the COL proceeding referencing the AP1000 DCR. The NRC will include the new rule language in any future amendments or renewals of the currently existing DCRs, as well as in new (i.e.,initial) DCRs. However, the NRC will not initiate rulemaking to change paragraph E of the existing DCRs, in an effort to minimize unnecessary resource expenditures by both the original DCR applicant and the NRC.

The purpose of Section VIII of this appendix is to set forth the processes for generic changes to, or plant-specific departures (including exemptions) from, the DCD. The Commission adopted this restrictive change process in order to achieve a more stable licensing process for applicants and licensees that reference this DCR. The change processes for the three different categories of Tier 2 information, namely, Tier 2, Tier 2*, and Tier 2* with a time of expiration, are presented in paragraph B.

Departures from Tier 2 that a licensee may make without prior NRC approval are addressed under paragraph B.5 (similar to the process in 10 CFR 50.59). The NRC is modifying Section VIII to address the change control process specific to departures from the information required by 10 CFR 52.47(a)(28) to address the NRC's AIA requirements in 10 CFR 50.150. Specifically, the NRC revised paragraph B.5.b to indicate that the criteria in this paragraph for determining if a proposed departure from Tier 2 requires a license amendment do not apply to a proposed departure affecting information required by 10 CFR 52.47(a)(28) to address 10 CFR 50.150. In addition, the NRC redesignated paragraphs B.5.d, B.5.e, and B.5.f as paragraphs B.5.e, B.5.f, and B.5.g, respectively, and added a new paragraph B.5.d. Paragraph B.5.d requires an applicant or licensee who proposed to depart from the information required by 10 CFR 52.47(a)(28) included in the final safety analysis report (FSAR) for the standard design certification to consider the effect of the changed feature or capability on the original assessment required by 10 CFR 50.150(a). The FSAR information required by the AIA rule, which is subject to this change control requirement, includes the descriptions of the design features and functional capabilities incorporated into the final design of the nuclear power facility and the description of how the identified design features and functional capabilities meet the assessment requirements in 10 CFR 50.150(a)(1). The objective of the change controls is to determine whether the design of the facility, as changed or modified, is shown to withstand the effects of the aircraft impact with reduced use of operator actions. In other words, the applicant or licensee must continue to show, with the modified design, that the acceptance criteria in 10 CFR 50.150(a)(1) are met with reduced use of operator actions. The AIA rule does not require an applicant or a licensee implementing a design change to redo the complete AIA to evaluate the effects of the change. The NRC believes it may be possible to demonstrate that a design change is bounded by the original design or that the change provides an equivalent level of protection, without redoing the original assessment.

Consistent with the NRC's intent when it issued the AIA rule, under this section, plant-specific departures from the AIA information in the FSAR would not require a license amendment, but may be made by the licensee upon compliance with the substantive requirements of the AIA rule (i.e.,the AIA rule acceptance criteria). The applicant or licensee is required to document, in the plant-specific departure, how the modified design features and functional capabilities continue to meet the assessment requirements in 10 CFR 50.150(a)(1), in accordance with Section X of Appendix D to 10 CFR part 52. Applicants andlicensees making changes to design features or capabilities included in the certified design may also need to develop alternate means to cope with the loss of large areas of the plant from explosions or fires to comply with the requirements in 10 CFR 50.54(hh). The addition of these provisions to Appendix D to 10 CFR part 52 is consistent with the NRC's intent when it issued the AIA rule in 2009, as noted in the SOC for that rule (74 FR 28112; June 12, 2009).

Paragraph B.6 of Appendix D to 10 CFR Part 52 provides a process for departing from Tier 2* information. The creation of, and restrictions on changing, Tier 2* information resulted from the development of the Tier 1 information for the ABWR design certification (Appendix A to 10 CFR part 52) and the ABB-CE [ASEA Brown Boveri—Combustion Engineering] System 80+ design certification (Appendix B to 10 CFR part 52). During this development process, these applicants requested that the amount of information in Tier 1 be minimized to provide additional flexibility for an applicant or licensee who references these appendices. Also, many codes, standards, and design processes that would not be specified in Tier 1, but were acceptable for meeting ITAAC, were specified in Tier 2. The result of these actions was that certain significant information only exists in Tier 2 and the Commission did not want this significant information to be changed without prior NRC approval. This Tier 2* information was identified in the generic DCD with italicized text and brackets (see Table 1-1 of the AP1000 DCD Introduction for a list of the Tier 2* items). Although the Tier 2* designation was originally intended to last for the lifetime of the facility, like Tier 1 information, the NRC determined that some of the Tier 2* information could expire when the plant first achieves full power (100 percent), after the finding required by 10 CFR 52.103(g), while other Tier 2* information must remain in effect throughout the life of the facility. The factors determining whether Tier 2* information could expire after the first full power was achieved were whether the Tier 1 information would govern these areas after first full power and the NRC's determination that prior approval was required before implementation of the change due to the significance of the information. Therefore, certain Tier 2* information listed in paragraph B.6.c would cease to retain its Tier 2* designation after full power operation is first achieved following the NRC finding under 10 CFR 52.103(g). Thereafter, that information would be deemed to be Tier 2 information that would be subject to the departure requirements in paragraph B.5. By contrast, the Tier 2* information identified in paragraph B.6.b would retain its Tier 2* designation throughout the duration of the license, including any period of license renewal.

The NRC is revising certain items designated as Tier 2*. As discussed in the proposed rule, the Commission is adding an item to Section VIII.B.6.b for reactor coolant pump type. In addition, a new item was added to paragraph B.5.b for RCP type. The NRC determined that certain specific characteristics of the RCP were significant to the safety review and that prior approval of changes affecting those characteristics would be required. This Tier 2* designation does not expire.

In the final rule, two additional items are being added to Section VIII.B.6.b. First, in its December 20, 2010, letter on long-term core cooling, the ACRS concluded that the regulatory requirements for long-term core cooling for designbasis accidents have been adequately met, based on cleanliness requirements specified in the amendment. In particular, the amount of latent debris that might be present in the containment is an important parameter. The ACRS further stated that any future proposed relaxation of the cleanliness requirements will require substantial additional data and analysis. In their January 24, 2011, report on the Vogtle COL application, which references the AP1000 design, the ACRS recommended that the containment interior cleanliness limits on latent debris should be included in the TSs. In a letter dated February 23, 2011, Westinghouse proposed DCD markups to designate information in Section 6.3 including debris sources such as latent debris (and the amount of fiber) as Tier 2*. The NRC believes this is a better approach to achieving the intent of the ACRS for regulatory control of any future relaxations of the limits and would thus require prior NRC approval, as discussed in the staff's March 3, 2011, response to the ACRS. Revision 19 includes DCD changes to mark selected information as Tier 2*. No changes to the content itself were made. The NRC made a conforming change to the final rule language to provide a new item as Section VIII.B.6.b(7), entitled “Screen design criteria,” for this new type of Tier 2* information.

The second change, which was also discussed in the December 13, 2010, ACRS letter report on the DC amendment, concerned an error ACRS identified in the previously certified Revision 15, concerning the containment cooling analysis. The error affected the time at which steady-state film coverage is achieved on the exterior of the containment vessel. In the corrected analysis, the calculated peak containment pressure for a LOCA increases somewhat, but remains below the design pressure. In the course of reviewing the correction of the error for the peak containment pressure, after the proposed rule was published, Westinghouse identified other errors in supporting analyses that affect the calculated post-accident peak containment pressure. The net impact is an increase in calculated peak containment pressure in the event of a large break LOCA (the highest peak pressure) of about 0.3 psi. As part of the revised analysis for all of the changes, Westinghouse relied upon a limited number of structural elements within the containment as heat sinks for the peak pressure analysis in order to maintain margin to the design limit. The NRC's safety evaluation is included in the FSER. Table 6.2.1.1-10 of Revision 19 of the DCD includes the credited elements. The final rule language designates this “heat sink data for containment analysis” by adding it as new Tier 2* in Section VIII.B.6.b(8). Because the geometry and location of the heat sinks could impact their effectiveness, the staff decided to control any future changes to the credited elements by designating the material as Tier 2*.

As discussed in the proposed rule, the NRC is clarifying some of the Tier 2* designations for structural requirements, with respect to Tier 2* information that expires at first full power operation. The item on human factors engineering (HFE) moved from paragraph B.5.b to paragraph B.5.c, with the effect that the Tier 2* designation on that information expires after full power operation is achieved rather than never expiring. In the final rule, an additional item (paragraph B.6.c(16)) is added to provide Tier 2* designation for certain details about the steel composite modules (as identified within the DCD); the designation expires at first full power operation. The NRC concludes that the details are the key elements of this unique design, and therefore warrant Tier 2* regulatory control.

The NRC also concluded that the Tier 2* designation is not necessary for the specific Code edition and addenda for the American Society of Mechanical Engineers Boiler and Pressure Vessel Code (ASME Code), as listed in item VIII.B.6.c(2). At the time of the initial certification, the NRC determined that this information should be Tier 2*.Subsequently, 10 CFR Part 50 was modified to include provisions in 10 CFR 50.55a(b)(1)(iii) to provide restrictions in the use of certain editions/addenda to the ASME Code, Section III, that the NRC found unacceptable. In addition, 10 CFR 50.55a(c)(3), (d)(2) and (e)(2), for reactor coolant pressure boundary, Quality Group B Components, and Quality Group C Components, respectively, provide regulatory controls on the use of later edition/addenda to the ASME Code, Section III, through the conditions NRC established on use of paragraph NCA-1140 of the Code. As a result, these rule requirements adequately control the ability of a licensee to use a later edition of the ASME Code and addenda such that Tier 2* designation is not necessary. Thus, the Tier 2* item in paragraph B.6.c(2) for ASME Code was modified to be limited to ASME Code piping design restrictions as identified in Section 5.2.1.1 of the AP1000 DCD and to include certain Code cases, including Code Case N-284-1, as discussed in Section 3.8.2.2 and other Code cases as designated in Table 5.2-3 of the DCD (Code Case N-284-1 is the only case currently specified in Appendix D to 10 CFR Part 52). The NRC retained the Tier 2* designation for applying ASME Code, Section III, Subsection NE to containment design, by moving this provision to the end of Section VIII.B.6.c(14). Section 3.8.2.2 of the DCD identifies the specific edition and addenda for containment design (2001 Edition of ASME Code, Section III, including 2002 Addenda) with the Tier 2* markings.

The purpose of Section X is to set forth the requirements that apply to maintaining records of changes to and departures from the generic DCD, which would be reflected in the plant-specific DCD. Section X also sets forth the requirements for submitting reports (including updates to the plant-specific DCD) to the NRC. Paragraph A.1 requires that a generic DCD and the PI and SGI referenced in the generic DCD be maintained by the applicant for this rule. The NRC revised paragraph A.1 to replace the term “proprietary information,” or PI, with the broader term “sensitive unclassified non-safeguards information,” or SUNSI. Information categorized as SUNSI is information that is generally not publicly available and encompasses a wide variety of categories. These categories include information about a licensee's or applicant's physical protection or material control and accounting program for special nuclear material not otherwise designated as SGI or classified as National Security Information or Restricted Data (security-related information), which is required by 10 CFR 2.390 to be protected in the same manner as commercial or financial information (i.e.,they are exempt from public disclosure). This change is necessary because the NRC is approving PI and security-related information. This change also ensures that Westinghouse (as well as any future applicants for amendments to the AP1000 DCR who intend to supply the certified design) are required to maintain a copy of the applicable generic DCD, and maintain the applicable SUNSI (including PI) and SGI—developed by that applicant—that were approved as part of the relevant design certification rulemakings.

The NRC notes that the generic DCD concept was developed, in part, to meet OFR requirements for incorporation by reference, including public availability of documents incorporated by reference. However, the PI and SGI were not included in the public version of the DCD. Only the public version of the generic DCD is identified and incorporated by reference into this rule. Nonetheless, the SUNSI for this amendment was reviewed by the NRC and, as stated in paragraph B.2, the NRC considers the information to be resolved within the meaning of 10 CFR 52.63(a)(5). Because this information is in the nonpublic version of the DCD, this SUNSI (including PI) and SGI, or its equivalent, is required to be provided by an applicant for a license referencing this DCR.

In addition, the NRC is adding a new paragraph A.4.a that requires the applicant for the AP1000 design to maintain a copy of the AIA performed to comply with the requirements of 10 CFR 50.150(a) for the term of the certification (including any period of renewal). The NRC added a new paragraph A.4.b that requires an applicant or licensee who references this appendix to maintain a copy of the AIA performed to comply with the requirements of 10 CFR 50.150(a) throughout the pendency of the application and for the term of the license (including any period of renewal). The addition of paragraphs A.4.a and A.4.b is consistent with the NRC's intent when it issued the AIA rule in 2009 (74 FR 28112; June 12, 2009).

The NRC is making this final rule immediately effective, and is also providing notice of this final rule (including the NRC-approved DCD, Revision 19) to Southern Nuclear Operating Company (SNOC). Under a provision of the Administrative Procedure Act (APA), 5 U.S.C. 553(d), there ordinarily must be a 30-day waiting period before a new rule is effective, subject to certain exceptions, including “good cause:”

Good cause can be demonstrated by any number of circumstances. Here the circumstances demonstrate that the basis for the 30-day waiting period—to allow those regulated by a new rule time to conform their activities to it—is absent. Several sources of guidance on Section 553(d) support the NRC's good cause finding for this rulemaking.

Specifically, in the legislative history of the 30-day provision, the final report of the House Committee on the Judiciary offered the following explanation of the “good cause” exception in 5 U.S.C. 553(d)(3):

On May 27, 2011, one of the first COL applicants to which this amended AP1000 DCR would potentially apply, SNOC, submitted a “white paper” that set forth alternatives to making the final AP1000 rule effective 30 days after publication (ADAMS Accession No. ML11152A189). Thereafter, SNOC submitted a July 20, 2011, letter (ADAMS Accession No. ML11210B421), indicating that making the certified design rule immediately effective would serve important policy objectives.2 SNOC's letter thus requested Commission action. During theVogtleuncontested, or “mandatory,” hearing held by the Commission on SNOC's applications for a COL and a limited work authorization (LWA), SNOC reiterated its request that the NRC issue the COL and LWA immediately upon Commission affirmation of the final rule amending the AP1000 DCR. Transcript ofVogtleCOL Mandatory Hearing at 22-23, 350 (September 27, 2011; ADAMS Accession No. ML11305A228).

Here, SNOC, which is likely to use (and be bound by) the AP1000 DCR in the short-term if the Commission otherwise authorizes issuance of the COL, wishes the rule be made immediately effective. Given SNOC's longstanding awareness of and participation in the AP1000 rulemaking, it does not need the 30-day waiting period to come into compliance with the final rule. Under the Attorney General's Manual,supra,at 37, SNOC's request that the rule be made effective in a shorter time period constitutes good cause to waive the 30-day waiting period. As noted previously, the extensive process for consideration of this design certification rulemaking would clearly constitute a situation where “the parties subject to [the regulation] may during the usually protracted hearing and decision procedures anticipate the regulation.” S. Doc. No. 79-249, Administrative Procedure Act: Legislative History 259-60 (1946). In fact, that “anticipation” is clearly manifested in SNOC's use of the design certification rulemaking, as well as use by other applicants for COLs referencing the AP1000 DCR, which would occur only after the completion of a public process that includes NRC adjudicatory processes for each COL application. The determination of good cause regarding the effective date of the final AP1000 rule is separate from, and does not prejudge, the licensing determinations that are otherwise required in the COL proceedings.

Finally, the NRC is providing actual service of the final AP1000 rule (including the NRC-approved DCD, Revision 19) to SNOC concurrently with the NRC's transmission of the final rule to the OFR for publication.3 Thus, either before, or simultaneous with, any issuance of a COL forVogtle(and any other COL application referencing the AP1000, upon request), SNOC (and any other COL applicant referencing the AP1000, upon request) will have actual notice of the requirements of the final AP1000 rule and Revision 19 of the DCD for which their NRC-licensed activities under the COL must conform.

The immediately effective rule cannot be used by anyone until the agency has made the necessary health and safety findings and completed the environmental review processes that necessarily precede the issuance of a COL relying on the design certification rulemaking. Each finding necessary under the Atomic Energy Act would have been made through public rulemaking and the NRC's adjudicatory processes that serve to allow consideration of public input before the agency issues its determination on an application referencing the AP1000. The rule itself does not force anyone to take action immediately based on its effective date because it does not compel, but rather permits, action. Therefore, from the standpoint of regulatory efficiency, delaying issuance of a licensing decision when the decision is ready to be issued is not in the public interest, whether the decision is to deny or grant the requested license.

On October 14, 2011, counsel for several organizations who were previously admitted as Joint Intervenors in the contested portion of theVogtleCOL proceeding indicated that they would be adversely affected by the issuance of an immediately effective rule. Letter from Mindy Goldstein, Counsel for Southern Alliance for Clean Energy, Georgia Women's Action for New Directions, and Center for a Sustainable Coast (Goldstein Letter) (ADAMS Accession No. ML11287A054).4 The Goldstein Letter states that SNOC has requested a waiver of 10 CFR 2.807 during the uncontested hearing, which the letter states is an improper forum, and that waiver of 10 CFR 2.807 would not afford them time to prepare for issuance of the Vogtle COL or LWA. The Goldstein Letter states that a waiver of 10 CFR 2.807 is required to be submitted under 10 CFR 2.335. The Goldstein Letter explains that when the DCR becomes effective, a COL and LWA will be issued, resulting in a nuclear power plant that will affect all persons located near the site. TheVogtleJoint Intervenors believe the 30-day effective period is necessary to determine whether they wish to appeal the rule and seek a stay of construction.

First, a waiver of 10 CFR 2.807 is not required to make a rule immediately effective; a rule can be made immediately effective pursuant to the requirements of 10 CFR 2.807. The Commission in this rulemaking has determined to use the good cause exception to the 30-day effective date for the rulemaking and thus, is acting consistently with the provisions of 10 CFR 2.807 rather than waiving its provisions.

Second, as noted previously in the discussion of the legislative history of the 30-day effective date provision, the primary purpose of the 30-day requirement is to allow affected persons time to comply with the new rule. The final rule amending the AP1000 designcertification is focused on the conduct of regulatory activities licensed by the NRC. But, theVogtleJoint Intervenors are neither current NRC licensees who must comply with the final rule amending the AP1000 rule, nor applicants for NRC licenses referencing the final AP1000 rule. Thus, the final AP1000 rule imposes no substantive legal obligations on them. The NRC does not believe that the Goldstein Letter describes any legally-cognizable harm within the scope of protection afforded to third parties by the APA's 30-day waiting period provision. That an immediately effective AP1000 rule may facilitate issuance of a COL for the Vogtle plant does not appear to adversely affect the rights or capability of any public stakeholder to do what they would otherwise do if the AP1000 rule were made effective 30 days after publication in theFederal Register. Whether the AP1000 rule is immediately effective or not does not change any public stakeholder's legal rights or options; it merely affects the timing of asserting such rights or exercising those options.

Further, the Commission is not aware of any regulatory history indicating that the purpose of the 30-day effective date is tied to or affects appeal rights. Regardless of the immediate effectiveness of the rule, theVogtleJoint Intervenors may seek legal action on the immediately effective rule in Federal court, or they may file an appropriate motion in theVogtleCOL proceeding if they satisfy the requirements in 10 CFR Part 2 to reopen the record and submit late-filed contentions.See10 CFR 2.309, 2.326. Thus, an immediately effective AP1000 rule does not foreclose, or render moot, challenges to the rule, including stay remedies. For these reasons, the NRC concludes that making the final AP1000 rule immediately effective would not adversely affect these organizations or any other public stakeholders.

In sum, the NRC finds good cause for making the final rule amending the AP1000 DCR immediately effective upon publication in theFederal Register. Therefore, the NRC is making the final rule immediately effective. In addition, there is sufficient reason to provide prompt actual notice of this final rule (including the NRC-approved DCD, Revision 19) to SNOC (and potentially to any other combined license applicant referencing the amended AP1000 DCR in its application).

The following discussion sets forth each amendment to the AP1000 DCR being made in this final rule. All section and paragraph references are to the provisions in the amendment to Appendix D to 10 CFR part 52, unless otherwise noted.

The NRC is amending Section III, Scope and Contents, to revise paragraph A to update the revision number of the DCD, from Revision 15 to Revision 19, approved for incorporation by reference by the Office of the Federal Register; update the contact information of the Westinghouse representative to be contacted should a member of the public request a copy of the generic DCD; and update other locations (e.g.,the NRC's PDR) where a member of the public could request a copy of or otherwise view the generic DCD.

The NRC is revising paragraph D to establish the generic DCD as the controlling document in the event of an inconsistency between the DCD and either the application or the FSER for the certified standard design. This clarification further distinguishes between the conflict scenarios presented in paragraphs D.1 (for the initial certification of the design) and D.2 (for Amendment 1 to the design).

The NRC is amending Section IV, Additional Requirements and Restrictions, to set forth additional requirements and restrictions imposed upon an applicant who references Appendix D to 10 CFR part 52. Paragraph A sets forth the information requirements for these applicants. The NRC is revising paragraph A.3 to replace the term “proprietary information” with the broader term “sensitive unclassified non-safeguards information.”

The NRC is also adding a new paragraph A.4 to indicate requirements that must be met in cases where the COL applicant is not using the entity that was the original applicant for the design certification (or amendment) to supply the design for the applicant's use.

The NRC is revising paragraph A to distinguish between the regulations that were applicable and in effect at the time the initial design certification was approved (paragraph A.1) and the regulations that are applicable and in effect as of the effective date of the final rule (paragraph A.2).

The NRC is amending Section VI, Issue Resolution, by revising paragraph B.1 to provide that all nuclear safety issues arising from the Act that are associated with the information in the NRC's FSER (NUREG-1793), the Tier 1 and Tier 2 information (including the availability controls in Section 16.3 of the generic DCD), and the rulemaking record for Appendix D to 10 CFR Part 52 are resolved within the meaning of 10 CFR 52.63(a)(5). These issues include the information referenced in the DCD that are requirements (i.e.,secondary references), as well as all issues arising from SUNSI (including PI) and SGI, which are intended to be requirements. This paragraph is revised to extend issue resolution beyond that of the previously certified design to also include the information in Supplement No. 2 of the 2011 FSER (Supplement 1 supported the initial certification) and the rulemaking record associated with Amendment 1 to the AP1000 design.

The NRC is revising paragraph B.2 to replace the term “proprietary information” with the broader term “sensitive unclassified non-safeguards information.”

Paragraph B.7 is revised to extend environmental issue resolution beyond that of the previously certified design to also include the information in Amendment 1 to the AP1000 design and Appendix 1B of Revision 19 of the generic DCD.

A new paragraph E is added to allow the NRC to specify at the appropriate time the procedures for interested persons to obtain access to PI, SUNSI, and SGI for the AP1000 DCR. Access to such information is for the sole purpose of requesting or participating in certain specified hearings, such as (1) the hearing required by 10 CFR 52.85 where the underlying application references Appendix D to 10 CFR Part 52; (2) any hearing provided under 10 CFR 52.103 where the underlying COL references Appendix D to 10 CFR part 52; and (3) any other hearing relating to Appendix D to 10 CFR Part 52 in which interested persons have the right to request an adjudicatory hearing.

The NRC is revising Section VIII to address the change control process specific to departures from the information required by 10 CFR 52.47(a)(28) to address the NRC's AIA requirements in 10 CFR 50.150. Specifically, the NRC is revising the introductory text of paragraph B.5.b to indicate that the criteria in this paragraph for determining if a proposed departure from Tier 2 requires a license amendment do not apply to a proposed departure affecting information requiredby 10 CFR 52.47(a)(28) to address aircraft impacts.

In addition, the NRC is redesignating paragraphs B.5.d, B.5.e, and B.5.f as paragraphs B.5.e, B.5.f, and B.5.g, respectively, and adding a new paragraph B.5.d. Paragraph B.5.d requires an applicant referencing the AP1000 DCR, who proposes to depart from the information required by 10 CFR 52.47(a)(28) to be included in the FSAR for the standard design certification, to consider the effect of the changed feature or capability on the original 10 CFR 50.150(a) assessment.

The NRC is revising certain items designated as Tier 2*. As discussed in the proposed rule, the NRC is adding an item to Section VIII.B.6.b for RCP type. In addition, a new item is added to paragraph B.5.b for RCP type. The NRC determined that certain specific characteristics of the RCP were significant to the safety review and that prior approval of changes affecting those characteristics would be required. This Tier 2* designation does not expire.

In the final rule, two additional items are added to Section VIII.B.6.b. Section VIII.B.6.b(7) provides Tier 2* designation for certain analysis assumptions related to latent debris and the effects on screens and fuel assemblies in post-LOCA conditions where debris is transported to the recirculation sump and into the in-containment refueling water storage tank. Finally, new paragraph VIII.B.6.b(8) is added to include the containment heat sinks credited in the peak pressure analysis. The Tier 2* designation for the requirements in this section of the rule does not expire.

As discussed in the proposed rule, the NRC is clarifying some of the Tier 2* designations for structural requirements, with respect to Tier 2* information that expires at first full power operation. The item on HFE moved from paragraph B.5.b to paragraph B.5.c, with the effect that the Tier 2* designation on that information expires after full power operation is achieved rather than never expiring. In the final rule, an additional item (paragraph B.6.c(16)) is added to provide Tier 2* designation for certain details about the steel composite modules (as identified within the DCD); the designation expires at first full power operation.

Finally, the NRC also concluded that the Tier 2* designation was not necessary for the specific Code edition and addenda for the ASME Code as listed in paragraph VIII.B.6.c(2). Thus, the item in paragraph VIII.B.6.c(2) for ASME Code was modified to be limited to piping and welding restrictions identified in Section 5.2.1.1, and to include certain Code cases, N-284-1 is discussed in Section 3.8.2.2 and other code cases designated as Tier 2* are listed in Table 5.2-3. The NRC retained the Tier 2* designation for applying ASME Code Section III to containment design, by moving this provision to the end of Section VIII.B.6.c(14). Section 3.8.2.2 identifies the specific edition and addenda for containment design (2001 Edition of ASME Code, Section III, including 2002 Addenda).

The NRC is amending Section X, Records and Reporting, to revise paragraph A.1 to replace the term “proprietary information” with the broader term “sensitive unclassified non-safeguards information.” Paragraph A.1 is revised to require the design certification amendment applicant to maintain the SUNSI, which it developed and used to support its design certification amendment application. This would ensure that the referencing applicant has direct access to this information from the design certification amendment applicant, if it has contracted with the applicant to provide the SUNSI to support its license application. The AP1000 generic DCD and the NRC-approved version of the SUNSI would be required to be maintained for the period that Appendix D to 10 CFR part 52 may be referenced.

The NRC is also adding a new paragraph A.4.a, which requires Westinghouse to maintain a copy of the AIA performed to comply with the requirements of 10 CFR 50.150(a) for the term of the certification (including any period of renewal). This provision, which is consistent with 10 CFR 50.150(c)(3), would facilitate any NRC inspections of the assessment that the NRC decides to conduct.

Similarly, the NRC is adding a new paragraph A.4.b, which requires an applicant or licensee who references Appendix D to 10 CFR Part 52 to maintain a copy of the AIA performed to comply with the requirements of 10 CFR 50.150(a) throughout the pendency of the application and for the term of the license (including any period of renewal).

Under the “Policy Statement on Adequacy and Compatibility of Agreement States Programs,” approved by the Commission on June 20, 1997, and published in theFederal Register(62 FR 46517; September 3, 1997), this rule is classified as compatibility “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Act or the provisions of this section. Although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements by a mechanism that is consistent with the particular State's administrative procedure laws. Category “NRC” regulations do not confer regulatory authority on the State.

The NRC is making the documents identified below available to interested persons through one or more of the following methods, as indicated. To access documents related to this action, see theADDRESSESsection of this document.

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or is otherwise impractical. In this final rule, the NRC is approving an amendment to the AP1000 standard plant design for use in nuclear power plant licensing under 10 CFR parts 50 or 52. Design certifications (and amendments thereto) are not generic rulemakings establishing a generally applicable standard with which all parts 50 and 52 nuclear power plant licensees must comply. Design certifications (and amendments thereto) are NRC approvals of specific nuclear power plant designs by rulemaking. Furthermore, design certifications (and amendments thereto) are initiated by an applicant for rulemaking, rather than by the NRC. For these reasons, the NRC concludes that the National Technology Transfer Advancement Act of 1995 does not apply to this final rule.

The Commission has determined under NEPA, and the Commission's regulations in subpart A, “National Environmental Policy Act; Regulations Implementing Section 102(2),” of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” that this DCR is not a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement (EIS) is not required. The basis for this determination, as documented in the final EA, is that the Commission has made a generic determination under 10 CFR 51.32(b)(2) that there is no significant environmental impact associated with the issuance of an amendment to a design certification. This amendment to 10 CFR part 52 does not authorize the siting, construction, or operation of a facility using the amended AP1000 design; it only codifies the amended AP1000 design in a rule. The NRC will evaluate the environmental impacts and issue an EIS as appropriate under NEPA as part of the application for the construction and operation of a facility referencing this amendment to the AP1000 DCR. In addition, as part of the final EA for the amendment to the AP1000 design, the NRC reviewed Westinghouse's evaluation of various design alternatives to prevent and mitigate severe accidents in Appendix 1B of the AP1000 DCD Tier 2. According to 10 CFR 51.30(d), an EA for a design certification amendment is limited to the consideration of whether the design change, which is the subject of the proposed amendment renders a SAMDA previously rejected in the earlier EA to become cost beneficial, or results in the identification of new SAMDAs, in which case the costs and benefits of new SAMDAs and the bases for not incorporating new SAMDAs in the design certification must be addressed. Based upon review of Westinghouse's evaluation, the NRC concludes that the proposed design changes: (1) Do not cause a SAMDA previously rejected in the EA for the initial AP1000 design certification to become cost-beneficial; and (2) do not result in the identification of any new SAMDAs that could become cost beneficial.

The NRC prepared a final EA following the close of the comment period for the proposed standard design certification. With the issuance of this final rule, all environmental issues concerning SAMDAs associated with the information in the final EA and Appendix 1B of the AP1000 DCD Tier 2 will be considered resolved for plants referencing Amendment 1 to the AP1000 design whose site parameters are within those specified in SAMDA evaluation. The existing site parameters specified in the SAMDA evaluation are not affected by this design certification amendment.

The final EA, upon which the NRC's finding of no significant impact is based, and Revision 19 of the AP1000 DCD are available as discussed in Section IV, Availability of Documents. The NRC sent a copy of the EA and final rule to every State Liaison Officer and no comments were received.

This final rule contains new or amended information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.). These requirements were approved by the Office of Management and Budget, approval number 3150-0151.

The burden to the public for these information collections is estimated to average 3 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of these information collections, including suggestions for reducing the burden, to the Information Services Branch (T-5F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail toINFOCOLLECTS.RESOURCE@NRC.gov;and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0151), Office of Management and Budget, Washington, DC 20503.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

The NRC has not prepared a regulatory analysis for this final rule. The NRC prepares regulatory analyses for rulemakings that establish generic regulatory requirements applicable to all licensees. Design certifications are not generic rulemakings in the sense that design certifications do not establish standards or requirements with which all licensees must comply. Rather, design certifications are Commission approvals of specific nuclear power plant designs by rulemaking, which then may be voluntarily referenced by applicants for COLs. Furthermore, design certification rulemakings are initiated by an applicant for a design certification, rather than the NRC. Preparation of a regulatory analysis in this circumstance would not be useful because the design to be certified is proposed by the applicant rather than the NRC. For these reasons, the Commission concludes that preparation of a regulatory analysis is neither required nor appropriate.

Under the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this final rule will not have a significant economic impact upon a substantial number of small entities. The final rule provides for certification of an amendment to a nuclear power plant design. Neither the design certification amendment applicant, nor prospective nuclear power plant licensees who reference this DCR, fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act, or the size standards established by the NRC (10 CFR 2.810). Thus, this rule does not fall within the purview of the Regulatory Flexibility Act.

The NRC has determined that this final rule meets the requirements of the backfit rule, 10 CFR 50.109, and the requirements governing changes to DCRs in 10 CFR 52.63(a)(1).

The final rule does not constitute backfitting as defined in the backfit rule (10 CFR 50.109) with respect to operating licenses under 10 CFR Part 50 because there are no operating licenses referencing this DCR.

Westinghouse requested many changes to the currently approved AP1000 DCD Revision 15 to correct spelling, punctuation, or similar errors, which result in text that has the same essential meaning. The NRC concludes that these Westinghouse-requested changes, which are editorial in nature, neither constitute backfitting as defined in 10 CFR 50.109(a)(1), nor are these changes inconsistent with the issue finality provisions of 10 CFR 52.63 or 10 CFR 52.83. The backfitting and issue finality provisions were not meant to apply to such editorial changes in as much as such changes would have insubstantial impact on licensees with respect to their design and operation, and are not the kind of changes falling within the policy considerations that underlie the backfit rule and the issue finality provisions of 10 CFR 52.63 and 10 CFR 52.83.

Westinghouse also made proposed changes to Revision 15 of the AP1000 DCD, which the NRC understands were the result of requests to Westinghouse from COL applicants referencing the AP1000 design, to achieve consistency in description and approach in different portions of the DCD. In the absence of a generic change to the AP1000, the referencing COL applicants stated to Westinghouse and the NRC that each would likely take plant-specific departures to address the inconsistency. While this could result in more consistency within any given COL application, it would result in inconsistencies among the different referencing COLs, which is inconsistent with the overall standardization goal of 10 CFR part 52. Accordingly, the NRC concludes that the Westinghouse-requested changes to the AP1000 to address consistency do not constitute backfitting under the backfit rule (in as much as they are voluntary) and are not otherwise inconsistent with the issue finality provisions of 10 CFR 52.63 and 52.83.

Westinghouse also proposed numerous substantive changes to the AP1000 design described in Revision 15 of the DCD, including, but not limited to, minor component design details, replacement of a design feature with another having similar performance (e.g.,turbine manufacturer, power for the auxiliary boiler), and changes allowing additional capability for operational flexibility (e.g.,liquid waste holdup tanks, unit reserve transformer). Westinghouse included within its application a detailed list of each DCD content change and the basis for concluding that one or more of the criteria in 10 CFR 52.63(a)(1) are satisfied for each change.

In the course of the NRC review of the technical changes proposed by Westinghouse, the NRC considered the basis offered by Westinghouse and made conclusions about whether the criteria of 10 CFR 52.63(a) were satisfied. These conclusions are included in the chapters of the FSER under ADAMS Accession No. ML112061231. The NRC concluded that all of these changes met at least one of the criteria in 10 CFR 52.63(a) and are not otherwise inconsistent with the issue finality provisions of 10 CFR 52.63 and 52.83. Fifteen of the most significant changes are discussed below, to show that each of the 15 substantive changes to the AP1000 certified design meet at least one of the criteria in 10 CFR 52.63(a)(1)(i) through (a)(1)(vii) and, therefore, do not constitute a violation of the finality provisions in that section.

Title:Removal of Human Factors Engineering Design Acceptance Criteria from the Design Control Document.

Item:1 of 15.

Description of Change:The ITAAC Design Commitments for HFE are in Tier 1, Table 3.2-1. In Revision 17 of the AP1000 DCD, Westinghouse proposed deletion of the Human Factors DAC (Design Commitments 1 through 4) and provided sufficient supporting documentation to meet the requirements of these ITAAC. Design Commitment 1 pertains to the integration of human reliability analysis with HFE design. Design Commitment 2 pertains to the HFE task analysis. Design Commitment 3 pertains to the human-systeminterface. Design Commitment 4 pertains to the HFE program verification and validation implementation. The information developed by Westinghouse to satisfy these ITAAC is included in Chapter 19 of the DCD.

Location within the Safety Evaluation (SER) where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the HFE DAC are in Sections 18.7.6 (Design Commitment 1), 18.5.9 (Design Commitment 2), 18.2.8 (Design Commitment 3), and 18.11 (Design Commitment 4) of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):The additional information included in Tier 2 provides detailed design information on human factors design that would otherwise have to be addressed through verification of implementation of the human factors DAC. Therefore, the changes to the DCD eliminate the need for DAC on human factors and meet the finality criteria in 10 CFR 52.63(a)(1)(iv).

Title:Change to Instrumentation and Control DAC and Associated ITAAC.

Item:2 of 15.

Description of Change:In the proposed revision to DCD Chapter 7, Westinghouse chose the Common Q platform to implement the Protection and Safety Monitoring System (PMS) and removed all references to the Eagle 21 platform. This design change, coupled with the development of other information about the PMS system definition design phase, was the basis for Westinghouse's proposed removal of its Tier 1, Chapter 2, Section 2.5.2, Design Commitment 11(a) Design Requirements phase from Table 2.5.2-8, “Inspections, Tests, Analyses, and Acceptance Criteria,” for the PMS.

In its proposed revision to the DCD in Chapter 7, Westinghouse altered its design for the Diverse Actuation System (DAS) by implementing it with Field Programmable Gate Array (FPGA) technology instead of microprocessor-based technology. Additional information about the design process for the DAS was added as the basis for Westinghouse's proposed completion of its Tier 1, Chapter 2, Section 2.5.1, Design Commitments 4(a) and 4(b) Design Requirements and System Definition phases from Table 2.5.1-4 “Inspections, Tests, Analyses, and Acceptance Criteria” for the DAS.

Location within the Safety Evaluation (SER) where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with I&C DAC and ITAAC are in Sections 7.2.2.3.14, 7.2.5, 7.8.2, 7.9.2, and 7.9.3 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Westinghouse provided additional information that incorporates the results of the design process implementation for the PMS and DAS (which both support completion of Design Commitment 11(a) from Table 2.5.2-8 and 4a and 4b from Table 2.5.1-4, respectively) into the DCD. The additional information included in Tier 2 provides detailed design information on I&C design that would otherwise have to be addressed through verification of implementation of the I&C DAC. Therefore, the changes to the DCD eliminate the need for DAC on I&Cs and meet the finality criteria in 10 CFR 52.63(a)(1)(iv).

