Background

The phytosanitary treatment regulations contained in 7 CFR part 305 (referred to below as the regulations) set out the general requirements for performing treatments and certifying or approving treatment facilities for fruits, vegetables, and other articles to prevent the introduction or dissemination of plant pests or noxious weeds into or through the United States. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) administers these regulations.

The regulations in § 305.9 set out irradiation treatment requirements for imported regulated articles; regulated articles moved interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands; and regulated articles moved interstate from areas quarantined for certain pests of concern. In § 305.9, paragraph (a)(1) allows irradiation treatment facilities to be located in any State of the United States, except for the Southern States of Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, and Virginia. The regulations do allow irradiation facilities to be located at the maritime ports of Gulfport, MS, and Wilmington, NC, and the airport of Atlanta, GA.

The regulations in § 305.9 also allow for irradiation treatment of articles either prior to or after arrival in the United States, provided an APHIS-approved facility is available. The regulations in parts 318 and 319 allow the importation of certain fruits from India (mangoes), Mexico (guavas), Pakistan (mangoes), Thailand (litchis, longans, mangoes, mangosteens, pineapples, and rambutans), and Vietnam (dragon fruits), and the interstate movement of several fruits and vegetables from Hawaii, after they have received irradiation treatment. While the regulations in parts 318 and 319 provide that fruits and vegetables moving from Mexico, Pakistan, Vietnam, and Hawaii may receive irradiation at either the point of origin or upon arrival in the mainland United States, the regulations in part 319 require fruit from India and Thailand to be treated prior to arrival in the United States.

On September 29, 2011, we published in the Federal Register a proposal  1 (76 FR 60390-60395, Docket No. APHIS-2009-0100) to amend § 305.9 by establishing generic phytosanitary criteria to replace the current criteria for irradiation facilities at the maritime ports of Gulfport, MS, and Wilmington, NC, and the airport of Atlanta, GA, and to apply the proposed generic criteria to any new irradiation treatment facilities in the Southern States of the United States. Under these criteria, in conjunction with the current criteria for irradiation facilities not located in the Southern States, we proposed to allow new irradiation facilities to be established in all the Southern States for the treatment of regulated articles that are imported, moved interstate from Hawaii or U.S. territories, or moved interstate from areas quarantined for certain pests of concern. We also proposed to amend § 319.56-46 to allow for irradiation treatment of mangoes from India either prior to or after arrival in the United States and § 319.56-47 to allow for irradiation treatment of tropical fruits from Thailand either prior to or after arrival in the United States.

We solicited comments concerning our proposal for 60 days ending November 28, 2011. We received seven comments by that date. One comment consisted of 3,529 identical or nearly identical letters. The comments were from an advocacy group, a State department of agriculture, and private citizens. Two commenters expressed support for the proposed rule. The remaining comments are discussed below by topic.

Some commenters stated that irradiation is an inappropriate way to deal with the risk of plant pests in imported foods. One commenter generally opposed the use of irradiation as a phytosanitary measure. One commenter opposed the rule as no irradiation facilities have been built in the currently approved locations in Southern States.

Under the Plant Protection Act (7 U.S.C. 7701 et seq. ), regulated articles may be subject to remedial measures necessary to prevent the spread of plant pests. APHIS has determined that irradiation is an effective form of treatment against certain plant pests, and the regulations in 7 CFR part 305 provide for irradiation as a phytosanitary treatment for commodities or articles that require treatment prior to interstate movement or importation. Before approving irradiation as a treatment alternative for a specific pest, APHIS performs an evaluation to determine its effectiveness. As irradiation has been determined to be effective, there is no reason to deny importers the use of this treatment option.

Several commenters expressed concern about importing commodities into the United States prior to irradiation treatment, with one commenter indicating that Florida is a high-risk area for fruit flies and other invasive exotic pests. Another commenter stated that allowing irradiation facilities in Southern States would make it easier for pests to infest key agricultural States and expressed concern about the cost of containing and eradicating exotic pests. One commenter questioned why pest mitigation is not occurring prior to export and did not understand why the United States would perform this task for exporters.

As we indicated in the proposed rule, the regulations in § 305.9 allow for irradiation treatment of articles either prior to or after arrival in the United States, provided that an APHIS-approved facility is available. Articles may be treated in the United States instead of the exporting country for several reasons, including when the exporting country lacks the resources, technical expertise, or infrastructure to treat articles prior to export. The regulations require safeguards that have successfully prevented the introduction or dissemination of plant pests into or within the United States via the importation or interstate movement of irradiated articles since 1996, when irradiation was first used as a phytosanitary treatment. Based on our experience, we are confident that exporting countries have the ability to comply with all APHIS requirements and commodities from exporting countries can be safely treated in the United States.

APHIS recognizes that the Southern States have conditions favorable for the establishment of exotic fruit flies, and that is why we proposed additional safeguards for irradiation facilities in these States that go beyond the current requirements that apply to all irradiation facilities. These safeguards include the requirements that untreated articles may not be removed from their packaging prior to treatment under any circumstances, that refrigerated or air-conditioned conveyances must be used to transport regulated articles to the treatment facility, and that facilities have contingency plans for safely destroying or disposing of regulated articles if the facility was unable to properly treat a shipment. To help prevent establishment of pests in the unlikely event that they escape despite the required precautions, we will require trapping and other pest monitoring activities within 4 square miles of the facility to help prevent establishment of any escaped pests of concern. Those activities will be paid for by the facility. In addition, while APHIS monitors the treatment, the costs of treatment are the responsibility of the exporter or the importer, not APHIS.

APHIS will only approve a proposed facility if the Administrator determines that regulated articles can be safely transported to the facility from a port of entry or points of origin in the United States. We believe that the mitigations included in this final rule have proven effective in mitigating the risk associated with the importation of commodities into the United States, and thus will provide protection against the introduction or dissemination of pests of concern into the United States. In the environmental assessment (EA) that we prepared for the proposed rule, we evaluated the potential environmental effects from allowing untreated commodities to be transported into the Southern United States. In the EA, we determined that the mitigation measures included in this final rule are adequate to manage pest risks associated with amending the irradiation regulations and are expected to provide an effective level of phytosanitary protection.

Several commenters were concerned that the increased importation of commodities into the United States would have adverse economic effects on domestic producers. One commenter expressed concern that irradiation facilities are expensive and would increase the cost of food.

This rule does not authorize the importation of any additional fruits or vegetables, so it will not in and of itself lead to the increased importation of commodities. Any new imports would have to be authorized through our existing provisions in 7 CFR part 319. While the availability of additional treatment capacity in new areas might spur businesses to explore new or additional imports of articles, the PPA authorizes APHIS to consider plant pest risks when determining whether to allow new articles to be imported, rather than potential economic competition.

With respect to the costs of irradiation increasing the costs of food, the final rule does not add irradiation requirements for any commodity and therefore will not add any costs. We also note that in most cases a variety of phytosanitary treatments for a particular article will be available, so importers and marketers will choose the treatment option that makes the most sense to them from an economic and competitive standpoint. Products are unlikely to be imported unless their importation is economically feasible.

Many comments raised several issues that concern matters under the regulatory authority of other Federal agencies, not APHIS. We do not intend to reopen debate over matters that have been resolved through rulemaking by other agencies that have primary authority in these areas.

For example, one commenter suggested that irradiation facilities are unsafe and that workers may be exposed to dangerous levels of radiation. Many other commenters stated that USDA should not put consumers, U.S. farmers, and communities at risk by expanding the use of irradiation.

The Nuclear Regulatory Commission, the Occupational Safety and Health Administration, and the U.S. Department of Transportation have the primary regulatory responsibility for issues including irradiation facility construction, operation, employee and public safety, and transportation of radioisotopes. Their requirements in these areas were established through public rulemaking by the respective agencies. In § 305.9(b) of the final rule, we are requiring other agencies that have regulatory oversight and requirements regarding irradiation facilities to concur in writing with the establishment of the facility prior to APHIS approval. In our EA, we evaluated the potential environmental effects from irradiation facilities and found that, provided required safety standards and control procedures are adhered to, no impacts to the human environment are expected.

Many commenters expressed concern that irradiation will make foods unsafe to eat. Commenters also stated that irradiation would reduce the nutritional value of fruits and vegetables, particularly through vitamin depletion. One commenter stated that “many of the exporting countries will not have regulatory frameworks comparable to what U.S. producers are subjected to and irradiation will be used as a panacea to address those shortcomings.” One commenter stated that irradiation can be a cover-up for poor food handling practices and could also mask the effects of spoilage.

The Food and Drug Administration (FDA) has primary regulatory responsibility for ensuring that approved irradiation doses do not render foods unsafe to eat. In our EA, we discuss the safety of food that has been irradiated, finding that irradiation does not harm the nutritional value of food, nor does it make the food unsafe to eat or adversely affect the balance between microbial spoilage organisms and pathogenic organisms. Regulation of these matters, however, is outside the scope of the current rulemaking and outside the statutory authority of APHIS. We do note for the record the following information from the August 2000 report by the U.S. General Accounting Office (now known as the U.S. Government Accountability Office), “Food Irradiation: Available Research Indicates That Benefits Outweigh Risks” (GAO/RCED-00-217):

One commenter stated that the FDA has not been able to keep up with the volume of imports to ensure that they are safe for human consumption.

This matter is outside the scope of the current rulemaking and outside the statutory authority of APHIS. However, on this point we do note that the Food Safety Modernization Act was enacted on January 4, 2011, to enable FDA to better protect public health by strengthening the food safety system.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .

The final rule will benefit U.S. entities by clearly and transparently presenting the criteria that will govern the approval of additional irradiation facilities in the Southern United States, thereby facilitating their establishment. APHIS has not identified any costs associated with establishing the generic criteria for irradiation facility approval described in the rule.

Beyond helping to make the approval of future irradiation facilities in the Southern United States an efficient process, we do not anticipate that the criteria set forth in this rule will result in economic impacts on U.S. entities, large or small.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that providing generic criteria for new irradiation treatment facilities in the Southern States of the United States will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site. 2 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, Room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 690-2817 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT .

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0383.

The Animal and Plant Health Inspection Service is committed to compliance 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 information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

Accordingly, we are amending 7 CFR parts 305 and 319 as follows:

On June 13, 2012, we published in the Federal Register (77 FR 35542-35571, Docket No. 00-108-8) an interim final rule that will establish a herd certification program to control chronic wasting disease (CWD) in farmed or captive cervids in the United States. The interim final rule will be effective on August 13, 2012.

In the interim final rule, we requested comments specifically on our decision not to preempt State and local laws and regulations that are more restrictive than our regulations with respect to CWD, except any such laws or regulations that prohibit or further restrict the transit through a State of deer, elk, and moose that are otherwise eligible for interstate movement. That decision was discussed in section III of the Background section of the interim final rule, under the heading “APHIS' Decision Not to Preempt More Restrictive State Requirements on Farmed or Captive Cervids With Respect to CWD,” beginning on 77 FR 35545.

Comments on our decisions regarding preemption of State and local laws and regulations were required to be received on or before July 13, 2012. We are reopening the comment period on Docket No. 00-108-8 until August 13, 2012. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between July 14, 2012, and the date of this notice.

The interim final rule indicated that we will publish another document in the Federal Register after the comment period closes that will include a discussion of any comments we receive on our preemption policy and any amendments we are making to the rule. We still plan to do this. However, we have received comments on aspects of the interim final rule other than our preemption policy. While we will not address these comments in our document discussing our preemption policy, we will consider these comments to determine whether future rulemaking may be necessary, and we encourage commenters to address any aspect of the interim final rule that they wish to.

History

On Tuesday, February 21, 2012, the FAA published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to modify VOR Federal airways V-10, V-12, and V-508, in the vicinity of Olathe, KS (77 FR 9876), due to the planned decommissioning of the Johnson County VOR navigation aid. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. One positive comment from the Aircraft Owners and Pilots Association was received supporting the proposed action and no negative comments were received.

The NPRM referenced the planned decommissioning of the Johnson County VOR/DME navigation aid in the Summary, Background, and Proposal sections, in error. The FAA's planned decommissioning action is for the VOR portion of the Johnson County VOR/DME navigation aid only. The DME equipment will remain in service.

Subsequent to the ending of the comment period, the proposed action to establish the WETZL fix in the same geographic location as the decommissioned Johnson County VOR, and use it to replace the VOR in the V-10 and V-12 airway descriptions, was changed to using the DODSN fix already established on the airways. The FAA took this action based on the airways not passing flight check at multiple altitudes from 4,000 feet MSL to 15,000 feet MSL due to the lack of extended service volume issues at WETZL fix. The effect of this change on the existing V-10 and V-12 airways is negligible; requiring a one-degree correction to the Napoleon, MO, navigation aid radial used to describe the fix's location from what was proposed in the NPRM. The corrected Napoleon, MO, radial information is changed from “Napoleon, MO, 242°(T)/235°(M) radial” to “Napoleon, MO, 243°(T)/236°(M) radial.” Only the true radial information is published in this rule.

With the exception of minor editorial changes and the changes noted above, this amendment is the same as that proposed in the NPRM.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying V-10, V-12, and V-508 in the vicinity of Olathe, KS, due to the planned decommissioning of the OJC VOR in July 2012.

To retain the airway structure of V-10 and V-12 in the vicinity of Olathe, KS, the DODSN fix (described by the intersection of Emporia, KS, and Napoleon, MO, navigation aid radials), replaces the OJC VOR in the airway descriptions. Specifically, the amended V-10 and V-12 airway descriptions replace the “Johnson County, KS” reference with “INT Emporia 063° and Napoleon, MO, 243° radials”.

The amended V-508 now terminates at the existing RUGBB fix (described by the intersection of Topeka, KS, and Kansas City, MO, navigation aid radials). Ending V-508 at the RUGBB fix retains the capability for eastbound aircraft to continue to destinations further east or northeast via transition from V-508 to V-502.

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

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 modifies VOR Federal airways in the vicinity of Olathe, KS.

The FAA has determined that this action is categorically excluded from further environmental documentation according to FAA Order 1050.1E, paragraphs 311a. The implementation of this action will not result in any extraordinary circumstances in accordance with paragraph 304 of Order 1050.1E.

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

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

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

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

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

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

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

NMFS manages the groundfish fisheries in the U.S. exclusive economic zone of the GOA under the Fishery Management Plan for Groundfish of the GOA (FMP). The North Pacific Fishery Management Council (Council) prepared, and NMFS approved, the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the FMP appear at 50 CFR parts 600 and 679.

The Notice of Availability for Amendment 93 was published in the Federal Register on November 23, 2011 (76 FR 72384), with a 60-day comment period that ended January 23, 2012. The Secretary of Commerce (Secretary) approved Amendment 93 on February 17, 2012. The proposed rule to implement Amendment 93 was published in the Federal Register on December 14, 2011 (76 FR 77757). The 45-day comment period on the proposed rule ended January 30, 2012. NMFS received written comments on Amendment 93 and the proposed rule from four different entities. After considering these comments, the Secretary of Commerce approved Amendment 93 on February 17, 2012. A summary of these comments and the responses by NMFS are provided under Response to Comments below.

The preamble to the proposed rule provides a detailed description of the reasons for and provisions of Amendment 93 and its implementing rule (76 FR 77757, December 14, 2011). The proposed rule is available from the NMFS Alaska Region Web site (see ADDRESSES ). This final rule makes the following regulatory amendments to the management of the directed pollock trawl fisheries in the Central and Western GOA to reduce Chinook salmon bycatch and to the PSD program.

This final rule adds prohibitions under § 679.7(b)(8) to specify when salmon must be retained and discarded in the Central and Western GOA directed pollock fisheries. The final rule adds paragraph (b)(8) to expressly prohibit any action that does not comply with the regulations described below for § 679.21(h). This is necessary to expressly inform participants in the pollock trawl fisheries in the Central and Western GOA that except for salmon under the PSD program at § 679.26, all salmon must be discarded, following notification by an observer that the number of salmon has been estimated and the collection of scientific data or biological samples has been completed.

