The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501et seq.,authorizes the establishment of the National List. The National List identifies synthetic substances that are exempted (allowed) and nonsynthetic substances that are prohibited in organic crop and livestock production. The National List also identifies nonsynthetic and synthetic substances that are exempted for use in organic handling. The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under the OFPA to renew such exemptions and prohibitions. If the substances are not reviewed by the NOSB and renewed by the Secretary within 5 years of their inclusion on the National List, their authorized use or prohibition expires under OFPA's sunset provision.

This ANPR announces the sunset of 11 exempted substances and 1 prohibition added to the National List on November 3, 2003 (68 FR 61987) and November 4, 2003 (68 FR 62215), and previously renewed under the sunset process on November 3, 2008 (73 FR 59479). This ANPR establishes November 3, 2013, as the date by which the sunset review and renewal process must be concluded. The exemptions and prohibitions not renewed by this date will be removed from the National List. This ANPR also begins the public comment process on whether the existing specific exemptions on the National List should be continued. This ANPR discusses how the NOP will manage the sunset review and renewal process.

Because these substances may be critical to the production and handling of raw and processed organic agricultural products, their expiration could cause disruption of well-established and accepted organic production, handling, and processing systems. Therefore, the NOP is initiating the sunset review and renewal process now, to provide ample opportunity for the public to make their views known and to inform the decisions of the NOSB.

The NOSB Crops Committee will review the continued exemption (use) of six listings of synthetic substances allowed for use in organic crop production on § 205.601: copper sulfate (2 listings), ozone gas, peracetic acid (2 listings), and EPA List 3 inert ingredients. These six listings are scheduled to sunset (expire) on November 3, 2013. The Crops Committee will also review the continued prohibition of onenonsynthetic substance, calcium chloride, listed on § 205.602, scheduled to sunset on November 3, 2013. Table 1 contains the full listings of crop production substances to be reviewed under the 2013 sunset process.

The NOSB Handling Committee will review the continued exemption (use) of six nonagricultural (nonorganic), nonsynthetic substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s)).” The allowed uses of the following six substances listed on § 205.605(a) are scheduled to expire on November 3, 2013: agar-agar, animal enzymes, calcium sulfate, carrageenan, glucono delta-lactone, and tartaric acid.

The Handling Committee will also review the continued exemption (use) of two nonagricultural (nonorganic), synthetic substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food groups(s)).” The allowed uses of the following two substances listed on § 205.605(b) are scheduled to expire November 3, 2013: cellulose and tartaric acid. Table 2 contains the full listings of handling substances that will be reviewed under the 2013 sunset process.

All substances currently on the National List have been previously evaluated by the NOSB for consistency with OFPA and its implementing regulations. According to § 6517(e) of the OFPA, these substances must be reviewed by the NOSB and renewed by the Secretary for their use or prohibition to continue after 5 years of their addition to the National List which will be November 3, 2013. All substances identified under this notice were previously renewed under the sunsetprocess on November 4, 2008 (73 FR 59479), and must be reviewed again by November 3, 2013.

This notice requests public comments about the continued use or prohibition of the substances identified. Public comments submitted will be considered in the review and renewal process. The NOP will forward comments received under this notice to the NOSB for review. The NOSB will review the listings of allowed and prohibited substances scheduled to sunset, including the public comments received during this review. The NOSB will review each of the substances listed in this notice and may determine that certain substances warrant a more in-depth review and require additional information or research that considers new scientific data and technological and market advances.

Following the NOSB's review, the NOSB will make a recommendation to the Secretary about the continuation of specific exemptions and prohibitions for the substances listed in this ANPR. After the Secretary receives and reviews the NOSB's recommendations, the NOP will publish a proposed rule regarding the NOSB recommendations. This proposed rule will provide an additional opportunity for the public to submit written comments. Comments received on the proposed rule will be used to develop a final rule. Because the sunset review and renewal process involves rulemaking, the NOP believes it is appropriate to initiate the process now for substances scheduled to sunset in 2013.

Written comments responding to this ANPR should be identified with the docket number AMS-NOP-11-0003; NOP-10-13. You should clearly indicate your position on continuing the allowance or prohibition of the substances identified in this ANPR and the reasons for your position. You should include relevant information and data to support your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.).

Comments, regardless of whether they support or do not support the continued use of a substance(s) listed within this ANPR, should provide evidence concerning the viability of alternatives for the substance under sunset review. Viable alternatives include, but are not limited to, alternative management practices that would eliminate the need for the specific substance; other currently exempted substances that are on the National List, which could eliminate the need for this specific substance; and other organic or nonorganic agricultural substances. Such evidence should adequately address whether any alternatives have a function and effect equivalent to or better than the specific exempted substance, and whether you want the substance to be renewed or do not want its use to be continued. Assertions about alternative substances, except for those alternatives that already appear on the National List, should, if possible, include the name and address of the manufacturer of the alternative. Further, your comments should include a copy or the specific source of any supportive literature, which could include product or practice descriptions; performance and test data; reference standards; names and addresses of producers or handlers who have used the alternative under similar conditions and the date of use; and an itemized comparison of the function and effect of the proposed alternative(s) with the substance under review. The information provided in Table 3 can help you describe recommended alternatives for different types of organic operations in place of a current exempted substance that you do not want to be continued.

An Appendix to this ANPR contains worksheets to assist you in gathering relevant information concerning these issues. These worksheets are not required to submit a comment. These worksheets are used by the NOSB to develop their recommendations to the Secretary to include an exempted substance on the National List. You do not have to answer the questions on the worksheets; they are intended only to help you provide substantive comments to the NOSB when you provide comments on the specific substance.

Comments in support of a continued exemption of a substance should demonstrate that the substance is: (1) Not harmful to human health or the environment, (2) necessary to the production of the agricultural products because of the unavailability of wholly nonsynthetic substitute products, and (3) consistent with organic production and handling. Comments in support of a continued prohibition should explain how the use of the substance would continue to be: (1) harmful to human health or the environment, or (2) inconsistent with organic farming and handling.

The current exemptions were originally recommended by the NOSB based on evidence available to the NOSB at the time of review which demonstrated that the substances were found to be: (1) Not harmful to human health or the environment, (2) necessary because of the unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic practices.

If you provide comments that do not support continuing an existing exemption or prohibition, you should provide reasons why the use of the substance should no longer be allowed or prohibited in organic agricultural production and handling. Specifically, comments that support the removal of a substance from the National List should provide information to demonstrate that the substance is: (1) Harmful to human health or the environment; (2) unnecessary because of the availability of alternatives; or (3) inconsistent with organic farming or handling. Comments that do not support a continued prohibition should explain how the use of the substance would not be: (1) harmful to human health or the environment, or (2) inconsistent with organic farming and handling.

The NOP understands that supportive technical or scientific information for synthetic alternatives not currently on the National List may not be easily available to organic producers and handlers. Such information may, however, be available from the research community including universities, or other sources, including international organic programs.

The NOP requests that you comment whether the NOSB should continue to recommend the exemptions and prohibitions listed above on the National List of Allowed and Prohibited Substances for organic agricultural production and handling. All comments will be considered in the development of the NOSB's recommendations to the Secretary.

This Appendix contains worksheets to assist you in gathering relevant information concerning the compatibility of substances with evaluation criteria of the OFPA. These worksheets are not required to submit a comment. These worksheets are used by the NOSB to develop their recommendations to the Secretary to include an exempted or prohibited substance on the National List. You do not have to answer the questions on the worksheets; they are intended only to help you provide substantive comments to the NOSB when you provide comments on the specific substance.

The regulations in 9 CFR part 94 govern the importation into the United States of certain animals and animal products in order to prevent the introduction of specified livestock diseases into the United States. The regulations currently list regions affected with or free of various diseases of livestock. The regulations also list Member States of the European Union (EU) that are part of the APHIS-defined region of the European Union that we recognize as low risk for classical swine fever (CSF). The regulations in 9 CFR part 93 govern the importation of animals into the United States. Part 93 also contains lists of regions affected with certain diseases of livestock and lists of regions where screwworm is considered to exist. It also contains lists of States that are approved by APHIS to receive stallions or mares over 731 days of age that are imported under specified conditions from regions affected with contagious equine metritis (CEM). The regulations in 9 CFR part 98 govern the importation into the United States of animal embryos and semen. Part 98 also lists the Member States of the European Union (EU) that are part of the APHIS-defined region of the European Union that we recognize as low risk for CSF. Each time we add or remove a Member State or other region from a list in the regulations, we must do so through rulemaking in order to change the Code of Federal Regulations.

We are proposing to remove the lists of States approved to receive stallions or mares from regions affected with CEM, the lists of Member States, and most of the other lists of regions from parts 93, 94, and 98 and instead post them to APHIS' Web site. The regulations would provide the Web address and a contact for requesting copies of the lists by mail, fax, or email. The regulations also would explain APHIS' process for adding or removing a Member State or other region to or from the lists. The technical criteria APHIS uses to evaluate whether a region should be added to or removed from a list would not change. With respect to States approved to receive stallions or mares from regions affected with CEM, the regulations currently set forth the conditions States must meet in order to be approved. These conditions would not change.

The proposed action would allow more timely changes to the lists. This should be particularly useful when a region must be added to a list of regions affected with a disease. APHIS considers a disease to exist in a region when we receive reports of an outbreak of the disease in the region from veterinary officials of the national government of the region and/or the World Organization for Animal Health (the OIE), or from another source that the Administrator determines to be reliable;e.g., APHIS inspectors based in foreign countries.

As now, when APHIS determines that a disease is present in a region and presents a potential threat to animal health in the United States, we would take immediate action to restrict imports from that region. We would no longer need to follow that action with an interim rule in theFederal Registerto change text in the regulations. Instead, we would immediately list the region on the APHIS Web site and announce the listing through a notice, rather than a rule, in theFederal Register. The notice would provide an opportunity for public comment.

We would add a region to a list of regions we recognize as free of a particular disease only after completing an evaluation and making it available for public comment. We would do this through a notice in theFederal Register. Following the close of the comment period, we would publish another notice responding to comments and announcing APHIS' decision. The criteria for evaluating a region's disease status, as outlined in 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions,” would not change. Additional details about the factors APHIS reviews to determine a region's status may be found on the APHIS Web site athttp://www.aphis.usda.gov/import_export/animals/reg_request.shtml.

In conjunction with our proposed removal of lists of regions from the regulations, we are proposing to amend part 92 to remove language that states we will do rulemaking to add or remove a region from one of the lists. We are also proposing to amend references in 9 CFR parts 93, 96, and 98 to the lists of regions in part 94. Instead of referring to regions listed “in” the regulations, we would refer to regions listed “under” the regulations.

We are also proposing to replace the term “infected” with the term “affected” in several places where the term is used to describe a region where a disease exists. We generally use the term “infected” when referring to an animal that has a disease, and “affected” when referring to a region in which the disease exists.

We are not proposing in this document to remove the lists in §§ 94.6 and 94.26 of regions free of exotic Newcastle disease or regions where highly pathogenic avian influenza subtype H5N1 is considered to exist because we are addressing the process for amending these lists in a separate rulemaking (see APHIS Docket 2006-0074 athttp://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0074). Similarly, this proposal will not address the lists in § 94.18 of regions from which imports are restricted because of bovine spongiform encephalopathy (BSE) because we are currently evaluating our BSE regulations.

This proposed 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. Currently, rulemaking is required to amend the Code of Federal Regulations to change the disease or pest status of a region. The basis for such a change is either an outbreak of a disease or pest in a foreign region that results in a downgrade in status or an evaluation by APHIS that provides a basis for an upgrade in status. The changes we are proposing would remove the need for rulemaking to change the disease or pest status of a foreign region, while still providing opportunity for public comment on the basis for the action. This action would enable APHIS to respond more quickly to changes in the disease or pest status of foreign regions. We are not proposing to change our criteria for recognizing a region as free of or affected with a disease or pest, or to add or remove any Member State or other region to or from the lists as part of this rulemaking.Similarly, rulemaking is required whenever APHIS approves a State to receive stallions or mares over 731 days of age from regions affected with CEM. The changes we are proposing would remove the need for rulemaking while still providing opportunity for public comment on the basis for the action. We are not proposing to change our criteria for approving a State to receive stallions or mares from CEM-affected regions.

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 proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) No retroactive effect will be given to this rule, and (2) administrative proceedings will not be required before parties may file suit in court challenging this rule.

This proposed rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.).

Accordingly, we propose to amend 9 CFR parts 92, 93, 94, 96, and 98 as follows:

The following correction is made to FR Doc. 2011-11927, published in theFederal Registeron May 17, 2011, on Page 28351, in the center column, under Section XI, “Regulatory Analysis,” third paragraph, seventh line; “ML102380248” is corrected to read “ML102380243.”

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2011-0476; Directorate Identifier 2010-NM-247-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, tohttp://www.regulations.gov,including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2010-0184, dated September 6, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Corrective actions include contacting the FAA or EASA (or its delegated agent) for repair instructions if corrosion is found, and drilling a drain hole. You may obtain further information by examining the MCAI in the AD docket.

Saab AB, Saab Aerosystems has issued Service Bulletin 2000-53-048, Revision 01, dated September 3, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In makingthese changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect 8 products of U.S. registry. We also estimate that it would take 12 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $8,160, or $1,020 per product.

We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this proposed AD. We have no way of determining the number of products that may need these actions.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

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

Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA-2010-1330; Airspace Docket No. 10-ASO-41) and be submitted in triplicate to the Docket Management System (seeADDRESSESsection for address and phone number). You may also submit comments through the Internet athttp://www.regulations.gov.

Annotators wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2010-1330; Airspace Docket No. 10-ASO-41.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded from and comments submitted throughhttp://www.regulations.gov.Recently published rulemaking documents can also be accessed through the FAA's web page athttp://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see theADDRESSESsection for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, room 210, 1701 Columbia Avenue, College Park, Georgia 30337.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace at Rutherfordton, NC to provide controlled airspace required to support new standard instrument approach procedures for Rutherford County Airport. The existing Class E airspace extending upward from 700 feet above the surface would be modified for the safety and management of IFR operations.

Class E airspace designations are published in Paragraph 6005 of FAA order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA has determined that this proposed 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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 proposed rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would amend Class E airspace at Rutherford County Airport, Rutherfordton, NC.

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

Background

On July 15, 1998, the Department published an Advance Notice of Proposed Rulemaking (ANPRM) (63 FR 28128) requesting comment on a variety of issues related to aviation economic data collection. The ANPRM noted that the Origin-Destination Survey of Airline Passenger Traffic (O&D Survey) and Form 41, Schedule T-100—U.S. Air Carrier Traffic and Capacity Data by Nonstop Segment and On-flight Market and Form 41, and Schedule T-100(f)—Foreign Air Carrier Traffic and Capacity Data by Nonstop Segment and On-flight Market (the last two are known collectively as the T-100/T-100(f))O&D Survey and the T-100/T-100(f)) may not provide sufficiently reliable data in some circumstances to ensure that the Department can meet its obligation to disseminate information that enables the transportation system to adapt to the present and future needs of the American public. At that time, we stated our concern that the aviation data systems should be reviewed and modernized in order to meet our statutory responsibilities.

Also, because of difficulties private industry would have in assembling these data, the need for scheduled air traffic information cannot be satisfied other than through governmental means. However, while there are no other sources of comprehensive traffic data available in the aviation industry, a significant market exists in supplying services to supplement the Department's information offerings using the service provider's own statistical insight and experience. The public, academics, manufacturers, airports, air carriers, local, state and various branches of the Federal government all remain dependent on the reliability of this commercially enhanced data.

Approximately 50 comments were filed in response to the ANPRM by airlines, airports, trade associations, unions, and private citizens who use this data. Commenters confirmed that these data are not only critical to the work of both private and public aviation stakeholders (including the reporting airlines themselves), but that there are universal concerns about the capability and accuracy of the existing data collection to satisfy the changing needs of the industry and its stakeholders. The respondents overwhelmingly agreedthat the O&D Survey and the T100 segment data were essential. Commenters repeatedly mentioned that the current data elements collected were insufficient to meet the data needs of the public and the aviation industry now and in the future. There was near universal agreement that the data suffer from lack of quality and lack of consistency. Deficiencies in the O&D Survey and in the T-100/T-100(f) further reduce the ability of the data to meet the needs of the aviation community.

On February 17, 2005, OST published a notice of proposed rulemaking (NPRM) (70 FR 8140et seq.) as part of the Department's effort to revise the requirements for aviation data to modernize the way we collect, process, and disseminate aviation data. The NPRM reflected analysis of the O&D Survey and T-100/T-100(f) data, and it documented the use of that data by the government, the airline industry, consumers, and other stakeholders. We proposed revisions to the rules governing the nature, scope, source of and means for collecting and processing this aviation traffic data.

At the time the notice was published, we noted that the Department has a statutory responsibility to collect and disseminate information about aviation transportation in the U.S. The Department must, at minimum, collect information on the origin and destination of passengers and information on the number of passengers traveling by air between any two points in air transportation, 49 U.S.C. sec. 329(b). Additionally, the Department is charged with maintaining a sound regulatory system that is responsive to the needs of the public, and must disseminate information to make it easier to adapt the air transportation system to the present and future needs of the commerce of the United States (49 U.S.C. 40101(a) (7)).

We also acknowledged the Department's responsibility to maximize the quality, objectivity, utility, and integrity of influential statistical information it disseminates. Although the O&D Survey collected quarterly and the T-100/T-100(f) collected monthly are the means by which the Department disseminates aviation traffic information, the NPRM identified various technical deficiencies and limitations in the data.

In the 2005 NPRM, we also proposed a plan to create the O&D Survey using a fundamentally different collection methodology and considered commensurate changes in the collection of the T-100/T-100(f). In addition to seeking comments on the change of methodology, we sought input into other key topics such as information about what kind of data should be withheld from release for reasons of competitive sensitivity.

In response to the 2005 NPRM, the Department received substantive comments from ten organizations or groups, and limited comments from twelve additional groups or organizations. Most of the commenters were airlines or aviation trade associations, but some of the other users of the data also provided comments. While there was opposition to certain aspects of the Department's proposed methodology for collecting data, no comments filed in response to the NPRM disputed the Department's authority to gather aviation information, the Department's review of the data's current deficiencies, the Department's assessment of the data's limitations, or the Department's assertion that the current traffic statistics had outlived the economic model for which it was designed. We, therefore, conclude that there is support for obtaining and disseminating accurate aviation traffic data by aligning it with modern airline business practices, but that the methodology we proposed may not have been the best solution to repair the deficiencies in the system.

The Department's proposal for collecting aviation traffic data continued to rely on the airline passenger revenue accounting system as the principal source of data. However, we proposed changing the carrier designated to report the data, increasing the scope and volume of data collected, and reducing the number of reporting exemptions. The NPRM also sought comments on several specific issues to achieve greater uniformity in statistical reporting in light of the industry's divergent business models. We believed that changing the carrier responsible for reporting a ticket to the ticket issuing carrier would be a significant simplification in the airline's process of reporting and would, therefore, result in a reduction of reporting costs. While there was considerable support for these changes, the comments indicated that some believed that the burdens of reporting the data would still be disproportionately high.

We proposed a specific set of data elements that we anticipated would be necessary in the new methodology to define one-way trips, and asked for comment on how to construct the one-way trips. However, no one-way trip methodology appeared in the record, leading a number of commenters to claim that the Department had not sufficiently articulated a rationale for collecting the newly proposed data elements.

Similarly, the Department proposed that the public supply guidance regarding how the Department should safeguard competitively sensitive information, but no such safeguards were suggested in the comments. With no specific proposals for safeguards in the record, a number of commenters asserted that the Department had not made sufficient plans to safeguard competitively sensitive information.