The changes in the AP1000 amendment generally fall into one of two categories: (1) Changes that provide additional information or a greater level of detail not previously available in the currently-approved version of the AP1000 DCD (Revision 15); or (2) changes requested by COL applicants referencing the AP1000 who would plan to include these changes in their application as departures if they were not approved in the AP1000 DCR amendment. The Commission concludes that both categories of changes meet the 10 CFR 52.63 criterion of “contributes to increased standardization.” The bases for the Commission's conclusions, including each category of change, are discussed below.

Westinghouse proposes that the DCD be changed by adding new, more detailed design information that expands upon the design information already included in the DCD. This information would be used by every COL referencing the AP1000 DCR. Incorporating these proposed changes into the AP1000 DCR as part of this amendment contributes to the increased standardization of the certification information by eliminating the possibility of multiple departures. Therefore, these changes enhance standardization, and meet the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Westinghouse proposes several changes to its DCD with the stated purpose of contributing to increased standardization. Westinghouse represents that these changes were requested by the lead COL applicants currently referencing the AP1000. The NRC, in meetings with these applicants as part of the “Design-Centered Working Group” process for jointly resolving licensing issues, confirmed that these applicants requested these changes and committed to pursue plant-specific departures from the AP1000 if Westinghouse did not initiate such changes to the AP1000 DCR. Such departures may be pursued by individual COL applicants (and licensees) as described in part VIII, “Processes for Changes and Departures” of the AP1000 DCR (Appendix D to 10 CFR part 52). Incorporating these proposed changes into the AP1000 DCR as part of this amendment contributes to the increased standardization of the certification information by eliminating the possibility of multiple departures. Therefore, all Westinghouse-initiated changes for the purpose of eliminating plant-specific departures enhance standardization, and meet the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Minimization of Contamination (10 CFR 20.1406(b)).

Item:3 of 15.

Description of Change:In DCD Section 12.1.2.4, Westinghouse discussed features incorporated into the amended design certification to demonstrate compliance with 10 CFR 52.47(a)(6), which requires that a design certification application include the information required by 10 CFR 20.1406(b), which was adopted in 2007 as part of the general revisions to 10 CFR Part 52. This regulation requires design certification applicants whose applications are submitted after August 20, 1997, to describe how the design will minimize, to the extent practicable, contamination of the facility and the environment, facilitate decommissioning and minimize the generation of radioactive waste. The DCD changes are documented in Westinghouse Technical Report 98, “Compliance with 10 CFR 20.1406” (APP-GW-GLN-098), Revision 0 (ADAMS Accession No. ML071010536). Westinghouse evaluated contaminated piping, the SFP air handling systems, and the radioactive waste drain system to show that piping and components utilize design features that will prevent or mitigate the spread of contamination within the facility or the environment. Westinghouse has incorporated modifications and features such as elimination of underground radioactive tanks, RCPs without mechanical seals, fewer embedded pipes, less radioactivepiping in the auxiliary building and containment vessel, and monitoring the radwaste discharge pipeline to demonstrate that the AP1000 design certification, as amended, will be in compliance with the subject regulation and Regulatory Guidance (RG) 4.21, “Minimization of Contamination and Radioactive Waste Generation: Life-Cycle Planning” (June 2008).

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features are in Section 12.2 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1)(vii):Inclusion in the DCD of the more detailed information about the features for minimization of contamination provides additional information to be included in the DCD for the AP1000 that increases standardization of the AP1000 design. Thus, the changes meet the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Extension of Seismic Spectra to Soil Sites and Changes to Stability and Uniformity of Subsurface Materials and Foundations.

Item:4 of 15.

Description of Change:In AP1000 DCD Tier 2, Sections 2.5.2 and 3.7, Westinghouse extended the AP1000 design to sites with five soil profiles, ranging from hard rock to soft soil, for Category I structures, systems, and components. The certified design included only hard rock conditions. To support the technical basis for the extension, Westinghouse provided: Seismic analysis methods, procedures for analytical modeling, soil-structure interaction analysis with three components of earthquake motion, and interaction of non-seismic Category I structures with seismic Category I structures. Also, in DCD Section 2.5.4, Westinghouse extended the AP1000 design with “Stability and Uniformity of Subsurface Materials and Foundations,” where the DCD presents the requirements related to subsurface materials and foundations for COL applicants referencing AP1000 standard design. The site-specific information includes excavation, bearing capacity, settlement, and liquefaction potential. On February 28, 2011, Westinghouse submitted Revision 5 to TR-03, “Extension of Nuclear Island Seismic Analysis to Soil Sites,” and summarized the report in DCD Appendix 3G, to provide more detail about its analyses.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with extension of seismic spectra to soil sites are in Section 3.7 of the FSER. The details of the NRC's evaluation of Westinghouse's design features associated with stability and uniformity of subsurface materials and foundations are in Sections 2.5.2 and 2.5.4 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Westinghouse submitted a change to the DCD that provides the seismic design and supporting analysis for a range of soil conditions representative of expected applicants for a COL referencing the AP1000 design. As a result, the certified design can be used at more sites without the need for departures to provide site-specific analyses or design changes, thus leading to a more uniform analysis and seismic design for all the AP1000 plants. Including in the DCD the information demonstrating adequacy of the design for seismic events for a wider range of soil conditions is a change that provides additional information leading to increased standardization of this aspect of the design. In addition, the change reduces the need for COL applicants to seek departures from the current AP1000 design in as much as most sites do not conform to the currently approved hard rock sites. Therefore, the change increases standardization and meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Long-Term Cooling.

Item:5 of 15.

Description of Change:DCD Tier 2, Section 6.3.8, describes the changes to COL information items related to containment cleanliness and verification of water sources for long-term recirculation cooling following a LOCA. The COL information item related to verification of water sources for long-term recirculation cooling following a LOCA was closed based on Westinghouse TR-26, “AP1000 Verification of Water Sources for Long-Term Recirculation Cooling Following a LOCA,” APP-GW-GLR-079 (ADAMS Accession No. ML102170123) and other information contained in DCD Chapter 6. Section 6.3.2.2.7 describes the evaluation of the water sources for long-term recirculation cooling following a LOCA, including the design and operation of the AP1000 PCCS debris screens. DCD Tier 1, Section 2.2.3, includes the associated design descriptions and ITAAC.

The COL information item requires a cleanliness program to limit the amount of latent debris in containment consistent with the analysis and testing assumptions.

Location within the SE where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with long-term cooling in the presence of LOCA-generated and latent debris and General Design Criteria 35 and 38 are in Subsection 6.2.1.8 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the design and analysis information that demonstrates adequacy of long-term core cooling provides additional information leading to increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Control Room Emergency Habitability System.

Item:6 of 15.

Description of Change:DCD Tier 2, Section 6.4, has undergone significant revision. Westinghouse redesigned its main control room emergency habitability system to meet control room radiation dose requirements using the standard assumed in-leakage of 5 cubic feet per minute in the event of a release of radiation. The changes include the addition of a single-failure proof passive filter train. The flow through the filter train is provided by an eductor downstream of a bottled air supply. These changes were prompted by Westinghouse's proposal to revise the atmospheric dispersion factors from those certified in Revision 15 to larger values to better accommodate COL sites. As a result, other design changes were needed to maintain doses in the control room within acceptable limits.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with radiation dose to personnel under accident conditions are in Section 6.4 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Incorporation of design changes to the main control room ventilation systems would contribute to increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Changes to the Component Cooling Water System.

Item:7 of 15.

Description of Change:In Revision 18 to AP1000 DCD Tier 2, Westinghouse proposed changes to the design of the component cooling water system (CCWS) to modify the closure logic for system motor-operated containment isolation valves and install safety-class relief valves on system supply and return lines. The closure logic would close the isolation valves upon a high RCP bearing water temperature signal,which might be indicative of a RCP heat exchanger tube rupture. This change would automatically isolate this potential leak to eliminate the possibility of reactor coolant from a faulted heat exchanger discharging to portions of the CCWS outside containment.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the CCWS are in Chapter 23, Section V, of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Westinghouse included changes to the component cooling water in the DCD. These changes will contribute to increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Changes to Instrumentation and Control Systems.

Item:8 of 15.

Description of Change:In AP1000 DCD Tier 2, Sections 7.1 through 7.3, Westinghouse completed planning activities related to the architecture of its safety related I&C protection system, referred to as the PMS. Westinghouse also proposed changes to the DCD to reflect resolution of PMS interdivisional data communications protocols and methods utilized to ensure a secure development and operational environment. A secure development and operational environment in this context refers to a set of protective actions taken against a predictable set of non-malicious acts (e.g.,inadvertent operator actions, undesirable behavior of connected systems) that could challenge the integrity, reliability, or functionality of a digital safety system. The establishment of a secure development and operational environment for digital safety systems involves: (i) Measures and controls taken to establish a secure environment for development of the digital safety system against undocumented, unneeded and unwanted modifications and (ii) protective actions taken against a predictable set of undesirable acts (e.g.,inadvertent operator actions or the undesirable behavior of connected systems) that could challenge the integrity, reliability, or functionality of a digital safety system during operations.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with I&C systems are in Sections 7.1 through 7.3, and 7.9 of NRC's Chapter 7 FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the more detailed information about the I&C architecture and communications provides additional information leading to increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Changes to the Passive Core Cooling System—Gas Intrusion.

Item:9 of 15.

Description of Change:In AP1000 DCD Tier 1 and Tier 2, Westinghouse proposed changes to the design of the PCCS to add manual maintenance vent valves and manual maintenance drain valves, and to reroute accumulator discharge line connections in order to address concerns related to gas intrusion. In addition, Westinghouse provided descriptions of surveillance and venting procedures to verify gas void elimination during plant startup and operations. These proposed changes are responsive to the actions requested by Generic Letter 2008-01, “Managing Gas Accumulation in Emergency Core Cooling, Decay Heat Removal, and Containment Spray Systems.”

The passive core cooling system (PCCS) provides rapid injection of borated water, which provides negative reactivity to reduce reactor power to residual levels and ensures sufficient core cooling flow. Noncondensible gas accumulation in the PCCS has the potential to delay injection of borated water, which would impact the moderating and heat removal capabilities, thus providing a challenge to the primary fission product barrier and maintenance of a coolable core geometry. As part of its review, the NRC determined that the proposed changes in the design of the PCCS were acceptable for providing protection for design-basis events, such as LOCAs.

Location within the SER where the changes are principally described:The NRC's evaluation of proposed changes to the DCD associated with changes to the PCCS is in Chapter 23, Section L, of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the design and analysis information that provides for venting of non-condensible gases provides additional information leading to increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Integrated Head Package—Use of the QuickLoc Mechanism.

Item:10 of 15.

Description of Change:In DCD Tier 2, Section 5.3.1.2, Westinghouse describes a revised integrated head package (IHP) design. The inclusion of eight QuickLoc penetrations in lieu of the forty-two individual in-core instrument thimble-tube-assembly penetrations on the reactor vessel head is a significant decrease in the number of reactor pressure vessel (RPV) closure head penetrations for access to in-core and core exit instrumentation. The QuickLoc mechanism allows the removal of the RPV closure head without removal of in-core and core exit instrumentation and, thus, decreases refueling outage time and overall occupational exposure. This head package design has been installed on a number of operating plants and, as noted, has several operational and safety advantages.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the (1) IHP and QuickLoc mechanism are in Section 5.2.3 of the FSER and (2) radiation protection pertaining to the addition of the integrated reactor head package and QuickLoc connectors are in Subsection 12.4.2.3 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the changes to the IHP would contribute to the increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Reactor Coolant Pump Design.

Item:11 of 15.

Description of Change:In AP1000 DCD Tier 2, Subsection 5.4.1, Westinghouse proposed changes related to the RCP design. These changes include: Change to a single-stage, hermetically sealed, high inertia, centrifugal sealless RCP of canned motor design; use of an externally mounted heat exchanger; and change of the RCP flywheel to bimetallic construction. These DCD changes are documented in: TR-34, “AP1000 Licensing Design Change Document for Generic Reactor Coolant Pump,” APP-GW-GLN-016, November 2006 and in other documentation in response to NRC inquiries. The supporting documentation includes an analysis demonstrating that failure of the flywheel would not generate a missile capable of penetrating the surrounding casing, and, therefore, that such failure would not damage the reactor coolant pressure boundary.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the RCP design are in Section 5.4.1 of the NRC's Chapter 5 FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the changes to the RCP would reduce the possibility of plant-specific departure requests by COL applicants referencing the AP1000 DCR. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Reactor Pressure Vessel Support System.

Item:12 of 15.

Description of Change:The RPV structural support system of the AP1000 standard design is designed to provide the necessary support for the heavy RPV in the AP1000 standard design. The original anchorage design was bolting into embedded plates of the CA04 structural module. Subsection 3.8.3.1.1 of the AP1000 DCD Tier 2 would be changed to reflect modifications to the RPV support design. In the revised design, there are four support “boxes” or “legs” located at the bottom of the RPV's cold leg nozzles. The support boxes are anchored directly to the primary shield wall concrete base via steel embedment plates. This CA04 structural module is no longer used in the new design. The four RPV support boxes are safety-related and the design of the RPV associated support structures is consistent with the safe shutdown earthquake design of Seismic Category I equipment. Subsections 3.8.3.5.1 and 5.4.10.2.1 of the DCD are modified.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with RPV supports are in Chapter 23, Section R, of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the changes to the RPV supports contributes to the increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Spent Fuel Pool Decay Heat Analysis and Associated Design Changes.

Item:13 of 15.

Description of Change:In AP1000 DCD Tier 2, Section 9.1.3, Westinghouse proposed changes to the SFP cooling system. Westinghouse proposed to increase the number of spent fuel storage locations from 619 to 889 fuel assemblies and implement the following associated design changes: (1) Increase in component cooling system (CCS) pump design capacity, (2) increase in the CCS supply temperature to plant components, and (3) changes in the CCS parameters related to the RCPs. The increase in the number of assemblies affects the decay heat removal/SFP heatup analyses. The supporting bases for these DCD changes are documented in: TR-111, “Component Cooling System and Service Water System Changes Required for Increased Heat Loads,” APP-GW-GLN-111, Revision 2, dated May 2007 (ADAMS Accession No. ML071500563); TR-103, “Fluid System Changes,” APP-GW-GLN-019, Revision 2, dated October 2007 (ADAMS Accession No. ML072830060); TR-108, “AP1000 Site Interface Temperature Limits,” APP-GW-GLN-108, Revision 2, dated September 2007 (ADAMS Accession No. ML072750137), and TR-APP-GW-GLR-097, “Evaluation of the Effect of the AP1000 Enhanced Shield Building on the Containment Response and Safety Analysis,” Revision 3, dated June 2011 (ADAMS Accession No. ML11168A041).

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the SFP decay heat analysis are in Section 9.2.2 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the changes to the SFP decay heat analysis would contribute to the increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Spent Fuel Rack Design and Criticality Analysis.

Item:14 of 15.

Description of Change:In DCD Tier 2, Section 9.1.2, Westinghouse proposed changes to the spent fuel racks: (1) To increase the storage capacity by 270 additional fuel assemblies, and (2) to integrate a new neutron poison into the rack design. These changes included a different rack design and associated structural analysis and a revised criticality analysis. These DCD changes are documented in TR-54, “Spent Fuel Storage Racks Structure and Seismic Analysis,” APP-GW-GLR-033, Revision 4, dated June 2, 2010 (ADAMS Accession No. ML101580475); and TR-65, “Spent Fuel Storage Racks Criticality Analysis,” APP-GW-GLR-029, Revision 2, dated January 5, 2010 (ADAMS Accession No. ML100082093).

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the spent fuel rack design and criticality analysis are in Section 9.1.2 of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the changes to the spent fuel rack design and criticality analysis would contribute to the increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

Title:Vacuum Relief System.

Item:15 of 15.

Description of Change:In Revision 18 to AP1000 DCD Tier 2, Chapters 3, 6, 7, 9, and 16, Westinghouse proposed a change to the design of the containment, which adds a vacuum relief system to the existing containment air filtration system vent line penetration. The proposed vacuum relief system consists of redundant vacuum relief devices inside and outside containment sized to prevent differential pressure between containment and the shield building from exceeding the design value of 1.7 psig, which could occur under extreme temperature conditions.

Each relief flow path consists of a check valve inside containment and a motor operated butterfly valve outside of containment. The redundant relief devices outside containment share a common inlet line with redundant outside air flow entry points. The outlet lines downstream of the outside containment relief devices are routed to a common header connected to the vent line penetration. The redundant relief devices inside containment share a common inlet line from the vent line penetration and have independent discharge lines into containment.

Location within the SER where the changes are principally described:The details of the NRC's evaluation of Westinghouse's design features associated with the addition of the vacuum relief system are in Chapter 23, Section W, of the FSER.

Evaluation of the Criteria in 10 CFR 52.63(a)(1):Inclusion in the DCD of the introduction of a containment vacuum relief system would contribute to the increased standardization of this aspect of the design. Therefore, the change meets the finality criterion for changes in 10 CFR 52.63(a)(1)(vii).

The above discussion on selected technical changes is illustrative of the NRC's consideration of applicability of the finality provisions to other technical changes proposed from Revision 15 of the DCD, which are reflected in Revision 19. As noted earlier, Westinghouse provided its proposed basis for each change as part of the application. The NRC concludes that the other technical changes meet one or more of the finality criteria and thus do not constitute a violation of the finality provisions of 10 CFR 52.63.

The final rule amends the existing AP1000 DCR, in part, to address the requirements of the AIA rule. The AIA rule itself mandated that a DCR be revised, if not during the DCR's current term, then no later than its renewal to address the requirements of the AIA rule. In addition, the AIA rule provided that any COL issued after the effective date of the final AIA rule must reference a DCR complying with the AIA rule, or itself demonstrate compliance with the AIA rule. The AIA rule may therefore be regarded as inconsistent with the finality provisions in 10 CFR 52.63(a) and Section VI of the AP1000 DCR. However, the NRC provided an administrative exemption from these finality requirements when the final AIA rule was issued (74 FR 28112; June 12, 2009). Accordingly, the NRC has already addressed the backfitting implications of applying the AIA rule to the AP1000 with respect to the AP1000 and referencing COL applicants.

The amended AP1000 DCR does not constitute backfitting and is consistent with the finality provisions in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis or documented evaluation for this rule.

In accordance with the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 52.

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 published in theFederal Registeron May 26, 2011 (76 FR 30573). That NPRM proposed to require ECI or spot FPI of the stages 1-2 seal teeth of the HPC stages 2-5 spool for cracks and to prohibit installation of HPC stator stage 1 interstage seals that are not pregrooved to prevent heavy rubs.

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

Two commenters, Boeing Company (Boeing) and GE, wanted us to remove the reference to “uncontained engine failure, and damage to the airplane” from the Summary and Unsafe Condition paragraphs. GE claimed that all instances to date of material liberation have been contained. The commenters further stated that it has been demonstrated that once the crack reaches the aft tooth, it turns circumferentially, which minimizes the amount of material liberated.

We disagree. While all of the fractures to date have resulted in small pieces that are contained by the engine case, the direction that the crack will propagate cannot be determined with great certainty. Cracks propagating into the seal will result in a more substantial failure of the HPC stages 1-2 seal. Historical experience has shown that catastrophic failure of critical rotating engine parts can result in an uncontained engine failure that can damage the airplane. We did not change the AD based on this comment.

Two commenters, Boeing and GE, requested that we change the “Previous Credit” section by replacing “SB GE90-100 S/B 72-0320, Revision 01, dated May 11, 2010 or earlier revision” with “SB GE90-100 S/B 72-0320, Revision 02, dated October 1, 2010, or earlier version.” The commenters indicated that the NPRM (76 FR 30573, May 26, 2011) mandates accomplishment of GE Service Bulletin (SB) GE90-100 S/B 72-0320, Revision 02, dated October 1, 2010, and therefore it would be consistent to provide credit for accomplishment of GE SB GE90-100 S/B 72-0320, Revision 02, dated October 1, 2010, or an earlier revision.

We agree. We changed the reference in the service bulletin to Revision 02 in the Previous Credit paragraph.

Three commenters, FedEx, Japan Airlines and All Nippon Airways, requested that the FAA allow the installation of previously worn seals. Use of these seals is allowed by GE SB GE90-100 S/B 72-0360.

We agree. We replaced the Installation Prohibition paragraph in the AD with a new paragraph called “Installation of HPC Stator Stage 1 Interstage Seals” to allow for the installation of previously worn seals. Refer to GE SB GE90-100 S/B 72-360, Revision 04, dated November 7, 2011, for seals eligible for installation.

FedEx requested that wording in the “Installation Prohibition” section that states “do not install any HPC forward case unless it has an HPC stator stage 1 interstage seals, P/N 351-109-503-0” be changed to “allow the installation of previously worn seals and/or potential future (post-SB 72-0358) interstage seal configurations.” FedEx indicated that the current wording unnecessarily prohibits the installation of any forthcoming design improvements to the interstage seals that GE might develop.

We partially agree. We agree with use of a previously worn interstage seal because a worn interstage seal could prevent the HPC stages 2-5 spool from cracking. We disagree with use of the phrase “potential future (post-SB 72-0358) interstage seal configurations” because the AD compliance section can only mandate the use of currently approved designs. We added a new paragraph called “Installation of HPC Stator Stage 1 Interstage Seals,” which allows for the installation of previously worn seals.

GE stated that the AD requires the HPC module be reassembled with pregrooved seals. GE indicated that this requirement to use pregrooved seals is beyond the inspection requirements in GE90-100 S/B 72-0320. GE said that the inclusion of pregrooved seal references would cause disagreement with the “Relevant Service Information” and “Previous Credit” paragraphs which refer only to the inspection requirement in GE90-100 S/B 72-0320.

We disagree. This AD is issued to mitigate a safety issue caused by failure of the HPC stages 2-5 spool stages 1-2 seal. Reassembling the HPC module with a pregrooved seal would prevent the heavy rubs that result in HPC stages 2-5 spool stages 1-2 seal failure. We did not change the AD based on this comment.

GE requested that its address in the Addresses paragraph be revised to correct a missing space.

We agree. We corrected the GE address in the Addresses paragraph of the AD.

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

• Αre consistent with the intent that was proposed in the NPRM (76 FR 30573, May 26, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 30573, May 26, 2011).

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

We estimate that this AD affects 19 GE90-110B1 and GE90-115B engines installed on airplanes of U.S. registry. We also estimate that it will take about2 work-hours per engine to perform the proposed actions, and that the average labor rate is $85 per work-hour. Required parts will cost about $9,857 per engine. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $190,513.

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

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

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in theFederal Registeron September 21, 2011 (76 FR 58416). That NPRM proposed to require repetitive inspections for cracking of the wing rear spar and upper surface zones, and repair if necessary.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 58416, September 21, 2011) or on the determination of the cost to the public.

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

We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.

We estimate that this AD affects 4 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

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

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

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

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

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to revise AD 2010-06-12, Amendment 39-16236 (75 FR 12439, March 16, 2010). That AD applies to the specified products. The NPRM published in theFederal Registeron October 18, 2011 (76 FR 64285). That NPRM proposed to require relaxing the initial compliance time from within 100 flight hours to within 600 flight hours for TAE 125-01 reciprocating engines.

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

Since we issued the NPRM, we determined that the compliance paragraph describing the Vrail plug modification needed clarification. We changed paragraph (e)(1)(i) in the AD to describe what existing parts need to be removed and what part number needs to be installed.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD with the change described previously.

Based on the service information, we estimate that this AD will affect about 370 TAE 125-01 and TAE 125-02-99 reciprocating engines installed on products of U.S. registry. We also estimate that it will take about 1.5 work-hours per engine to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $500 per engine. Based on these figures, we estimate the cost of the AD for initial replacement on U.S. operators to be $232,175.

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 onproducts identified in this rulemaking action.

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron October 5, 2011 (76 FR 61643). That NPRM proposed to require replacement of the thumbnail fairing edge seals on both sides of the engines with Nitronic 60 stainless steel alloy seals.

We gave the public the opportunity to participate in developing this AD. We have considered the comment received. Boeing supports the NPRM (76 FR 61643, October 5, 2011).

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD affects 989 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

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

History

On October 17, 2011, the FAA published in theFederal Registera notice of proposed rulemaking to amend controlled airspace at Show Low, AZ (76 FR 64041). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V 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 that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface, at Show Low Regional Airport, to accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined 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 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 discusses 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 modifies controlled airspace at Show Low Regional Airport, Show Low, AZ.

On Monday, November 7, 2011, the FAA published in theFederal Registera notice of proposed rulemaking to amend VOR Federal airways V-320 and V-440 in Alaska, due to the relocation of the Anchorage VOR navigation aid (76 FR 68674). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Alaskan VOR Federal airways V-320 and V-440. The airway descriptions reflect the Anchorage VOR relocation from Fire Island, AK, to Ted Stevens Anchorage International Airport, Anchorage, AK. Specifically, the descriptions incorporate the new navigation aid location and updated radials used to describe the airway intersections to be used by air traffic control for instrument flight rules aircraft in the vicinity of Anchorage, AK.

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 Department of Transportation (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 United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the 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 Federal airways in Alaska.

Alaskan VOR Federal Airways are published in paragraph 6010(b) 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 Alaskan VOR Federal Airways listed in this document will be published subsequently in the Order.

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:

The Department of Transportation's Office of the Secretary (OST) published a direct final rule with a request for comments in theFederal Registeron December 16, 2011 (76 FR 78145). The direct final rule delayed the effective date of the full fare and other advertising requirements from January 24, 2012, to January 26, 2012, to provide regulatory relief to petitioner American Airlines by allowing the carrier and any other similarly situated carrier or ticket agent to avoid having to update full fare information in on-line reservations systems on a day of the week that is the petitioner's, and may be other carriers' and ticket agents', heaviest on-line traffic and revenue day. OST uses the direct final rulemaking procedure for non-controversial rules where OST believes that there will be no adverse public comment. The direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment was received by December 23, 2011, the full fare and other advertising requirements in 14 CFR 399.84 would become effective on January 26, 2011. No adverse comments were received, and thus this notice confirms that the direct final rule will become effective on that date.

The Department of Labor (Department) published the Wage Methodology for the Temporary Non-agricultural Employment H-2B Program; Final Rule (the Wage Rule) on January 19, 2011, 76 FR 3452. The Wage Rule revised the methodology by which we calculate the prevailing wages to be paid to H-2B workers and United States (U.S.) workers recruited in connection with a temporary labor certification for use in petitioning the Department of Homeland Security to employ a nonimmigrant worker in H-2B status. The Department originally set the effective date of the Wage Rule for January 1, 2012. However, due to a court ruling that invalidated the January 1, 2012 effective date of the Wage Rule,1 we issued a Notice of Proposed Rulemaking (NPRM) on June 28, 2011, which proposed that the Wage Rule take effect 60 days from the date of publication of a final rule resulting from the NPRM. 76 FR 37686, June 28, 2011. After a period of public comment, we published a Final Rule on August 1, 2011, which set the new effective date for the Wage Rule of September 30, 2011 (the Effective Date Rule).

Both the Wage Rule and the Effective Date Rule recently were challenged in two separate lawsuits2 seeking to bar their implementation. In considerationof the two pending challenges to the Wage Rule and its new effective date, and the possibility that the litigation would be transferred to another court,3 the Department issued a final rule, 76 FR 59896, September 28, 2011, postponing the effective date of the Wage Rule from September 30, 2011, until November 30, 2011, in accordance with the Administrative Procedure Act, 5 U.S.C. 705.

On November 18, 2011, President Obama signed into law the Consolidated and Further Continuing Appropriations Act, 2012, which provides that “[n]one of the funds made available by this or any other Act for fiscal year 2012 may be used to implement, administer, or enforce, prior to January 1, 2012 the [Wage Rule].” Public Law 112-55, Div. B, Title V, § 546 (Nov. 18, 2011) (the November Appropriations Act). While the November Appropriations Act prevents the expenditure of funds to implement, administer, or enforce the Wage Rule before January 1, 2012, it did not prohibit the Wage Rule from going into effect, which was scheduled to occur on November 30, 2011. When the Wage Rule goes into effect, it will supersede and make null the prevailing wage provisions at 20 CFR 655.10(b) of the Department's existing H-2B regulations, which were promulgated under Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States (H-2B Workers), and Other Technical Changes; Final Rule, 73 FR 78020, Dec. 19, 2008 (the H-2B 2008 Rule). The Department determined that allowing the Wage Rule to go into effect as planned on November 30, 2011, would therefore render the Department unable to issue prevailing wage determinations under the 2008 H-2B Rule, because it would no longer exist. Accordingly, the Department issued a final rule, 76 FR 73508, on November 29, 2011 which delayed the effective date of the Wage Rule until January 1, 2012.

On December 23, 2011, President Obama signed into law the Consolidated Appropriations Act, 2012, which provides that “[n]one of the amounts made available under this Act may be used to implement the [Wage Rule].” Similar to the November Appropriations Act, the December Appropriations Act prevents the expenditure of funds to implement the Wage Rule for the remainder of FY 2012, but it does not prohibit the Wage Rule from going into effect. If the Wage Rule were to go into “effect” on January 1, 2012, we would be unable to issue prevailing wage determinations under the 2008 H-2B rule and the H-2B program would have to be held in abeyance for the remainder of FY 2012, as we would be legally precluded from issuing prevailing wage determinations for the remainder of FY 2012. Because of the imminent threat that we will be unable to operate the H-2B program for the remainder of FY 2012, the Department considers this situation an emergency warranting the publication of a final rule under the good cause exception of the Administrative Procedure Act. See 5 U.S.C. 553(b)(B) and 553(d)(3).

In order to avoid an operational hiatus during the remainder of FY 2012, the Department finds good cause to adopt this rule, effective immediately, and without prior notice and comment. See 5 U.S.C. 553(b)(B) and 553(d)(3). As such, a delay in promulgating this rule past the date of publication would be impracticable and unnecessary and disrupt the program to the detriment of the public interest.

The Department published the Wage Rule on January 19, 2011, 76 FR 3452. The Wage Rule revised the methodology by which we calculate the prevailing wage to be paid to H-2B workers and United States (U.S.) workers recruited in connection with a temporary labor certification used in petitioning the Department of Homeland Security to employ a nonimmigrant worker in H-2B status. We originally set the effective date of the Wage Rule for January 1, 2012. However, as a result of a court ruling that invalidated the January 1, 2012 effective date of the Wage Rule,1 we issued a Notice of Proposed Rulemaking (NPRM) on June 28, 2011, proposing that the Wage Rule take effect 60 days from the date of publication of a final rule resulting from the NPRM. 76 FR 37686, Jun. 28, 2011. We published a Final Rule on August 1, 2011, which set the new effective date of September 30,2011 for the Wage Rule (the Effective Date Rule).

In anticipation of the revised effective date of the Wage Rule, the Department issued supplemental prevailing wage determinations to those employers granted labor certification for an H-2B application where work would be performed on or after September 30, 2011. Those supplemental determinations were provided to employers to enable them to meet their amended wage obligations.

Both the Wage Rule and the Effective Date Rule were challenged in two separate lawsuits2 seeking to bar their implementation. In consideration of the two pending challenges to the Wage Rule and its new effective date, and the possibility that the litigation could be transferred to another court,3 the Department issued a final rule, 76 FR 59896, Sep. 28, 2011, postponing the effective date of the rule from September 30, 2011, until November 30, 2011, in accordance with the Administrative Procedure Act, 5 U.S.C. 705.

Following the postponement of the effective date to November 30, 2011, and in anticipation of the new effective date, the Office of Foreign Labor Certification (OFLC) issued participating employers two simultaneous (or dual) wage determinations for work to be potentially performed before and after the new effective date of the Wage Rule. The first determination was based on the former regulations that applied until November 30, and the second determination was based on the new prevailing wage methodology set forth in the Wage Rule, that was to be effective for work performed on and after November 30, 2011.

On November 18, 2011, the President signed into law the Consolidated and Further Continuing Appropriations Act, 2012, Pub. L. 112-55, Div. B, Title V, § 546 (Nov. 18, 2011) (the November Appropriations Act). The November Appropriations Act contains language preventing the expenditure of funds to implement, administer, or enforce the Wage Rule prior to January 1, 2012. Accordingly, the Department issued a final rule in theFederal Register, 76 FR 73508 (Nov. 29, 2011), again postponing the effective date of the rule, this time from November 30, 2011, until January 1, 2012. As a result, the Department issued in the first half of December 2011 prevailing wage determinations, with the advisory that additional determinations would be forthcoming.

On December 23, 2011, the President signed into law the Consolidated Appropriations Act, 2012, which provides that [“[n]one of the amounts made available under this Act may be used to implement the [Wage Rule].”] Because of the distinct possibility that we would be unable to operate the H-2B program for the remainder of FY 2012 if the effective date of the Wage Rule were not postponed, the Department determined that this situation constituted an emergency warranting the publication of a final rule under the good cause exception of the Administrative Procedure Act to delay the effective date of the Wage Rule to October 1, 2012. Consequently, the Department is publishing a final rule to extend the effective date of the Wage Final Rule to October 1, 2012. See the final rule delaying the effective date of the H-2B Wage Rule, published elsewhere in this issue of theFederal Register.

In light of the postponement of the effective date of the Wage Rule until October 1, 2012, the Department is hereby providing public notice that the wage determinations previously issued in anticipation of the effective date of, and in accordance with, the Wage Rule will not be effective until October 1, 2012, and will then apply only to work performed on or after that date, if applicable. In addition, we are hereby providing notice that those prevailing wage determinations issued under the Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States (H-2B Workers), and Other Technical Changes; Final Rule, 73 FR 78020, Dec. 19, 2008 (the 2008 H-2B Rule), which were listed as valid until either November 30, 2011 or December 31, 2011, are now valid for a period of 90 days beyond December 31, 2011, i.e. until March 30, 2012, and only apply to work performed on or before September 30, 2012.

Any employer who received an H-2B prevailing wage determination issued in anticipation of the September 30, 2011, November 30, 2011, or January 1, 2012 effective dates of the Wage Rule is not required to pay, and the Department's Wage and Hour Division will not enforce, the wage provided in those prevailing wage determinations issued in anticipation of the effective date of the Wage Rule for any work performed by H-2B workers or U.S. workers recruited in connection with the H-2B application process until October 1, 2012. Employers are expected to continue to pay at least the prevailing wage as provided in a prevailing wage determination issued under the 2008 H-2B Rule for any work performed before October 1, 2012. Further, employers who received a supplemental H-2B prevailing wage determination, or a prevailing wage determination issued in anticipation of the effective date of the Wage Rule, who are still employing H-2B workers employed under labor certifications issued in connection with those prevailing wage determinations, must pay at least the wage issued under the Wage Rule to any H-2B worker and any U.S. worker recruited in connection with the labor certification for work performed on or after October 1, 2012.

The Department is providing notice that, as a result of the December Appropriations Act, it is precluded from addressing issues raised in Center Director Review requests submitted by employers in connection with prevailing wage determinations issued in anticipation of the effective date of, and in accordance with, the Wage Rule.

Last, the Department in anticipation of questions from the filing community and as a measure of customer service has established the following email box for questions:H2Bwagerule@dol.gov.

I. Background of This Rulemaking

On August 17, 2010, the Department issued a Notice of Proposed Rulemaking (NPRM) under the LHWCA, 33 U.S.C. 901et seq.,proposing rules implementing amendments to LHWCA section 2(3)(F) governing recreational vessels. 75 FR 50718-30 (Aug. 17, 2010). The Department reissued the proposal on October 15, 2010, to implement a technical amendment to the title of 20 CFR chapter VI and to allow an additional 30 days for public comment. 75 FR 63425-27 (Oct. 15, 2010). The comment period closed on November 17, 2010.

As explained in the NPRM, 75 FR 50718-19, LHWCA section 2(3) defines “employee” to mean “any person engaged in maritime employment, including any longshoreman or other person engaged in longshoring operations, and any harbor-worker including a ship repairman, shipbuilder, and ship-breaker * * *.” 33 U.S.C. 902(3). The section then lists eight categories of workers who are excluded from the definition of “employee” and therefore excluded from LHWCA coverage. 33 U.S.C. 902(3)(A)-(H). Section 2(3)(F) in particular excluded from coverage “individuals employed to build, repair, or dismantle any recreational vessel under sixty-five feet in length,” provided that such individuals were “subject to coverage under a State workers' compensation law.” 33 U.S.C. 902(3)(F).

Section 803 of Title IX of the American Recovery and Reinvestment Act of 2009, Public Law 111-5, 123 Stat. 115, 127 (2009), amended the section 2(3)(F) exclusion. That provision now excludes “individuals employed to build any recreational vessel under sixty-five feet in length,or individuals employed to repair any recreational vessel, or to dismantle any part of a recreational vessel in connection with the repair of such vessel,”and retains the state-workers'-compensation-coverage proviso. 33 U.S.C. 902(3)(F), as amended by Pub. L. 111-5 section 803, 123 Stat. 115, 187 (2009) (emphasis added).

The Department's proposed rules were intended to implement amended section 2(3)(F) and clarify its application in several respects. The proposed rules set standards for when the amendment applied, refined the definition of “recreational vessel,” clarified what types of recreational-vessel work may result in an individual being excluded from the definition “employee,” and revised the current regulatory definition of how recreational-vessel length is measured. The proposal also codified the Department's longstanding view that employees are covered under the LHWCA so long as some of their work constitutes “maritime employment” within the meaning of the statute. Finally, the Department included a summary of its initial regulatory flexibility analysis.