The final rule revises PSC management measures under § 679.21 to establish Chinook salmon PSC limits and management measures for directed pollock trawl fishing in the Central and Western Reporting Areas of the GOA. The final rule revises paragraph (b)(2)(ii) to add an exception for salmon PSC caught by vessels directed fishing for pollock with trawl gear in the Central and Western GOA to the requirement to immediately sort catch and return salmon PSC to the sea. The final rule also revises paragraph (b)(2)(ii) to clarify that the requirement to immediately sort catch and discard PSC does not apply to PSC that may be retained pursuant to a permit issued under the PSD program. This clarification is necessary to ensure participants in the PSD program may retain salmon for donation purposes and to facilitate observer sampling and counting of all salmon. The final rule revises paragraph (b)(3) to limit the scope of the rebuttable presumption regarding PSC retained on board that was previously in place. As revised, paragraph (b)(3) does not establish a rebuttable presumption that any salmon retained on board during a directed pollock fishery in the Central or Western GOA was caught and retained in violation of § 679.21. This change is necessary to ensure that vessels that comply with the requirement to retain salmon are not presumed to violate § 679.21. In addition, this change maintains the existing rebuttable presumption that any Chinook salmon retained on board during a directed pollock fishery in the GOA outside of the Western and Central reporting areas was caught and retained in violation of this section.

The final rule adds PSC management measures under § 679.21(h) to establish Chinook salmon PSC limits for the pollock trawl fisheries in the Central and Western GOA. Paragraph (h)(1) specifies that the regulations in this paragraph apply to federally permitted vessels directed fishing for pollock in the Central and Western GOA reporting areas and processors taking deliveries from such vessels. Paragraph (h)(2) establishes GOA Chinook salmon PSC limits. Paragraph (h)(2)(i) specifies an annual PSC limit of 18,316 Chinook salmon for vessels engaged in directed fishing for pollock in the Central reporting area of the GOA. Paragraph (h)(2)(ii) specifies an annual limit of 6,684 Chinook salmon for vessels engaged in directed fishing for pollock in the Western reporting area of the GOA. Paragraph (h)(3) sets Chinook salmon PSC limits and allocations for the Central and Western GOA pollock fisheries during the C and D seasons in 2012. The 2012 PSC limits are effective until November 1, 2012. Paragraphs (h)(3)(i) and (ii) specify a PSC limit of 8,929 Chinook salmon for vessels engaged in directed fishing for pollock in the Central reporting area of the GOA for the C and D seasons in 2012, and a PSC limit of 5,598 Chinook salmon for vessels engaged in directed fishing for pollock in the Western reporting area of the GOA for the C and D seasons in 2012. These revisions are necessary to establish the annual Chinook salmon PSC limits and the 2012 C and D season limits recommended by the Council and approved by the Secretary.

Paragraph (h)(4) of § 679.21 requires temporary salmon retention in the Central and Western GOA directed pollock fisheries. The operator of a vessel and the manager of a shoreside processor or stationary floating processor may not discard any salmon or transfer or process any salmon under the PSD program at § 679.26, if the salmon are taken incidental to a Central or Western GOA directed pollock fishery, until after an observer at the processing facility has been provided the opportunity to count the number of salmon and to collect any scientific data or biological samples from the salmon.

Paragraph (h)(5) of § 679.21 requires that all salmon, except for salmon donated pursuant to the PSD program at § 679.26, must be discarded following notification by an observer that the number of salmon has been estimated and the collection of scientific data or biological samples has been completed. This requirement is necessary to ensure observers are provided the opportunity to count salmon and to take biological samples, and to ensure that the salmon not donated is discarded, as required of all PSC.

Paragraph (h)(6) of § 679.21 establishes Chinook salmon PSC closure management. NMFS would close pollock fisheries using trawl gear if, during the fishing year, the Regional Administrator determines that vessels engaged in directed fishing for pollock in the Central or Western GOA will catch all the Chinook salmon PSC limit specified for that area. NMFS will publish a notice in the Federal Register closing the applicable regulatory area to directed fishing for pollock. This step is necessary to allow NMFS to manage area closures for the pollock fisheries in the Central and Western Regulatory Areas of the GOA based on Chinook salmon PSC reaching the Chinook salmon PSC limits for the Central and Western Reporting Areas. The State of Alaska will manage the closure of the State waters parallel pollock fishery.

This final rule revises § 679.26(c)(1) reporting and recordkeeping requirements for the PSD program to add the Central and Western GOA pollock fisheries and to ensure observer sampling of donated fish. This is necessary to facilitate the counting and biological sampling of donated salmon and to ensure NMFS applies the Chinook salmon donated to the PSD program to the PSC limits.

In addition, this final rule modifies the PSD program regulations to implement the intent of the program to allow participation by all types of near shore, stationary processors for halibut donations. Paragraph (a)(2) of § 679.26 is revised to include stationary floating processors as eligible to receive and process donated halibut. Stationary floating processors are generally located near shore and remain in one location and are therefore similar to a shoreside processor for purposes of the halibut donation program. This revision is necessary to meet the Council's intent under Amendment 50 to the GOA FMP that halibut that cannot be sorted at sea and delivered to a processor located in one location in a near shore area may be donated to the PSD program.

The final rule revises paragraph (b)(1)(xi) of § 679.26 to clarify information required for the application process to become an authorized PSD distributor. This rule removes the requirement that the vessel or processor provide a fax number, as faxes are no longer used for communication between NMFS and the vessels or processors for the purposes of this program. This revision reduces the reporting burden for the PSD applicant.

The final rule revises paragraph (b)(2)(iv) of § 679.26 to change the selection criteria considered by the Regional Administrator in issuing a PSD permit. The revision changes the consideration of the potential number of groundfish trawl vessels and processors in the fishery to the potential number of vessels and processors participating in the PSD program. The number of vessels and processors in the groundfish fishery is not an important consideration to determine how many distributors should participate in the program. Instead, the Regional Administrator will consider the number of vessels and processors currently in the PSD program, along with the number and qualification of applicants, the number of harvesters and quantity of fish that applicants can effectively administer, and the anticipated level of bycatch of prohibited species. A comparison of the number of vessels and processors currently in the program with the number of harvesters that prospective distributors can effectively administer provides a more meaningful basis by which to determine the appropriate number of distributors for the program. This revision focuses the considerations for issuing a permit on pertinent vessel and processor information.

This final rule does not include a provision imposing increased observer coverage on vessels less than 60 feet length overall (LOA) that participate in the directed pollock fishery in the Central or Western regulatory areas of the GOA by January 2013. Consistent with the Council's intent, the proposed rule stated that increased observer coverage on vessels less than 60 feet LOA under this action would only be effective until the restructured observer program is implemented (76 FR 77762). It would be premature to adopt a final rule that imposes such increased observer coverage at this time, because NMFS approved Amendment 86 to the FMP for Groundfish of the Bering Sea and Aleutian Islands Management Area and Amendment 76 to the GOA FMP on June 7, 2012. Having approved these FMP amendments that provide for a restructured observer program, NMFS intends to fulfill its legal responsibility to implement the amendments. The proposed rule for Amendment 86 and Amendment 76 was published on April 18, 2012, with the comment period ending on June 18, 2012 (77 FR 23266). NMFS has not yet made any final decisions regarding the publication of a final rule to implement Amendments 86 and 76 and NMFS recognizes that revisions to the proposed rule may occur as a result of public comments. Nonetheless, at this time, NMFS anticipates that the restructured observer program will be implemented by January 1, 2013, meeting the Council's intent of increased coverage under Amendment 93.

Implementing a short-term change to the observer program for these vessels between the effective date of this final rule and January 2013, would burden NMFS and fishery participants without providing much improvement over current data collection efforts. Moreover, such a short-term change is not needed to meet the Council's intent under Amendment 93. Rather than require an interim change to observer requirements that would provide little data collection benefit relative to the effort the agency would expend to implement this short-term program, resources will be used to ready NMFS and the industry for the restructured observer program that NMFS has proposed and anticipates will be implemented beginning in 2013. If NMFS does not implement the restructured observer program by January 1, 2013, the agency will consult with the Council regarding how to achieve observer coverage for vessels less than 60 feet LOA under Amendment 93 until the restructured observer program is implemented. Therefore, NMFS changed this final rule for GOA Chinook PSC management to omit the increased observer coverage set forth in the proposed rule. NMFS consulted with the Council in June 2012 regarding this approach to observer coverage for these vessels under the final rule for Amendment 93.

NMFS received 4 letters containing 12 unique comments during the public comment periods for the Notice of Availability and for the proposed rule. One letter received was not responsive to this action. A summary of relevant comments, grouped by subject matter and NMFS' responses, follows.

Comment 1: Several commenters expressed general support for Amendment 93 to the FMP and its implementing regulations.

Response: NMFS acknowledges these comments.

Comment 2: The range of alternatives considered in the environmental assessment was inadequate, and NMFS should have considered lower PSC limits.

Response: The environmental assessment for this action included a reasonable range of alternatives that met the purpose and need of this action to take prompt action to protect against the risk of high Chinook salmon PSC levels. The Council's problem statement recognizes the obligation under the MSA to minimize Chinook salmon bycatch to the extent practicable. The alternatives included (1) no action; (2) GOA-wide PSC limits of 15,000, 22,500, 25,000, and 30,000 Chinook salmon; (3) alternative ways of allocating the PSC limits between the Central and Western Reporting Areas; and (4) a 25-percent buffer for the PSC limit in one out of three consecutive years. Alternative 2 included a range of PSC caps that would reduce Chinook salmon PSC to varying degrees, with lower limits resulting in potentially greater adverse economic impacts on fishery participants. During the Council's development of this action, no member of the public objected to the adequacy of the range of GOA-wide PSC limits evaluated in the Council's Public Review draft of the Environmental Assessment. Throughout the Council process, no member of the public commented that the Council must consider GOA-wide PSC limits below 15,000 Chinook salmon, nor did any member of the public suggest that a lower GOA-wide PSC limit was needed to achieve the Council's stated purpose, which was to diminish the risk of high Chinook salmon PSC levels to the extent practicable.

The Council considered the importance of equity among user groups in recommending Amendment 93. The Council noted that the Chinook salmon resource is of value to many stakeholders, including but not limited to commercial, recreational, and cultural user groups, and it is a resource that is currently fully allocated. The Council also recognized that efforts to reduce Chinook salmon PSC in the pollock fishery would impose costs on participants in the pollock fishery. The preferred alternative balances the need to minimize Chinook PSC to the extent practicable, consistent with the MSA National Standard 9, with the requirements of National Standard 1, to enable the pollock fishery to contribute to the achievement of optimum yield in the groundfish fishery. In an effort to strike this balance, the Council considered a range of PSC limits. As indicated by the analysis (see ADDRESSES ), a PSC limit of 15,000 fish would result in considerable amounts of foregone harvest in the pollock fishery, and relatively high costs (in terms of foregone revenue) per salmon saved. PSC limits lower than 15,000 fish would be expected to further increase these costs.

A Chinook salmon PSC limit of 15,000 would impose a greater burden on small entities that participate in the pollock fishery by constraining pollock fishing to a greater degree than the 25,000 fish limit of the preferred alternative. Any lower PSC limits would have further burdened fishery participants and were not considered practicable by the Council for minimizing Chinook salmon bycatch because they were determined to be unnecessarily constraining to the pollock fisheries. Given the considerable costs per salmon saved at PSC limits of 15,000 or less and uncertainty over the added benefits to individual Chinook stocks of such limits, the environmental assessment evaluated a reasonable range of alternatives.

Comment 3: The proposed limit does not comply with National Standard 9 and the precautionary principle.

Response: In developing Amendment 93, the Council considered consistency with the MSA's ten National Standards, including National Standard 9, which requires NMFS to minimize bycatch to the extent practicable, and National Standard 1, to achieve optimum yield for the managed fishery. The Council designed Amendment 93 to balance the competing requirements of the National Standards. Specifically, the Council recognized the need to balance and be consistent with the mandate of National Standard 9 and the mandate of National Standard 1. In selecting the overall limit on Chinook salmon PSC, the Council considered a range of alternatives to assess the impacts of minimizing Chinook salmon bycatch to the extent practicable while preserving the potential for the full harvest of the pollock TAC. The Council considered the trade-offs between Chinook salmon saved and the forgone pollock catch. The EA and RIR include a description of the alternatives and a comparative analysis of the potential impacts of the alternative PSC limits (see ADDRESSES ).

The action follows the precautionary principle by implementing conservation measures to reduce overall Chinook salmon PSC, even though data is not available to determine the impact of Chinook salmon PSC on individual Chinook salmon stocks. Even though effects on individual Chinook salmon stocks cannot be determined at this time, this action reduces overall potential impacts and improves data collection, which is a necessary precursor to any future analysis of the potential impacts of the pollock fisheries on individual Chinook salmon stocks. The PSC limits minimize bycatch to the extent practicable given the tools currently available to the fleet, the derby-style prosecution of the fishery, the uncertainty about whether the bycatch has adverse effects on any particular Chinook salmon stocks, and the need to ensure that the pollock fishery contributes to the achievement of optimum yield in the groundfish fishery.

Comment 4: The proposed limit does not adequately address the full costs and benefits to each user sector and did not provide the public with the opportunity to review more stringent PSC limits that appropriately respond to uncertainties about the Chinook resource, impacts to downstream users, and the requirements of National Standard 9.

Response: See response above to comment 2 regarding a more stringent PSC limit and response to comment 3 above regarding uncertainties about impacts to the Chinook salmon resource. The Council considered the importance of equity among user groups in recommending Amendment 93. In addition to providing a fair and equitable apportionment of the total GOA-wide PSC limit between the Central and Western GOA pollock fisheries, the Council also considered the needs of Chinook salmon users. The Council noted that the Chinook salmon resource is of value to many stakeholders, including, but not limited to, commercial, recreational, and cultural user groups, and it is a resource that is currently fully allocated. By recommending a PSC limit that reduces Chinook salmon PSC in relatively high bycatch years, the Council also has considered the needs of these other user groups and has recommended measures to promote their access to the Chinook salmon resource. The RIR included a qualitative discussion of the benefits of a PSC limit to users of Chinook salmon (both consumptive and non-consumptive uses); therefore, the benefits have been described, albeit with some limitations due to the information that is available (see ADDRESSES ). With the information that is currently available, neither the total “cost” of Chinook salmon PSC nor the total “value” of Chinook salmon savings can be estimated for the various user groups. The potential salmon savings that are estimated in the analysis do not translate directly into adult salmon that would otherwise have survived to return to spawning streams. Because of these and other data limitations, it is beyond the scope of the analysis to monetize or even quantify the benefits of this action, which is expected to reduce Chinook salmon PSC by, on average, 5,800 fish annually. However, the Council heard and considered testimony and was provided additional information by representatives of most groups that utilize the Chinook salmon resource demonstrating the breadth and variety of values associated with this species.

An analysis of the preferred alternative suggests that the imposition of PSC limits is likely to be constraining to the GOA pollock fisheries in some years, and consequently may result in impacts to the communities that depend on those fisheries. The preferred alternative that is implemented by this final rule balances the need to minimize Chinook salmon PSC consistent with National Standard 9, with the requirement to achieve optimum yield in the managed fishery, consistent with National Standard 1. The preferred alternative also reflects consideration of the requirements of National Standard 8—to minimize adverse impacts on fishing communities, consistent with the conservation requirements of the MSA. To this end, the final rule establishes PSC limits for the Western and Central GOA that could allow the pollock quota to be fully harvested in both areas, if the fleet can maintain the average long-term (17-year) Chinook salmon PSC rate, recognizing that in years of high PSC, if the fleet is unable to work together to come up with mechanisms to reduce Chinook salmon PSC, the PSC limit may result in an early closure to the fishery. One consequence of such a closure may be a benefit to fishing communities that depend on Chinook salmon. In approving the final rule, the Secretary minimizes the risk of adverse impacts to fishing communities, while adhering to her conservation obligations under National Standard 9.

Comment 5: Mid-year implementation is opposed and the Secretary should disapprove this part of the rule. The caps to be put in place for the C and D seasons in 2012 will constrain the 2012 fall GOA pollock fisheries in the Central GOA.

Response: The Council recommended the PSC limits for the 2012 C and D seasons to be 8,929 Chinook salmon in the GOA Central Reporting Area and 5,598 Chinook salmon in the GOA Western Reporting Area. NMFS has determined that implementing these limits is consistent with the MSA and other applicable law.