In addition, the Department pointed to evidence that the current ticket sample methodology produces a sample that could be impacted by decisions at travel agencies to assign ticket numbers at their own convenience for their own reasons. We have no authority to regulate such activities of travel agents, and so the Department proposed to either change the method of creating the sample or to do away with sampling and collect a census of data. Despite evidence presented in the NPRM that the current 10% sampling system produces a biased sample of inconsistent size and inadequate scope, and the Department's calculation indicating that to ensure reasonable accuracy the target sample size should be a minimum of 24.34% of the total enplaned passengers, several airlines commented that a 20% sample with no change in collection methodology would be easier to implement and therefore preferable to the Department's proposal.

Although many stakeholders provided comments on the manner in which data could be collected, it is the airlines who must supply the data and are, therefore, in the best position to effectively comment on the difficulty of producing the data. Some airlines questioned certain aspects of the rulemaking's data collection proposal, characterizing the changes as potentially expensive and cumbersome. No airline, however, suggested an alternative, statistically defensible proposal for collection of data that would be less expensive and less cumbersome while simultaneously producing the desired improvements in the utility of the data.

The stated purposes of this rulemaking were to (1) Reduce the long-term reporting burden on the Participating Carriers, (2) make the O&D Survey more relevant and useful, (3) reduce the time it takes to disseminate the information and (4) achieve 95% statistical correlation between the O&D Survey and the T-100/T-100(f).

In light of the responses to the NPRM, we have determined that it will be in the public interest to significantly modify our proposal to modernize aviation data products. We have also determined that an additional request for public comment based on the current proposal would not provide us with the information we need in order to accomplish our purpose.

We have engaged a contractor with expertise in the industry to identify necessary and useful system features, and to address how data collection can be aligned with modern airline information technology so as to minimize the data-reporting burden on air carriers. Further, the contractor will assist the Department in assessing alternatives to the Department's proposal as stated in the NPRM that will help all stakeholders realize a better value for the investment in the data modernization effort.

Although this rulemaking is being withdrawn, the Department anticipates the issuance at a later date of a new NPRM and will continue to involve the public in its effort to increase efficiency, effectiveness, integrity, quality, and utility of the aviation traffic information available, in a way that is also sensitive to the information collection costs that would be imposed on the carriers.

The Energy Policy Act of 1992 (EPAct 92 or Act)1 established federal programs that encourage the development of alternative fuels and alternative fueled vehicles (AFVs). Section 406(a) of the Act directed the Commission to establish uniform labeling requirements for alternative fuels and AFVs. Under the Act, such labels should provide “appropriate information with respect to costs and benefits [of alternative fuels and AFVs], so as to reasonably enable the consumer to make choices and comparisons.”2 In addition, the required labels must be “simple and, where appropriate, consolidated with other labels providing information to the consumer.”3

In response to EPAct 92, the Commission published the Alternative Fuels Rule in 1995, addressing both alternative fuels and AFVs.4 The Rule requires labels on fuel dispensers fornon-liquidalternative fuels, such as electricity, compressed natural gas, and hydrogen.5 The labels for electricity provide the dispensing system's kilowatt capacity, voltage, and other related information. The labels for other non-liquid fuels disclose the fuel's commonly used name and principal component (expressed as a percentage).6 Examples of the fuel labels appear below.

The Rule also requires labels on new and used AFVs that run on liquid and non-liquid fuels, such as ethanol and other alcohols including E85 ethanol-gasoline mixtures, natural gas, liquefied petroleum gas, hydrogen, coal-derived liquid fuels, fuels derived from biological materials (e.g.,100% biodiesel), and electricity. The labels for new AFVs disclose the vehicle's estimated cruising range (i.e.,the travel distance on a single charge or tank of fuel), general factors consumers should consider before buying an AFV, and toll free telephone numbers and Web sites for additional information from the Department of Energy (DOE) and NHTSA.7 An example of the label for new AFVs appears below. Labels for used AFVs contain only the general buying factors and DOE/NHTSA contact information.8

The Commission is accelerating its regularly scheduled review of the Alternative Fuels Rule, previously set for 2014, to ensure that FTC-required vehicle labels and EPA fuel economy labeling requirements are consistent. Regulatory reviews seek information about the costs and benefits of rules and guides as well as their regulatory and economic impact. The information obtained assists in identifying rules and guides that warrant modification or rescission. As part of this review, the Commission seeks comment on the current Alternative Fuels Rule. Among other things, commenters should address the economic impact of, and the continuing need for the Rule; the Rule's benefits to alternative fuel and AFV purchasers; and burdens the Rule places on firms subject to its requirements. In addition, the Commission seeks comment on three specific issues related to the Rule (Section III below) and response to general questions about the Rule (Section IV below).

In conducting this regulatory review, the Commission seeks comment on the following three specific issues: (1) Whether to consolidate its AFV labels with EPA/NHTSA fuel economy labels; (2) how to address new definitions for AFVs that are contained in recent legislation; and (3) whether to change labeling requirements for used AFVs.

The Commission requests comment on whether it should consolidate its AFV labels with fuel economy labels recently proposed by EPA and NHTSA to ensure consistency between the two.9 The proposed new fuel economy labels apply to both conventional and alternative fuel vehicles, including most AFVs subject to the FTC's labeling requirements.10 The content of the proposed labels differs slightly depending on the type of AFV, as described below.

For various types of electric vehicles (including those operating solely on batteries and those operating on a combination of battery and conventional engine power) as well as compressed natural gas powered vehicles, EPA's proposed labels disclose the vehicle's fuel economy, CO2 and other emissions, cruising range, and estimated annual fuel cost.11 The proposed labels also referencehttp://www.fueleconomy.gov, which provides comprehensive consumer information about fuel economy and alternative fuels.

For ethanol-fueled vehicles, including flexible fuel vehicles (FFVs) that operate on a combination of gasoline and ethanol, the EPA proposed three labeloptions: (1) Disclosing the fuel economy obtained using gasoline and a statement that alternative fuel use will yield different results;12 (2) disclosing fuel economy for both gasoline and alternative fuel use (e.g., E85); and (3) disclosing fuel economy for gasoline as well as miles per gallon equivalent information for the alternative fuel.13

In light of these proposals, the Commission seeks comment on whether it is appropriate to consolidate its label with EPA's by allowing use of the EPA label in lieu of FTC's. Although there are some differences between the labels (e.g., the EPA label for ethanol FFVs would not disclose cruising range), all of the EPA's proposed labels provide vehicle-specific fuel economy information. The EPA's proposed labels also would not include the general buying tips that appear on the FTC's label, but would refer consumers to a website to obtain more information about fuel economy and alternative fuels. The Commission, therefore, requests comment on whether the EPA label accomplishes the EPAct 92's goal of providing appropriate information regarding the costs and benefits of AFVs and reasonably enabling consumers to make choices and comparisons. Consolidating the FTC and EPA labels would benefit consumers and industry by eliminating potential confusion caused by duplicative and possibly inconsistent labels,14 and reducing the burden on manufacturers to create and post two labels.

The National Defense Authorization Act for Fiscal Year 2008 extended coverage of the EPAct 92 to hydrogen fuel cell motor vehicles (as defined in 26 U.S.C. 30B (b)(3)), advanced lean burn technology motor vehicles (as defined in 26 U.S.C. 30B(c)(3)), and hybrid motor vehicles (as defined in 26 U.S.C. 30B(d)(3)). Specifically, it added these three types of vehicles to the statutory definition of “alternative fuel vehicle.”15 Therefore, the Commission is now considering how the Rule should address these vehicles. Because the Alternative Fuels Rule already covers hydrogen fuel cell vehicles, additional labeling requirements for them appear unnecessary. Similarly, lean burn and hybrid vehicles already bear the EPA fuel economy label because they qualify as conventional vehicles under that program. Thus, it appears unlikely that new FTC labels for those models would provide significant benefit. Accordingly, the Commission seeks comment on whether to issue new labels for lean burn and hybrid vehicles or, instead, to allow the EPA label on these vehicles in lieu of a new FTC label.

The Commission seeks comment on whether to change the Rule's labeling requirements for used AFVs.16 Currently, used AFVs must bear labels with general tips and references to telephone numbers and websites that provide additional information. However, these labels do not contain any vehicle-specific information, such as cruising range. Because these used vehicle labels provide limited information and are likely to impose increasing burdens on used car dealers as the AFV market expands, the Commission seeks comment on whether to retain the requirement and, if so, whether to change the label's current content. Commenters should address whether the used vehicle labels provide “appropriate information”; whether the benefits to consumers justify the burdens imposed on used vehicle dealers; and whether other resources, such ashttp://www.fueleconomy.gov, provide used vehicle shoppers with adequate information. Comments should also address whether vehicle specific information (e.g., cruising range) is appropriate for used AFV labels. For example, will an electric vehicle's original cruising range estimate, as determined by the manufacturer, remain valid when the vehicle is later sold in the used market?

In addition to the specific issues discussed in Section II, the Commission solicits comment on the following questions related to the Rule:

(1) Is there a continuing need for the Rule as currently promulgated? Why or why not?

(2) What benefits has the Rule provided to consumers? What evidence supports the asserted benefits?

(3) What modifications, if any, should the Commission make to the Rule to increase its benefits to consumers?

(a) What evidence supports your proposed modifications?

(b) How would these modifications affect the costs and benefits of the Rule for consumers?

(c) How would these modifications affect the costs and benefits of the Rule for businesses, particularly small businesses?

(4) What impact, if any, has the Rule had on the flow of appropriate information to consumers about alternative fuels and AFVs?

(5) What significant costs has the Rule imposed on consumers? What evidence supports the asserted costs?

(6) What modifications, if any, should be made to the Rule to reduce the costs imposed on consumers?

(a) What evidence supports your proposed modifications?

(b) How would these modifications affect the costs and benefits of the Rule for consumers?

(c) How would these modifications affect the costs and benefits of the Rule for businesses, particularly small businesses?

(7) Please provide any evidence that has become available since 2005 concerning consumer perception of AFV and non-liquid alternative fuel labeling. Does this new information indicate that the Rule should be modified? If so, why, and how? If not, why not?

(8) Please provide any evidence that has become available since 2005 concerning consumer interest in alternative fuel and AFV labeling. Does this new information indicate that the Rule should be modified? If so, why, and how? If not, why not?

(9) What benefits, if any, has the Rule provided to businesses, and in particular to small businesses? What evidence supports the asserted benefits?

(10) What modifications, if any, should be made to the Rule to increase its benefits to businesses, and particularly to small businesses?

(a) What evidence supports your proposed modifications?

(b) How would these modifications affect the costs and benefits of the Rule for consumers?

(c) How would these modifications affect the costs and benefits of the Rule for businesses?

(11) What significant costs, including costs of compliance, has the Rule imposed on businesses, particularly small businesses? What evidence supports the asserted costs?

(12) What modifications, if any, should be made to the Rule to reduce the costs imposed on businesses, particularly on small businesses?

(a) What evidence supports your proposed modifications?

(b) How would these modifications affect the costs and benefits of the Rule for consumers?

(c) How would these modifications affect the costs and benefits of the Rule for businesses?

(13) What evidence is available concerning the degree of industry compliance with the Rule? Does this evidence indicate that the Rule should be modified? If so, why, and how? If not, why not?

(14) Are any of the Rule's requirements no longer needed? If so, explain. Please provide supporting evidence.

(15) What modifications, if any, should be made to the Rule to account for changes in relevant technology, including development of new alternative fuels, or economic conditions?

(a) What evidence supports the proposed modifications?

(b) How would these modifications affect the costs and benefits of the Rule for consumers and businesses, particularly small businesses?

(16) Does the Rule overlap or conflict with other federal, state, or local laws or regulations? If so, how?

(a) What evidence supports the asserted conflicts?

(b) With reference to the asserted conflicts, should the Rule be modified? If so, why, and how? If not, why not?

(c) Is there evidence concerning whether the Rule has assisted in promoting national uniformity with respect to the rating, certifying, and posting the rating of non-liquid alternative fuels and AFV labeling? If so, please provide that evidence.

(17) Are there foreign or international laws, regulations, or standards with respect to the rating, certifying, and posting the rating of non-liquid alternative fuels and AFV labeling that the Commission should consider as it reviews the Rule? If so, what are they?

(a) Should the Rule be modified to harmonize with these foreign or international laws, regulations, or standards? If so, why, and how? If not, why not?

(b) How would such harmonization affect the costs and benefits of the Rule for consumers and businesses, particularly small businesses?

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 25, 2011. Write “Regulatory Review for Alternative Fuels Rule, (16 CFR part 309, Matter No. R311002, Program Code M04)” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, athttp://www.ftc.gov/os/publiccomments.shtm.As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Website.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).17 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it athttps://ftcpublic.commentworks.com/ftc/altfuelsreviewanpr,by following the instructions on the web-based form. If this Notice appears athttp://www.regulations.gov/#!home,you also may file a comment through that website.

If you file your comment on paper, write “Regulatory Review for Alternative Fuels Rule, (16 CFR part 309, Matter No. R311002, Program Code M04)” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex N), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Website athttp://www.ftc.govto read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before July 25, 2011. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, athttp://www.ftc.gov/ftc/privacy.htm.

The roundtable discussion will take place on Friday, June 3, 2011, commencing at 9:30 a.m. and ending at 5 p.m. Members of the public who wish to comment on the topics addressed at the discussion, or on any other topics related to customer collateral protection in the context of the Act, may do so via:

• Paper submission to David Stawick, Secretary, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581; or

• Electronic submission by visitinghttp://comments.cftc.govand following the instructions for submitting comments through the CFTC's Web site.

All comments must be in English or be accompanied by an English translation. All submissions provided to the CFTC in any electronic form or on paper may be published on the website of the CFTC, without review and without removal of personally identifying information. Please submit only information that you wish to make publicly available.

We propose to amend Rules 5011 and 5062 of Regulation D3 and Form D4 under the Securities Act of 1933 (“Securities Act”).5

The subject of the public hearing is the notice of proposed rulemaking (REG-118761-09) that was published in theFederal Registeron Thursday, April 21, 2011 (76 FR 22336).

Persons who wish to present oral comments at the hearing that submitted written comments, must submit an outline of the topics to be discussed and the amount of time to be devoted to each topic (signed original and eight (8) copies) by Thursday, July 21, 2011.

A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing or in the Freedom of Information Reading Room (FOIA RR) (Room 1621) which is located at the 11th and Pennsylvania Avenue, NW. entrance, 1111 Constitution Avenue, NW., Washington, DC.

Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see theFOR FURTHER INFORMATION CONTACTsection of this document.

A notice of proposed rulemaking and a notice ofpublic hearing that appeared in theFederal Registeron Friday, March 18, 2011 (76 FR 14827) announced that a public hearing was scheduled for June 9, 2011, at 10 a.m. in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. The subject of the public hearing is under section 6103 of the Internal Revenue Code.

The public comment period for the proposed rulemaking expired on May 17, 2011. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit an outline of the topics to be addressed. As of May 23, 2011, no one has requested to speak. Therefore, the public hearing scheduled for June 9, 2011, is cancelled.

On July 16, 2010, the Department published in theFederal Registeran interim final rule enhancing required disclosure from certain pension plan service providers to plan fiduciaries as part of a “reasonable” contract or arrangement for services under ERISA section 408(b)(2) (75 FR 41600) (the “408(b)(2) regulation”). 29 CFR 2550.408b-2(c). The Department subsequently published in theFederal Register, on October 20, 2010, a final rule concerning the disclosure of plan fee and expense information by plan administrators to plan participants and beneficiaries (75 FR 64910) (the “participant-level disclosure regulation”). 29 CFR 2550.404a-5. The participant-level disclosure regulation includes modifications to the disclosure requirements in the Department's regulation under ERISA section 404(c), at 29 CFR 2550.404c-1 (the “404(c) regulation”), in order to avoid duplication and integrate its requirements with those of the new participant-level disclosure regulation.1

Unless extended, the effective date for the interim final 408(b)(2) regulation will be on July 16, 2011 as to both new, and pre-existing, contracts or arrangements between covered plans and covered service providers. The Department has received many requests that this effective date be extended. A significant number of parties have argued that more time is essential to update systems and procedures for information collection and disclosure. Pointing out that the Department has not yet published a final rule, parties have explained that, if the Department modifies the current interim final rule, service providers will need additional time to make further changes. Based on these concerns, the Department believes that an extension of the rule's effective date would lead to fuller and timelier compliance by plans and service providers, and thus would be in the interests of participants and beneficiaries. Moreover, as discussed below, an extension will enable the Department to align the effective date for this regulation with the applicability date of the participant-level disclosure regulation. Accordingly, in February 2011, the Department announced its intention to extend the 408(b)(2) regulation's effective date until January 1, 2012.2 The Department has not received any negative comments on this announcement. The amendments proposed in this notice, if finalized, would effectuate this announcement.

Although the final participant-level disclosure regulation was effective on December 20, 2010, its requirements only begin to apply for plan years beginning on or after November 1, 2011. The regulation also includes a transitional rule, in paragraph (j)(3)(i), for furnishing disclosures required on or before the date on which a participant or beneficiary can first direct his or her investment. For participants or beneficiaries who, as of their plan's applicability date, had the right to direct the investment of their individual accounts, the plan must furnish these initial disclosures no later than 60 days after the applicability date. As with the 408(b)(2) regulation, the Department has continued to receive requests that additional time be provided in order for parties to comply. Further, because the Department announced its intention to extend the 408(b)(2) regulation's effective date to January 1, 2012, parties argue that it would be preferable to extend application of the participant-level disclosure regulation until after the effective date of the 408(b)(2) regulation. Specifically, these parties point to the provision in the 408(b)(2) interim final regulation which requirescovered service providers to furnish information requested by a responsible plan fiduciary or plan administrator in order to comply with ERISA's reporting and disclosure requirements,3 which would include relevant information required to comply with the participant-level disclosure regulation. It would facilitate compliance with the participant-level disclosure regulation, they argue, if contracts and arrangements were brought into compliance with the 408(b)(2) regulation, so that this reporting and disclosure provision is in effect, prior to the applicability of the participant-level disclosure regulation.

The Department agrees that aligning the application of these two regulations would assist plan fiduciaries and plan administrators in obtaining information required to comply with the participant-level disclosure regulation. Further, the Department believes that, similar to the 408(b)(2) regulation, a limited extension is in the best interests of covered individual account plans and their participants and beneficiaries. Delayed application will better afford plans sufficient time to ensure an efficient and effective implementation of the participant-level disclosure regulation. To accomplish this end, the Department does not believe it is necessary to extend the regulation's effective date or its general application to plan years beginning on or after November 1, 2011. However, the Department proposes to extend the transition rule in paragraph (j)(3)(i), which specifies the date by which initial disclosures must actually be provided. Under this proposal, a plan would have 120 days (rather than 60) after its applicability date to furnish the initial disclosures that are otherwise required to be furnished before the date on which a participant or beneficiary can first direct his or her investments. Thus, a calendar year plan would have to furnish the initial disclosures no later than April 30, 2012, and the disclosures required by paragraphs (c)(2)(ii) and (c)(3)(ii) (e.g.,quarterly statement of fees/expenses actually deducted) would have to be furnished no later than May 15, 2012. Under the proposed transition rule, the initial disclosures must be provided to all participants and beneficiaries who have the right to direct their investments when such disclosures are furnished, not just to those individuals who had the right to direct their investments on the applicability date. This is to ensure that individuals who become plan participants in between the applicability date and the end of the 120-day period receive the important information required under the regulation. To the extent the plan also has contracts or arrangements with covered service providers, as defined by the 408(b)(2) regulation, those contracts or arrangements must be in compliance with the 408(b)(2) regulation as of January 1, 2012, in advance of the required initial disclosures under the participant-level disclosure regulation.

The Department has not been persuaded to extend the application of the participant-level disclosure regulation, or the 408(b)(2) regulation, beyond these dates. Although the Department believes it is appropriate to provide some relief to help ensure a timely, efficient, and coordinated implementation of the two rules, the Department also believes that it is critical for responsible plan fiduciaries, plan administrators, and plan participants and beneficiaries to benefit from the increased transparency provided by the rules as soon as possible.