The Department received many written comments in response to the NPRM from a variety of sources connected to the recreational-vessel community. The commenters included Longshore claimant and employee groups, recreational vessel manufacturers, marina owners and operators, repair shop owners, insurance-industry members, members of Congress, and the Small Business Administration's Office of Advocacy. The Department has found these comments very helpful and, in several important respects, has revised the final rule in response.

As an initial matter, the Department notes that several comments responding to the NPRM appear to be based on the fundamental misunderstanding that these rules eliminate the LHWCA's “situs” requirement. For example, one commenter uses a hypothetical landlocked vessel manufacturing facility to illustrate how in its view the proposed rules would be unworkable. Similarly, several landlocked vessel manufacturers commented that the proposed rules would add to their costs of doing business, potentially resulting in a loss of jobs.

Neither the proposed nor the final rules eliminate the LHWCA's situs requirement for recreational-vessel workers. As explained in the NPRM, 75 FR 50723-24 (Aug. 17, 2010), the LHWCA imposes both a “situs” and a “status” requirement.Northeast Marine Terminal Co.v.Caputo,432 U.S. 249, 256-265 (1977) (describing history of “situs” and “status” tests). The situs test considers whether the injury occurred on “the navigable waters of the United States (including any adjoining pier, wharf, dry dock, terminal, building way, marine railway, or other adjoining area customarily used by an employer in loading, unloading, repairing, dismantling, or building a vessel.” 33 U.S.C. 903(a);Caputo,432 U.S. at 279. The status test considers whether the worker was “engaged in maritime employment” and therefore a covered “employee” when injured. 33 U.S.C. 902(3);Caputo,432 U.S. at 265.

Because the ARRA amendment revised the definition of “employee,” the proposed rules chiefly pertain to the status test. But the regulations in no way eliminate the situs requirement. Thus, workers at completely landlocked recreational vessel manufacturing facilities, repair shops, boat dealers and the like (i.e.,facilities that do not meet the situs test) are not covered by the LHWCA, regardless of the section 2(3)(F) exclusion for recreational-vessel workers.

A significant number of marinas and a marina trade association submitted comments in response to the NPRM. Most of these commenters expressed concern that the proposed rules would require marinas to purchase LHWCA insurance in addition to state workers' compensation insurance. The Department notes, however, that the LHWCA excludes from the term “employee” those “individuals employed by a marina and who are not engaged in construction, replacement, or expansion of such marina (except for routine maintenance),” provided the worker is subject to a state compensation law. 33 U.S.C. 902(3)(C).This exclusion has rarely been tested in litigation, and the LHWCA does not define the term “marina.” Whether any particular facility is a marina and whether its workers are excluded under the terms of section 2(3)(C) is a highly fact-bound question.See generally Keatingv.City of Titusville,31 BRBS 187 (1997). But at least some of these marinas' workers would likely be excluded from LHWCA coverage under section 2(3)(C).

The Department received many comments addressing the proposed “recreational vessel” definition and has made several important changes to the final rule. The proposed definition incorporated the Coast Guard's standards for categorizing vessels as recreational and non-recreational. While the Department has retained those standards, the final rule contains two additional provisions designed to make the definition easier to apply. First, the final rule provides that manufacturers and builders may determine whether a vessel is recreational by the nature of the vessel's design rather than the end use of the vessel. And second, the rule includes within the definition of recreational vessels non-military vessels that are recreational by design and owned or chartered by federal, state or municipal governments. Both of these changes are explained in detail below. The Department believes that these changes answer many of the concerns raised by the commenters.

The Department has decided to withdraw proposed § 701.303. This rule codified both the Director's longstanding position and controlling case law that the LHWCA covers a maritime employee if he or she regularly performs at least some duties that come within the ambit of the statute as part of his or her overall employment (i.e.,“qualifying” employment). 75 FR 50722 (Aug. 17, 2010). The rule also clarified that LHWCA coverage does not depend on whether the employee is performing qualifying maritime work or non-qualifying work at the time of injury. In discussing the proposal, the Department conducted an exhaustive review of the governing Supreme Court case law and noted the Court's “bedrock principle that `maritime employment' for LHWCA purposes is a unitary concept: Coverage is established whether or not the employee was performing a particular covered activity when injured so long as his overall employment includes ‘some' qualifying maritime employment.” 75 FR 50723,quoting Caputo,432 U.S. at 265, 273. The Department viewed the rule as important to advising the regulated public of the LHWCA's coverage. 75 FR 50722.

The Department received many comments on the proposed regulation. A great number of these commenters saw proposed § 701.303 as an unwarranted expansion of the LHWCA's coverage and expressed great concern over the additional costs employers would incur if required to carry LHWCA insurance. Most of these comments focused on the nature of the facility (e.g.,repair shop, manufacturing plant) where recreational vessel work is performed or the identity of the employer, rather than on the nature of an employee's work at those facilities. The commenters stated that it would be difficult to ascertain when a particular facility or employer conducted sufficient LHWCA-covered operations to trigger LHWCA coverage for the entire facility. Stating that the “some” standard was too vague and would lead to litigation, the commenters urged the Department to adopt a bright-line rule that would be easy to administer and set a high threshold for coverage to comport with the purpose of the recreational-vessel exclusion. Most commenters proposed an 80%-20% split: So long as less than 20% of a facility's or employer's work was on commercial vessels and the remainder on recreational vessels, all work at the facility would be excluded from LHWCA coverage.

The comments misconstrue both the section 2(3)(F) exclusion and the import of proposed § 701.303. Some of the exclusions from the definition of “employee” in LHWCA section 2(3) focus on the nature of the employer. For instance, section 2(3)(B) excludes “individualsemployed bya club, camp, recreational operation, restaurant, museum, or retail outlet.” 33 U.S.C. 902(3)(B) (emphasis added).See Boomtown Belle Casinov.Bazor,313 F.3d 300, 303-04 (5th Cir. 2002) (holding that plain language of section 2(3)(B) exclusion turns “on the nature of the employing entity, and not on the nature of the duties an employee performs”). But section 2(3)(F) excludes individuals based solely on the type of work they do: It excludes “individualsemployed tobuild * * * repair * * * or to dismantle * * * in connection with the repair” of a recreational vessel. 33 U.S.C. 902(3)(F) (emphasis added).Cf. Boomtown Belle Casino,313 F.3d at 303-04 (contrasting section 2(3)(B)'s recreational exclusion with section 2(3)(C)'s exclusion for certain marina employees based on their job duties). Thus, for recreational vessel workers, the statute focuses exclusively on the kind of work the employee performs and not on the identity of the employer or the type of facility where the work is performed. Those comments urging the Department to adopt an 80%-20% rule based on the nature of the work performed by a particular employer or at a particular facility as a whole are inconsistent with the statute's plain language.

Moreover, as noted, proposed § 701.303 was not intended to expand LHWCA coverage. Rather, the rule codified the Supreme Court's interpretation of the LHWCA. The Department stands by its analysis of the governing case law. Thus, even in the absence of a regulation, a worker who regularly performs at least some duties that come within the ambit of the LHWCA as part of his or her overall employment is covered under the LHWCA, even if the injury occurs while the worker was not performing qualifying maritime duties.Caputo,432 U.S. at 273. So too is a worker who is injured while performing qualifying maritime duties, regardless of his or her other job duties, so long as that employment is not excluded under section 2(3).See, e.g., Chesapeake and Ohio Ry. Co.v.Schwalb,493 U.S. 40, 47 (1989) (“It is irrelevant that an employee's contribution to the loading process is not continuous or that repair or maintenance is not always needed. Employees are surely covered when they are injured while performing a task integral to loading a ship.”).

Nevertheless, the Department has elected to withdraw the proposed rule. The Department appreciates the difficulties recreational-vessel employers and facilities face in determining whether their workers are performing LHWCA-covered activities in order to purchase the appropriate insurance. Further investigation into the industry's needs is warranted. Moreover, even though this rule would have an impact on the entire longshoring industry, the Department received only a few comments from individuals or groups with interests extending beyond the recreational-vessel segment of that industry. This result is not surprising because the NPRM chiefly involved implementation of the section 2(3)(F) exclusion for recreational-vessel workers. Given the rule's broad application, however, the Department is reluctant to promulgate the rule without input from the greater longshoring community.

In response to a number of persuasive comments, the final rule makes several changes and one addition to proposed § 701.504. This rule sets out standards for determining the date of injury, which governs whether the section 2(3)(F) amendment applies. The final rule makes the date of harmful or causative workplace exposure—rather than the date of death or manifestation—the date of injury for determining whether the amendment applies in cases of occupational disease, hearing loss, and death. The rule also adds a new section addressing date of injury for cumulative trauma, which fixes the date of injury as any date on which a workplace trauma worsened the individual's condition.

The Department proposed only technical revisions to this section to accommodate other substantive additions. In particular, the Department moved this section's lengthy definition of “employee” into a new § 701.302. No comments were received, and the rule is promulgated as proposed.

Proposed paragraph (c)(6) updated the paragraph in the definition of “employee” pertaining to the recreational vessel exclusion, which currently appears at § 701.301(a)(12)(i)(F), to incorporate the amended section 2(3)(F) language and cross-reference new §§ 701.501-701.505. No comments were received, and the rule is promulgated as proposed.

As discussed above, the Department has decided to withdraw this proposed regulation.

(a) The Department proposed an updated and refined definition of “recreational vessel.” The Department explained that the current regulations, promulgated in 1984, adopted the definition of recreational vessel from a statute administered by the Coast Guard. 75 FR 50721 (Aug. 17, 2010). That statute, and the Department's current regulations, define “recreational vessel” as a vessel “manufactured or operated primarily for pleasure, or rented, leased or chartered by another for the latter's pleasure.” 20 CFR 701.301(a)(12)(iii)(F) (2009).See46 U.S.C. 2101(25); 51 FR 4273 (Feb. 3, 1986). Prior to the ARRA amendment, this definition was limited by length: Section 2(3)(F) excluded only those individuals who worked on recreational vessels under sixty-five feet in length. Because the ARRA amendment removed the vessel-length limitation for workers who either repair recreational vessels or dismantle them for repair, the Department noted that both employers and employees could more frequently encounter difficulties determining which vessels were recreational. 75 FR 50721. The Department also wanted to ensure that individuals who perform repair work on vessels that have a significant commercial purpose were not improperly excluded under amended section 2(3)(F). 75 FR 50721.

To accomplish these goals, the Department proposed using Coast Guard vessel categories to define a “recreational vessel.” Essentially, the Coast Guard deems the following to be recreational: Any unchartered passenger vessel used for pleasure and carrying no passengers-for-hire (i.e.,paying passengers); and any chartered passenger vessel used for pleasure with no crew provided and with fewer than twelve passengers, none of whom is for hire. All other passenger-carrying vessels fall into one of the following three non-recreational categories: Uninspected passenger vessel; small passenger vessel; and passenger vessel. 46 CFR 2.01-7; Navigation and Vessel Inspection Circular No. 7-94 (Sept. 30, 1994).

The Department noted that these categories were used in boating safety and environmental contexts, and thus would be generally known to the recreational boating community.Id.The categories also provided a clear, objective basis by which employers and employees could readily ascertain whether a vessel being repaired was a “recreational vessel” for LHWCA coverage purposes. The Department received many comments regarding this proposed rule and has made several significant changes to the final rule in response.

(b) Many comments state that the proposed “recreational vessel” definition is ambiguous. Some of the more specific criticisms state that the proposed definition would be difficult to apply in cases where a boat has multiple uses or is in-between uses, and where, over the course of its operations, the boat falls within different Coast Guard inspection categories. Some believe that the Coast Guard definitions are unfamiliar to boat builders and repairers.

The Department has revised the rule to clarify that the time for evaluating the vessel's use is when the vessel is being built, repaired or dismantled. But the final rule continues to use the Coast Guard classifications to identify recreational vessels. In general, the comments did not offer any constructive alternatives to using the Coast Guard classifications except to leave the “recreational vessel” definition unchanged. As set forth in the NPRM, the Department believes that the definition needs greater clarity so that employers and employees may properly evaluate both their obligations and their rights under the LHWCA.

The Coast Guard categories set a bright-line rule for determining whether any particular vessel is recreational. Presumably, a vessel's owner or operator is familiar with its use and whether the vessel is inspected or uninspected under the Coast Guard standards. An employer's simple inquiry may be all that is necessary to resolve the question. Further, as noted in the NPRM, some outward indicia point to a vessel's non-recreational status. For instance, passenger vessels and small passenger vessels must display certificates of inspection, and uninspected passenger vessels are subject to certain safety requirements and must have a licensed operator. These indicia of non-recreational status will make it easier for employers and employees to recognize vessels that should not be considered “recreational vessels” for purposes of the section 2(3)(F) exclusion.

(c) One commenter suggests simplifying the rule by describing the vessel categories excluded from the definition of “recreational vessel” rather than cross-referencing the Coast Guard statutes. The Department has not adopted this suggestion. Outside of the manufacturing and building context, a vessel's use at the time the repair or dismantling led to the compensable injury determines its recreational status. Using the general Coast Guard categories will allow the definition of “recreational vessel” to remain current and consistent with the term as used in the recreational boating industry. The Department has made a technical revision to the language in proposed § 701.501(c) to simplify it. No change in meaning is intended by this revision.

(d) Many comments state the proposed definition would unduly burden employers by requiring them to investigate their customers' vessel usage in order to determine whether the boat is recreational. Another comment urges a rule that uses the intent of the owner in buying a vessel instead of its actual use. Others question the feasibility and fairness of holding employers to accountfor usage of a boat when off their premises.

The Department does not believe a change in this requirement is necessary. Since 1984, the regulatory “recreational vessel” definition has required employers to determine whether a vessel is “manufactured or operated primarily for pleasure.” 20 CFR 701.301(a)(12)(iii)(F) (2009). To the Department's knowledge, making this inquiry has not proved to be problematic. In fact, two commenters stated that for insurance purposes, they track how much work they do on commercial vessels and how much on recreational vessels. That would only be possible by evaluating whether the vessels they service are used for pleasure. Moreover, using a standard other than usage could lead to the improper exclusion of workers from LHWCA coverage. As one commenter pointed out, vessels manufactured to recreational-vessel standards may in fact be used entirely for commercial purposes.See, e.g., Munguiav.Chevron U.S.A. Inc.,999 F.2d 808, 809-10 (5th Cir. 1993) (noting that employer maintained a fleet of small vessels, including Lafitte skiffs, Boston whalers, and Jo-boats, solely to allow its employees to service an oil-production field located on water). Retaining the “primarily for pleasure” touchstone and looking to the vessel's use avoids the problem of improperly excluding a worker from LHWCA coverage.

(e) Several comments from recreational-vessel manufacturers object to defining a recreational vessel by the vessel's end use because a manufacturer typically does not know it. Instead, manufacturers usually build to recreational-vessel standards established by the Coast Guard and market their products through retail sales channels. These commenters ask the Department to adopt a specific rule defining recreational vessels for manufacturers building new vessels or doing warranty work along the following lines: “recreational vessel * * * means a vessel which by design and construction is intended by the manufacturer to be operated primarily for pleasure * * * (rather than for commercial or military purposes).” In a related vein, one comment urges the Department to hold the manufacturer responsible for producing evidence regarding the relevant percentage of end-user purposes to establish that its purported intent is legitimate.

The Department has revised the final rule to accommodate the manufacturers' concerns. A recreational-vessel manufacturer or builder is usually in a different position than entities that service, repair and dismantle vessels while in use because the manufacturer may not know either the purchaser's identity or the vessel's actual use. Thus, the final rule provides that a vessel being manufactured or built (including warranty service) is a recreational vessel when intended, based on design and construction, to be for ultimate recreational use. The final rule also places the burden on the manufacturer or builder to prove that the vessel or vessels under construction are built in accordance with applicable recreational-vessel standards. Because recreational-vessel manufacturing facilities are typically landlocked, the Department does not expect this change in the final rule to have a significant impact on the number of employees covered by the LHWCA.

(f) Some commenters urge the Department to base the recreational-vessel definition on a vessel's design or construction for repairers as well as for manufacturers, because repair work on vessels that are recreational by design is less hazardous than other maritime work covered by the LHWCA. The statutory language does not support this result. In setting forth section 2(3)(F), Congress described the vessels subject to its exclusion simply as “recreational,” a term which naturally denotes a form of usage. Manufacturers receive the benefit of a different definition solely because of the impracticality of a usage-based definition. Indeed, the statute from which the current regulatory definition is derived, 46 U.S.C. 2101(25), offers a bifurcated approach under which some vessels may be recreational if they are “manufactured” for pleasure, and others if they are “operated” for pleasure, thus suggesting that the definition might vary depending on the setting. In a repair setting, where a vessel's operations are ascertainable, usage is the more appropriate approach.

(g) One comment states that paragraphs (a) and (b) of the proposed definition are in tension because a vessel used “primarily for pleasure” may still have incidental use as a passenger vessel or other commercial purpose that renders the vessel non-recreational under the Coast Guard categories set forth in paragraph (b). This commenter suggests that the regulation be rewritten so that incidental non-recreational use does not make the boat non-recreational for purposes of the section 2(3)(F) exclusion. While agreeing that a bright line may be necessary to determine recreational status, the commenter suggests looking to Coast Guard registration or state registration, whether a vessel is routinely engaged in various forms of commercial activity, and whether it falls within the Coast Guard definition of a non-recreational vessel less than 20% of the time. Other commenters echo this incidental use concern.

The Department agrees that occasional non-recreational use does not alter the vessel's core recreational purpose and should not take a vessel outside of the “recreational vessel” definition. To clarify this point and to resolve the tension the commenter notes between paragraphs (a) and (b), the final rule provides that a vessel remains recreational unless it falls within the designated Coast Guard vessel categories on a more than infrequent basis during the time the vessel is in operation.

(h) A few comments note that some repairers work on a small number of government-operated boats which resemble recreational vessels in design aspects. Examples given of government-owned vessels serviced include fish and wildlife enforcement boats, public-safety boats, and recreational vessels used by police in undercover operations. The commenters observe that they would have to discontinue this work (which they often perform at a discounted rate as a service to their communities) if repairing this small number of vessels would bring them under LHWCA coverage.

The Department agrees that servicing publicly owned or bareboat-chartered vessels that would otherwise be considered recreational generally should not be considered commercial work subject to LHWCA coverage. The final rule changes the definition of “recreational vessel” to accommodate this approach.

The final rule reflects a framework used in maritime and environmental statutes to define public vessels.See33 U.S.C. 1321(4) (definition of public vessel for environmental protection statute); 46 U.S.C. 2101(24) (definition of public vessel for Coast Guard statute);Blancov.U.S.,775 F.2d 53, 57-60 (2d Cir. 1985) (discussing “public vessels” as defined in various maritime statutes). This definition requires that the governmental entity own or charter the vessel and use it for a non-commercial and non-military purpose. It encompasses the various kinds of government vessels that the commenters seek to have excluded from LHWCA coverage: Firefighting vessels, police vessels, some Coast Guard vessels, sheriff's office vessels, and state natural-resource-department vessels. But to ensure the definition is not over-expansive, vessels owned or charteredby a governmental entity that are not of conventional recreational vessel construction or design, or that perform a traditionally commercial service (such as ferrying passengers), or that are military in nature are not considered public vessels.

To identify the governmental entity that must own or operate a vessel in order for it to be eligible for “public vessel” status, the final rule uses the phrase “the United States, or by a State or political subdivision thereof.” The Department intends this phrase to be construed broadly, and to include entities such as a State's municipalities that meet the well-established factor-based inquiry for determining whether a public entity is a subdivision.See Wheatonv.Golden Gate Bridge, Highway & Transportation District,559 F.3d 979, 981-82 (9th Cir. 2009).

(a) The Department proposed this rule to clarify what types of recreational-vessel work were covered both before and after the ARRA amendment. 75 FR 50721-22. The rule also made clear that the amendment did not have retroactive effect and that its application was based on the worker's date of injury. The section further defined the terms “length,” “repair” and “dismantle.” Finally, the rule cross-referenced § 701.303 and provided that workers who engaged in both excluded recreational vessel work and qualifying maritime work were covered by the LHWCA.

(b) Proposed paragraph (a) established that with respect to injuries before the amendment's effective date, February 17, 2009, a worker employed to repair, build, or dismantle any recreational vessel less than sixty-five feet in length is not an “employee” under the LHWCA, provided he or she is covered under a state workers' compensation law for such work. 75 FR 50729. On or after the amendment's effective date, a worker employed to build any recreational vessel under sixty-five feet in length, or repair or dismantle for repair any recreational vessel of any length is not an “employee” under the LHWCA, again provided he or she is covered under a state workers' compensation law.Id.This paragraph also establishes that the amendment only operates prospectively from its effective date. In the accompanying preamble, the Department noted that building recreational vessels sixty-five feet in length or greater and dismantling recreational vessels of any length (except in connection with a repair) was LHWCA-covered employment post-amendment. 75 FR 50722. The Department believed that this paragraph's provisions were consistent with congressional intent and the rules of statutory construction.

No comments found fault with this section, and several offered approval of some aspects of it, including the non-retroactivity of the amendment, the state workers' compensation proviso, and the treatment of dismantling of vessels. Accordingly, paragraph (a) is promulgated as proposed.

(c) Proposed paragraph (b)(1) defined vessel “length,” notably excluding bow sprits, bumpkins, rudders, outboard motor brackets, handles and other similar fittings, attachments and extensions from the vessel-length measurement. It also defined “repair” and “dismantle”. 75 FR 50729. In establishing these definitions, the Department relied on common-sense and industry-familiar definitions to make these concepts clearer and more objective, with the goal of avoiding future litigation. 75 FR 50722.

Several comments supported the changes to the definition of length. There were no comments critical of these definitions. Thus, the final rule is promulgated as proposed.

(d) The Department has made a technical change to the final definition of “dismantle” in paragraph (b)(3). As explained in the NPRM, 75 FR 50721-22, section 2(3)(F) originally excluded workers employed to “dismantle” recreational vessels less than sixty-five feet in length. This unqualified term would have excluded workers who dismantled a vessel at the end of the vessel's life. The amended statute, however, excludes only those workers who dismantle recreational vessels “in connection with the repair of such vessel.” Given this express limitation, the Department concluded that workers governed by the amended statute would not be excluded from LHWCA coverage when employed to dismantle obsolete recreational vessels. Although § 701.502(a)(1) and (2) make this distinction clear, proposed paragraph (b)(3)'s definition of “dismantle” does not. Accordingly, the Department has added the language “if the date of injury is on or after February 17, 2009” to paragraph (b)(3)'s last phrase.

(e) Proposed paragraph (c) essentially reiterated the walking-in-and-out rule that was set forth more fully in proposed § 701.303,i.e.,it stated that a worker engaged part of the time in excepted recreational vessel work and part of the time in qualifying work is covered by the LHWCA. 75 FR 50729. Because the Department has withdrawn § 701.303, paragraph (c) has been deleted from the final rule.

This proposed rule reiterated the basic thrust of the amendment—to amend the recreational vessel exclusion—and set forth the amendment's effective date based on congressional intent and governing principles of statutory construction. No negative comments were received on the proposed rule, and it remains unchanged in the final regulation.

(a) In the NPRM, the Department defined what date constitutes the “date of injury” for different kinds of claims. 75 FR 50720, 50729-30 (Aug. 17, 2010). The date of injury is the date at which a legally recognized harm occurs to a worker, giving rise to a compensation claim. It is the relevant point in time for determining whether the section 2(3)(F) amendment applies to a given claim: If the date of injury is on or after the amendment's effective date, February 17, 2009, then the amendment's provisions apply to a claim; otherwise, the pre-amendment statute governs. The NPRM set forth different rules for traumatic injury, occupational disease, hearing loss and death claims.

(b)Traumatic injury.For traumatic injury, proposed paragraph (a)(1) defined the date of injury as the date the worker is harmed. One comment generally supported this provision; no negative comments were received. Accordingly, this paragraph is promulgated as proposed.

(c)Occupational disease.For occupational disease, proposed paragraph (a)(2) adopted the manifestation date—i.e.,the date that the individual actually became aware of a disabling, work-related condition—to define the date of injury. The Department reasoned that this approach was consistent with judicial precedent and other statutory language making the manifestation date relevant for various purposes. 75 FR 50720.

While a few comments offered general support for the proposed rule with respect to occupational disease, other comments strongly questioned the proposed rule's approach. Several comments pointed out that linking the date of injury to disease manifestation inappropriately borrows from statute-of-limitations contexts and is otherwise unfair and contrary to the position taken by the Department in the past. Instead, one comment urged using a rule that makes the date of exposure to harmful stimuli the relevant date for determining the ARRA amendment's applicability.

The Department agrees with these comments and the final rule makes thedate of injurious exposure the date of injury for occupational diseases. Such an approach is both fairer and more consistent with the position taken by the Department in the past.

Using an exposure date is far less arbitrary than using a manifestation date for occupational diseases. The causative physiological harm occurs when an employee is exposed to the noxious substance, even though the deleterious effects might not be felt until years later; in addition, the date the disease's symptoms manifest may vary greatly among individuals. Indeed, under a rule that makes manifestation the date of injury, similarly-situated employees may be treated differently: An employee who was both exposed and developed symptoms before the amendment would be accorded pre-amendment coverage, while one who was exposed pre-amendment but happened to develop symptoms after the amendment's effective date would not.

And, as the comments allude to, using the exposure date as the date of injury affords workers, insurers, and employers the benefit of their legal expectations. Employees going to work on vessels that were covered pre-amendment did so with the expectation that they would benefit from LHWCA coverage for harmful on-the-job exposures, regardless of when those exposures manifested themselves in the form of a debilitating disease. Concomitantly, employers paid for insurance coverage in the event of harm to an employee caused by on-the-job exposure—whether harm from the exposure was realized immediately or in the long-run.

As the comments also note, the Department has previously recognized the fundamental fairness of a rule that makes the date of exposure determinative for gauging the effective date of an amendment. Analyzing whether the District of Columbia Workmen's Compensation Act of 1928, D.C. Code 36-501et seq.,which extended LHWCA coverage to private workers in the District from 1928 to 1982, should continue to apply to claims based on employment events prior to that Act's repeal, the Department concluded that, “for the purpose of determining whether a workers' compensation statute applies to such an injury (`coverage'), the relevant legal provisions are those in effect at the time of the employment exposure to the conditions that cause the disease.” 51 FR 4270, 4272 (Feb. 3, 1986). The Department reasoned that “[w]orkers' compensation laws operate upon the employment relationship. The occurrence of an event or events in the course of that relationship is the foundation of any compensation-law liabilities that arise thereafter. The insurance requirement that is a socially and practically critical aspect of compensation legislation attaches to the conduct of covered employment.” Because insurers are responsible for diseases resulting from exposure during the terms of their policies, a manifestation rule would unfairly “relieve[] [insurance carriers] of liabilities they contracted to bear.”Id.at 4272-73.

Based on this analysis, the Department has reconsidered the reasoning it gave in the NPRM to support adopting a manifestation rule in occupational disease claims. Although cases the Department cited have applied the manifestation rule to determine the applicability of the 1972 amendments to the LHWCA, which expanded the categories of workers covered by the LHWCA, those cases relied on congressional intent specific to those amendments. InSAIF Corp./Oregon Shipv.Johnson,908 F.2d 1434, 1439 (9th Cir. 1990), the court worried that an exposure rule would be contrary to Congress' intent to maximally expand LHWCA coverage. In order to conform to congressional intent, the court held that the manifestation date determined the amendments' coverage, because such a rule swept in the greatest number of workers.Id.; see also Insurance Company of North Americav.Dep't of Labor,969 F.2d 1400, 1404 (2d Cir. 1992) (describingSAIFas holding that “the manifestation rule best comports with the LHWCA's `paramount goal' of compensating workers for lost earning capacity stemming from occupational diseases”).

The ARRA amendments present a different scenario. Under the ARRA amendment, a manifestation rule could result in fewer LHWCA-covered employees. But there is no evidence that Congress intended to exclude the largest number of workers possible from LHWCA coverage. Rather, by expanding the recreational-vessel exclusion via the ARRA amendment, Congress primarily sought to relieve businesses from paying for duplicative state workers' compensation and LHWCA insurance coverage for recreational-vessel workers.SeeH. Rpt. 111-4, at 49 (Jan. 26, 2009). A manifestation rule does not serve that purpose. When the harmful exposure occurred while working on a covered vessel pre-amendment, the insurance in place at the time would cover that injury. Any expense to businesses for pre-amendment exposures has already been incurred, and an exposure rule does not impose any new prospective LHWCA financial obligations. Thus, there is no basis to believe that Congress wished to deny workers the legal remedy in place when they were exposed to an injurious stimulus.

In the NPRM, the Department cited other provisions of the LHWCA making manifestation the date of injury in a statute of limitations context. 75 FR 50720.See33 U.S.C. 912, 913. But as the comments point out, this analogy was inapt. The definition of date of injury in a statute of limitations context is designed to preserve the ability to file a claim for individuals who might not have notice of their right to compensation until manifestation. The date of injury in the context of a statutory amendment serves a far different goal: Satisfying congressional intent and ensuring that the legitimate expectations of the parties with respect to coverage are met.

One comment questioned how the last-employer rule would operate under the proposed manifestation-date rule.See generally Travelers Ins. Co.v.Cardillo,225 F.2d 137 (2d Cir. 1955). The commenter noted concern about how the liable employer and insurance carrier would be identified in claims involving exposure at both covered and non-covered employment, and in cases with multiple employers. Because the final rule adopts date of exposure as the date of injury, current precedent provides clear guidance on the questions the commenter raised. The Department adheres to the well-established rule that the employee is eligible for LHWCA benefits if some of the exposure leading to the occupational disease occurred while covered under the Act.See Newport News Shipbuilding and Dry Dock Co.v.Stilley,243 F.3d 179, 183-84 (4th Cir. 2001). In cases where the harmful exposure spans both an employee's covered pre-amendment work and his or her exempt post-amendment work, or spans covered commercial vessel work and exempt recreational vessel work, the employee will be eligible for benefits based on the covered work. The last employer for whom the employee performed covered work and that exposed him or her to a harmful stimulus is responsible for LHWCA benefits payable when injury results.See generally Avondale Industries, Inc.v.Director, Office of Workers' Compensation Programs,977 F.2d 186 (5th Cir. 1992) (setting forth last covered employer rule).

(d) Hearing loss.For hearing loss cases, proposed paragraph (a)(3) adopted the audiogram date—i.e.,the date that the individual received a diagnosis quantifying hearing loss viaan audiogram—to define the date of injury. The Department offered similar reasons to those offered in support of a manifestation rule in occupational disease cases, and additionally pointed out the difficulty of pinpointing a date of exposure in hearing loss cases.

Although some comments offer general support for the proposed rule, other comments raise compelling questions similar to those raised concerning the date of injury for occupational disease cases. One commenter questions the fairness of an audiogram-date rule for hearing loss claims. For the same reasons the Department has now adopted an exposure rule in occupational disease cases, the Department also adopts an exposure rule for hearing loss cases as well. Such a rule is less arbitrary, recognizes that the genesis of the injury is when the exposure occurs, and is fair to all parties by giving them the benefit of an insurance contract that covers injuries based on when the exposure occurred.

The comments suggest, and the Department agrees, that the reasoning set forth in the NPRM for using an audiogram rule is unpersuasive. There, the Department posited that an audiogram date was a better measure than an exposure rule for determining the ARRA amendment's applicability because of the difficulty in determining a precise date of harmful exposure. However, although exposure in hearing-loss claims typically occurs over an extended period of time, determining a single precise date is not necessary to administration of an exposure rule, and current law provides ample tools for handling claims involving exposure over periods of time. If some or all exposures occurred prior to February 17, 2009, the amendment would simply not apply with respect to a disability resulting from those exposures. And a worker would be eligible for full benefits if any of the exposure occurring during LHWCA-covered employment resulted in a hearing loss.See Port of Portlandv.Director, Office of Workers Compensation Programs,932 F.2d 836, 839-40 (9th Cir. 1991). Moreover, pursuant to the last-covered-employer rule, the most recent employer, if any, for whom the claimant performed LHWCA-covered work at which he or she suffered harmful exposure would be responsible for benefits.See id.

(c)Death claims.For death claims, proposed paragraph (a)(4) adopted the date of death as the date of injury for determining the amendment's application. The Department based this proposal on court precedent applying the law in place at the time of death in death benefit cases.

Although some comments expressed general support for the proposed rule, others urged the Department to use the date of the harmful workplace exposure or event that ultimately led to death as the date of injury, arguing that such a rule was more equitable. For essentially the same reasons stated above in the discussion of occupational disease cases, the Department agrees. Notably, as one comment suggests, in death cases, businesses have already paid and insurers have received the appropriate premiums to cover the death based on a causative workplace event that occurred while a worker was in covered employment.

In the proposal, the Department relied onInsurance Company of North Americav.Dep't of Labor,969 F.2d 1400, 1406 (2d Cir. 1992), and similar cases for the proposition that death should be the date of injury. However, although the court held that the time of one's death was the date of injury for determining the applicability of the 1972 amendments, it observed that the goal of the 1972 amendments was “an expansion * * * of the class of persons entitled to benefits under the Act.”Id.Here, the core purpose of the ARRA amendment is sparing businesses from the expense of duplicative state workers' compensation and LHWCA insurance coverage. One simply cannot infer that Congress sought to deny LHWCA benefits where workers were injured while covered by the LHWCA, but died post-amendment, given that employers would have already paid for LHWCA insurance coverage for a death resulting from an injury while a worker was performing LHWCA-covered employment.

(d)Cumulative trauma.In the NPRM, the Department did not specifically address the date of injury in claims involving cumulative trauma. One comment urged that the final rule address this issue. To avoid any confusion on this subject, the Department agrees, and the final rule adds a new paragraph for cumulative trauma injuries. The rule states that the date of injury is any date on which a work-related trauma occurs that contributes to the cumulative condition.See Metro. Stevedore Co.v.Crescent Wharf and Warehouse Co.,339 F.3d 1102, 1105-06 (9th Cir. 2003) (a trauma that worsens a cumulative condition is generally compensable). If, however, the injury is the result of a natural progression of an earlier trauma, then the date of the earlier trauma is the date of injury.

(e) Proposed paragraph (b) and (c) set out the consequences of applying the date-of-injury to the ARRA amendment's effective date. If that date occurs before February 17, 2009, ARRA's effective date, then the pre-amendment section 2(3)(F) exclusion applies; if that date occurs on or after February 17, 2009, the post-amendment exclusion applies. The Department received no specific comments on these rules and they are promulgated without substantive change. To make these two paragraphs consistent, however, the Department has made a technical change to paragraph (c). The Department has replaced the phrase “employee's eligibility,” which appeared in the proposed rule, with the phrase “individual's entitlement” in the final rule.

The proposed rule provided that an employer may not stop paying compensation for an injury awarded prior to February 17, 2009, the ARRA amendment's effective date, even if that employee's work is excluded from coverage by the amendment. The Department proposed this paragraph in accordance with basic principles of finality and the presumption against retroactivity. The Department has received no specific comments on this section but has received some generally positive remarks on its interpretation of the non-retroactive character of the ARRA amendment. Thus, the proposed rule remains unchanged in the final regulation.

Section 39(a) of the LHWCA (33 U.S.C. 939(a)) authorizes the Secretary of Labor to prescribe rules and regulations necessary for the administration and enforcement of the LHWCA and its extensions.

The final rule imposes no new collections of information.

This rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), entitled “The Principles of Regulation.” The Department has determined that the rule is not a “significant regulatory action” under Executive Order 12866, section 3(f). Accordingly, it does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. Moreover, because it is not asignificant rule within the meaning of the Executive Order, the Office of Management and Budget has not reviewed it.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996, enacted as Title II of Public Law 104-121 §§ 201-253, 110 Stat. 847, 857 (1996), the Department will report promulgation of this final rule to both Houses of the Congress and to the Comptroller General prior to its effective date. The report will state that the Department has concluded that the rule is not a “major rule” as defined under 5 U.S.C. 804(2).

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531et seq.) directs agencies to assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector, “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this rule does not include any Federal mandate that may result in increased expenditures by State, local, and tribal governments, or increased expenditures by the private sector of more than $100,000,000.

The Regulatory Flexibility Act of 1980, as amended (5 U.S.C. 601et seq.), requires an agency to prepare a regulatory flexibility analysis when it proposes regulations that will have “a significant economic impact on a substantial number of small entities,” or to certify that the proposed regulations will have no such impact, and to make the analysis or certification available for public comment.

The Department believes that the LHWCA itself accounts for most, if not all, of the costs imposed on the industry, and that this final rule does not directly add to those costs. The primary cost of the LHWCA lies in purchasing commercial insurance or qualifying as a self-insurer to insure covered workers. This requirement is imposed by statute. 33 U.S.C. 904, 932. By expanding the number of recreational vessel workers who will be excluded from coverage, the section 2(3)(F) amendment will generally reduce the recreational vessel industry's costs for purchasing workers' compensation insurance or, in the case of a self-insurer, providing compensation. This final rule simply seeks to make the potentially ambiguous language of the ARRA amendment clearer and more easily applied, and it does not deliberately seek to expand or contract businesses' eligibility for the recreational vessel exclusion. Moreover, to the extent comments have raised concerns that the proposed rule might be improved by making its provisions more easily workable for businesses without compromising the rule's underlying objective, the final rule, as discussed below, has accommodated such comments.

Nonetheless, because the recreational-vessel building and repair industries include many small firms, and because the comments raise issues concerning how the Department might maximize benefits to small businesses via rulemaking, the Department has evaluated how the ARRA amendment, as implemented in this final rule, might affect small businesses. The Department prepared an initial regulatory flexibility analysis (IRFA) before proposing this rule and included a summary of that analysis in the NPRM. 75 FR 50725-28 (Aug. 17, 2010). The Department incorporates those documents by reference into this final regulatory flexibility analysis.