These PSC limits were calculated by multiplying the annual PSC limit in each area by the average percentage of annual Chinook salmon PSC taken in the C and D seasons within each area, over the same time series of 2001 to 2010 but excluding 2007 and 2010, and adjusting upward by 25 percent. The Council adjusted the amount upward by 25 percent the first year to provide a buffer and reduce the constraint of mid-year implementation limits on the pollock fisheries. The Council recommended the 25 percent increase recognizing that pollock total allowable catch limits (TACs) may be higher in 2012 than they were in 2011. NMFS expects the upward adjustment of the PSC limits that will be implemented in 2012 will result in PSC limits that are not overly restrictive on the Central GOA pollock fishery. Nevertheless, the limits are intended to be constraining in years of high Chinook salmon PSC. If they are constraining, they are performing their intended function to prevent excessively high PSC. By the commenter's own analysis, full prosecution of the C season in the Central Gulf should be expected. If the fleet is able to achieve a modest reduction in its Chinook PSC rate compared to 2011, when there was no PSC limit in place, it may be able to avoid a closure before the TAC is reached in the D season as well.

Comment 6: There are numerous recent and upcoming Council and State actions that cumulatively may restrict the harvesters.

Response: Beyond the cumulative impact analyses in the EA for this action, the 2006 and 2007 harvest specifications EA, Groundfish Harvest Specifications Environmental Impact Statement, Allocation of Pacific Cod among Sectors in the Western and Central GOA EA, and the Central GOA Rockfish Program EA, no other additional past or present cumulative impact issues were identified. The combination of effects from the cumulative effects of past, present, and reasonably foreseeable future actions and this action are not likely to result in significant effects for any of the environmental components analyzed and are therefore not significant. Socioeconomic impacts are a direct result of the action of imposing PSC limits on the fisheries. These impacts are independent of the natural or physical effects of imposing PSC limits on the fisheries and are not expected to be significant. The environmental analyses listed are available at http://alaskafisheries.noaa.gov.

Comment 7: Due to inshore/offshore regulations, no pollock catcher/processors participate in the GOA pollock fisheries.

Response: NMFS acknowledges this comment. This final rule applies to the directed pollock trawl fisheries in the Central and Western Reporting Areas of the GOA, including pollock catcher/processors if they were to participate in the GOA pollock fishery in the future.

Comment 8: The proposed rule states in the preamble that the only State of Alaska-managed pollock guideline harvest level fishery in those areas is the Prince William Sound (PWS) pollock fishery. If “those areas” refers to the Central and Western GOA, the PWS area (649) is considered part of the Eastern GOA, not the Central or Western GOA.

Response: NMFS acknowledges this comment, and agrees that the PWS area (649) is considered part of the Eastern GOA. “Those areas” referred to the entire GOA.

Comment 9: The proposed rule preamble stated paragraph (h)(2)(ii) would specify an annual limit of 6,684 Chinook salmon for vessels engaged in directed fishing for pollock in the Central reporting area of the GOA. “Central” should be “Western.”

Response: NMFS agrees. This was an erroneous statement in the proposed rule preamble which was not reflected in the proposed regulatory text set forth in the proposed rule. The correct annual PSC limits of 6,684 Chinook salmon for vessels engaged in directed fishing for pollock in the Western reporting area of the GOA, and 18,316 Chinook salmon for vessels engaged in directed fishing for pollock in the Central reporting area of the GOA, were stated in the proposed regulatory text and elsewhere throughout the preamble of the proposed rule.

Comment 10: The proposed rule needs clarification for regulatory text for observers on catcher/processors in a directed pollock fishery in the Central or Western reporting areas of the GOA. Catcher/processors do not participate in GOA directed pollock fisheries, so requiring catcher/processors less than 60 ft. to carry an observer for pollock directed fishing seems unnecessary and conflicting.

Response: NMFS acknowledges this comment. For reasons noted in the preamble, no observer requirements are included in this final rule.

Comment 11: Unlike the Bering Sea American Fisheries Act (AFA) fleet, the GOA pollock catcher vessels are subject to 30 percent observer coverage, not 100 percent coverage, so the PSC estimates will not be based entirely on observer census numbers for all deliveries. Given the high number of permutations of area/target/gear type and the 30 percent observed rate, a high Chinook salmon bycatch rate in one area/target/gear with poor observer coverage could result in underestimated or overestimated salmon numbers for the entire fleet in that area/target/gear fishery. The Bering Sea, with 100 percent observer coverage for distinct pollock trips (no mixing of catch species, which happens in the Central GOA) and mid-water fishery only, results in 100 percent census data to manage the hard caps for Chinook salmon PSC. For the GOA, the data will be more variable and less robust; this will challenge NMFS to accurately manage a hard cap for Chinook salmon PSC and will challenge the fleet to stay within the cap. A better approach could be to have PSC estimates derived from all pollock trips as one group by regulatory area instead of creating separate estimates across all the different possible permutations. Variability and precision may improve and this type of approach should be evaluated.

Response: NMFS acknowledges this comment. The current Catch Accounting System is described in Chapter 5 of the analysis for this action (see ADDRESSES ). NMFS estimates of Chinook salmon are based on well-established sampling methodology implemented by the observer program and ratio estimators based on post stratification of catch. Changes to the estimation process are outside the scope of this rule.

Comment 12: The GOA pollock fishery is not the Bering Sea AFA pollock fishery. A hard cap with no tools or incentives for saving is a very blunt and antiquated management scheme.

Response: NMFS acknowledges this comment. This action sets PSC limits, but it does not restructure the management of the pollock fishery. The Council acknowledged that the selection of a Chinook salmon PSC limit for the GOA pollock fishery requires a balance of obligations under the MSA National Standards and the needs of different user groups. The Council intends for the Chinook salmon PSC limits to allow the full prosecution of the pollock fishery in the Central and Western GOA in most years, while truncating the fishery in high bycatch years, to prevent events of relatively high Chinook salmon PSC in these areas, such as occurred in 2010 (44,813 Chinook salmon).

The Administrator, Alaska Region, NMFS determined that the FMP amendment is necessary for the conservation and management of the groundfish fisheries off Alaska and that it is consistent with the MSA and other applicable law. After considering the comments received on the amendment, the Secretary of Commerce approved Amendment 93 on February 17, 2012.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a Final Regulatory Flexibility Analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The preambles to the proposed rule and this final rule serve as the small entity compliance guide. This action does not require any additional compliance from small entities that is not described in the preambles. Copies of the proposed rule and this final rule are available from NMFS at the following Web site: http://alaskafisheries.noaa.gov.

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

This final regulatory flexibility analysis (FRFA) incorporates the Initial Regulatory Flexibility Analysis (IRFA), a summary of the significant issues raised by the public comments, NMFS' responses to those comments, and a summary of the analyses completed to support the action. NMFS published the proposed rule on December 14, 2011 (76 FR 77757), with comments invited through January 30, 2012. An IRFA was prepared and summarized in the “Classification” section of the preamble to the proposed rule. The FRFA describes the impacts on small entities, which are defined in the IRFA for this action and not repeated here. Analytical requirements for the FRFA are described in Regulatory Flexibility Act, section 304(a)(1) through (5), and summarized below.

The FRFA must contain:

1. A succinct statement of the need for, and objectives of, the rule;

2. A summary of the significant issues raised by the public comments in response to the IRFA, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;

3. A description and an estimate of the number of small entities to which the rule will apply, or an explanation of why no such estimate is available;

4. A description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and

5. A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

The “universe” of entities to be considered in a FRFA generally includes only those small entities that can reasonably be expected to be directly regulated by the action. If the effects of the rule fall primarily on a distinct segment of the industry, or portion thereof (e.g., user group, gear type, geographic area), that segment would be considered the universe for purposes of this analysis.

In preparing a FRFA, an agency may provide either a quantifiable or numerical description of the effects of a rule (and alternatives to the rule), or more general descriptive statements, if quantification is not practicable or reliable.

The Council developed a purpose and need statement defining the reasons for considering this action, as described in Section 1.1 and 3.3 of the analysis for this action (see ADDRESSES ). The MSA National Standards require balancing optimum yield with minimizing bycatch and minimizing adverse impacts to fishery dependent communities. Chinook salmon bycatch taken incidentally in GOA pollock fisheries is a concern, historically accounting for the greatest proportion of Chinook salmon taken in GOA groundfish fisheries. Salmon bycatch control measures have not yet been implemented in the GOA, and 2010 Chinook salmon bycatch levels in the area were unacceptably high. Limited information on the origin of Chinook salmon in the GOA indicates that stocks of Asian, Alaska, British Columbia, and lower-48 origin are present, including Endangered Species Act-listed stocks.

The legal basis for this action is the MSA. Under the authority of the MSA, the Secretary of Commerce (NMFS Alaska Regional Office) and the Council have the responsibility to prepare fishery management plans and associated regulations for the marine resources found to require conservation and management. NMFS is charged with carrying out the federal mandates of the Secretary of Commerce with regard to marine fish, including the publication of federal regulations. The Alaska Regional Office of NMFS and the Alaska Fisheries Science Center research, draft, and support the management actions recommended by the Council. The GOA groundfish fisheries are managed under the FMP. The action represents amendments to the FMP, as well as amendments to associated Federal regulations. Two principal objectives of the FMP amendment and regulations are to reduce Chinook salmon PSC in the Central and Western GOA pollock fisheries to the minimal level practicable, consistent with National Standard 9 of the MSA, and to enable pollock harvests to contribute to the achievement of optimum yield on a continuing basis in the GOA groundfish fishery, consistent with National Standard 1 of the MSA.

No comments were received that raised significant issues in response to the IRFA specifically; therefore, no changes were made to the rule as a result of comments on the IRFA. However, several comments were received on the economic impacts of Amendment 93 on different sectors of the industry. For a summary of the comments received and the agency's responses, refer to the section above titled “Response to Comments.”

This final action directly regulates those federally-permitted or licensed entities that participate in harvesting groundfish from the Federal or State of Alaska-managed parallel pollock target fisheries of the Central or Western GOA. Fishing vessels are considered small entities if their total annual gross receipts, from all their activities combined, are less than $4.0 million. The analysis identified 63 vessels in 2010 that would be affected by this action, 37 catcher vessels of which fished for pollock in the Central or Western GOA pollock fisheries and are members of a cooperative. These vessels are members of an AFA cooperative for Bering Sea pollock, a rockfish program cooperative in the GOA, a Bering Sea crab cooperative, or members of two or more of these cooperatives. The remaining 26 vessels are not part of a cooperative and are considered to be small entities.

During consideration of this action, the Council evaluated a number of alternatives to the preferred alternative, including (1) no action: (2) GOA-wide PSC limits of 15,000, 22,500, 25,000, and 30,000 Chinook salmon; (3) alternative ways of allocating the PSC limits between the Central and Western Reporting Areas; and (4) a 25-percent buffer for the PSC limit in one out of three consecutive years. The preferred alternative selected for Amendment 93 was a 25,000 fish limit, with 73 percent going to the Central GOA and 27 percent to the Western GOA. None of the other alternatives met the objectives of the action and had a smaller impact on small entities.

No action would have left the Chinook salmon PSC unlimited, which would have failed to meet the objective of the action. The 30,000 GOA-wide Chinook salmon PSC limit would likewise have failed to significantly control Chinook salmon PSC, and therefore failed to balance the benefits of the action to the Chinook salmon stocks and target fisheries for Chinook salmon with the needs of pollock trawlers in the way sought by the Council. A Chinook salmon PSC limit of 15,000 would have imposed a greater burden on small entities by constraining pollock fishing beyond the preferred alternative. The Chinook salmon PSC limit of 22,500 would be constraining in more years for the Central GOA compared to the recommended 25,000 PSC limit. The option for a 25-percent buffer to the PSC limits did not meet the intended objectives of reducing Chinook salmon PSC to the maximum extent practicable. Under the apportionment options, the Central GOA's proportion of the GOA-wide PSC limit ranges from 61 percent to 77 percent, or 9,122 Chinook salmon to 23,224 Chinook salmon, depending on the overall PSC limit. For the Western GOA, the range is from 23 percent to 39 percent, which results in a range of 3,388 Chinook salmon to 11,757 Chinook salmon. The apportionment options were based on the relative historical pollock catch in each regulatory area, the relative historical Chinook salmon catch amounts in each area, or a weighted ratio of the two. The Council determined lower percentages for either area were unnecessarily constraining to the pollock fisheries in the area while larger percentages for either area did not provide the incentive to minimize PSC to the extent practicable.

The changes to the PSD program regulations reduce reporting burden for applicants, streamline the application process considerations, and improve the description of eligible processors. No alternatives were identified for these regulatory amendments that would further reduce any potential impacts on small entities.

This rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by the Office of Management and Budget (OMB) under Control Number 0648-0316.

Public reporting burden for the Application to become a NMFS Authorized Distributor in the PSD program is estimated to average 13 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES ) and by email to OIRA_Submission@omb.eop.gov, or fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

Section 3507(c)(B)(i) of the PRA requires that agencies inventory and display a current control number assigned by the Director, OMB, for each agency information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB approval numbers have been issued. Because this final rule adds a collection-of-information for recordkeeping and reporting requirements, 15 CFR 902.1(b) is revised to reference correctly the new section resulting from this final rule.

Executive Order (E.O.) 13175 of November 6, 2000 (25 U.S.C. 450 note), the Executive Memorandum of April 29, 1994 (25 U.S.C. 450 note), and the American Indian and Alaska Native Policy of the U.S. Department of Commerce (March 30, 1995) outline the responsibilities of NMFS in matters affecting tribal interests. Section 161 of Public Law 108-199 (188 Stat. 452), as amended by section 518 of Public Law 109-447 (118 Stat. 3267), extends the consultation requirements of E.O. 13175 to Alaska Native corporations.

NMFS is obligated to consult and coordinate with federally recognized tribal governments and Alaska Native Claims Settlement Act regional and village corporations on a government-to-government basis pursuant to E.O. 13175 which establishes several requirements for NMFS, including (1) to provide regular and meaningful consultation and collaboration with Indian tribal governments and Alaska Native corporations in the development of Federal regulatory practices that significantly or uniquely affect their communities, (2) to reduce the imposition of unfunded mandates on Indian tribal governments, (3) and to streamline the applications process for and increase the availability of waivers to Indian tribal governments. This Executive Order requires Federal agencies to have an effective process to involve and consult with representatives of Indian tribal governments in developing regulatory policies and prohibits regulations that impose substantial, direct compliance costs on Indian tribal communities.

Section 5(b)(2)(B) of E.O. 13175 requires NMFS to prepare a tribal summary impact statement as part of the final rule. This statement must contain (1) a description of the extent of the agency's prior consultation with tribal officials, (2) a summary of the nature of their concerns, (3) the agency's position supporting the need to issue the regulation, and (4) a statement of the extent to which the concerns of tribal officials have been met.

On December 14, 2011, NMFS consulted on this action by mailing letters to all Alaska tribal governments, Alaska Native corporations, and related organizations (“Alaska Native representatives”) by notifying them of the opportunity to comment when the Notice of Availability for Amendment 93 and the proposed rule were published in the Federal Register . The letter invited requests for further consultation on this action. One letter was received from the tribes in support of implementation of Amendment 93. The agency will implement Amendment 93 to establish PSC limits of salmon in the Central and Western GOA pollock fisheries. There were no concerns regarding the proposed action raised by tribal officials during this consultation process.

For the reasons set out in the preamble, NMFS amends 15 CFR chapter IX and 50 CFR chapter VI as follows:

Background

On June 21, 2012 (77 FR 37305), the Coast Guard published a final rule entitled “Navigation and Navigable Waters; Technical, Organizational, and Conforming Amendments.” Subsequent to the publication of that notice, the Coast Guard discovered that the changes discussed in the Preamble to 33 CFR 84.15 and 33 CFR 115.60 were not included in the regulatory text.