At this time, the Department solicits comments on this proposal to formally extend the effective date of the 408(b)(2) regulation and the transitional rule for application of the participant-level disclosure regulation.

For the reasons set forth in the preamble, the Department of Labor proposes to amend 29 CFR part 2550 as follows:

A. Background

Currently, as provided in 41 CFR 102-34.35, a motor vehicle rental is limited to less than 60 continuous days. If an agency obtains a motor vehicle for 60 continuous days or more, then it is a commercial lease under current regulations. Agencies, however, often have a valid temporary mission requirement for a motor vehicle of 60 continuous days or more in duration but of significantly fewer days in duration than is typically available under commercial leases, which commonly require a minimum lease period of one year. Also, some agencies have requirements from time to time for additional vehicles for relatively short periods of time. As a result, agencies are turning to short-term rentals to meet these motor vehicle needs but have encountered impediments when those needs meet or exceed 60 continuous days but are less than a year (for which commercial leases are commonly available). In order to address these issues, GSA is proposing to amend section 102-34.35 of the FMR (41 CFR 102-34.35) to redefine the term “motor vehicle rental” to increase the less than 60 continuous day rental timeframe to less than 120 continuous days and adjust the definition of the term “commercial lease or lease commercially” accordingly. GSA is cognizant of the impact of such a proposed policy change on motor vehicle identification in that the identification requirements attach to Government motor vehicles only, a term that does not encompass motor vehicle rentals.

This proposed regulatory amendment would provide greater flexibility to Federal agencies in meeting their motor vehicle needs.

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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. This proposed rule is also exempt from the Regulatory Flexibility Act per 5 U.S.C. 553(a)(2) because it applies to agency management. However, this proposed rule is being published to provide transparency in the promulgation of Federal policies.

The Paperwork Reduction Act does not apply because the proposed changes to the FMR do not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501,et seq.

This proposed rule is exempt from Congressional review under 5 U.S.C. 801 since it relates solely to agency management and personnel.

For the reasons set forth in the preamble, GSA proposes to amend 41 CFR part 102-34 as set forth below:

Status:The meeting will be open to the public.

Purpose:The purpose of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas is to establish a criteria and a comprehensive methodology for Designation of Medically Underserved Populations and Primary Care Health Professional Shortage Areas, using a Negotiated Rulemaking (NR) process. It is hoped that use of the NR process will yield a consensus among technical experts and stakeholders on a new rule for designation of medically underserved populations and primary care health professions shortage areas, which would be published as an Interim Final Rule in accordance with Section 5602 of the Affordable Care Act, Public Law 111-148.

Agenda:The meeting will be held on Wednesday, June 22; Thursday, June 23; and Friday, June 24. It will include a discussion of various components of a possible methodology for identifying areas of shortage and underservice, based on the recommendations of the Committee in the previous meeting. Members of the public will have the opportunity to provide comments during the meeting on Friday afternoon.

Requests from the public to make oral comments or to provide written comments to the Committee should be sent to Nicole Patterson at the contact address above at least 10 days prior to the first day of the meeting, Wednesday, June 22. The meetings will be open to the public as indicated above, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed above at least 10 days prior to the meeting.

Inspection of Public Comments:All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all commentsreceived before the close of the comment period on the following Web site as soon as possible after they have been received:http://www.regulations.gov.Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Section 132 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), Public Law 110-275, authorized the Secretary to establish a program to encourage the adoption and use of eRx technology. Implemented in 2009, the program offers a combination of financial incentives and payment adjustments to eligible professionals, which are defined under section 1848(k)(3)(B) of the Social Security Act (the Act). We understand that the term “eligible professional” is used in multiple CMS programs. However, for the purpose of this proposed rule, the eligible professionals to whom we refer are only those professionals eligible to participate in the eRx Incentive Program unless we specify otherwise. For more information on which professionals are eligible to participate in the eRx Incentive Program, we refer readers to the Eligible Professionals page of the eRx Incentive Program section of the CMS Web site at:http://www.cms.gov/ERxIncentive/05_Eligible%20Professionals.asp#TopOfPage.Under section 1848(m)(2)(C) of the Act, an eligible professional (or group practice participating in the eRx group practice reporting option (GPRO)) who is a successful electronic prescriber during 2011 can qualify for an incentive payment equal to 1.0 percent of its total estimated Medicare Part B Physician Fee Schedule (PFS) allowed charges for covered professional services furnished during the 2011 reporting period.

In accordance with section 1848(a)(5)(A) of the Act, a PFS payment adjustment will begin in 2012 for those eligible professionals and group practices who are not successful electronic prescribers and will increase each year through 2014. Specifically, under 42 CFR 414.92(c)(2), for covered professional services furnished by an eligible professional during 2012, 2013, and 2014, if an eligible professional (or in the case of a group practice, the group practice) is not a successful electronic prescriber (as specified by CMS for purposes of the payment adjustment) for an applicable reporting period (as specified by CMS), then the PFS amount for such services furnished by such professional (or group practice) during the year shall be equal to the applicable percent (99 percent for 2012, 98.5 percent for 2013, and 98 percent for 2014) of the PFS amount that would otherwise apply. For each year of the program thus far, we have established program requirements for the eRx Incentive Program in the annual Medicare PFS rulemaking, including the applicable reporting period(s) for the year and how an eligible professional can become a successful electronic prescriber for the year. For example, we finalized the program requirements for qualifying for 2009 and 2010 eRx incentive payments in the CY 2009 and 2010 PFS final rules with comment period (73 FR 69847 through 69852 and 74 FR 61849 through 61861), respectively. In the November 29, 2010Federal Register(75 FR 73551 through 73556), we published the CY 2011 PFS final rule with comment period, which set forth the requirements for qualifying for a CY 2011 incentive payment, as well as the requirements for the 2012 and 2013 eRx payment adjustments.

Since publication of the CY 2011 PFS final rule with comment period, we have received a number of inquiries from stakeholders regarding the eRx Incentive Program. Many stakeholders voiced concerns about differences between the requirements under the eRx Incentive Program and the Medicare Electronic Health Record (EHR) Incentive Program, which also requires, among other things, eligible professionals to satisfy an eRx objective and measure to be considered a meaningful user of certified EHR technology (“eligible professional” is defined at 42 CFR 495.100 for purposes of the Medicare EHR Incentive Program). (For more information regarding the EHR Incentive Program see the publishedFederal Registeron July 28, 2010; 75 FR 44314 through 44588.) While Medicare eligible professionals and group practices cannot earn an incentive under both the eRx Incentive Program and the EHR Incentive Program for the same year, eligible professionals will be subject to an eRx payment adjustment if they do not meet the requirements under the eRx Incentive Program, regardless of whether the eligible professional participates in and earns an incentive under the Medicare EHR Incentive Program.

Stakeholders claim that the requirements under both programs are administratively confusing, cumbersome, and unnecessarily duplicative. On February 17, 2011, the Government Accountability Office (GAO) also published a report which indicated that CMS should address the inconsistencies between the eRx Incentive Program and the EHR Incentive Program (GAO-11-159, “Electronic Prescribing: CMS Should Address Inconsistencies in Its Two Incentive Programs That Encourage the Use of Health Information Technology,” available athttp://www.gao.gov/products/GAO-11-159).

As a result of the above concerns and in accordance with Executive Order 13563, which directs government agencies to identify and reduce redundant, inconsistent, or overlapping regulatory requirements and, among other things, identify and consider regulatory approaches that reduce burden and maintain flexibility of choice when possible, we are proposing to make changes to the eRx Incentive Program. As described further in section II.A. of the proposed rule, we are specifically proposing to modify the 2011 eRx quality measure (that is, the eRx quality measure used for certain reporting periods in CY 2011) and to create additional significant hardship exemption categories for the 2012 eRx payment adjustment.

In the CY 2011 PFS final rule with comment period (75 FR 73553 through 76566), we finalized an eRx quality measure that would be used during the reporting periods in 2011 used to determine whether an eligible professional is a successful electronic prescriber under the eRx Incentive Program for the 2011 eRx incentive, as well as for the 2012 and 2013 eRx payment adjustments. The measure that we adopted for reporting in 2011 (which is the same measure that was adopted for the 2010 eRx Incentive Program) is described as a measure that documents whether an eligible professional or group practice has adopted a “qualified” eRx system.

A qualified eRx system is a system that is capable of performing the following four specific functionalities:

• Generate a complete active medication list incorporating electronicdata received from applicable pharmacies and pharmacy benefit managers (PBMs), if available.

• Allow eligible professionals to select medications, print prescriptions, electronically transmit prescriptions, and conduct alerts (that is, written or acoustic signals to warn the prescriber of possible undesirable or unsafe situations including potentially inappropriate doses or routes of administration of a drug, drug-drug interactions, allergy concerns, or warnings and cautions) and this functionality must be enabled,

• Provide information related to lower cost therapeutically appropriate alternatives (if any) (that is, the ability of an eRx system to receive tiered formulary information, if available, would again suffice for this requirement for 2011 and until this function is more widely available in the marketplace)

• Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan (if available).

In addition, to be a qualified eRx system under the eRx Incentive Program, electronic systems must convey the information above using the standards currently in effect for the Part D eRx program, including certain National Council for Prescription Drug Programs' (NCPDP) standards. (To view the current eRx quality measure specifications, we refer readers to the “2011 eRx Measure Specifications, Release Notes, and Claims-Based Reporting Principles” download found on the E-Prescribing Measure page of the eRx Incentive Program section of the CMS Web site at:http://www.cms.gov/ERxIncentive/06_E-Prescribing_Measure.asp#TopOfPage.)

The technological requirements for eRx in the EHR Incentive Program are similar to the technological requirements for the eRx Incentive Program. Under the EHR Incentive Program, eligible professionals are required to adopt certified EHR technology, which must include the capability to perform certain eRx functions that are similar to those required for the eRx Incentive Program. Certified EHR technology must be tested and certified by a certification body authorized by the National Coordinator for Health Information Technology (at the present time, these bodies are Office of the National Coordinator for Health Information Technology (ONC)-Authorized Testing and Certification Bodies (ONC-ATCBs)). This means that eligible professionals participating in the EHR Incentive Program can rely on a third party certification body to ensure that the vendor's EHR technology includes certain technical capabilities. EHR technology is certified as a “Complete EHR” or an “EHR module,” as those terms are defined at 45 CFR 170.102. A Complete EHR is EHR technology that has been developed to meet, at a minimum, all applicable certification criteria adopted by the Secretary. An EHR Module is any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

In contrast, the eRx Incentive Program does not require certification of the system used for eRx. Thus, eligible professionals or group practices are generally required to rely on information that they obtain from the vendors of the systems and demonstration of the functionalities of the system, to determine if the system meets the required standard. We believe that the eRx capabilities of certified EHR technology are sufficiently similar in nature (and in fact, would more than likely be capable of performing all of the required functionalities) and would be appropriate for purposes of the eRx Incentive Program. Among other requirements, certified EHR technology must be able to electronically generate and transmit prescriptions and prescription-related information in accordance with certain standards, some of which have been adopted for purposes of electronic prescribing under Part D. Similar to the required functionalities of a qualified eRx system, certified EHR technology also must be able to check for drug-drug interactions and check whether drugs are in a formulary or a preferred drug list, although the certification criteria do not specify any standards for the performance of those functions. We believe that it is acceptable that not all of the Part D eRx standards are required for certified EHR technology in light of our desire to better align the requirements of the eRx and the Medicare EHR Incentive Program and potentially reduce unnecessary investment in multiple technologies for purposes of meeting the requirements for each program. Furthermore, to the extent that an eligible professional uses certified EHR technology to electronically prescribe under Part D, he or she would still be required to comply with the Part D standards to do so.

In addition, we believe it is important to provide more certainty to eligible professionals (including those in group practices) that may be participating in both the EHR Incentive Program and the eRx Incentive Program with regard to purchasing systems for use under these programs, and to encourage adoption of certified EHR technology. Accordingly, we are proposing changes to the eRx measure reported in 2011 for purposes of reporting for the 2011 eRx incentive and the 2013 eRx payment adjustment (the “2011 eRx quality measure”) in accordance with section 1848(k)(2)(C) of the Act. This section of the Act requires the eRx measure to be endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (currently, that entity is the National Quality Forum (NQF)) except for in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF. While the electronic prescribing measure, as originally implemented in the 2009 eRx Incentive Program is an NQF-endorsed measure, subsequent modifications made to the measure for implementation purposes (for example, to reduce eligible professionals' reporting burden and to increase applicability of the measure to a broader range of eligible professionals) have not yet been reviewed by the NQF. In light of this, we are not aware of any other NQF-endorsed measure related to electronic prescribing by eligible professionals that would be appropriate for use in the eRx Incentive Program. Therefore, we believe that the use of this eRx measure falls within the exception under section 1848(k)(2)(C)(ii) of the Act.

Specifically, we are proposing to revise the description statement for the 2011 eRx measure that we adopted for reporting in 2011 for purposes of the 2011 eRx incentive and the 2013 eRx payment adjustment. Currently, the description statement indicates that the measure documents whether an eligible professional or group practice has adopted a “qualified” eRx system that performs the four functionalities discussed above. We propose to revise this description statement to indicate that the measure documents whether an eligible professional or group practice has adopted a “qualified” eRx system that performs the four functionalities previously discussedoris certified EHR technology as defined at 42 CFR 495.4 and 45 CFR 170.102. We believe that this proposed change merely expands on the definition of a “qualified” eRx system without altering the original intent of the measure, which was to evaluate the extent to which eligible professionals generate and transmit prescriptions and prescription-related information electronically. Both eRx systems that perform the fourfunctionalities previously discussed and certified EHR technology are able to generate and transmit prescriptions and prescription-related information electronically. An eligible professional or group practice that has already purchased an eRx system that meets the definition of a “qualified” eRx system would be able to continue using that system (that is, even with the proposed changes to the measure, systems that meet the four functionalities would continue to constitute “qualified” eRx systems). In accordance with section 1848(m)(3)(B)(v) of the Act, which requires the Secretary, to the extent practicable, to ensure that eligible professionals utilize electronic prescribing systems in compliance with standards established for such systems pursuant to the Part D eRx Program under section 1860D-4(e) of the Act, we also propose that for purposes of the 2011 eRx measure certified EHR technology must comply with the Part D standards for the electronic transmission of prescriptions at 42 CFR 423.160(b)(2)(ii). This proposed requirement is consistent with the ONC certification requirements at 45 CFR 170.304(b) and 170.205(b)(1) and (2). With this proposed change to the 2011 eRx measure, eligible professionals (including those in group practices) that are participating in the eRx Incentive Program would have the option of adopting either a qualified eRx system that performs the four functionalities previously discussed or certified EHR technology as defined at 42 CFR 495.4 and 45 CFR 170.102. Thus, under this proposal, certified EHR technology would be recognized as a qualified system under the revised eRx quality measure regardless of whether the certified EHR technology has all four of the functionalities previously described. Because the proposed change to the 2011 eRx measure, if finalized, would not be effective until the effective date of a subsequent final rule, this change would only be effective for the remainder of the reporting periods in CY 2011 for the 2011 eRx incentive and the 2013 eRx payment adjustment. The proposed change to the 2011 eRx quality measure, if finalized, would not apply retrospectively to any part of the CY 2011 reporting periods for the 2011 eRx incentive or the 2013 eRx payment adjustments that occurred prior to the effective date of a subsequent final rule. The proposed change to the eRx measure does not change any of the regulations for the eRx Incentive Program payment adjustment, which are codified at 42 CFR 414.92(c)(2). In addition, because this proposed change would not be finalized prior to the end of the 2012 eRx payment adjustment reporting period (that is, June 30, 2011), such a change would not apply for purposes of reporting the eRx measure for the 2012 eRx payment adjustment. However, as we noted previously, we believe that most certified EHR technology meet the requirements for “qualified” eRx systems under the current 2011 eRx quality measure. Therefore, for purposes of reporting the current eRx quality measure during 2011 (including reporting for purposes of the 2012 eRx payment adjustment), nothing precludes eligible professionals (or a group practice) that already have certified EHR technology that meet the four functionalities from using the certified EHR technology for purposes of the eRx Incentive Program (that is, the technology would constitute a “qualified” system under the current 2011 eRx quality measure because such system meets the four specified functionalities). For future program years, we anticipate using the revised eRx quality measure, which we would adopt through future notice and comment rulemaking. We invite public comment on the proposed modification to the 2011 eRx quality measure.

As required by section 1848(a)(5) of the Act, and in accordance with our regulations at 42 CFR 414.92(c)(2), eligible professionals or group practices who are not successful electronic prescribers (as specified by CMS for purposes of the payment adjustment) are subject to the eRx payment adjustment in 2012. In the CY 2011 PFS final rule with comment period (75 FR 73560 through 73565), we finalized the program requirements for the 2012 eRx payment adjustment. Specifically, the 2012 eRx payment adjustment does not apply to the following: (1) An eligible professional who is not a physician (includes doctors of medicine, doctors of osteopathy, and podiatrists), nurse practitioner, or physician assistant as of June 30, 2011; (2) an eligible professional who does not have at least 100 cases (that is, claims for patient services) containing an encounter code that falls within the denominator of the eRx measure for dates of service between January 1, 2011 and June 30, 2011; or (3) an eligible professional who is a successful electronic prescriber for the January 1, 2011 through June 30, 2011 reporting period (that is, reports the eRx measure 10 times via claims between January 1, 2011 and June 30, 2011).

We also finalized the requirement that the 2012 eRx payment adjustment does not apply to an individual eligible professional or group practice if less than 10 percent of an eligible professional's or group practice's estimated total allowed charges for the January 1, 2011 through June 30, 2011 reporting period are comprised of services that appear in the denominator of the 2011 eRx measure. Information and other details about the eRx Incentive Program, including the requirements for group practices participating in the eRx GPRO in 2011 with regard to the 2012 eRx payment adjustment can be found on the eRx Incentive Program section of the CMS Web site at:http://www.cms.gov/erxincentive.

In addition to the requirements for the 2012 eRx payment adjustment, 42 CFR 414.92(c)(2)(ii) provides that we may, on a case-by-case basis, exempt an eligible professional (or group practice) from the application of the payment adjustment, if we determine, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship. In the CY 2011 PFS final rule with comment period (75 FR 73564 through 75 FR 73565), we finalized two circumstances under which an eligible professional or group practice can request consideration for a significant hardship exemption for the 2012 eRx payment adjustment—

• The eligible professional or group practice practices in a rural area with limited high speed Internet access; or

• The eligible professional or group practice practices in an area with limited available pharmacies for eRx.

In order for eligible professionals and group practices to identify these categories for purposes of requesting a hardship exemption, we created a G-code for each of the above situations. Thus, to request consideration for a significant hardship exemption for the 2012 eRx payment adjustment, individual eligible professionals must report the appropriate G-code at least once on claims for services rendered between January 1, 2011 and June 30, 2011. Group practices that wished to participate in the 2011 eRx GPRO and be considered for exemption under one of the significant hardship categories were required to request a hardship exemption at the time they self-nominated to participate in the 2011 eRx GPRO earlier this year.

Since publication of the CY 2011 PFS final rule with comment period, we have received numerous requests to expand the categories under the significant hardship exemption for the 2012 eRx payment adjustment. Some stakeholders have recommended specific circumstances of significant hardship for our consideration (for example, eligible professionals who have prescribing privileges but do not prescribe under their NPI, eligible professionals who prescribe a high volume of narcotics, and eligible professionals who electronically prescribe but typically do not do so for any of the services included in the eRx measure's denominator), while others strongly suggested we consider increasing the number of specific hardship exemption categories. We believe that many of the circumstances raised by stakeholders may pose a significant hardship and limit eligible professionals and group practices in their ability to meet the requirements for being successful electronic prescribers either because of the nature of their practice or because of the limitations of the eRx measure itself, and as a result, such professionals might be unfairly penalized. Therefore, we are proposing to revise the significant hardship regulation at 42 CFR 414.92(c)(2)(ii) to add paragraphs that—(1) codify the two hardship exemption categories for the 2012 eRx payment adjustment that we finalized in the CY 2011 PFS final rule; and (2) codify the additional significant hardship categories for the 2012 eRx payment adjustment that we are proposing in this proposed rule. We also are proposing to allow some additional time for submitting significant hardship exemption requests to CMS.