The primary goal of this rule is to provide a clear, workable definition of “recreational vessel.” Because the ARRA amendment to section 2(3)(F) removed the sixty-five-foot limitation on what constitutes a recreational vessel for all purposes but construction, the amended exclusion presents more opportunities for confusion among vessel-repair enterprises and their workers about whether the boats they work on are “recreational vessels” within the meaning of the LHWCA. The Department determined that the current regulatory definition of “recreational vessel” does not provide adequate guidance to the industry and its employees, and therefore adopts this rule to more clearly define the term.

This definition, in turn, serves several purposes. It gives entities that build or repair vessels guidance regarding the classification of vessels their employees are working on so that they may insure themselves under the appropriate workers' compensation scheme (i.e.,the LHWCA or a state law). Similarly, the definition provides guidance to workers who might otherwise be unsure of their rights under the LHWCA. Finally, a clear definition reduces the possibility of litigation over the applicability of the section 2(3)(F) exclusion.1

The Director, Office of Workers' Compensation Programs, has the legal authority to issue this final rule. The LHWCA empowers the Secretary of Labor “to make such rules and regulations * * * as may be necessary” to administer the statute. 33 U.S.C. 939(a). The Secretary has delegated her authority to the Director, Office of Workers' Compensation Programs. Secretary's Order 10-2009 (Nov. 6, 2009). In addition, the Department, like any other administrative agency, possesses the inherent authority to promulgate regulations in order to fill gaps in the legislation that it is responsible for administering.Chevronv.Natural Resources Defense Council,467 U.S. 837, 843-44 (1984).

(a) Comments from the Small Business Administration's Office of Advocacy (SBA) and the National Marine Manufacturers Association (NMMA) raise questions as to whether the IRFA utilized correct data to estimate the number of small businesses affected by this rule. The Department has fully addressed these comments in the following section regarding the estimate of the number of small entities to which the final rule will apply.

(b) Some commenters, including the SBA, assert that using the Coast Guard standards for classifying recreational vessels will expand the number of small businesses covered by the LHWCA, thereby increasing their costs. Because the term “recreational vessel” has been only generally defined in the past, it is impossible to ascertain the extent to which the revised definition will alter the exclusion's scope and thereby affect small entities. Moreover, the final rule retools the definition so that it involves significantly less verification effort, and to make the definition's scope clear so that businesses can avoid purchasing LHWCA insurance on a precautionary basis.

(c) Addressing proposed § 701.501, the NMMA comments that the definition of recreational vessel and its use of the Coast Guard standards is ambiguous and will impose additional costs on small businesses that may not be able to determine whether a vessel meets the definition and, as a result, may turn away important work rather than incur the costs associated with LHWCA insurance. The NMMA also posits that insurance firms will be less apt to write LHWCA policies on these businesses, again increasing costs. The NMMA further encourages the Department to adopt a different recreational-vessel definition for boat manufacturers that focuses on the manufacturer's intent in building the vessel rather than on its end use. The SBA similarly states that the Department should consider this regulatory alternative. In addition, a few small repair businesses note that under the proposed definition, they would have to turn away public-vessel work if performing such work made purchasing LHWCA insurance necessary.

The Department has set forth its full response to these and other comments pertaining to the recreational-vessel definition in the section-by-section analysis for § 701.501 above. The Department has made two important changes to the final recreational-vessel definition in response to these comments. These changes will help small businesses identify recreational vessels within the meaning of the section 2(3)(F) exclusion and make informed decisions regarding their need to obtain LHWCA insurance. First, the Department has promulgated an alternative definition for manufacturers and builders, which allows them to assess a vessel's recreational nature based on design and construction data reasonably available to them. Second, the final rule carves out an exception for public-purpose vessels so that businesses that repair these vessels in addition to other recreational vessels will not have to purchase LHWCA insurance.

(d) Addressing proposed § 701.303, many comments expressed the view that the Department should have considered alternative measures for determining coverage for workers who perform both qualifying maritime duties and non-qualifying work (walking-in-and-out of qualifying coverage). The commenters believed the rule would force businesses to secure expensive LHWCA insurance for their workers, instead of less expensive state workers' compensation insurance. In this regard, several commenters rejected the Department's suggestion that businesses could minimize the cost implications of the proposed rule by segmenting their workplaces into recreational and non-recreational vessel operations. 75 FR 50728. These commenters (mostly small businesses) noted that their staffs were too small to segregate in this fashion. Most commenters proposed an 80%-20% split as an alternative: So long as less than 20% of a facility's or employer's work was on commercial vessels and the remainder on recreational vessels, all work at the facility would be excluded from LHWCA coverage. The SBA also suggested that the Department adopt this alternative.

The Department has set forth its full response to these comments in subsection D of the General Response to Significant Comments and Explanation of Major Changes section above. For the reasons explained there, the Department is withdrawing proposed § 701.303 and has not promulgated it in this final rule.

(a) In the IRFA, the Department looked to available data to estimate the number of small entities that might be affected by the proposed rule. 75 FR 50725-27. The IRFA estimated that, in 2007, there were 1,102 recreational vessel building establishments, employing 53,466 workers, generating $11.1 billion in shipments, and with a payroll of $1.9 billion; and 1,837 recreational boat repair establishments, employing 12,203 workers, generating $1.6 billion in revenue, and with $436 million in annual payroll. These entities were predominantly estimated to be small businesses.

In reaching its conclusions, the IRFA recognized difficulties in finding well-tailored NAICS categories to capture the affected small businesses. The Department relied chiefly on two NAICS industry categories: (1) NAICS industry 336612 (Boat Building); and(2) NAICS industry 811490 (Other Personal and Household Goods Repair and Maintenance). The NAICS system is described in detail in the IRFA. 75 FR 50726.

(b) Several commenters, notably the NMMA and the SBA, state that the universe of affected small entities is larger than estimated in the IRFA. These commenters note that the IRFA did not look to several relevant NAICS categories in developing its profile of the small entities affected: NAICS industry 713930 (Marinas), NAICS industry 441222 (Boat Dealers), and NAICS industry 441221 (Personal Watercraft Dealers). These commenters also suggest that NAICS industry 811490 (Other Personal and Household Goods Repair and Maintenance) may be too broad to be useful in assessing the number of small recreational vessel repairers. The commenters assert that businesses falling into these categories are mostly small under the Small Business Association's size standards.

While there is data suggesting that the additional categories pointed to by the commenters consist mostly of small businesses, it is analytically impossible to determine a precise number that actually perform work on recreational vessels. Some dealers may simply sell boats without performing repairs, while some marinas may simply offer docking space, but not repair services. This difficulty is compounded by the fact that, as noted in the IRFA, 75 FR 50726 n.1, some marinas' workers are excluded from LHWCA coverage by section 2(3)(C) of the statute. Nonetheless, although these categories pose analytical difficulties, the Department notes that they likely include affected small businesses.

Based on industry surveys, the NMMA and the SBA state that in 2008, there were approximately 33,000 retail/repair businesses employing 217,788 individuals; and 5,284 marine manufacturers employing 135,900 individuals. The vast majority of these are claimed to be small businesses. However, this data does not distinguish businesses that solely conduct retail sales versus those that repair recreational vessels. The data also does not consider whether some portion of the manufacturers are landlocked—the comments made clear that some portion of this industry is not located on navigable waterways-and thus does not meet the LHWCA's situs requirement.

(c) The Department fully acknowledges the data put forward by comments, including the industry surveys and the additional NAICS categories. However, it is impossible to state, in this informational vacuum, the accuracy of this data relative to the Department's conclusions in the IRFA. In any event, assuming the larger number of affected small businesses suggested by the commenters is correct, this final rule maximizes, to the extent consistent with sound administration of the LHWCA, the benefit of the recreational vessel exemption for small businesses by adopting several alternative proposals raised by, or on behalf of, small businesses. Because the final rule addresses these substantive concerns and ensures that small business can take maximum advantage of the section 2(3)(F) recreational vessel exclusion, while nevertheless protecting those employees whose duties arecovered by the LHWCA, the Department believes that reaching a precise conclusion concerning the number of affected small businesses is not critical.

The final rule does not directly impose any reporting or recordkeeping requirements on any entities, regardless of size. Nor do the rules impose other significant costs beyond those imposed by the LHWCA itself. The statute requires employers whose employees are covered by the LHWCA to secure the payment of compensation either by purchasing commercial insurance or qualifying as a Department-approved self-insurer. 33 U.S.C. 904, 932. The ARRA amendment to section 2(3)(F) significantly expanded the exclusion for recreational vessel workers, thereby reducing the number of workers considered employees for LHWCA coverage purposes. Thus, both small and large businesses that repair recreational vessels sixty-five feet or greater in length who had previously been required to purchase LHWCA insurance may be relieved of that obligation. Instead, these employers generally will only be required to purchase lower-cost state insurance for their workers who repair recreational vessels.

In preparing the IRFA, the Department surveyed the cost of purchasing LHWCA insurance and compared it to the cost of various states' workers' compensation insurance. On average, LHWCA insurance is 50-100 percent more expensive than state workers' compensation insurance. This range is based on data collected by the National Council on Compensation Insurance (NCCI), which discloses the premium or load that states impose on businesses that carry LHWCA insurance. Because the premium for both LHWCA and state workers' compensation coverage is calculated as a percentage of the employer's payroll, regardless of payroll size, the cost for both small establishments and larger employers is the same in relative terms.

One insurance broker who commented agreed with the Department's cost estimate. But the SBA's comment suggests that the increase in insurance costs will be higher than the Department's estimate, and individual comments suggest a wide range of potential cost increases. In positing that costs in the Maryland-Delaware-Virginia region will increase 200 to 300 percent, the SBA states that an increase from $20,000 to $53,000 would be a 265 percent change. By the Department's calculations, such a change would only be a 165 percent increase. Further, the state of Virginia imposes a 1.77 factor on each sector of the marine industry subject to the Longshore Act, while the state of Maryland imposes a 1.55 factor. Thus, the cost of LHWCA insurance in these regions is 55 to 77 percent greater than the cost of state workers' compensation insurance.

The comments, including SBA's, present anecdotal and geographically specific assertions on cost differences for LHWCA coverage. The Department acknowledges the possibility of such differences, including higher cost premiums, in different locations. However, the higher cost of LHWCA coverage, whatever it may be, is made less of a factor by the final rule's revisions to the proposal; as noted above, these revisions clarify the need for some businesses to carry LHWCA coverage and maximize the effect of the recreational vessel exemption to the extent feasible and permissible under the statute.

Several comments raise the prospect of a compliance-related burden, in that businesses will have to determine and document the nature of vessels they work on. But it is the statute itself that implicitly imposes this burden if employers wish to claim their workers are excluded from LHWCA coverage under section 2(3)(F). Moreover, the burden is a modest and unavoidable one. The stronger point made by some comments is that the proposed rule would make it more cumbersome to investigate and determine a vessel's status as recreational. The revisions made to the final recreational vessel definition should make this determination less burdensome to businesses.

The exemption for recreational-vessel workers is a creature of statute. All businesses, small or otherwise, must make determinations regarding their need to procure LHWCA or state workers' compensation insurance. The Department has fully explained the factual, policy and legal reasons for adopting the final rule—as well as its reasons for rejecting other significant alternatives—in the sections above titled General Response to Significant Comments and Explanation of Major Changes and Section-by-Section Analysis. As already explained, the Department adopted several alternatives suggested by the commenters that will serve to minimize the economic impact on small entities.

For the reasons set forth in the preamble, the Department of Labor amends 20 CFR part 701 as follows:

An ovarian adnexal mass assessment score test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.

The ovarian adnexal mass assessment score test system is not indicated for use as a screening or diagnostic test for ovarian cancer. Off-label use of the test (e.g.,in patients who are not already identified as needing surgery for pelvic mass or without reference to an independent clinical/radiological evaluation of the patient), may lead to a high frequency of unnecessary further testing and surgery due to false positive results, or to delay in tumor diagnosis due to false negative results.

FDA has determined that in order to provide reasonable assurance of safety and effectiveness, it is necessary to restrict the ovarian adnexal mass assessment score test system to sale, distribution, and use with labeling, advertising, and promotional material that bears a warning statement in a black box that alerts users to the risk associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. In theFederal Registerof March 23, 2011 (76 FR 16292 at 12694), FDA published a final rule that classified this device into class II and established as a special control the guidance entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System” that recommends a black box warning to address the risk of off-label use. In theFederal Registerof March 23, 2011 (76 FR 16425), FDA published a notice of availability of this special controls guidance document. However, FDA believes it is necessary to require this warning in labeling and advertising by restricting the device under section 520(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(e)). In theFederal Registerof March 23, 2011 (76 FR 16350 at 16352), FDA published a proposed rule to require the black box warning.

For devices that have significant risks that would make the devices unsafe if used inappropriately, FDA may require that the risks be explained in warning statements placed in a black box that is displayed prominently in the labeling, advertising, and promotional material to ensure awareness by the end user. Awareness of these important risks by the end user enables these devices to be used safely. In this case, a prominent black box warning, which alerts the user to the limitations of this device, is necessary in all labeling, advertising, and promotional materials to allow ovarian adnexal mass assessment score test system devices to be used safely. The prominent black box warning must read as follows:

In theFederal Registerof March 23, 2011 (76 FR 16350 at 16352), FDA announced the proposed rule to require the black box warning. Comments on the proposed rule were due by May 23, 2011. FDA received one comment in the docket for the proposed rule from a consumer. The comment supported the proposed rule.

FDA is issuing this final rule under the authority of section 520(e) of the FD&C Act, which authorizes FDA to restrict sale, distribution, and use of devices upon certain conditions. FDA is also issuing this final rule under general device and administrative provisions of the FD&C Act (sections 501, 510, 513, 515, 520, and 701 (21 U.S.C. 351, 360, 360c, 360e, 360j, and 371, respectively)).

FDA has determined under 21 CFR 25.34(b) and (f) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule strengthens existing cautions against misuse of a product, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

An ovarian adnexal mass assessment test system is a device that measures one or more proteins in serum to yield a single result for the likelihood that an adnexal pelvic mass in a woman is malignant. Such a test would identify women whose planned gynecologic surgery would benefit from referral to a gynecological oncologist, despite negative results from other clinical and radiographic tests for ovarian cancer.

In considering the appropriate level of regulatory oversight for this device, FDA concluded in classifying the device that general and special controls to minimize the risk of false positive and false negative results, and risks associated with improper off-label use would provide a reasonable assurance of safety and effectiveness of the ovarian adnexal mass assessment test system. The special controls guidance recommends use of a black box warning to minimize these risks. Without such a strong warning, ovarian adnexal mass assessment test systems might be used as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery. Off-label use of the test or the use of test results without consideration of other diagnostic testing and clinical assessment could pose a risk for morbidity and mortality due to nonreferral for oncologic evaluation and treatment.

In order to require the specific black box warning on labeling and on all advertising and promotional materials for the device, FDA is issuing this final rule under section 520(e) of the FD&C Act. Through this action, the Agency requires a black box warning on product labeling, advertising, and promotional materials for ovarian adnexal mass assessment test systems. This warning will make users aware of the limitations of this device and the serious risks associated with its misuse. With the addition of this black box warning to product labeling, advertising, and marketing materials, the Agency concludes there will be a reasonable assurance of the safety and effectiveness of ovarian adnexal mass assessment test systems.

The economic impact of this final rule is expected to be very small. We are aware of a single manufacturer producing a single product that will be affected by this black box warning. The manufacturer should be able to incorporate the warning in the course of developing its product labeling. The admonition against off-label use for this device already exists, so the addition of this type of warning is not expected to have a significant effect on the market for this product. The expected impact of this final rule on the market for this product would be a reduction in off-label use among the small number of users who would be undeterred by a less visible warning.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize anysignificant impact of a rule on small entities. This final rule would impose almost no cost on manufacturers. The black box warning will strengthen an existing admonition against off-label use and will not significantly affect usage. Impacts on any entities will be so small as to be difficult to quantify. For these reasons, the Agency certifies that this rule will not have a significant economic impact on a substantial number of small entities.

FDA concludes that labeling provisions of this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the black box warning on all labeling, advertising, and promotional materials for ovarian adnexal mass assessment score test system devices is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public.” (see 5 CFR 1320.3(c)(2)).

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain State requirements “different from or in addition to” certain Federal requirements applicable to devices (21 U.S.C. 360k; SeeMedtronic, Inc.v.Lohr,518 U.S. 470 (1996);Riegelv.Medtronic, Inc.,552 U.S. 312 (2008)). This final rule creates a requirement under 21 U.S.C. 360k for a black box warning statement that must appear in all advertising, labeling, and promotional material for ovarian adnexal mass assessment score test systems.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, FDA amends 21 CFR part 866 as follows.

The National Labor Relations Board is revising its rule requiring the automatic impoundment of ballots in representation cases when a party files a request for review. This rules revision is an addendum to the Board's December 14, 2011 rules revisions,which added a new Subpart X to the NLRB's Rules and Regulations (29 CFR 102.178-102.181; see 76 FR 77699). The December 14 revisions covered the consideration of certain pleadings in unfair labor practice cases that require a quorum of Board Members for final action, during periods when the number of Board members falls below three, the number required to establish a quorum of the Board. See 29 U.S.C. 153(b);New Process Steelv.NLRB,130 S.Ct. 2635 (2010). In representation cases, final action on requests for review by the Board also requires a three-member quorum. The instant rule revision, which adds 29 CFR 102.182 to the NLRB's Rules and Regulations, is being adopted to facilitate, as far as possible, the expeditious processing by the Agency of representation cases during periods in which the Board lacks a quorum. No Notice of Proposed Rulemaking (NPRM) is required with respect to this rules revision, as it falls under the Administrative Procedure Act's exception to the NPRM requirement for regulatory actions involving agencyorganization, procedure, or practice.See 5 U.S.C. 553. In addition, the Agency finds that notice and comment would be impracticable within the meaning of 5 U.S.C. 5553(b)(3)(B) before the Board loses a quorum on January 3, 2012, as now appears possible.

At present, the NLRB's Rules and Regulations provide only for the adjudication of representation cases and the issuance of decisions on review by the Board when it is composed of three or more members, which constitutes the Congressionally-designated quorum of the Board. InNew Process Steelv.NLRB, supra,130 S. Ct. 2635, the Supreme Court held that Congress empowered the Board to delegate its powers to no fewer than three members, and that, to maintain a valid quorum, a membership of three must be maintained.Id.at 2640. It can be anticipated that, from time to time, the number of individuals appointed by the President and confirmed by Congress to serve as members of the Board may fall below three. Current Section 102.67(b) of the NLRB's Rules and Regulations requires that all ballots cast in a representation election be impounded whenever the Board has not acted on a pending request for review, thus halting the processing of the representation case at the end of the voting, but before the ballots are counted. During periods when the Board lacks a quorum, the effect of the current rule would be to withhold information concerning the results of the election from employees and employers, who are usually eager to know the results, until the Board regains a quorum and rules on the request for review. The investigation and adjudication of objections and determinative challenges would be delayed during the same period. And in all likelihood the request for review would ultimately be denied, as are about 85% of requests for review currently filed. If the request for review is denied, the delay of the tally and any ensuing proceedings would have served no purpose whatsoever.

The Board has determined that the purposes of the National Labor Relations Act will best be served, and the Board's Congressional mandate will best be carried out, if its rules are revised to suspend, during any period the Board lacks a quorum, the second proviso of Section 102.67(b) of the NLRB's Rules and Regulations. Section 102.67(b) provides that a decision by the Regional Director upon the record shall set forth his findings, conclusions, and order or direction. The decision of the Regional Director shall be final:Provided, however,that within 14 days after service thereof any party may file a request for review with the Board in Washington, DC. The Regional Director shall schedule and conduct any election directed by the decision notwithstanding that a request for review has been filed with or granted by the Board. The filing of such a request shall not, unless otherwise ordered by the Board, operate as a stay of the election or any other action taken or directed by the Regional Director:Provided, however,that if a pending request for review has not been ruled upon or has been granted ballots whose validity might be affected by the final Board decision shall be segregated in an appropriate manner, and all ballots shall be impounded and remain unopened pending such decision.

Thus, suspension of the automatic impoundment of ballots during periods in which the Board lacks a quorum will permit Regional Directors promptly to tally the ballots cast by bargaining unit employees. The Board anticipates that the suspension of the automatic impoundment of ballots will serve the interests of the public and the parties in the speedy resolution of representation cases by avoiding extended and unnecessary delays in the tally of ballots. In addition, the Board anticipates that, in some cases the prompt tallying of ballots and recording the results of the election will cause parties to determine that it is unnecessary to pursue a request for review. In such cases, the choice of the bargaining unit employees will be effectuated expeditiously. Thus, the instant rules revision will provide the parties the opportunity to pursue numerous representation cases through to certification, while deferring consideration of requests for review by the Board until a quorum has been restored. The rules revision expressly preserves the Board's authority, based on a properly filed request for review, to revise or revoke any certification issued by a regional director. Member Brian E. Hayes voted against the rules revision.

The regulatory review provisions of Executive Order 12866 do not apply to independent regulatory agencies. However, even if they did, the proposed changes in the Board's rules would not be classified as “significant rules” under Section 6 of Executive Order 12866, because they will not result in (1) an annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or foreign markets. Accordingly, no regulatory impact assessment is required.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Because no notice of proposed rulemaking is required for procedural rules, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601et seq.) pertaining to regulatory flexibility analysis do not apply to these rules. However, even if the Regulatory Flexibility Act were to apply, the NLRB certifies that these rules will not have a significant economic impact on a substantial number of small business entities as they merely provide parties with avenues for expeditiously resolving certain representation cases before the Board.

These rules are not subject to Section 3504(h) of the Paperwork Reduction Act (44 U.S.C. 3501) since they do not contain any new information collection requirements.

Because these rules relate to Agency procedure and practice and merely modify the Agency's internal processing of ballots in representation cases, the Board has determined that the Congressional review provisions of the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801) do not apply.

Accordingly, the Board amends 29 CFR part 102 as follows:

On August 30, 2011, the National Labor Relations Board published a final rule requiring employers, including labor organizations in their capacity as employers, subject to the National Labor Relations Act (NLRA) to post notices informing their employees of their rights as employees under the NLRA. The Board subsequently determined that in the interest of ensuring broad voluntary compliance with the rule concerning notification of employee rights under the National Labor Relations Act, further public education and outreach efforts would be helpful. Accordingly, the Board changed the effective date of the rule from November 14, 2011, to January 31, 2012, in order to allow time for such an education and outreach effort. On December 19, 2011, the U.S. District Court for the District of Columbia requested that the Board consider postponing the effective date of the rule in connection with a pending proceeding concerning the rule. The Board has determined that postponing the effective date of the rule would facilitate the resolution of the legal challenges that have been filed with respect to the rule. Accordingly, the Board has decided to change the effective date of the rule from January 31, 2012 to April 30, 2012.

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

On September 14, 2011 (76 FR 56694), EPA proposed to determine, under the Clean Air Act (CAA or “Act”), that three areas previously designated nonattainment for the one-hour ozone NAAQS—the South Coast, the San Joaquin Valley, and the Southeast Desert—failed to attain the NAAQS for one-hour ozone by their applicable one-hour NAAQS attainment dates.

The Act requires us to establish NAAQS for certain widespread pollutants that cause or contribute to air pollution that is reasonably anticipated to endanger public health or welfare (sections 108 and 109 of the Act). In 1979, we promulgated the revised one-hour ozone standard of 0.12 parts per million (ppm) (44 FR 8202, February 8, 1979).1

An area is considered to have attained the one-hour ozone standard if there are no violations of the standard, as determined in accordance with the regulation codified at 40 CFR section 50.9, based on three consecutive calendar years of complete, quality-assured and certified monitoring data. A violation occurs when the ambient ozone air quality monitoring data show greater than one (1.0) “expected number” of exceedances per year at any site in the area, when averaged over three consecutive calendar years.2 An exceedance occurs when the maximum hourly ozone concentration during any day exceeds 0.124 ppm. For more information, please see “National 1-hour primary and secondary ambient air quality standards for ozone” (40 CFR 50.9) and “Interpretation of the 1-Hour Primary and Secondary National Ambient Air Quality Standards for Ozone” (40 CFR part 50, appendix H).

The Act, as amended in 1990, required EPA to designate as nonattainment any area that was violating the one-hour ozone standard, generally based on air quality monitoring data from the 1987 through 1989 period (section 107(d)(4) of the Act; 56 FR 56694, November 6, 1991). The Act further classified these areas, based on the severity of their nonattainment problem, as Marginal, Moderate, Serious, Severe, or Extreme.

The control requirements and date by which attainment of the one-hour ozone standard was to be achieved varied with an area's classification. Marginal areas were subject to the fewest mandated control requirements and had the earliest attainment date, November 15, 1993, while Severe and Extreme areas were subject to more stringent planning requirements and were provided more time to attain the standard. Two measures that are triggered if a Severe or Extreme area fails to attain the standard by the applicable attainment date are contingency measures [section 172(c)(9)] and a major stationary source fee provision [sections 182(d)(3) and 185](“major source fee program” or “section 185 fee program”).

On November 6, 1991, EPA designated the South Coast3 as “Extreme” nonattainment for the one-hour ozone standard, with an attainment date no later than November 15, 2010 (56 FR 56694). In its November 6, 1991 final rule, EPA designated the San Joaquin Valley4 as “Serious” nonattainment for the one-hour ozone standard, but later reclassified the valley as “Severe” (66 FR 56476, November 8, 2001), and then as “Extreme” (69 FR 20550, April 16, 2004) for the one-hour ozone standard, with the same attainment date (November 15, 2010) as the South Coast. In its 1991 final rule, EPA designated the Southeast Desert5 as “Severe-17” nonattainment for the one-hour ozone standard, with an attainment date no later than November 15, 2007.

Outside of Indian country,6 the South Coast lies within the jurisdiction of the South Coast Air Quality Management District (SCAQMD). Similarly, with the exception of Indian country, San Joaquin Valley lies within the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD). Likewise, excluding Indian country, the Los Angeles portion of the Southeast Desert lies within the Antelope Valley Air Quality Management District (AVAQMD), the San Bernardino County portion of the Southeast Desert lies within the Mojave Desert Air Quality Management District (MDAQMD), and the Riverside County portion of the Southeast Desert lies within the SCAQMD.

Under California law, each air district is responsible for adopting and implementing stationary source rules, such as the fee program rules required under CAA section 185, while the California Air Resources Board (CARB) adopts and implements consumer products and mobile source rules. The district and state rules are submitted to EPA by CARB.

In 1997, EPA promulgated a new, more protective standard for ozone based on an eight-hour average concentration (the 1997 eight-hour ozone standard). In 2004, EPA published the 1997 eight-hour ozone designations and classifications and a rule governing certain facets of implementation of the eight-hour ozone standard (herein referred to as the “Phase 1 Rule”) (69 FR 23858 and 69 FR 23951, respectively, April 30, 2004).

Although EPA revoked the one-hour ozone standard (effective June 15, 2005), to comply with anti-backsliding requirements of the Act, eight-hour ozone nonattainment areas remain subject to certain requirements based on their one-hour ozone classification. Initially, in our rules to address the transition from the one-hour to the eight-hour ozone standard, EPA did not include contingency measures or the section 185 fee program among the measures retained as one-hour ozone anti-backsliding requirements.7 However, on December 23, 2006, the United States Court of Appeals for the District of Columbia Circuit determined that EPA should not have excluded these requirements (and certain others not relevant here) from its anti-backsliding requirements.South Coast Air Quality Management Districtv.EPA,472 F.3d 882 (DC Cir. 2006) reh'g denied 489 F.3d 1245 (clarifying that the vacatur was limited to the issues on which the court granted the petitions for review) (referred to herein as theSouth Coastcase).

Thus, the Court vacated the provisions that excluded these requirements. As a result, States must continue to meet the obligations for one-hour ozone NAAQS contingency measures and, for Severe and Extreme areas, section 185 major source fee programs. EPA has issued a proposed rule that would remove those specific portions of40 CFR 51.905(e)that the court vacated, and that addresses contingency measures for failure to attain or make reasonable further progress toward attainment of the one-hour standard. See74 FR 2936,January 16, 2009 (proposed rule);74 FR 7027,February 12, 2009 (notice of public hearing and extension of comment period).

In our September 14, 2011 proposed rule, we explained that, after revocation of the one-hour ozone standard, EPA must continue to provide a mechanism to give effect to the one-hour anti-backsliding requirements that have been specifically retained. SeeSouth Coast,47 F.3d 882, at 903. In keeping with this responsibility with respect to one-hour anti-backsliding contingency measures and section 185 fee programs for these three California areas, on September 14, 2011, EPA proposed to determine that each area failed to attain the one-hour ozone standard by its applicable attainment date.

A determination of whether an area's air quality meets the one-hour ozone standard is generally based upon three years of complete,8 quality-assured and certified air quality monitoring data gathered at established State and Local Air Monitoring Stations (“SLAMS”) in the nonattainment area and entered into the EPA's Air Quality System (AQS) database. Data from air monitors operated by state/local agencies in compliance with EPA monitoring requirements must be submitted to the AQS database. Monitoring agencies annually certify that these data are accurate to the best of their knowledge. Accordingly, EPA relies primarily on data in its AQS database when determining the attainment status of an area. See 40 CFR 50.9; 40 CFR part 50, appendix H; 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 H.

Under EPA regulations at 40 CFR 50.9, the one-hour ozone standard is attained at a monitoring site when the expected number of days per calendar year with maximum hourly average concentrations above 0.12 parts per million (235 micrograms per cubic meter) is equal to or less than 1, as determined by 40 CFR part 50, appendix H.9

In our September 14, 2011 proposed rule, EPA proposed to determine that the South Coast, the San Joaquin Valley, and the Southeast Desert failed to attain the one-hour ozone standard by their applicable attainment dates based on findings that the number of expected exceedances at sites in each of the three nonattainment areas was greater than one per year in the period prior to the applicable attainment date. These proposed determinations were based on three years of quality-assured and certified ambient air quality monitoring data in AQS for the 2008-2010 monitoring period for the South Coast and the San Joaquin Valley, and quality-assured and certified data in AQS for 2005-2007 for the Southeast Desert.

In so doing, in our September 14, 2011 proposed rule, we reviewed documents prepared by CARB and the local air districts in connection with the ozone monitoring networks as well as any applicable EPA technical systems audits to determine the comprehensiveness and reliability of the data reported to AQS and used by EPA to determine the attainment status of the areas with respect to the one-hour ozone standard. We then evaluated the ozone monitoring data contained in AQS from each area against the criterion discussed above to determine whether the areas attained the one-hour ozone standard by their applicable attainment dates.

With respect to the South Coast, based on the monitoring data from 29 ozone monitoring sites for the years 2008-2010, we found that, generally, the highest ozone concentrations in the South Coast occur in the northern and eastern portions of the area. We also determined that the highest three-year average of expected exceedances at any site in the South Coast Air Basin for 2008-2010 is 10.4 (at Crestline, a site located at 4,500 feet elevation in the San Bernardino Mountains). Because the calculated exceedance rate of 10.4 represents a violation of the one-hour ozone standard (a three-year average of expected exceedances less than or equal to 1), and taking into account the extent and reliability of the applicable ozone monitoring network, and the data collected therefrom, we proposed in our September 14, 2011 action to determine that the South Coast Air Basin failed to attain the one-hour ozone standard (as defined in 40 CFR part 50, appendix H) by the applicable attainment date (i.e.,November 15, 2010). Please see pages 56696-56698 in the September 14, 2011 proposed rule for additional information on the ozone monitoring network operating in the South Coast during the relevant period and the data collected therefrom.

With respect to the San Joaquin Valley, based on the monitoring data from 22 ozone monitoring sites for the years 2008-2010, we found that, generally, the highest ozone concentrations in San Joaquin Valley occur in the central (i.e.,in and around the city of Fresno) and the southern portions (i.e.,southeast of Bakersfield) of the area. We also determined that the highest three-year average of expected exceedances at any site in the San Joaquin Valley for 2008-2010 is 6.6 at Arvin, a site located with mountains to the east, west, and south. Because the calculated exceedance rate of 6.6 represents a violation of the one-hour ozone standard (a three-year average of expected exceedances less than or equalto 1), and taking into account the extent and reliability of the applicable ozone monitoring network, and the data collected therefrom, we proposed in our September 14, 2011 action to determine that the San Joaquin Valley failed to attain the one-hour ozone standard (as defined in 40 CFR part 50, appendix H) by the applicable attainment date (i.e.,November 15, 2010). Please see pages 56698-56699 in the September 14, 2011 proposed rule for additional information on the ozone monitoring network operating in the San Joaquin Valley during the relevant period and the data collected therefrom.

With respect to the Southeast Desert, based on the monitoring data from nine ozone monitoring sites for the years 2005-2007, we found that, generally, the highest ozone concentrations in the Southeast Desert occur in the far southwestern portion of the area, near mountain passes through which pollutants are transported to the Southeast Desert from the South Coast Air Basin. We also determined that the highest three-year average of expected exceedances at any site in the Southeast Desert for 2005-2007 is 2.3 at Palm Springs in Riverside County and Hesperia in San Bernardino County. Because the calculated exceedance rate of 2.3 represents a violation of the one-hour ozone standard (a three-year average of expected exceedances less than or equal to 1), and taking into account the extent and reliability of the applicable ozone monitoring network, and the data collected therefrom, we proposed to determine in our September 14, 2011 proposed action that the Southeast Desert failed to attain the one-hour ozone standard (as defined in 40 CFR part 50, appendix H) by the applicable attainment date (i.e.,November 15, 2007). Please see pages 56699-56700 in the September 14, 2011 proposed rule for additional information on the ozone monitoring network operating in the Southeast Desert during the relevant period and the data collected therefrom.

In our September 14, 2011 proposed rule, we explained that a final determination of a Severe or Extreme area's failure to attain by its one-hour ozone NAAQS attainment date would trigger the obligation to implement one-hour contingency measures for failure to attain under section 172(c)(9) and fee programs under sections 182(d)(3), 182(f), and 185. Section 172(c)(9) requires one-hour ozone SIPs, other than for “Marginal” areas, to provide for implementation of specific measures (referred to herein as “contingency measures”) to be undertaken if the area fails to attain the NAAQS by the attainment date. Thus, in our September 14, 2011 proposed rules, we stated that a consequence of the proposed determinations, if finalized, would be to give effect to any one-hour ozone contingency measures that are not already in effect within the three subject California nonattainment areas.

Section 182(d)(3) requires SIPs to include provisions required under section 185, and section 185 requires one-hour ozone SIPs in areas classified as “Severe” or “Extreme” to provide that, if the area has failed to attain the standard by the applicable attainment date, each major stationary source of ozone precursors located in the area must begin paying a fee [computed in accordance with section 185(b)] to the State. Section 182(f) extends the section 185 requirements, among others, that apply to major stationary sources of VOCs to major stationary sources of NOXunless EPA has waived such requirements for NOXsources in the particular nonattainment area. Thus, in our September 14, 2011 proposed rules, we stated that another consequence of the determinations, if finalized, would be to give effect to the section 185 fee requirements to the extent they are not already in effect within the three subject California nonattainment areas.

Please see pages 56700-56701 in the September 14, 2011 proposed rule for additional information on the consequences of our proposed determinations in the three subject California one-hour ozone nonattainment areas.

Our September 14, 2011 proposed rule provided a 30-day comment period. During this period, we received three comment letters: a letter from the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) dated October 12, 2011; a letter from the South Coast Air Quality Management District (SCAQMD) dated October 13, 2011; and a letter from Earthjustice dated October 14, 2011. None of the commenters challenge EPA's proposed air quality determinations themselves, nor any aspect of the technical basis for the proposed determinations. Rather, they variously challenge the necessity, rationale, and statutory basis for the proposed actions and the consequences that they entail. We have summarized the comments from each commenter's letter and provide EPA's responses below.

SJVUAPCD Comment #1:The SJVUAPCD provides a number of grounds to support its argument that EPA should not make a determination that the San Joaquin Valley failed to meet its deadline for attaining the one-hour ozone standard. The District's reasons include: the one-hour ozone standard has been revoked; EPA's Phase 1 Ozone Implementation rule stated that EPA will no longer make findings of failure to attain for one-hour ozone nonattainment areas, citing 69 FR 23951, at 23984 (April 30, 2004); while certain provisions of EPA's April 2004 Ozone Implementation rule were vacated, the applicable provision related to findings of failure to attain was not challenged, and thus EPA remains bound by it.

EPA Response to SJVUAPCD Comment #1:Under EPA's April 30, 2004 Phase 1 Rule, EPA is no longer obligated, after revocation of the one-hour ozone standard, to determine pursuant to section 179(c) or 181(b)(2) of the CAA whether an area attained the one-hour ozone standard by that area's attainment date for the one-hour ozone standard. See 40 CFR 51.905(e)(2). EPA agrees that the relevant provision from EPA's Phase 1 Rule [i.e.,40 CFR 51.905(e)(2)] was not challenged and has not been vacated, but disagrees that this provision precludes EPA from making the determinations that are the subject of this notice. First, although the provision states that the Agency is no longer obligated to make certain determinations, it does not prohibit the Agency from exercising its discretion to do so. However, more to the point, EPA is not today invoking the authority of section 179(c) to determine that the San Joaquin Valley failed to attain the one-hour ozone standard by the applicable attainment date. Rather, EPA is acting pursuant to its obligations to give effect to two specific one-hour ozone anti-backsliding requirements whose implementation is dependent on such determinations. In doing so, EPA is complying with the DC Circuit's directive to formulate the Agency's procedures to dovetail with the required anti-backsliding measures. For the reasons explained in our September 14, 2011 proposed rule and further below, EPA is acting pursuant to its authority under section 301(a) and also the relevant portion of section 181(b)(2).