As published, the final regulations do not capture two changes to Title 33 of the CFR and need to be corrected. In § 84.15, there is a formula for intensity of lights. This formula contains a legend describing the variables which includes an equals sign without a hard return for the definition. This formula instead should include a colon after each letter representation and a hard return following each colon. In § 115.60, the word “construction” is in the heading. The word “construction” should be removed because this section focuses on applications for permits to construct, modify, or replace bridges. Therefore, the word “construction” in the title does not accurately indicate the breadth of the regulation so the word needs to be removed.

Accordingly, 33 CFR part 84 and part 115 are corrected by making the following correcting amendments:

The BNSF Railway Company has requested a temporary deviation from the operating schedule of the swing span railroad bridge across Bayou Boeuf, mile 10.2, at Amelia, St. Mary Parish, Louisiana. The bridge provides no vertical clearance in the closed-to-navigation position.

In accordance with 33 CFR 117.5, the bridge currently opens on signal for the passage of vessels. This deviation allows the vertical lift span of the bridge to remain in the closed-to-navigation position from 7 a.m. through 11 p.m. on Thursday, August 16, 2012.

The closure is necessary in order to change out a shaft and reducer gear damaged during a bridge allision earlier this year. Notices will be published in the Eighth Coast Guard District Local Notice to Mariners and will be broadcast via the Coast Guard Broadcast Notice to Mariners System.

Navigation at the site of the bridge consists mainly of tows with barges and some recreational pleasure craft. Due to prior experience, as well as coordination with waterway users, it has been determined that this closure will not have a significant effect on these vessels. An alternate route is available by using the GIWW, Morgan City to Port Allen Alternate Route.

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

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) because such a publication would be impracticable. Immediate action is necessary to ensure the safety of vessels, spectators, participants, and others in the vicinity of the marine event on the dates and times this rule will be in effect.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Publishing an NPRM would be impracticable, since immediate action is needed to ensure the public's safety.

Sea World is sponsoring the Sea World Fireworks, which will include a fireworks presentation from a barge in Mission Bay. The fireworks display is scheduled to occur between 8:50 p.m. and 10 p.m. on most evenings between May 26, 2012 and September 3, 2012. This safety zone is necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway.

The Coast Guard is establishing a safety zone that will be enforced from 8:50 p.m. to 10 p.m. on the following evenings: May 26 to May 28, June 2 and 3, June 9 and 10, June 14 through August 19, August 24 through August 26, and September 1 through September 3. The safety zone will cover a 600 foot radius surrounding the fireworks barge in approximate position 32°46′03″ N, 117°13′11″ W. The safety zone is necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway. When this safety zone is being enforced, persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This determination is based on the size and location of the safety zone. Commercial vessels will not be hindered by the safety zone. Recreational vessels will not be allowed to transit through the designated safety zone during the specified times.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

(1) This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Mission Bay from 8:50 p.m. to 10 p.m. from May 26, 2012 through September 3, 2012.

(2) This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone will only be in effect for one hour and 10 minutes late in the evening when vessel traffic is low.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would be impracticable and contrary to the public interest.

Between 9:45 p.m. and 10:15 p.m. on July 21, 2012, a fireworks display will be held on Black River Bay near Sackets Harbor, NY. The Captain of the Port Buffalo has determined that fireworks launched proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Can-Am Festival Fireworks. This zone will be effective and enforced from 9:15 p.m. until 10:45 p.m. on July 21, 2012. This zone will encompass all waters of Black River Bay, Sackets Harbor, NY within a 1120 foot radius of position 43°57′15.94″ N and 76°06′39.20″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Black River Bay on the evening of July 21, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for only 90 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the activation of the zone, we would issue local Broadcast Notice to Mariners.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would be impracticable and contrary to the public interest.

Between 10:00 p.m. and 10:30 p.m. on July 27, 2012, a fireworks display will be held on the St. Lawrence River near Ogdensburg, NY. The Captain of the Port Buffalo has determined that fireworks launched proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the City of Ogdensburg Fireworks. This zone will be effective and enforced from 9:30 p.m. until 11:00 p.m. on July 27, 2012. This zone will encompass all waters of the St. Lawrence River, Ogdensburg, NY within an 840 foot radius of position 44°42′02.79″ N and 75°29′42.73″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the St. Lawrence River on the evening of July 27, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for only 90 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the activation of the zone, we would issue local Broadcast Notice to Mariners.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would be impracticable and contrary to the public interest.

Between 9:30 p.m. and 10:00 p.m. on July 22, 2012, a fireworks display will be held on the Erie Canal near Tonawanda, NY. The Captain of the Port Buffalo has determined that fireworks launched proximate to a gathering of watercraft pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Canal Fest of the Tonawandas Fireworks. This zone will be effective and enforced from 9:00 p.m. until 10:30 p.m. on July 22, 2012. This zone will encompass all waters of the Erie Canal, Tonawanda, NY within a 210 foot radius of position 43°01′17.84″ N and 78°52′40.97″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Erie Canal on the evening of July 22, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for only 90 minutes late in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the activation of the zone, we would issue local Broadcast Notice to Mariners.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) because publishing an NPRM would be impracticable. Immediate action is necessary to ensure the safety of vessels, spectators, participants, and others in the vicinity of the marine event on the dates and times this rule will be in effect.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Publication of an NPRM would be impracticable, since immediate action is needed to ensure the public's safety.

The San Diego Symphony Orchestra and Copley Symphony Hall are sponsoring the San Diego POPS Fireworks, which will include a fireworks presentation conducted from a barge in San Diego Bay. The barge will be located near the navigational channel in the vicinity of North Embarcadero. The safety zone will include the area within 400 feet of the firing barge. The sponsor will provide a chase boat to patrol the safety zone and inform vessels of the safety zone. This safety zone is necessary to provide for the safety of the crew, spectators, and other vessels and users of the waterway.

The Coast Guard is establishing a safety zone that will be enforced from 9 p.m. to 10 p.m. on the following evenings: June 23, 29 and 30, July 1, 6 and 7, 13 and 14, 20 and 21, 27 and 28, August 3 and 4, 10 and 11, 17 and 18, 24 and 25, 31, and September 1 and 2. The safety zone will include the area within 400 feet of the fireworks barge in approximate position 32°42.13′ N, 117°10.01′ W. The safety zone is necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway. When this safety zone is being enforced, persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This determination is based on the size and location of the safety zone. Commercial vessels will not be hindered by the safety zone. Recreational vessels will not be allowed to transit through the designated safety zone during the specified times.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

(1) This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of San Diego Bay from 9 p.m. to 10 p.m. from June 23 through September 2, 2012.

(2) This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone impacts a relatively small area, and will only be in enforced for one hour at a time, late in the evening when vessel traffic is low.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) because publication of an NPRM would be impracticable. Immediate action is necessary to ensure the safety of vessels, spectators, participants, and others in the vicinity of the marine event on the dates and times this rule will be in effect.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Publication of an NPRM would be impracticable, since immediate action is needed to ensure the public's safety.

The Ports and Waterways Safety Act gives the Coast Guard authority to create and enforce safety zones. The Coast Guard is establishing a temporary safety zone on the navigable waters of the Lower Colorado River in support of a fireworks show in the navigation channel of the Lower Colorado River, Laughlin, NV. The fireworks show is being sponsored by AVI Resort and Casino. The temporary safety zone will include all navigable waters within 800 feet of the firing location adjacent to the AVI Resort and Casino. The temporary safety zone is necessary to provide for the safety of the show's crew, spectators, and participants of the event, participating vessels, and other vessels and users of the waterway.

The Coast Guard is establishing a safety zone that will be enforced from 8 p.m. to 9:45 p.m. on September 2, 2012. The limits of the safety zone include all navigable waters within 800 feet of the firing location. The firing location will be on land, centered across from the AVI Resort and Casino Cove in approximate position: 35°00′55″ N, 114°38′12″ W.

This safety zone is necessary to provide for the safety of the crews, spectators, and participants of the event and to protect other vessels and users of the waterway. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

U.S. Coast Guard personnel will enforce this safety zone. Other Federal, State, or local agencies may assist the Coast Guard, including the Coast Guard Auxiliary. Vessels or persons violating this rule may be subject to both criminal and civil penalties.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This determination is based on the size, and location, and duration of the safety zone. The zone encompasses an area that is only about a quarter mile in diameter, and is located in an area that will not impact commercial vessels. Additionally, the zone will only be in effect for one hour and 45 minutes, late at night when vessel traffic is low.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

(1) This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Colorado River from 8 p.m. to 9:45 p.m. on September 2, 2012.

(2) This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone is very small, and will only be in effect for one hour and 45 minutes late in the evening when vessel traffic is low.

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

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

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

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

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

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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

By letter received May 5, 2011, the commanding officer of Naval Station Newport, requested the removal of the restricted area located 4 nautical miles due south of Lands End in Newport, Rhode Island. The RA is no longer needed by the USN. In response to this request, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3), the Corps is amending the regulations in 33 CFR Part 334 by disestablishing the RA.

The proposed rule was published in the April 4, 2012, edition of the Federal Register (77 FR 20330), with regulations.gov docket number COE-2012-0001. In April 2012, the Corps New England District issued a public notice soliciting comments on the proposal to all known interested parties. No comments were received in response to the proposed rule and the public notice.

a. Review Under Executive Order 12866. This rule is issued with respect to a military function of the Department of Defense and the provisions of Executive Order 12866 do not apply.

b. Regulatory Flexibility Act, as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq. This rule has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354), which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities (i.e., small businesses and small governments). The Corps determined that the disestablishment of the RA would not have a significant economic impact on small entities. For more detailed analysis of potential impacts of this rule, please see the regulatory analysis in the EA.

c. Review Under the National Environmental Policy Act. We have concluded that the disestablishment of the restricted area will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement is not required. An environmental assessment and Finding of No Significant Impact have been prepared and may be reviewed at the New England District Office. Please contact Ms. Angela C. Repella at the phone number specified above for further information.

d. Unfunded Mandates Reform Act. This rule does not impose an enforceable duty among the private sector and, therefore, is not a Federal private sector mandate and is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501 et seq.). We have also found, under Section 203 of the Act, that small governments will not be significantly or uniquely affected by this rule.

For the reasons stated in the preamble, the Corps is amending 33 CFR part 334 to read as follows:

Pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3) the Corps is amending the regulation at 33 CFR part 334 by establishing a new restricted area in the waters near Meloy Channel, Government Cut Channel, and Miami Main Channel surrounding Base Miami Beach. The amendment to the regulation is described below.

The proposed rule was published in the May 3, 2012, issue of the Federal Register (77 FR 26229), and its regulations.gov docket number is COE-2012-0009. No comments were received in response to the proposed rule.

The amendment to this regulation will allow the Commander, U.S. Coast Guard Base Miami Beach to restrict passage of persons, watercraft, and vessels in waters contiguous to this Command, thereby increasing the ability to protect the facilities and personnel at Base Miami Beach from potential threats. The amendment will also provide a measure of protection to the public by reducing the potential for injury or property damage during routine and emergency USCG operations at the facilities and by providing a permanent explosive safety arc during the transfer of ammunition between cutters.

a. Review Under Executive Order 12866. This regulation is issued with respect to a military function of the Department of Defense and the provisions of Executive Order 12866 do not apply.

b. Review Under the Regulatory Flexibility Act. The regulation has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354) which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities (i.e., small businesses and small governments). The Corps determined that this regulation would have practically no economic impact on the public nor would it result in any anticipated navigational hazard or interference with existing waterway traffic. This regulation will have no significant economic impact on small entities.

c. Review Under the National Environmental Policy Act. This regulation will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement is not required. An environmental assessment has been prepared. It may be reviewed at the district office listed at the end of the FOR FURTHER INFORMATION CONTACT section, above.

d. Unfunded Mandates Act. This regulation does not impose an enforceable duty among the private sector and, therefore, is not a Federal private sector mandate and is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501 et seq. ). We have also found under Section 203 of the Act, that small governments will not be significantly or uniquely affected by this regulation.

For the reasons set out in the preamble, the Corps is amending 33 CFR part 334 as follows:

The Supervisor of Shipbuilding, Conversion and Repair (SUPERVISOR), USN, Gulf Coast (SUPSHIP Gulf Coast) assumed the duties of administering new construction contracts at AUSTAL USA in Mobile, AL, on October 9, 2011, replacing the Supervisor of Shipbuilding, Conversion, and Repair, USN, Bath (SUPSHIP Bath). The SUPERVISOR is responsible for United States Navy shipbuilding activities at AUSTAL, USA located in Mobile, Alabama. In accordance with Department of Defense and Department of the Navy guidance, the SUPERVISOR is responsible for the antiterrorism efforts and force protection of Department of the Navy assets under his or her charge. As such, the restricted area was established on September 22, 2009 (see 74 FR 48151). There are no changes to the limits of the restricted area.

The proposed rule was published in the December 2, 2011, edition of the Federal Register (76 FR 75508) and the regulations.gov docket number was COE-2011-0034. In response to the proposal, one comment was received. The commenter stated that the proposed rule will have no effect on historic properties.

In response to a request by the United States Navy, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3), the Corps is amending 33 CFR 334.782 by changing the responsible party from SUPSHIP Bath to SUPSHIP Gulf Coast.

a. Review Under Executive Order 12866. This rule is issued with respect to a military function of the Defense Department and the provisions of Executive Order 12866 do not apply.

b. Review Under the Regulatory Flexibility Act. The rule has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354) which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities (i.e., small businesses and small governments). The Corps determined that the restricted area amendment will have practically no economic impact on the public, no anticipated navigational hazard, and no interference with existing waterway traffic. This rule will have no significant economic impact on small entities.

c. Review Under the National Environmental Policy Act. This rule will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement is not required. An environmental assessment has been prepared. It may be reviewed at the District office listed at the end of the FOR FURTHER INFORMATION CONTACT section, above.

d. Unfunded Mandates Act. This rule does not impose an enforceable duty among the private sector and, therefore, is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501 et seq.). We have also found under Section 203 of the Act, that small governments will not be significantly or uniquely affected by this rule.

For the reasons set out in the preamble, the Corps amends 33 CFR part 334 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 under FOR 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 at http://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-2011-0458 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 September 18, 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-2011-0458, by one of the following methods:

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

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

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

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

In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-4), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7845) by Bayer CropScience, 2 TW Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.555 be amended by establishing tolerances for residues of the fungicide trifloxystrobin, [benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene] amino]oxy]methyl]-methyl ester], in or on artichoke, globe at 1.0 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov.

There were no comments received in response to the notice of filing.

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

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

Trifloxystrobin exhibits very low toxicity following single oral, dermal and inhalation exposures. It is a strong dermal sensitizer. In repeated dose tests in rats, the liver is the target organ for trifloxystrobin; toxicity is induced following oral and dermal exposure for 28 days. There is no evidence of increased susceptibility following prenatal exposure to rats and rabbits and postnatal exposures to rats. Trifloxystrobin was determined not to be carcinogenic in mice or rats following long-term dietary administration. Trifloxystrobin is positive for mutagenicity in Chinese Hamster V79 cells, albeit at cytotoxic dose levels. However, trifloxystrobin is negative in the remaining mutagenicity studies. Specific information on the studies received and the nature of the adverse effects caused by trifloxystrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of June 11, 2010 (75 FR 33190) (FRL-8829-2), and at http://www.regulations.gov in the document “Trifloxystrobin. Human Health Risk Assessment for a Section 3 Petition Proposing Increased Tolerances for Residues in/on Field, Sweet and Pop Corn,” pp. 17-21 in docket ID number EPA-HQ-OPP-2009-0278.

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, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for trifloxystrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 11, 2010.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to trifloxystrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing trifloxystrobin tolerances in 40 CFR 180.555. EPA assessed dietary exposures from trifloxystrobin 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 trifloxystrobin. In estimating acute dietary exposure for females 13-49 years old, EPA conducted an analysis using the Dietary Exposure Evaluation Model (DEEM\TM\ 7.81), which 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. EPA assumed all commodities with established or proposed tolerances were treated with trifloxystrobin.

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 used tolerance level residues for all commodities with the exception of apples, oranges and grapes. For these commodities EPA used anticipated residues from field residue trials. EPA assumed all commodities with established or proposed tolerances were treated with trifloxystrobin.

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

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of trifloxystrobin plus its major degradation product, CGA-321113 for the proposed artichoke, globe use are estimated to be 47.98 parts per billion (ppb) and 47.31 ppb for surface water for acute and chronic exposures, respectively. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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).