Specifically, we are proposing the following additional significant hardship exemption categories for the 2012 eRx payment adjustment with regard to the reporting period of January 1, 2011 through June 30, 2011:

We are proposing this exemption category at proposed 42 CFR 414.92(c)(2)(ii)(C) because eligible professionals (including those in group practices) that intended to participate in the EHR Incentive Program may have delayed adopting eRx technology for purposes of the eRx Incentive Program until the list of certified EHR technology became available so that the same technology could be used to satisfy both programs' requirements. The ONC final rule establishing a temporary certification program for health information technology (75 FR 36158) was not published in theFederal Registeruntil June 24, 2010. The certification and listing of EHR technologies (certified Complete EHRs and certified EHR Modules) on the ONC Certified HIT Products List (CHPL) did not begin until September 2010. Until then, eligible professionals and group practices had no way of knowing which EHR technologies would be certified. At the same time, we did not propose to use the first half of 2011 as the reporting period for the 2012 eRx payment adjustment until the CY 2011 PFS proposed rule went on public display at the Office of the Federal Register on June 25, 2010. As such, we believe it may be a significant hardship for eligible professionals in this situation to have both adopted certified EHR technology and fully integrated the technology into their practice's clinical workflows and processes so that they would be able to successfully report the eRx measure prior to June 30, 2011, especially given that an eligible professional under the Medicare EHR Incentive Program has until October 1, 2011, to begin a 90-day EHR reporting period for the 2011 payment year. Similarly, this extended time period provides Medicare eligible professionals under the eRx Incentive Program but who are eligible for incentives under the Medicaid EHR Incentive Program with a majority of 2011 to adopt, implement, or upgrade to certified EHR technology. We believe this hardship exemption category is necessary and appropriate in order to fully support and encourage eligible professionals to actively take steps to become meaningful users of certified EHR technology. Also, in the absence of this significant hardship exemption category, eligible professionals may potentially have to adopt two systems (for example, a standalone eRx system for purposes of participation in the eRx Incentive Program, followed by certified EHR technology), which could potentially be financially burdensome. To be considered for a significant hardship exemption under this category, we are proposing that the eligible professional, at a minimum, must: (1) Have registered for either the Medicare or Medicaid EHR Incentive Program (for instructions on how to register for one of the EHR Incentive Programs, we refer readers to the Registration and Attestation page of the EHR Incentive Programs section of the CMS Web site athttp://www.cms.gov/EHRIncentivePrograms/20_RegistrationandAttestation.asp#TopOfPage); and (2) provide identifying information as to the certified EHR technology (as defined at 45 CFR 170.102) that has been adopted for use no later than October 1, 2011, for a hardship exemption to be submitted, which then would be reviewed on a case-by-case basis. We propose that for purposes of this proposed significant hardship exemption category, the identifying information would consist of the certification number that is assigned to the EHR technology for purposes of ONC's CHPL. In addition, we are considering requiring eligible professionals to provide a serial number for their specific product but have concerns about whether such information would be readily accessible by eligible professionals. We invite comments on the feasibility of requiring eligible professionals to provide a serial number in addition to the certification number for the certified EHR technology, or other information identifying and verifying the specific product. In requesting a significant hardship exemption under this proposed category, an eligible professional would be attesting that he or she either has purchased the specified certified EHR technology (as identified by the certification number and/or serial number) or has the specified certified EHR technology available for immediate use and that the professional intends to use that technology to qualify for a Medicare or Medicaid EHR incentive for payment year 2011.

We are proposing at 42 CFR 414.92(c)(2)(ii)(D) that, to the extent that local, State, or Federal law or regulation limits or prevents an eligible professional or group practice that otherwise has general prescribing authority from electronically prescribing (for example, eligible professionals who prescribe a large volume of narcotics, which may not be electronically prescribed in some states, or eligible professionals who practice in a State that prohibits or limits the transmission of electronic prescriptions via a third party network such as Surescripts), the eligible professional or group practice would be able to request consideration for an exemption from application of the 2012 eRx payment adjustment, which would be reviewed on a case-by-casebasis. We believe eligible professionals in this situation face a significant hardship with regard to the requirements for being successful electronic prescribers because while they may meet the 10-percent threshold for applicability of the payment adjustment, they may not have sufficient opportunities to meet the requirements for being a successful electronic prescriber because Federal, State, or local law or regulation may limit the number of opportunities that an eligible professional or group practice has to electronically prescribe (that is, having at least 100 denominator-eligible visits prior to June 30, 2011, but being unable to electronically prescribe for at least 10 of these denominator-eligible visits due to Federal, State, or local law or regulation).

We are proposing at 42 CFR 414.92(c)(2)(ii)(E) that an eligible professional who has prescribing privileges but does not prescribe or very infrequently prescribes in his or her practice (for example, a nurse practitioner who may not write prescriptions under his or her own NPI, a physician who decides to let his Drug Enforcement Administration registration expire during the reporting period without renewing it, or an eligible professional who prescribed fewer than 10 prescriptions between January 1, 2011 and June 30, 2011 regardless of whether the prescriptions were electronically prescribed or not), yet still meets the 10-percent threshold for applicability of the payment adjustment, would be able to request consideration for a significant hardship exemption from application of the 2012 eRx payment adjustment, which would be reviewed on a case-by-case basis. We believe that it is a significant hardship for eligible professionals who have prescribing privileges, but infrequently prescribe, to become successful electronic prescribers because the nature of their practice may limit the number of opportunities an eligible professional or group practice to prescribe, much less electronically prescribe.

To the extent an eligible professional or group practice has an eRx system, electronically prescribes, and has denominator-eligible visits, but does not normally write prescriptions associated with any of the types of visits included in the eRx measure's denominator (for example, certain types of physicians such as surgeons), we are proposing at 42 CFR 414.92(c)(2)(ii)(F) that the eligible professional or group practice would be able to request consideration for a significant hardship exemption from application of the 2012 eRx payment adjustment, which would be reviewed on a case-by-case basis. Similar to the proposed hardship category for lack of prescribing activity, we believe it would be a significant hardship for eligible professionals who do not have a sufficient opportunity to report the eRx measure because of the limitations of the eRx measure's denominator to meet the criteria for being a successful electronic prescriber. While such eligible professionals may meet the 10-percent threshold for applicability of the payment adjustment and have at least 100 denominator-eligible visits prior to June 30, 2011, they may not be able to report their eRx activity at least 10 times because the bulk of their prescribing activity occurs in other circumstances that are not accounted for by the measure's denominator.

We invite public comments on the additional hardship exemption categories proposed in this proposed rule. In addition, we also invite input on other categories of significant hardship that were not specifically proposed so that we may consider them for purposes of the 2013 or 2014 eRx payment adjustment.

To request a hardship exemption for any of the categories proposed and previously described, we are proposing that an eligible professional or group practice participating in the 2011 eRx GPRO provide to us by the date specified below, the following:

• Identifying information such as the TIN, NPI, name, mailing address, and e-mail address of all affected eligible professionals.

• The significant hardship exemption category(ies) above that apply.

• A justification statement describing how compliance with the requirement for being a successful electronic prescriber for the 2012 eRx payment adjustment during the reporting period would result in a significant hardship to the eligible professional or group practice.

• An attestation of the accuracy of the information provided.

The justification statement should be specific to the category under which the eligible professional or group practice is submitting its request and must explain how the exemption applies to the professional or group practice. For example, if the eligible professional is requesting a significant hardship exemption due to Federal, State, or local law or regulation, he or she must cite the applicable law and how the law restricts the eligible professional's ability to electronically prescribe. Similarly, if the eligible professional is requesting a significant hardship due to lack of prescribing activity, the eligible professional must provide the number of prescriptions generated during the 2012 eRx payment adjustment reporting period. We would review the information submitted by each eligible professional and group practice on a case-by-case basis. In addition, we are proposing that an eligible professional or group practice must, upon request, provide additional supporting documentation if there is insufficient information (such as, but not limited to, a TIN or NPI that we cannot match to the Medicare claims, a certification number for the certified EHR technology that does not appear on the list of certified EHR technology, or an incomplete justification for the significant hardship exemption request) to justify the request or make the determination of whether a significant hardship exists.

We also are proposing that eligible professionals or group practices would be able to submit significant hardship exemption requests using a Web-based tool or interface. However, our ability to receive the significant hardship requests in this manner would be dependent on the development of such a Web site being completed prior to the publication of the final rule. In the event that such a Web site is not available, an eligible professional or group practice would be required to send us an application for a hardship exemption with such information by mail. We are not proposing to allow an eligible professional or group practice to submit significant hardship exemption requests via e-mail or fax because additional security precautions would need to be put into place. In some cases, a TIN may consist of an eligible professional's social security number, which is considered to be personally identifiable information.

We are proposing that the eligible professional or group practice must submit the hardship request by no later than October 1, 2011, which, if submitted by mail, means postmarked no later than October 1, 2011. We also propose to extend the deadline for submitting requests for consideration for the two significant hardship exemption categories (that is, eligible professional or group practice practices in rural areas with limited high speed Internet access and eligible professional or grouppractice practices in an area with limited available pharmacies for eRx) for the 2012 eRx payment adjustment that were finalized in the CY 2011 PFS final rule (75 FR 73564 through 73565) to October 1, 2011. Since this rule is not expected to be finalized prior to the current deadline of June 30, 2011, for submitting the G-codes that were created for these two significant hardship exemption categories via claims (or, for group practices, at the time group practices self-nominate), we propose that the Web-based tool or interface, if available, would be used to submit all significant hardship exemption requests (including those for the current significant hardship exemption categories). Eligible professionals who wish to request a significant hardship exemption for one of the current significant hardship exemption categories via claims-based submission of a G-code would still have to do so prior to the current deadline of June 30, 2011. If the Web-based tool is not developed prior to the publication of the final rule, then we would default to mail submission of all significant hardship exemption requests (including those for the current hardship exemption categories).

We are proposing October 1, 2011, because we seek to complete our review of the requests in time to instruct the carriers/MACs as to those eligible professionals or group practices that are not subject to the 2012 eRx payment adjustments based on the proposed additional significant hardship exemption categories. We would like to be able to process all such requests before we begin making the claims processing systems changes later this year to adjust eligible professionals' or group practices' payments starting on January 1, 2012. However, we anticipate that, in some cases, we may not be able to complete our review of the requests before the claims processing systems updates are made to begin reducing eligible professionals' and group practices' PFS amounts in 2012. In such cases, if we ultimately approve the eligible professional's or group practice's request for a significant hardship exemption, we would need to reprocess all claims for services furnished up to that point in 2012 that were paid at the reduced PFS amount. We also believe that this date allows sufficient time for eligible professionals (including those in group practices) that intend to use certified EHR technology and to qualify for the 2011 EHR Incentive Program in 2011 to have adopted the technology.

While we considered providing eligible professionals and group practices with additional time to submit requests for a significant hardship exemption under the proposed additional categories, we believe that doing so might result in the need to reprocess claims for 2012 services for eligible professionals. We invite public comment on the proposed process for submitting these requests for significant hardship exemptions to us (including comments on the type of information we are proposing eligible professionals and group practices must submit, the proposed options for how the information could be submitted, and the proposed timeframes for submission). We also invite comment on our proposal to extend the timeframe for submitting hardship exemption requests for the two categories we finalized in the CY 2011 PFS final rule and the proposed process for submitting these requests under the extended timeframe.

To the extent the final rule is not effective by October 1, 2011, then we propose that the eligible professional or group practice must submit the hardship request by no later than 5 business days after the effective date of the final rule. Eligible professionals and group practices may begin submitting significant hardship exemption requests at any time after the final rule is made available for public inspection by the Office of the Federal Register. In the event that the final rule is not made available for public inspection by the Office of the Federal Register by October 1, 2011, we seek comment on whether 5 business days after the effective date of the final rule would be an adequate amount of time for eligible professionals and group practices to submit a significant hardship exemption request.

We also are proposing that once we have completed our review of the eligible professional's or group practice's request and made a decision, we will notify the eligible professional or group practice of our decision and all such decisions would be final. Eligible professionals and group practices would not have the opportunity to request reconsiderations of their requests for significant hardship exemption.

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in theFederal Registerand solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):

We do not believe there is any burden associated with the proposed changes to the 2011 eRx measure as the changes solely clarify whether we consider certified EHR technology to meet the technological requirements of the eRx measure and do not change the reporting requirements for purposes of reporting the eRx quality measure for the 2011 eRx incentive and 2013 eRx payment adjustment.

We believe that any burden associated with submitting the hardship exemption requests for the additional categories we are proposing would be minimal and would be limited to the time and effort associated with gathering the requested information and submitting the information to CMS in the specified form and manner. Whether the application can be submitted online or through other means, we do not anticipate it taking more than a 2 hours per eligible professional to review the hardship exemption codes available, determine which code(s) applies to their particular situation, gather the information needed for the justification, and then complete and submit the information to CMS.

To provide an estimate of the burden associated with submitting a hardship exemption request, we need to determine the approximate number of physicians and eligible professionals that could be subject to the eRx payment adjustment in 2012 as well as the number of eligible professionals that could submit a hardship exemption request. Based on Medicare Part B claims data, it is estimated that approximately 209,000 eligible professionals could potentially besubject to the 2012 payment adjustment unless they become a successful electronic prescriber (that is, report the electronic prescribing measure at least 10 times during the 6-month reporting period) or request a significant hardship exemption. Thus, the maximum total number of eligible professionals that could potentially need to request a significant hardship exemption is believed to be approximately 209,000. However based on participation numbers from previous eRx Incentive Program years, we predict that the number of eligible professionals impacted will in fact be lower. In 2009, 92,132 eligible professionals participated in the eRx program and preliminary data for 2010 indicates that 100,444 professionals have participated in the eRx Incentive Program. Based on this data, we have determined that it is more accurate to estimate that approximately 109,000 eligible professionals could potentially submit a significant hardship exemption request as over 100,000 eligible professionals are already participating in the program. While we do not have a precise estimate of how many of the eligible professionals that are not able to be successful electronic prescribers will request a significant hardship, we do know that since the proposed hardship exemption categories will not apply to all eligible professionals since they represent specific circumstances. Therefore, for purposes of this burden estimate, we will assume that, at a minimum, approximately 10 percent of the 109,000 eligible professionals that could potentially request a significant hardship exemption will do so. This brings our minimum estimated number of eligible professionals impacted to approximately 10,900. Based on our estimate that the time needed to collect and report the information requested will be 2 hours, we believe that the total burden associated with requesting a significant hardship exemption will range from approximately 21,800 hours (10,900 eligible professionals × 2 hours per eligible professional) to 418,000 hours (209,000 eligible professionals × 2 hours per eligible professional). Based on an average group practice labor cost of $58 per hour, we predict the annual burden cost to be between approximately $1,264,400 ($58 per hour × 21,800 hours) and $24,244,000 ($58 per hour × 418,000 hours). We welcome comments on the above estimates.

If you comment on these information collection and recordkeeping requirements, please do either of the following:

1. Submit your comments electronically as specified in theADDRESSESsection of this proposed rule; or

2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget,Attention:CMS Desk Officer, CMS-3248-P.Fax:(202) 395-7245; orE-mail: OIRA_submission@omb.eop.gov.

Because of the large number of public comments we normally receive onFederal Registerdocuments, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in theDATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

This proposed rule includes changes to the eRx Incentive Program. The first proposed change involves modifying the eRx quality measure used for certain reporting periods in CY 2011 to address uncertainties related to the technological requirements of the Medicare eRx Incentive Program. The eRx measure would be revised to indicate whether an eligible professional has adopted a qualified electronic prescribing system or certified EHR technology as defined at 45 CFR 170.102. The second proposed change involves proposing additions to the significant hardship exemption categories for the 2012 eRx payment adjustment. The proposed additional exemption categories for the 2012 e Rx payment adjustment include—(1) Eligible professionals who register to participate in the Medicare or Medicaid EHR Incentive Program and Adopt Certified EHR Technology; (2) the inability to electronically prescribe due to local, State, or Federal law; (3) limited prescribing activity; and (4) insufficient opportunities to report the electronic prescribing measure due to limitations of the measure's denominator. Finally, this rule proposes an extension of the deadline for the 2012 eRx payment adjustment, thereby allowing eligible professionals and group practices to submit the existing two significant hardship codes established in the 2011 PFS final rule with comment period. These hardship exemption categories are: (1) The eligible professional practices in a rural area without sufficient high speed Internet access; and (2) the eligible professional practices in an area without sufficient available pharmacies for electronic prescribing.

We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

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 1 year). We estimate that the impact of the proposed changes would be $30 million for fiscal year (FY) 2012, net of premium offset based on the FY 2012 President's budget baseline and $20 million for FY 2013. Therefore, this proposed rule does not reach the economic threshold and thus is not considered a major rule.

The RFA requires agencies to analyze options for regulatory relief of small entities if a rule has a significant economic impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and States are not included in the definition of a small entity. A majority of the physicians and other eligible professionals affected by this proposed rule are small entities either by being nonprofit organizations or by meeting the Small Business Administration size thresholds for a small healthcare business (having revenues of less than $7.0 million to $34.5 million in any 1 year). While we do not have precise estimates, we believe this proposed rule would affect a substantial number of small entities (that is, several thousand or more). We welcome detailed information on the number of physicians and other professionals who would be affected by these proposals (that is, the number of physicians and other professionals who currently believe they are not able to meet the requirements for the 2012 eRx payment adjustment on the grounds that it would pose a significant hardship and for whom one or more of the proposedsignificant hardship exemption categories could apply).

We interpret the requirement for preparation of an Initial Regulatory Flexibility Analysis as applying to proposed rules that impose significant economic burden. The Office of the Chief Council for Advocacy within the Small Business Administration believes that the requirement applies whether the economic impact is positive or negative. Regardless, we normally prepare a voluntary analysis when proposed rules would have a significant positive impact. In this case, the proposed change to the eRx measure under the eRx Incentive Program for purpose of reporting for the 2011 eRx incentive and the 2013 eRx payment adjustment and the proposed additional significant hardship exemption categories, if applicable, for purposes of the 2012 eRx payment adjustment would reduce burden for eligible professionals. The proposed modification to the eRx measure would eliminate any uncertainty as to whether eligible professionals who are participating in both the eRx Incentive Program and the EHR Incentive Program can use the certified EHR technology that they adopted for the EHR Incentive Program to electronically prescribe under the eRx Incentive Program. Therefore, there would no longer be any ambiguity as to whether eligible professionals can use the same technology for both programs and less time and effort spent by eligible professionals to determine whether the certified EHR technology they have adopted for purposes of the EHR Incentive Program could be used to meet the eRx quality measure under the eRx Incentive Program. It is difficult to estimate the precise economic impacts of these changes on the affected entities.

We believe that the proposed additional significant hardship exemption categories for the 2012 eRx payment adjustment would reduce the number of eligible professionals that would otherwise be subject to a 1.0 percent adjustment in the PFS amount for covered professional services furnished in 2012. Also, the proposed changes would continue to encourage adoption of electronic prescribing in the interest of improving the medication prescription process while acknowledging circumstances that may prevent physicians and other professionals from successfully participating in the eRx Incentive Program. Based on 2010 Medicare Part B claims data, we believe approximately 209,000 eligible professionals would need to either be a successful electronic prescriber or request a hardship exemption to avoid the 2012 payment adjustment. However, we are unable to provide a precise estimate as to the number of eligible professionals, out of the total 209,000, that would potentially request a significant hardship exemption for one of the proposed hardship exemption categories. While we are aware, from public comments received in response to the 2011 PFS proposed and final rules with comment period, correspondence, inquiries received by our help desk, and comments made by eligible professionals on our national provider calls, open door forums, and a February 9, 2011 Town Hall Meeting, that there are eligible professionals who have expressed their inability to meet the successful electronic prescriber requirements for the 2012 eRx payment adjustment for one or more of the circumstances addressed by the proposed additional significant hardship exemption categories, we are not able to quantify in detail how many eligible professionals these proposed additional significant hardship exemptions could apply to since each eligible professional's individual circumstances are unique. We believe that any cost associated with requesting the significant hardship exemptions would be minimal since it would be limited to the time and effort associated with submitting a significant hardship exemption from the 2012 eRx payment adjustment either via the proposed Web tool or by mail. We believe that any cost associated with requesting a significant hardship exemption would, if applicable to the eligible professional, be offset by the eligible professional avoiding the payment adjustment in 2012.