SJVUAPCD Comment #2:The SJVUAPCD believes that EPA's action is unnecessary with respect to the San Joaquin Valley because the District'sone-hour ozone contingency measures take effect without further action by the District or EPA, and because, with respect to section 185 fees, the DC Circuit did not specify the mechanism that EPA must use to trigger section 185 fees, and the District's rule implementing section 185 has been proposed for approval by EPA.

EPA Response to SJVUAPCD Comment #2:EPA recognizes that the approved one-hour ozone plan for the San Joaquin Valley relies on existing State and federal on- and off-road road new engine standards to meet the contingency measure requirements in section 172(c)(9), 75 FR 10420, at 10432 (March 8, 2010) and that such standards are already being implemented and provide an estimated additional benefit in 2011 beyond the reductions from those measures in 2010 regardless of our determination of failure to attain the one-hour ozone standard for the San Joaquin Valley. EPA also recognizes that the District's rule (i.e.,District Rule 3170) that is intended to implement section 185 of the CAA in connection with the one-hour ozone standard does not condition its applicability upon EPA's determination of failure by the area to attain the one-hour ozone standard by the applicable attainment date and that the rule has been submitted to EPA for review.10 EPA, however, believes that a determination of failure to attain the one-hour ozone standard is appropriate to eliminate any uncertainty as to whether such measures and rules must continue to be implemented in San Joaquin Valley for anti-backsliding purposes.

SCAQMD Comment #1:SCAQMD asserts that there is no need for EPA to make the proposed determinations. SCAQMD believes that, with respect to the South Coast, there is no need for a “trigger mechanism” which would inform the area that, due to its failure to attain, the area must implement section 185 fees and contingency measures because the related section 185 fees rule (SCAQMD Rule 317) has been adopted and submitted to EPA and because the contingency measures have already been implemented.

EPA Response to SCAQMD Comment #1:We recognize that SCAQMD Rule 317 has already been adopted by the District and submitted to EPA by CARB as a revision to the California SIP. As is true for the corresponding SJVUAPCD rule, SCAQMD Rule 317 does not condition applicability on EPA making a determination of failure to attain the one-hour ozone standard (by the applicable attainment date), and thus, the rule is in effect regardless of EPA's determination herein. EPA has not yet acted to approve this SIP revision.

Furthermore, prior to today's action, there has been no final determination of the area's failure to attain, which is what establishes the requirement to implement a rule developed to comply with section 185. Without a dispositive determination that implementation is required, it would be difficult if not impossible to clearly establish and enforce the obligation, and to assess when it may cease. Moreover, because EPA has not yet taken final action to approve SCAQMD Rule 317, and if we were to disapprove the rule, or if we were to approve SCAQMD Rule 317, but find that the SCAQMD is not administering and enforcing the rule, EPA could be under an obligation to implement the fee program required under section 185 [see CAA section 185(d)]. Thus, in order to comply with the process set forth in section 185, and to provide a legal basis for the State and/or EPA as appropriate to collect fees, EPA must ensure that the necessary determination for application of section 185 has been made. Thus, EPA concludes that, in the circumstances presented, the agency must make the determination that triggers the obligation to implement section 185, and we do so today in this document.

Moreover, the Agency has grounds to make today's determination other than for purposes of implementing contingency measures. EPA's determination is also linked to implementation of anti-backsliding requirements under section 185. Thus, today's action is not aimed solely at one-hour ozone contingency measures.

SCAQMD Comment #2:Even if it were necessary for EPA to have a “trigger mechanism” to cause an area to implement its section 185 fee, or to implement contingency measures, the SCAQMD believes it is not necessary to use a formal determination of failure to attain. The SCAQMD states that there is nothing in theSouth Coastcase that indicated that a formal determination of failure to attain is necessary and that, as a result, EPA could simply send the affected districts a letter informing them that those obligations had been triggered based on submitted monitoring data.

EPA Response to SCAQMD Comment #2:EPA's established practice for making a determination whether an area has attained, or failed to attain, the NAAQS is to conduct a rulemaking under the Administrative Procedure Act (APA), not to issue a letter, a list or some other informal document. In other words, if there has not been a rulemaking providing notice and an opportunity for comment, there has not been an attainment determination. EPA's longstanding practice in this regard was explicitly recognized and upheld more than a decade ago by the United States Court of Appeals for the DC Circuit. The Court rejected the Sierra Club's arguments that means other than rulemaking were sufficient for this purpose, especially when a determination results in additional obligations for an area. SeeSierra Clubv.Whitman,285 F.3d 63, at 66 (DC Cir. 2002). In determining through notice and comment rulemaking that the South Coast failed to attain the one-hour ozone standard by the applicable attainment date, EPA is acting consistently with its established practice and applicable administrative procedure law in making such determinations.

SCAQMD Comment #3:The SCAQMD asserts that the CAA does not authorize EPA to make the proposed determinations. In support of this assertion, the SCAQMD argues that:

• While CAA sections 179(c) and 179(d) require EPA to determine whether an area attained the standard by the applicable attainment date and that a new attainment demonstration requirement is triggered by a determination of failure to attain the standard by the applicable attainment date under those provisions, the one-hour ozone standard has been revoked and, as a result, the one-hour ozone standard is no longer a “standard” for the purposes of section 179(c) and section 179(d);

• EPA's past statements, such as those from EPA's April 30, 2004 Phase 1 Rule, indicate that areas would no longer have the obligation to demonstrate attainment of the revoked one-hour ozone standard if the area had an approved one-hour ozone attainment demonstration; and

• The recent decision published by the U.S. Court of Appeals for the Ninth Circuit (Association of Irritated Residentsv.EPA,632 F.3d 584 (9th Cir. 2011) that appears to require EPA to assure that California demonstrate attainment of the one-hour ozone standard for the South Coast was rendered without consideration of the fact that the plan in issue there was aimed at attaining the one-hour ozone standard, which had been revoked by the time EPA acted on the plan, and that the decision is pending appeal and not yet final.

EPA Response to SCAQMD Comment #3:In making today's final determinations, we are not acting pursuant to section 179(c) nor triggering the related requirements under section 179(d). Neither of these provisions was retained as a 1-hour ozone anti-backsliding requirement, and the relevant provisions of the anti-backsliding rule in this respect were not challenged. As explained in our September 14, 2011 proposed rule, we are acting here in accordance with our obligation to enforce specific one-hour ozone anti-backsliding requirements, and the DC Circuit's instruction to us in theSouth Coastcase that we determine the process necessary for that purpose. Thus, as explained in our proposal and elsewhere in this notice, we are acting here pursuant to our general authority in section 301(a) and the relevant portion of section 181(b)(2) concerning attainment determinations (i.e.,not the portion concerning reclassifications, which the commenter correctly notes was not retained for anti-backsliding purposes), and for the purpose of effectuating the two anti-backsliding provisions that are triggered by a determination of failure to meet the attainment deadline—contingency measures and section 185 fees.

EPA believes that the Ninth Circuit's decision in theAssociation of Irritated Residents(AIR) case cited by SCAQMD has no bearing on the question raised in this rulemaking regarding whether EPA must invoke section 179 when it seeks to make a determination regarding 1-hour ozone contingency and fee anti-backsliding measures. TheAIRcase centers on EPA's duties under section 110(l) of the CAA when it reviews a SIP revision, particularly, a SIP revision that includes an attainment demonstration. It does not pertain to the issue raised in this rulemaking—whether section 179, though not preserved in EPA's anti-backsliding provisions, should nonetheless be tacked on for the first time here as an additional anti-backsliding requirement to impose yet further planning for a revoked standard. In contrast toAIR,which considers EPA's duty at the time it reviews a plan, the question raised in this rulemaking is not whether the plan's faults were known at the time of plan review. The question here regarding section 179(c) concerns only whether that section's provision, which was not preserved as an anti-backsliding requirement, can be applied to extract an additional round of planning based on a subsequent failure to attain. As EPA explains elsewhere in this notice, the answer is that it cannot. Section 179's requirement for additional planning was not included in the anti-backsliding measures that were exhaustively litigated, reviewed and dispositively determined by the DC Circuit. As noted, the exclusion of section 179, and in particular the additional planning requirements in section 179(d), from the list of applicable requirements that continue to apply for anti-backsliding purposes was not challenged and remains the current law. Above all, sections 179(c) and (d) are not necessary to the enforcement of any of the anti-backsliding requirements whichareincluded.

SCAQMD Comment #4:SCAQMD acknowledges that EPA's proposal described the consequences of the determinations only in terms of section 185 fees and contingency measures, but is concerned that if EPA finalizes the proposed action, it will be used in an effort to compel SCAQMD to submit a plan to attain the revoked one-hour standard.

EPA Response to SCAQMD Comment #4:EPA's final determinations in this rulemaking are intended to effectuate only those 1-hour anti-backsliding requirements that have been specifically retained, and which are activated by a finding of failure to attain. For the reasons set forth at length elsewhere in these responses, EPA is not acting pursuant to section 179, and does not believe that section's provisions can be invoked to require additional rounds of planning for the revoked 1-hour standard. EPA and the states are implementing the one-hour standard, which has been revoked, by means of the specified one-hour anti-backsliding requirements. While EPA agrees that it must continue to make determinations of attainment or failure to attain the one-hour ozone standard by the applicable attainment date, it is for the sole purpose of ensuring implementation of those one-hour ozone anti-backsliding requirements (section 185 fees and contingency measures) and not to trigger new attainment demonstration plans or reclassifications for the revoked one-hour ozone standard. EPA's reasoning is elaborated further in its responses below to the comments of Earthjustice.

SCAQMD Comment #5:SCAQMD states that it has recently initiated the 2012 Air Quality Management Plan (AQMP) development process. SCAQMD anticipates that the 2012 AQMP will be submitted to EPA by the end of 2012 and will include a demonstration of attainment of the 24-hour PM2.5standard and an update to the “black box” commitment under CAA section 182(e)(5) for attainment of the 1997 8-hour ozone standard. SCAQMD asserts that this plan will necessarily include all feasible measures and believes that it is doubtful that additional measures could be identified solely for the purposes of addressing the revoked one-hour ozone standard. SCAQMD also asserts that the strategies for emissions reductions would essentially be the same for both the one and eight-hour ozone standards. SCAQMD argues that no separate additional plan for the revoked one-hour ozone standard should be required, since the 2012 plan for the eight-hour standard will evaluate future one-hour ozone design values and, all feasible measures are being taken, and the additional resource needed to prepare such a demonstration would divert resources away from the effort to demonstrate attainment with the current NAAQS. Thus, SCAQMD believes that requiring a new attainment demonstration for the one-hour ozone standard is not necessary and is overly burdensome given the upcoming 2012 AQMP.

EPA Response to SCAQMD Comment #5:As stated above, EPA believes that the anti-backsliding requirements applicable for the revoked 1-hour ozone standard are limited to those specified in EPA's regulations and theSouth Coastdecision, and do not and should not compel additional planning for the one-hour standard here. We agree that requiring a new attainment demonstration for the one-hour ozone standard for the South Coast is not necessary or required by a final determination today that the South Coast failed to attain the one-hour ozone standard by the applicable attainment date. As set forth in our September 14, 2011 proposed rule and elsewhere in this document, we are making today's determination pursuant to our authority under CAA section 301(a) and also under the relevant portion of section 181(b)(2), in order to ensure implementation of only those measures specifically identified as one-hour ozone anti-backsliding requirements—in this case—contingency measures and section 185 fees.

SCAQMD Comment #6:SCAQMD requests that EPA clarify that a final determination of failure to attain does not trigger any obligation to submit an attainment demonstration for the revoked one-hour ozone standard.

EPA Response to SCAQMD Comment #6:In this final rule, EPA explains and responds to comments concerning the statutory basis and rationale set forth in our September 14, 2011 proposed rule for the determination of failure to attain the one-hour ozone standard by the applicable attainment date. EPA is taking this action under its authority toensure implementation of one-hour ozone anti-backsliding requirements under CAA section 301(a) and the relevant portion of section 181(b)(2). Thus, EPA is stating plainly that today's determination does not trigger any requirement for the State of California to prepare and submit a new attainment demonstration for the one-hour ozone standard under section 179(c) and (d) for any of the three subject California nonattainment areas. As EPA has stated elsewhere, a new additional attainment demonstration triggered by a failure to attain the one-hour ozone standard by the attainment date is not an “applicable requirement” for the purposes of anti-backsliding in 40 CFR 51.905 and 40 CFR 51.900(f).

SCAQMD Comment #7:The SCAQMD requests that EPA separate the Coachella Valley from the remainder of the Southeast Desert Air Basin and determine that the Coachella Valley has attained the one-hour ozone standard. SCAQMD acknowledges that the Coachella Valley still exceeded the revoked one-hour ozone standard in the three-year period before 2007, but believes that Coachella Valley can now show it has attained the revoked one-hour standard based on data from the 2008-2010 period.

EPA Response to SCAQMD Comment #7:The air quality determinations that are the subject of this rulemaking focus solely on whether the areas attained the one-hour ozone standard by the applicable attainment dates. Whether an area is currently attaining the standard is not relevant to these determinations. In the case of the South Coast and the San Joaquin Valley, the applicable attainment date was November 15, 2010, and the determination of whether the areas attained by the applicable attainment date is based on data from 2008-2010. For the Southeast Desert, the determination of whether the area met its attainment date is based on data for 2005-2007. As a Severe-17 area, the area's applicable attainment date for the one-hour ozone standard was November 15, 2007.

In today's rulemaking, EPA is not addressing current attainment of the one-hour ozone standard in these areas or making a determination regarding current attainment of any area. Should the SCAQMD wish to seek a revision of the boundary of the Southeast Desert one-hour ozone nonattainment area in order to establish a separate Coachella Valley one-hour ozone nonattainment area and a determination by EPA that this area is currently attaining the one-hour ozone standard, the SCAQMD should work with CARB to prepare and submit a request for a boundary redesignation under CAA section 107(d)(3)(D) and for a related attainment determination. EPA would then consider such requests in a separate rulemaking.

SCAQMD Comment #8:SCAQMD states that it believes that, for the sake of consistency and to avoid future litigation, EPA should make determinations similar to today's determinations for all areas in the United States that failed to attain the revoked ozone standard by their applicable attainment dates.

EPA Response to SCAQMD Comment #8:By mid-2012, EPA intends to make a determination of attainment or failure to attain the one-hour ozone standard for approximately 20 areas throughout the country, consisting of almost every one-hour ozone nonattainment area that was classified as Moderate or above on June 15, 2005 (the date of revocation of the one-hour ozone standard) and that is currently designated as nonattainment for the 1997 8-hour ozone standard. The only two exceptions, Portsmouth-Dover-Rochester, New Hampshire and Providence, Rhode Island were classified as “Serious” for the one-hour ozone standard, and thus not subject to section 185 fee requirements, and EPA has determined through rulemaking that they are attaining the 1997 eight-hour ozone standard. See 75 FR 64949 (October 21, 2010)(Providence, RI); and 76 FR 14805 (March 18, 2011) (Portsmouth-Dover-Rochester, NH).

The areas for which EPA has made determinations regarding attainment of the one-hour ozone standard, or for which EPA is committed to make determinations, are: South Coast (CA); San Joaquin Valley (CA); Southeast Desert (CA); Chicago-Gary-Lake County (IL-IN); Houston-Galveston (TX); Milwaukee-Racine (WI); New York-N. New Jersey-Long Island (NY-NJ-CT); Baltimore (MD); Baton Rouge (LA); Philadelphia-Wilmington-Trenton (PA-NJ-DE-MD); Sacramento Metro (CA); Ventura County (CA); Metropolitan Washington (DC-MD-VA); Beaumont-Port Arthur (TX); Boston-Lawrence-Worcester (MA-NH); Dallas-Fort Worth (TX); El Paso (TX); Greater Connecticut (CT); Springfield (Western MA); Atlantic City (NJ); and Poughkeepsie (NY).

Earthjustice Comment #1:Earthjustice states that it assumes that EPA's failure to cite the relevant sections of the CAA and fully explain the implications of a failure to attain is an oversight because it contends that the requirements in CAA sections 179(c) and 181(b)(2) plainly mandate EPA to determine whether a nonattainment area attained the standard by the applicable attainment date.

EPA Response to Earthjustice Comment #1:For a number of reasons, EPA does not agree that it is compelled to act under the authority of CAA sections 179(c) and 181(b)(2) when making determinations for the revoked one-hour ozone standard. CAA section 179(c) requires, in relevant part, that EPA determine, based on the area's air quality as of the attainment date, whether the area attained the standard by that date. CAA section 179(c) applies to all of the NAAQS whereas CAA section 181(b)(2), in relevant part, largely mirrors section 179(c) and applies specifically to the ozone standard.

Both section 179(c) and 181(b)(2) refer to the “standard,” which doubtless applies to the NAAQS, but which does not clearly apply to a revoked standard, such as the one-hour ozone standard, which was revoked after promulgation of the 1997 eight-hour ozone standard, one year after the effective date of designations for the 1997 ozone standard. See 40 CFR 50.9(b). Based on an effective date of June 15, 2004 for designations for the eight-hour ozone standard (see 69 FR 23951, April 30, 2004), the date for revocation of the one-hour ozone standard was June 15, 2005. Because we are well past that date, the revoked one-hour ozone NAAQS no longer constitutes a “standard” for the purposes of sections 179(c) or 181(b)(2).

Moreover, not all CAA provisions that applied prior to revocation of the one-hour standard were preserved as anti-backsliding requirements. Only specified requirements were identified and retained as applicable requirements. While EPA's identification of these requirements was challenged in theSouth Coastlitigation, the DC Circuit's decisions in that case disposed of those challenges and closed the door on the issue of what constitutes an anti-backsliding requirement. The provisions of the rule indicating that EPA would not be obligated to make determinations under section 179(c) for purposes of future planning or section 181(b)(2) for purposes of reclassifications were not challenged and stand as promulgated. Even more significantly, the consequences of determinations set forth in portions of those provisions—reclassification and additional one-hour planning—were not retained as anti-backsliding requirements. This aspect of the anti-backsliding regime was not challenged by litigants or addressed by the South Coast Court. The court vacated only those portions of EPA's implementation rule that it addressed initsSouth Coastdecision. In accordance with EPA's Phase 1 Ozone Implementation Rule, EPA is no longer obligated, after revocation of the one-hour ozone standard, to determine pursuant to section 179(c) or section 181(b)(2) of the CAA whether an area attained the one-hour ozone standard by that area's attainment date for the one-hour ozone standard. See 40 CFR 51.905(e)(2). While EPA remains obligated to ensure implementation of those one-hour ozone anti-backsliding measures that were retained as applicable requirements, EPA is not obligated to, and has elected not to apply section 179(c) to make determinations whether an area attained the one-hour ozone standard by the applicable attainment date. EPA is undertaking these determinations expressly and solely to give effect to the anti-backsliding requirements for contingency measures and section 185 fees that have been retained as applicable requirements and which are linked to such determinations, under our authority under CAA section 301(a) and the relevant portion of section 181(b)(2) consistent with theSouth Coastdecision. The only anti-backsliding requirements related to attainment planning for the one-hour ozone standard are contained in EPA's regulation 40 CFR 51.905(a), which does not include any obligations for subsequent planning rounds under section 179(d). Section 179(d) prescribes consequences that were not retained for purposes of anti-backsliding after revocation of the one-hour ozone standard.

Earthjustice Comment #2:Earthjustice states its belief that the consequences of a failure to attain are plainly enumerated in the Act—a new plan meeting the requirements of section 110 and 172 [see section 179(d)], contingency measures approved under section 172(c)(9) and section 185 fees.

EPA Response to Earthjustice Comment #2:As stated on page 56700 of our September 14, 2011 proposed rule, we agree that a final determination that a Severe or Extreme area failed to attain by its one-hour ozone NAAQS attainment date triggers a State's obligation to implement one-hour contingency measures for failure to attain under section 172(c)(9) and fee programs under sections 182(d)(3), 182(f), and 185. Because the South Coast, San Joaquin Valley, and Southeast Desert areas are classified as Extreme (or Severe in the case of the Southeast Desert) for the one-hour ozone standard, today's final determinations of failure to attain by the applicable attainment date trigger the obligation to implement such one-hour contingency measures and fee programs.

We do not agree, however, that these determinations re-activate a requirement to prepare and submit an additional round of one-hour attainment planning pursuant to CAA section 179(d). Section 179(d) was not retained as an anti-backsliding requirement, and as explained in Response to Comment #1, above, EPA is not applying section 179 in order to make the determinations of failure to attain for the three subject California areas under section 179(c). For these and other reasons set forth elsewhere in this notice, the additional plan requirements under section 179(d) are not triggered.

Earthjustice Comment #3:Earthjustice cites the decision by the Court of Appeals for the DC Circuit in theSouth Coast Air Quality Mgmt. Dist.v.EPAcase (472 F.3d 882, 903-904 (DC Cir. 2007) in asserting that EPA unsuccessfully attempted to delete certain statutory requirements (i.e.,new plan under section 179(d), contingency measures under section 172(c), and section 185 fees) in the Agency's 2004 Phase 1 Rule.

EPA Response to Earthjustice Comment #3:We agree that theSouth Coastcase, cited above, vacated the provisions of EPA's Phase 1 Rule that excluded section 172(c)(9) contingency measures and section 185 fees from the list of applicable requirements for purposes of anti-backsliding after revocation of the one-hour ozone standard. We disagree, however, that theSouth Coastdecision preserves EPA's obligations under CAA section 179(c) or the related State obligations under CAA section 179(d) after revocation of the one-hour ozone standard. EPA's authority to revoke the one-hour ozone standard was specifically challenged in theSouth Coastcase but upheld by the DC Circuit. SeeSouth Coast,472 F.3d 882, at 899 (“Therefore, EPA retains the authority to revoke the one-hour standard so long as adequate anti-backsliding provisions are introduced.”) As we have noted, the claim that all the specific requirements of sections 179(c) and (d) and 181(b)(2) should be retained and imposed as anti-backsliding measures was not raised in theSouth Coastcase and cannot be resurrected at this time. Because the one-hour ozone standard has been revoked, it is no longer a “standard” for the purposes of CAA section 179(c) and thus the statutory requirements of section 179(d) also no longer apply. While EPA is obliged to make those determinations necessary to effectuate the contingency measure and fee anti-backsliding requirements, there is nothing that requires EPA to make those determinations under section 179 or 181, or that dictates the imposition of the consequences formerly imposed by those sections before revocation,i.e.,reclassification, second-round attainment planning. These were not retained as anti-backsliding requirements and 40 CFR 51.905(e)(2) made that explicit, was never challenged, and was not vacated by theSouth Coastdecision. Commenters are conflating EPA's obligation to determine whether an area attained by its one-hour ozone attainment date with the terms of section 179, which exceed the limits of, and are not necessary for purposes of anti-backsliding requirements.

Earthjustice Comment #4:Earthjustice observes that EPA promulgated, as part of the Agency's Phase 1 Rule, a provision that states in essence that, after revocation, EPA is no longer obliged to determine pursuant to section 179(c) or section 181(b)(2) whether an area attained the one-hour ozone standard by that area's attainment date for the one-hour ozone standard, but asserts that EPA has never interpreted the statute or EPA's regulations as allowing EPA to avoid making the required determinations under sections 179(c) or 181(b)(2) when needed to fulfill the obligations of the CAA. In support of this contention, Earthjustice points to the text found in EPA's one-hour ozone attainment determinations for Washoe County [as citing both 179(c) and 181(b)(2)], Philadelphia and District of Columbia [as citing section 181(b)(2)], Southern New Jersey [as citing section 181(b)(2)] and Milwaukee [as citing section 181(b)(2)].

EPA Response to Earthjustice Comment #4:First, the only example that Earthjustice claims as evidence that EPA has conceded that it remains obligated after revocation of the one-hour ozone standard to make attainment determinations for the one-hour ozone standard under section 179(c), is an attainment determination that was madebeforethe one-hour ozone standard was revoked. EPA's one-hour ozone attainment determination for Washoe County, Nevada was published on May 3, 2005 (70 FR 22803), the one-hour ozone standard was revoked on June 15, 2005. Therefore, EPA's determination for Washoe County proves nothing about EPA's obligation to make attainment determinations under section 179(c) of the Act after revocation. To the contrary, 40 CFR 51.905(e)(2) clearly provides: “Upon revocation of the 1-hour NAAQS for an area, EPA is no longer obligated (A) To determine pursuant to section 181(b)(2)or section 179(c) of the CAA whether an area attained * * *.”

Second, although after revocation, on a number of occasions, EPA has cited section 181(b)(2)—but never section 179—when determining that areas attained the one-hour ozone standard by the applicable deadline, all of these rulemakings were determinations of attainment rather than determinations of failure to attain. Because the areas met their attainment deadlines, EPA was not determining or imposing the consequences of failure to attain. Moreover, when EPA invoked section 181(b)(2) in determining that areas had attained the one-hour ozone deadline, EPA made clear in those actions that the only portion of section 181(b)(2) applicable for purposes of the one-hour ozone anti-backsliding requirements was the obligation to make the determination itself, since the portions of the section prescribing the consequence of reclassification had not been retained. 40 CFR 51.905(e).

For example, in one of the determinations of attainment, EPA noted that:

As EPA has noted, after revocation, the only possible anti-backsliding requirements triggered by a failure to attain the one-hour ozone attainment deadline are the requirements of sections 172(c)(9) (i.e.,contingency measures) and 185 (i.e.,fees). Thus, even if EPA were to invoke section 181(b)(2) as the statutory basis under which EPA is obligated to make determinations of attainment or failure to attain the one-hour ozone standard in the South Coast, San Joaquin Valley, and Southeast Desert, no requirement for new plans would be triggered for these areas. None of EPA's post-revocation determinations regarding one-hour attainment deadlines cite section 179(c). All of the post-revocation rulemakings determining attainment by the attainment deadline that cite section 181(b)(2) do so only with respect to the obligation to make the requisite air quality determination for the sole purpose of the applicable one-hour anti-backsliding requirements linked to such determinations,i.e.,contingency measures and section 185 fees. An additional round of one-hour attainment planning is not one of these “applicable requirements.” See 40 CFR 51.900(f) and 51.905(a)(1). One could also conclude that the requirement and corresponding obligation to adopt and implement a new one-hour attainment plan for failure to attain the one-hour ozone standard by the applicable attainment date, in contrast to the obligation to adopt and implement contingency measures and fees, could not be an “applicable requirement” for anti-backsliding purposes for the purposes of 40 CFR 51.900(f) and 51.905(a)(1) in the South Coast, San Joaquin Valley and Southeast Desert because the only applicable attainment dates that could trigger new planning requirements for these areas were well after June 15, 2004, the date of designation for the eight-hour ozone standard and the date that determines which “applicable requirements” apply to any given eight-hour ozone nonattainment area. As such, new planning requirements triggered by a failure to attain by the applicable attainment date could not have been a requirement on that date, and thus could not be an “applicable requirement” for the purposes of anti-backsliding.

Earthjustice Comment #5:Earthjustice contends that, between the plain language of the CAA and EPA's consistent interpretation of these provisions, there is no question that section 179(c) or section 181(b)(2) is the appropriate authority for making the determinations that the South Coast, San Joaquin Valley, and Southeast Desert one-hour ozone nonattainment areas have failed to attain the applicable attainment dates but notes that EPA cites neither one, but instead cites section 301(a) as providing the authority for EPA's determination. Earthjustice faults the September 14, 2011 proposed rule for failing to explain how or why section 301(a) provides the appropriate authority for the action, what regulations are being “prescribed” under section 301(a), and why such regulations are “necessary” given the statutory and regulatory commands.

EPA Response to Earthjustice Comment #5:Section 301(a)(1) of the CAA, in relevant part, provides that: “The Administrator is authorized to prescribe such regulations as are necessary to carry out his functions under this chapter.” Today's final rule is a regulation that included EPA review and evaluation of air quality information in relation to a standard and that followed the procedural requirements of the Administrative Procedure Act, including publication of a proposed rule and the consideration of public comments.

EPA's invocation of section 301(a) is appropriate because theSouth CoastCourt required EPA to determine the procedures necessary to enforce the contingency measures and section 185 fees requirements, but did not specify those procedures. In the words of theSouth Coastcourt: “While EPA maintains that it would be impractical to enforce [section 185 fees] because EPA will no longer make findings of attainment * * *, section 172(e) does not condition its strict distaste for backsliding on EPA's determinations of expediency; EPA must determine its procedures after it has identified what findings must be made under the Act.”South Coast,472 F.3d 882, at 903. The court's decision inSouth Coastdid not compel EPA to make determinations for the one-hour ozone standard under any specific provision of the statute, much less CAA sections 179(c) or 181(b)(2). Nor did the Court's decision vacate 40 CFR 51.905(e)(2), which relieves EPA of the obligation to make determinations under sections 181(b) and section 179. TheSouth Coastdecision simply required EPA to identify the procedures to make the findings related to anti-backsliding measures.

In response, EPA has identified a determination of attainment or failure to attain the one-hour ozone standard by the applicable attainment date, made through notice and comment rulemaking, as the necessary and appropriate procedure to be followed to effectuate the specific one-hour ozone anti-backsliding measures of sections 172(c)(9) and 185. EPA believes that section 301(a) therefore provides appropriate authority for EPA to promulgate the necessary procedures to fulfill the objective of ensuring implementation of anti-backsliding measures and be consistent with 40 CFR 51.905(e)(2). EPA also believes that it would not bring about any different result were EPA instead to invoke that portion of section 181(b)(2) that addresses such attainment determinations. To this extent, EPA agrees with the suggestion of the commenter that it may also rely on authority of section 181(b)(2) as a basis for continuing to make determinations for the limited purpose of effectuating one-hour ozone contingency measures and section 185 fees. After revocation, the other portions of section 181(b)(2) regarding consequences of these determinations, includingreclassifications, are no longer applicable under 40 CFR 51.905(e)(2). Conversely, there is no need or justification for reliance on section 179(c), which has played no role with respect to the one-hour standard since revocation of the standard. For the purpose of ensuring the contingency measure and fee anti-backsliding measures, it is not necessary for EPA to trigger the obsolete planning requirements of section 179(d) with which section 179(c) was linked, nor is EPA obligated to do so. In these circumstances, section 179 should not be used to revive an additional one-hour planning obligation that has not been preserved as an anti-backsliding requirement.

We recognize that, subsequent to revocation of the one-hour ozone standard, we have cited section 181(b)(2) as preserving an obligation to make determinations of attainment for the one-hour ozone standard by the applicable attainment date. As we have observed, however, we have been careful in every instance to sever the attainment determination itself from other portions of that section—notably, the obligation to reclassify areas that fail to attain the one-hour ozone standard by the applicable attainment date. EPA believes it is consistent with the statute, theSouth Coastdecision and EPA's Phase 1 Rule to proceed either under section 301(a) or section 181(b)(2)'s provision for making a determination, for the limited purpose of ensuring implementation of anti-backsliding measures. In acting under either provision, EPA is enforcing those specific requirements that are applicable for anti-backsliding. In no way do EPA's determinations act to revive the additional one-hour requirements that have not been retained for anti-backsliding—one-hour planning requirements under section 179(d) and reclassification.

Earthjustice Comment #6:Earthjustice questions whether the action to determine that the three subject California nonattainment areas failed to attain the one-hour ozone standard by the applicable attainment dates is an authority that has been delegated to the Regional Administrator from the EPA Administrator.

EPA Response to Earthjustice Comment #6:Section 301(a)(1) of the CAA, in relevant part, provides that: “The Administrator may delegate to any officer or employee of the Environmental Protection Agency such of his powers and duties under this chapter, except the making of regulations subject to section 7607(d) of this title, as he may deem necessary or expedient.” This rulemaking is not one of the regulations subject to section 7607(d) (i.e.,section 307(d)).

Under the authority of CAA section 301(a)(1), the Administrator has delegated numerous authorities under the Clean Air Act. As noted above, EPA believes that it may also rely on authority of section 181(b)(2) as a basis for continuing to make determinations for the limited purpose of effectuating one-hour ozone contingency measures and section 185 fees, and with respect to section 181(b)(2), Delegation 7-110 in the Delegations Manual provides authority for Regional Administrators to make these determinations. Delegation 7-110 in relevant part delegates authority to regional administrators: “[t]o determine, based on the number of exceedances, whether an area attained its ozone standard by the date required (181(b)(2)).” Therefore, the EPA Region IX Regional Administrator is duly authorized to take the final action that he does today through this document.

In addition, under Delegation 7-10 (in Chapter 7 of EPA's Delegations Manual), the EPA Administrator has delegated authority to propose or take final action on any SIP under section 110 of the CAA to the Regional Administrators. Among the references cited in Delegation 7-10 are section 110 and section 301(a) of the CAA. EPA's final determinations of failure to attain the one-hour ozone standard by the applicable attainment dates for South Coast, San Joaquin Valley, and Southeast Desert are not SIP actions themselves but are made herein under CAA section 301(a) for the express purpose of ensuring implementation of one-hour ozone SIP requirements, namely, contingency measures and section 185 fees, that applied to these areas as Severe or Extreme areas for the revoked one-hour ozone standard at the time of designation of these areas for the eight-hour ozone standard. For these reasons, EPA's final determinations made herein by the EPA Region IX Regional Administrator are covered by both Delegation 7-110 and 7-10.

Earthjustice Comment #7:Earthjustice contends that EPA's invocation of section 301(a) is not adequate to prescribe new regulatory requirements revising the well-established “obligations” to make findings under sections 179(c) and 181(b)(2) to implement the requirements of the CAA. Earthjustice argues that EPA is attempting to change its interpretation of its statutory requirements, and asks EPA to explain its reasoning for this alleged change so as to allow commenters to meaningfully comment on the Agency's rationale. Earthjustice further states that such a change in the ozone implementation rules must be made through national rulemaking signed by the Administrator.

EPA Response to Earthjustice Comment #7:EPA disagrees with Earthjustice's characterization of EPA's actions here as somehow prescribing new regulatory requirements. Rather, it is Earthjustice that is seeking to use EPA's determinations here to impose additional plan requirements that have not been retained for one-hour anti-backsliding. EPA here is simply making the same air quality determinations and applying the same notice and comment rulemaking process that it used prior to revocation. The only difference is that, after revocation of the one-hour standard, the purpose and consequences of these determinations are no longer “reclassification” (section 181(b)(2)) or requiring additional rounds of SIP revisions (section 179(d)). The purpose is to ensure implementation of those one-hour ozone requirements that EPA and theSouth CoastCourt have taken pains to identify with specificity. EPA is thus acting consistently with the 2004 Phase 1 Rule and with the directives of the Court in theSouth Coastcase. Simply because EPA acknowledges it now has an obligation to make these determinations for purposes of legitimate anti-backsliding requirements does not mean that these determinations call down all the consequences that had been excluded from those identified by EPA and the Court. See 40 CFR 51.905(e)(2). Earthjustice, not EPA, is attempting to change the established rules of anti-backsliding by reviving moribund portions of sections 179 under the guise of enforcing EPA's obligation to make attainment determinations for quite different purposes. It is Earthjustice that seeks improperly to add to the list of anti-backsliding requirements by representing new requirements as merely a procedural mechanism to enforce those that have been legitimately recognized.

We strongly disagree with the commenter's claim that we are changing our interpretation of the Agency's statutory obligations with respect to the one-hour ozone standard. As explained above, since revocation of the one-hour ozone standard, we have never cited section 179(c) as preserving an obligation on our part to determine whether an area attained the one-hour ozone standard by the applicable attainment date. We certainly have never stated or implied, after revocation of the one-hour standard that a determination of failure to attain by the one-hour attainment deadline wouldcall for additional section 179(d) planning requirements. As pointed out above, since revocation we have cited section 181(b)(2) only in the context of making determinations of attainment that do not result in any attendant requirements relating to additional planning or reclassifications, but rather only to implement two specific anti-backsliding measures.

Lastly, contrary to Earthjustice's contention, we believe that, the specific language in 40 CFR 51.905(e)(2) eliminating any compulsion for EPA to make determinations under section 179(c) for the one-hour ozone standard and the availability of other more appropriate procedures to enforce anti-backsliding requirements, refute any argument for reliance on that section. The only reason to involve section 179(c) would be the illegitimate one of seeking, long after anti-backsliding requirements have been debated and established, to add section 179(d) plans to the list. It is disingenuous to argue the necessity of invoking the authority of section 179(c) to enforce the only anti-backsliding requirements in play, which clearly do not include additional one-hour attainment demonstration plans under section 179(d). TheSouth Coastdecision did not vacate 40 CFR 51.905(e)(2). It established only that, notwithstanding that provision, EPA must continue to make determinations of attainment for purposes other than those addressed by that regulation. EPA today is complying with the directive of the Court, and making through notice and comment rulemaking the requisite determinations to implement the specific anti-backsliding measures of contingency measures and section 185 fees.

Earthjustice Comment #8:By relying on CAA section 301(a), Earthjustice is concerned that EPA is attempting to invent new procedures for determining attainment in order to avoid the obligation under section 179(d) to prepare a new one-hour ozone plan. Waiving the planning obligations would, in Earthjustice's view, violate the statute.

EPA Response to Earthjustice Comment #8:EPA is not waiving any planning requirements under section 179(d), because they are not applicable as one-hour anti-backsliding requirements. In accordance with 40 CFR 51.905(e)(2), we are no longer obligated to make attainment determinations under section 179(c) and there is nothing in theSouth Coastcase or in EPA's past statements to the contrary. In any event, there is no provision for retaining further planning under section 179(d) with respect to the revoked one-hour ozone standard. See also EPA Responses to Earthjustice Comments elsewhere in this final rule.

Earthjustice Comment #9:Earthjustice contends that spikes in one-hour ozone concentrations over 0.12 ppm are harmful to public health and that EPA's decision to adopt an eight-hour ozone standard was not based on any determination that these shorter-term exposures were no longer of concern. Earthjustice cites EPA's 1997 final rule establishing the eight-hour ozone standard as describing new evidence that EPA had found of an array of adverse health effects associated with short-term exposures (i.e.,1 to 3 hours) above the standard level of 0.12 ppm.

EPA Response to Earthjustice Comment #9:At root, Earthjustice objects to EPA's decision in 1997 to replace the one-hour ozone standard with the eight-hour ozone standard rather than retaining both standards. 62 FR 38856 (July 18, 1997). This issue was raised many years ago in the comments on EPA's proposal (61 FR 65716, December 13, 1996) to revise the ozone standard. A number of commenters on EPA's 1996 proposal urged EPA to maintain standards based on both one-hour and eight-hour averaging times to provide protection from one- and eight-hour exposures of concern. 62 FR 38856, at 38863 (column 1). These commenters generally argued that an 8-hour standard alone could still allow for unhealthful high one-hour exposures. While EPA acknowledged the possibility that an eight-hour ozone standard alone could allow for high one-hour exposures of concern, at and above 0.12 ppm, EPA concluded for the reasons set forth in the 1997 final rule that replacing the one-hour ozone standard with an eight-hour ozone standard, considering the level and form adopted, was appropriate to provide adequate and more uniform protection of public health from both short-term (1-3 hours) and prolonged (6 to 8 hours) exposure to ozone in the ambient air. 62 FR 38856, at 38863 (column 2). The decision to retain only the new eight-hour ozone standard included the result that, apart from the specific requirements of 40 CFR 51.905(a) regarding one-hour ozone plans, an attainment demonstration for the eight-hour standard would provide requisite protection against violations of both the one- and the eight-hour standards. EPA's decision to replace the one-hour ozone standard with an eight-hour ozone standard has long been settled, and EPA does not intend, and is not required to re-open that issue in the context of today's determinations.

Earthjustice Comment #10:Citing CAA section 181(a) and theSouth Coastcase, Earthjustice believes that Congress clearly intended the most polluted ozone areas to address the harms caused by these peak concentrations within 20 years of the 1990 CAA Amendments, and contends that it would not make sense to decide that attainment of the one-hour standard was no longer needed when the one-hour ozone problem is just as serious as Congress believed it to be.

EPA Response to Earthjustice Comment #10:This comment essentially restates the objection to EPA's decision in 1997 to replace the one-hour ozone standard with an eight-hour ozone standard and EPA's decision in 2004 to revoke the one-hour ozone standard for all areas of the country by a fixed date, rather than by the date when areas were found to have attained the one-hour ozone standard. In response to the proposed rule that culminated in our 2004 Phase 1 Rule, we received and considered comments that EPA should retain the one-hour ozone standard because it is necessary to protect public health. Comments submitted in that rulemaking included the same assertion that the one-hour ozone standard may be more protective of public health than the eight-hour ozone standard in several areas such as the South Coast and Houston, and the same assertion that revocation would be contrary to the CAA and Congressional intent. In our 2004 Phase 1 Rule, we responded to these comments, pointing out that the question whether the one-hour ozone standard is necessary to protect public health is a standard-setting issue that was resolved in EPA's 1997 final rule promulgating the eight-hour ozone standard to replace the one-hour ozone standard. See 69 FR 23951, at 23970 (column 1) (April 30, 2004).

Earthjustice's comment here regarding Congressional intent is the same argument that was made in theSouth Coastcase challenging EPA's authority to revoke the one-hour standard. There, the environmental petitioners contended that the one-hour ozone standard cannot be withdrawn because Congress “codified” the one-hour ozone standard in subpart 2, but the court recognized that, by establishing the periodic NAAQS review process in section 109(d)(1) of the CAA, Congress clearly contemplated the possibility that scientific advances would require amendment of the national ambient air quality standard, and upheld EPA's authority to revoke the one-hour ozone standard so long as adequate anti-backsliding provisions were applied.South Coast,472 F.3d 882, at 899.

In our 2004 Phase 1 Rule, in response to comments on the scope of its anti-backsliding requirements, EPA specifically addressed planning requirements under the one-hour ozone standard: “Where they are not required by anti-backsliding provisions, EPA does not believe that the additional burden States would undertake in planning to achieve both the 1-hour and the 8-hour NAAQS is necessary to protect public health.” 69 FR 23951, at 23971 (April 30, 2004). TheSouth Coastcase also disposed of the specific challenges raised as to the adequacy of the anti-backsliding provisions in EPA's implementation rule, and established specifically which measures were required to be retained. As EPA has explained elsewhere in responses to comments, those provisions do not include additional attainment plans under section 179. The provisions of 40 CFR 51.905(e)(2) relating to section 179(c) were not challenged or vacated by theSouth Coastcourt. Contrary to commenter's contention, today's determinations fully discharge EPA's responsibility to address the only one-hour ozone anti-backsliding measures (contingency measures and section 185 fees) activated by determinations of failure to meet one-hour attainment deadlines. EPA has struck the balance between preserving old one-hour ozone requirements and allowing current planning and control requirements for the newer standards to function on their behalf. It is long past the time to challenge this balance and dispute the revocation of the one-hour ozone standard and the established set of one-hour anti-backsliding requirements, which do not include additional rounds of one-hour ozone planning. We also note that California has submitted attainment demonstration plans for all three subject California nonattainment areas for the 1997 eight-hour ozone standard; such plans also serve to promote attainment of the revoked one-hour standard.

Earthjustice's comment seeks to remind EPA that the DC Circuit stated: “The Act placed states onto a one-way street whose only outlet is attainment.”South Coastat 472 F.3d 882, at 900. In making today's determinations to ensure implementation of one-hour ozone contingency measures and section 185 fees, which the DC Circuit has resolved are those required by anti-backsliding upon failure to attain the revoked standard, EPA is heeding the DC Circuit's admonition inSouth Coastand fulfilling the requirements of the Act.

Earthjustice Comment #11:Earthjustice contends that EPA cannot reasonably conclude that the South Coast, San Joaquin Valley and Southeast Desert areas, now that they have failed to attain and their attainment plans appear inadequate, can be relieved of this obligation to demonstrate attainment. In support of this contention, Earthjustice cites two Ninth Circuit decisions,Association of Irritated Residentsv.EPA,632 F.3d 584, at 594 (9th Cir. 2011) (herein referred to as theAIRcase), andHallv.EPA,273 F.3d 1146, at 1159 (9th Cir. 2001) (herein referred to as theHallcase).

EPA Response to Earthjustice Comment #11:As explained elsewhere in these responses, EPA evaluates the adequacy of a plan containing a demonstration of attainment, and whether it meets all applicable requirements, when EPA acts to approve or disapprove the plan and not after the applicable attainment date. In the case of the three subject California nonattainment areas, EPA approved the one-hour ozone plans prior to the applicable attainment dates and thus, the determinations that the areas did not actually attain the one-hour ozone standard by the applicable attainment dates was not an issue under consideration at that time and does not undermine the validity of EPA's prior approvals of the plans at the time they were taken.

The anti-backsliding requirements for one-hour ozone attainment demonstrations are set forth in 40 CFR 51.900(f)(13) and 51.905(a)(1)(i). For the purposes of anti-backsliding, an eight-hour ozone nonattainment area is obligated to have a fully-approved attainment demonstration plan for the one-hour ozone standard based on the area's ozone classification that the area had at the time of designation for the eight-hour ozone standard. Thus, the State of California is obligated to have a fully-approved “Extreme” area attainment demonstration plan for the South Coast and the San Joaquin Valley and a fully-approved “Severe-17” area attainment demonstration plan for the Southeast Desert. EPA approved the relevant South Coast plan in April 2000 (65 FR 18903, April 10, 2000), the relevant San Joaquin Valley plan in March 2010 (75 FR 10420, March 8, 2010),11 and the relevant Southeast Desert plan in January 1997 (62 FR 1150, January 8, 1997).

EPA did disapprove a revision to the attainment demonstration plan for the South Coast in March 2009 (74 FR 10176, March 10, 2009) because the measures upon which the revised attainment demonstration relied had been withdrawn, but such disapproval does not necessarily undermine EPA's prior approval of the attainment demonstration plan for the South Coast. This will depend on the final decision in theAIRcase, once all appeals have been resolved. It is possible that EPA will need to consider requiring California to prepare and submit a new one-hour ozone attainment demonstration plan for the South Coast, but if EPA were to do so, the Agency would be acting pursuant to a decision that the State had not complied with the anti-backsliding requirement for a one-hour ozone attainment demonstration under 40 CFR 51.905(a)(1) for the South Coast, and not because the area had failed to attain the one-hour ozone standard by the applicable attainment date.

Earthjustice cites theAIRcase andHallin support of its contention that it is unreasonable for EPA to conclude that, in light of the failure of the three subject California nonattainment areas to attain the one-hour ozone standard by the applicable attainment dates, the areas can be relieved of the obligation to demonstrate attainment of the one-hour ozone standard. This argument erroneously assumes that there is an additional obligation to submit a revised one-hour attainment plan even after valid approval of the State's plan as required under 40 CFR 51.905(a). These two cases stand for the principle that, under section 110(l) of the CAA, when EPA reviews a SIP revision, EPA must evaluate the existing SIP and make a determination as to whether the existing SIP, as modified by the SIP revision at hand, would provide for attainment of the national ambient air quality standards. InAIR,the specific SIP revision at issue was a revised attainment demonstration plan for the one-hour ozone standard for the South Coast. InHall,the specific SIP revision at issue was a set of revised new source review rules for Clark County, Nevada.

Section 110(l) of the CAA applies to SIP revisions, and, unlike the case inAIR,EPA is not acting today on any SIP revision and thus section 110 and both theHallandAIRcases are not relevant to this action. After revocation of the one-hour standard, a State's obligation with respect to attainment demonstration plans for the one-hour ozone standard is defined in 40 CFR 51.905(a)(1)(i). As stated above, because California has submitted and EPA has approved the one-hour ozone plans for San Joaquin Valley and the Southeast Desert, the State has addressed its one-hour ozone attainment plan obligationsfor these areas. For the South Coast, as explained above, whether the State has satisfied this obligation may depend on the final resolution and mandate by the Court in theAIRcase, but does not depend on today's determination. For all three subject areas, today's determinations serve to ensure the implementation of one-hour ozone contingency measures and section 185 fees, which, unlike further one-hour attainment planning, are the measures required by the Court-approved anti-backsliding provisions.

Earthjustice Comment #12:Earthjustice demands that, in the final rule, EPA clearly communicate that, for the South Coast, San Joaquin Valley and Southeast Desert areas, new one-hour ozone plans complying with the requirements of section 179(d) must be submitted to EPA within one year of the date EPA publishes the final determinations.

EPA Response to Earthjustice Comment #12:For the reasons set forth elsewhere in EPA's response to comments, we disagree that the determinations that we make in this document trigger a requirement under CAA section 179(d) on the State of California to prepare and submit SIP revisions including new demonstrations of attainment for the one-hour ozone standard for the three subject California nonattainment areas. A new section 179(d) ozone plan, triggered by section 179(c) is not an applicable anti-backsliding requirement.

With respect to anti-backsliding requirements, theSouth CoastCourt vacated the Phase 1 Rule only with respect to the measures addressed. Here, the only pertinent anti-backsliding measures triggered by a determination of failure to meet the one-hour deadline are one-hour contingency measures for failure to attain and section 185 fees. In theSouth Coastdecision reviewing EPA's implementation rule, neither 51.905(e)'s provisions regarding sections 179 and 181, nor the exclusion of section 179(d) from one-hour anti-backsliding requirements was challenged by the parties or addressed by the Court. Challenges regarding anti-backsliding specifically addressed sections 172(c)(9) and 185 and two other anti-backsliding provisions not relevant here (NSR and conformity). To effectuate section 172(c)(9) and section 185 anti-backsliding provisions, EPA is determining that these three areas failed to attain by their one-hour attainment dates. But EPA has explained at length why these determinations do not reinstate the additional planning requirements of section 179(d) that were not retained as anti-backsliding measures.

Earthjustice Comment #13:Earthjustice contends that the South Coast, San Joaquin Valley, and Southeast Desert continue to exceed the 0.12 ppm one-hour ozone standard on a regular basis, that these spikes have consequences. Earthjustice asserts that, after more than 20 years, the residents of these areas have not been afforded the protections needed and required by the Clean Air Act to meet even this standard.

EPA Response to Earthjustice Comment #13:EPA recognizes that exceedances of the one-hour ozone standard in the three subject California nonattainment areas have occurred, and is making final determinations that the three areas have failed to attain the one-hour ozone standard by their applicable attainment dates. However, EPA also recognizes that significant progress has been made in lowering peak hourly concentrations, frequency of exceedances, and the geographic extent of exceedances in these areas. Since passage of the CAA Amendments of 1990, one-hour ozone concentrations in these areas have decreased, despite significant increases in population and vehicle miles traveled. For example, CARB data indicates that the number of days on which concentrations exceeded the one-hour ozone standard have dropped from 131 in 1990 to only 9 in 2010 in the South Coast, from 45 in 1990 to only 7 in 2010 in San Joaquin Valley, and from 76 in 1990 to only 3 in the Mojave Desert portion of the Southeast Desert. Moreover, a comparison of CARB's one-hour ozone data from the three-year period prior to revocation (2002-2004) with corresponding data from the three-year period following revocation (2006-2008) shows a decrease in the annual number of days on which the one-hour standard was exceeded from 46 to 27 in the South Coast, from 26 to 13 in San Joaquin Valley, and from 11 to 4 in the Mojave Desert portion of the Southeast Desert. While we acknowledge that even this significant progress has not yet resulted in attainment, it does not bear the hallmark of backsliding.

We disagree that the residents of these areas are not afforded the protections needed and required by the Clean Air Act. Through today's determinations, all applicable anti-backsliding requirements for the revoked one-hour ozone standard must be implemented. One-hour anti-backsliding measures, moreover, do not operate in a vacuum. State planning efforts for attainment of the current, more protective eight-hour ozone standard, and adoption and implementation of control measures actively continue.12 These provide an ongoing regimen for reducing ozone concentrations in terms of both the one- and the eight-hour ozone standards. Thus, EPA believes that the residents of these areas are being afforded the protections that are required in accordance with EPA regulations and the CAA.

After revocation of the one-hour ozone standard, EPA must continue to provide a mechanism to give effect to the one-hour anti-backsliding requirements, seeSouth Coast,47 F.3d 882, at 903. Thus, pursuant to EPA's obligation and authority under section 301(a) and the relevant portion of section 181(b)(2) to ensure implementation of one-hour ozone anti-backsliding requirements, and for the reasons given above and in our September 14, 2011 proposed rule, EPA is taking final action to determine that the South Coast, the San Joaquin Valley, and the Southeast Desert failed to attain the one-hour ozone standard by the applicable attainment dates. For South Coast and San Joaquin Valley, quality-assured and certified data collected during 2008-2010 show that these two “Extreme” one-hour ozone nonattainment areas failed to attain the standard by November 15, 2010. For Southeast Desert, a “Severe-17” one-hour ozone nonattainment area, quality-assured and certified data for 2005-2007 show that the area failed to attain the standard by November 15, 2007.

These determinations bear on the areas' obligations with respect to the one-hour ozone standard anti-backsliding requirements whose implementation is triggered by a failure to attain by the applicable attainment date: section 172(c)(9) contingency measures for failure to attain and sections 182(d)(3) and 185 major stationary source fee programs.

These actions make determinations that certain areas did not attain the applicable standard based on air quality, and do not impose any requirements beyond those required by statute and regulation. For that reason, these actions:

• Are not a “significant regulatory action” subject to review by the Office of Management and Budget underExecutive Order 12866 (58 FR 51735, October 4, 1993);

• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Are not subject to the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Do not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. section 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. section 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 28, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.To access the harmonized test guidelines referenced in this document electronically, please gohttp://www.epa.gov/ocsppand 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-2010-0865 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 28, 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0865, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the on-line instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof December 15, 2010 (75 FR 78240) (FRL-8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E7788) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.573 be amended by establishing tolerances for residues of the herbicide tepraloxydim, 2-[1-[[[(2E)-3-chloro-2-propen-1-yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one and its metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as tepraloxydim, in or on Pea and bean, dried shelled, except soybean, subgroup 6C and Sunflower subgroup 20B at 0.10 parts per million (ppm) and 0.25 ppm, respectively. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has reduced the proposed tolerance for Sunflower subgroup 20B from 0.25 ppm to 0.20 ppm. The reason for this change is explained in Unit IV.C.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 tepraloxydim including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tepraloxydim 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.

Tepraloxydim has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It produces minimaleye irritation, is a slight dermal irritant, and is not a dermal sensitizer.

In subchronic and chronic toxicity studies, the main target organs for tepraloxydim toxicity were the liver, the spleen/hematopoietic system and reproductive system. Liver findings were reported in all subchronic and chronic toxicity/carcinogenicity feeding studies and included increased incidences of hepatocellular foci, abnormal liver function parameters, increased relative liver weight, hepatocyte hypertrophy, and increased hepatocellular neoplasms in the mouse and rat carcinogenicity studies. Tepraloxydim also affected the hematopoietic system. In dogs, hemolytic anemia was demonstrated by depressed hematocrit, hemoglobin, and red blood cells (RBCs). These changes were accompanied by compensatory responses, including splenic hematopoiesis, femoral and sternal bone marrow hyperplasia, increased erythroid precursors and hemosiderin-laden macrophages, and splenic hemosiderosis. The reproductive system was affected by tepraloxydim at relatively high doses (in excess of LOAELs (lowest observed adverse effect levels) established in repeat-dose mouse, rat and dog studies). Reproductive effects included morphological microscopic changes indicative of reduced secretory activity in the seminal vesicles and preputial glands in male mice; increased uterine sclerosis, decreased corpora lutea, and decreased follicles in female mice; increased incidences of focal calcification of the testes in the high dose group in the rat carcinogenicity feeding study; and effects on male sex organs at high doses in dogs.

In the rat developmental toxicity study, fetal effects (reduced fetal body weights, delayed ossification and the occurrence of hydroureter) were seen at a dose threefold lower than the dose resulting in maternal toxicity (reduced body weight and body weight gain). Additional developmental anomalies or malformations (dilatation of both heart ventricles and filiform tails that were observed externally and corresponded to absent caudal and sacral vertebrae) were observed at the maternal LOAEL in the study. The results indicate potential increased quantitative and qualitative susceptibility of fetuses to tepraloxydim exposure. In contrast, no developmental effects were seen in the rabbit developmental toxicity study up to the highest tested dose, the LOAEL for maternal toxicity (reduced body weight and food consumption). In the multi-generation rat reproduction study, there were no effects on any of the measured reproductive parameters up to and including the highest tested dose and no evidence of quantitative or qualitative susceptibility of the offspring.

In both the acute and subchronic rat neurotoxicity studies, there were mild changes in motor activity and grip strength indices. On day 0 of the acute oral neurotoxicity study in rats, motor activity was decreased in all treated female groups, while forelimb grip strength was slightly increased in all treated females. In the rat subchronic neurotoxicity study, motor activity was increased in the high dose females at day 50 and in both sexes on day 85 at the highest dose tested. None of the studies, including both neurotoxicity studies, reported treatment-related effects on brain weight or gross/microscopic lesions in the tissues of the nervous system.

In cancer studies conducted in rats and mice, there was weak and/or conflicting evidence of carcinogenicity. In rats, there was some evidence of carcinogenicity in the females based on an increased incidence of liver tumors at the high dose only in the carcinogenicity phase of the study, but this finding was not supported by the results of the chronic phase in the same strain and sex of rats. In mice, liver tumors were seen in females at an excessively toxic dose. EPA's concern for carcinogenicity is low, and the Agency has determined that the chronic population-adjusted dose (cPAD) of 0.05 milligrams/kilogram/day (mg/kg/day) will adequately account for all chronic effects, including carcinogenicity, likely to result from exposure to tepraloxydim. This determination is based on the following considerations:

• The liver tumors in female rats were seen only at the high dose (i.e.,lack of dose response);

• The incidences of these tumors were within the ranges for the historical controls;

• The rat liver tumors observed in one study were not seen in a parallel study conducted at the same dose and duration (i.e.,tumorogenic potential not replicated);

• In mice, liver tumors were seen only at excessive doses (i.e.,greater than the Limit Dose of 1,000 mg/kg/day) which may have resulted in indirect effects that may not occur at lower doses;

• The liver tumors did not result in reduced latency in either species;

• There is no concern for mutagenicity/genotoxicity; and

• The NOAEL (no observed adverse effect level) of 5 mg/kg/day used for deriving the chronic reference dose (cRfD) is approximately 55-fold lower than the lowest dose (272 mg/kg/day) that induced liver tumors in rats.

Specific information on the studies received and the nature of the adverse effects caused by tepraloxydim as well as the NOAEL and the lowest-observed-adverse-effect-level LOAEL from the toxicity studies can be found athttp://www.regulations.govin the document “Amended: Tepraloxydim: Human Health Risk Assessment for New Tolerances on Imported Dry Bean and Dry Pea Subgroup 6C and Sunflower Subgroup 20B”at page 31 in docket ID number EPA-HQ-OPP-2010-0865.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological point of departure (POD) is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a PAD or a 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.A summary of the toxicological endpoints for tepraloxydim used for human risk assessment is shown in the following Table .

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to tepraloxydim, EPA considered exposure under the petitioned-for tolerances as well as all existing tepraloxydim tolerances in 40 CFR 180.573. EPA assessed dietary exposures from tepraloxydim 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 tepraloxydim. As shown in the Table above, EPA identified different points of departure for assessing acute dietary exposure for the general population (including infants and children) and women of childbearing age (13 to 49).

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 assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with tepraloxydim.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with tepraloxydim.

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

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

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of tepraloxydim for acute exposures are estimated to be 1.4 parts per billion (ppb) for surface water and 0.002 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 0.7 ppb for surface water and 0.002 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 1.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.7 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). Tepraloxydim is not registered for any specific use patterns that would result in residential exposure.

4.Cumulative effects from substances with a common mechanism of toxicity.Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found tepraloxydim to share a common mechanism of toxicity with any other substances, and tepraloxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that tepraloxydim does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10×) margin ofsafety 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 available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.As discussed in Unit III.A, there was evidence of increased qualitative and quantitative susceptibility of fetuses in the rat developmental toxicity study. There was no evidence of increased susceptibility seen in the rabbit developmental toxicity study or multi-generation rat reproduction study. The degree of concern is low for the increased susceptibility seen in the developmental study in rats (prenatal exposure), since a clear NOAEL/LOAEL was established for developmental toxicity and the endpoints of concern are used to assess exposure for the most sensitive population of concern (i.e.,Females 13to 49). There is no residual uncertainty for prenatal and/or postnatal toxicity.

3.Conclusion.EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1× for all exposure scenarios, except acute dietary exposure of the general population.

A 10× FQPA Safety Factor in the form of a UFLis retained for assessing acute dietary risk for the general population, including infants and children, to account for the uncertainty resulting from using a LOAEL, rather than a NOAEL, as the POD (i.e.,a NOAEL was not identified in the critical study). The critical effect (decreased motor activity in females) observed at the LOAEL of 500 mg/kg/day in the acute neurotoxicity study was neither severe nor irreversible; and the dose-responsive decrease in motor activity was observed in females on Day 0 in the absence of any other treatment-related clinical signs (including functional observation battery) or neurohistopathological effects. The dose-response relationship of tepraloxydim indicates that an uncertainty factor of 10× is sufficiently protective against the critical effect and any other adverse effects at the aRfD.

The decision to reduce the FQPA SF to 1× for all other exposure scenarios is based on the following findings:

i. The toxicity database is complete except for immunotoxicity testing (OPPTS Guideline 870.7800). Recent changes to 40 CFR part 158 make this testing required for pesticide registration. In the absence of specific immunotoxicity studies, EPA has evaluated the available tepraloxydim toxicity database to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. No evidence of immunotoxicity was found. Treatment-related effects seen in the spleen (splenic hematopoiesis) and bone marrow (hyperplasia) are compensatory responses to tepraloxydim-induced hemolytic anemia.

Considering the lack of evidence of immunotoxicity in the database for tepraloxydim, EPA does not believe that conducting an immunotoxicity study will result in a NOAEL less than that (5 mg/kg/day) used to derive the current cRfD. Consequently, the EPA believes the existing data are sufficient for endpoint selection for exposure/risk assessment purposes and for evaluation of the requirements under the FQPA, and an additional database uncertainty factor is unnecessary.

ii. In both the acute and subchronic rat neurotoxicity studies, there were mild changes in motor activity and grip strength indices. However, EPA has concluded that there is no need for a developmental neurotoxicity (DNT) study or additional UFs to account for neurotoxicity, based on the following considerations:

• Neurotoxic effects were seen at high doses of 500 mg/kg (1/4of the limit dose), 1,000 mg/kg, and 2,000 mg/kg following bolus (gavage) dosing in the acute neurotoxicity study and at 428 mg/kg/day in males and 513 mg/kg/day in females following dietary administration in the subchronic neurotoxicity study.

• In the two-generation reproduction study, no clinical signs indicative of neurotoxicity were seen in the parental animals or offspring; nor was there evidence for increased susceptibility of offspring.

• Because a DNT study would necessarily be conducted at high doses in order to elicit neurotoxicity, it would not yield a POD lower than those currently used for acute (40 mg/kg [aPAD = 0.40 mg/kg] and 500 mg/kg [cPAD = 0.5 mg/kg]) and chronic (5 mg/kg/day) risk assessments.

iii. Although there was evidence of increased qualitative and quantitative susceptibility of fetuses in the rat developmental toxicity study, the concern for the increased susceptibility is low, and EPA did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of tepraloxydim.

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

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

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tepraloxydim will occupy 2.2% of the aPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. The acute dietary exposure from food and water to tepraloxydim will occupy 1.0% or less of the aPAD for all other population subgroups, including females 13 to 49 years old.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tepraloxydim from food and water will utilize 9.6% of the cPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. There are no residential uses for tepraloxydim.

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

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

5.Aggregate cancer risk for U.S. population.Based on the results of two adequate rodent carcinogenicity studies and the explanation given in Unit III.A, tepraloxydim is not expected to pose a cancer risk to humans.

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

Adequate enforcement methodology (gas chromatography/mass spectrometry (GC/MS) BASF Analytical Method D9701/1) is available to enforce the tolerance expression. 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 U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for tepraloxydim.

EPA has reduced the proposed tolerance for Sunflower subgroup 20B from 0.25 ppm to 0.20 ppm to harmonize with the established MRL in Canada. Since the highest average field trial residue and maximum field trial residue for sunflower seed were 0.14 ppm and 0.18 ppm, respectively, EPA has determined that the Canadian level is adequate to cover expected residues on commodities in subgroup 20B.

EPA is also revising the introductory text of § 180.573(a)(1), (a)(2) and (c), which contain the tolerance expression for the existing and new tolerances, to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be determined. Tolerances for plant commodities are currently expressed in terms of the combined residues tepraloxydim, 2-[1-[[[(2E)-3-chloro-2-propen-1-yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one, and its metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as tepraloxydim. Livestock tolerances are currently expressed in terms of the combined residues of tepraloxydim and its metabolites convertible to GP, OH-GP, and GL (3-(2-oyotetrahydropyran-4-yl)-1,5-dioic acid), calculated as tepraloxydim. The tolerance expression for plants is being revised to make clear that the tolerances cover residues of tepraloxydim, including its metabolites and degradates, but that compliance with the tolerances is to be determined by measuring only the combined residues of tepraloxydim and its metabolites convertible to GP and OH-GP, calculated as tepraloxydim. Similarly, the tolerance expression for livestock commodities is being revised to clarify that the tolerances cover residues of tepraloxydim, including its metabolites and degradates, but that compliance with the tolerance levels will be determined by measuring only the combined residues of tepraloxydim and its metabolites convertible to GP, OH-GP, and GL, calculated as tepraloxydim. EPA has determined that it is reasonable to make these changes final without prior proposal and opportunity for comment, because public comment is not necessary, in that the changes have no substantive effect on the tolerances, but rather are merely intended to clarify the existing tolerance expressions.

Finally, EPA is removing established tolerances for residues of tepraloxydim on “Lentil, seed” and “Pea, dry, seed” because residues on these commodities are covered by the new tolerances for residues of tepraloxydim on the pea and bean subgroup 6C.

Therefore, the established tolerances for residues of tepraloxydim on “Lentil, seed” and “Pea, dry, seed” are removed, and new tolerances are established for residues of tepraloxydim, including its metabolites and degradates, in or on “Pea and bean, dried shelled, except soybean, subgroup 6C” and “Sunflower subgroup 20B” as set forth in the regulatory text.

This final rule establishes tolerances under section 408(d) of FFDCA 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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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 petitionunder section 408(d) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 section 408(n)(4) of FFDCA. 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, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0283 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 28, 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0283, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the on-line instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof April 20, 2011 (76 FR 22067) (FRL-8869-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7836) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.576 be amended by reestablishing and making permanent tolerances for residues of the herbicide, cyhalofop-butyl, R-(+)-n-butyl-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionate, plus cyhalofop acid, R-(+)-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionic acid) and the di-acid metabolite, (2R)-4-[4-(1-carboxyethoxy)phenoxy]-3-fluorobenzoic acid, in or on rice, grain and rice, wild, grain at 0.35 parts per million (ppm), respectively. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing. These amended tolerances are required due to recent side-by-side field trial data submitted to support a new formulation of cyhalofop-butyl, which resulted in higher than anticipated residues associated with the currently registered formulation with this active ingredient. Based upon review of the data supporting the petition, EPA has increased the proposed tolerances from 0.35 ppm to 0.40 ppm and has revised the tolerance expression. The reasons for these changes are explained in Unit IV.D.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 cyhalofop-butyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyhalofop-butyl 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.

Cyhalofop-butyl has low or minimal acute toxicity via the oral, dermal and inhalation routes of exposure. It is minimally irritating to the eye, nonirritating to the skin and is not a dermal sensitizer.

Kidney effects were observed after subchronic and chronic dosing of the rat and mouse as well as in the rabbit developmental and rat reproduction studies. In the 90-day rat study, lipofuscin pigment deposition in proximal tubule kidney cells was noted in both sexes in addition to hepatocyte eosinophilic granules (males only); and in the 90-day mouse study (females only), there was an increase in absolute and relative kidney weights as well as swelling of the proximal tubule cells. In the rabbit developmental study, 1/18 dams in the mid-dose group and 9/18 dams in the high-dose group died or were sacrificed in extremis after exhibiting hematuria (gross pathological examinations revealed cloudy or dark colored kidneys). Slight kidney tubular cell swelling was observed only in adult males in the rat reproductive toxicity study. In the 18-month mouse carcinogenicity study, kidney findings included tubular dilatation, chronic glomurulonephritis and hyaline casts in females (not males). In both sexes in the chronic/carcinogenicity rat study increased deposition of kidney changes (early and increased deposition of the pigments lipofuscin and hemosiderin in the renal proximal tubular cells) was observed. In addition, in females only, renal mineralization was observed.

Non-kidney effects observed following subchronic or chronic exposure to cyhalofop-butyl included hyperplasia of the stomach mucosal epithelium (male mice only) in the 18-month mouse carcinogenicity study and brown and/or atrophied thymuses and decreased thymus weight in the 90-day dog study. The thymus effects, which could be an indication of potential immunotoxicity, were not observed in the 1-year dog study or in other species (rats, mice or rabbits) and were not seen in any tested species following chronic exposure to cyhalofop-butyl.

There was no evidence of developmental, reproductive or endocrine toxicity in the toxicology studies for cyhalofop-butyl. In the rat developmental toxicity study, there were no maternal or fetal effects observed up to the limit dose. In the rabbit developmental toxicity study, no fetal effects were observed up to the limit dose; whereas kidney effects (deaths related to hematuria and the occurrence of cloudy or dark colored kidneys on gross pathological examination) were seen in maternal animals. Slight kidney tubular cell swelling was observed in adult males in the rat reproductive toxicity study with no evidence of treatment-related effects observed in females or offspring. There were no systemic or neurotoxic effects noted at the limit dose in the gavage acute neurotoxicity study or in the 90-day feeding neurotoxicity study.

In a previous 2002 risk assessment for cyhalofop-butyl, it was not possible to assess the carcinogenic potential of cyhalofop-butyl due to insufficient dosing in the rat and mouse carcinogenicity studies. In the absence of acceptable data, EPA assumed that cyhalofop-butyl had the same carcinogenic potential as the structural analog, diclofop-methyl, and conducted an exposure assessment to evaluate cancer risk using quantitative linear low-dose extrapolation and the Q1* for diclofop-methyl of 2.3 × 10−1(mg/kg/day)−1. Subsequently, two specific mechanistic studies (Peroxisome Proliferator Receptor-Alpha Reporter Assays) in the mouse were submitted to EPA. Review of the mechanistic data indicated that cyhalofop-butyl is not a liver toxicant/carcinogen for humans, since the rodent liver mode of action is not likely to occur in humans; and that the doses in the original long-term studies were approaching a maximum tolerated dose. In addition, there were no positive effects in the battery of mutagenic studies. Based on these findings, EPA has classified cyhalofop-butyl as “Not Likely to be Carcinogenic to Humans.”

Specific information on the studies received and the nature of the adverse effects caused by cyhalofop-butyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document “Cyhalofop-butyl. Human Health Risk Assessment for Proposed Amended Tolerances on Rice and Wild Rice,” p. 8 in docket ID number EPA-HQ-OPP-2011-0283 and are also discussed in the final rule published in theFederal Registerof April 8, 2009 (74 FR 15876) (FRL-8406-8).

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

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to cyhalofop-butyl, EPA considered exposure under the petitioned-for tolerances as well as all existing cyhalofop-butyl tolerances in 40 CFR 180.576. EPA assessed dietary exposures from cyhalofop-butyl in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for cyhalofop-butyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed that all rice and wild rice commodities would be treated with cyhalofop-butyl and contain tolerance-level residues.

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

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

Based on the Tier 1 Rice Model and Screening Concentration in Ground Water (SCI-GROW) model, the estimated drinking water concentrations (EDWCs) of cyhalofop-butyl for chronic exposures for non-cancer assessments (the only dietary exposure scenario for which a toxicological endpoint of concern was identified) are estimated to be 21 parts per billion (ppb) for surface water and 0.152 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 21 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). Cyhalofop-butyl is not registered for any specific use patterns that would result in residential exposure.

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

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

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

2.Prenatal and postnatal sensitivity.The prenatal and postnatal toxicology data base for cyhalofop-butyl includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There were no treatment-related effects observed in fetuses or offspring in any of these studies.

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

i. The toxicity database for cyhalofop-butyl is complete except for immunotoxicity data. EPA has evaluated the available cyhalofop-butyl toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. Brown and/or atrophied thymuses and decreased thymus weight were observed in the 90-day dog study. However, these effects, which could be an indication of potential immunotoxicity, were not observed in the 1-year dog study or in other species (rats, mice or rabbits) and were not seen in any tested species following chronic exposure to cyhalofop-butyl. Based on these considerations, EPA has concluded that the doses and endpoints selected for risk assessment (along with traditional uncertainty factors) are protective of potential immunotoxicity and an additional uncertainty factor is not needed. The required immunotoxicity study has been received by EPA and is currently being reviewed. A screening- level review of this study indicates that there are no immunotoxic effects associated with cyhalofop-butyl.

ii. There is no indication that cyhalofop-butyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that cyhalofop-butyl results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 percent crop treated and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyhalofop-butyl in drinking water. Residential exposure of infants and children is not expected. These assessments will not underestimate the exposure and risks posed by cyhalofop-butyl.

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

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, cyhalofop-butyl is not expected to pose an acute risk.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyhalofop-butyl from food and water will utilize 18% of the cPAD for All Infants (< 1 year old), the population group receiving the greatest exposure. There are no residential uses for cyhalofop-butyl.

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). Cyhalofop-butyl is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to cyhalofop-butyl through food and water and will not be greater than the chronic aggregate risk.

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). Cyhalofop-butyl is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to cyhalofop-butyl through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5.Aggregate cancer risk for U.S. population.Based on the evidence summarized in Unit III.A., cyhalofop-butyl is classified as “not likely to be carcinogenic to humans” and is, therefore, not expected to pose a cancer risk.

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

Adequate enforcement methodology (Gas Chromatography/Mass Spectrometry (GC/MS) Method GRM 99.06) is available to enforce the tolerance expression. 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 U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for cyhalofop-butyl.

EPA has revised the proposed tolerances levels. The petitioner requested tolerances of 0.35 ppm based on the use of the North American Free Trade Agreement (NAFTA) tolerance calculation procedures. Based on the submitted rice data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures that were implemented in April 2011, EPA calculated that the rice, grain and wild rice, grain tolerances should be 0.40 ppm.

Also, EPA is revising the tolerance expression in order to make clear that the tolerances cover residues of the herbicide cyhalofop-butyl, including its metabolites and degradates. Compliance with the tolerance levels is to be determined by measuring cyhalofop butyl, cyhalofop acid, and the di-acid metabolite.

Therefore, tolerances are established for residues of cyhalofop-butyl, including its metabolites and degradates, as set forth in the regulatory text.

This final rule establishes tolerances under section 408(d) of FFDCA 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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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 section 408(d) of FFDCA, 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. 601et 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 section 408(n)(4) of FFDCA. 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, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0959 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 28, 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0959, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the on-line instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof Wednesday, July 20, 2011 (76 FR 43231) (FRL-8880-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7785) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.475 be amended by establishing tolerances for residues of the fungicide, difenoconazole, [1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole], in or on oats, forage at 0.1ppm; oats, hay at 0.1 ppm; oats, straw at 0.1 ppm; oats, grain at 0.1 ppm; rye, forage at 0.1 ppm; rye, straw at 0.1 ppm; rye, grain at 0.1 ppm; and wheat, hay at 0.1 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket,http://www.regulations.gov.

One comment on the notice of filing was received from an anonymous submitter. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting this petition, EPA has revised the proposed tolerance levels for oat, grain; oat, forage; oat, hay; oat, straw; rye, grain; rye, forage; rye, straw; and wheat, hay. In addition, EPA modified commodity definitions submitted by the registrant, Syngenta Crop Protection, Inc. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C)(ii)(I) 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 difenoconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with difenoconazole 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.

Difenoconazole possesses low acute toxicity by the oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant and is not a sensitizer. Subchronic and chronic studies with difenoconazole in mice and rats showed decreased body weights, decreased body weight gains and effects on the liver. In an acute neurotoxicity study in rats, reduced fore-limb grip strength was observed on day 1 in males and clinical signs of neurotoxicity were observed in females at the limit dose of 2000 milligrams/kilograms (mg/kg). In a subchronic neurotoxicity study in rats, decreased hind limb strength was observed in males only at the mid- and high-doses. However, the effects observed in acute and subchronic neurotoxicity studies are transient, and the dose-response is well characterized with identified no-observed-adverse-effects-levels (NOAELs). No systemic toxicity was observed at the limit dose in the most recently submitted 28-day rat dermal toxicity study.

There is no concern for increased qualitative an/or quantitative susceptibility after exposure to difenoconazole in developmental toxicity studies in rats and rabbits, and a reproduction study in rats as fetal/offspring effects occurred in the presence of maternal toxicity. There are no indications in the available studies that organs associated with immune function, such as the thymus and spleen, are affected by difenoconazole.

In accordance with the Agency's current policy, difenoconazole is classified as “Suggestive Evidence of Carcingenic Potential” and EPA is using the Margin of Exposure (MOE) approach to assess cancer risk. Difenoconazole is not mutagenic, and no evidence of carcinogenicity was seen in rats. Evidence for carcinogenicity was seen in mice (liver tumors), but statistically significant carcinomas tumors were only induced at excessively-high doses. Adenomas (benign tumors) and liver necrosis only were seen at 300 parts per million (ppm) (46 and 58 mg/kg/day in males and females, respectively). Based on excessive toxicity observed the two highest doses in the study, the presence of only benign tumors and necrosis at the mid-dose, the absence of tumors at the study's lower doses, and the absence of genotoxic effects, EPA has concluded that the chronic point of departure (POD) from the chronic mouse study will be protective of any cancer effects. The POD from this study is the NOAEL of 30 ppm (4.7 and 5.6 mg/kg/day in males and females, respectively) which was chosen based upon only those biological endpoints which were relevant to tumor development (i.e.,hepatocellular hypertrophy, liver necrosis, fatty changes in the liver and bile stasis).

Specific information on the studies received and the nature of the adverse effects caused by difenoconazole as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document entitled, “Difenoconazole Human Health Risk Assessment for Amended Section 3 Registration to Add Seed Treatment Use on Oats and Rye and Establish a Tolerance in/on Wheat Hay,” dated October 27, 2011 at page number 25 in docket ID number EPA-HQ-OPP-2010-0959-0007.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for difenoconazole used for human risk assessment is discussed in Unit III. B. of the final rule published in theFederal Registerof June 15, 2011 (76 FR 34877) (FRL-8876-4).

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to difenoconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing difenoconazole tolerances in 40 CFR 180.475. EPA assessed dietary exposures from difenoconazole 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 difenoconazole. 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 used tolerance-level residues, 100 percent crop treated (PCT), and the available empirical or DEEMTM(ver. 7.81) default processing factors.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-level residues for some commodities, average field trial residues for the majority of commodities, the available empirical or DEEMTM(ver. 7.81) default processing factors, and 100 PCT.

iii.Cancer.Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to difenoconazole. A separate quantitative cancer exposure assessment is unnecessary since the NOAEL (4.7 and 5.6 mg/kg/day in males and females, respectively) to assess cancer risk is higher than the NOAEL (0.96 and 1.27 mg/kg/day in males and females, respectively) to assess chronic risks and exposure for the purpose of assessing cancer risk would be no higher than chronic exposure. Therefore, the chronic dietary risk estimate will be protective of potential cancer risk.

iv.Anticipated residue and percent crop treated (PCT) information.EPA did not use PCT information in the dietary assessment for difenoconazole. EPA used anticipated residues in the form of average field trial residues for the majority of commodities.

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, demonstratingthat 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.

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) for the registered and proposed new uses and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of difenoconazole for acute exposures are estimated to be 15.8 parts per billion (ppb) for surface water and 0.0128 ppb for ground water.

For chronic exposures for non-cancer assessments are estimated to be 10.4 ppb for surface water and 0.0128 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 15.8 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 10.4 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).

Difenoconazole is currently registered for the following uses that could result in residential exposures: Ornamentals. EPA assessed residential exposure using the following assumptions: Adults may be exposed to difenoconazole from its currently registered use on ornamentals. Residential pesticide handlers may be exposed to short-term duration (1-30 days) only. The dermal and inhalation (short-term) residential exposure was assessed for “homeowners” mixer/loader/applicator wearing short pants and short-sleeved shirts as well as shoes plus socks using garden hose-end sprayer, “pump-up” compressed air sprayer, and backpack sprayer.

Residential post-application exposure may occur from use of difenoconozole on golf course turf. Short-term dermal exposure was assessed for post-application exposure to golf course turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://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.”

Difenoconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web sites at:http://www.epa.gov/pesticides/cumulativeandhttp://www.epa.gov/fedrgstr/EPA_PEST/2002/January/Day_16/.

Difenoconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including difenoconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g.,use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e.,high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10× FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's risk assessment is found in the propiconazole reregistration docket athttp://www.regulations.gov,Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and the most recent update that assessed additional new commodities for triazoles may be found in docket ID number EPA-HQ-OPP-2010-0959 in the document titled “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address Tolerance Petitions for Metconazole”, dated April 27, 2011. The requested amended uses of difenoconazole did not result in an increase in dietary exposure estimates for free triazole or conjugated triazoles. Therefore, the last dietary exposure analyses cited above addresses potential exposures resulting from commodities discussed in this action.

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 available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.EPA determined that the available dataindicated no increased susceptibility of rats or rabbits toin uteroand/or postnatal exposure to difenoconazole. In the prenatal developmental toxicity studies in rats and rabbits and the 2-generation reproduction study in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals. In the prenatal developmental toxicity study in rats, maternal toxicity was manifested as decreased body weight gain and food consumption at the LOAEL of 85 mg/kg/day; the NOAEL was 16 mg/kg/day. The developmental toxicity was manifested as alterations in fetal ossifications at 171 mg/kg/day; the developmental NOAEL was 85 mg/kg/day. In a developmental toxicity study in rabbits, maternal and developmental toxicity were seen at the same dose level (75 mg/kg/day). Maternal toxicity in rabbits was manifested as decreased body weight gain and decreased food consumption, while developmental toxicity was manifested as decreased fetal weight. In a 2-generation reproduction study in rats, there were decreases in maternal body weight gain and decreases in body weights of F1 males at the LOAEL of 12.5 mg/kg/day; the parental systemic and off spring toxicity NOAEL was 1.25 mg/kg/day.

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

i. The toxicity database is complete except for an immunotoxicity study which is now required as a part of new data requirements in the 40 CFR part 158 for conventional pesticide registration. However, the toxicology database for difenoconazole does not show any evidence of treatment-related effects on the immune system. The overall weight of evidence suggests that this chemical does not directly target the immune system. Accordingly, the Agency does not believe that conducting a functional immunotoxicity study will result in a lower point of departure POD than that currently in use for overall risk assessment, and therefore, a database uncertainty factor is not needed to account for lack of this study.

ii. The acute and subchronic neurotoxicity studies in rats are available. These data show that difenoconazole exhibits some evidence of neurotoxicity, but the effects are transient or occur at the limit dose. EPA concluded that difenoconazole is not a neurotoxic compound. Based on the toxicity profile, and lack of neurotoxicity, a developmental neurotoxicity study in rats is not required.

iii. There is no evidence that difenoconazole results in increased susceptibility of rats or rabbit fetuses toin uteroand/or postnatal exposure in the developmental and reproductive toxicity data.

iv. There are no residual uncertainties identified in the exposure databases. A conservative dietary food exposure assessment was conducted. Acute dietary food exposure assessments were performed based on tolerance-level residues, 100 PCT, and the available empirical or DEEM (ver. 7.81) default processing factors.

Chronic dietary exposure assessments were based on tolerance-level residues for some commodities, average field trial residues for the majority of commodities, the available empirical or DEEM (ver. 7.81) default processing factors, and 100 PCT. These are conservative approaches and are unlikely to understate the residues in food commodities.

EPA also made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to difenoconazole in drinking water. Post-application residential exposure of children is not expected. These assessments will not underestimate the exposure and risks posed by difenoconazole.

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

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to difenoconazole will occupy 19% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to difenoconazole from food and water will utilize 46% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of difenoconazole is not expected.

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).

Difenoconazole is currently registered for uses on ornamentals 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 difenoconazole.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 260 or greater. Because EPA's level of concern for difenoconazole is a MOE of 100 or below, these MOEs resulting from short-termed exposure to difenoconazole 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 adverse effect was identified; however, difenoconazole is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for difenoconazole.

5.Aggregate cancer risk for U.S. population.As discussed in Unit III.A., the chronic dietary risk assessment is protective of any potential cancer effects.

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

An adequate enforcement method, gas chromatography with nitrogen/phosphorus detection (GC/NPD) method AG-575B, is available for the determination of residues of difenoconazoleper sein/on plant commodities. An adequate enforcement method, liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method REM 147.07b, is available for the determination of residues of difenoconazole and CGA-205375 in livestock commodities.

The methods 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 U.N. 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.

Codex maximum residue limits (MRLs) for residues of difenoconazole have been established. However, since no Codex MRLs have been established for residues of difenoconazole in/on oat commodities, rye commodities, and wheat hay, harmonization with Codex is not an issue. Canadian MRLs for residues of difenoconazole have been established at 0.01 ppm for oat grain and 0.01 ppm for rye grain and U.S. tolerances for oat grain and rye grain are harmonization with these established Canadian MRLs. Mexican MRLs for residues of difenoconazole have been established; however, no Mexican MRLs have been established for any of the cereal grain commodities.

One comment was received from a private citizen who opposed authorization by EPA to allow pesticide use on oats and other petitioned-for uses that would result in any pesticide residue on food. The Agency has received this same comment on numerous previous occasions and rejects it for the reasons previously stated in theFederal Registerat 70 FR 1349, January 7, 2005.

EPA determined that the proposed tolerance for oat, grain at 0.1 ppm should be established at 0.01 ppm. This decision was based on the translation and re-evaluation of available barley grain data. No detectable residues of difenoconazole are expected in/on oat grain from the maximum seed treatment use under consideration. Therefore, the tolerance should be established at the limit of quantitation (LOQ) of the current enforcement method, 0.01 ppm in/on oat grain. EPA increased the proposed tolerance in/on oat, forage from 0.1 ppm to 0.15 ppm based on the translation and re-evaluation of available wheat forage data; using the Organization for Economic Cooperation and Development (OECD) MRL calculator, a tolerance of 0.15 ppm is appropriate. For both oat, hay and oat, straw EPA decreased the proposed tolerances of 0.1 ppm to 0.05 ppm based on the translation and re-evaluation of available wheat hay and wheat straw data; residues of difenoconazole are not expected to exceed the LOQ of the current enforcement method, 0.05 ppm in/on oat straw or hay.

EPA determined that the proposed tolerance for rye, grain at 0.1 ppm should be established at 0.01 ppm. This decision was based on the translation and re-evaluation of available wheat grain data. No detectable residues of difenoconazole are expected in/on rye grain; therefore, the tolerance should be established at the LOQ of the current enforcement method, 0.01 ppm in/on rye grain. Also, the EPA recommended tolerance for rye, grain at 0.01 ppm replaces the existing difenoconazole import only tolerance for rye, grain 0.1 ppm. EPA increased the proposed tolerance for rye, forage from 0.1 ppm to 0.15 ppm based on the translation and re-evaluation of available wheat forage data; using the OECD MRL calculator, a tolerance of 0.15 ppm is appropriate. For rye, straw, EPA decreased the proposed tolerance of 0.1 ppm to 0.05 ppm based on the translation and re-evaluation of available wheat straw data; residues of difenoconazole are not expected to exceed the LOQ of the current enforcement method, 0.05 ppm in/on rye straw.

For wheat, hay, EPA decreased the proposed tolerance of 0.1 ppm to 0.05 ppm based on the re-evaluation of available wheat hay data; residues of difenoconazole are not expected to exceed the LOQ of the current enforcement method, 0.05 ppm in/on wheat hay.

Therefore, tolerances are established for residues of difenoconazole, including its metabolites and degradates, in or on the commodities listed in the table at the end of this document. Compliance with the tolerance levels specified in the table below is to be determined by measuring only difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on oat, forage at 0.15 ppm; oat, grain at 0.01 ppm; oat, hay at 0.05 ppm; oat, straw at 0.05 ppm; rye, forage at 0.15 ppm; rye, grain at 0.01 ppm; rye, straw at 0.05 ppm; and wheat, hay at 0.05 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA 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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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 section 408(d) of FFDCA, 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. 601et 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 section 408(n)(4) of FFDCA. 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, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On January 19, 2011, PHMSA published a final rule under Docket PHMSA-2009-0126 (HM-215K; 76 FR 3308) that revised the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to align with various international standards. The final rule adopted amendments to the HMR regarding hazard communication, hazard classification including packing group assignment, packaging authorization, air transport quantity limitations, and various other international harmonization-related topics. The amendments were necessary to align the HMR with the latest revisions to the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), the International Maritime Organization's Dangerous Goods Code (IMDG Code), Transport Canada's Transportation of Dangerous Goods Regulations (TDG Regulations), and the United Nations Recommendations on the Transport of Dangerous Goods: Model Regulations (UN Model Regulations) to facilitate to the seamless transportation of hazardous materials internationally, to, through and from the United States.

In this document, PHMSA responds to administrative appeals, provides clarifications, and corrects typographical and other minor errors adopted in the January 19, 2011 final rule.

In response to the January 19, 2011 final rule, administrative appeals were submitted by the following companies and organizations:

The administrative appeals addressed in this document are discussed in detail below. Because some of the issues raised by appellants require notice and public comment under the Administrative Procedure Act (APA; 5 U.S.C. 553), they are being proposed in a separate notice of proposed rulemaking (NPRM) under this docket number (PHMSA-2009-0126; RIN 2137-AE83). For example, FCHEA and LSI requested that PHMSA revise § 175.10 to align with the ICAO Technical Instructions and allow spare fuel cell cartridges containing Division 2.1 flammable gas to be carried in checked baggage. We are also aware of recent actions taken by the International Civil Aviation Organization's Dangerous Goods Panel regarding certain lithium ion battery-powered mobility aids (e.g.,wheelchairs, travel scooters) offered by passengers for air transport. Such actions could affect the outcome of the administrative appeal submitted by IATA in response to the January 19, 2011 final rule and, therefore, those actions will also be addressed in the separate NPRM.

We can, however, in some instances adopt a provision submitted in an administrative appeal that was inadvertently omitted in the final rule if it is clearly within the scope of changes proposed in the notice, does not require substantive changes from the international standard on which it is based, and imposes minimal or no cost impacts on persons subject to the requirement. Otherwise, in order to provide opportunity for notice and comment, the change must first be proposed in an NPRM.

Currently, under § 172.315 of the HMR and except for transportation by aircraft, a packaging containing a limited quantity material is not required to be marked with the proper shipping name when marked with a square-on-point containing the UN identification (ID) number of the limited quantity material. In the January 19, 2011 final rule, we provided a one-year transition period to authorize continued use of this marking before the revisions to the limited quantity markings become effective. ACA, DGAC, and PPG all state the one-year transition period does not allow sufficient time to deplete stock(s) of packagings pre-printed with the square-on-point mark containing the ID number and requested an extension of three- to five-years. Appellants request that PHMSA provide a transition period similar to the transition period provided for the phase-out of the ORM-D marking, depending on the mode of transportation. Appellants also requested that any transition periods be included in §§ 171.14 (transitional provisions) and 172.300 (marking applicability).

We agree. Shippers should be provided the same transition period that authorizes the continued use of the square-on-point mark containing the UN ID number provided for ORM-D markings. In this document, we are granting the appeals submitted by ACA, DGAC, and PPG and revising § 172.315 by extending the transition period, until December 31, 2013 for other than air transportation. For domestic air transportation, we are authorizing use of the square-on-point mark containing the ID number to continue until December 31, 2012 as adopted in the January 19, 2011 final rule. However, we are not revising §§ 171.14 and 172.300 to include the transition periods because we believe it is overly duplicative.

In this document, we respond to two administrative appeals related to the transportation of fuel cell cartridges. The administrative appeals are discussed as follows:

In the January 19, 2011 final rule, we revised the limited quantityrequirements for fuel cell cartridges to allow transportation as “Consumer commodity, ORM-D,” except when transported by aircraft.

FCHEA states not allowing the transportation by aircraft of fuel cell cartridges as ORM-D-AIR is inconsistent with the ICAO Technical Instructions and the UN Model Regulations and claims that the difference is “impractical” from an international trade and enforcement standpoint. They note there are no safety consequences when comparing the air transportation of fuel cell cartridges shipped as limited quantity material and those shipped as ORM-D-AIR. They also note that fuel cell cartridges are sturdy articles that meet a range of tests and requirements to ensure they do not pose unreasonable risks in transportation. FCHEA requests PHMSA to allow fuel cell cartridges to be transported as ORM-D-AIR by aircraft so that fuel cell technologies are not placed at a disadvantage compared to other technologies authorized to be transported by aircraft.

PHMSA response.

We deny FCHEA's administrative appeal that would authorize fuel cell cartridges to be offered and transported as “Consumer commodity, ORM-D-AIR,” by aircraft. When packages of articles or substances are renamed “Consumer commodity” and are reclassed as “ORM-D-AIR,” the identity and risk posed by the substance or article is no longer communicated. This is one of the primary reasons the ORM-D-AIR hazard class is being phased-out by the end of 2012. We believe the authorization to offer fuel cell cartridges as limited quantities by passenger-carrying and cargo-only aircraft satisfies the need for the expedient transportation of such articles, while communicating their risk, and imposing minimal regulatory burden.

FCHEA's administrative appeal indicated that in addition to the differences in fuel cell cartridge chemistries authorized in checked baggage, there are a number of inconsistencies and editorial issues when comparing § 175.10 and the ICAO Technical Instructions regarding fuel cell systems and cartridges used to power portable electronic devices authorized to be carried aboard passenger-carrying aircraft. They note that over the last several years, revisions to the ICAO Technical Instructions have made the regulatory language clearer. FCHEA requests that PHMSA make similar revisions to avoid any potential confusion between requirements under the HMR and the ICAO Technical Instructions.

PHMSA response.

We agree. Thus, we are granting FCHEA's administrative appeal to editorially revise§ 175.10(a)(19) to be consistent with language in 8; 1.1.2 (t) of the ICAO Technical Instructions. This clarification does not, however, revise current HMR provisions regarding such articles and is entirely editorial in nature.

As adopted in the January 19, 2011 final rule, the general air packaging requirements for combination packagings prohibit Class 1 (explosive) and Class 7 (radioactive) material to be offered for transportation as limited quantity material by aircraft.See76 FR 3369. In their administrative appeal, DGAC and SAAMI state this is inconsistent with other provisions in the HMR that allow the transportation of these materials by aircraft, specifically, §§ 173.421 through 173.425 for limited quantity radioactive material, instruments, and articles and § 173.63(b) for certain Division 1.4S explosive articles. DGAC and SAAMI request that PHMSA revise the list of prohibited hazardous material and articles and Table 3 in § 173.27(f) to clarify that Class 1 (explosive) material conforming to § 173.63(b) and Class 7 (radioactive) material conforming to §§ 173.421 through 173.425, as applicable, are authorized for transportation by aircraft. Additionally, DGAC requests UN3334 (“Aviation regulated liquid, n.o.s.”) and UN3335 (“Aviation regulated solid, n.o.s.”) be added to the list of Class 9 (miscellaneous hazard) material as the substances are currently authorized as limited quantity material under the § 173.155 exceptions for Class 9 material and for consistency with the ICAO Technical Instructions.

PHMSA response.

We agree. DGAC and SAAMI are correct, and we are therefore granting their administrative appeals by revising § 173.27(f) to reflect current regulations that authorize the shipment of these substances and articles by aircraft. We want to point out that although certain Class 1 and Class 7 materials are indicated as eligible for air transport in § 173.27(f), such indication is provided for informational purposes to aid readers in indentifying the appropriate packaging and other regulatory provisions for such materials. For example, packages of such materials are not marked with the limited quantity “Y” mark prescribed in § 172.315 but rather as prescribed in §§ 173.63 and 173.421 through 173.425, as appropriate.

In the UN Model Regulations, certain Division 4.1 self-reactive materials are authorized limited quantity exceptions. Currently, the HMR do not authorize such exceptions. AHS appealed to PHMSA to include a limited quantity exception for the material “Self-reactive solid, Type F, UN3230.” AHS notes that they filed a petition for rulemaking in 2009 (P-1542), to which PHMSA replied by stating that the petition merited rulemaking action and that it would be addressed in the January 19, 2011 final rule.

PHMSA response.

We recognize the merits of AHS's appeal and petition for rulemaking, but are denying AHS's administrative appeal because it is beyond the scope of this rulemaking. To accommodate the federally mandated requirement for notice and comment during a significant rulemaking action, the petition must be presented under a notice of proposed rulemaking to allow for comment by all interested parties. We regret the unintentional omission of a proposal in the NPRM for a limited quantity exception for “Self-reactive solid, Type F, UN3230” and for adoption under the January 19, 2011 final rule. We fully intend to include a proposal for this material as a broader effort to revise the packaging requirements for all eligible self-reactive materials in a near-term rulemaking action.

In the January 19, 2011 final rule, we adopted new limited quantity markings consistent with the ICAO Technical Instructions, IMDG Code, and the UN Model Regulations to include a limited quantity “Y” marking for display on packagings prepared for air transportation. In their administrative appeals, ACA and DGAC ask for a clearer indication of when this new marking may be used in modes of transportation by other than aircraft. They note PHMSA's consideration in the January 19 final rule of a comment stating that the limited quantity “Y” marking should be authorized for use in all modes of transportation if displayed on a packaging that meets all conditions and requirements for air transportation.See 76 FR 3313.Additionally, on thebasis of their opposition to adoption of the air transport requirements for limited quantities consistent with the ICAO Technical Instructions, DGAC recommends that:

We agreed with the DGAC recommendation that a “Y” marked package in full conformance with the air transport provisions prescribed for a limited quantity package should be authorized in all modes of transportation and also stated we would revise § 171.22 accordingly. Although we indicated our intent to revise § 171.22, which prescribes the authorization and conditions for use of international standards, we inadvertently failed to amend the corresponding regulatory text of the section. In its administrative appeal, ACA also requests that PHMSA amend this section to indicate the limited quantity “Y” marking is authorized for use in all modes of transportation. Further, DGAC suggests that we revise§ 172.315 to include language authorizing the use of this marking by modes other than air.

PHMSA response.

We agree. Our indication in the final rule to revise § 171.22 was in error as that section prescribes the authorization to use the various international standards. Regardless, we clearly indicated in the preamble of the final rule that the display of a “Y” marking on limited quantity package that is not intended for transportation by aircraft is authorized. Thus, because a limited quantity package prepared for air transportation by default is authorized by all modes of transportation, the administrative appeals requesting that PHMSA align with the international standards are hereby granted. See the Section-by-Section review of changes for a full discussion of the § 172.315 revisions and requirements.

In the January 19, 2011 final rule, we revised the § 173.27 general requirements for transportation of packagings by aircraft. Specifically, we revised paragraph (f) by including a new Table 3 that prescribes the requirements for authorized limited quantity material intended for air transportation consistent with the 2011-2012 ICAO Technical Instructions, where appropriate.

AHS notes that PHMSA included “Consumer commodity, ID8000” as authorized Class 9 material but failed to revise paragraph (f)(2)(i)(G) for Class 9 material not authorized as limited quantity material by aircraft. As indicated by AHS, “Consumer commodity, ID8000” may be shipped as limited quantity material by aircraft, thus “ID8000” should be added to the list of materials excepted from the Class 9 prohibition in paragraph (f)(2)(i)(G).

PHMSA response.

We agree. In this final rule, we are revising § 173.27(f)(2)(i)(G) to include “ID8000” as a material excepted from the Class 9 prohibition. In addition, for clarification, we are revising Table 3 to indicate that the note associated with Class 9 liquid material applies to both liquid and solid material.

In the January 19, 2011 final rule, we added a new section, § 173.311, for packaging requirements for “Metal hydride storage systems, UN3468” used for the transport of hydrogen. Prior to the January 19, 2011 final rule, the HMR did not prescribe methods for the construction, qualification, marking, and requalification of these systems although we issued a number of special permits and competent authority approvals (CAA) to allow the manufacture and use of similar systems for the transport of hydrogen.

In a January 24, 2011 request for clarification, Ovonic Hydrogen Systems, LLC (OHS) expresses concern that the new § 173.311 requires transportable metal hydride storage systems to meet ISO Standard 16111:2008 (ISO 16111) which does not recognize the storage canisters manufactured by OHS under its currently-held CAA. Specifically, OHS manufactures storage canisters based on refillable aluminum cylinders designed, constructed, and tested to DOT 3AL specifications. Instead, ISO 16111 requires the use of aluminum cylinders constructed and tested to ISO 7866 specifications. Testing and marking requirements under ISO 7866 differ from testing and marking requirements for DOT 3AL specifications and OHS states its storage canisters are non-compliant as a result.

PHMSA response.

We disagree with OHS's assertion. The adoption of packaging requirements for metal hydride storage systems in § 173.311 does not invalidate any active special permits or CAAs authorizing the transportation of hydrogen in “metal hydride storage canisters.” When a special permit or CAA expires and is not renewed, systems must conform with the § 173.311 requirements for metal hydride storage systems to include the requirements of ISO 16111. Special permits issued by the Associate Administrator authorize the transportation of hazardous material and packaging within the United States only. International regulatory agencies may not recognize a special permit granted by PHMSA. However, metal hydride storage canisters designed, constructed, and otherwise conforming to requirements authorized under a CAA issued by PHMSA should be honored by other competent authorities worldwide as a valid alternative to ISO 16111.

This section provides a hazardous materials table that identifies listed materials as hazardous material for purposes of transportation.

For the table entry “Calcium hypochlorite, hydrated or Calcium hypochlorite, hydrated mixtures, with not less than 5.5 percent but not more than 16 percent water, UN2880,” the PG III information was inadvertently removed. Under a final rule published December 29, 2006 (HM-215I, 71 FR 78596), we revised the PG II information to remove Special provision 166. However, the instruction to revise this entry did not include the PG III information and, therefore, it was inadvertently removed from the 49 CFR. In this document, we are revising the entry to add the PG III information to the entry to reflect the correct descriptions for this entry. This correction reads as a “remove/add.”

For the table entry “Tellurium compound, n.o.s., UN3284,” effective October 1, 2010, we inadvertently added the term “solid” to the proper shipping name to read “Tellurium compound, solid, n.o.s.” in the January 19, 2011 final rule. In this document, we are revising the proper shipping name to remove the term “solid.” This correction reads as a “remove/add.”

This section prescribes the requirements for marking packages containing limited quantity material. Based on administrative appeals submitted in response to the January 19, 2011 final rule (HM-215K; 76 FR 3308), and numerous requests for clarification of the limited quantity marking requirements, we are revising § 172.315 to authorize continued use of the limited quantity marking (i.e.,square-on-point and Identification Number) prescribed in§ 172.315, in effect on October 1, 2010, for the same duration offered for continued use of the ORM-D-AIR and ORM-D markings, December 31, 2012 and December 31, 2013, respectively. For transportation by aircraft, the hazard class label (when applicable) and proper shipping name marking are still required. Additionally, we are revising § 172.315 to allow marking of a limited quantity package not intended for transportation by air with the limited quantity “Y” marking if the packaging is prepared in accordance with § 173.27(f) indicating it is suitable for transportation as a limited quantity package by aircraft. A “Y” marked package transported by a mode other than air indicates the package would be suitable for air transport if marked, labeled and accompanied by a shipping paper and is otherwise packaged in accordance with 3; 4 of the ICAO Technical Instructions as limited by subpart C of Part 171 and Part 175 of the HMR or§ 173.27(f) and Part 175 of the HMR.

In the January 19 final rule, we erroneously adopted limited quantity marking requirements applicable to cargo transport units (CTU) containing packages of hazardous materials in only limited quantities. We erred by stating the marking must be applied to only one side and one end of the CTU when we should have required the marking on all four exterior sides of the CTU consistent with 3.4.5.5 of the IMDG Code. In this document, we are correcting that error in § 172.315. Finally, we are reorganizing the format of the language used in this section solely for editorial clarification.

This section prescribes general requirements for the transportation of hazardous material by aircraft. Based on appeals and requests for clarification, in this document we are revising§ 173.27(f). Specifically, we are revising paragraph (f)(2) and Table 3 in paragraph (f) by adding materials currently authorized elsewhere in the HMR and to provide additional clarification regarding those hazardous materials and articles eligible for transport by aircraft under the conditions prescribed in this paragraph. The authorized hazardous materials and articles added and referenced are as follows: (1) Class 1 (explosive) articles in accordance with § 173.63(b); (2) Class 7 (radioactive) material in accordance with applicable §§ 173.421 through 173.425; and (3) “Aviation regulated liquid, n.o.s., UN3334,” “Aviation regulated solid, n.o.s., UN3335,” and “Consumer commodity, ID8000.” As stated earlier in this preamble, although certain Class 1 and Class 7 materials are indicated as eligible for air transport in§ 173.27(f), because they do not meet guiding principles established for limited quantities such indication is provided for informational purposes to aid readers in identifying the appropriate packaging and other provisions for such materials. For example, packages of Class 7 are not marked with the limited quantity “Y” mark prescribed in § 172.315 but rather as prescribed in 173.421 through 173.425, as appropriate.

Section 173.124 defines a Class 4 material. For consistency with a revision adopted in the UN Model Regulations, PHMSA amended the definition of “self-heating” in § 173.124(b)(2) of the HMR in the January 19 final rule. In this document, PHMSA is correcting the typographical error in the heading of the definition.

Section 173.151 prescribes exceptions for a Class 4 material. Paragraph (d) prescribes exceptions for Division 4.3 solid material of Packing Groups II and III. The HMR do not authorize limited quantity packages of such substances to be reclassified as ORM-D or to be renamed “Consumer commodity.” In the January 19, 2011 final rule, PHMSA inadvertently revised the third sentence of paragraph (d) to extend the additional exceptions for limited quantities and ORM in § 173.156 to Division 4.3 substances, when no such authorization prior to this rulemaking existed nor was it considered in this rulemaking due to the obvious risk to transportation safety. Therefore, in this final rule, PHMSA is removing the reference to§ 173.156 in the third sentence of § 173.151(d).

Section 173.156 provides additional exceptions for limited quantity and ORM packages. In the January 19, 2011 final rule, PHMSA unintentionally amended paragraph (b)(1) by requiring the marking of such packages in accordance with subpart D of part 172. In this final rule, PHMSA is amending § 173.156(b)(1) by removing the requirement to mark such packages. Because paragraph (b)(2) authorizes the common carriage of such packages, the marking requirements that existed prior to the January 19, 2011 final rule will remain as adopted.

Section 173.306 prescribes requirements for limited quantity of compressed gases. In this document, we are revising certain paragraphs for clarification of requirements adopted in the final rule and to correct minor grammatical errors.

This section specifies packaging instructions for hydrogen in metal hydride storage systems. The January 19, 2011 final rule incorrectly refers to ISO standards in § 178.71(f) that apply to the design and construction of UN refillable welded cylinders rather than § 178.71(m) for the design and construction of UN metal hydride storage systems. In this final rule, we are revising the section to correctly refer to § 178.71(m).

Section 175.10 prescribes the conditions under which a passenger, crew member, or an operator may carry hazardous materials aboard a passenger-carrying aircraft. In response to FCHEA's administrative appeal, in this final rule we are editorially revising the language in§ 175.10(a)(19) for the carriage of fuel cell systems and fuel cell cartridges for consistency with the ICAO Technical Instructions. These revisions do not amend the fuel cell cartridge chemistries authorized in checked baggage as adopted in the January 19 final rule.

Section 175.75 prescribes quantity limitations and cargo location requirements for hazardous materials transported by aircraft. In this document, we are revising for clarification the definition of “Inaccessible” in paragraph (d)(2) to mean any package that is loaded where a crew member or other authorized person cannot access, handle and, when size and weight permit, separate such packages from other cargo during flight, including a freight container in an accessible cargo compartment when packages are loaded in an inaccessible manner. This definition is consistent with the defined term “Accessible” and is revised for clarification only. Additionally, PHMSA is revising the heading in the third column of the paragraph (f) Quantity and Loading Table for clarity by adding the words “per cargo compartment.” Since issuing the January 19 final rule, we have fielded numerous inquiries regarding whether the limitation was now “peraircraft” as opposed to “per compartment.” Additionally, we are correcting the error in Note a. of the table as published in the January 19 final rule. Notwithstanding the correction made to Note a. of the § 175.75(f) table, we want to emphasize the revisions made in this document to § 175.75 are for editorial clarification only.

This section specifies requirements for vessel transport of motor vehicles and equipment. In this final rule, we are revising paragraph (j) to refer to the correct section paragraph regarding items of equipment containing hazardous materials, specifically, § 173.220(f), that are integral components of a motor vehicle, engine or mechanical equipment.

In an effort to clarify the amendments to the HMR associated with the transition from the domestic ORM-D system for transportation of limited quantity material to the international system, we offer the following:

For FMCSA and PHMSA's Final Rule published on December 2, 2011 (76 FR 75470), the following correction is made:

Electronic Access

This interim rule is also accessible athttp://www.gpoaccess.gov/fr.

The Convention Area comprises the majority of the western and central Pacific Ocean (WCPO). A map showing the boundaries of the Convention Area can be found on the WCPFC Web site at:http://www.wcpfc.int/doc/convention-area-map.The Convention focuses on the conservation and management of highly migratory species (HMS) and the management of fisheries for HMS. The objective of the Convention is to ensure, through effective management, the long-term conservation and sustainable use of HMS in the WCPO.

As a Contracting Party to the Convention and a Member of the WCPFC, the United States is obligated to implement the decisions of the WCPFC. The WCPFC Implementation Act (16 U.S.C. 6901et seq.), authorizes the Secretary of Commerce, in consultation with the Secretary of State and the Secretary of the Department in which the United States Coast Guard is operating (currently the Department of Homeland Security), to promulgate such regulations as may be necessary to carry out the obligations of the United States under the Convention, including the decisions of the WCPFC. The Secretary of Commerce has delegated the authority to promulgate regulations to NMFS.

At its Fifth Regular Session, in December 2008, the WCPFC adopted CMM 2008-01. The CMM, available with other decisions of the WCPFC athttp://www.wcpfc.int/decisions.htm,places certain obligations on the WCPFC Members, Participating Territories, and Cooperating Non-members (collectively, CCMs). The CMM was based in part on the findings by the WCPFC that the stock of bigeye tuna (Thunnus obesus) in the WCPO was experiencing a fishingmortality rate greater than the rate associated with maximum sustainable yield and that the stock of yellowfin tuna (Thunnus albacares) in the WCPO was experiencing a fishing mortality rate close to the rate associated with maximum sustainable yield. The Convention calls for the WCPFC to adopt measures designed to maintain or restore stocks at levels capable of producing maximum sustainable yield, as qualified by relevant environmental and economic factors. Accordingly, the objectives of CMM 2008-01 include achieving, over the 2009-2011 period, a reduction in fishing mortality on bigeye tuna in the WCPO of at least 30 percent and no increase in fishing mortality on yellowfin tuna in the WCPO, relative to a specified historical baseline.

In 2009, NMFS issued regulations to implement the applicable provisions of CMM 2008-01, with one rule devoted to the purse seine-related provisions of the CMM (final rule published August 4, 2009; 74 FR 38544) and another rule devoted to the longline-related provisions (final rule published December 7, 2009; 74 FR 63999). The regulations for purse seine fishing are codified at 50 CFR 300.223(a)-(e) (paragraph (f), which addresses sea turtle take mitigation, is unaffected by this rulemaking and remains effective) and the regulations for longline fishing are codified at 50 CFR 300.224. In accordance with the effective dates of CMM 2008-01, these regulations apply through December 31, 2011.

The existing regulations for purse seine fishing include: (1) Specific limits on the number of fishing days that may be spent by the U.S. purse seine fleet on the high seas and in areas under U.S. jurisdiction (including the U.S. exclusive economic zone, or EEZ) within the Convention Area for each of: The one-year periods 2009, 2010, and 2011 (3,882 fishing days each); the two-year periods 2009-2010 and 2010-2011 (6,470 fishing days each); and the three-year period 2009-2011 (7,764 fishing days); (2) specific periods in each of the years 2009 (August-September), 2010 (July-September) and 2011 (July-September) during which U.S. fishing vessels are prohibited from setting purse seines around or within one nautical mile of fish aggregating devices (FADs), deploying FADs, or servicing FADs or their associated electronic equipment in the Convention Area; (3) two specific areas of high seas within the Convention Area in which U.S. purse seine vessels are prohibited from fishing, effective from January 1, 2010, through December 31, 2011; (4) a prohibition, which went into effect June 14, 2010, and continues through December 31, 2011, on U.S. purse seine fishing vessels from discarding at sea within the Convention Area any bigeye tuna, yellowfin tuna, or skipjack tuna (Katsuwonus pelamis), with certain exceptions; and (5) a requirement, effective August 1 through September 30, 2009, and from January 1, 2010, through December 31, 2011, that U.S. purse seine vessels carry a WCPFC observer on all trips in the Convention Area in the area between 20° N. latitude and 20° S. latitude, with certain exceptions.