Trifloxystrobin is currently registered for the following uses that could result in residential exposures: Ornamentals and turfgrass. EPA assessed residential exposure under the following exposure scenarios: Adult post-application dermal exposure; and children's post-application dermal and/or hand to mouth exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.

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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin. In the prenatal developmental study in rats, there was no developmental toxicity at the limit dose. In the prenatal developmental study in rabbits, developmental toxicity was seen at a dose that was higher than the dose that caused maternal toxicity. In the 2-generation reproduction study, there was no offspring toxicity at the highest dose tested.

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 database is complete except for an immunotoxicity study and an inhalation study. Although an immunotoxicity study is needed, the entire trifloxystrobin toxicity database was examined and there was no indication that this chemical directly targets the immune system. EPA does not believe that conducting an immunotoxicity study will result in a dose less than the points of departure already used in this risk assessment and an additional database uncertainty factor (UF) for potential immunotoxicity does not need to be applied. Regarding the requirement for an inhalation toxicity study, the Agency has increased its focus on the uncertainties associated with route-to-route extrapolation (i.e., the use of oral toxicity studies for inhalation risk assessment) and is presently requiring inhalation toxicity studies more frequently. Although an inhalation toxicity study is now required for trifloxystrobin based on OPP's current weight of the evidence (WOE) approach, residential inhalation exposure is not anticipated; therefore, there are no uncertainties with respect to residential inhalation exposures to trifloxystrobin and no need to retain an additional database uncertainty factor for this safety finding.

ii. There is no indication that trifloxystrobin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. A waiver for a subchronic neurotoxicity study has been granted. There is no evidence of neurotoxicity in subchronic and chronic toxicity studies (rats, dogs, mice), in developmental toxicity studies (rats, rabbits), or in a reproductive toxicity study (rats). There is no concern for neurotoxicity for trifloxystrobin based on the available database, limited findings in an acute neurotoxicity study, and lack of neurotoxicity in other fungicides of the strobilurin class.

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

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure assessment was unrefined, and the chronic dietary exposure assessment was partially refined, assuming 100 PCT and tolerance-level residues for all commodities except for apples, grapes, and oranges where the average field trial residues were used. By using these screening-level assessments with minor refinement, actual exposures/risks from residues in food will not be underestimated. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to trifloxystrobin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by trifloxystrobin.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to trifloxystrobin will occupy 1.9% of the aPAD for females 13-49 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 trifloxystrobin from food and water will utilize 64% of the cPAD for children 1-2 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 trifloxystrobin 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).

Trifloxystrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to trifloxystrobin. 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 1,100 for adults (dermal residential + dietary food and drinking water exposures); 650 for children 1-2 years (dermal residential + dietary food and drinking water exposures); and 130 for children 1-2 years (incidental oral residential + dietary food and drinking water exposures). Because EPA's level of concern for trifloxystrobin is a MOE of 100 or less, these MOEs 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). Trifloxystrobin is not expected to pose an intermediate-term risk based on a short soil half-life (approximately 2 days).

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, chemical name 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 trifloxystrobin residues.

Adequate enforcement methodology (gas chromatography with nitrogen phosphorus detection (GC/NPD), Method AG-659A and liquid chromatography with tandem mass spectrometry detection (LC/MS/MS), Method No. 200177) 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 United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for trifloxystrobin on artichoke, globe. Therefore, international harmonization is not an issue.

Therefore, a tolerance is established for residues of trifloxystrobin, [benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene] amino]oxy]methyl]-methyl ester], in or on artichoke, globe at 1.0 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (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. 801 et 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 the Federal 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:

Executive Summary

Beginning in 2014, all non-grandfathered health plans in the individual and small group market, and other plans will cover the essential health benefits (EHB), as defined by the Secretary of Health and Human Services (the Secretary). The Affordable Care Act directs that the EHB reflect the scope of benefits covered by a typical employer plan and cover at least the following 10 general categories of items and services: Ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care. EHB will promote predictability for consumers who purchase coverage in these markets, facilitate comparison across health plans, and ensure that individual and small group subscribers have the same access to the same scope of benefits provided under a typical employer plan.

This final rule includes data reporting standards for health plans that represent potential State-specific benchmark plans. Specifically, the final rule establishes that issuers of the largest three small group market products in each state report information on covered benefits.

In addition, this rule establishes the first phase of a two-phased approach for recognizing accrediting entities to implement the standards established under the Affordable Care Act for qualified health plans (QHPs) to be accredited on the basis of local performance by an accrediting entity recognized by the Secretary on a timeline established by the Exchange and addresses some data sharing and performance requirements of the recognized accrediting entities. In phase one, the National Committee for Quality Assurance (NCQA) and URAC are recognized as accrediting entities on an interim basis. In phase two, a criteria-based review process will be adopted through future rulemaking.

Section 2707 of the Public Health Service Act, as added by section 1201 of the Affordable Care Act, directs that, for plan years beginning on or after January 1, 2014, health insurance issuers offering non-grandfathered plans in the individual or small group market ensure such coverage includes EHB as described in section 1302(a) of the Affordable Care Act. Section 1302 of the Affordable Care Act provides for the establishment of EHB, to be defined by the Secretary. The law also directs that EHB reflect the scope of benefits covered by a typical employer plan and cover at least the 10 general categories of items and services previously listed. Section 1302(b)(4) of the Affordable Care Act further establishes that the Secretary define EHB such that it:

• Sets an appropriate balance among the 10 general categories;

• Does not discriminate based on age, disability, or expected length of life;

• Takes into account the health care needs of diverse segments of the population; and

• Does not allow denials of essential benefits based on age, life expectancy, disability, or degree of medical dependency and quality of life.

Section 1302(b)(4) of the Affordable Care Act further directs the Secretary to consider the provision of emergency services and dental benefits when determining whether a particular health plan covers the EHB. Finally, sections 1302(b)(4)(G) and (H) of the Affordable Care Act direct the Secretary to periodically review the EHB, report the findings of the review to the Congress and to the public, and update the EHB as needed. A bulletin on HHS's intended benchmark approach to defining essential health benefits was made available for comment on December 16, 2011 (EHB Bulletin). 1

Section 1311(c)(1)(D)(i) of the Affordable Care Act provides that in order to be certified as a QHP and operate in an Exchange, a health plan must be accredited by a recognized accrediting entity on a uniform timeline established by the applicable Exchange. In a separate rule titled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers” (Exchange Rule) published in the March 27, 2012 Federal Register (77 FR 18310), HHS finalized 45 CFR 156.275, specifying that a QHP issuer must be accredited by an entity recognized by HHS.

The Data Collection to Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans proposed rule was published in the Federal Register on June 5, 2012 and the comment period closed on July 5, 2012 (77 FR 33133). In total, we received 80 public comments on the proposed regulation.

We received numerous comments on the EHB data collection portion of the proposed rule. Commenters represented a variety of stakeholders, including issuers, states, consumer groups, and others interested parties. We received a number of comments in support of the proposed data collection, including the required submission of data on treatment limitations, prescription drug coverage, and other descriptive information for small group plans.

Commenters also recommended specific uses of the data we proposed to collect, for example that consumers and states have access to the data. Several commenters urged HHS to use the data for specific purposes, such as to ensure that certain services are covered, that plans are not discriminatory, that prescription drug coverage is comparable to a typical employer plan and that benefit limits do not reduce actuarial value (AV). We note that the purpose of the data collection in this final rule is to collect benefit and coverage information from potential benchmark plans. Accordingly, we addressed comments on potential uses of the data collected to the extent that they are related to the development of benchmark plans.

We received a number of comments that fall outside of the scope of this regulation, which is specific to data collection from certain issuers to support the definition of essential health benefits. Because we intend to publish additional rules on EHB standards in the future, we do not specifically address these comments in this final rule.

We also received numerous comments on the proposed rule regarding recognition of accrediting entities. Commenters represented a diverse set of stakeholders including but not limited to accrediting entities, healthcare provider organizations, consumer groups, health plans, industry experts, and members of the public. The vast majority of commenters supported the recognition of NCQA and URAC for the accreditation of QHPs in the interim phase one and agreed with the proposed provisions that we outlined in the NPRM. We received a number of comments on the timeline, financial and operational requirements for accreditation, the Federally Facilitated Exchange (FFE), the broader quality requirements in the Affordable Care Act, network adequacy and access standards for QHPs, coordination of quality requirements inside and outside Exchanges, and Exchange requirements. We have not addressed such comments and others that are outside the scope of this final rule. HHS will be releasing future rulemaking and guidance on these other topics. Several commenters requested clarifications regarding the future recognition process for accrediting entities, clinical quality measures criteria, accreditation standards related to network adequacy and access, documentation and data sharing requirements. In this final rule, we have responded to comments submitted in response to the recognition of entities for the accreditation of QHPs within the scope of the proposal and this final rule.

Under § 156.120(a), we proposed definitions for terms that are used throughout the section. For the most part, the definitions presented in § 156.120(a) were taken from existing regulations.

We proposed to define “health benefits” as “benefits for medical care, as defined at § 144.103 of this chapter, that may be delivered through the purchase of insurance or otherwise.” This proposed definition is adapted from the definition of health benefits finalized in the Early Retiree Reinsurance Program regulation at 45 CFR 149.2.

We proposed that for the purposes of this data collection “health plan” has the meaning given to the term “portal plan” in § 159.110 of this chapter, which is the discrete pairing of a package of benefits and a particular cost sharing option (not including premium rates or premium quotes). We note that a “portal plan” is collected as a unique combination of benefits, which may include optional benefits available for an additional premium (often referred to as “riders”) as well as benefits that are legally considered riders but are not optional for consumers (“mandatory riders”), if those benefits are part of the most commonly purchased set of benefits within the product by enrollment.

We proposed that “health insurance product” has the meaning given to the term at § 159.110 of this chapter, which is a package of benefits that an issuer offers that is reported to state regulators in an insurance filing. We proposed that “small group market” has the meaning given to the term in § 155.20 of this chapter, which is the meaning in section 1304(a)(3) of the Affordable Care Act. We also proposed that “State” has the meaning given at § 155.20. We noted that the Public Health Service Act definition of “State” that would apply to section 2707(a) is broader than the definition in section 1304 of the Affordable Care Act.

We proposed that “treatment limitations” have the meaning found in § 146.136 of this chapter, which includes both quantitative and nonquantitative limits on benefits. Examples of quantitative limits include limits based on the frequency of treatment, days of coverage, or other similar limits on the scope and duration of treatment. Examples of nonquantitative limits include prior authorization and step therapy requirements. In response to comments received on this proposal, we are changing the definition of “treatment limitations” for the purpose of this final rule to include only quantitative limits.

Additionally, throughout the proposed rule we referred to “issuers,” which is defined in previous rulemaking at 45 CFR 156.20.

Comment: We received several comments on the treatment of riders, or optional benefits available for an additional premium, under proposed § 156.120. Commenters requested that HHS clarify the treatment of riders with respect to EHB; specifically some commenters recommended that HHS collect information on riders made available as part of a plan and stated that benefits offered through riders be considered part of EHB. Another commenter expressed concern that the definition of “health insurance product” included in the final rule could make it difficult for issuers and states to identify the largest plan within that product as a benchmark option.

Response: In response to these comments, we now use the term portal plan defined in § 159.110 for this identification in the final rule, which as described above may include riders. The issuers subject to this reporting requirement will submit the requested benefit data on the largest plan by enrollment within that product. By using the “portal plan” definition for this data collection, the largest plan by enrollment will be comprised of the most commonly purchased unique set of benefits, which may include riders.

In § 156.120(b), we proposed that certain issuers of applicable plans described in paragraph (c) of this section submit certain benefit and enrollment information to HHS. We stated that this information could be used by HHS and eventually states, Exchanges, and issuers to define, evaluate, and provide the EHB.

First, at § 156.120(b)(1), we proposed that the relevant issuers would submit administrative data necessary to identify their health plan. Since an issuer may offer multiple similar plans within a product, this information is critical to the identification of a single, uniquely identified benchmark plan.

At § 156.120(b)(2), we proposed that the relevant issuers would submit data and descriptive information on the plans identified in paragraph (d) in four areas. Additional detail describing the specific data elements that issuers would submit can be found in the revision of the currently approved Health Insurance Web Portal information collection request (ICR). The ICR is approved under OCN: 0938-1086, and is available to the public under a notice and comment period separate from the notice of proposed rulemaking. That notice and comment period is ongoing until August 5, 2012. Section 156.120(b)(2)(i) proposed that certain issuers submit information on covered health benefits in the applicable plans to be used to define certain benchmark plan options.

In section 156.120(b)(2)(ii), we proposed to collect from issuers data on treatment limitations imposed on coverage, if applicable. For example, a quantitative scope and duration treatment limitation might limit a physical therapy benefit to 10 physical therapy visits per year.

At § 156.120(b)(2)(iii), we proposed to collect data on drug coverage. This would include a list of covered drugs and whether each drug is subject to prior authorization and/or step therapy. In response to comments received on this proposal, we no longer intend to collect data on prior authorization and/or step therapy for drug coverage.

At § 156.120(b)(2)(iv) we proposed to collect plan enrollment data, which is discussed in more detail in the “Plans Impacted” section below.

Comment: Many commenters requested that HHS collect data in addition to the elements listed in the proposed rule, such as data on exclusions, medical necessity, habilitative services, cost-sharing (including premiums and co-pays), additional drug data, additional data on treatment limits, and a more extensive list of benefits.

Response: We believe the data collection proposed balances a minimal data collection burden on issuers while being sufficient to support the establishment of a potential benchmark for each state. Therefore, we are not requiring issuers to report any additional data elements in this final rule.

Comment: Some commenters expressed concern with the data collection of treatment limitations, particularly with regard to nonquantitative treatment limits, stating that the data elements are related to product design as opposed to benefit coverage and that the data are not necessary to establish EHB standards. Others expressed concern with the collection of prescription drug formularies.

Response: We believe that the data collection described in the proposed rule reflects the appropriate balance between the need to collect data that are sufficiently specific to establish benchmark plans while minimizing the burden on issuers. However, we agree with the commenters that the data on nonquantitative limits are not necessary for benchmark plan purposes and are therefore amending our definition of treatment limitations and data collection to include only quantitative limits. We encourage commenters to continue to submit comments on the PRA package associated with this rule.

Comment: Two commenters expressed concern that the proposed data collection asks for information that is proprietary and confidential.

Response: The data HHS intends to collect are part of the contract agreement between the issuer and enrollees in the plan and available to every enrollee. Therefore, we believe issuers will not experience adverse commercial effects as a result of reporting the data.

Comment: Some commenters recommended that HHS leverage data already collected by states and by HealthCare.gov for purposes of establishing default benchmark plans and urged HHS to synchronize the collection of data described in the proposed rule with data collection to support HealthCare.gov.

Response: The benefit data are consistent with the data collected to support HealthCare.gov. We believe it is necessary to collect additional information related to treatment limitations and drug coverage to establish the definition of essential health benefits. We also note that the data we intend to collect to establish potential benchmark plans are more recent and at a plan level.

Comment: Several commenters requested that HHS clarify specific data elements of the proposed data collection, for example that HHS describe the level of specificity and establish the format for data submission. One commenter recommended that HHS modify the language in its data collection on drugs from “drug coverage” to “formulary” and urged HHS to ensure a flexible prescription drug benefit.

Response: We refer commenters to the relevant parts of the PRA package associated with the NPRM and available at http://www.cms.gov/Regulations-and Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS1247405.html. The PRA package includes additional information on the data HHS intends to collect with regard to treatment limitations, as well as a list of the data elements.

Section 156.120(c) of the proposed regulation specified that these reporting requirements would apply only to certain issuers. Specifically, we proposed to collect data from the issuers in each state that offer the three largest health insurance products, by enrollment, in that state's small group market. We proposed that enrollment data submitted to www.HealthCare.gov would be the source of product enrollment and therefore, the products eligible to be benchmarks based on enrollment (described in part 159 of this title) on March 31, 2012, the date set forth in the December 16, 2011 EHB bulletin. State data may vary from www.HealthCare.gov data, and we requested comment on whether states should be permitted to use an alternative data source for determining the enrollment in the small group market. We also solicited comment on whether closed block products or association products should be included as options in the selection of the largest three products.