Overall, we estimate that the impact of the proposed changes would be $30 million for FY 2012, net of premium offset based on the FY 2012 President's budget baseline and $20 million for FY 2013. We also welcome comments and information on the likely magnitudes of savings, and the likely numbers of affected physicians and other professionals who would achieve savings of various sizes, under the specific alternatives we propose. We note that each of the regulatory relief options discussed previously in this preamble constitutes a distinct alternative that we have considered. We welcome comments on whether there are any additional alternatives that are both reasonable and achievable under the time constraints imposed by the existing rule.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals. The eRx Incentive Program does not apply to small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This rule would have no consequential effect on State, local, or Tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

For the reasons set forth in the preamble of this proposed rule, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 414 as set forth below:

Background

On May 24, 2010, the National Marine Fisheries Service (NMFS) received a petition from the Center for Biological Diversity (CBD) (hereafter referred to as the Petitioner), requesting that we list the entire species of Atlantic bluefin tuna (Thunnus thynnus) or in the alternative, an Atlantic bluefin tuna distinct population segment (DPS) consisting of one or more subpopulations in United States waters, as endangered or threatened under the ESA, and designate critical habitat for the species. The petition contains information on the species, including the taxonomy; historical and current distribution; physical and biological characteristics of its habitat and ecosystem relationships; population status and trends; and factors contributing to the species' decline. The Petitioners also included information regarding possible DPSs of Atlantic bluefin tuna. The petition addresses the five factors identified in section 4(a)(1) of the ESA as they pertain to Atlantic bluefin tuna: (A) Current or threatened habitat destruction or modification or curtailment of habitat or range; (B) overutilization for commercial purposes; (C) disease or predation; (D) inadequacy of existing regulatory mechanisms; and (E) other natural or man-made factors affecting the species' continued existence.

On September 21, 2010, we determined that the petition presented substantial information indicating that the petitioned action may be warranted and published a positive 90-day finding in theFederal Register(FR) (75 FR 57431). Following our positive 90-day finding, we convened an Atlantic bluefin tuna status review team (SRT) to review the status of the species.

In order to conduct a comprehensive review, we asked the SRT to assess the species' status and degree of threat to the species with regard to the factors provided in Section 4(a)(1) of the ESA without making a recommendation regarding listing. The SRT was provided a copy of the petition and all information submitted in response to the data request in the FR notice announcing the 90-day finding. In order to provide the SRT with all available information, we invited several Atlantic bluefin tuna experts to present information on the life history, genetics, and habitat used by Atlantic bluefin tuna to the SRT.

We also hosted five listening sessions with Atlantic bluefin tuna fishermen. These sessions were held in Maine, Massachusetts, New Jersey, North Carolina, and Mississippi. Those with information relevant to the discussion topics for the sessions were also encouraged to submit information via mail or electronic mail. The SRT reviewed all this information during its consideration and analysis of potential threats to the species. The SRR is a summary of the information assembled by the SRT and incorporates the best scientific and commercial data available(e.g.,fisheries data that are available to assist in assessing the status of the species). In addition, the SRT summarized current conservation and research efforts that may yield protection, and drew scientific conclusions about the status of Atlantic bluefin tuna throughout its range.

The SRT completed a draft SRR in March 2011. As part of the full evaluation of the status of Atlantic bluefin tuna under the ESA, we requested that the Center for Independent Experts (CIE) select three independent experts to peer review the SRR. The reviewers were asked to provide written summaries of their comments to ensure that the content of the SRR is factually supported and based on the best available data, and the methodology and conclusions are scientifically valid. Prior to finalizing the SRR, the SRT considered and incorporated, as appropriate, the peer reviewers' comments. The final SRR was submitted to us on May 20, 2011.

Atlantic bluefin tuna are highly migratory pelagic fish that range across most of the North Atlantic and its adjacent seas, particularly the Mediterranean Sea. They are the only large pelagic fish living permanently in temperate Atlantic waters (Bardet al.,1998, as cited in Fromentin and Fonteneau, 2001). In the Atlantic Ocean and adjacent seas, they can range from Newfoundland south to Brazil in the western Atlantic, and in the eastern Atlantic from Norway south to western Africa (Wilsonet al.,2005).

Atlantic bluefin tuna are epipelagic and typically oceanic; however, they do come close to shore seasonally (Collette and Nauen, 1983). They often occur over the continental shelf and in embayments, especially during the summer months when they feed actively on herring, mackerel, and squids in the North Atlantic. Larger individuals move into higher latitudes than smaller fish. Surface temperatures where large Atlantic bluefin tuna have been found offshore in the northwest Atlantic range between 6.4 and 28.8 °C, whereas smaller Atlantic bluefin tuna are generally found in warmer surface water ranging from 15 to 17 °C (Collette and Klein-MacPhee, 2002). In general, Atlantic bluefin tuna occupy surface waters around 24 °C in the Western Atlantic (Blocket al.,2005; Teoet al.,2007) and in the Eastern Atlantic/Mediterranean, generally around 20.5 to 21.5 °C (Royeret al.,2004) and above 24 °C for spawning (Matheret al.,1995; Schaefer, 2001; Garciaet al.,2005).

Archival tagging and tracking information have confirmed that Atlantic bluefin tuna are endothermic (i.e.,able to endure cold as well as warm temperatures while maintaining a stable internal body temperature). It was once thought that Atlantic bluefin tuna preferentially occupy surface and subsurface waters of the coastal and open-sea areas; however, data from archival tagging and ultrasonic telemetry indicate that they frequently dive to depths of 500 m to 1,000 m (Lutcavageet al.,2000). While they do dive frequently to deeper depths, they generally spend most of their time in waters less than 500 m, and often much shallower.

As stated previously, Atlantic bluefin tuna are highly migratory; however, they do display homing behavior and spawning site fidelity in both the Gulf of Mexico and the Mediterranean Sea, and these two areas constitute the two primary spawning areas identified to date. Larvae have, however, been documented outside of the Gulf of Mexico in the western Atlantic, and the possibility of additional spawning areas cannot be discounted (McGowan and Richards, 1989).

It appears that larvae are generally retained in the Gulf of Mexico until June, and schools of young-of-the-year (YOY) begin migrating to juvenile habitats (McGowan and Richards, 1989) thought to be located over the continental shelf around 34°N and 41°W in the summer, and further offshore in the winter. They have also been identified from the Dry Tortugas area in June and July (McGowan and Richards, 1989; ICCAT, 1997). Juveniles migrate to nursery areas located between Cape Hatteras, North Carolina and Cape Cod, Massachusetts (Matheret al.,1995).

Atlantic bluefin tuna have not been observed spawning (Richards, 1991); however, recent work has identified putative breeding behaviors by Atlantic bluefin tuna while in the Gulf of Mexico (Teoet al.,2007). Presumed Atlantic bluefin tuna breeding behaviors were associated with bathymetry (continental slope waters), sea surface temperature (moderate), eddy kinetic energy (moderate), surface chlorophyll (low concentrations), and surface wind speed (moderate) (Teoet al.,2007).

Essential fish habitat (EFH) is defined under the Magnuson-Stevens Act as waters, aquatic areas and their associated physical, chemical, and biological properties that are used by fish and may include aquatic areas historically used by fish where appropriate; and the substrate, sediment, hard bottom, structures underlying the waters, and associated biological communities that are necessary to fish for spawning, breeding, feeding, or growth to maturity, representing the species full life cycle.

For western Atlantic bluefin tuna, EFH was defined in the Final Amendment 1 to the Consolidated Highly Migratory Species Fishery Management Plan (NMFS Amendment 1, 2009). Atlantic bluefin tuna EFH for spawning, eggs, and larvae was defined as following the 100 m depth contour in the Gulf of Mexico to the Exclusive Economic Zone (EEZ), and continuing to the mid-east coast of Florida. For juveniles sized less than 231 cm fork length (FL), EFH was defined as waters off North Carolina, south of Cape Hatteras to Cape Cod. For adult sizes equal to or greater than 231 cm FL, it was defined as pelagic waters of the central Gulf of Mexico and the mid-east coast of Florida, North Carolina from Cape Lookout to Cape Hatteras, and New England from Connecticut to the mid-coast of Maine.

It is believed that there are certain features of the Atlantic bluefin tuna larval habitat in the Gulf of Mexico which determine growth and survival rates and that these features show variability from year to year, perhaps accounting for a significant portion of the fluctuation in yearly recruitment success (McGowan and Richards, 1989). The habitat requirements for larval success are not known, but larvae are collected within narrow ranges of temperature and salinity; approximately 26 °C and salinities of 36 parts per thousand (ppt). Along the coast of the southeastern United States, onshore meanders of the Gulf Stream can produce upwelling of nutrient rich water along the shelf edge. In addition, compression of the isotherms on the edge of the Gulf Stream can form a stable region which, together with upwelling nutrients, provides an area favorable to maximum growth and retention of food for the larvae (McGowan and Richards, 1989).

Additionally, NMFS Amendment 1 designated a Habitat Area of Particular Concern (HAPC) for bluefin tuna. The bluefin tuna HAPC is located west of 86 ° W and seaward of the 100 m isobath, extending from the 100 m isobath to the EEZ. The area includes a majority of the locations where Atlantic bluefin tuna larval collections have been documented, overlaps with adult and larval Atlantic bluefin tuna EFH, and incorporates portions of an area identified as a primary spawninglocation by Teoet al.(2007). The Gulf of Mexico is believed to be the primary spawning area for western Atlantic bluefin tuna, and the HAPC designation highlights the importance of the area for Atlantic bluefin tuna spawning. It may also provide added conservation benefits if steps are taken to reduce impacts from development activities through the consultation process.

The best known spawning areas for the eastern Atlantic bluefin tuna are southwest of the Balearic Sea, the central and southern Tyrrhenian Sea, the central Mediterranean Sea southwest of Malta, and the eastern Mediterranean Sea in the south Aegean to the area north of Cyprus, particularly the area between Anamur and Mersin in the Levantine Sea. Important spatial changes in some of the most relevant spawning areas have been noticed in the last 10 years, particularly in the south Tyrrhenian and central Mediterranean. Most of the available information reports a major presence of bluefin tuna along the coasts of Croatia, south Adriatic Sea, western Ionian Sea, Tyrrhenian Sea, all the northwestern Mediterranean coast, in some areas of Morocco and Tunisia, in a few Aegean areas, and in the Levantine Sea (between Anamur and Mersin).

Areas where juveniles concentrate have been noticed to change from year to year. Juveniles are mostly present in feeding aggregations or schools during fall, from September to December. Mature specimens have been reported from most of the Mediterranean areas, with the only exceptions being the Gulf of Lions and the northern Adriatic Sea. Larvae have also been found in most of the Mediterranean surface waters, with a major concentration in areas where gyres and fronts are present, particularly in the second part of summer.

Young-of-the-year (YOY) Atlantic bluefin tuna have been found mostly in coastal areas over the continental shelf, whenever preferred prey is present. Tagging data showed that Atlantic bluefin tuna movement within the Mediterranean Sea is often limited, particularly for individuals tagged in the eastern regions of the basin. Movements of Atlantic bluefin tuna tagged in the central and western Mediterranean Sea were more pronounced than those tagged in the eastern portion. Seasonal prey abundance drives the concentration of both young and adult specimens in those Mediterranean Sea areas not used for reproduction (e.g.Ligurian Sea, north-central Adriatic Sea). Many larger individuals (> 150 kg) move out of the Mediterranean, and their movement patterns and displacement distance seem to be related to size and the exploitation of feeding grounds outside the Mediterranean Sea (Wurtz, 2010), while some are resident year round.

According to Section 3 of the ESA, the term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife that interbreeds when mature.” Congress included the term “distinct population segment” in the 1978 amendments to the ESA. On February 7, 1996, the U.S. Fish and Wildlife Service and NMFS (jointly referred to as the Services) adopted a policy to clarify their interpretation of the phrase “distinct population segment” for the purpose of listing, delisting, and reclassifying species (61 FR 4721). The policy described two criteria a population segment must meet in order to be considered a DPS (61 FR 4721):

1. It must be discrete in relation to the remainder of the species to which it belongs; and

2. It must be significant to the species to which it belongs.

Determining if a population is discrete requires either one of the following conditions:

1. It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors. Quantitative measures of genetic or morphological discontinuity may provide evidence of this separation; or

2. It is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the ESA.

If a population is deemed discrete, then the population segment is evaluated in terms of significance, which may include, but is not limited to, the following:

1. Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon.

2. Evidence that loss of the discrete population segment would result in a significant gap in the range of the taxon.

3. Evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historic range; or

4. Evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics.

If a population segment is deemed discrete and significant, then it qualifies as a DPS.

Rookeret al.(2008) analyzed the chemical composition of otoliths (e.g.,fish ear bones) from Atlantic bluefin tuna that were 12 to 18 months of age and that were caught between 1999 and 2004 in both the eastern (Mediterranean Sea/eastern Atlantic Ocean) and western (Gulf of Mexico/eastern coast of the United States) nurseries. These authors found that otolith composition was distinct between yearlings from the two different nursery areas, and that the chemical signature was significantly different for yearlings from the eastern nursery in five of the years (all except 2001) (Rookeret al.,2008).

Dickhutet al.(2009) used organochlorine and polychlorinated biphenyl (PCB) tracers from Atlantic bluefin tuna foraging grounds to determine the rate of mixing of different size classes between the eastern and western stocks. Their results indicated that mixing of juvenile Atlantic bluefin tuna from the eastern to the western foraging grounds could be as high as 80 percent for certain age classes and that juveniles from the Mediterranean Sea may migrate to western Atlantic foraging grounds as early as age 1 (Dickhutet al.,2009). However, this study also indicated that medium to giant sized Atlantic bluefin tuna entering the Gulf of Mexico breeding grounds showed PCB ratios similar to that of the western Atlantic young-of-the-year (YOY), which suggests little or no mixing on the spawning grounds in the Gulf of Mexico, as these fish have been foraging in the western Atlantic rather than foraging grounds used by Mediterranean bluefin tuna (Dickhutet al.,2009).

Carlssonet al.(2006) conducted analyses of 320 YOY Atlantic bluefin tuna to evaluate the hypothesis that 2 separate spawning grounds exist for the western and eastern stocks—Gulf of Mexico and Mediterranean Sea, respectively. In this study, Carlssonet al.(2006) conducted a microsatellite analysis of 8 loci and examined the mitochondrial DNA control region and found significant genetic differentiation among YOY fish captured in the Gulf of Mexico spawning grounds versus those captured in the Mediterranean spawning area. Their results support a high degree of spawning site fidelity, and thus, they noted that the recognition of genetically distinct populations requires independentmanagement of the stocks of this species (Carlssonet al.,2006).

Riccioniet al.(2010) indicated that genetic analyses and microchemical signatures from otoliths strongly support the existence of two distinct primary spawning areas for Atlantic bluefin tuna (the Mediterranean and Gulf of Mexico). These authors noted that significant genetic divergence was found between these two spawning stocks using microsatellite (Carlssonet al.,2007) and mitochondrial DNA analyses (Boustanyet al.,2008), and they also indicated that there are high rates of spawning site fidelity of 95.8 percent and 99.3 percent for the Mediterranean Sea and Gulf of Mexico, respectively (Rookeret al.,2008; Blocket al.,2005).

The best available information indicates that fish from the Mediterranean stock, while making some trans-Atlantic migrations, return to the Mediterranean to spawn while fish from the Gulf of Mexico stock return to the Gulf of Mexico to spawn. This separation between the stocks is supported by the aforementioned genetic analyses which indicate significant genetic differentiation between the two stocks as described above. In addition, the results of the otolith microchemistry analyses indicate that natal homing or spawning site fidelity does occur, and the study by Dickhutet al.(2009) using organochlorine and PCB tracers also indicate that there is little to no mixing on the spawning grounds. Furthermore, according to Rookeret al.(2008), the rates of spawning site fidelity are 95.8 percent and 99.3 percent for the Mediterranean Sea and Gulf of Mexico, respectively. Thus, the two populations in the North Atlantic are discrete.

The available data further suggest that the eastern Atlantic stock exhibits genetic differentiation, spatial separation during spawning as a result of spawning site fidelity/natal homing, and differences in behavior (e.g.,some resident fish in the eastern Mediterranean versus non-resident/migratory fish in the western Mediterranean) with different spawning areas in the western and eastern Mediterranean. According to Reeb (2010), the eastern and western basins of the Mediterranean exhibit differences in temperature, circulation patterns, and salinity, and the basins are considered oceanographically to be separated by the straits of Sicily and Messina. Thus, even though Atlantic bluefin tuna are highly migratory, the areas that they home to in order to spawn may possess unique characteristics. All of this evidence combined with the recent evidence suggesting a separate spawning area in the eastern Mediterranean and genetic analyses which demonstrate significant genetic differences between western and eastern Mediterranean fish and between the Mediterranean and Gulf of Mexico spawning areas led Fromentin (2009) to hypothesize that Atlantic bluefin tuna are comprised of at least three sub-populations: (1) A highly migratory stock over all of the North Atlantic that spawns in western and central Mediterranean areas; (2) a more resident stock in the Mediterranean which spawns in the central and eastern Mediterranean; and (3) a more resident stock in the West Atlantic which spawns in the Gulf of Mexico. As such, two discrete populations may exist within the larger eastern Mediterranean population. While there is some evidence which indicates that there may be other, discrete spawning areas outside of the Gulf of Mexico, the locations of these areas have not been confirmed or fully described at this time.

Using the best available information, the SRT concluded that the western Atlantic and the eastern Atlantic populations are discrete from each other. Within the eastern Atlantic, the available information suggests that there may be two discrete populations of Atlantic bluefin tuna; however, the data are inconclusive regarding the Mediterranean at this time.

If a population is deemed discrete, then the population segment is evaluated in terms of significance. The western Atlantic population has been determined to be a discrete population from the two possible Mediterranean populations as described above. Consequently, it is necessary to assess the biological and ecological significance of each discrete population as described in the Services' DPS policy.

Several studies have documented that Atlantic bluefin tuna in the Mediterranean appear to prefer sea surface temperatures above 24 °C for spawning (Matheret al.,1995; Schaefer, 2001; Garciaet al.,2005), and in the Gulf of Mexico, Teoet al.(2007) noted that they prefer areas with surface temperatures between 24 and 27 °C. Since adult Atlantic bluefin tuna are present in the Gulf of Mexico as early as winter but are not usually in spawning condition until mid-April (Blocket al.,2001), an environmental cue such as temperature or photoperiod may trigger spawning (Muhlinget al.,2010).

Muhlinget al.(2010) also indicated that Atlantic bluefin tuna larvae are generally absent from continental shelf areas with low surface temperatures and salinities at the beginning of the spawning period. They theorized that Atlantic bluefin tuna may avoid spawning in these areas as they are typically high in chlorophyll concentrations and, therefore, contain dense phytoplankton blooms which support high concentrations of zooplankton. While the high concentrations of zooplankton provide a source of larval prey, they attract other planktonic predators (Bakun, 2006). According to Muhlinget al.(2010), larval tuna have specialized diets, often feeding on pelagic tunicates found in oligotrophic open ocean areas (Sommer and Stibor, 2002, as cited in Muhlinget al.,2010). Thus, these authors concluded that larval tuna in the Gulf of Mexico may be adapted to survive in nutrient poor waters. Muhlinget al.(2010) concluded that favorable habitat for Atlantic bluefin tuna larvae in the Gulf of Mexico consists of areas of moderately warm water temperatures outside of the loop current, loop current eddies, and outside of continental shelf waters that contain cooler water with higher chlorophyll concentrations (Muhlinget al.,2010).

Oray and Karakulak (2005) described the spawning area surveyed in the northern Levantine Sea as containing waters with sea surface temperatures between 21.8 to 29.3 °C, salinity from 34.9 to 38.8 ppt, and depths between 63 to 2,448 m. Oray and Karakulak (2005) indicate that larval Atlantic bluefin tuna were found in areas with physical oceanographic features such as cyclonic eddies, which may indicate that the main larval populations are within these cyclonic eddies and that the tuna spawning site is within close proximity to the area in which the larvae were observed. According to Oray and Karakulak (2005), the optimal seawater temperatures in the Atlantic bluefin tuna spawning area in the northern Levantine Sea are between 23 to 25 °C, which generally occur early in June, whereas optimum temperatures for spawning in the western Mediterranean generally occur later, toward the end of June.

Garciaet al.(2005) characterized the Atlantic bluefin tuna spawning habitat off the Balearic Archipelago. These authors noted that Atlantic bluefin tuna larval abundance is associated with surface water temperatures between 24 and 25 °C in areas of inflowing Atlantic waters or transitional areas with Atlantic waters mixing with Mediterranean waters and that generally possess hydrographic features such as fronts and gyres (Garciaet al.,2005).According to Garciaet al.(2005), significant concentrations of Atlantic bluefin tuna larvae were found off the Mallorca channel in an area with frontal formations and south of Minorca where an anticyclonic gyre was observed. Garciaet al.(2005) note that these frontal structures and gyres may play an important role in providing concentrated prey resources for larval fish, which may in turn constitute an important part of the diet of larval Atlantic bluefin tuna. Low and isolated larval concentrations were observed in Mediterranean water masses north of the islands (Garciaet al.,2005). The strong eastward current that flows from Ibiza towards Minorca may act as a transport mechanism for larvae (Garciaet al.,2005). The area near Mallorca and the Ibiza channels is generally characterized by low concentrations of chlorophylla,which is primarily due to the major influence of the nutrient poor water masses originating from the Atlantic (Garciaet al.,2005).

While spawning areas for Atlantic bluefin tuna may at times be stressful environments, Atlantic bluefin tuna migrate long distances to reach the particular areas in which they spawn (Blocket al.,2001), and homing fidelity to these sites is high. Muhlinget al.(2010) concluded that adults are targeting specific areas and oceanographic features in order to maximize larval survival. Consequently, the spawning areas in the Gulf of Mexico and Mediterranean are unique ecologically and possess the features (e.g.,appropriate water conditions such as temperatures, depths, salinities, and chlorophyll concentrations, hydrography) that are necessary for maximizing bluefin tuna spawning success for each population.

As noted previously, Atlantic bluefin tuna exhibit strong natal homing or spawning site fidelity. Therefore, it is unlikely individuals from the Mediterranean would spawn in the Gulf of Mexico, or that individuals from the Gulf of Mexico population would spawn in the Mediterranean. Thus, if one of the discrete populations was to be extirpated, it would represent a significant gap in the range of the taxon, in that either the Gulf of Mexico or the Mediterranean Sea would no longer support Atlantic bluefin tuna.

As presented above and as noted in the discreteness discussion, Atlantic bluefin tuna that spawn in the Gulf of Mexico and in the Mediterranean utilize unique ecological areas for spawning. There is information presented above that indicates that these areas possess unique features or characteristics to which larval tuna may be adapted. Also, some authors indicated that natal homing may be the result of behavior learned from older fish in the population and thus, the loss of a spawning group or of the mature fish could result in the permanent loss of a spawning area, and this area would most likely not be re-colonized by fish from another spawning group. This would represent a significant gap in the range of the taxon.

There is some evidence suggesting that there may be two discrete populations within the Mediterranean, but the SRT is unable to determine the significance of these populations to the species as a whole. While the two Mediterranean populations may be discrete, the SRT does not have enough information to conclude that they are significant, by themselves, to Atlantic bluefin tuna.

Based on the best available information, the SRT concluded that the western Atlantic and eastern Atlantic/Mediterranean populations represent two DPSs of Atlantic bluefin tuna. We agree with the SRT's DPS delineation, and refer to these DPSs as the western Atlantic DPS and eastern Atlantic/Mediterranean DPS of Atlantic bluefin tuna. The information presented in the remainder of this finding, therefore, pertains to the status of the western Atlantic and eastern Atlantic/Mediterranean DPSs of Atlantic bluefin tuna.

Atlantic bluefin tuna are managed domestically by NMFS' Highly Migratory Species (HMS) Management Division and internationally by the International Commission for the Conservation of Atlantic Tunas (ICCAT). ICCAT manages the western Atlantic and eastern Atlantic/Mediterranean DPSs as two separate stocks (eastern and western stocks), separated by the 45 ° W meridian. In recent years, stock assessments for Atlantic bluefin tuna have been conducted approximately every 2 years by the Standing Committee on Research and Statistics (SCRS). The most recent ICCAT stock assessment was conducted by SCRS in 2010. Models and methodologies employed by ICCAT during the stock assessments were used by the SRT to develop an extinction risk analysis; therefore, a description of the models, methods, and results is provided in the SRR, and significant conclusions are summarized below.

According to the ICCAT SCRS stock assessment in 2010, the total catch for the western Atlantic peaked at 18,671 t (16,938.05 mt) in 1964, with catches dropping sharply thereafter with the collapse of the Atlantic bluefin tuna longline fishery off Brazil in 1967 and the decline in purse seine catches. Catch increased again to average over 5,000 t (4,535.92 mt) in the 1970s due to the expansion of the Japanese longline fleet into the northwest Atlantic and Gulf of Mexico, and an increase in purse seine effort targeting larger fish for the sashimi market.

Since 1982, the total catch for the western Atlantic including discards has generally been relatively stable due to the imposition of quotas by ICCAT. However, following a total catch level of 3,319 t (3,010.95 mt) in 2002 (the highest since 1981), total catch in the western Atlantic declined steadily to a level of 1,638 t (1,485.97 mt) in 2007 (the lowest level since 1982), before rising to 1,935 t (1,755.4 mt) in 2009, which was near the total allowable catch (TAC). The decline prior to 2007 was primarily due to considerable reductions in catch levels for U.S. fisheries. The major harvesters of western Atlantic bluefin tuna are Canada, Japan, and the United States.

Safina and Klinger (2008) summarized ICCAT management regulations and catch history for the western Atlantic stock; however, it was not a quantitative assessment of the stock. Due to the timing of publication, the authors were only able to consider catch data through 2006, and there have been changes to the western Atlantic bluefin tuna fishery since then. MacKenzieet al.(2009) projected a similar collapse; however due to timing of publication, they were also only considering catch data through 2006. The 2006 U.S. catches of Atlantic bluefin tuna were the lowest in recent history; however, since then, the U.S. fishery has seen increasing catches, and the U.S. base quota was fully realized in 2009 and 2010. MacKenzieet al.(2009) projected that by 2011, the adult population of Atlantic bluefin tuna would be 75 percent lower than the population in 2005. Furthermore, Safina and Klinger (2008) stated that “these trends [in U.S. catches] suggest U.S. bluefin may approach widespread commercial unavailability as early as 2008”; however, the results of the ICCAT 2010 bluefin tuna stock assessment (as described in more detail below) and the catch statistics submitted to ICCAT clearly refute these assertions.

The base case assessment is consistent with previous analyses in that spawning stock biomass (SSB) declined dramatically between the early 1970s and early 1990s. Since then, SSB was estimated to have fluctuated between 21 and 29 percent of the 1970 level, but with a gradual increase in recent years from the low of 21 percent in 2003 to 29 percent in 2009. Thus, the stock has undergone substantial declines since historic highs were reported in the 1970s. The stock has experienced different levels of fishing mortality over time, depending on the size of fish targeted by various fleets. Fishing mortality on spawners (ages 9 and older) declined markedly after 2003. The estimates of recruitment (age 1) are very high for the early 1970s, but are much lower for the years since, with the exception of a strong year-class documented in 2003.

There are two alternative spawner-recruit hypotheses for the western stock: the two-line (low recruitment potential scenario) and the Beverton and Holt spawner-recruit formulation (high recruitment potential scenario). Under the low recruitment scenario, average levels of observed recruitment are based on levels from 1976-2006 (85,000 recruits) while in the high recruitment scenario, recruitment levels increase as the stock rebuilds (MSY level of 270,000 recruits). SCRS has indicated that it does not have strong evidence to favor either scenario over the other and notes that both are reasonable (but not extreme) lower and upper bounds on rebuilding potential. Both of these models take into account multiple variables affecting abundance, including fishing mortality, recruitment and vulnerabilities, and terminal ages. During the 2010 stock assessment, the SCRS re-examined the two alternative spawner-recruit hypotheses explored in several prior assessments. Stock status was determined under both scenarios for the base model from 1970 to 2009. The results under the two-line (low recruitment potential) scenario suggested that the stock has not been overfished since 1970, and that overfishing has not occurred since 1983. The results under the Beverton-Holt (high recruitment potential) scenario suggested that the stock has been overfished since 1970, and the fishing mortality rates (F) have been above fishing at maximum sustainable yield (FMSY), except for the years 1985, 1986, and 2007 to 2009. The low recruitment scenario is the more optimistic scenario because the result is that the stock biomass is above the rebuilding goal. Under the high recruitment scenario, rebuilding cannot be met by the end of ICCAT's 20-year rebuilding period. However, it is important to note that this change in the perception of current stock status (to not overfished, no overfishing occurring) under the low recruitment scenario is largely the result of applying a new growth curve rather than the result of management measures under the rebuilding plan.

ICCAT estimated the status of the western Atlantic stock in 2009 as well as status trajectories for the two recruitment levels. Using MSY-related benchmarks, ICCAT determined that the western Atlantic stock is not overfished and is not undergoing overfishing under the low recruitment potential scenario. However, under the Beverton-Holt recruitment hypothesis (high recruitment potential scenario), the stock remains overfished and overfishing is occurring. It was noted, however, that the assessment did not capture the full degree of uncertainty in the assessments and projections. Based on earlier work, the estimates of stock status can be expected to vary considerably depending on the type of data used to estimate mixing (conventional tagging or isotope signature samples) and modeling assumptions made. Improved knowledge of maturity at age will also affect the perception of changes in stock size. Finally, the lack of representative samples of otoliths requires determining the catch at age from length samples, which is imprecise for larger Atlantic bluefin tuna.

The results of the 2010 stock assessment for western Atlantic bluefin tuna were strongly influenced by a new growth curve (Restrepoet al.,2010). The new growth curve assigns older ages to fish larger than 120 cm. As a result, the age structure of the catch included a higher proportion of older fish, which implied that the stock was subjected to a lower fishing mortality than previously estimated. Under the low recruitment potential scenario, therefore, SSB was now estimated to have greater than a 60 percent chance of being above the level that will support MSY, and overfishing is not occurring. SSB remained low relative to the level at MSY under the high recruitment potential scenario. The fishing mortality rate under the high recruitment potential scenario indicated overfishing was still occurring.

Under both scenarios, the SSB trend shows an increase in the last few years of the time series considered. The SCRS also noted the strength of the 2003 year class, the largest since 1974, although it also acknowledged that the recruitment estimated by the model for subsequent year classes appears to be the lowest on record and, therefore, these subsequent year classes may be a cause of concern. However, anecdotal information from U.S. recreational and commercial fishermen pointed to a perceived high abundance of small Atlantic bluefin tuna in U.S. waters in 2010.

The SCRS noted that the productivity of both the western Atlantic bluefin tuna and western Atlantic bluefin tuna fisheries is linked to the eastern Atlantic/Mediterranean stock. There is very strong evidence that eastern DPS fish contribute to the catches that occur along the eastern seaboard of North America, particularly in the Mid-Atlantic Bight. Consequently, improvements to the stock status in the eastern DPS, which result in increases to the number of eastern fish in the Mid-Atlantic Bight fishery, could reduce the proportion of the TAC that comes from western DPS fish. Therefore, management actions taken in the eastern Atlantic and Mediterranean are likely to influence the recovery in the western Atlantic, because even small rates of mixing from the eastern Atlantic/Mediterranean to the western Atlantic can have significant effects on the western Atlantic due to the fact that the eastern Atlantic/Mediterranean resource is much larger than that of the western Atlantic (i.e.,approximately 10 times the size).

Reported catches in the eastern Atlantic/Mediterranean peaked at over 50,000 t (45,359.24 mt) in 1996 and then decreased substantially, stabilizing around TAC levels established by ICCAT. Both the increase and the subsequent decrease in declared production occurred mainly for the Mediterranean. Available information showed that catches of Atlantic bluefin tuna from the eastern Atlantic/Mediterranean were seriously under-reported from 1998 to 2007. In addition, farming activities in the Mediterranean since 1997 significantly changed the fishing strategy of purse seiners and resulted in a deterioration of Atlantic bluefin tuna catch at size (CAS) data reported to ICCAT. This is because Atlantic bluefin tuna size samples were obtained only at the time of harvest from the farms and not at the time of capture. The 2008 and 2009 reported catch was reviewed by the SCRS during the Atlantic bluefin tuna data preparatory meeting. The SCRS indicated that the reporting of catches significantly improved in those 2 years. However, the SCRS also indicated thatsome misreporting could still have been taking place. The assessment for the eastern stock used data for the period 1950-2009. Historically, illegal, unreported and unregulated fishing resulted in catch levels far exceeding the TAC levels mandated by ICCAT in the east. The United States has been looking closely at eastern bluefin tuna compliance and IUU issues over the years. Indications over the last two years are that progress has been made to address non-compliance and IUU issues, and catches over the last two years appear to be in line with agreed limits based on the monthly catch reports and SCRS information. Recruitment at the start of the time series varied between 2 and 3 million fish, dropped to around 1 million fish during the 1960s, followed by a steady increase toward maximum values in the 1990s and early 2000s while recruits dropped steeply in the last years. However, the recent levels are known to be less reliable because of the lack of data to estimate them. SCRS also notes that the potential decline in the recruitment in the most recent years is not in agreement with scientific information from aerial surveys carried out in the Mediterranean Sea (Bonhommeauet al.,2009).

Final SSB estimates differed slightly between the model runs that were used. The SSB peaked over 300,000 t (272,155.42 mt) in the late 1950s and early 1970s, followed by a decline. One model run indicated that the SSB continued to decline slightly to about 150,000 t (136,077.71 mt), while the other indicated that biomass increased slightly during the late 2000s to about 200,000 t (181,436.95 mt). Considering both runs, the analyses indicated that recent (2007-2009) SSB is about 57 percent of the highest estimated SSB levels (1957-1959).

The ESA defines an “endangered species” as “any species which is in danger of extinction throughout all or a significant portion of its range,” while a “threatened species” is defined as “any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The phrase “throughout all or a significant portion of its range” is neither defined nor explained in the ESA, and a final policy on how to interpret this language has not been developed by NMFS.

As previously noted, Atlantic bluefin tuna are highly migratory pelagic fish that range across most of the North Atlantic and its adjacent seas, particularly the Mediterranean Sea. Although the Atlantic bluefin tuna DPSs are described or defined by the location of their spawning grounds, they use the Atlantic Ocean and adjacent seas for various life stages and migrations for foraging, nursery grounds, and spawning. If a DPS was threatened or endangered in a spawning area, it would be threatened or endangered throughout its range (and not only in the spawning area) because a species cannot survive if individuals cannot spawn. Therefore, any determination we would make on the status of the DPSs would be based on the status of the DPSs throughout their ranges.

During a meeting to discuss the SRR, the SRT also considered the foreseeable future for Atlantic bluefin tuna and estimated the mean generation time for both the eastern Atlantic/Mediterranean DPS and western Atlantic DPS. For the purpose of the SRR, the mean generation time was determined to be 17 years for the western Atlantic DPS and 19 years for the eastern Atlantic/Mediterranean DPS. Mean generation time was computed as the fecundity-weighted average age of the spawning population at equilibrium in the absence of fishing, where the values for the age at maturity and natural mortality rate associated with the eastern and western DPSs were set to those used by the SCRS (and average weight was used as a proxy for fecundity). The mean generation time was similar for the two stocks because the younger age of maturity assumed for the eastern stock (which would imply a younger generation time) is mitigated by the lower natural mortality rate assumed for spawning age fish (which implies an older generation time). The SRT also reasoned that it will take a generation time to fully realize the impacts of various management measures, and thus, determined that approximately 17 to 19 years is a reasonable timeframe to define the foreseeable future for Atlantic bluefin tuna. Further support for this timeframe is provided in the 1998 rebuilding plan, as this was based on a mean generation time of 20 years (K. Blankenbeker, 2010, Pers. comm.). Additionally, projections through ICCAT have been estimated for 20 years for the western Atlantic. Because of ICCAT negotiations that can result in changes to annual quotas, we cannot estimate abundance beyond 20 years with any degree of confidence.

As described above, section 4(a)(1) of the ESA and NMFS implementing regulations (50 CFR 424) state that we must determine whether a species is endangered or threatened because of any one or a combination of the following factors: (A) Current or threatened habitat destruction or modification or curtailment of habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) inadequacy of existing regulatory mechanisms; and (E) other natural or man-made factors affecting the species' continued existence. This section briefly summarizes the findings regarding these factors. Additional details can be found in the SRR.

The Gulf of Mexico is believed to possess certain features for Atlantic bluefin tuna larval habitat which determine growth and survival rates of Atlantic bluefin tuna and can be variable from year to year (McGowan and Richards, 1989). The Gulf Stream can produce upwelling of nutrient rich waters along the shelf edge, which may provide an area favorable to maximum growth and retention of food for the larvae (McGowan and Richards, 1989).

The Mediterranean Sea is a basin with unique characteristics, being a semi-enclosed sea connected to the Atlantic Ocean through the narrow Strait of Gibraltar, to the Red Sea by the man-made Suez Canal and to the smaller enclosed Black Sea via the narrow Bosphorus Strait. The Mediterranean Sea exchanges water, salt, heat, and other properties with the North Atlantic Ocean, and is thus an important factor affecting global water formation processes and variability, and subsequently, the stability of the global thermohaline state of equilibrium (Wurtz, 2010).

There are a variety of past, present, and reasonably foreseeable future actions that have the potential to affect Atlantic bluefin tuna habitat. They range, among other things, from coastal development and associated coastal runoff and non-point source pollution in coastal areas to outer continental shelf (OCS) oil and gas development, and global climate change. Since most Atlantic bluefin tuna habitat is comprised of open ocean environments occurring over broad geographic ranges, large-scale impacts such as global climate change that affect ocean temperatures, currents, and potentially food chain dynamics, likely pose the greatest threat to Atlantic bluefin tuna habitat. Anecdotal information suggests that such changes may be occurring and influencing the distribution and habitat usage patterns of Atlantic bluefin tuna as well as other highly migratory species (HMS) and non-HMS fish stocks. Oceantemperature changes of a few degrees can disrupt upwelling currents that reduce or eliminate the nutrients necessary for phytoplankton and thereby, could have potential repercussions throughout the food chain. As a result, changes in migratory patterns may be the first indication that large scale shifts in oceanic habitats may be occurring. Some have pointed to the shift in availability of Atlantic bluefin tuna from fishing grounds off North Carolina to waters off Canada during the winter months as evidence of changes in oceanographic conditions that may be affecting historical distribution patterns. Although the evidence is still lacking, causative factors in the shift include preferences for cooler water temperatures and prey availability. A recent report by the Conservation Law Foundation indicated that low food availability had reduced growth rates in larval cod and haddock and that rising sea surface temperatures had the potential to further reduce productivity for these and other fish stocks off the New England coast (Bandura and Vucson, 2006).

Wetland loss is a cumulative impact that results from activities related to coastal development: Residential and industrial construction, dredging and dredge spoil placement, port development, marinas and recreational boating, sewage treatment and disposal, industrial wastewater and solid waste disposal, ocean disposal, marine mining, and aquaculture. In the late 1970s and early 1980s, the United States was losing wetlands at an estimated rate of 300,000 acres (1,214 sq km) per year. The Clean Water Act and state wetland protection programs helped decrease wetland losses to 117,000 acres (473 sq km) per year between 1985 and 1995. Estimates of wetlands loss vary according to the different agencies. The U.S. Department of Agriculture attributes 57 percent of wetland loss to development, 20 percent to agriculture, 13 percent to deepwater habitat, and 10 percent to forest land, rangeland, and other uses. Of the wetlands lost to uplands between 1985 and 1995, the FWS estimates that 79 percent of wetlands were lost to upland agriculture. Urban development and other types of land use activities were responsible for 6 percent and 15 percent of wetland loss, respectively.

Nutrient enrichment has become a major cumulative problem for many coastal waters. Nutrient loading results from the individual activities of coastal development, non-point source pollution, marinas and recreational boating, sewage treatment and disposal, industrial wastewater and solid waste disposal, ocean disposal, agriculture, and aquaculture. Excess nutrients from land based activities accumulate in the soil, pollute the atmosphere, pollute ground water, or move into streams and coastal waters. Nutrient inputs are known to have a direct effect on water quality. For example, in extreme conditions, excess nutrients can stimulate excessive algal blooms or dinoflagellate growth that can lead to increased turbidity, decreased dissolved oxygen, and changes in community structure, a condition known as eutrophication.

In addition to the direct cumulative effects incurred by development activities, inshore and coastal habitats are also jeopardized by persistent increases in certain chemical discharges. The combination of incremental losses of wetland habitat, changes in hydrology, and nutrient and chemical inputs produced over time can be extremely harmful to marine and estuarine biota, resulting in diseases and declines in the abundance and quality of the affected resources.

One of the major activities with the potential to impact Atlantic bluefin tuna habitat is oil and gas development on the OCS. Anecdotal information suggests that some recreational fishermen may target various fish species, including HMS, in the vicinity of oil platforms due to increased abundance and availability near platforms. The apparent increase in abundance of several species may be due to increased prey availability resulting from various fish and invertebrate communities that are attracted or attach directly to the structures and submerged pilings. While the apparent increase in abundance of fish near oil platforms may appear to be beneficial, little is known about the long-term environmental impacts of changes caused by these structures to fish communities, including potential changes to migratory patterns, spawning behavior, and development of early life stages. Currently, there is debate about whether the positive effects of the structures in attracting fish communities would be reduced by removal of the platforms when they are decommissioned.

As of 2009, there were approximately 4,000 oil and gas platforms in the Gulf of Mexico and fewer than 100 in the Atlantic. Most of the platforms were in waters shallower than 1,000 feet (305 m); however, there are ongoing efforts to expand oil drilling to deeper areas of the Gulf. Approximately 72 percent of the Gulf of Mexico's oil production comes from wells drilled in 1,000 feet (305 m) of water or greater (MMS, 2008(b)). Eight new deepwater discoveries were announced by oil and gas operators in 2007, with the deepest in 7,400 ft (2,256 m) of water (MMS, 2008(a)). Many of the shallower sites and most of the deepwater sites fall within habitats used by HMS, particularly by Atlantic bluefin tuna. Many of the deeper sites are also located within the HAPC for Atlantic bluefin tuna.

In the Atlantic, ten oil and gas lease sales were held between 1976 and 1983. Fifty-one wells were drilled in the Atlantic OCS; five Continental Offshore Stratigraphic Test wells between 1975 and 1979, and 46 industry wells between 1977 and 1984. Five wells off New Jersey had successful drillstem tests of natural gas and/or condensate. These five wells were abandoned as non-commercial.

In addition to the oil and gas wells, several liquefied natural gas (LNG) facilities have been proposed in the Gulf of Mexico. For LNG facilities, a major environmental concern is the saltwater intake system used to heat LNG and regasify it before piping it to shore. LNG facilities sometimes have open loop, once through heating systems known as open rack vaporizers, which require large amounts of sea water to heat LNG. As described in a draft environmental impact statement (DEIS) for an LNG project in the Gulf of Mexico, the use of the sea water intake system would subject early life stages of marine species to entrainment, impingement, thermal shock, and water chemistry changes, potentially causing the annual mortality of hundreds of billions of zooplankton, including fish and shellfish eggs and larvae. Depending on the location of the facility, this could have an adverse effect on habitat for Atlantic bluefin tuna or other HMS species. Closed loop systems are currently being used in the United States to regasify LNG and are proposed for multiple onshore and offshore LNG terminals throughout the nation, with the notable exception of the offshore waters of the Gulf of Mexico. These systems, which do not rely on an external saltwater intake source, and thus, do not require large amounts of seawater, have considerably lower impacts on fish eggs, larvae, and zooplankton than open loop systems.

For oil platforms, there are direct and indirect impacts to the environment such as disturbance created by the activity of drilling, associated pollution from drilling activities, discharge of wastes associated with offshore exploration and development, operational wastes from drilling muds and cuttings, potential for oil spills, and potential for catastrophic spills causedby accidents, such as the Deepwater Horizon (DWH) oil spill in 2010 (described below), or hurricanes and alteration of food webs created by the submerged portions of the oil platform, which attract various invertebrate and fish communities.

The potential effect of the DWH oil spill on the future abundance of western Atlantic bluefin tuna was evaluated by comparing the projections made by the SCRS (SCRS, 2010) to similar projections that assume the number of yearlings (1-year-old-fish) in 2011 will be reduced by 20 percent. The 20 percent value was based on the recent report by the European Space Agency that suggested 20% of the surface was oiled. However, this value does not reflect subsurface oil investigations and are ongoing on its potential distribution and impacts.

The SRT noted that another study (SEFSC, 2011, pers. comm.) suggested that considerably less than 20 percent of the spawning habitat for the western Atlantic DPS was affected by the spill. Moreover, if some larvae survived their encounter with oil and associated toxicants, or if density dependent processes are involved in the mortality of Atlantic bluefin tuna after the larval phase, then a 20 percent loss of spawning habitat might result in something less than a 20 percent reduction in the expected number of yearlings. However, factors such as the distribution of oil below the surface and the advection of larvae into the spill area after spawning are not well known. Accordingly, the SRT regarded 20 percent as a reasonable upper bound for the mortality rate of Atlantic bluefin tuna larvae owing to the spill event.

The effect of the DWH spill on bluefin tuna is an area of focus of NOAA's Natural Resources Damage Assessment (NRDA) team. That team is conducting targeted analyses on the effects of the spill on tuna, but most of those analyses are not yet available. The SRT coordinated with the NRDA team, and we have incorporated its information into the decision making process. The NRDA scientists provided plots of the paths of 12 satellite-tagged bluefin tuna that entered the Gulf of Mexico between 2008 and 2010. The NRDA scientists also reported on the progress of other work (e.g.,physiological effect of toxicants), but the work was not yet at a stage that could be considered by the SRT.

In summary, independent projections with two different types of models show that a 20 percent reduction in the 2010 year-class will likely result in less than a 4 percent reduction in future spawning biomass. However, if a significant fraction of adult Atlantic bluefin tuna were killed or rendered impotent by the spill, then subsequent year-classes might also be reduced, leading to greater reductions in SSB than estimated above. For example, if 20 percent of the adults were also killed in 2010, then the SSB would be immediately reduced by 20 percent, which might lead to additional reductions in the 2011 and subsequent year-classes (relative to what they would have been in the absence of the spill). The reduction in the 2010, 2011, and subsequent year classes would, in turn, lead to reductions in future SSB levels (9 years later as they begin to mature). To date, however, there is no evidence to suggest that any portion of adults were immediately affected although studies are ongoing that may give more information on possible long term impacts. The results from several electronic tagging studies confirm that some Atlantic bluefin tuna have historically spent at least a portion of their time in the waters in the vicinity of the spill area, but the exact fraction is difficult to quantify because of the uncertainties associated with inferring tracks and the rather low number of samples. All of the electronically-tagged bluefin tuna that were known to have spent time in the Gulf of Mexico during the actual spill event (8 fish) survived long after leaving the Gulf of Mexico.

Given that it is not possible to determine the level of impact on adults from the DWH oil spill at this time, scientists at the SEFSC re-ran the extinction risk models assuming spill-induced mortality rates of 20 percent for larvae and from 5 to 50 percent for adults. The short-term (10 year) risk of extinction was negligible for all levels of mortality examined. The long-term risk (e.g.,projected to 2100) did not exceed 5 percent except under the high recruitment scenario when adult mortality rates exceeded 15 percent. Using the latest information, including the 2010 larval survey, SEFSC scientists developed a worst-case scenario for larval mortality of 15 percent (their best estimate was about 7 percent). Accordingly, adult mortality rates of 15 percent also represent a worst-case scenario because it implies the same proportion of adults encountered oil as the larvae and that all of those “oiled” adults subsequently died. Thus, it appears that adult mortality rates would have to be extremely high in order to incur a substantial risk of extinction.

Because the information on larval and adult mortality from the DWH oil spill is not certain, NOAA used the best available science to model “worst case scenarios.” From these model projections, we were able to determine that although it is not possible to accurately determine the level of effect at this time, even if the oil spill had the highest level of effect currently viewed as scientifically plausible, the species would not warrant listing at this time. While we cannot wait for the targeted analyses being conducted in the NRDA process, we intend to revisit this decision no later than 2013 once the NRDA analyses have been concluded to determine whether the DWH oil spill altered the condition of the species. Additionally, new stock assessments will be conducted for bluefin tuna in 2012 and will be available in the fall, and new compliance reports will be available from ICCAT. Thus, this information will be considered as well.

Currently, there are numerous potential coastal habitat threats as identified above (e.g.,dredging, mining, navigation); however, the ones of most significance for Atlantic bluefin tuna are offshore (e.g.,petroleum, LNG). While these could represent potential future threats to the species, at this time, these activities are not negatively affecting Atlantic bluefin tuna, and the SRT concluded, and we concur that they do not represent a substantial risk to the long-term persistence of the species. In the future, should offshore effects such as petroleum and LNG be proposed, the EFH and HAPC process would provide a mechanism by which those impacts could be addressed.

Fishing for Atlantic bluefin tuna has occurred in the Mediterranean since the 7th millennium BC (Desse and Desse-Berset, 1994, in Fromentin and Powers, 2005). According to Fromentin and Ravier (2005) and Porch (2005), the development of the sushi-sashimi market during the 1980s made fishing for Atlantic bluefin tuna significantly more profitable than it was in earlier times, and this resulted in a considerable increase in the efficiency and capacity of fisheries during this time. The increased profitability associated with these new technologies resulted in the rapid development of new and powerful fleets in the Mediterranean countries, and the expansion of effort which exploited fish in the Mediterranean and North Atlantic Japanese longline fisheries also expanded in the Central North Atlantic, adding pressure on Atlantic bluefin tuna stocks (Fromentin and Powers, 2005).

The development and redistribution of all the fisheries resulted in rapid increases in yields since the 1980s, especially in the Mediterranean Sea. Eastern Atlantic and Mediterranean catches reached an historical peak of over 50,000 mt during the mid-1990s. Catches in the West Atlantic, including discards, have been relatively stable since the imposition of quotas in 1982. However, total western Atlantic catch declined steadily from the high of 2002 until 2007, primarily due to considerable reductions in catches by U.S. fisheries. Two plausible explanations for this situation were considered by the SCRS: (1) Availability of fish to the U.S. fishery was abnormally low, and/or (2) the overall size of the population in the western Atlantic declined substantially from the levels of recent years. SCRS noted in its 2010 stock assessment report that there is no overwhelming evidence to favor one explanation over the other but that the base case assessment implicitly favors the idea of changes in regional availability by virtue of the estimated increase in SSB. The decrease indicated by the U.S. catch rate of large fish was matched by the increase in several other large fish indices. In 2009, the United States harvested its national base quota.

In U.S. fisheries, bluefin tuna are caught with purse seines, handgear (rod and reel, handline, and harpoon), and pelagic longlines. As of October 2010, there were over 32,000 permitted vessels that may participate in the Atlantic tuna fisheries (NMFS, 2010). All owners/operators of vessels (commercial, charter/headboat, or recreational) fishing for regulated Atlantic tunas (Atlantic bluefin, bigeye, albacore, yellowfin and skipjack tunas) in the management area must obtain an Atlantic tunas permit or an Atlantic HMS vessel permit. Commercial categories are monitored by a census of landing cards, whereas the recreational catch is monitored primarily by a survey, although the states of Maryland and North Carolina have implemented recreational census bluefin tuna tagging programs as well. Commercial fisheries are focused on `large medium' (73 in (185 cm) to less than 81 in (206 cm) curved fork length (CFL)) and `giant' (81 in (206 cm) CFL or greater) Atlantic bluefin tuna, while recreational fisheries are focused on `large school/small medium' Atlantic bluefin tuna (47 in (119 cm) to less than 73 in (185 cm) CFL), with allowances for `school' (27 in (68 cm) to less than 47 in (119 cm) CFL), `large medium', and `giant' Atlantic bluefin tuna. Recreational fisheries are carried out by private vessels fishing in the Angling category, and vessels for hire fishing under the Charter/Headboat category.

There are numerous scientific studies on Atlantic bluefin tuna, the largest of which is being coordinated by ICCAT's SCRS—the Atlantic wide Grande Bluefin Tuna Year Program (GBYP). It has multiple objectives, including improving the understanding of key biological and ecological processes, basic data collection (including information from farms, observers, and VMS), provision of scientific advice on stock status through improved modeling of key biological processes (including growth and stock-recruitment and mixing between various areas), and developing and using biologically realistic operating models for more rigorous management option testing. Research undertaken to date through the ICCAT program, or in coordination with it by scientists from ICCAT's membership, has been either non-lethal (i.e.,aerial surveys) or has been intended to be non-lethal (i.e.,tagging programs), although mortalities, while minimal, do sometimes occur after a tagging event.

Other types of research (i.e.,microconstituent analysis, organochlorine tracer analysis, genetic analysis) primarily rely on samples taken from fish harvested in commercial fishing operations or from historical collections. Larval surveys, such as those conducted by the United States, and activities to monitor YOY do harvest Atlantic bluefin tuna specifically for research purposes, but the mortality caused by these activities is low. With respect to collections for education, this activity is minor and relies largely on products obtained from other activities, such as commercial fishing. Where it does cause Atlantic bluefin tuna mortalities directly, such as the collection of YOY, it is minor. Furthermore, there was no information to suggest that a substantial live aquarium trade in Atlantic bluefin tuna exists.

Current impacts from commercial, recreational, scientific or educational purposes do not represent a substantial risk to the long-term persistence of the species. Atlantic bluefin tuna fisheries are closely managed by various regulatory mechanisms, and current TAC levels are projected to result in increased population levels of the DPSs as long as there is a high degree of compliance. In addition, scientific collections or collections for educational purposes described above do not seem to be significantly affecting the status of Atlantic bluefin tuna, and are not likely to significantly affect the long-term persistence of Atlantic bluefin tuna now or into the future.

As large apex predators, Atlantic bluefin tuna are not heavily preyed upon. However, predators such as killer whales (Orcinus orca) and pilot whales (Globicephalaspp.), and several shark species such as white sharks (Carcharodon carcharias), shortfin mako (Isurus oxyrinchus), and longfin mako (Isurus paucus) (Nortarbartolo di Sciara, 1987; Collette and Klein-MacPhee, 2002; de Stephanis, 2004; Fromentin and Powers, 2005) may prey on Atlantic bluefin tuna. Juvenile Atlantic bluefin tuna may also be preyed upon by bluefish (Pomatomus saltatrix) and seabirds (Fishwatch, NMFS, 2010).

Little information exists on diseases in Atlantic bluefin tuna. Most of the available disease information for this species, Pacific bluefin tuna (Thunnus orientalis), and southern bluefin tuna (Thunnus maccoyii) comes from studies on fish reared in net pens prior to harvesting for the market (Mundayet al.,2003; Bullardet al.,2004; Oraic and Zrncic, 2005; Mladineoet al.,2006; Haywardet al.,2007).

Peric (2002) reported lesions consistent with pasteurellosis (Photobacterium damsel piscicida) after examining carcasses of 25 harvested Atlantic bluefin tuna. Lesions were similar to those seen in sparids with chronic pasteurellosis. As the causative organism, pasteurellosis does not survive for long outside the host, and prevalence is reported to be very low in Atlantic bluefin tuna (Mundayet al.,2003). However, high mortalities of Atlantic bluefin tuna reared in Adriatic Sea cages occurred during winter 2003 and spring 2004. Based on the results of bacteriological, serological, and histological analysis, Mladineoet al.(2006) concluded that pasteurellosis was the causative agent of the mortalities, which was the first outbreak of this kind in reared tuna. Putative tuberculosis was reported in a single specimen of Atlantic bluefin tuna (Biavati and Manera, 1991, as reported by Mundayet al.,2003), but the cause is unknown.

Adult Atlantic bluefin tuna are not likely affected to any large degree by predation by large whales and other large predators, nor are they likely to be affected to any large degree by diseases caused by viruses, bacteria, protozoans, metazoans, or microalgae. Most of theinformation on diseases in tunas comes from studies on cultured tuna, and the culture environment introduces stresses to the fish; therefore, even if studies indicated that cultured Atlantic bluefin tuna were highly susceptible to diseases and suffered high mortality rates, it is not possible to infer from these data that wild Atlantic bluefin tuna experience the same diseases and mortality rates. The best available scientific and commercial information indicates that threats to Atlantic bluefin tuna from predation and disease do not significantly affect the long-term persistence of Atlantic bluefin tuna now or into the future.

Since 1982, Atlantic bluefin tuna have been separated into two management units or stocks (western Atlantic and eastern Atlantic/Mediterranean), which coincide with the two DPSs identified in the SRR. ICCAT has established various conservation and management measures for both stocks over the years, most often in those years where new stock assessments have been completed by SCRS, as these inform management decisions. ICCAT, however, is free to adopt or alter conservation and management measures even in years where no new stock assessment has been conducted, and it has occasionally done so. In addition to the stock assessment meetings (which have been held recently about every 2 years), the SCRS reports on fishery trends each year. These metrics can include catch, effort and size trends, as well as updated abundance indices (such as standardized catch rate trends by age category and larval survey results), and trends can provide information on threats to the stock even during non-assessment years.

In light of the connection between the two stocks and fisheries, SCRS has advised that robust management is needed for both stocks to ensure effective conservation. Recognizing that management could potentially benefit from an improved understanding of bluefin tuna stock structure and mixing, ICCAT and its members have taken a number of steps to improve information in this area. Pending the outcome of ongoing research on stock structure and mixing, ICCAT has actively looked at management strategies that can take better account of mixing. In that regard, ICCAT has had a measure in place intended to limit catches in the central North Atlantic, an area with high mixing rates, since 2003. Catches from this area are now significantly reduced from previous levels. In addition, ICCAT has adopted the requirement that parties cannot shift effort across the 45 degree management boundary separating the two stocks of bluefin tuna.

The western Atlantic bluefin tuna fishery in the United States is managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tunas Convention Act (ATCA). ATCA authorizes the Secretary of Commerce to implement the binding recommendations of ICCAT. As the United States implements legislation for ICCAT, ATCA also requires that the United States implement binding recommendations adopted by that organization, as necessary and appropriate; stipulates that the United States may not promulgate a regulation that has the effect of increasing or decreasing any allocation or quota of fish or fishing mortality allocated by ICCAT; and establishes a number of procedural requirements.

At the 2010 ICCAT meeting, a measure was adopted for the western Atlantic stock that, among other things, reduced the TAC from 1,800 t (1,632.93 mt) to 1,750 t (1,587.57 mt) for both the 2011 and 2012 fishing seasons—a 2.8-percent reduction overall. Under the low recruitment potential scenario, the new TAC has a 99-percent probability of maintaining the fishing mortality of western Atlantic bluefin tuna below the fishing mortality associated with MSY and a 95-percent probability of maintaining the stock above the biomass that will support MSY through the end of the rebuilding period. Combining the results of the high and low recruitment potential scenarios, the TAC has a 54-percent probability of ending overfishing within 2 years and a 48-percent probability of rebuilding the stock to the Bmsylevel by the end of the rebuilding period. Under the high recruitment potential scenario, the TAC has an 8-percent probability of ending overfishing within 2 years and a zero-percent chance of rebuilding the stock to the Bmsylevel by the end of the rebuilding period. It is important to note that, under any scenario, the agreed TAC is expected to support continued stock growth if compliance with agreed rules remains strong. For the western Atlantic bluefin tuna fishery, compliance with ICCAT measures has typically been high.

In addition to a new TAC, the measure includes an emergency clause similar to the one added in 2009 to the eastern Atlantic/Mediterranean bluefin tuna recommendation. It specified that if SCRS detects a serious threat of stock collapse, ICCAT shall suspend all Atlantic bluefin tuna fisheries in the western Atlantic for the following year. The recommendation further calls on ICCAT members to contribute to ICCAT's Atlantic-wide Bluefin Tuna Research Program, including the enhancement of biological sampling. Consistent with past practice, the provisions contained in previous conservation and management recommendations were retained, including the prohibition on directed fishing for Atlantic bluefin tuna in the Gulf of Mexico and minimum size requirements.

Finally, the measure includes a request to SCRS to provide additional information in the future that might be helpful to management—including with respect to spawning grounds and the size selectivity of the fishery. The next western Atlantic bluefin tuna stock assessment is scheduled for 2012, and management measures will be reconsidered at that time, taking into consideration the scientific advice provided by SCRS.

During its 2010 annual meeting, ICCAT adopted a new recommendation for eastern and Mediterranean Atlantic bluefin tuna. The TAC for 2011 and beyond (until changed) was set at 12,900 t (11,702.68 mt), 4.4-percent reduction from the 2010 level of 13,500 t (12,246.99 mt). This reduction is in addition to existing quota paybacks for previous overharvests by the European Union and Tunisia. Thus, the adjusted allowable catch for 2011 and 2012 is approximately 11,500 t (10,432.62 mt). Before taking into account these required reductions, the new TAC has at least a 95-percent probability that the condition of the stock will improve in the coming years and a 67-percent probability of rebuilding the stock by 2023, the end of the rebuilding period.

Western Atlantic bluefin tuna are highly regulated with TAC limits generally set within the range recommended by SCRS. Greater reductions in TAC for the eastern stock were discussed to account more fully for the assessment uncertainties and to increase the probability and rate of stock growth and recovery. For both eastern and western bluefin tuna DPSs, catch levels agreed to in 2010 are expected to support continued growth and recovery of the stocks if compliance with agreed rules continues. Given the mixing between the stocks, improved stock conservation in the east can be expected to benefit the western stock as well. Based on the information above, the SRT concluded that the existingregulatory mechanisms if adequately enforced are sufficiently protective of Atlantic bluefin tuna now and into the future, and we concur with this conclusion.

The SRT examined other natural or manmade factors affecting the continued existence of Atlantic bluefin tuna. Spatial distribution and movement of Atlantic bluefin tuna were previously hypothesized to be controlled by preferential ranges of temperature (ICCAT, 2006-2009); but more recently, scientists hypothesized that juveniles and adults are associated with ocean fronts, likely for purposes of foraging for prey (Humstonet al.,2001; ICCAT, 2006-2009). However, the complexity of Atlantic bluefin tuna distribution and behavior is unlikely to be explained by association with these fronts alone (Shicket al.,2004; Royeret al.,2004). Because of the relationship of Atlantic bluefin tuna to sea surface temperature, the SRT considered the impact of climate change to Atlantic bluefin tuna.

Research studies have shown that migration and movement patterns vary considerably between individuals, years, and areas (Lutcavageet al.,1999; Blocket al.,2001; De Metrioet al.,2004; ICCAT, 2006-2009). The appearance and disappearance of past fisheries (e.g.,Brazil during the 1960s) could be a result of changes in spatial distribution and/or migration (Fromentin and Powers, 2005; Fromentin, 2009). Rijnsdorpet al.(2009) hypothesized a shift in distribution in response to increased temperature associated with climate change, and similar distribution shifts for other species have also been observed (Nyeet al.,2009). However, without a better understanding of the processes that determine Atlantic bluefin tuna distribution, it is difficult to project a response of the species to climate change.

Rijnsdorpet al.(2009) further hypothesized that if the habitat for a certain life-history stage is spatially restricted (e.g.,spawning), the species may be more sensitive to climate change. We designated an HAPC for bluefin tuna spawning in the Gulf of Mexico in Amendment 1 to the U.S. Consolidated HMS Fishery Management Plan (NMFS, 2009). This area is the primary spawning habitat for the western stock of Atlantic bluefin tuna, although the potential for other spawning locations has also been suggested (Galuardiet al.,2010). Climate-induced temperature increases could increase stress for Atlantic bluefin tuna during spawning in the Gulf of Mexico. Average ambient temperatures measured during bluefin spawning activity ranged from 23.5 to 27.3 °C (Teoet al.,2007). Atlantic bluefin tuna have been found to withstand temperatures ranging from 3 to 30 °C (Blocket al.,2001).

Although Atlantic bluefin tuna are believed to use deep diving to thermoregulate, spawning behavior may preclude thermoregulation behavior (Teoet al.,2007). Blocket al.(2005) indicated that thermal stress appeared to be contributing to mortality of pelagic longline-caught Atlantic bluefin tuna on the Gulf of Mexico spawning grounds. If increases in ocean temperature will mirror those forecasted for air temperature by the Intergovernmental Panel on Climate Change (IPCC) (2007) (i.e.,+ 0.20 °C per decade), and add ten decade's worth of temperature increase (i.e.,a total of 2.0 °C) to the temperatures reported by Teoet al.(2007), then Gulf of Mexico temperatures during Atlantic bluefin tuna spawning season could be estimated to reach 25.5 to 29.3 °C by the turn of the century. Muhlinget al.(2011) modeled a variety of climate change simulations in the Gulf of Mexico to quantify potential effects of warming on the suitability of the Gulf of Mexico as a spawning ground for Atlantic bluefin tuna. Model results showed that Atlantic bluefin tuna were indeed vulnerable to climate change impacts, with increasing water temperature affecting both spawning times and locations, as well as larval growth, feeding and survival (Muhlinget al.,2011). Furthermore, if ambient values of abiotic factors such as salinity or pH exceed the tolerance limits for planktonic Atlantic bluefin tuna eggs and larvae, these life stages could be negatively affected physiologically.

Fabryet al.(2008) reviewed the potential impacts of ocean acidification on marine fauna and ecosystem processes. The information reviewed indicated that marine fish were physiologically highly tolerant of carbon dioxide. Ishimatsuet al.(2004) found that hatchling stages of some species appeared fairly sensitive to pH decreases on the order of 0.5 or more, but high carbon dioxide tolerance developed within a few days of hatching.

Indirect trophic level dynamics may have some impact to Atlantic bluefin tuna as a result of climate change and ocean acidification. Acidification could lead to dissolution of shallow-water carbonate sediments and could affect marine calcifying organisms, including pteropods, an important component of the plankton in many marine ecosystems (Orret al.,2005). In their review article, Waltheret al.(2002) stated that indirect impacts on marine systems appear to be the most widespread effects of climate change. For example, the persistence of a positive vector for the North Atlantic Oscillation (NAO) modifies marine primary and secondary production (Fromentin and Planque, 1996), which could in turn affect the availability of planktonic food for fish larvae and recruitment success (Cushing, 1990). However, ICCAT scientists analyzed the association of the NAO with eastern Atlantic bluefin tuna recruitment and found no relationship (ICCAT, 2002).

Availability of nutrients could also be affected by changes in carbon dioxide, which could affect primary production, changes in species composition, and higher trophic levels (Fabryet al.,2008). Kimura (2010) modeled a combination of environmental factors when considering the impact to the recruitment of juvenile Pacific bluefin tuna. For example, an increase in ocean temperature would speed the transport of larvae in the Kuroshio current, causing the larvae to arrive too quickly to cold coastal waters. When coupled with high temperatures exceeding the optimal range on the spawning grounds, larval recruitment was predicted in 2010 to decline to 36 percent of present recruitment levels (Kimuraet al.,2010). In addition, a long-lived species such as Atlantic bluefin tuna could have less evolutionary ability to adapt to climate change than shorter-lived species.

Chase (2002) identified squid as one of several important food sources for Atlantic bluefin tuna caught off New England. Epipelagic squid (e.g., IllexandLoligosp.) have been found to be highly sensitive to carbon dioxide because of their unique physiology (Portneret al.,2004; Seibel, 2007). Yamada and Ikeda (1999) found increased mortality for certain arthropod plankton (krill and certain copepods) with increasing exposure time and decreasing pH. LarvalThunnussp. have been found to feed primarily on copepods (Catalanet al.,2007; Llopiz and Cowen, 2009). As pelagic predators, Atlantic bluefin tuna are considered opportunistic, and loss of one food source may not have negative consequences. However, in the Florida straits, larvalThunnussp. appeared to exhibit selective feeding behavior (Llopiz and Cowen, 2009) and thus, larvae may not be as opportunistic in feeding as adult Atlantic bluefin tuna are.

Offshore aquaculture was identified as a potential threat to Atlantic bluefintuna by the SRT. Potential impacts resulting from offshore aquaculture could include increased nutrient loading, habitat degradation, fish escapement, competition with wild stocks, entanglement of endangered or threatened species and migratory birds, spread of pathogens, user conflicts, economic and social impacts on domestic fisheries, and navigational hazards (GMFMC, 2009); however, there is no information to indicate that offshore aquaculture is impacting Atlantic bluefin tuna.

The most recent available information indicated that there are no finfish offshore aquaculture operations in U.S. Federal waters. According to the Gulf of Mexico Fishery Management Council (GMFMC) FMP for offshore aquaculture in the Gulf of Mexico, marine aquaculture would be prohibited in Gulf of Mexico EEZ HAPCs, marine reserves, marine protected areas, Special Management Zones, permitted artificial reef areas, and coral reef areas as defined and specified in 50 CFR 622 (GMFMC, 2009). In addition, areas where marine aquaculture is prohibited in the Gulf of Mexico overlap with the spawning areas of the western Atlantic DPS, and thus, the SRT did not expect any impacts to the spawning habitat of the DPS from offshore aquaculture. The SRT was not aware of specific information pertaining to the effects of offshore aquaculture on the habitat in the eastern Atlantic/Mediterranean; however, impacts to the DPS may be similar to the potential impact resulting from offshore aquaculture as noted above.

The SRT considered all other natural or manmade factors that may affect the DPSs, including climate change impacts, ocean acidification, and aquaculture/enhancement. The SRT identified several potential natural or manmade threats to Atlantic bluefin tuna, and while these could represent potential future threats to the species, at this time, the SRT determined that current and future impacts are not likely and do not represent a substantial risk to the long-term persistence of either DPS. We concur with this conclusion.

In February 2011, a special meeting of ICCAT's Compliance Committee (COC) was held. The purpose was to reinforce the commitment of all parties to implement the eastern Atlantic bluefin tuna recommendation from the start of the 2011 season and, toward that end, to review the implementation plans (which included fishery management, inspection, and capacity reduction aspects) of eastern Atlantic bluefin tuna harvesters with a view to endorsing those plans in advance of the season.

In addition to taking action on the implementation plans, the COC adopted an allocation table specifying the allowable harvest limits by ICCAT members, which included all adjustments, and a fleet capacity table reflecting required reductions for 2011. Given input from those present at the COC intersessional, the adjusted TAC of 11,502.89 t (10,435.25 mt) should be the upper bound of realized catches. Factoring in that a few countries have indicated they will not be fishing and their combined quota level is 364.33 t (330.51 mt), actual catches may be more on the order of 11,138.56 t (10,104.73 mt)—notwithstanding any action by ICCAT to suspend one or more fisheries in 2011 due to lack of implementation plan endorsement. Any additional reductions in catch will increase the probability of rebuilding the stock by 2023.

In addition, the 2010 eastern Atlantic bluefin tuna recommendation also strengthened the monitoring and control scheme, including enhanced monitoring of farming operations, further restrictions on joint fishing operations (e.g.,generally prohibiting joint operations between contracting parties and clarifying that each party is responsible and accountable for catches made under such operations), and requiring fishing capacity issues to be fully addressed by 2013.

Western Atlantic bluefin tuna harvesters are expected to fully implement Recommendation 10-03 by mid-June 2011. This will involve reduced quotas for the United States, Canada, and Japan for 2011 and 2012. In addition, NMFS has published a proposed rule to implement the ICCAT recommended U.S. base quota, distributing the quota among domestic quota categories consistent with the 2006 Consolidated HMS Fishery Management Plan, and to adjust the 2011 U.S. quota and subquotas to account for Atlantic bluefin tuna dead discards and unharvested 2010 quota allowed by ICCAT to be carried forward to 2011 (76 FR 13583). Furthermore, NMFS monitors the Atlantic bluefin tuna fishery and has the authority to take in-season actions such as fishery closures and retention limit adjustments to ensure available quotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas.

Effective May 5, 2011, NMFS requires the use of “weak hooks” by pelagic longline vessels fishing in the Gulf of Mexico. A weak hook is a circle hook that meets NMFS' current size and offset restrictions but is constructed of round wire stock that is thinner-gauge (i.e.,no larger than 3.65 mm in diameter) than the 16/0 circle hooks currently used in the Gulf of Mexico pelagic longline fishery. The purpose of the proposed action is to reduce pelagic longline incidental catch of bluefin tuna in the Gulf of Mexico, which is the known spawning area for the western Atlantic DPS of bluefin tuna (as described above). The action is intended to increase Atlantic bluefin tuna spawning potential and subsequent recruitment into the fishery, and could also potentially reduce negative ecological and fishing impacts on non-target or protected species.

Long-term (2010-2100) projections of abundance of the two Atlantic bluefin tuna DPSs (western Atlantic and eastern Atlantic/Mediterranean) were conducted by the SRT using the protocols adopted by the ICCAT SCRS (SCRS, 2010). We have determined that a 5-percent probability of extinction in 20 years is a reasonable threshold for endangered status. The probability of extinction was projected by the SRT to be near zero for both DPSs over the 5 to 10-year horizon normally examined by the SCRS, even for catch quotas that are much larger than allowed under the current ICCAT management regulations. Even after 20 years, the probability of extinction does not exceed 5 percent unless the level of sustained catch after 2010 is 3,000 mt or more for the western Atlantic DPS, and 40,000 mt or more for the eastern Atlantic/Mediterranean DPS (the 2011 TACs for the western Atlantic and eastern Atlantic/Mediterranean DPSs are 1,750 t (1,587.57 mt) and 12,900 t (11,702.68 mt) respectively, with the adjusted quota for the eastern fishery being below 11,599 t (10,522.44 mt) in 2011 and 2012.

Several authors have suggested that populations with fewer than 500 individuals are doomed to eventual extinction due to the loss of genetic diversity (Franklin, 1980; Soule, 1980). Matsudaet al.(1998) used 500 mature animals as the threshold for their extinction risk assessment of southern bluefin tuna. In order to address the potential for quasi-extinction, the SRT performed a second set of analyses with the extinction threshold set at 500 spawners, rather than 2 spawners (see Tables 1 and 2 below for the results with 500 spawners and section 9.1.3 of the status review report for the tables with the results for 2 spawners).

The SRT determined that the probability of extinction increases substantially over the long term, due to inherent uncertainties in the assumptions made for long-term projections; however, even with these uncertainties, the risk still remains quite low for the catch levels permitted under current management even when projected out to 2100 (about 2-percent probability for the western DPS and less than 1 percent for the eastern DPS). The level of extinction risk was found to be only slightly higher when the threshold for extinction was set to 500 spawners rather than 2 spawners and projected out to 2100 (2.3-percent probability for the western DPS, and 0.2-percent probability for the eastern DPS). However, given the high inherent uncertainties in long-term projections, projections made out to 2100 cannot reliably estimate a probable risk of extinction.

One important source of uncertainty not considered in the above projections was the nature of intermixing between the eastern and western DPSs. Two-stock virtual population analyses used by SCRS (2008) to estimate the level of mixing from stock composition (otolith microcontituent) data produced estimates of spawning biomass that were similar to the levels estimated without mixing. However, similar models that estimated mixing from tagging data produced estimates of spawning biomass that were generally higher than the models without mixing, particularly for recent years. If spawning biomass is higher than estimated by the base (no-mixing) models, then the short-term extinction risk may be lower than suggested in the analyses above by virtue of the fact that any given catch level will amount to a lower percentage of the adult population. This is especially true for the western DPS where the effect of estimating mixing is most profound as discussed above. The long-term implications for extinction risk are less clear as they would involve changes in the estimated productivity of the two stocks, which have not yet been evaluated. It should be noted, however, that ICCAT (2008) considered their analyses of mixing as not reliable enough to be used as the basis for management advice because both the tagging and stock composition data were regarded as incomplete in the sense that they did not represent random samples of the overall Atlantic bluefin tuna population.

Another important source of uncertainty not addressed in the extinction risk analysis is the possible effect of adult mortality from the DWH oil spill. As noted previously, there is no evidence of adult mortality; however, it is still possible some adult mortality or impact to reproductive capacity occurred. Because the information on larval and adult mortality from theDWH oil spill is not certain, NOAA used the best available science to model “worst case scenarios.” From these model projections, it was possible to determine that if the oil spill had the highest level of effect currently viewed as scientifically plausible (e.g.,15 percent mortality), the species would not warrant listing at this time.

In summary, the projections presented in the SRR suggest that the probability of extinction of either DPS is negligible within the generation time of both DPSs (generation time is equivalent to 17 to 19 years) unless the catches were nearly doubled over those allowed by current regulations. The long-term projections out to 2100 indicate that if rigorously enforced, current regulations are sufficient to avoid a significant probability of extinction (greater than 5 percent), but suggest a risk of extinction if management were to abandon the existing rebuilding plans in favor of substantially higher catches or if compliance is insufficient.

As mentioned above, the ESA defines an endangered species as any species in danger of extinction throughout all or a significant portion of its range, and a threatened species as any species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. Section 4(b)(1) of the ESA requires that the listing determination be based solely on the best scientific and commercial data available, after conducting a review of the status of the species and after taking into account those efforts, if any, that are being made to protect such species.As stated previously, we have concluded that there are two DPSs of Atlantic bluefin tuna. We have considered the available information on the abundance of Atlantic bluefin tuna from both DPSs, and whether any one or a combination of the five ESA section 4(a)(1) factors significantly affect the long-term persistence of Atlantic bluefin tuna now or into the foreseeable future. We have reviewed the SRR, the high and low recruitment potential projections, the CIE reviewers' comments, and other available literature, and consulted with scientists, fishermen, and fishery resource managers familiar with Atlantic bluefin tuna and related research areas. After reviewing this information, we have determined that listing the eastern Atlantic/Mediterranean and western Atlantic bluefin tuna DPSs as either endangered or threatened throughout all or a significant portion of its range is not warranted at this time. Because of the remaining uncertainties regarding the effects of the DWH oil spill, we will add the bluefin tuna to our Species of Concern list (http://www.nmfs.noaa.gov/pr/species/concern/#list; See 69 FR 19975, April 15, 2004 for description of program). This will serve to (1) increase public awareness about the species; (2) further identify data deficiencies and uncertainties in the species' status and the threats it faces; (3) and stimulate cooperative research efforts to obtain the information necessary to evaluate the species' status and threats.

As stated previously, we also intend to revisit this decision no later than 2013 once the NRDA analyses have been concluded to determine whether the DWH oil spill altered the condition of the species.