The WCPFC was scheduled to hold its regular annual session in December 2011, and intended to discuss at that time CMM 2008-01, including whether to adopt the same or changed measures for 2012 and beyond. However, that session was postponed unexpectedly due to a fire at a major power plant and resulting power failures in Palau, where the meeting was scheduled to be held. The annual session is now tentatively scheduled to take place in March 2012. Because of the postponement of its regular annual session and the expiration of CMM 2008-01 at the end of 2011, the WCPFC made an intersessional decision on December 20, 2011, to extend the effectiveness of CMM 2008-01 until the WCPFC is able to hold its regular annual session. The decision specifies that those provisions of the CMM that are tied to specific years will continue to operate as they did in 2011 (e.g.,the dates of the FAD prohibition period for 2012 are the same as for 2011).

This interim rule implements, for purse seine fisheries, the decision of the WCPFC to extend the effectiveness of CMM 2008-01 past December 31, 2011. Specifically, it extends the applicable dates of the five elements of the existing implementing regulations for purse seine fishing, at 50 CFR 300.223(a)-(e), through December 31, 2012.

NMFS would implement the longline-related provisions of the WCPFC's recent decision to extend CMM 2008-01 in a separate rulemaking in early 2012. Implementation of the longline-related provisions of the extended CMM 2008-01 would need to take into account Section 113 of the recently enacted Consolidated and Further Continuing Appropriations Act, 2012 (Act), which could affect the way NMFS assigns catches in U.S. longline fisheries with respect to the catch limits. All other existing regulations for longline fishing remain in place and NMFS remains able to account for all catches.

This interim rule amends the existing regulations for purse seine fishing such that they apply in 2012 as follows:

Limits are established on the number of fishing days that may be spent by the U.S. purse seine fleet on the high seas and in areas under U.S. jurisdiction within the Convention Area for each of: 2012 (3,882 fishing days); the two-year period 2011-2012 (6,470 fishing days); and the three-year period 2010-2012 (7,764 fishing days). If one of the limits is reached and the fishery is closed with notice from NMFS, it will be prohibited to use a U.S. purse seine vessel to fish in the Convention Area on the high seas or in areas under U.S. jurisdiction until the end of the applicable period.

From July 1 through September 30, 2012, owners, operators, and crew of U.S. fishing vessels will be prohibited from setting a purse seine around a FAD or within one nautical mile of a FAD or deploying or servicing a FAD or its associated electronic equipment in the Convention Area. It will also be prohibited during this period to set a purse seine in a manner intended to capture fish that have aggregated in association with a FAD, such as by setting the purse seine in an area from which a FAD has been moved or removed within the previous eight hours or setting the purse seine in an area into which fish were drawn by a vessel from the vicinity of a FAD.

Two specific areas of high seas within the Convention Area are closed to purse seine fishing through December 31, 2012. The two areas are depicted on the map in Figure 1. Figure 1. High seas closed areas. Areas of high seas are indicated in white; areas of claimed national jurisdiction, including territorial seas, archipelagic waters, and exclusive economic zones, are indicated in dark shading. Areas closed to purse seine fishing through December 31, 2012, are all high seas areas (in white) within the two rectangles bounded by the bold black lines. The coordinates of the two rectangles are set forth in the regulation. This map displays indicative maritime boundaries only.

It is prohibited to discard any bigeye tuna, yellowfin tuna, or skipjack tuna from a U.S. purse seine vessel at sea within the Convention Area through December 31, 2012. Exceptions are provided for fish that are unfit for human consumption for reasons other than their size, for the last set of the trip if there is insufficient well space to accommodate the entire catch, and for cases of serious malfunction of equipment that necessitate that fish be discarded.

U.S. purse seine vessels must, through December 31, 2012, carry observers deployed as part of the WCPFC Regional Observer Programme (WCPFC ROP) or deployed by NMFS on all trips in the Convention Area. These observer requirements do not apply to fishing trips for which: the portion of the fishing trip within the Convention Area takes place entirely within areas under U.S. jurisdiction or entirely within areas under the jurisdiction of any other single nation; no fishing takes place in the Convention Area in the area between 20° N. latitude and 20° S. latitude; or NMFS has determined that an observer is not available.

These regulations are being issued without prior notice or public comment because of the unexpected postponement of this year's regular annual session of the WCPFC and its consequent intersessional decision to extend the effectiveness of CMM 2008-01. That decision, made December 20, 2011, allowed NMFS extremely limited time for implementation. In order to satisfy the international obligations of the United States as a Contracting Party to the Convention, NMFS must implement three of the five elements—the high seas closed areas, the catch retention requirements, and the observer coverage requirements—by January 1, 2012, or as soon as possible thereafter. NMFS believes it appropriate to include the remaining two elements, extension of the fishing effort limits and the FAD prohibition period, in this interim rule because these elements are directly related to the other three elements, and because their inclusion will provide the public with notice of how these two elements will apply in 2012. However, NMFS notes that any closure resulting from reaching one of the limits on fishing effort will go into effect only if and when one of the limits is reached in 2012, and that the FAD-related restrictions will be in effect from July 1, 2012, through September 30, 2012. NMFS will consider public comments on this interim rule and issue a final rule, as appropriate.

The WCPFC may make a binding decision at its anticipated annual session in early 2012 that would alter the extended provisions of CMM 2008-01 as they apply in 2012. NMFS would undertake another rulemaking, as appropriate, to implement that decision.

The NMFS Assistant Administrator has determined that this interim rule is consistent with the WCPFC Implementation Act and other applicable laws.

There is good cause under 5 U.S.C. 553(b)(B) to waive prior notice and prior opportunity for public comment on this action. This rule will continue regulations implemented under the authority of CMM 2008-01 and the WCPFC Implementation Act beyond the current expiration of December 31, 2011. Affected entities have been subject to these measures since 2009. The conditions prompting the regulations established in 2009 remain largely unchanged. However, the WCPFC did not decide to extend CMM 2008-01 until December 20, 2011. The decision was prompted by the unexpected postponement of the WCPFC annual session scheduled for December 2011. Thus, NMFS hadlimited notice of the need to implement the WCPFC decision to extend CMM 2008-01. In order to satisfy its international obligations under the Convention and ensure there is no gap, or as brief a gap as possible, in the application of important conservation measures for bigeye tuna and yellowfin tuna, NMFS must implement the provisions of the WCPFC's decision to extend the provisions of CMM 2008-01 applicable to purse seine fisheries by January 1, 2012, or as soon as possible thereafter. NMFS would not be able to do so if it provided opportunity for prior notice and prior public comment. Therefore, prior notice and prior opportunity for public comment on this action would be impracticable and contrary to the public interest.

There is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. As described above, NMFS had limited notice of the need to implement the WCPFC intersessional decision to extend CMM 2008-01. These measures are intended to reduce fishing pressure on bigeye tuna and yellowfin tuna in the WCPO in order to maintain or restore stocks at levels capable of producing maximum sustainable yield on a continuing basis. The conditions prompting the existing regulations remain largely unchanged, and failure to immediately extend those regulations consistent with the WCPFC intersessional decision while the WCPFC develops more lasting international conservation measures could result in excessive fishing pressure on these stocks, in violation of international and domestic obligations. Therefore, NMFS must implement the provisions of the WCPFC's decision to extend the provisions of CMM 2008-01 applicable to purse seine fisheries by January 1, 2012, or as soon as possible thereafter. NMFS would not be able to do so if it provided a 30-day delay in effective date. Therefore, compliance with the 30-day delay requirement would be impracticable and contrary to the public interest.

NMFS has determined that this rule will be implemented in a manner consistent, to the maximum extent practicable, with the enforceable policies of the approved coastal zone management programs of American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the State of Hawaii. This determination has been submitted for review by the responsible territorial and state agencies under section 307 of the CZMA.

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

This interim rule is an extension or a change in the period of effectiveness of a regulation that has been subject to prior analyses supporting a finding of no significant impact determination. As such, NMFS has determined that this action is categorically excluded from the need to prepare an Environmental Assessment or an Environmental Impact Statement, pursuant to NOAA Administrative Order 216-6, Section 6.03d.4(a).

This interim rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is issued without opportunity for prior public comment.

For the reasons set out in the preamble, 50 CFR part 300 is amended as follows:

The fisheries for CMP species; coral, coral reefs, and live/hard bottom habitats; pelagicSargassum;and snapper-grouper off the southern Atlantic states are managed under their respective FMPs. The FMPs were prepared by the Council(s) and are implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

On September 26, 2011, NMFS published a notice of availability for CE-BA 2 and requested public comment (76 FR 59371). On November 8, 2011, NMFS published a proposed rule for CE-BA 2 and requested public comment (76 FR 69230). The proposed rule and CE-BA 2 outline the rationale for the actions contained in this final rule. A summary of the actions implemented by this final rule are provided below.

This rule modifies the FMU for octocorals under the Coral FMP to include octocorals in the EEZ off North Carolina, South Carolina, and Georgia only. Federal management of octocorals in the EEZ off Florida is no longer included under the Coral FMP. Florida's Fish and Wildlife Conservation Commission (FWC) is currently responsible for the majority of the management, implementation, and enforcement of octocorals, because the majority of octocoral harvest occurs in Florida state waters. The FWC intends to extend management of octocorals into Federal waters off Florida.

This rule specifies an ACL of zero for octocorals in the South Atlantic EEZ. Prior to implementation of this final rule, a 50,000 colony quota for octocorals was in place in the Gulf of Mexico (Gulf) and South Atlantic regions and a prohibition was in effect to harvest octocorals north of Florida. Florida has implemented regulations compatible to the applicable Federal regulations, which allow the state octocoral fishery to close when the Federal quota is met. Because the majority of octocoral harvest occurs in state waters off Florida and the prohibition on the harvest of octocorals north of Florida would continue, the Council voted to remove octocorals off Florida from the FMU and establish an ACL of zero for octocorals off Georgia, South Carolina, and North Carolina.

This final rule limits the harvest and possession of South Atlantic snapper-grouper species and CMP species (with the use of all non-prohibited fishing gear) in the SMZs off South Carolina to the recreational bag limit. This rule prohibits fishermen from harvesting commercial quantities of snapper-grouper and CMP in these SMZs.

This final rule also modifies the sea turtle and smalltooth sawfish release gear requirements. The sea turtle and smalltooth sawfish release gear requirements are revised based on the freeboard height of the vessels to provide flexibility to fisherman based on their vessel characteristics.

CE-BA 2 also amends South Atlantic FMPs as needed to designate new EFH and EFH-HAPCs. CE-BA 2 amends the Snapper-Grouper FMP to designate deepwater marine protected areas (MPAs) as EFH-HAPCs. The Coral FMP is amended to designate deep-water coral HAPCs as EFH-HAPCs. To meet the Magnuson-Stevens Act requirement that all federally managed species have EFH designated, CE-BA 2 amends theSargassumFMP to designate the top 33 ft (10 m) of the water column in the South Atlantic EEZ bounded by the Gulf Stream, as EFH for pelagicSargassum.The addition of this information does not require any changes in regulatory language.

NMFS received two comment letters with a total of five separate comments, on CE-BA 2 and the proposed rule. One comment letter was in support of the actions in CE-BA 2. The other comment letter, from an industry group, restated their previous recommendations made to the Council regarding the actions in CE-BA 2. Comments related to the actions contained in the amendment or the proposed rule are summarized and responded to below.

Comment 1:One commenter supports the actions to modify management in the SMZs of South Carolina, establish EFH-HAPCs for the snapper-grouper fishery, and establish EFH for theSargassumfishery.

Response:NMFS concurs and believes that these actions are consistent with the Magnuson-Stevens Act and CE-BA 2.

Comment 2:One commenter supports retaining Florida octocorals in the FMU, the 50,000 colony octocoral quota, and extending octocoral management into the Gulf.

Response:The commenter did not provide any rationale for the recommendations submitted, and the comments were previously submitted to the Council before the current preferred alternatives were selected. The Council recommended revising the FMU for the Coral FMP to include only octocorals off Georgia, North Carolina, and South Carolina because the need for Federal conservation and management off Florida no longer exists. The FWC is responsible for most of the management, implementation, and enforcement of octocorals because the majority of the harvest occurs in Florida state waters, and the Federal quota has never been reached. In a letter dated April 11, 2011, the FWC describes octocoralmanagement measures it would implement if the Federal FMU is modified to remove the octocorals off Florida. According to the FWC letter, the FWC intends to extend Florida octocoral regulations into the Federal waters off Florida (Gulf and South Atlantic), to establish an annual quota of 70,000 colonies for allowable octocoral harvest in state and Federal waters combined off Florida, and to prohibit the harvest of octocorals in Florida waters north of Cape Canaveral, Florida and in the Coral HAPCs off Florida. The Gulf Fishery Management Council has also recommended removing octocorals in the Gulf off Florida from their FMU within the FMP for Coral and Coral Reefs of the Gulf for consistency of management.

In addition, the Council recommended the establishment of an ACL equal to zero for octocorals off South Carolina, North Carolina, and Georgia in the revised FMU. Functionally, this would not have any impact on active octocoral harvesters as there has been a prohibition on octocoral harvest north of Cape Canaveral, Florida since 1995. Under this scenario, management of octocorals off Florida would continue to be managed by the FWC.

Comment 3:One commenter recommended that the Council select Alternative 5, which modifies the design specifications of the current sea turtle release gear requirements to allow for more appropriate gear with respect to the lighter tackle used by snapper-grouper fishermen.

Response:The Council selected Alternative 4, and associated sub-alternatives 4a and 4b as the Preferred Alternative for the action to have the sea turtle release gear requirements dependent on vessel freeboard height, to accommodate both smaller vessels using lighter tackle to harvest snapper-grouper species (vessels with a freeboard height of 4 ft (1.2 m) or less) and larger vessels using heavier gear (vessels with a freeboard height of 4 ft (1.2 m) or more). This Preferred Alternative is consistent with the requirements of the June 7, 2006, Biological Opinion on the Snapper-Grouper Fishery and responds to the concerns of fishermen that sea turtle handling gear are unwieldy and inappropriate for all vessel sizes. While Alternative 5, and associated sub-alternatives, may also be consistent with the biological opinion, the Council sought to maximize biological benefits by allowing sea turtle release gear that is more appropriate to a particular vessel. Alternative 4, and associated sub-alternatives, is also consistent with sea turtle release gear requirements in the Gulf, and simplifies requirements for fishermen participating in both fisheries.

Comment 4:One commenter supports the alternative that would not designate new EFH-HAPCs in the Coral FMP and would allow the existing designations to remain in effect.

Response:The commenter provided no rationale for its recommendation. The establishment of EFH and EFH-HAPCs requires that further consideration be given to fishing and non-fishing activities that occur in these areas. However, in itself, the establishment of EFH and EFH-HAPCs does not modify Federal fishery regulations in any way. The Council and NMFS also expect that the establishment of the EFH and EFH-HAPCs will benefit ocean and coastal habitats in the future through the EFH consultation process. Through that process, the Council will be in a better position to evaluate whether further protections are necessary.

Comment 5:One commenter does not support the establishment of EFH-HAPCs forSargassum.

Response:In March 2011, the Council decided to remove this action from consideration within CE-BA 2 because the areas proposed for this designation (the Charleston Bump Complex, and The Point, NC) were already designated as EFH-HAPCs for snapper-grouper and dolphin and wahoo, and conservation of these specific EFH-HAPCs would be addressed through actions associated with EFH consultations pertaining to existing EFH-HAPC designations. Therefore, EFH forSargassumis designated as the top 33 ft (10 m) of the water column in the South Atlantic EEZ bounded by the Gulfstream, but no EFH-HAPCs were designated forSargassumin CE-BA 2.

The Regional Administrator, Southeast Region, NMFS has determined that this final rule is necessary for the conservation and management of the species within CE-BA 2 and is consistent with the Magnuson-Stevens Act, and other applicable law.

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

NMFS prepared an IRFA for the proposed rule that described the economic impact of the rule. As described in the IRFA, the only action in this rule that may have any direct adverse economic effect on the profits of any small entities is the limitation on harvest of snapper-grouper and CMP species in the SMZs off South Carolina to the recreational bag limit. Because data on the number of commercial vessels that fish in these SMZs, and the associated harvest, is not available at sufficient spatial resolution to quantitatively assess the impacts of the action, it is not possible to determine if the reduction in profits for any small entities would be significant. However, based on tabulation of the number of appropriate commercial permits in nearby coastal areas, the IRFA determined that the number of affected vessels would encompass at most approximately 4 percent of South Atlantic vessels with king mackerel permits, 2 percent of South Atlantic vessels with Spanish mackerel permits (king mackerel and Spanish mackerel permits allow fishing in both the Gulf and South Atlantic and, because of the narrow geographic applicability this action, only counts for permits with homeport addresses in the South Atlantic were included in the assessment), and 9 percent of vessels with snapper-grouper permits. Additionally, because the problem of commercial harvest in the SMZs is believed to be mostly limited to vessels using spear gear (hand spear or spear guns), which is not the dominant gear type used to harvest these species, substantially fewer vessels than these maximum amounts would be expected to be affected. As a result, only a small number of vessels in the CMP and snapper-grouper fleets would be expected to be directly affected by this rule. Because of this finding, the IRFA concluded that the actions in this rule would not be expected to significantly reduce profits for a substantial number of small entities. Nevertheless, because of the lack of data on vessels that historically harvest commercial quantities of these species from these areas, public comment was requested on this determination and a certification was not prepared. No comments were received regarding the determination. Therefore, NMFS concluded that the determination was correct and the Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration at this stage in the rulemaking that this action will not have a significant economic impact on a substantial number of small entities. As a result, a final regulatory flexibility analysis was not required and none was prepared.

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

Specifications General Specification Background

Fishery specifications include various catch and landing subdivisions, including the commercial and recreational sector annual catch limits (ACLs), annual catch targets (ACTs), sector-specific landing limits, (i.e.,the commercial fishery quota and recreational harvest limit) and research set-aside (RSA) established for the upcoming fishing year. An explanation of each subdivision appears later in this rule.

Rulemaking for measures used to manage the recreational fisheries for these three species occurs separately and typically takes place in the first quarter of the fishing year. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and its implementing regulations outline the Council's process for establishing specifications. Implementing regulations for these fisheries are found at 50 CFR part 648, subpart A (General Provisions), subpart G (summer flounder), subpart H (scup), and subpart I (black sea bass).

The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass fisheries. The management units specified in the FMP include summer flounder (Paralichthys dentatus) in U.S. waters of the Atlantic Ocean from the southern border of North Carolina northward to the U.S./Canada border, and scup (Stenotomus chrysops) and black sea bass (Centropristis striata) in U.S. waters of the Atlantic Ocean from 35°13.3′ N. lat. (the latitude of Cape Hatteras Lighthouse, Buxton, NC) northward to the U.S./Canada border.

All requirements of the Magnuson-Stevens Fishery Conservation andManagement Act (MSA), including the 10 national standards, also apply to specifications.

In a typical year, the Council's Scientific and Statistical Committee (SSC) reviews updated stock assessment information in July as the starting point in the specifications process. The specification process also allows changes to a select number of management measures such as commercial minimum fish size and minimum trawl net mesh sizes. The Council convenes in August to make specification recommendations to NMFS. NMFS reviews these recommendations for consistency with applicable law and other requirements before proceeding to implement the measures via notice-and-comment rulemaking. The rulemaking process usually takes place from October-December. Final specifications are typically in place on or about January 1, as this is both the start of the fishing year, and the annual date NMFS has used to implement the requirement specified in a 1997 Court order (North Carolina Fisheries Assoc. Inc. et al.v.DaleyCivil NO. 2:97cv339 (RGD)) directing the agency to finalize each year's fishing quota within a reasonable period of time.

For the 2012 summer flounder, scup, and black sea bass specifications, the rulemaking process has encountered some complications. As usual, the SSC and Council met in July and August, respectively, and conveyed recommendations to NMFS for review, rulemaking, and implementation. The Council then provided its recommendation and supporting analyses to NMFS in late September. While NMFS was reviewing the Council's recommendations and preparing a proposed rule, the Northeast Fisheries Science Center (NEFSC) published new assessment information for both summer flounder and scup. These assessment updates presented different results regarding the status of both stocks from the information available to the Council in August. Specifically, the new assessments concluded that the 2012 specification recommendations from the Council could result in overfishing of summer flounder and scup, and that summer flounder could be subject to overfishing during 2011 if the catch approaches the established allowance for this year. The updated stock assessment did provide verification that the summer flounder stock was rebuilt in 2010, ending the rebuilding program that had been in place since 2000.

The SSC and Council met December 14, 2011, to reconsider the new assessment information and will provide revised recommendations to NMFS. The Council voted to recommend specifications based on the new summer flounder and scup assessment information at this meeting. The Council will be forwarding recommendations to NMFS to implement revised summer flounder and scup specifications. The exact timing and process for this resubmission of recommendations is unclear; however, it is clear that it would not be possible to implement the Council's revised specifications for summer flounder, scup, and black sea bass by the start of the 2012 fishing year on January 1.

In response to these complications that have impaired the normal timing and process, NMFS is implementing interim measures consistent with the new stock assessments to ensure specifications that prevent overfishing and that apply the best available science are in place on January 1, 2012. NMFS is soliciting comment on these interim measures and may adjust, as needed, the final 2012 specifications based on Council recommendations and public comment on the interim measures. NMFS notes that the Council recommendations from the December meeting were for the same summer flounder and scup ACLs and ACTs being implemented by this interim rule. The black sea bass measures of this interim rule are consistent with the Council's recommendations from its August 2011 meeting.

If NMFS had not implemented interim measures, no quotas for summer flounder, scup, or black sea bass would be in place on January 1, 2012. There are no quota rollover provisions for these species, so inaction would result in no quotas being in place for the start of the 2012 fishing year. This result would be inconsistent with the MSA, the FMP, the standing Court order, and would cause additional, substantial complications for all those involved in fishing for or managing summer flounder, scup, and black sea bass.

NMFS developed these interim specifications for summer flounder and scup using the updated assessment information for both species and by applying the same calculations used by the SSC, Monitoring Committees, and the Council. Both species' stock assessments were categorized as Level 3 under the ABC Control Rules at 50 CFR 648.20. Assessments categorized at this level are judged by the SSC to over- or underestimate the accuracy of the Overfishing Limit (OFL). NMFS replicated the SSC's ABC derivation approach using an assumed coefficient of variance of the Overfishing Limit (OFL) with a lognormal distribution of 100 percent. NMFS also determined the biomass ratio (biomass(B)/BMAXIMUM SUSTAINABLE YIELD (MSY)) based on the 2012 stock projections, categorized both species as having a typical life history, and applied the Council's risk policy (P*= risk of overfishing the stock) as described in § 648.21. These approaches are the same used by the SSC and Council. The Monitoring Committees did not recommend to the Council any reduction from the ACL to ACT to address management uncertainty for summer flounder and scup. NMFS also adopted this approach in deriving summer flounder and scup ACTs based on the updated stock assessment information. Thus, there is no offset between ACL and ACT to address management uncertainty in these interim specifications for summer flounder and scup. More detail is provided in the following sections.

The updated stock assessment OFL is 31,588,000 lb (14,328 mt). This amount represents a 28-percent reduction from the OFL of 43.89 million lb (19,908 mt) provided in the July 2011, stock projection information. The projected 2012 spawning stock biomass (SSB) is 134,667,008 lb (61,084 mt), above the SSBMSYlevel of 132,440,000 lb (60,074 mt). Thus, the B/BMSYratio is 1.01. Applying the Council's risk policy results in an overfishing risk tolerance (P*) of 0.40, or a 40-percent risk of overfishing the summer flounder stock. Using this information, the resulting ABC is 25,581,054 lb (11,603 mt), which is a 28-percent reduction from the Council's original recommendation submitted to NMFS in September, and a 25-percent reduction from the 2011 ABC. This ABC is 81 percent of the OFL (i.e.,scientific uncertainty offset is a 19-percent reduction from OFL).

Consistent with § 648.102(a), for summer flounder, the sum of the recreational and commercial sector ACLs is equal to ABC. ACL is an expression of total catch (i.e.,landings and dead discarded fish). To derive the ACLs, NMFS used the methods developed by the Council: The sum of the sector-specific estimated discards is removed from the ABC to derive the landing allowance. The resulting landing allowance is apportioned to the commercial and recreational sectors by applying the FMP allocation criteria: 60 percent to the commercial fishery and40 percent to the recreational fishery. Using this method ensures that each sector is accountable for its respective discards, rather than simply apportioning the ABC by the allocation percentages to derive the sector ACLs. This means that the derived ACLs are not split exactly at 60/40; however, the landing portions of the ACLs do preserve the 60/40 allocation split, consistent with the FMP. The NMFS-derived commercial ACL is 14,002,000 lb (6,351 mt); the recreational ACL is 11,579,000 lb (5,252 mt).

As previously mentioned, NMFS is adopting the Council's recommended approach for 2012 and did not reduce ACT from the ACL for the interim summer flounder specifications. Thus, the sector ACTs are equal to the sector ACLs, and management uncertainty is assumed to be zero. The estimated sector-specific commercial discards for summer flounder total 459,000 lb (208 mt), which, when removed from the commercial ACT, results in a commercial quota of 13,136,000 lb (5,958 mt). Sector-specific recreational discards estimated for 2012 are 2,550,000 lb (1,157 mt), resulting in a recreational harvest limit (i.e.,recreational landing quota) of 8,758,000 lb (3,973 mt). Consistent with the FMP and the Council's previous recommendation, up to 3 percent of the total landing allowances may be set aside for research; 3 percent of the recalculated landings in this interim rule is 677,128 lb (307 mt). This amount has been preliminarily awarded through the grant award process for 2012.

As stated previously, the timing and change in information resulting from the updated stock assessments leaves no option except implementing interim measures to ensure some summer flounder catch constraints are in place at the start of the fishing year. The Council's previous catch quota recommendation for summer flounder was inconsistent with the MSA and FMP, as overfishing would result if those catch levels were fully attained in 2012. NMFS will review the Council's revised recommendation and public input on the interim measures, and may adjust the interim measures through a final rule in early 2012.

Table 1 presents the interim allocations of summer flounder by state with and without the commercial portion of the RSA deduction. Consistent with the revised quota setting procedures for the FMP (67 FR 6877, February 14, 2002), summer flounder overages are determined based upon landings for the period January-October 2011, plus any previously unaccounted-for overages from January-December 2010. Table 1 summarizes, for each state, the commercial summer flounder percent shares as outlined in § 600.102(c)(1)(i), the resultant 2011 commercial quota (both initial and less the RSA), the quota overages as described above, and the final adjusted 2011 commercial quota, less the RSA. Delaware and New York both have overages requiring reduction of their 2012 state commercial quota allocations. For New York, the overage was from 2010 and not previously accounted for in the 2011 specifications rulemaking. The Delaware overage is explained in the next section.

In 2007, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) was reauthorized to require that fishery management councils establish a mechanism for specifying annual catch limits (ACLs) for each managed fishery such that overfishing does not occur in the fishery. The reauthorized Magnuson-Stevens Act also required that FMPs include measures to ensure accountability in case ACLs were exceeded, and to prevent future overages from occurring. The final rule implementing Amendment 16 to the NE Multispecies FMP (April 9, 2010, 75 FR 18262) established a process to set and distribute ACLs among the various components of the fishery that catch regulated NE multispecies and ocean pout (also known as groundfish) stocks. Amendment 16 also established accountability measures (AMs) that would be implemented if any ACL is exceeded during a particular fishing year (FY).

The recreational groundfish fishery consists of anglers on private recreational and charter/party vessels. This fishery is responsible for nearly 30 percent of haddock catch in the Gulf of Maine (GOM) in recent years. Accordingly, Amendment 16 allocated the recreational fishery 27.5 percent of the GOM haddock ACL available to the groundfish fishery. Amendment 16 also specified that if the sub-ACL allocated to the recreational fishery is exceeded, the Regional Administrator must implement the appropriate AMs in the subsequent FY to address the overage and prevent such an overage from occurring in the future following consultation with the New England Fishery Management Council (Council). The recreational AM may include adjustments to season, minimum fish size, or possession limits. Separate AMs may be specified for the private boat and charter/party components of the recreational fishery. Due to the availability of recreational catch data, Amendment 16 anticipated that an overage would be implemented by January of the FY following the overage, and may remain in effect for an undefined period of time.

In FY 2010, the recreational fishery was allocated 324 mt of GOM haddock as part of Framework Adjustment 44 to the FMP (April 9, 2010, 75 FR 18356). Based on available information, NMFS has determined that the recreational fishery caught 396.3 mt of GOM haddock during FY 2010. This represents an overage of 72.3 mt, or 22.3 percent. In November 2011, NMFS consulted with the Council and its Recreational Advisory Panel to seek input on the appropriate AMs to address this overage. The Recreational Advisory Panel recommended that NMFS implement increases in the GOM haddock size limit to address the overage, while the Council recommended that NMFS consider a possession limit first, adjustments to the current minimize fish size second, and additional closed seasons last in developing recreational AMs to address the overage.

This interim final rule implements a 9-fish possession limit (a reduction, as previously there was no constraint on possession) and increases the minimum fish size for haddock caught in the GOM Regulated Mesh Area from 18 inches (45.72 cm) to 19 inches (48.26 cm) total length. These measures will remain in effect until changed in a future action. Based on the flexibility provided in Amendment 16, as codified at § 648.89(f), the effective period of such measures could be modified through notice consistent with the Administrative Procedure Act if it is determined that such measures are not necessary to prevent overfishing or ensure that a similar overage does not occur during future FYs. NMFS is specifically interested in public input regarding the duration necessary for these measures.

The AMs implemented by this action were selected because they are expected to achieve the necessary fishing mortality reduction due to the overage of the FY 2010 sub-ACL for this stock, reflect the Council's general preference for recreational AMs, are similar to measures in place for this stock until recently, and could be implemented in a timely manner. For example, a 10-fish possession limit was in effect for GOM haddock until 2004, and the minimum size limit for GOM haddock was only recently reduced from 19 inches (48.26 cm) to 18 inches (45.7 cm) in 2009. Because these AMs have already been analyzed under the Amendment 16 FEIS, no additional analysis is necessary for such measures. This minimizes unnecessary delays in implementing this action. Implementation of these measures in a timely manner is critical to enabling charter/party operations to finalize business plans and advertising strategies as quickly as possible.

These AMs conflict with the Recreational Advisory Panel's recommendation to address the 2010 overage using only increases in size limits. However, during the discussion at the Recreational Advisory Panel, private anglers supported possession limits in conjunction with an increased size limit as an acceptable AM, despite opposition from charter/party vessel operators.

The 9-fish possession limit and 19-inch (48.26 cm) minimum size limit for GOM haddock were originally considered during the development of Amendment 16 as one of several options designed to reduce the fishing mortality rate (F) on GOM haddock by the recreational fishery. Amendment 16considered such measures in the context of effort reductions that would have been necessary if other options to distribute the GOM haddock ACL between the commercial and recreational groundfish fisheries were adopted by the Council. However, such measures can also be used to reduce recreational catch as part of AMs, as described in this action.

The biological and economic impacts of the AMs implemented by this action were analyzed in Section 7.2.2.3.2.3 and 7.5.2.3.2.3 of the Amendment 16 FEIS, respectively. The F reduction resulting from the measures implemented by this action is nearly identical to the amount of overage of the GOM haddock sub-ACL during FY 2010 (22.3 percent), and is expected to result in the necessary reduction in catch once implemented.

The Amendment 16 analysis does not quantify the precise economic impacts of these measures, but indicates that a 9-fish possession limit and a 19-inch (48.26 cm) minimum fish size may result in greater negative economic impacts than increasing the minimum fish size to 21 inches (53.34 cm) to reduce recreational catch of GOM haddock, and less economic impacts than implementing a 7-fish possession limit and an 18-inch (45.72 cm) minimum fish size. The analysis notes that anglers likely prefer options that focus on maintaining a higher possession limit because of the reliance upon high possession limits to attract customers for charter/party trips. However, it was suggested that because haddock do not grow as large as cod, exclusive reliance upon size limits to achieve the necessary F reductions for GOM haddock may reduce the probability of catching and being able to keep a legal-sized fish to such an extent that anglers may prefer a lower possession limit to a higher size limit.

The Administrator, Northeast Region, NMFS, determined that the management measures implemented by this interim final rule are necessary for the conservation and management of the NE multispecies fishery, and that they are consistent with the Magnuson-Stevens Act and other applicable law.

There is good cause under 5 U.S.C. 553(b)(3)(B) and (d)(3) to waive prior notice and opportunity for public comment, and the 30-day delay in effective date, respectively, for the measures implemented by this interim final rule because such a delay would be impracticable and contrary to the public interest. This interim final rule is necessary to implement AMs to address an overage of the FY 2010 GOM haddock sub-ACL by the recreational groundfish fishery and prevent a similar overage from occurring in the future. Data available to estimate the recreational catch of GOM haddock come from the Marine Recreational Fisheries Statistics Survey (MRFSS), a telephone and shore-side intercept survey of fishing effort and angler catch. This process results in “waves” (a 2-month period) of data that estimate catch throughout the year. Catch data through the end of a particular FY (April of each year) are only available in June or July. These data must then be analyzed based on the distribution of anglers and fishing effort to estimate the catch of haddock in the GOM and on Georges Bank, the two stocks of haddock managed under the FMP. An estimate of the recreational catch of GOM haddock during FY 2010 (May 2010-April 2011) was made available to NMFS and the Council just before the September Council meeting. However, because the issue was not on the published Council agenda and there was no information available on which to base potential AMs at the time of the meeting, the Council did not offer recommendations about the appropriate AMs to address the FY 2010 overage by the recreational fishery. Further, there were substantial concerns raised by the Council about the accuracy of the recreational data, primarily because the existing MRFSS process is expected to be replaced in the near future by a more accurate and thorough process for estimating recreational catch. It is unclear at this time whether the updated methodology will result in different estimates of recreational catch of GOM haddock during FY 2010, or other years. As a result, it was not until November that the Council or its advisory bodies were able to discuss the recreational overage of the FY 2010 GOM haddock sub-ACL, and recommend appropriate AMs to NMFS, as required by the existing regulations. Thus, it was impracticable for NMFS to publish rulemaking soliciting public comment on appropriate AMs in the recreational fishery until first consulting with the Council at its November 15-17, 2011, meeting.

As noted above, this interim final rule immediately reduces fishing mortality on GOM haddock by the recreational fishery in order to address an overage of the FY 2010 recreational sub-ACL. This is important for preventing overfishing from occurring, as required in the Magnuson-Stevens Act, especially considering that the biomass for GOM haddock is expected to continue to decline over the next few years. The recreational fishing season, particularly for charter/party vessels, begins in earnest in March and April of each year. Charter/party operations advertise and try to book fishing trips prior to the start of the fishing season as part of their yearly business plans. As a result, it is important to implement recreational AMs in a timely manner and before the recreational fishing begins to not only increase the effectiveness of such measures at achieving desired F reductions in the recreational fishery, but also to enable charter/party vessel operators to effectively plan, advertise, and book trips for the upcoming fishing season. Delays in implementing recreational AMs to consider additional public input for the measures implemented by this action will only complicate business plans currently being developed by charter/party operations for the upcoming fishing season. Further, delays in implementing such measures could result in the AMs becoming effective midway into the spring recreational fishing season. This could result in unanticipated negative economic impacts to charter/party vessel operators and associated supporting businesses due to confusion in applicable regulations, changes to advertisements, and potentially cancelled trips. In addition, mid-season implementation may undermine compliance with such measures and reduce the effectiveness of the AMs and their benefits to the GOM haddock stock. If such measures are not effective at reducing recreational catch and, therefore, F on this stock, further measures may be necessary in the future to ensure that overfishing does not occur, as required by the Magnuson-Stevens Act. Therefore, it is contrary to the public interest to unnecessarily delay the implementation of such measures due to the potential biological and economic impacts that may result.

The measures implemented by this interim final rule have already been considered by the public as part of Amendment 16 to the FMP. During the development of Amendment 16, several public meetings were held in which these measures were discussed. Further, the public had an opportunity to comment on these measures as part of the public review of the notices of availability for both the Amendment 16 Draft Environmental Impact Statement (DEIS) and FEIS that were published in theFederal Registeron April 24, 2009 (74 FR 18705), and October 30, 2009 (74 FR 56194), respectively. During both comment periods, public comments were received concerning recreational measures considered in Amendment 16,including specific comments regarding the haddock minimum size limit and the recreational AMs. These comments were considered during the decision by the Council to adopt final measures in Amendment 16 (DEIS comments only), and by the Secretary in the partial approval of Amendment 16. Moreover, the public also had an opportunity to discuss such measures during the comment period for the proposed rule to implement measures adopted by the Council in Amendment 16 (December 31, 2009, 74 FR 69382). As noted above, NMFS consulted with the Council, the Groundfish Recreational Advisory Panel, and the Groundfish Oversight Committee at meetings in November 2011 to elicit their input into appropriate AMs to address the recreational fishery overage of the GOM haddock sub-ACL during FY 2010. During the Advisory Panel and Committee meetings, the measures implemented by this interim final rule were specifically discussed as potential AMs to address the overage. The public, including both private recreational anglers and charter/party vessel operators, provided input into their preference for AMs to address this overage during these meetings. Finally, additional public comment on these measures is being sought through the implementation of this action as an interim final rule.

Pursuant to the procedures established to implement section 6 of E.O. 12866, the Office of Management and Budget has initially determined that this interim rule is not significant.

This interim final rule does not contain policies with Federalism or “takings” implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.