Under the approach outlined in the EHB bulletin, states would be permitted to select their own benchmark plans from a set of options. State submissions of these selections are information collections under the PRA. As part of the PRA package, we requested comment on the draft instructions for states to submit benefits for their selected benchmark plan.

Comment: Several commenters made recommendations with respect to which plans should be available as benchmark plan options. Some commenters recommended that HHS exclude association plans and plans closed to new enrollment as benchmark plan options. In contrast, a few commenters stated that plans closed to new enrollment should be available as benchmark plan options.

Response: As described in the EHB Bulletin, HHS intends to propose that EHB be defined in reference to one of four benchmark plan options. With respect to potential default benchmark plans, we refer commenters to the guidance published on July 2, 2012, titled “Essential Health Benefits: List of the Largest Three Small Group Products by State,”  2 which provides a state-by-state list of small group market products available for selection as benchmark plans.

Comment: Several commenters expressed concern that HHS is only collecting data on the small group market benchmark options.

Response: We note that this regulation is narrow in scope and collects data in order to establish potential default benchmark plans in each state. As stated in the EHB Bulletin, the default benchmark plan in each state is the largest small group market plan within the largest small group market product by enrollment, supplemented to reflect coverage in the 10 statutory benefit categories.

Comment: Several commenters recommended that HHS consider additional data to establish EHB, such as national claims data or data from Medicaid.

Response: Our proposed data collection from issuers is consistent with the benchmark approach described in the EHB bulletin, which uses a typical employer plan as a reference to define EHB.

In § 156.120(d), we proposed that issuers of the largest three products in each state provide information based on the plan with the highest enrollment within the product. For purposes of identifying the benchmark plan, we proposed to identify the plan following the definition of “portal plan” in § 159.110 of this chapter.

We stated in the proposed rule that issuers may use their own data to determine which plan within each product has the highest enrollment, although we expect that for many products, the benefits will be the same across plans within the product. We also specified that enrollment data should reflect a plan's entire service area and to the extent possible should align with the timing of the www.HealthCare.gov data collection (reflecting enrollment as of March 31, 2012). We requested comment on the necessity of plan-level specificity.

Comment: Several commenters offered feedback on the enrollment data used to identify the plans eligible for benchmark consideration. Several comments supported the use of the HealthCare.gov for determining enrollment. Commenters also urged HHS to allow states to use their own enrollment data and recommended that if state enrollment data conflict with HealthCare.gov data, the state data should be considered. In contrast, one commenter recommended that if state enrollment data are permitted, states should be required to demonstrate that the state data are more accurate.

Response: The guidance published on July 2, 2012, titled “Essential Health Benefits: List of the Largest Three Small Group Products by State,”  3 clarifies the small group market products that are available for benchmark plan consideration in each state. In developing this list, HHS worked with states to reconcile enrollment data from HealthCare.gov with state data when necessary.

Finally, § 156.120(e) proposed that issuers described in subparagraph (c) submit the information described in subparagraph (b) to HHS in a form and manner to be determined by HHS. We stated that we intend to make information on final state selections of benchmarks publicly available as soon as possible so that issuers can use it for benefit design and rate setting for 2014. We intend to publish the State-specific benchmarks for notice and comment and then finalize those benchmarks, as approved by the Secretary. We welcomed public comment on this approach.

Comment: Several commenters requested additional guidance on the schedule for collecting data pursuant to this final rule.

Response: We clarify in this final rule that the submission window for applicable issuers will open upon the effective date of this final regulation and remain open until September 4, 2012. Issuers will use the Health Insurance Oversight system to make these submissions.

Comment: Several commenters urged HHS to make the data collected pursuant to this final rule, including data on benefits, treatment limits, and prescription drugs, publicly available to all stakeholders. Several commenters urged HHS to release these data as soon as possible. In addition, some commenters recommended that HHS establish a federal oversight role in the evaluation and approval of state-specific EHB packages.

Response: HHS intends to publish State-specific benchmarks for notice and comment.

Section 1302(b) of the Affordable Care Act outlines the ten statutory benefit categories, including pediatric oral care, which must be covered by applicable plans. Section 1302(b)(4)(F) allows QHPs in an Exchange in a state to choose not to offer coverage for pediatric oral services provided that a stand-alone dental benefit plan that covers pediatric oral services is offered through the same Exchange. In order for QHPs to know whether their plan design must include pediatric oral services, issuers need to know if stand-alone dental plans would be offered through their Exchange. To facilitate and streamline the communication of this information, we proposed to collect, on a voluntary basis, information from likely stand-alone dental issuers to find out whether various Exchanges are likely to have stand-alone plans as options.

Comment: One commenter expressed concern that the data collection from stand-alone dental plans described in the proposed rule would be voluntary, and recommended that HHS require QHPs to offer pediatric dental benefits unless there is confirmation that a stand-alone dental plan will be offered.

Response: We appreciate the commenter's concern and note that the goal of this data collection is to begin the process of identifying which issuers intend to offer stand-alone dental coverage in Exchanges. We believe that a requirement is not necessary and this voluntary collection was only proposed to facilitate the most efficient exchange of information between issuers.

Section 1311(c)(1)(D)(i) of the Affordable Care Act directs a health plan to “be accredited with respect to local performance on clinical quality measures * * * by any entity recognized by the Secretary for the accreditation of health insurance issuers or plans (so long as any such entity has transparent and rigorous methodological and scoring criteria).” HHS has determined that recognizing entities through an interim phase one process is necessary to meet the timeline for Exchange QHP certification activities and may include the accreditation requirement, depending on the uniform timeline established by an Exchange. In the proposed rule, we stated that after a survey of the market, to HHS's knowledge, only two entities that accredit health plans meet or plan to meet the statutory requirements this year. We proposed recognition of the National Committee for Quality Assurance (NCQA) and URAC on an interim basis for the purpose of accreditation of QHPs, subject to the conditions specified in paragraphs (c)(2), (c)(3), and (c)(4) of § 156.275 of the proposed rule. As such, we proposed for this recognition to be effective once these conditions are met, at which time HHS would provide notification in the Federal Register . We requested comment on whether or not there are other accrediting entities that meet or would meet the statutory requirements this year.

In addition, we proposed certain data sharing and performance standards for the recognized accrediting entities.

We are making a technical correction in this final rule to clarify that both NCQA and URAC currently meet certain statutory requirements for accreditation. At the time the proposed rule was published, we did not include the fact that URAC had already released its Health Plan Accreditation Program Version 7 effective January 3, 2012, which includes reporting on a CAHPS survey and a set of clinical performance measures which are statutorily required to be considered as part of accreditation. Here, we clarify that both entities have already issued health plan accreditation standards that meet the conditions for recognition as detailed in paragraphs (c)(2)(ii), (c)(2)(iv) and (c)(3) of this rule.

Comment: The vast majority of commenters expressed support for recognizing NCQA and URAC in phase one of the process to recognize accrediting entities. Commenters agreed with provisions to identify these two entities in this interim phase and encouraged HHS to finalize its recognition of NCQA and URAC as soon as possible.

Response: We intend to provide notification in the Federal Register to make this recognition effective once the documentation requirements in (c)(4) are satisfied.

Comment: One commenter stated that the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) should be recognized as an accrediting entity for the purposes of QHP certification in addition to the NCQA and URAC in the phase one recognition process. The commenter contends that AAAHC meets the requirements for the phase one recognized accrediting entities.

Response: Upon review of the AAAHC's accreditation processes and standards, we believe that, currently, the AAAHC does not meet the statutory requirements necessary to be recognized for phase one. Our review indicates that the AAAHC does not currently score clinical quality and CAHPS data from health plans as part of accreditation in a standardized, comparable way across health plans using transparent and rigorous methodological and scoring criteria, as directed by section 1311(c)(1)(D)(i) of the Affordable Care Act and 45 CFR156.275(c)(3), which is finalized in this rule. We believe that the methodology and scoring criteria for accreditation by recognized accrediting entities is a significant requirement that contributes to the strength and validity of the accreditation of QHPs. For these reasons, the statutory accreditation requirements for QHP issuers would not be met if AAAHC were recognized as an accrediting entity as part of the phase one recognition process. In the final rule, we are maintaining the proposed recognition of the NCQA and URAC in the interim phase one process of recognizing accrediting entities. We encourage entities that would like to be recognized as accrediting entities for the purposes of fulfilling the accreditation requirement for QHPs in the future to prepare and plan to apply for the phase two recognition process. We anticipate that the future recognition process will, at a minimum, require accreditation on local performance in the nine categories specified in 45 CFR 156.275(a)(1) and clinical measures that span a broad range of conditions and domains.

Comment: Two commenters requested that CMS establish an accreditation recognition process that enables New York and other states with rigorous issuer regulation, state licensing and quality monitoring requirements to be recognized as accrediting entities in phase one such that accreditation by entities such as NCQA and URAC is unnecessary if QHP issuers are licensed in such states. The commenters state that the licensing and oversight processes and standards in New York exceed those of NCQA and URAC.

Response: The standards described by commenters are currently for state licensing and oversight requirements and not for accreditation of health plans. However, the statute specifically directs that QHPs be accredited and that the Secretary recognize accrediting entities. In the final rule, we are maintaining the proposed recognition of the NCQA and URAC in the interim phase one process of recognizing accrediting entities. However, we will consider the role of states in the phase two recognition process for accrediting entities.

Comment: One commenter requested a specific public deadline for URAC to obtain full approval as a recognized accrediting entity so that QHPs may confidently choose their accreditation provider and begin their accreditation process immediately. The commenter suggests that if URAC does not meet full approval for being a recognized accrediting entity by a specified deadline, that the accreditation requirement be delayed until sufficient accrediting entity choices are available.

Response: As noted, we have made a technical correction to the proposed rule to accurately state that URAC has already released its Health Plan Accreditation Program Version 7 which includes reporting on a CAHPS survey and a set of clinical performance measures. We intend to recognize both URAC and the NCQA as recognized accrediting entities for the interim phase one recognition process once both entities fulfill the documentation requirements finalized in § 156.275(c)(4).

Comment: One commenter requested clarification regarding which health plan accreditation program URAC is proposing because there are multiple materials referenced including Health Plan Accreditation Program 7.0, Health Insurance Exchange Version 7.1 and measures Version 1.3

Response: We clarify that URAC's publicly released Health Plan Accreditation Program Version 7 includes the standards that meet the statutory requirements to be recognized as an accrediting entity of QHPs and has been effective since January 3, 2012.

Comment: Several commenters expressed concern that NCQA or URAC accreditation is not the best measure of the quality and effectiveness of Consumer Operated and Oriented Plans (CO-OP). The commenters are concerned that the accreditation processes of NCQA and URAC do not adequately address many of the key goals established for CO-OPs under the Affordable Care Act, including member control, consumer focus and benefit delivery innovation. Commenters proposed that the accrediting entities modify their accreditation processes to include a focus on the unique nature of CO-OPs.

Response: Pursuant to 45 CFR 156.520(e)(2), CO-OPs must meet the same accreditation standards as other QHPs. We maintain, in this final rule, the recognition of accrediting entities for phase one. We will consider the unique goals established for all QHPs including CO-OP plans as we develop the requirements for the phase two recognition process.

We proposed that the recognition as an approved entity for accreditation of QHPs is effective until it is rescinded or this interim phase one process is replaced by the process that we intend to identify in future rulemaking. We proposed for the future phase two recognition process to include an application procedure, standards for recognition, criteria-based review of applications, public participation, and public notice of the recognition for entities seeking to become a recognized accrediting entity. We welcomed comments to inform this future rulemaking.

Comment: A few commenters stated that recognized accrediting entities' accreditation processes should be equally rigorous, include comparable accreditation results and use consistent standards. One commenter urged CMS to establish standards as part of the phase two recognition process, then compare these standards with the phase two accrediting entities' standards to recognize them as accrediting entities for the purposes of QHP accreditation.

Response: We agree that recognized accrediting entities should have rigorous, comparable processes and standards. We will consider the commenter's suggestion regarding use of a crosswalk to compare and ensure that each recognized accrediting entity meet the standards for the phase two recognition process. We will be establishing these standards in future rulemaking and will replace the phase one process codified in § 156.275(c)(1).

Comment: One commenter requested clarification and public transparency of a timeline for moving from phase one to phase two of recognizing accrediting entities. The commenter questioned whether the proposed phases will align with the phased approach also being planned for new quality reporting and display requirements. The commenter recommended that HHS consider the different timelines across Exchanges for requiring accreditation of QHP issuers.

Response: We intend to establish through future rulemaking the recognition process of accrediting entities to align with the timeframe of other quality reporting requirements, including establishing a quality rating system. We recognize that it is important to coordinate these requirements for effective quality reporting and minimal burden on issuers. We will consider commenters' recommendations regarding the phase two recognition process as we develop future rulemaking.

Comment: One commenter requested clarification that the recognized accrediting entities from phase one would need to go through the full application process proposed for phase two rather than be grandfathered into phase two recognition.

Response: As we stated in the proposed rule, we maintain that the recognition of accrediting entities in phase one is effective until it is rescinded or this interim phase one process is replaced by the phase two process. We are clarifying that a phase one recognized accrediting entity must complete the application to be recognized for the phase two recognition process that we intend to identify in future rulemaking. We intend to propose in future rulemaking that the accreditation that is obtained from NCQA or URAC would be recognized for the purposes of QHP certification until this accreditation expired, regardless of whether NCQA or URAC continue to be recognized as accrediting entities in the future phase two recognition process.

Comment: A few commenters requested HHS to clearly distinguish the broader quality requirements on Exchanges and health insurance issuers and stated that accreditation should not be considered a permanent substitute for such requirements.

Response: We acknowledge that accreditation is not a substitute for the broader quality requirements included in the Affordable Care Act. We intend to issue rulemaking and welcome future public comment and stakeholder input regarding the quality requirements on Exchanges and health insurance issuers.

Comment: One commenter recommended that HHS monitor fees that accrediting entities charge and to potentially place a limit on fees that may not be included in the medical loss ratio (MLR) calculation. The commenter recommended that the criteria for review in the phase two recognition process for accrediting entities include full transparency in pricing.

Response: Accreditation user fees are part of the quality improvement component of MLR under 45 CFR 158.150(b)(2)(i)(5). We believe more entities will apply to meet the standards that we will be issuing for the phase two recognition process for accrediting entities, increasing competition.

We proposed that the first condition of recognition is based on section 1311(c)(1)(D)(i) of the Affordable Care Act, which requires accreditation on local performance in nine categories, which are codified in 45 CFR 156.275(a)(1):

• Clinical quality measures such as the Healthcare Effectiveness Data and Information Set (HEDIS);

• Patient experience ratings on a standardized Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey;

• Consumer access;

• Utilization management;

• Quality Assurance;

• Provider credentialing;

• Complaints and appeals;

• Network adequacy and access; and

• Patient information programs.

We proposed in § 156.275(c)(2)(ii) that the clinical quality measures meet certain criteria in order for the accreditation to meet the requirements outlined in section 1311(c)(1)(D) of the Affordable Care Act and 45 CFR 156.275(a)(1)(i). These criteria were chosen based on stakeholder input and to ensure that the clinical quality measures used in accreditation are applicable to the Exchange enrollee population.

We proposed that the clinical quality measure set must:

• Span a breadth of conditions and domains, including, but not limited to, preventive care, mental health and substance abuse disorders, chronic care, and acute care;

• Include measures that are applicable to adults and separate measures that are applicable to children;

• Align with the priorities of the National Strategy for Quality Improvement in Health Care issued by the Secretary and submitted to Congress on March 12, 2011 (see http://www.healthcare.gov/law/resources/reports/quality03212011a.html ) and the National Quality Strategy: 2012 Annual Progress Report released by HHS on April 30, 2012 (see http://www.healthcare.gov/news/factsheets/2012/04/national-quality-strategy04302012a.html );

• Only include measures that are either developed or adopted by a voluntary consensus standards setting body (such as those described in the National Technology and Transfer Advancement Act of 1995 (NTTAA) and Office of Management and Budget (OMB) Circular A-119 (1998)) or, where appropriate endorsed measures are unavailable, are in common use for health plan quality measurement and meet health plan industry standards; and,

• Be evidence based.

We solicited comments on these standards for clinical quality measures, including whether additional standards for such measures should be included, the standards for using endorsed and non-endorsed measures, and whether HHS should require entities seeking recognition as accrediting entities to review specific clinical measures as part of accreditation and if so, which ones.

Comment: One commenter recommended additional criteria for clinical quality measures to include domains such as outcomes and process apart from access and patient satisfaction, be risk-adjusted when appropriate, be scientifically sound and be periodically updated for use within the accreditation standards. A few commenters recommended prioritizing measures that are being used concurrently by public and private sector purchasers and payers. Commenters also suggested that HHS require accrediting entities to review health plan processes including marketing practices, member privacy, language access services and health plan efforts to reduce health care disparities and to provide culturally competent services.

Response: Much of the recommended criteria for clinical quality measures are already current components of accreditation standards and processes of the accrediting entities being recognized in the interim phase one. In this final rule, we are maintaining the standards that we proposed for clinical quality measure sets but will consider the additional suggested criteria in future rulemaking on phase two.

Comment: Several commenters expressed concern that clinical quality measure standards used by current accrediting entities and the CAHPS survey process do not include people with disabilities. Several commenters recommended that phase two recognition process requirements for recognized accrediting entities should include standards for clinical quality measures that address the needs of people with disabilities and that specifically address persons in need of habilitative and rehabilitative services and devices. Commenters suggested that the accreditation process should address habilitative and rehabilitative related quality measures, the evaluation of quality of life beyond that represented by the typical quality indicators and network adequacy.

Response: As part of future rulemaking on the phase two recognition process, we will consider these standards.

Comment: One commenter requested clarification regarding which CAHPS survey will be used to measure patient experience or whether a future CAHPS survey will be developed. The commenter opposed the use of instruments such as the CAHPS Surgical Care Survey and the Clinician/Group CAHPS as proposed measure tools and recommended inclusion of all types of providers such as advanced practice registered nurses and certified registered nurse anesthetists in any measurement tools developed to adequately capture the patient and caregiver experience.

Response: We are finalizing the requirement that the recognized accrediting entities require accreditation on local performance in patient experience ratings on a standardized CAHPS survey. We are not specifying which CAHPS surveys that the recognized accrediting entities must use as part of accreditation but expect that the recognized accrediting entities will use health plan CAHPS surveys and will not use the surgical care and/or Clinician/Group CAHPS surveys.

Comment: Several commenters expressed support that accreditation include, to the extent possible, measures that are already developed or endorsed by recognized consensus standards setting bodies. A few commenters stated that measures should be based on national standards such as National Quality Forum (NQF) endorsed measures. One commenter requested clarification regarding the language related to measures that are developed or adopted by a voluntary consensus standards setting body. This commenter recommended that CMS specify that measure sets used for QHP accreditation only include measures that are endorsed by the entity with a contract with the Secretary, which is currently only the National Quality Forum (NQF).

Response: We agree that NQF plays a significant role in endorsing quality measures. However, we do not require clinical quality measures to either be endorsed by NQF or submitted for review to NQF since recognized accrediting entities may use a diverse measurement set. We maintain the criteria we proposed for the clinical quality measure set. We will consider the commenter's recommendations as we set the measurement standards as part of the future rulemaking on phase two.

Comment: One commenter suggested that the clinical quality measure requirements for recognized accrediting entities include measures that reflect patients' and families' perspectives and measures that advance primary care services and medical homes.

Response: We believe that the patient perspective is captured by the requirement that accreditation include patient experience ratings on a standardized CAHPS survey in 45 CFR 156.275(a)(1). We also maintain in this final rule that clinical quality measures be aligned with priorities of the National Strategy for Quality Improvement in Health Care (“the National Strategy”). The National Strategy includes as core principles, person-centeredness and family engagement, and strengthening primary care using models such as patient-centered medical homes.

Comment: A few commenters recommended requiring independent auditing of results as an additional criterion for clinical quality measures considered as part of accreditation to ensure the accuracy and comparability of results, to provide an important feedback loop for plans, and to instill support among all stakeholders.

Response: While independent auditing of results could be an effective way to assure accuracy and comparability and provide useful verification information to issuers and stakeholders, we maintain in the final rule the criteria we proposed in § 156.275(c)(2)(ii), which was based on diverse stakeholder input.

Comment: One commenter suggested that the phase two recognition process should include clinical measures, such as those from Minnesota Community Measurement, which address health outcomes for patients rather than process measures concerning the kind of care or tests that patients receive. Another commenter suggested that HHS examine and consider adoption of the uSPEQ measurement tool, which incorporates both consumer and employee satisfaction as primary factors in assessing the success of a program and that has been used to evaluate programs from a consumer perspective.

Response: Many of the quality measures currently used by the recognized accrediting entities address patients' health outcomes and patient experience. We will consider clinical health outcomes measures from organizations such as the Minnesota Community Measurement and measurement tools such as uSPEQ when we propose rules on phase two.

Comment: One commenter recommended that recognized accrediting entities require qualified health plans seeking accreditation to submit data on HIV quality measures to ensure that the care supported by qualified health plans can be effectively monitored and evaluated. The commenter suggested that, at a minimum, plans should be required to submit data for HIV measures proposed for Stage II Meaningful Use and to select from measures that are being used by Medicare, Medicaid and the HIV/AIDS Bureau.

Response: The recognized accrediting entities do not currently use an HIV-related quality measure in their accreditation scoring. However, there are such measures under development for accreditation standards. We maintain in the final rule that measures selected should be developed or adopted by a voluntary consensus standards setting body, appropriately endorsed whenever possible and span a breadth of conditions. We support the alignment of measures with existing public and private measurement initiatives and intend to consider other measures during rulemaking for phase two.

Comment: One commenter endorsed HHS's recognition of URAC as an accrediting entity largely because it supports data collection requirements URAC has already implemented to help ensure QHP issuers seeking accreditation are currently complying with the Paul Wellstone-Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The commenter encouraged HHS to require that as a condition of becoming a QHP accrediting entity, NCQA, as well as other possible future QHP accrediting entities, data collection of MHPAEA compliance as part of each QHP's local performance in the nine categories, including utilization management.

Response: We will consider the commenter's suggestion to include data collection related to MHPAEA compliance when we develop standards for the phase two process for recognizing accrediting entities in future rulemaking.

In § 156.275(c)(2)(iii), we proposed that recognized accrediting entities provide separate accreditation determinations for each product type offered by a QHP issuer in each Exchange (for example, Exchange HMO, Exchange point of service (POS) plans, and Exchange preferred provider organization (PPO) plans), based on data submitted by the issuer that are representative of the population of each QHP in that Exchange product type. We believe that the product type is the appropriate level for accreditation as it would balance capturing the QHP experience and enabling the reporting of valid and reliable performance measures. An issuer may offer multiple QHPs under the same product type, in the same Exchange, if the product type for that Exchange is accredited, each of the corresponding QHPs would be considered to be accredited. We solicited comments on the proposed level of accreditation. We also solicited comments on circumstances under which an exception should be made to the accreditation determination being made at the Exchange product type level.

Comment: A few commenters opposed requiring accreditation at the Exchange product type level due to their belief that product type level accreditation is not current market practice and potential challenges of inadequate sample size if accreditation moves to more granular levels. Several commenters expressed support for product type level accreditation to facilitate comparisons based on quality and transparency. One commenter recommended that states should have the responsibility to dictate the product level requiring accreditation because implementation of federally-defined product types would disrupt states' existing regulatory classifications and accreditation requirements for insurance products.

Response: We maintain in the final rule that recognized accrediting entities provide separate accreditation determinations for each Exchange product type since QHP issuers must be accredited on the basis of local performance per § 156.275(a)(1). We believe that accreditation at the overall QHP issuer level would not adequately meet the requirement that QHP issuers be accredited on the basis of local performance. We believe that accreditation at the plan or metal-level would also be unreasonable because of the likely inadequate sample size for reliable performance data reporting.

Comment: One commenter stated that although NCQA generally accredits by product type, which combines product line (that is, Commercial, Medicare, Medicaid or Exchange) with product (that is, HMO, POS or PPO), there are some exceptions. For example, with NCQA approval, issuers can combine HMO and PPO or POS and PPO (or all three) products for HEDIS reporting purposes or they can combine the same product across contiguous states for statistically valid HEDIS and CAHPS results.

Response: We understand that there may be some necessary exceptions to product type level accreditation for methodological reasons. We maintain that recognized accrediting entities provide separate accreditation determinations for each QHP product type offered in an Exchange (for example, Exchange HMO or Exchange PPO). However, we agree that in some instances, such as when sample sizes are inadequate to provide statistically valid results at the Exchange product type level, an exception to Exchange product level accreditation would then be reasonable. In the final rule, we are modifying the requirement that recognized accrediting entities provide accreditation at the Exchange product type level to permit an exception when this Exchange product type level accreditation is not methodologically sound. In such cases, the recognized accrediting entity must demonstrate that the Exchange product type level accreditation is not methodologically sound as a condition of the Exchange granting an exception such as authorizing Exchange product type combinations across contiguous states (for example, Exchange HMO in New York and Exchange HMO in New Jersey.) We encourage Exchanges to collaborate and consult with state Departments of Insurance and other state regulatory and licensing bodies in granting the exception.

Comment: One commenter requested clarification on whether NCQA and URAC will be responsible for accrediting dental plans. The commenter suggested that designated accrediting entities use specific clinical quality measures developed by the Dental Quality Alliance (DQA) to accredit dental plans.

Response: We are not currently requiring that recognized accrediting entities accredit stand-alone dental plans. The Exchange final rule specifies that to the extent that accreditation standards specific to stand-alone dental plans do not exist, 4 then such plans would not be required to meet the accreditation timeline required by 45 CFR 155.1045.

Comment: A few commenters recommended allowing plans to meet Exchange-specific requirements as part of their current accreditation instead of undergoing a separate accreditation process solely for Exchanges. One commenter recommended that at a minimum, issuer-level accreditation on policies and procedures should apply across product types offered within Exchanges.

Response: We agree with commenters and clarify our interpretation of this final rule that the recognized accrediting entities may review policies and procedures at the issuer level, provided that the same policies and procedures apply across an issuer's product lines and product types. We maintain that the recognized accrediting entity must provide accreditation at the Exchange product type level but we do not require recognized accrediting entities to duplicate valid and applicable work or reviews conducted in connection with accreditations provided at a different level for the same issuer.

As part of our proposal that recognized accrediting entities include network adequacy and access in the accreditation standards, we proposed in subparagraph (c)(2)(iv) that the network adequacy and access standards outlined in section 1311(c)(1)(D) of the Affordable Care Act and 45 CFR 156.275(a)(1)(viii) must, at a minimum, be consistent with the general requirements for network adequacy standards for QHP issuers codified in § 156.230(a). We solicited comments on this proposed requirement.

Comment: We received one comment that the current accreditation standards relating to network adequacy in use by NCQA are not fully consistent with the general requirements for network adequacy standards in § 156.230(a) because NCQA does not currently address the inclusion of essential community providers in their network adequacy assessment. However, in its comment on the proposed rule, NCQA stated willingness to work with CMS to address this in their accreditation standards in the future.

Response: We acknowledge that NCQA does not currently capture information regarding essential community providers as part of its current accreditation standards. Because the direction to cover essential community providers is included as a separate provision defined in § 156.235, we are finalizing the rule for the phase one recognition process such that network adequacy and access accreditation standards must be consistent with § 156.230(a)(2) and § 156.230(a)(3) only. A review of the inclusion of essential community providers as part of accreditation standards will not be required in the interim phase one recognition process. This change does not affect the QHP certification standard that QHPs demonstrate essential community provider network adequacy. We will consider proposing that accreditation standards be fully consistent with all general requirements of network adequacy in § 156.230(a) in future rulemaking on phase two.

Comment: One commenter expressed concerns about making network adequacy a part of the accreditation process and stated that it should not be delegated to private accreditors. The commenter believes that this is inherently a regulatory function and should be retained by a regulatory body. One commenter recommends that HHS clearly specify and distinguish the network adequacy responsibilities of Exchanges, QHP issuers, and recognized accrediting entities to ensure that consumers' access and rights are protected and information on provider networks is accurate.

Response: Section 1311(c)(1)(D)(i) of the Affordable Care Act and 45 CFR 156.275(c)(2)(iv) direct that recognized accrediting entities include network adequacy and access in the accreditation standards. We clarify in the final rule that for the phase one recognition process, network adequacy and access accreditation standards should be consistent with § 156.230(a)(2) and § 156.230(a)(3), including maintaining a network that is sufficient in number and types of providers to assure that all services will be accessible without unreasonable delay and is consistent with the network adequacy provisions of section 2702(c) of the PHS Act.

In § 156.275(c)(3), we proposed that each recognized accrediting entity must use transparent and rigorous methodological and scoring criteria, as required by section 1311(c)(1)(D)(i) of the Affordable Care Act. We did not receive comments on this section and are finalizing the provisions as proposed.

In § 156.275(c)(4), we proposed that each accrediting entity recognized by the Secretary, as a condition of gaining and maintaining recognition, provide to HHS its current accreditation processes to demonstrate that the entity meets the conditions described in §§ 156.275(c)(2) and 156.275(c)(3). Documentation should include accreditation standards and requirements, processes, and measure specifications for performance measures. We proposed that the initial submission of documentation be made at a time specified by HHS. We solicited comment on this timing requirement, specifically whether NCQA and URAC may only be recognized if this documentation is provided within a certain number of days of the final rule. Recognized accrediting entities must also submit any proposed changes or updates to the accreditation and measurement process with 60 days notice prior to implementation such that HHS has ample opportunity to review and comment on whether these changes or updates are significant enough to mean that the conditions in §§ 156.275(c)(2) and 156.275(c)(3) would no longer be met. We solicited comments on these documentation standards.

Comment: One commenter recommended a timeframe of ninety days for submission of required documentation by accrediting entities. The accrediting entities being recognized in phase one stated no opposition to submitting documentation within a timeframe specified by HHS; one commented that it would provide documentation at any time it is required. And we received numerous comments in support of the proposed 60 day timeframe for changes and updates.

Response: We only received one comment regarding a specific timeframe for documentation submission. We finalize in this rule that the documentation from recognized accrediting entities, due under § 156.275(c)(4) be provided within 60 days of the publication of this final rule. We believe that 60 days is a reasonable time for accrediting entities to submit their current accreditation processes, standards, and requirements.

Comment: A few commenters requested clarification regarding providing notice on updates or changes to the accreditation and measurement process and providing health plans with adequate time to implement the proposed changes. We received numerous comments in support of the proposed 60 day timeframe for changes and updates. The commenters' recommended that HHS clarify that issuers should be provided with a one year advance notice of changes in accreditation and measurement process. One commenter recommended that regulations should permit accrediting entities to address any errors found in technical specifications within a shorter timeframe. One commenter recommended that HHS seek input from affected stakeholders to determine whether any proposed changes are significant enough to mean that the conditions in §§ 156.275(c)(2) and 156.275(c)(3) would no longer be met. The commenter also requested clarification regarding HHS's turnaround time to review and comment on accrediting entities' planned changes and updates.

Response: In the rule, we finalize this standard to state that recognized accrediting entities submit to HHS any proposed changes or updates to the accreditation and measurement process with 60 days prior to public notice. HHS does not intend to interfere with current practices of accrediting entities to provide advance notice to health plans and agree with commenters that health plans should have adequate time to implement any proposed changes. We also agree with the commenter's recommendation that accrediting entities should correct any errors to technical specifications within a shorter time period. We clarify that recognized accrediting entities do not have to provide advance notice to CMS of non-substantive error corrections. We intend to seek diverse stakeholder input if conditions in §§ 156.275(c)(2) and 156.275(c)(2) are no longer met. We intend to be expeditious during our review of any changes and updates of accreditation and measurement process.

As codified in § 156.275(a)(2), a QHP issuer must authorize the accrediting entity that accredits its QHPs to release to the Exchange and HHS certain materials related to QHP accreditation. In accordance, we proposed that when authorized by an accredited QHP issuer, recognized accrediting entities provide the following accreditation survey data elements to the Exchange in which the issuer plans to operate one or more QHPs:

• The name, address, Health Insurance Oversight System (HIOS) issuer identifier, 5 and unique accreditation identifier(s) of the QHP issuer.

• The QHP issuer's accredited product line(s) (that is, Commercial, Medicaid, Exchange) and type(s) which have been released;

• For each of the QHP issuer's accredited product type(s), HIOS product identifier (if applicable); accreditation status, survey type or level (if applicable); accreditation score; expiration date of accreditation; and clinical quality measure results and adult and child CAHPS measure survey results (and corresponding expiration dates of these data) at the level specified by the Exchange (for example, QHP product or plan level).

Such disclosure was proposed to occur on the following occasions: during the annual certification period or as changes occur to these data throughout the coverage year. We solicited comment, including whether fewer or more categories of information should be included.

The proposed rule would permit Exchanges to arrange additional data sharing agreements with the recognized accrediting entities if they choose, such as information on the QHP issuer's policies and procedures. We solicited comments as to whether recognized accrediting entities must provide this additional information upon request from an Exchange.

Comment: Several commenters recommended that recognized accrediting entities provide the Exchange a copy of the most recent accreditation survey for each accredited product as well as any corrective action plans and summaries of findings or other similar written comments or analysis that is provided to each insurer by the accrediting entities. A few commenters expressed concern regarding the release of proprietary health plan data and data containing sensitive personal health information. The commenters recommended that data sharing should be limited to quality measures and CAHPS survey results that will be displayed and not include the full accreditation survey or additional information that would undermine the accreditation process. One commenter requested that data be shared with state quality improvement organizations for additional oversight.

Response: 45 CFR 156.275(a)(2) directs QHP issuers to authorize the accrediting entity to release to the Exchanges survey-related information such as corrective action plans or summaries of findings. However, we maintain in the final rule that the recognized accrediting entity provide data through data sharing agreements to an Exchange. We interpret this regulation to permit an Exchange the flexibility, through data sharing agreements, to request additional information or to engage in data sharing with another entity, such as a state quality improvement organization. We did not propose the requirement in this rule that recognized accrediting entities share additional data not identified in § 156.275(a)(2) or § 156.275(c)(5) with Exchanges. We agree with the commenters' recommendations that this qualitative information may provide useful insight to an Exchange. We are modifying the data sharing requirements between the recognized accrediting entities and Exchanges to expressly exclude personally identifiable data.

Comment: One commenter requested more information regarding the process for recognized accrediting entities to provide data to Exchanges.

Response: We will be working closely with the recognized accrediting entities to further clarify the process including definitions of data elements.

Comment: One commenter requested clarification on whether accreditation data must be provided on non-Exchange products during early years of the Exchange and whether a recognized accrediting entity can collect authorizations from issuers to release data elements to an Exchange.

Response: Because it will take time for QHP product type specific accreditation to be available, consistent with the proposed rule, recognized accrediting entities will provide accreditation data from a QHP issuer's existing accreditation on non-Exchange products (for example, commercial and Medicaid) if these data are requested by an Exchange, once the QHP issuer authorizes the release of these data. As codified in § 156.275(a)(2), QHP issuers will authorize the release of their accreditation survey data as part of QHP certification.

Comment: One commenter requested clarification regarding what clinical quality and CAHPS measure results data must be reported (for example, numerators and denominators only or more detailed data like member-level survey results).

Response: The clinical quality measure results and adult and child CAHPS measure survey results specified in the final rule refer to only those measure results attained through a QHP issuer's accreditation from a recognized accrediting entity. To allow Exchanges the flexibility to specify the level of detail that is appropriate and reasonable for the QHPs, we are not further defining the level of reporting of these data for each Exchange.

Comment: One commenter requested clarification regarding what is meant by providing clinical or CAHPS data at the level specified by the Exchange. The commenter stated that there should be sufficient numbers for valid data collection by issuers, but not necessarily at the metal (Bronze, Silver, Gold or Platinum) level.

Response: We recognize that adequate sample size for valid data collection is a critical element of accreditation. We maintain that Exchanges should have the flexibility to request clinical and CAHPS data at the QHP product or plan level if there are adequate sample sizes to capture the QHP experience and enable reporting of valid and reliable performance measures.

Comment: One commenter recommended that CMS collect accrediting entity data on plan performance and scoring information of network adequacy requirements to support CMS' network adequacy review and to minimize documentation requirements.

Response: We agree that these data could support the Exchange in the review of network adequacy standards as part of QHP certification; however, at this time, we are not requiring recognized accrediting entities to provide accreditation survey data elements relating to network adequacy requirements, that are in excess of the disclosure required under § 156.275(a)(2), to the Exchange.

This final rule incorporates the provisions of the proposed rule with some substantive modifications, along with additional non-substantive changes to improve clarity, not noted here. Those provisions of the final rule that differ from the proposed rule are as follows:

• Changes the definition of treatment limitations to include only quantitative limits, which also removes the requirement to provide data on nonquantitative limits for purposes of this final rule.

• Establishes a submission deadline for applicable issuers. Issuer submissions are due on September 4, 2012.

• Establishes exception authority to the product type level accreditation requirement when the product type level of accreditation is not methodologically sound. In such cases, the recognized accrediting entity must demonstrate that the Exchange product type level accreditation is not methodologically sound as a condition of the Exchange granting an exception to authorize accreditation at an aggregated level.

• Removes inclusion of essential community providers under the network adequacy standards for accreditation.

• Maintains that network adequacy standards for accreditation be, at a minimum, consistent with general requirements for network adequacy for QHP issuers codified in § 156.230(a)(2) and (a)(3).

• Establishes timeframe of within 60 days of publication of the final rule that an accrediting entity must provide current accreditation standards and requirements, processes, and measure specifications for performance measures to demonstrate that each entity meets the conditions specified.

• Clarifies that recognized accrediting entities must provide to HHS any proposed changes or updates to accreditation standards, processes and measure specifications for performance measures with 60 days prior to public notification.

• Adds an exception to protect personally identifiable information.

As part of the proposed rule, and in accordance with the Paperwork Reduction Act, we sought comment on the information collection requests (ICRs) associated with the proposed rule. This included the of EHB data (§ 156.120) information collections. We received some comments on this section, which are discussed below. As described above, we finalize § 156.120 as it was proposed, with the addition of a deadline for the reporting requirement in § 156.120(e). On June 5, 2012, we issued a 60-day Federal Register notice (77 FR 33221) seeking comments on the revision to the information collection request (ICR), “Health Care Reform Insurance Web Portal Requirements.”  6

In the proposed rule and the June 5, 2012 60-day Federal Register Notice, we also sought comment on ICRs that are not discussed in the regulations text contained in this document, including the state selection of a benchmark and the voluntary data collection from standalone dental plans. We received some comments related to these ICRs, which we will consider before submitting the ICR to the Office of Management and Budget for review and approval. We plan to finalize the ICR on benchmark data collection and stand-alone dental separately from the other portions of the “Health Care Reform Insurance Web Portal Requirements” ICR. The comment period for this package remains open through August 5, 2012, and we encourage interested parties to submit comments.

In the proposed rule, we also sought comment on ICRs for recognized accrediting entities (§ 156.275). We did not receive comments on the accrediting entities ICRs described in the proposed rule. As described above, although we made some changes to § 156.275 in this final rule, the ICRs are unchanged. We also issued a 60-day Federal Register notice seeking comments on these ICRs. 7 That comment period closes on August 1, 2012, and we encourage interested parties to submit comments. Following close of the 60-day comment period, we will submit the accrediting entities ICR to OMB for approval.

What follows is a discussion of comments received on the ICRs related to the EHB data (§ 156.120).

Section 156.120 states that issuers that offer the three largest health insurance products by enrollment in each state's small group market, as determined by HHS based on data submitted in accordance with part 159 of this title for March 31, 2012, must provide the data described in paragraph (b) for the health plan with the highest enrollment within that product. This data collection mirrors the benefit data fields currently collected under the Health Insurance Web Portal PRA package (OCN: 0938-1086) and also includes: The administrative data necessary to identify the health plan, data on covered benefits, any treatment limitations on those benefits, data on drug coverage, and enrollment.

We estimate that it will take four hours for a health insurance issuer to meet this reporting requirement, including data collection, submission, and validation. This estimate is based on current industry surveys collected to monitor the burden of submission of similar data in the Medicare Advantage and Prescription Drug Programs. Given that the three health insurance issuers with the largest products by enrollment in each state (including the District of Columbia) would submit this information, the total burden is estimated to be 612 hours. We anticipate that the reporting requirement would require four hours for one employee at a cost of $77.00 an hour, based on the hourly cost reported by industry in responses to a CMS survey of Medicare Advantage and Prescription Drug Programs which requires employees with similar technical expertise, for a total cost of $308.00 a year per issuer. The total number of respondents required to report would be 153, the largest three issuers/products in each state and the District of Columbia by enrollment, for a total burden of $47,124. Issuers would provide HHS with the data collection requirements through an online tool that we would make available to them.

Comment: We received some comments expressing concern that HHS's burden estimates related to the proposed data collection were too low.

Response: We appreciate these concerns, but for the reasons discussed above, believe that our estimates accurately reflect the burden of reporting.

Comment: One commenter recommended that HHS avoid collection of an “other” benefit category because the category is somewhat ambiguous.

Response: HHS included the “other” category to allow for full reporting of the benefits, including benefits that do not fall into the set of categories provided under HealthCare.gov.

We have examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993) and Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year).

It is HHS's belief that this rule does not reach this economic threshold and thus is not considered a major rule. This rule consists of a data collection from a limited number of health insurance issuers and a data submission by two accrediting entities to HHS. Because of the very limited scope of this final rule, we do not anticipate that there would be any costs associated with this rulemaking in addition to those costs, as outlined below. We derived the costs outlined below from the labor costs as outlined in the Collection of Information section above. The data collection from issuers only applies to the issuers of the three largest products by enrollment in each state's small group market, which would result in a minor economic burden to an estimated 153 issuers, at a total cost across all issuers of $47,124. Additionally, the PRA package that accompanied the proposed rule requested that issuers that wish to offer stand-alone dental plans in an Exchange notify HHS of their intent to participate. We estimate that 20 dental issuers would voluntarily respond, at a total cost across all responding issuers of $770. The two entities which we are recognizing as accrediting entities already meet most of the conditions for phase one of the recognition process, and we anticipate that any required changes to their accreditation processes would be minor and result economic burden that we have estimated at $48,625.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) (RFA) requires agencies to prepare an initial regulatory flexibility analysis to describe the impact of the proposed rule on small entities, unless the head of the agency can certify that the rule would not have a significant economic impact on a substantial number of small entities. The RFA generally defines a “small entity” as—(1) A proprietary firm meeting the size standards of the Small Business Administration (SBA); (2) a not-for-profit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of “small entity.” HHS uses as its measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3 percent.

The RFA requires agencies to analyze options for regulatory relief of small businesses, if a proposed rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. Small businesses are those with sizes below thresholds established by the Small Business Administration (SBA).

As discussed above, this final rule is necessary to implement certain standards related to the establishment of essential health benefits and recognition of accrediting entities as authorized by the Affordable Care Act. Specifically, this rule outlines collecting data from issuers that offer the three largest small group products in each state and from NCQA and URAC, which are the phase one recognized accrediting entities. For the purposes of the regulatory flexibility analysis, we expect the following types of entities to be affected by this final rule—(1) QHP issuers (2) and NCQA and URAC.

As discussed in the Medical Loss Ratio interim final rule (75 FR 74918), few, if any, issuers are small enough to fall below the size thresholds for small business established by the SBA. In that rule, we used a data set created from 2009 National Association of Insurance Commissioners (NAIC) Health and Life Blank annual financial statement data to develop an updated estimate of the number of small entities that offer comprehensive major medical coverage in the individual and group markets. For purposes of that analysis, the Department used total Accident and Health earned premiums as a proxy for annual receipts. We estimated that there are 28 small entities with less than $7 million in accident and health earned premiums offering individual or group comprehensive major medical coverage. However, this estimate may overstate the actual number of small health insurance issuers offering such coverage, since it does not include receipts from these companies' other lines of business. 8 We further estimate that any issuers that would be considered small businesses are likely to be subsidiaries of larger issuers that are not small businesses.

This rule also directs two accrediting entities, NCQA and URAC, to submit documentation to HHS. The RFA, as noted previously, considers a non-profit entity that is not dominant in its field to be a small entity. We selected both NCQA and URAC because they are the two most dominant actors in the field of health plan accreditation. NCQA is a not-for-profit entity that has been in existence since 1990 and is widely recognized as a national leader in developing health care performance measures and quality standards. NCQA has accredited health plans covering over 70 percent of all Americans. 9 URAC is also a not-for-profit entity that was formed over 20 years ago. URAC accredits plans in every state and, according to its Web site, is the largest accrediting body for health care. 10 Finally, based on their dominant role in accrediting health plans, we believe that NCQA and URAC are both likely to have total annual receipts exceeding the Small Business Administration size standard. 11

Based on the foregoing, we are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this final rule would not have a significant economic impact on a substantial number of small entities.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a state, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2012, that threshold is approximately $139 million. UMRA does not address the total cost of a rule. Rather, it focuses on certain categories of costs, mainly those “Federal mandate” costs resulting from: (1) Imposing enforceable duties on state, local, or Tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, state, local, or tribal governments under entitlement programs.

This final rule does not place any financial mandates on state, local, or Tribal governments. This rule authorizes a narrow data collection from an estimated 153 issuers, and the only costs associated with this reporting are labor costs, which we anticipate to total $47,124, which is significantly less than the threshold of $139 million. States may, at their option, select a benchmark plan and submit this information to HHS. We anticipate that it would take each state five hours of labor to complete and submit this information and that the per hour labor cost would be similar to that for the issuer data submission, which is $77 per hour. We cannot reasonably anticipate how many states will respond. However, assuming for the sake of argument that all states respond, the total cost would still be under $20,000, which is well below the $139 million threshold. The rule also sets standards for two accrediting entities to submit documentation to HHS as specified in the rule. We expect the cost to the two accrediting entities to be $48,898.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct costs on state and local governments, preempts state law, or otherwise has Federalism implications. This final regulation, as it relates to the recognition of accrediting entities, does not impose any costs on state or local governments. However, this regulation includes reporting requirements if a state selects a benchmark plan.

In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policy making discretion of the states, HHS has engaged in efforts to consult with and work cooperatively with affected states, including participating in conference calls with and attending conferences of the National Association of Insurance Commissioners (NAIC), and consulting with state insurance officials on an individual basis. We believe that this final rule does not impose substantial direct costs on state and local governments, preempt state law, or otherwise have federalism implications. We note that states that choose to select a benchmark plan would be required to submit their benchmark plan selection to HHS, and provide information on the benchmark plan in the same format that is used by issuers. However, we anticipate that the administrative costs related to this requirement are likely to be minimal because the states are likely to obtain this information from the issuers.

Pursuant to the requirements set forth in section 8(a) of Executive Order 13132, and by the signatures affixed to this regulation, the Department of Health and Human Services certifies that CMS has complied with the requirements of Executive Order 13132 for the attached regulation in a meaningful and timely manner.

For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR subtitle A, subchapter B, as set forth below:

This is a synopsis of the Commission's Report and Order, MB Docket No. 12-115, adopted July 5, 2012, and released July 6, 2012. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street SW., Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or via email www.BCPIWEB.com. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. The Commission will not send a copy of this Report and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability.

The allotment of Channel 287A at Saint Paul, Arkansas is not currently listed in the FM Table of Allotments. Channel 287A at Saint Paul, Arkansas was allotted in MM Docket No. 97-34. See Saint Paul, Arkansas, 62 FR 65765, published December 16, 1997. Cumulus Licensing, LLC, permittee of Station DWYAK-FM, Channel 287A, Saint Paul, Arkansas received a construction permit to operate the station on Channel 287A at Saint Paul, Arkansas. However, the Audio Division subsequently cancelled the construction permit (File No. BNPH-20041230ADG), rendering Channel 287A at Saint Paul, Arkansas a vacant allotment.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: