Federal Register Vol. 82, No.151,

The Federal Government's patent rights in these inventions are assigned to the United States of America, as represented by the Secretary of Agriculture. It is in the public interest to so license these inventions as Zoetis, LLC, of Kalamazoo, Michigan, has submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The regulations in 9 CFR part 92 subpart B, “Importation of Animals and Animal Products; Procedures for Requesting BSE Risk Status Classification With Regard to Bovines” (referred to below as the regulations), set forth the process by which the Animal and Plant Health Inspection Service (APHIS) classifies regions for bovine spongiform encephalopathy (BSE) risk. Section 92.5 of the regulations provides that all countries of the world are considered by APHIS to be in one of three BSE risk categories: Negligible risk, controlled risk, or undetermined risk. These risk categories are defined in § 92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. The list of those regions classified by APHIS as having either negligible risk or controlled risk can be accessed on the APHIS Web site at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/ct_animal_disease_status. The list can also be obtained by writing to APHIS at National Import Export Services, 4700 River Road, Unit 38, Riverdale, MD 20737.

Under the regulations, APHIS may classify a region for BSE in one of two ways. One way is for countries that have not received a risk classification from the World Organization for Animal Health (OIE) to request classification by APHIS. The other way is for APHIS to concur with the classification given to a country by the OIE.

If the OIE has recognized a country as either BSE negligible risk or BSE controlled risk, APHIS will seek information to support our concurrence with the OIE classification. This information may be publicly available information, or APHIS may request that countries supply the same information given to the OIE. APHIS will announce in the Federal Register, subject to public comment, its intent to concur with an OIE classification.

In accordance with that process, we published a notice 1 in the Federal Register on January 23, 2017 (82 FR 7786, Docket No. APHIS-2016-0092), in which we announced our intent to concur with the OIE risk designations for seven regions. The OIE recognizes these regions as being of negligible risk for BSE. We solicited comments on the notice for 60 days ending on March 24, 2017. We received one comment by that date, from a private citizen.

The commenter expressed concern that there is no process for verifying whether ruminant-to-ruminant feed bans are effectively enforced.

As part of its risk assessment process, the OIE considers the likelihood that the BSE agent either could be introduced into or spread within a country through contaminated commodities, including animal feed and feed ingredients. They consider both the production of processed animal proteins from domestic livestock, and the use of imported processed animal proteins, animal feed, and feed ingredients when assessing that risk. APHIS reviews similar information before concurring with the OIE designation.

Once recognized as either negligible or controlled risk for BSE by the OIE, a country must submit data on surveillance results and feed controls for the previous 12 months annually to maintain that status. If a country fails to provide that data in a timely manner, or the data shows changes that increase the risk of BSE introduction or spread, the country's risk designation may be changed. In the event that a country's risk status is demoted by the OIE, APHIS would also change its risk designation for the country.

Within the United States, the Food and Drug Administration (FDA) is the Federal agency responsible for regulating animal feed. The FDA has established regulations in 21 CFR part 589 that prohibit mammalian protein in ruminant feed (which includes a ruminant-to-ruminant feed ban) and the use of tissues that have the highest risk for carrying the BSE agent in all animal feed. These high risk cattle materials, known as specified risk materials (SRM), include the brains and spinal cords from cattle 30 months of age and older.

To assess and monitor for compliance with the feed ban, the FDA established the ruminant feed ban inspection program and guidance to assist both the FDA and State investigators. Feed mill and rendering plant inspections conducted since 1998 indicate a very high level of compliance with the feed ban. Summaries of inspections can be viewed on the FDA Web site at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/ucm114507.htm. The FDA also established a feed testing program in 2001. The FDA's highest priority for sample selection is given to finished products intended for ruminants, and feed ingredients that may reasonably be expected to be later used in ruminant feed.

The commenter also expressed concern that products from cattle slaughtered at 36 months of age pose a health risk to consumers.

The commenter is correct that certain bovine products and live cattle from specific countries with a higher risk of BSE release may carry BSE infectivity and therefore present a health risk to consumers if no measures are taken to mitigate that risk. For this reason, the OIE also describes specific requirements for certain commodities originating from regions of controlled and undetermined risk.

APHIS regulations require implementation of and compliance with very similar requirements for both live bovines and bovine commodities in a region before we concur with the OIE's BSE risk designation. These requirements mitigate the risk of exposure to a negligible level. Therefore, countries with either controlled or undetermined risk statuses must demonstrate that they have the authority to conduct oversight of the compliance with such requirements.

Therefore, in accordance with the regulations in § 92.5, we are announcing our decision to concur with the OIE risk classifications of the following countries:

• Regions of negligible risk for BSE: Costa Rica, Germany, Lithuania, Mexico, Namibia, Romania, and Spain.

The regulations in 7 CFR chapter III are intended, among other things, to prevent the introduction or dissemination of plant pests and noxious weeds into or within the United States. Under the regulations, certain plants, fruits, vegetables, and other articles must be treated before they may be moved into the United States or interstate. The phytosanitary treatments regulations contained in part 305 of 7 CFR chapter III (referred to below as the regulations) set out standards for treatments required in parts 301, 318, and 319 of 7 CFR chapter III for fruits, vegetables, and other articles.

In § 305.2, paragraph (b) states that approved treatment schedules are set out in the Plant Protection and Quarantine (PPQ) Treatment Manual.1 Section 305.3 sets out the processes for adding, revising, or removing treatment schedules in the PPQ Treatment Manual. In that section, paragraph (b) sets out the process for adding, revising, or removing treatment schedules when there is an immediate need to make a change. The circumstances in which an immediate need exists are described in § 305.3(b)(1). They are:

• PPQ has determined that an approved treatment schedule is ineffective at neutralizing the targeted plant pest(s).

• PPQ has determined that, in order to neutralize the targeted plant pest(s), the treatment schedule must be administered using a different process than was previously used.

• PPQ has determined that a new treatment schedule is effective, based on efficacy data, and that ongoing trade in a commodity or commodities may be adversely impacted unless the new treatment schedule is approved for use.

• The use of a treatment schedule is no longer authorized by the U.S. Environmental Protection Agency or by any other Federal entity.

In accordance with § 305.3(b)(1), we are providing notice that we have determined that it is necessary to add two new treatments to the PPQ Treatment Manual: T409-a, a surface spray with deltamethrin 4.75 percent active ingredient to mitigate the risk of Khapra beetle on aircraft; and T409-b-3, an aerosol spray with `1-Shot' treatment containing 2 percent d-phenothrin and 2 percent permethrin to mitigate the risk of Japanese beetle and other hitchhiking pests, except Khapra beetle, on aircraft.

To accommodate the addition of treatment T409-b-3, we have redesignated treatment schedule T409-b as T409-b-1.

The reasons for these additions to the treatment manual are described in detail in the treatment evaluation document (TED) we have prepared to support this action. The TED may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for instructions for accessing Regulations.gov and information on the location and hours of the reading room). You may also request paper copies of the TED by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the subject of the TED when requesting copies.

After reviewing the comments we receive, we will announce our decision regarding the new treatment schedules described in the TED in a subsequent notice. If we do not receive any comments, or the comments we receive do not change our determination that the proposed changes are effective, we will affirm these changes to the PPQ Treatment Manual and make available a new version of the PPQ Treatment Manual reflecting these changes. If we receive comments that cause us to determine that additional changes need to be made to one or more of the treatment schedules discussed above, we will make available a new version of the PPQ Treatment Manual that reflects the changes.

The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. The regulations in 9 CFR part 94 (referred to below as the regulations) prohibit or restrict the importation of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including classical swine fever (CSF), foot-and-mouth disease, swine vesicular disease, and rinderpest. These are dangerous and communicable diseases of ruminants and swine.

APHIS currently recognizes nine Mexican States as free of CSF: Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan. Because of the proximity of those nine States to CSF-affected regions and/or other risk factors, however, their live swine, pork, and pork products may only be imported into the United States under the conditions specified in § 94.32. These conditions include, among others, a requirement for certification by a full-time salaried veterinary officer of the national government of the region of export that the pork or pork products originated in a CSF-free region, requirements that the pork or pork products be derived only from swine that were born and raised in such a region and never lived in a CSF-affected region, a prohibition against the comingling of the pork or pork products with pork or pork products that have been in an affected region, and a requirement that any processing of the pork or pork products be done in a federally inspected processing plant in a CSF-free region.

The regulations in 9 CFR part 92, § 92.2, contain requirements for requesting the recognition of the animal health status of a region (as well as for the approval of the export of a particular type of animal or animal product to the United States from a foreign region). If, after review and evaluation of the information submitted in support of the request, APHIS believes the request can be safely granted, APHIS will make its evaluation available for public comment through a document published in the Federal Register. Following the close of the comment period, APHIS will review all comments received and will make a final determination regarding the request that will be detailed in another document published in the Federal Register.

Between 2007 and 2009, the Government of Mexico submitted a series of requests to APHIS seeking recognition of additional States as CSF-free. The last of those requests, submitted in January 2009, after the Government of Mexico had declared that CSF had been eradicated in the country, was for APHIS to recognize all of Mexico as CSF-free.

In response to these requests, we conducted a qualitative risk evaluation to evaluate the CSF status of the Mexican States not already recognized by APHIS as CSF-free. This evaluation included site visits to farms and diagnostic laboratories, as well as examinations of Mexico's capabilities with respect to veterinary control and oversight, disease history and vaccination, livestock demographics and traceability, epidemiological separation from potential sources of infection, disease surveillance, diagnostic laboratory capabilities, and emergency preparedness and response. The resulting risk evaluation document, “APHIS Evaluation of the CSF Status of a Region in Mexico” (referred to below as the “2013 risk evaluation”), did not support CSF-free recognition of all of Mexico; however, it did support access to the U.S. domestic market under certain risk-mitigating conditions.

Based on the findings of the 2013 risk evaluation, on July 29, 2014, we published in the Federal Register (79 FR 43974-43980, Docket No. APHIS-2013-0061) a proposal 1 to amend the regulations by recognizing a new APHIS-defined low-risk CSF region consisting of all Mexican States except the nine CSF-free States and the State of Chiapas, which we did not recognize as CSF-free.

In February 2015, Mexico received notice that the World Organization for Animal Health (OIE) recognized the country as CSF-free. Citing the OIE decision, the Government of Mexico then requested that APHIS suspend its rulemaking and instead continue evaluating Mexico for CSF-free status.

In response to this request, APHIS reopened its evaluation of the CSF status of Mexico. This reevaluation incorporated findings from a 2015 APHIS site visit report, along with updated surveillance data and information submitted by Mexico. These findings are documented in an April 2016 addendum to the 2013 risk evaluation.

Based on improved conditions observed through the end of 2015, APHIS has determined that concerns identified in the 2013 risk evaluation that had supported the July 2014 proposed rule have been addressed and that conditions now support CSF-free recognition for all of Mexico. Additionally, our determinations support including the entire country of Mexico on the Web-based list 2 of regions that are considered to be free of CSF but from which live swine, pork, and pork products may only be imported into the United States under the conditions specified in § 94.32. As stated in the April 2016 addendum to the 2013 risk evaluation, we consider the risk of the introduction of CSF into the United States via the importation of live swine, pork, and pork products from Mexico to be very low. We would note, however, that this determination applies only to Mexico's CSF status and that any existing restrictions on the importation of live swine, pork, and pork products from that country into the United States due to other animal diseases will remain in place.

Therefore, in accordance with § 92.2(e), we are announcing the availability of our updated risk evaluation of the CSF status of Mexico for public review and comment. The risk evaluation may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this notice.)

Information submitted in support of Mexico's request is available by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

After reviewing any comments we receive, we will announce our decision regarding the CSF status of Mexico and the import status of live swine, pork, and pork products from that country in a subsequent notice.

Under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), the Animal and Plant Health Inspection Service (APHIS) is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious before a veterinary biological product license may be issued. Veterinary biological products include viruses, serums, toxins, and analogous products of natural or synthetic origin, such as vaccines, antitoxins, or the immunizing components of microorganisms intended for the diagnosis, treatment, or prevention of diseases in domestic animals.

APHIS issues licenses to qualified establishments that produce veterinary biological products and issues permits to importers of such products. APHIS also enforces requirements concerning production, packaging, labeling, and shipping of these products and sets standards for the testing of these products. Regulations concerning veterinary biological products are contained in 9 CFR parts 101 to 124.

A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. Prior to conducting a field test on an unlicensed product, an applicant must obtain approval from APHIS, as well as obtain APHIS' authorization to ship the product for field testing.

To determine whether to authorize shipment and grant approval for the field testing of the unlicensed product referenced in this notice, APHIS considers the potential effects of this product on the safety of animals, public health, and the environment. Based upon a risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product:

Requester: Zoetis Inc.

Product: Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector.

Possible Field Test Locations: Alabama, Delaware, Georgia, Iowa, and North Carolina.

The above-mentioned product is a live Marek's Disease serotype 3 vaccine virus containing a gene from the infectious bursal disease virus. The attenuated vaccine is intended for use in healthy 18-day-old or older chicken embryos by the in ovo route or day-old chicks by subcutaneous inoculation, as an aid in the prevention of Marek's disease and infectious bursal disease.

The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

We are publishing this notice to inform the public that we will accept written comments regarding the EA from interested or affected persons for a period of 30 days from the date of this notice. Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact (FONSI) based on the EA and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice.

Because the issues raised by field testing and by issuance of a license are identical, APHIS has concluded that the EA that is generated for field testing would also be applicable to the proposed licensing action. Provided that the field test data support the conclusions of the original EA and the issuance of a FONSI, APHIS does not intend to issue a separate EA and FONSI to support the issuance of the associated product license, and would determine that an environmental impact statement need not be prepared. APHIS intends to issue a veterinary biological product license for this vaccine following satisfactory completion of the field test, provided no adverse impacts on the human environment are identified and provided the product meets all other requirements for licensing.

Title: Repowering Assistance Program.

OMB Number: OMB No. 0570-0066.

Expiration Date of Approval: November 30, 2017.

Type of Request: Extension and revision of a currently approved information Collection.

Abstract: Authorized under Section 9004 of the Food, Conservation, and Energy Act of 2008, the purpose of this program is to provide financial incentives to biorefineries to replace the use of fossil fuels used to produce heat or power at their facilities by installing new systems that use renewable biomass, or to produce new energy from renewable biomass.

Estimate of Burden:

Estimated Number of Respondents: 3.

Estimated Number of Responses per Respondent: 12.

Estimated Number of Responses: 36.

Estimated Total Annual Burden on Respondents: 701 Hours.

Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Division, at (202) 692-0040.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of RBS, including whether the information will have practical utility; (b) the accuracy of the RBS' estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or forms of information technology. Comments may be sent to Jeanne Jacobs, Regulation and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP, Washington, DC 20250-0742. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-874-1565, conference ID: 9651290. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office by August 25, 2017. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562-7005, or emailed to Regional Director, Jeffrey Hinton at [email protected]. Persons who desire additional information may contact the Southern Regional Office at (404) 562-7000.

Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, North Carolina Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Southern Regional Office at the above email or street address.

Background

On June 20, 2017, the Department of Commerce (the Department) initiated countervailing duty (CVD) investigations of imports of fine denier polyester fiber (fine denier PSF) from the PRC and India.1 Currently, the preliminary determinations are due no later than August 24, 2017.

Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires the Department to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which the Department initiated the investigation. However, section 703(c)(1) of the Act permits the Department to postpone the preliminary determination until no later than 130 days after the date on which the Department initiated the investigation if: (A) The petitioners makes a timely request for a postponement; or (B) the Department concludes that the parties concerned are cooperating, and determines that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. The Department will grant the request unless it finds compelling reasons to deny the request.

On July 26, 2017, the petitioners 2 submitted a timely request that the Department postpone the preliminary CVD determinations.3 The petitioners state that they request postponement of the preliminary determinations because the current deadline for initial questionnaire responses is August 30, 2017, in the India investigation and September 1, 2017, in the PRC investigation. According to the petitioners, postponement of the preliminary determination deadline in each case would allow sufficient time for the Department and interested parties to analyze questionnaire responses and permit the issuance of supplemental questionnaires, if necessary.

In accordance with 19 CFR 351.205(e), the petitioners have stated the reasons for requesting a postponement of the preliminary determinations, and the Department finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, the Department is postponing the deadline for the preliminary determinations to no later than 130 days after the date on which these investigations were initiated, i.e., October 30, 2017.4 Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations of these investigations will continue to be 75 days after the date of the preliminary determinations.

This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

The Petition

On July 13, 2017, the Department of Commerce (the Department) received a countervailing duty (CVD) petition concerning imports of cast iron soil pipe fittings (soil pipe fittings) from the People's Republic of China (PRC), filed in proper form, on behalf of the Cast Iron Soil Pipe Institute (the petitioner).1 The petitioner is a trade association, whose members are all domestic producers of soil pipe fittings.2 The CVD petition was accompanied by an antidumping duty (AD) petition for soil pipe fittings from the PRC.3

On July 17, 2017, the petitioner filed an amendment to Volume I of the Petition.4 On July 18, 2017, the Department requested additional information and clarification of certain areas of the Petition.5 The petitioner filed responses to these requests on July 20, 2017.6

Background

On May 1, 2017, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on PSF from Korea for the POR of May 1, 2016, through April 30, 2017.1 On May 30, 2017, Huvis Corporation (Huvis) submitted a timely-filed request for an administrative review of its POR sales.2 On May 31, 2017, pursuant to 19 CFR 351.213, the Department received a timely-filed request from DAK Americas LLC and Auriga Polymers, Inc. (collectively, the petitioners) for an administrative review of Toray Chemical Korea, Inc. (Toray) and Huvis.3 On July 6, 2017, pursuant to these requests and in accordance with 19 CFR 351.221(c)(1)(i), the Department published a notice of initiation of an administrative review of Toray and Huvis.4 On July 11, 2017, and July 12, 2017, pursuant to 19 CFR 351.213(d)(1), the petitioners and Huvis, respectively, timely withdrew their requests for an administrative review.5

Pursuant to 19 CFR 351.213(d)(l), the Department will rescind an administrative review, in whole or in part, if the party, or parties, that requested a review withdraw the request/s within 90 days of the publication date of the notice of initiation of the requested review. As noted above, the petitioners withdrew their request for review of Toray and Huvis within 90 days of the publication date of the notice of initiation. In addition, Huvis also timely withdrew its request for an administrative review. No other parties requested an administrative review of the antidumping duty order on PSF from Korea. Therefore, in response to the timely withdrawal of requests for review and, in accordance with 19 CFR 351.213(d)(l), the Department is rescinding this review.

The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of PSF from Korea during the POR. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption in accordance with 19 CFR 351.212(c)(l)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the Federal Register.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3), which continues to govern the business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 75l(a)(l) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

The Petition

On July 13, 2017, the Department of Commerce (the Department) received an antidumping duty (AD) petition concerning imports of cast iron soil pipe fittings (soil pipe fittings) from the People's Republic of China (the PRC), filed in proper form, on behalf of the Cast Iron Soil Pipe Institute (the petitioner).1 The petitioner is a trade association, whose members are all domestic producers of soil pipe fittings.2 The AD petition was accompanied by a countervailing duty (CVD) petition for soil pipe fittings from the PRC.3

On July 17, 2017, the petitioner filed an amendment to Volume I of the Petition.4 On July 18, 2017, the Department requested additional information and clarification of certain areas of the Petition.5 The petitioner filed responses to these requests on July 20, 2017.6 In response to the Department's further requests for information and clarification of Volume II of the Petition,7 the petitioner submitted additional amendments to the Petition on July 26, 2017, and July 28, 2017.8

In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of soil pipe fittings from the PRC are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that, such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.

The Department finds that the petitioner filed the Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(E) of the Act. The Department also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the AD investigation that the petitioner is requesting.9

Because the Petition was filed on July 13, 2017, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) is January 1, 2017, through June 30, 2017.

The product covered by this investigation is soil pipe fittings from the PRC. For a full description of the scope of this investigation, see the “Scope of the Investigation,” in the Appendix to this notice.

During our review of the Petition, the Department discussed with the petitioner the language pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.10 On July 20, 2017, the petitioner filed a revision to the scope language.11

As discussed in the preamble to the Department's regulations,12 we are setting aside a period for interested parties to raise issues regarding product coverage (i.e., scope). The Department will consider all comments received from interested parties and, if necessary, will consult with the interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,13 all such factual information should be limited to public information. In order to facilitate preparation of its questionnaire, the Department requests all interested parties to submit such comments by 5:00 p.m. Eastern Time (ET) on Tuesday, August 22, 2017, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on Friday, September 1, 2017, which is 10 calendar days from the deadline for initial comments.14 All such comments must be filed on the record of each of the concurrent AD and CVD investigations.

The Department requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact the Department and request permission to submit the additional information. As stated above, all such comments must be filed on the record of each of the concurrent AD and CVD investigations.

All submissions to the Department must be filed electronically using Enforcement & Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).15 An electronically-filed document must be received successfully in its entirety by the time and date when it is due. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement & Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

The Department requests comments from interested parties regarding the appropriate physical characteristics of soil pipe fittings to be reported in response to the Department's AD questionnaire. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant factors and costs of production accurately as well as to develop appropriate product-comparison criteria.

Interested parties will have the opportunity to provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics; and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics used by manufacturers to describe soil pipe fittings, it may be that only a select few product characteristics take into account commercially-meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.

In order to consider the suggestions of interested parties in developing and issuing the AD questionnaire, all comments must be filed by 5:00 p.m. ET on August 17, 2017. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on August 24, 2017. All comments and submissions to the Department must be filed electronically using ACCESS, as explained above, on the record of the less-than-fair-value investigation.

Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,16 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.17

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that soil pipe fittings, as defined in the scope, constitute a single domestic like product, and we have analyzed industry support in terms of that domestic like product.18

In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition and the petitioner's subsequent submissions with reference to the domestic like product as defined in the “Scope of the Investigation,” in Appendix I of this notice. The petitioner provided the 2016 production of the domestic like product by its members.19 The petitioner states that its members are the only known producers of soil pipe fittings in the United States; therefore, the Petition is supported by 100 percent of the U.S. industry.20

Our review of the data provided in the Petition, Petition Amendment, General Issues Supplement, and other information readily available to the Department indicates that the petitioner has established industry support for the Petition.21 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, the Department is not required to take further action in order to evaluate industry support (e.g., polling).22 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.23 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.24 Accordingly, the Department determines that the Petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.

The Department finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(E) of the Act, and it has demonstrated sufficient industry support with respect to the AD investigation that it is requesting that the Department initiate.25

The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.26

The petitioner contends that the industry's injured condition is illustrated by reduced market share; underselling and price depression or suppression; lost sales and revenues; and negative impact on profit.27 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.28

The following is a description of the allegations of sales at less than fair value upon which the Department based its decision to initiate the AD investigation of imports of soil pipe fittings from the PRC. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the Initiation Checklist.29

The petitioner based the U.S. price on export price (EP) using average unit values (AUVs) of publicly available import data.30 The petitioner made deductions to U.S. price for foreign inland freight and brokerage and handling.31

The petitioner stated that the Department has consistently treated the PRC as a non-market economy (NME) country.32 In accordance with section 771(18)(C)(i) of the Act, the presumption of NME status remains in effect until revoked by the Department. The presumption of NME status for the PRC has not been revoked by the Department and, therefore, remains in effect for purposes of the initiation of this investigation. Accordingly, the NV of the product is appropriately based on factors of production (FOPs) valued in a surrogate market economy country, in accordance with section 773(c) of the Act.

The petitioner argues that South Africa is an appropriate surrogate country for the PRC because it is a market economy that is at a level of economic development comparable to that of the PRC, it is a significant producer of comparable merchandise, and public information from South Africa is available to value all FOPs.33 Based on the information provided by the petitioner, we determine that it is appropriate to use South Africa as a surrogate country for the PRC. Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs no later than 30 days before the scheduled date of the preliminary determination.

Because information regarding the volume of inputs consumed by Chinese producers/exporters is not reasonably available, the petitioner based the FOPs for materials, labor, and energy on the production experience of one of its member companies.34 The petitioner asserts that the production process for soil pipe fittings is similar regardless of whether the product is produced in the United States or in the PRC.35 The petitioner valued the estimated FOPs using surrogate values from South Africa.

The petitioner valued direct materials based on publicly-available import data for South Africa obtained from the Global Trade Atlas (GTA) for the period November 2016 through April 2017.36 The petitioner excluded all import data from countries previously determined by the Department to maintain broadly available, non-industry-specific export subsidies and countries previously determined by the Department to be NME countries.37 In addition, in accordance with the Department's practice, the petitioner excluded imports that were labeled as originating from an unidentified country.38

The petitioner relied on 2012 data published by the International Labor Organization, inflated to 2017 using the South African Consumer Price Index.39

The petitioner valued natural gas using GTA import data.40 The petitioner valued electricity using values reported in the Eskom 2016/2017 Tariff Book.41

The petitioner calculated ratios for selling, general, and administrative expenses, and profit based on the 2016 consolidated financial statements of Tata Africa Steel Processors Proprietary Ltd., a South African steel processor and producer of aluminum wire rods.42

Based on the data provided by the petitioner, there is reason to believe that imports of soil pipe fittings from the PRC are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP to NV, in accordance with section 773(c) of the Act, the estimated dumping margin for soil pipe fittings from the PRC is 92.48 percent.43

Based upon the examination of the AD Petition on soil pipe fittings from the PRC, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating an AD investigation to determine whether imports of soil pipe fittings from the PRC are being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.

Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD laws were made.44 The 2015 law does not specify dates of application for those amendments. On August 6, 2015, the Department published an interpretative rule, in which it announced the applicability dates for each amendment to the Act, except for amendments contained in section 771(7) of the Act, which relate to determinations of material injury by the ITC.45 The amendments to sections 771(15), 773, 776, and 782 of the Act are applicable to all determinations made on or after August 6, 2015, and, therefore, apply to this AD investigation.46

The petitioner named 22 companies in the PRC as producers/exporters of soil pipe fittings.47 In accordance with our standard practice for respondent selection in cases involving NME countries, we intend to issue quantity and value (Q&V) questionnaires to producers/exporters of merchandise subject to this investigation and, in the event we determine to limit the number of companies individually examined, base respondent selection on the responses received.48 For this investigation, the Department will request Q&V information from known exporters and producers identified, with complete contact information, in the Petition. In addition, the Department will post the Q&V questionnaire along with filing instructions on the Enforcement & Compliance Web site at http://www.trade.gov/enforcement/news.asp.

Exporters/producers of soil pipe fittings from the PRC that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy from the Enforcement & Compliance Web site. The Q&V response must be submitted by all PRC exporters/producers no later than August 14, 2017. All Q&V responses must be filed electronically via ACCESS.

In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.49 The specific requirements for submitting a separate-rate application are outlined in detail in the application itself, which is available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html. The separate-rate application will be due 30 days after publication of this initiation notice.50 Exporters and producers who submit a separate-rate application and are selected as mandatory respondents will be eligible for consideration for separate-rate status only if they respond to all parts of the Department's AD questionnaire as mandatory respondents. The Department requires that respondents submit a response to both the Q&V questionnaire and the separate-rate application by their respective deadlines in order to receive consideration for separate-rate status.

The Department will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:

In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the Government of the PRC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

We will notify the ITC of our initiation, as required by section 732(d) of the Act.

The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of soil pipe fittings from the PRC are materially injuring or threatening material injury to a U.S. industry.52 A negative ITC determination will result in the investigation being terminated; 53 otherwise, this investigation will proceed according to statutory and regulatory time limits.

Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i) through (iv). The regulation requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties are advised to review the regulations prior to submitting factual information in this investigation.

Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.54 Parties must use the certification formats provided in 19 CFR 351.303(g).55 56 The Department intends to reject factual submissions if the submitting party does not comply with the applicable revised certification requirements.

Interested parties must submit applications for disclosure under Administrative Protective Order (APO) in accordance with 19 CFR 351.305. On January 22, 2008, the Department published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed at 19 CFR 351.103(d)).

This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act.

Background

On January 13, 2017, the Department published in the Federal Register the notice of initiation of an administrative review of the antidumping duty (AD) order on seamless refined copper pipe and tube (copper pipe) from the PRC for the period of review November 1, 2015, through October 31, 2016.1 On January 18, 2017, Hong Kong Hailiang Metal Trading Limited (Hong Kong Hailiang), Shanghai Hailiang Copper Co., Ltd. (Shanghai Hailiang), and Zhejiang Hailiang Co., Ltd. (Zhejiang Hailiang) (collectively, Hailiang) notified the Department that the spelling of each company's name in the Initiation Notice was incorrect.2 Accordingly, on February 13, 2017, the Department published in the Federal Register a revision of the notice of initiation of the 6th administrative review of the AD order due to a spelling error in certain companies' names.3 4 On February 24, 2017, Hailiang submitted a letter indicating it would not participate in the review.5 On March 14, 2017, the petitioners 6 timely withdrew their request for review with respect to 11 companies,7 but did not withdraw their request for review for the following five companies: China Hailiang Metal Trading (China Hailiang), Shanghai Hailiang Metal Trading Limited (Shanghai Hailiang Trading), Hong Kong Hailiang, Shanghai Hailiang, and Zhejiang Hailiang.8 Accordingly, these five companies remain under review.

The merchandise subject to the order is seamless refined copper pipe and tube. The product is currently classified under Harmonized Tariff Schedule of the United States (HTSUS) item numbers 7411.10.1030 and 7411.10.1090. Products subject to this order may also enter under HTSUS item numbers 7407.10.1500, 7419.99.5050, 8415.90.8065, and 8415.90.8085. Although the HTSUS numbers are provided for convenience and customs purposes, the written description of the scope of this order remains dispositive.9

Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party or parties that requested a review withdraws the request within 90 days of the publication date of the notice of initiation of the requested review. As noted above, the petitioners withdrew their request for an administrative review with respect to 11 companies within 90 days of the publication date of the notice of initiation. No other parties requested an administrative review of the order with respect to these 11 companies. Therefore, in accordance with 19 CFR 351.213(d)(1), the Department is rescinding this review of the AD order on copper pipe from the PRC with respect to these companies.

The Department is conducting this review in accordance with sections 751(a)(1)(B) and 751(a)(2)(A) of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum. A list of topics included in the Preliminary Decision Memorandum is included as the Appendix to this notice.

The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

The Department preliminarily determines that the five companies under review, China Hailiang, Hong Kong Hailiang, Shanghai Hailiang, and Zhejiang Hailiang, failed to demonstrate eligibility for a separate rate. In making our findings, two of the five companies, China Hailiang and Shanghai Hailiang Trading, did not submit no shipment letters or separate rate applications/certifications by the specified deadlines, and, as noted above, Hong Kong Hailiang, Shanghai Hailiang, and Zhejiang Hailiang, notified the Department that they would not be participating in this review and also did not submit no shipment letters or separate rate applications/certifications by the specified deadlines.10 Accordingly, these five companies did not demonstrate that they are each entitled to a separate rate. Thus, we consider all five companies to be part of the PRC-Wide Entity.11 The rate previously established for the PRC-wide entity is 60.82 percent.12

Normally, the Department discloses to interested parties the calculations performed in connection with the preliminary results within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because the Department preliminarily determined that the five remaining companies under review are part of the PRC-wide entity, there are no calculations to disclose.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 50 days after the date of publication of these preliminary results, unless the Secretary alters the time limit.13 Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.14 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

The Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.15 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

For any individually examined respondent whose weighted average dumping margin is above de minimis (i.e., 0.50 percent) in the final results of this review, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific ad valorem rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.16 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer- (or customer-) specific ad valorem is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.17

The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the PRC-wide entity; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

Background

On June 20, 2016, we received a petition from the Center for Biological Diversity (CBD), on behalf of 13 other co-petitioners, to list the Pacific bluefin tuna as threatened or endangered under the ESA and to designate critical habitat concurrently with its listing. On October 11, 2016, we published a positive 90-day finding (81 FR 70074) announcing that the petition presented substantial scientific or commercial information indicating that the petitioned action may be warranted. In our 90-day finding, we also announced the initiation of a status review of the Pacific bluefin tuna and requested information to inform our decision on whether the species warrants listing as threatened or endangered under the ESA.

The ESA defines “species” to include any subspecies of fish or wildlife or plants, and any distinct population segment (DPS) of any vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). The U.S. Fish and Wildlife Service (FWS) and NMFS have adopted a joint policy describing what constitutes a DPS under the ESA (61 FR 4722; February 7, 1996). The joint DPS policy identifies two criteria for making a determination that a population is a DPS: (1) The population must be discrete in relation to the remainder of the species to which it belongs; and (2) the population must be significant to the species to which it belongs.

Section 3 of the ESA defines an endangered species as any species which is in danger of extinction throughout all or a significant portion of its range and a threatened species as one which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. Thus, we interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened).

We determine whether any species is endangered or threatened as a result of any one or a combination of the following five factors: The present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence (ESA section 4(a)(1)(A)-(E)). Section 4(b)(1)(A) of the ESA requires us to make listing determinations 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 efforts being made by any State or foreign nation or political subdivision thereof to protect the species.

The petition to list Pacific bluefin tuna identified the risk classification made by the International Union for Conservation of Nature (IUCN). The IUCN assessed the status of Pacific bluefin tuna and categorized the species as “vulnerable” in 2014, meaning that the species was considered to be facing a high risk of extinction in the wild (Collette et al., 2014). Species classifications under IUCN and the ESA are not equivalent; data standards, criteria used to evaluate species, and treatment of uncertainty are not necessarily the same. Thus, when a petition cites such classifications, we will evaluate the source of information that the classification is based upon in light of the ESA's standards on extinction risk and threats discussed above.

As part of our comprehensive status review of the Pacific bluefin tuna, we formed a status review team (SRT) comprised of Federal scientists from NMFS' Southwest Fisheries Science Center (SWFSC) having scientific expertise in tuna and other highly migratory species biology and ecology, population estimation and modeling, fisheries management, conservation biology, and climatology. We asked the SRT to compile and review the best available scientific and commercial information, and then to: (1) Conduct a “distinct population segment” (DPS) analysis to determine if there are any DPSs of Pacific bluefin tuna; (2) identify whether there are any portions of the species' geographic range that are significant in terms of the species' overall viability; and (3) evaluate the extinction risk of the population, taking into account both threats to the population and its biological status. While the petitioner did not request that we list any particular DPS(s) of the Pacific bluefin tuna, we decided to evaluate whether any populations met the criteria of our DPS Policy, in case doing so might result in a conservation benefit to the species. Generally, however, we opt to consider the species' rangewide status, rather than considering whether any DPSs might exist.

In order to complete the status review, the SRT considered a variety of scientific information from the literature, unpublished documents, and direct communications with researchers working on Pacific bluefin tuna, as well as technical information submitted to NMFS. Information that was not previously peer-reviewed was formally reviewed by the SRT. Only the best-available science was considered further. The SRT evaluated all factors highlighted by the petitioners as well as additional factors that may contribute to Pacific bluefin tuna vulnerability.

In assessing population (stock) structure and trends in abundance and productivity, the SRT relied on the International Scientific Committee for Tuna and Tuna-Like Species' (ISC) recently completed peer-reviewed stock assessment (ISC 2016). The ISC was established in 1995 for the purpose of enhancing scientific research and cooperation for conservation and rational utilization of HMS species of the North Pacific Ocean, and to establish the scientific groundwork for the conservation and rational utilization of the HMS species in the North Pacific Ocean. The ISC is currently composed of scientists representing the following seven countries: Canada, Chinese Taipei, Japan, Republic of Korea, Mexico, People's Republic of China, and the United States. The ISC conducts regular stock assessments to assemble fishery statistics and biological information, estimate population parameters, summarize stock status, and develop conservation advice. The results are submitted to Regional Fishery Management Organizations (RFMOs), in particular the Western and Central Pacific Fisheries Commission (WCPFC) and the Inter-American Tropical Tuna Commission (IATTC), for review and are used as a basis of management actions. NMFS believes the ISC stock assessment (ISC 2016) represents best available science because: (1) It is the only scientifically based stock assessment of Pacific bluefin tuna; (2) it was completed by expert scientists of the ISC, including key contributions from the United States; (3) it was peer reviewed; and (4) we consider the input parameters to the assessment to represent the best available data, information, and assumptions.

The SRT analyzed the status of Pacific bluefin tuna in a 3-step progressive process. First, the SRT evaluated 25 individual threats (covering the five factors in ESA section 4(a)(1)(A)-(E)). The SRT evaluated how each threat affects the species and contributes to a decline or degradation of Pacific bluefin tuna by ranking each threat in terms of severity (1-4, with “1” representing the lowest contribution, and “4” representing the highest contribution). The threats were evaluated in light of the Pacific bluefin tuna's vulnerability of and exposure to the threat, and its biological response.

Following the initial rankings of specific threats, the SRT identified those threats where the range of rankings across the SRT was greater than one. For these threats, subsequent discussions ensured that the interpretation of the threat and its time-frame were clear and consistent across team members. For example, it was necessary to clarify that threats were considered only as they related to existing management measures and not historical management. After clarification, and a final round of discussion, each team member provided a final set of severity rankings for each specific threat.

There were three specific threats (Illegal, Unregulated, and Unreported fishing, International Management, and sea surface temperature rise) for which the range of severity rankings remained greater than one after they had been discussed thoroughly. For these threats the SRT carried out a Structured Expert Decision Making process (SEDM) to determine the final severity rank. In this SEDM approach, each team member was asked to apportion 100 plausibility points across the four levels of severity. Points were totaled and mean scores were calculated. The severity level with the highest mean was determined to be the final ranking. As will be further detailed in the Analysis of Threats and Extinction Risk Analysis sections of this notice, the SRT also used SEDM in steps 2 and 3 of its analysis.

The purpose of decision structuring is to provide a rational, thorough, and transparent decision, the basis for which is clear to both the decision maker(s) and to other observers, and to provide a means to capture uncertainty in the decision(s). Use of qualitative risk analysis and structured expert opinion methods allows for a rigorous decision-making process, the defensible use of expert opinion, and a well-documented record of how a decision was made. These tools also accommodate limitations in human understanding and allow for problem solving in complex situations. Risk analysis and other structured processes require uncertainty to be dealt with explicitly and biases controlled for. The information used may be empirical data, or it may come from subjective rankings or expert opinion expressed in explicit terms. Even in cases where data are sufficient to allow a quantitative analysis, the structuring process is important to clearly link outcomes and decision standards, and thereby reveal the reasoning behind the decision.

This initial evaluation of individual threats and the potential demographic risk they pose forms the basis of understanding used during steps 2 and 3 of the SRT's analysis.

In the second step of its analysis, the SRT used the same ranking system to evaluate the risk of each of the five factors in ESA section 4(a)(1)(A)-(E) contributing to a decline or degradation of Pacific bluefin tuna. This involved a consideration of the combination of all threats that fall under each of the five factors. In the final step, the SRT evaluated the overall extinction risk for Pacific bluefin tuna over two timeframes—25 years and 100 years.

The SRT's draft status review report was subjected to independent peer review as required by the Office of Management and Budget (OMB) Final Information Quality Bulletin for Peer Review (M- 05-03; December 16, 2004). The draft status review report was peer reviewed by independent specialists selected from the academic and scientific community, with expertise in tuna and/or highly migratory species biology, conservation, and management. The peer reviewers were asked to evaluate the adequacy, appropriateness, and application of data used in the status review report, including the extinction risk analysis. All peer reviewer comments were addressed prior to dissemination and finalization of the draft status review report and publication of this finding.

We subsequently reviewed the status review report, its cited references, and peer review comments, and believe the status review report, upon which this 12-month finding is based, provides the best available scientific and commercial information on the Pacific bluefin tuna. Much of the information discussed below on Pacific bluefin tuna biology, distribution, abundance, threats, and extinction risk is attributable to the status review report. However, in making the 12-month finding determination, we have independently applied the statutory provisions of the ESA, including evaluation of the factors set forth in section 4(a)(1)(A)-(E); our regulations regarding listing determinations (50 CFR part 424); our Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act (DPS Policy, 61 FR 4722; February 7, 1996); and our Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species (SPR Policy, 79 FR 37578; July 1, 2014).

Pacific bluefin tuna (Thunnus orientalis) belong to the family Scombridae (order Perciformes). They are one of three species of bluefin tuna; the other two are the southern bluefin tuna (Thunnus maccoyii) and the Atlantic bluefin tuna (Thunnus thynnus). The three species can be distinguished based on internal and external morphology as described by Collette (1999). The three species are also distinct genetically (Chow and Inoue 1993; Chow and Kishino 1995) and have limited overlap in their geographic ranges.

Pacific bluefin tuna are large predators reaching nearly 3 meters (m) in length and 500 kilograms (kg) in weight (ISC 2016). They are pelagic species known to form large schools. As with all tunas and mackerels, Pacific bluefin tuna are fusiform in shape and possess numerous adaptations to facilitate efficient swimming. These include depressions in the body that accommodate the retraction of fins to reduce drag and a lunate tail that is among the most efficient tail shapes for generating thrust in sustained swimming (Bernal et al., 2001).

One of the most unique aspects of Pacific bluefin tuna biology is their ability to maintain a body temperature that is above ambient temperature (endothermy). While some other tunas and billfishes are also endothermic, these adaptations are highly advanced in the bluefin tunas (Carey et al., 1971; Graham and Dickson 2001) that can elevate the temperature of their viscera, locomotor muscle and cranial region. The elevation of their body temperature enables a more efficient energy usage and allows for the exploitation of a broader habitat range than would be available otherwise (Bernal, et al., 2001).

The Pacific bluefin tuna is a highly migratory species that is primarily distributed in sub-tropical and temperate latitudes of the North Pacific Ocean (NPO) between 20° N. and 50° N., but is occasionally found in tropical waters and in the southern hemisphere, in waters around New Zealand (Bayliff 1994).

As members of a pelagic species, Pacific bluefin tuna use a range of habitats including open-water, coastal seas, and seamounts. Pacific bluefin tuna occur from the surface to depths of at least 550 m, although they spend most of their time in the upper 120 m of the water column (Kitagawa, et al., 2000; 2004; 2007; Boustany et al. 2010). As with many other pelagic species, Pacific bluefin tuna are often found along frontal zones where forage fish tend to be concentrated (Kitagawa, et al., 2009). Off the west coast of the United States, Pacific bluefin tuna are often more tightly clustered near areas of high productivity and more dispersed in areas of low productivity (Boustany, et al., 2010).

Pacific bluefin tuna exhibit large inter-annual variations in movement (e.g., numbers of migrants, timing of migration and migration routes); however, general patterns of migration have been established using catch data and tagging study results (Bayliff 1994; Boustany et al., 2010; Block et al., 2011; Whitlock et al., 2015). Pacific bluefin tuna begin their lives in the western Pacific Ocean (WPO). Generally, age 0-1 fish migrate north along the Japanese and Korean coasts in the summer and south in the winter (Inagake et al., 2001; Itoh et al., 2003; Yoon et al., 2012). Depending on ocean conditions, an unknown portion of young individuals (1-3 years old) from the WPO migrate eastward across the NPO, spending several years as juveniles in the eastern Pacific Ocean (EPO) before returning to the WPO (Bayliff 1994; Inagake et al., 2001; Perle 2011). Their migration rates have not been quantified and it is unknown what proportion of the population migrates to the EPO and what factors contribute to the high degree of variability across years.

While in the EPO, the juveniles make north-south migrations along the west coast of North America (Kitagawa et al., 2007; Boustany et al., 2010; Perle, 2011). Pacific bluefin tuna tagged in the California Current span approximately 10° of latitude between Monterey Bay (36° N.) and northern Baja California (26° N.) (Boustany et al., 2010; Block et al., 2011; Whitlock et al., 2015), although some individuals have been recorded as far north as Washington. This migration loosely follows the seasonal cycle of sea surface temperature, such that Pacific bluefin tuna move northward as temperatures warm in late summer to fall (Block et al., 2011). These movements also follow shifts in local peaks in primary productivity (as measured by surface chlorophyll) (Boustany et al., 2010; Block et al., 2011). In the spring, Pacific bluefin tuna are concentrated off the southern coast of Baja California; in summer, Pacific bluefin tuna move northwest into the Southern California Bight; by fall, they are largely distributed between northern Baja California and northern California. In winter, Pacific bluefin tuna are generally more dispersed, with some individuals remaining near the coast, and some moving farther offshore (Boustany et al., 2010).

After spending up to 5 years in the EPO, individuals return to the WPO where the only two spawning grounds (a southern area near the Philippines and Ryukyu Islands, and a northern area in the Sea of Japan) have been documented. No spawning activity, eggs, or larvae have been observed in the EPO. The timing of spawning and the particular spawning ground used after their return to the WPO has not been established. Mature adults in the WPO generally migrate northwards to feeding grounds after spawning, although a small proportion of fish may move southward or eastward (Itoh 2006). Some of the mature individuals that migrate south are taken in New Zealand fisheries (Bayliff 1994, Smith et al., 2001), but the migration pathway of these individuals is unknown. It is also not known how long they may remain in the South Pacific.

Like most pelagic fish, Pacific bluefin tuna are broadcast spawners and spawn more than once in their lifetime, and they spawn multiple times in a single spawning season (Okochi, et al., 2016). They are highly fecund, and the number of eggs they release during each spawning event is positively and linearly correlated with fish length and weight (Okochi et al., 2016; Ashida et al., 2015). Estimates of fecundity for female tuna from the southern spawning area (Philippines and Ryukyu Islands) indicate that individual fish can produce from 5 to 35 million eggs per spawning event (Ashida et al., 2015; Shimose et al., 2016; Chen et al., 2006). Females in the northern spawning ground (Sea of Japan) produce 780,000-13.89 million eggs per spawning event in fish 116-170 cm fork length (FL) (Okochi, et al., 2016).

Histological studies have shown that approximately 80 percent of the individuals found in the Sea of Japan from June to August are reproductively mature (Tanaka, et al., 2006, Okochi et al., 2016). This percentage does not necessarily represent the whole population as fish outside the Sea of Japan were not examined.

Spawning in Pacific bluefin tuna occurs in only comparatively warm waters, so larvae are found within a relatively narrow sea surface temperature (SST) range (23.5-29.5 °C) compared to juveniles and adults (Kimura et al., 2010; Tanaka & Suzuki 2016). Larvae are thought to be transported primarily by the northward flowing Kuroshio Current and are largely found off coastal Japan, both in the Pacific Ocean and Sea of Japan (Kimura et al., 2010).

As discussed above, spawning in Pacific bluefin tuna has been recorded only in two locations: Near the Philippines and Ryukyu Islands, and in the Sea of Japan (Okochi et al., 2016; Shimose & Farley 2016). These two spawning grounds differ in both timing and the size composition of individuals. Near the Philippines and Ryukyu Islands, spawning occurs from April to July and fish are from 6-25 years of age, though most are older than 9 years of age. In the Sea of Japan, spawning occurs later (June to August) and fish are 3-26 years old.

Pacific bluefin tuna exhibit rapid growth, reaching 58 cm or more in length by age 1 and frequently more than 1 m in length by age 3 (Shimose et al., 2009; Shimose and Ishihara 2015). The species tends to reach its maximum length of around 2.3 m at age 15 (Shimose et al., 2009; Shimose and Ishihara 2015). The oldest Pacific bluefin tuna recorded was 26 years old and measured nearly 2.5 m in length (Shimose et al., 2009).

Pacific bluefin tuna are opportunistic feeders. Small individuals (age 0) feed on small squid and zooplankton (Shimose et al., 2013). Larger individuals (age 1+) have a diverse forage base that is temporally variable and, in both the EPO and WPO, they feed on a variety of fishes, cephalopods, and crustaceans (Pinkas et al., 1971; Shimose et al., 2013; Madigan et al., 2016; O. Snodgrass, NMFS SWFSC, unpublished data). Diet data indicate they forage in surface waters, on mesopelagic prey and even on benthic prey. The SWFSC conducted stomach content analysis of age 1-5 Pacific bluefin tuna caught off the coast of California from 2008 to 2016 and found that Pacific bluefin tuna are generalists altering their feeding habits depending on localized prey abundance (O. Snodgrass, NMFS SWFSC, unpublished data).

Based on the best available scientific and commercial information summarized above, we find that the Pacific bluefin tuna is currently considered a taxonomically-distinct species and, therefore, meets the definition of “species” pursuant to section 3 of the ESA. Below, we evaluate whether the species warrants listing as endangered or threatened under the ESA throughout all or a significant portion of its range.

While we were not petitioned to list a distinct population segment (DPS) of the Pacific bluefin tuna and are therefore not required to identify DPSs, we decided, in this case, to evaluate whether any populations of the species meet the DPS Policy criteria. As described above, the ESA's definition of “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” The DPS Policy requires the consideration of two elements: (1) The discreteness of the population segment in relation to the remainder of the species to which it belongs; and (2) the significance of the population segment to the species to which it belongs.

A population segment of a vertebrate species may be considered discrete if it satisfies 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 segment is found to be discrete under one or both of the above conditions, its biological and ecological significance to the taxon to which it belongs is evaluated. Factors that can be considered in evaluating significance may include, but are not limited to: (1) Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon; (2) evidence that the loss of the discrete population segment would result in a significant gap in the range of a 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.

Pacific bluefin tuna are currently managed as a single stock with a trans-Pacific range. We considered a number of factors related to Pacific bluefin tuna movement patterns, geographic range, and life history that relate to the discreteness criteria. Among the many characteristics of Pacific bluefin tuna that were discussed as contributing factors to the determination of ESA discreteness, three were regarded as carrying the most weight in the identification of DPSs. The strongest argument for the existence of a DPS was the spatial specificity of Pacific bluefin tuna spawning. The strongest arguments against the existence of a DPS included Pacific bluefin tuna migratory behavior and genetic characteristics of the Pacific bluefin tuna.

Based on the current understanding of Pacific bluefin tuna movements, Pacific bluefin tuna use one of two areas in the WPO to spawn. There is no evidence to suggest that these represent two separate populations but rather that, as fish increase in size, they shift from using the Sea of Japan to using the spawning ground near the Ryukyu Islands (e.g., Shimose et al., 2016). The spawning areas are also characterized by physical oceanographic conditions (e.g., temperature), rather than a spatially fixed feature (e.g., a seamount or promontory). This implies that the location of the spawning grounds may be temporally and spatially fluid, as conditions change over time. Given these considerations, the existence of two spatially distinct spawning grounds does not provide compelling evidence that discrete population segments exist for Pacific bluefin tuna. In addition, concentrations of adult Pacific bluefin tuna on the spawning grounds are found only during spawning times and not year-round.

Catch data and conventional and electronic tagging data demonstrate the highly migratory nature of Pacific bluefin tuna. Results support broad mixing around the Pacific. While fish cross the Pacific from the WPO to the EPO, results indicate that they then return to the WPO to spawn. Furthermore, the limited genetic data currently available (Tseng et al., 2012; Nomura et al., 2014) do not support the presence of genetically distinct population segments within the Pacific bluefin tuna.

The ISC stock assessment presented population dynamics of Pacific bluefin tuna based on catch per unit effort data from 1952-2015 using a fully integrated age-structured model. The model included various life-history parameters including a length/age relationship and natural mortality estimates from tag-recapture and empirical life-history studies. Specific details on the modelling methods can be found in the ISC stock assessment available at http://isc.fra.go.jp/reports/stock_assessments.html.

The 2016 ISC Pacific bluefin tuna stock assessment indicated three major trends: (1) Spawning stock biomass (SSB) fluctuated from 1952-2014; (2) SSB declined from 1996 to 2010; and (3) the decline in SSB has ceased since 2010 yet remains near to its historical low.

Based on the stock assessment model, the 2014 SSB was estimated to be around 17,000 mt, which represents 143,053 individuals capable of spawning. Relative to the theoretical, model-derived SSB had there been no fishing (i.e., the “unfished” SSB; 644,466 mt), 17,000 mt represents approximately 2.6 percent of fish in the spawning year classes. It is important to note that unfished SSB is a theoretical number derived from the stock assessment model and does not represent a “true” estimate of what the SSB would have been with no fishing. This is because it is based on the equilibrium assumptions of the model (e.g., no environmental or density-dependent effects) and it changes with model structures. That is, in the absence of density-dependent effects on the population, the estimate may overestimate the population size that can be supported by the environment and may change with improved input parameters. When compared to the highest SSB of 160,004 mt estimated by the model in 1959, the SSB in 2014 is 10.6 percent of the 1952-2014 historical peak.

It is important to note that while the SSB as estimated by the ISC stock assessment is 2.6 percent of the theoretical, model-derived, “unfished” SSB, this value is based on a theoretical unfished population, and only includes fish of spawning size/age. Based on the estimated number of individuals at each age class, the number of individuals capable of spawning in 2014 was 143,053. However, total population size, including non-spawning capable individuals that have not yet reached spawning age, is estimated at 1,625,837. This yields an 8 percent ratio of spawning-capable individuals to total population. From 1952-2014, this ratio has ranged from 28 percent in 1960 to 2.5 percent in 1984, with a mean of 8 percent. The ratio in 2014 indicates that, relative to population size, there were more spawning-capable fish than in some years even with a similarly low total population size (e.g., 1982-84), and the ratio was at the average for the period 1952-2014.

The 2016 ISC stock assessment was also used to project changes in SSB through the year 2034. The assessment evaluated 11 scenarios in which various management strategies were altered from the status quo (e.g., reduction in landings of smaller vs. larger individuals) and recruitment scenarios were variable (e.g., low to high recruitment). None of these 11 scenarios resulted in a projected reduction in SSB through fishing year 2034.

The stock assessment also indicates that Pacific bluefin tuna is overfished and that overfishing is occurring. This assessment, however, is based on the abundance of the species through 2014. As described in the following section on existing regulatory measures, the first Pacific bluefin tuna regulations that placed limits on harvest were implemented in 2012 with additional regulations implemented in 2014 and 2015.

As described above, section 4(a)(1) of the ESA and NMFS' implementing regulations (50 CFR 424.11(c)) state that we must determine whether a species is endangered or threatened because of any one or a combination of the following factors: The present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence. We evaluated whether and the extent to which each of the foregoing factors contribute to the overall extinction risk of Pacific bluefin tuna, with a “significant” contribution defined, for purposes of this evaluation, as increasing the risk to such a degree that the factor affects the species' demographics (i.e., abundance, productivity, spatial structure, diversity) either to the point where the species is strongly influenced by stochastic or depensatory processes or is on a trajectory toward this point.

For their extinction risk analysis, the SRT members evaluated threats and the extinction risk over two time frames. The SRT used 25 years (~3 generations for Pacific bluefin tuna) for the short time frame and 100 years (~13 generations) for the long time frame. The SRT concluded that the short time frame was a realistic window to evaluate current effects of potential threats with a good degree of reliability, especially when considering the limits of population forecasting models (e.g., projected population trends in stock assessment models). The SRT also concluded that 100 years was a more realistic window through which to evaluate the effects of a threat in the more distant future that, by nature, may not be able to be evaluated over shorter time periods. For example, the potential effects of climate change from external forces are best considered on multi-decadal to centennial timescales, due to the predominance of natural variability in determining environmental conditions in the shorter term.

The following sections briefly summarize our findings and conclusions regarding threats to the Pacific bluefin tuna and their impact on the overall extinction risk of the species. More details can be found in the status review report, which is incorporated here by reference.

Given their highly migratory nature, Pacific bluefin tuna may be exposed to a variety of contaminants and pollutants. Pollutants vary in terms of their concentrations and composition depending on location, with higher concentrations typically occurring in coastal waters. There are two classes of pollutants in the sea that are most prevalent and that could pose potential risks to Pacific bluefin tuna: Persistent Organic Pollutants (POPs) and mercury. However, the SRT also considered Fukushima derived radiation and oil pollution as independent threats.

Persistent organic pollutants are organic compounds that are resistant to environmental degradation and are most often derived from pesticides, solvents, pharmaceuticals, or industrial chemicals. Common POPs in the marine environment include the organochlorine Dichlorodiphenyltrichloroethane (DDT) and Polychlorinated biphenyls (PCBs). Because they are not readily broken down and enter the food-web, POPs tend to bioaccumulate in marine organisms. In fishes, some POPs have been shown to impair reproductive function (e.g., white croaker; Cross et al., 1988; Hose et al., 1989).

Specific information on POPs in Pacific bluefin tuna is limited. Ueno et al. (2002) examined the accumulation of POPs (e.g., PCBs, DDTs, and chlordanes (CHLs)) in the livers of Pacific bluefin tuna collected from coastal Japan. They determined, as expected, that the uptake of these organochlorines was driven by dietary uptake rather than through exposure to contaminated water (i.e., through the gills). This research showed that levels of organochlorines were positively and linearly correlated with body length. Body length normalized values for PCBs, DDTs, and CHLs were calculated as 530-2,600 ng/g lipid weight, 660-800 ng/g lipid weight, and 87-300 ng/g lipid weight, respectively. More recently, Chiesa et al. (2016) measured pollutants from Pacific bluefin tuna in the Western Central Pacific Ocean and found that 100 percent of the individuals sampled tested positive for five of the six PCBs assayed. Three POPs (specifically, polybrominated diphenyl ethers) were detected in 5-60 percent of fish examined. Two organochlorines were detected in 30-80 percent of samples. Unlike the findings of Ueno et al. (2002) from coastal Japan, no DDT or its end-products were detected in Pacific bluefin tuna in the Western Central Pacific Ocean.

While POPs have been detected in the tissues of Pacific bluefin tuna (see above), much higher levels have been measured in other marine fish (e.g., pelagic sharks; Lyons et al., 2015). While there is a lack of direct experimentation on the potential impacts of POPs on Pacific bluefin tuna, there are currently no studies which indicate that they exist at levels that are harmful to Pacific bluefin tuna. Based on the findings in the status review, we conclude that POPs pose no to low risk of contributing to a decline or degradation of the Pacific bluefin tuna.

Mercury (Hg) enters the oceans primarily through the atmosphere-water interface. Initial sources of Hg are both natural and anthropogenic. One of the main sources of anthropogenic Hg is coal-fired power-plants. Total Hg emissions to the atmosphere have been estimated at 6,500-8,200 Mg/yr, of which 4,600-5,300 Mg/yr (50-75 percent) are from natural sources (Driscoll et al., 2013). In water, elemental Hg is converted to methyl-Hg by bacteria. Once methylated, Hg is easily absorbed by plankton and thus enters the marine food-web. As with POPs, Hg bioaccumulates and concentrations increase in higher trophic level organisms.

As a top predator, Pacific bluefin tuna can potentially accumulate high levels of Hg. Several studies have examined Hg in Pacific bluefin tuna and reported a wide range of concentrations that vary based on geographic location. In the WPO, measured Hg concentrations ranged from 0.66-3.23 μg/g wet mass (Hisamichi et al., 2010; Yamashita et al., 2005), whereas in the EPO they ranged from 0.31-0.508 μg/g wet mass (Lares et al., 2012; Coman et al., 2015). The latter study demonstrated that in the EPO individuals that had recently arrived from the WPO contained higher Hg concentrations than those that had resided in the EPO for 1-3 years, including wild-caught individuals being raised in net pens. By comparison, concentrations of Hg in Atlantic bluefin tuna have been measured at 0.25-3.15 mg/kg wet mass (Lee et al., 2016). Notably, Lee et al. (2016) demonstrated that Hg concentrations in Atlantic bluefin tuna declined 19 percent over an 8-year period from the 1990s to the early 2000s, a result of reduced anthropogenic Hg emissions in North America. Tunas are also known to accumulate high levels of selenium (Se), which is suggested to have a detoxifying effect on methyl-Hg compounds (reviewed in Ralston et al., 2016).

The petitioners suggest that since some bluefin products are above 1 ppm, the U.S. Food and Drug Administration's (FDA) threshold, there is cause for concern with regard to bluefin tuna health. The FDA levels are set at the point at which consumption is not recommended for children and women of child bearing age and are not linked to fish health. While methyl Hg compounds have been shown to cause neurobiological changes in a variety of animals, there have been no studies on tuna or tuna-like species showing detrimental effects from methyl Hg. As with the POPs, other marine species have much higher levels of Hg contamination (Montiero and Lopes 1990; Lyons et al., 2015). The SRT was unanimous in the determination that Hg contamination does not pose a direct threat to Pacific bluefin tuna.

We find that water pollution poses no risk of contributing to a decline or degradation of the Pacific bluefin tuna. While we acknowledge that bioaccumulation of pollutants in Pacific bluefin tuna may result in some risk to consumers, the absence of empirical studies showing that water pollution has direct effects on Pacific bluefin tuna implies that water pollution is not a high risk for Pacific bluefin tuna themselves.

Plastics have become a major source of pollution on a global scale and in all major marine habitats (Law 2017). In 2014, global plastic production was estimated to be 311 million metric tons (mt) (Plast. Eur. 2015). Plastics are the most abundant material collected as floating marine debris or from beaches (Law et al., 2010; Law 2017) and are known to occur on the seafloor. Impacts on the marine environment vary with type of plastic debris. Larger plastic debris can cause entanglement leading to injury or death, while ingestion of smaller plastic debris has the potential to cause injury to the digestive tract or accumulation of indigestible material in the gut. Studies have also shown that chemical pollutants may be adsorbed into plastic debris which would provide an additional pathway for exposure (e.g., Chua et al., 2014). Small plastics (microplastics) have been documented as the primary source of ingested plastic materials among fish species, particularly opportunistic planktivores (e.g., Rochman et al., 2013; 2014; Matsson et al., 2015). Few studies have examined microplastic ingestion by larger predatory fishes such as Pacific bluefin tuna and results from these studies are mixed.

Cannon et al. (2016) found no evidence of plastics in the digestive tracts of skipjack tuna (Katsuwonis pelamis) and blue mackerel (Scomber australensis) in Tasmania. Choy and Drazen (2013) found no evidence of plastic ingestion in K. pelamis and yellowfin tuna (Thunnus albacares) in Hawaiian waters, but found that approximately 33 percent of bigeye tuna (Thunnus obesus) had anthropogenic plastic debris in their stomachs. While no specific studies on plastic ingestion in Pacific bluefin tuna are available, a study of foraging ecology in the EPO found no plastic in over 500 stomachs examined from 2008-2016 (O. Snodgrass, NMFS, unpublished data).

We find that plastic ingestion by Pacific bluefin tuna poses no to low risk of contributing to a decline or degradation of the Pacific bluefin tuna. This was based in large part upon the absence of empirical evidence of large amounts of macro- and micro-plastic directly impacting individual Pacific bluefin tuna health.

There are numerous examples of oil and gas exploration and operations posing a threat to marine organisms and habitats. Threats include seismic activities during exploration and construction and events such as oil spills or uncontrolled natural gas escape where released chemicals can have severe and immediate effects on wildlife.

Unfortunately, there is limited information on the direct impacts of oil and gas exploration and operation on pelagic fishes such as Pacific bluefin tuna. Studies looking at the impacts of seismic exploration on fish have mixed results. Wardle et al. (2001) and Popper et al. (2005) documented low to moderate impacts on behavior or hearing, whereas McCauley et al. (2003) reported long-term hearing loss from air-gun exposure. Risk associated with seismic exploration would likely be less of a concern for highly migratory species that can move away and do not use sounds to communicate. Reduced catch rates in areas for a period of time after air guns have been used are considered evidence for this avoidance behavior in a range of species (Popper and Hastings 2009).

The effects of seismic exploration on larval Pacific bluefin tuna, however, could be greater than on older individuals due in part to the reduced capacity of larvae to move away from affected areas. Davies et al. (1989) stated that fish eggs and larvae can be killed at sound levels of 226-234 decibel (dB), which are typically found at 0.6-3.0 m from an air gun such as those used during seismic exploration. Visual damage to larvae can occur at 216 dB, levels found approximately 5 m from the air gun. Less obvious impacts such as disruptions to developing organs are harder to gauge and are little explored in the scientific literature; however, severe physical damage or mortality appears to be limited to larvae within a few meters of an air gun discharge (Dalen et al., 1987; Patin & Cascio 1999).

The most relevant study, for the purposes of the SRT, is an evaluation of the impacts of oil pollution on the larval stage of Atlantic bluefin tuna. Oil released from the 2010 Deepwater Horizon oil spill in the Gulf of Mexico covered approximately 10 percent of the spawning habitat, prompting concerns about larval survival (Muhling et al., 2012). Modeled western Atlantic bluefin tuna recruitment for 2010 was low compared to historical values, but it is not yet clear whether this was primarily due to oil-induced mortality, or unfavorable oceanographic conditions (Domingues et al., 2016). Results from laboratory studies showed that exposure to oil resulted in significant defects in heart development in larval Atlantic bluefin tuna (Incardona et al., 2014) with a likely reduction in fitness. A similar response would be expected in Pacific bluefin tuna. Consequently, an oil spill in or around the spawning grounds has the potential to impact larval survival of Pacific bluefin tuna. Previous spills near the spawning grounds have mostly been from ships (e.g., Varlamov et al., 1999; Chiau 2005), and have resulted in much smaller, more coastally confined releases into the marine environment than from the Deepwater Horizon incident. However, offshore oil exploration has increased in the region in recent years, potentially increasing the risks of a large-scale spill. Despite these considerations, the overall risks to Pacific bluefin tuna associated with an oil spill were considered to be low for a number of reasons: (1) Large oil spills are rare events; (2) Pacific bluefin tuna larvae are spread over two spawning grounds with little oceanographic connectivity between them, reducing risk to the population as a whole; and (3) the population is broadly dispersed overall.

Oil and gas infrastructure may have beneficial impacts on the marine environment by providing habitat for a range of species and de facto no fishing zones. California has been a prime area of research into the effects of decommissioned oil platforms. Claisse et al. (2014) showed that offshore oil platforms have the highest measured fish production of any habitat in the world, exceeding even coral reefs and estuaries. Caselle et al. (2002) showed that even remnant oil field debris (e.g., defunct pipe lines, piers, and associated structures) harbored diverse fish communities. This pattern is not unique to California. For example, Fabi et al. (2004) showed that fish diversity and richness increased within the first year after installation of two gas platforms in the Adriatic Sea, and that biomass of fishes on these platforms was substantial. Consequently, oil platforms may provide forage and refuge for Pacific bluefin tuna.

In summary, we consider oil and gas development to pose no to low risk of contributing to a decline or degradation of the Pacific bluefin tuna.

Concerns about climate impacts linked to the use of petroleum products has led to an increase in renewable energy programs over the past two decades. Offshore and coastal wind energy generating stations have been among the fastest growing renewable energy sectors, particularly in shallow coastal areas, which generally have consistent wind patterns and reduced infrastructure costs due to shallow depths and proximity to land.

Impacts of wind energy generating stations on marine fauna have been well studied (see Köppel, 2017 for examples). There have been some studies predicting negative effects on marine life, particularly birds and benthic organisms, but few empirical studies have demonstrated direct impacts to fishes. Wilson et al. (2010) reviewed numerous papers discussing the impacts of wind energy infrastructure and concluded that while they are not environmentally benign, the impacts are minor and can often be ameliorated by proper placement.

Studies on wind energy development and its impact on fishes has largely focused on demersal species assemblages. Similar to oil and gas platforms, wind energy platforms have been shown to have a positive effect on demersal fish communities in that they tend to harbor high diversity and biomass of fish populations (e.g., Wilhelmsson et al., 2006). Following construction of “wind farms,” one particular concern has been the effects of noise created by the operating mechanisms on fish. Wahlberg and Westerberg (2005) concluded that wind farm noise does not have any destructive effects on the hearing ability of fish, even within a few meters. The major impact of the noise is largely restricted to masking communication between fish species which use sounds (Wahlberg and Westerberg, 2005). Given that Pacific bluefin tuna are not known to use sounds for communication, the impact of noise would be minimal if any. Additionally, wind farms are likely to serve as de facto fish aggregating devices and may prove beneficial at attracting prey and thus Pacific bluefin tuna as well. Also, given the highly migratory nature of Pacific bluefin tuna and their broad range, wind farms would not take up a large portion of their range and could be avoided.

We find that wind energy development poses no to low risk of contributing to a decline or degradation of the Pacific bluefin tuna. This was based largely on the ability of Pacific bluefin tuna to avoid wind farms and the absence of empirical evidence showing harm directly to Pacific bluefin tuna.

Operation of coastal aquaculture facilities can degrade local water quality, mostly through uneaten fish feed and feces, leading to nutrient pollution. The severity of these issues depends on the species being farmed, food composition and uptake efficiency, fish density in net pens, and the location and design of pens (Naylor et al., 2005). There are several offshore culture facilities throughout the world, most being within 25 kilometers (km) of shore.

The petition by CBD highlights a proposed offshore aquaculture facility in California as a potential threat to Pacific bluefin tuna. The proposed Rose Canyon aquaculture project would construct a facility to raise yellowtail jack approximately 7 km from the San Diego coast. The high capacity of the proposed project (reaching up to 5,000 mt annually after 8 years of operation) has raised concerns about resulting impacts to the surrounding marine environment. As the proposed aquaculture facility would act as a point source of pollutants, the potential impacts to widely distributed pelagic species such as Pacific bluefin tuna will depend on oceanographic dispersal of these pollutants within the Southern California Bight (SCB) and surrounding regions.

Data from current meters and Acoustic Doppler Current Profilers (ADCPs) near Point Loma have recorded seasonally reversing, and highly variable, alongshore flows (Hendricks 1977; Carson et al., 2010). However, cross-shelf currents were much weaker. Similarly, Lahet and Stramski (2010) showed that river plumes in the San Diego area identified by satellite ocean color imagery moved variably north or south along the coast until dispersing, but were not advected offshore. Recent studies using high-resolution simulations of a regional oceanic modeling system have also shown limited connectivity between the nearshore region off San Diego and the open SCB (Dong et al., 2009; Mitari et al., 2009). This suggests that pollutants resulting from the proposed Rose Canyon aquaculture facility would likely be dispersed along the southern California and northern Baja California coasts rather than offshore. Pacific bluefin tuna are distributed throughout much of the California Current ecosystem, and are often caught more than 100 km from shore (Holbeck et al., 2017). Tagging studies have also shown very broad habitat use of Pacific bluefin tuna offshore of Baja California and California (Boustany et al., 2010). It should be noted that any aquaculture facilities in the United States are subjected to rigorous environmental reviews and standards prior to being permitted.

We find that habitat degradation from large-scale aquaculture poses no to low risk of contributing to population decline or degradation in Pacific bluefin tuna over both time-scales largely due to the very small proportion of their habitat which would be impacted as well as the absence of empirical evidence showing harm directly to Pacific bluefin tuna.

As highly migratory, fast-swimming top predators, tunas have relatively high energy requirements (Olson and Boggs 1986; Korsmeyer and Dewar 2001; Whitlock et al., 2013; Golet et al., 2015). They fulfill these needs by feeding on a wide range of vertebrate and invertebrate prey, the relative contribution of which varies by species, region, and time period. Pacific bluefin tuna in the California Current ecosystem have been shown to prey on forage fish such as anchovy, as well as squid and crustaceans (Pinkas et al., 1971; Snodgrass et al., unpublished data). As commercial fisheries also target some of these species, substantial removals could conceivably reduce the prey base for predators such as Pacific bluefin tuna. Previous studies have used trophic ecosystem models to show that high rates of fishing on forage species could adversely impact other portions of the ecosystem, including higher-order predators (Smith et al., 2011; Pikitch et al., 2012).

Biomass of the two main forage fish in the California Current, sardine and anchovy, has been low in recent years (Lindegren et al., 2013; Lluch-Cota 2013). This likely represents part of the natural cycle of these species, which appear to undergo frequent “boom and bust” cycles, even in the absence of industrial-scale fishing (Schwartzlose et al., 1999; McClatchie et al., 2017). Pacific bluefin tuna appear to be generalists and consequently are less impacted by these shifts in abundance than specialists. Pinkas et al. (1971) found that Pacific bluefin tuna diets in the late 1960s were mostly anchovy (>80 percent), coinciding with a period of relatively high anchovy biomass. In contrast, more recent data from the 2000s show a much higher dominance of squid and crustaceans in Pacific bluefin tuna diets, with high interannual variability (Snodgrass et al., unpublished data). Neither study recorded a substantial contribution of sardine to Pacific bluefin tuna diets, but both diet studies (Pinkas et al., Snodgrass et al., unpublished data) were conducted during years in which sardine biomass was comparatively low.

This ability to switch between prey species may be one reason why Hilborn et al. (2017) found little evidence that forage fish population fluctuations drive biomass of higher order consumers, including tunas. This disconnect is clear for Pacific bluefin tuna. For example, in the 1980s, Pacific bluefin tuna biomass and recruitment were both very low, but forage fish abundances in both the California Current and Kuroshio-Oyashio ecosystems were high (Lindegren et al., 2013; Yatsu et al., 2014). Hilborn et al. (2017) considered that a major weakness of previous trophic studies was a lack of consideration of this strongly fluctuating nature of forage fish populations through time. Predators have thus likely adapted to high variability in abundance of forage fish and other prey species by being generalists.

However, although Pacific bluefin tuna have a broad and varied prey base in the California Current, the physiological effects of switching between dominant prey types are not well known. Some species are more energy-rich than others, and may have lower metabolic costs to catch and digest (Olson & Boggs 1986; Whitlock et al., 2013). Fluctuations in the energy content and size spectra of a prey species may also be important, as was found for the closely-related Atlantic bluefin tuna (Golet et al., 2015). It is therefore not yet clear how periods of strong reliance on anchovy vs. invertebrates, for example, may impact the condition and fitness of Pacific bluefin tuna.

We find that prey depletion poses a very low threat to Pacific bluefin tuna over the 25-year time frame, primarily because it is clear that they are generally adapted to natural fluctuations of forage fish biomass through prey switching. We also find that prey depletion may pose a low to moderate threat over the 100-year timeframe, albeit with low certainty. This was mainly because climate change is expected to alter ecosystem structure and function to produce potentially novel conditions, over an evolutionarily short time period. If this results in a less favorable prey base for Pacific bluefin tuna, in either the California Current or other foraging areas, impacts on the population may be more deleterious than they have been in the past.

Potential threats to the Pacific bluefin tuna from overutilization for commercial, recreational, scientific or educational purposes also includes illegal, unregulated and unreported fishing. Each of these potential threats is discussed in the following sections.

Commercial fishing for Pacific bluefin tuna has occurred in the western Pacific since at least the late 1800s. Records from Japan indicate that several methods were used prior to 1952 when catch records began to be taken in earnest and included longline, pole and line, drift net, and set net fisheries. Estimates of global landings prior to 1952 peaked around 47,635 mt (36,217 mt in the WPO and 11,418 mt in the EPO) in 1935 (Muto et al., 2008). After 1935, landings dropped in response to a shift in maritime activities caused by World War II. Fishing activities expanded across the North Pacific Ocean after the conclusion of the war, and landings increased consistently for the next decade prior to becoming more variable (Muto et al., 2008).

There are currently five major contributors to the Pacific bluefin tuna fisheries: Japan, Korea, Mexico, Taiwan, and the United States. Each operates in nearshore coastal waters in the Pacific Ocean while a few also operate in distant offshore waters. In modern fisheries, Pacific bluefin tuna are taken by a wide range of fishing gears (e.g., longline, purse seine, set net, troll, pole-and-line, drift nets, and hand line fisheries), which target different size classes (see below). Among these fisheries, purse seine fisheries are currently the primary contributor to landings, with the Japanese fleet being responsible for the majority of the catch. Much of the global purse-seine catch supports commercial grow-out facilities where fish aged approximately 1-3 are kept in floating pens for fattening prior to sale.

Estimates of landings indicate that annual catches of Pacific bluefin tuna by country have fluctuated dramatically from 1952-2015. During this period reported catches from the five major contributors to the ISC peaked at 40,144 mt in 1956 and reached a low of 8,627 mt in 1990, with an average of 21,955 mt. Japanese fisheries are responsible for the majority of landings, followed by Mexico, the United States, Korea and Taiwan. In 2014, the United States reported commercial landings of 408 mt, Taiwan reported 525 mt, Korea reported 1,311 mt, Mexico reported 4,862 mt, and Japan reported 9,573 mt. These represent 2.4 percent, 3 percent, 7.7 percent, 28.4 percent, and 56 percent of the total landings, respectively. Landings in the southern hemisphere are small and concentrated around New Zealand.

The commercial Japanese Pacific bluefin tuna fisheries are comprised of both distant-water and coastal longline vessels, coastal trolling vessels, coastal pole-and-line vessels, coastal set net vessels, coastal hand line vessels, and purse seiners. Each fishery targets specific age classes of Pacific bluefin tuna: Coastal trolling and pole and line target fish less than 1 year old, coastal set net and coastal hand-line target ages 1-5, purse seiners target ages 0-10, and the distant-water and coastal longline vessels target ages 5-20. The distant water longline fisheries have operated for the longest time while the coastal longline fisheries did not begin in earnest until the mid-1960s. Between 1952 and 2015, total annual catches by Japanese fisheries have fluctuated between a maximum of approximately 34,000 mt in 1956 and a minimum of approximately 6,000 mt in 2012, and they have averaged 15,653 mt.

The Japanese troll fleet harvests small, age-0 Pacific bluefin tuna for its commercial aquaculture grow-out facilities. From 2005-2015, the harvest of Pacific bluefin tuna for grow-out by the troll fishery has averaged 14 percent of Japan's total landings (approximately 8.5 percent of global landings) by weight.

Nearly all commercial Pacific bluefin tuna catches by U.S. flagged vessels on the west coast of the United States are landed in California. Historically, the commercial fisheries for Pacific bluefin tuna focused their efforts on the fishing grounds off Baja California, Mexico, until the 1980s. Following the creation of Mexico's EEZ, the U.S. purse seine fisheries largely ceased their efforts in Mexico and became more opportunistic (Aires-da-Silva et al., 2007). Since 1980, commercial landings of Pacific bluefin tuna have fluctuated dramatically, averaging 859.2 mt with two peaks in 1986 (4,731.4 mt) and 1996 (4,687.6 mt). The low catch rates are not caused by the absence of Pacific bluefin tuna, but rather the absence of a dedicated fishery, low market price, and the inability to fish in the Mexican EEZ. In 2014, commercial landings of Pacific bluefin tuna in the United States were 408 mt, representing 2.4 percent of the total global landings.

Mexico's harvest of Pacific bluefin tuna is dominated by its purse seine fisheries, which dramatically increased in size following the creation of Mexico's EEZ. While most of the purse seine fisheries target yellowfin tuna (the dominant species in the catch) in tropical waters, Pacific bluefin tuna are caught by purse seine near Baja California. Since 1952, reported landings in Mexico have ranged from 1-9,927 mt with an average of 1,766.7 mt (ISC catch database http://isc.fra.go.jp/fisheries_statistics/index.html). Since grow-out facilities began in Mexico in 1997, the purse seine fishery for Pacific bluefin tuna almost exclusively supports these facilities. These facilities take in age 1-3 Pacific bluefin tuna and “fatten” them in floating pens for export and represent virtually all of Mexico's reported capture of Pacific bluefin tuna. From 2005-2015, Mexico's harvest for its grow-out facilities has averaged 26.8 percent of the global landings.

The Korean take of Pacific bluefin tuna is dominated by its offshore purse seine fishery with a small contribution by the coastal troll fisheries. The fisheries generally operate off Jeju Island with occasional forays into the Yellow Sea (Yoon et al., 2014). The purse seine fisheries did not fully develop until the mid-1990s, and landings were below 500 mt prior to this. Landings gradually increased and peaked at 2,601 mt in 2003, but have declined since then, with 676 mt landed in 2015. Since 1952, the average reported Korean landings of Pacific bluefin tuna has been 535 mt (data not reported from 1952-1971).

Historically, the Taiwanese fisheries have used a wide array of gears, but since the early 1990s the fisheries are largely comprised of small-scale longline vessels. These vessels are targeting fish on the spawning grounds near the Ryukyu Islands. The highest reported catch was in 1990 at 3,000 mt; however, landings declined to less than 1,000 mt in 2008 and to their lowest level of about 200 mt in 2012. Landings have since increased and the preliminary estimate of Pacific bluefin tuna landings in 2015 was 542 mt. Since 1952, Taiwanese landings of Pacific bluefin tuna have averaged 658 mt.

We acknowledge the Petitioner's concern that a large proportion of Pacific bluefin tuna caught are between 0 and 2 years of age. The petition states that 97.6 percent of fish are caught before they have a chance to reproduce, and argues that this is a worrisome example of growth overfishing. The interpretation of the severity of this statement requires acknowledging several factors that are used to evaluate the production (amount of “new” fish capable of being produced by the current stock). Importantly, the estimate of production includes considering factors such as recruitment, growth of individuals (thus moving from one age class to the next and potentially reaching sexual maturity), catch, and natural mortality. Excluding all other parameters except catch results in erroneous interpretations of the severity of a high proportion of immature fish being landed on an annual basis. If all year classes are taken into account, the percentage of fish in the entire population (not just in the age 0 age class) that are harvested before reaching maturity is closer to 82 percent. While we acknowledge that this is not an ideal harvest target, it is a more accurate representation of the catch of immature fish.

Growth overfishing occurs when the average size of harvested individuals is smaller than the size that would produce the maximum yield per recruit. The effect of growth overfishing is that total yield (i.e., population size) is less than it would be if all fish were allowed to grow to a larger size. Reductions in yield per recruit due to growth overfishing can be ameliorated by reducing fishing mortality (i.e., reduced landings) and/or increasing the average size of harvested fish, both of which have been recommended by the relevant Regional Fisheries Management Organizations (RFMOs) and adopted for the purse seine fisheries in the western and central Pacific Ocean.

We consider commercial fishing to pose the greatest risk to contribute to the decline or degradation of the Pacific bluefin tuna. Threat scores given by the BRT members for commercial fishing ranged from moderate to high (severity score of 2 to 3 with a mean of 2.29). While we acknowledge that past trends in commercial landings have been the largest contributor to the decline in the Pacific bluefin tuna, we find the population size in the terminal year of the ISC stock assessment (2014; >1,625,000 individuals and >143,000 spawning-capable individuals) as sufficient to prevent extinction in the foreseeable future. This is due to the fact that the population size is large enough to prevent small population effects (e.g., Allee effects) from having negative consequences. We also note that none of the scenarios evaluated in the ISC stock projections showed declining trends. This likely indicates that the proposed reductions in landings in the ISC stock assessment that were adopted by the relevant RFMOs and have been implemented by participating countries are likely to prevent future declines. Therefore, we consider commercial fishing to pose a moderate to high risk to contribute to the degradation of Pacific bluefin tuna.

Recreational fishing for Pacific bluefin tuna occurs to some extent in most areas where Pacific bluefin tuna occur relatively close to shore. The majority of recreational effort appears to be in the United States, although this may be an artifact of a lack of record keeping outside of the United States. From the mid-1980s onward, the majority of U.S. Pacific bluefin tuna landings have been from recreational fisheries. Along the west coast of the United States, the recreational fishing fleet for highly migratory species such as Pacific bluefin tuna is comprised of commercial passenger fishing vessels (CPFVs) and privately owned vessels operating from ports in southern California.

The vast majority of recreational fishing vessels operate from ports in southern California from Los Angeles south to the U.S./Mexico border, with a large proportion operating out of San Diego. Much of the catch actually occurs in Mexican waters. The recreational catch for Pacific bluefin tuna is dominated by hook and line fishing with a very small contribution from spear fishing. The landings for Pacific bluefin tuna are highly variable. This variability is linked to changes in the number of young fish that move from the western Pacific (Bayliff 1994), and potentially regional oceanographic variability, and is not taken to reflect changes in overall Pacific-wide abundance.

In addition to variability in immigration to the EPO, regulatory measures impact the number of fish caught. As mentioned, most U.S. fishing effort occurs in Mexican waters. In July 2014, Mexico banned the capture of Pacific bluefin tuna in its EEZ for the remainder of the year, reducing the catch by the U.S. recreational fleet. In 2015, while this ban was lifted, the United States instituted a two fish per angler per day bag limit and a 6 fish per multi-day fishing trip bag limit on Pacific bluefin tuna, lowered from 10 fish per angler per day and 30 fish total for multi-day trips (80 FR 44887; July 28, 2015). It is difficult to quantify the effects of the reduced bag limit at the current time as there are only two years of landings data following the reduction (2015-16). This is further complicated by an absence of an index of availability of Pacific bluefin tuna to the recreational fishery. Anecdotal evidence in the form of informal crew and fisher interviews suggests that Pacific bluefin tuna have been in high abundance since 2012. CPFV landings in 2014-16 declined following an exceptionally productive year in 2013. Whether this was an effect of the reduced bag limit or an artifact of Pacific bluefin tuna availability is uncertain. While the petition raises the concern that the two fish per day per angler bag limit is insufficient as the fishery is “open access” (an angler may fish as many days as they wish), it is important to note that the number of anglers participating in CPFV trips has not increased dramatically since the late 1990s. It should also be noted that the average number of Pacific bluefin tuna caught per angler on an annual basis has never exceeded 1.4 (2013), thus the two fish per day per angler bag limit will effectively prevent a major expansion of the Pacific bluefin tuna recreational landings.

Since 1980, the peak of the U.S. recreational fishery was in 2013 when 63,702 individual fish were reported in CPFV log books, with an estimated weight of 809 tons. This was more than the total U.S. commercial catch in 2013 (10.1 mt), keeping in mind that commercial vessels cannot go into Mexican waters. The average recreational catch is far lower (264 mt average from 2006-2015). The peak recreational CPFV landings in the United States in 2013 represented 7 percent of the total global catch of Pacific bluefin tuna in that same year, whereas in 2015 it represented 3.2 percent of total global catch.

Private vessel landings are more difficult to quantify as they rely on voluntary interviews with fishers at only a few of the many landing ports. In 2015, the estimated landings by private vessels was 6,195 individual Pacific bluefin tuna, which represented approximately 30 percent of all U.S. recreational landings. Note, that these values are not included in the estimates above and represent additional landings.

At 3.2 percent of the total global landings, we consider the U.S. recreational fishery to be a minor overall contributor to the global catch of Pacific bluefin tuna, and recent measures have been implemented to reduce landings. Given that recreational landings have been reduced through increased management, we consider recreational fishing as posing no or a low risk of contributing to population decline or degradation in Pacific bluefin tuna.

Illegal, Unreported or Unregulated (IUU) fishing, as defined in 50 CFR 300.201, means:

(1) In the case of parties to an international fishery management agreement to which the United States is a party, fishing activities that violate conservation and management measures required under an international fishery management agreement to which the United States is a party, including but not limited to catch limits or quotas, capacity restrictions, bycatch reduction requirements, shark conservation measures, and data reporting;

(2) In the case of non-parties to an international fishery management agreement to which the United States is a party, fishing activities that would undermine the conservation of the resources managed under that agreement;

(3) Overfishing of fish stocks shared by the United States, for which there are no applicable international conservation or management measures, or in areas with no applicable international fishery management organization or agreement, that has adverse impacts on such stocks;

(4) Fishing activity that has a significant adverse impact on seamounts, hydrothermal vents, cold water corals and other vulnerable marine ecosystems located beyond any national jurisdiction, for which there are no applicable conservation or management measures or in areas with no applicable international fishery management organization or agreement; or

(5) Fishing activities by foreign flagged vessels in U.S. waters without authorization of the United States.

While there is likely some level of IUU fishing for Pacific bluefin tuna in the Pacific, no reports of substantial IUU fishing have emerged, thus the amount cannot be determined. However, improvements to catch document schemes in several countries have been proposed/implemented in an effort to combat IUU harvest, and the most recent advice from the relevant RFMOs requires improvements to reporting. The SRT members had a range of opinions on the effects of IUU fishing on population decline or degradation for Pacific bluefin tuna, ranging from no impact to moderate impact. The SRT therefore performed a SEDM analysis to arrive at the conclusion that the magnitude of potential IUU fishing losses for Pacific bluefin tuna were likely low relative to existing commercial catches and thus not likely to increase substantially in the future; however, the certainty around this determination is low.

Given the absence of estimates of IUU fishing losses for Pacific bluefin tuna, we have a low level of certainty for this threat. However, with the continued improvements in catch documentation and the assumption of low IUU take relative to the commercial harvest, we determined that IUU fishing represented a low to moderate risk of contributing to population decline or degradation in Pacific bluefin tuna.

Pacific bluefin tuna are used in scientific research for a range of studies such as migration patterns, stable isotope analysis, and feeding preference. The amount of lethal use of Pacific bluefin tuna in scientific and educational pursuits is negligible, as most tissues used in research (e.g. otoliths, muscle samples) are sourced from fish already landed by fishers. We therefore find no evidence that scientific or educational use poses a risk to contribute to the decline or degradation of Pacific bluefin tuna.

Studies of disease in Pacific bluefin tuna are largely absent from the literature. Most studies involve the identification of parasites normally associated with cage culture. Parasites are often associated with mortalities and reduced production among farmed marine fishes (Hayward et al., 2007). Epizootic levels of parasites with short, direct, one-host life cycles, such as monogeneans, can be reached very quickly in cultured fish because of the confinement and proximity of these fish (Thoney and Hargis 1991). Among wild marine fishes, parasites are usually considered benign, though they can be associated with reduced fecundity of their hosts (Jones 2005; Hayward et al., 2007).

Munday et al. (2003) provided a summary of metazoan infections (myxosporeans, Kudoa sp., monogeneans, blood flukes, larval cestodes, nematodes, copepods) in tuna species. Many metazoans infect Thunnus spp., but not many are known to cause mortalities; most studies to date have focused on the health and/or economic importance of these diseases. For example, postmortem liquefaction of muscle due to myxosporean infections occurs in albacore, yellowfin tuna, and bigeye tuna (Thunnus obesus), and in poorly identified Thunnus spp. Lesions caused by Kudoa sp. have been found in yellowfin tuna and southern bluefin tuna (Langdon 1990; Kent et al., 2001). Munday et al. (2003) report that southern bluefin tuna have been found to be infected with an unidentified, capsalid monogenean that causes respiratory stress but does not lead to mortality.

Young Pacific bluefin tuna are often infected with red sea bream iridoviral, but the disease never appears in Pacific bluefin tuna more than 1 year of age, and occurrence is restricted to periods of water temperatures greater than 24 °C (Munday et al., 2003). Mortality rates rarely reach greater than 10 percent for young fish. The fish either die during the acute phase of the disease, or they become emaciated and die later.

There is no evidence of transmission of parasites or other pathogens from captive Pacific bluefin tuna in tuna ranches. This is likely due to the fact that wild Pacific bluefin tuna are not likely to be in close enough proximity to pens used to house Pacific bluefin tuna.

We find that disease poses no to low risk of contributing to population decline or degradation in Pacific bluefin tuna. This was based largely on the absence of empirical evidence of abnormal levels of natural disease outbreaks in Pacific bluefin tuna, the absence of observations of wild Pacific bluefin tuna swimming in close enough proximity to “farms” such that disease transmission is possible, and the absence of empirical evidence showing disease transmission from “farms” to wild Pacific bluefin tuna.

As large predators, Pacific bluefin tuna are not heavily preyed upon naturally after their first few years. Predators of adult Pacific bluefin tuna may include marine mammals such as killer whales (Orcinus orca) or shark species such as white (Carcharodon carcharias) and mako sharks (Isurus spp.) (Nortarbartolo di Sciara 1987; Collette and Klein-MacPhee 2002; de Stephanis 2004; Fromentin and Powers 2005). Juvenile Pacific bluefin tuna may be preyed upon by larger opportunistic predators and, to a lesser degree, seabirds.

We find that natural predation poses no to low risk of contributing to population decline or degradation in Pacific bluefin tuna. This was based primarily on the limited diversity of predators and absence of empirical evidence showing abnormal decline/degradation of Pacific bluefin tuna by predation.

The current management and regulatory schemes for Pacific bluefin tuna are intrinsically linked to the patterns of utilization discussed in the previous section “Overutilization for Commercial, Recreational, Scientific or Educational Purposes.” The evaluation in this section focuses on the adequacy or inadequacy of the current management and regulatory schemes to address the threats identified in the section on “Overutilization for Commercial, Recreational, Scientific or Educational Purposes.”

Pacific bluefin tuna fisheries are managed under the authorities of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), the Tuna Conventions Act of 1950 (TCA), and the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA). The TCA and WCPFCIA authorize the Secretary of Commerce to implement the conservation and management measures of the Inter-American Tropical Tuna Commission (IATTC) and Western and Central Pacific Fisheries Commission (WCPFC), respectively.

Pacific bluefin tuna is managed as a single Pacific-wide stock under two RFMOs: The IATTC and the WCPFC. Both RFMOs are responsible for establishing conservation and management measures based on the scientific information, such as stock status, obtained from the ISC.

The IATTC has scientific staff that, in addition to conducting scientific studies and stock assessments, also provides science-based management advice. After reviewing the Pacific bluefin tuna stock assessment prepared by the ISC, the IATTC develops resolutions. Mexico and the United States are the two IATTC member countries that currently fish for, and have historically fished for, Pacific bluefin tuna in the EPO. Thus, the IATTC resolutions adopted were intended to apply to these two countries.

The WCPFC has a Northern Committee (WCPFC-NC), which consists of a subset of the WCPFC members and cooperating non-members, that meets annually in advance of the WCPFC meeting to discuss management of designated “northern stocks” (currently North Pacific albacore, Pacific bluefin tuna, and North Pacific swordfish). After reviewing the stock assessments prepared by the ISC, the WCPFC-NC develops the conservation and management measures for northern stocks and makes recommendations to the full Commission for the adoption of measures. Because Pacific bluefin tuna is a “northern stock” in the WCPFC Convention Area, without the recommendation of the Northern Committee, those measures would not be adopted by the WCPFC. The WCPFC's Scientific Committee also has a role in providing advice to the WCPFC with respect to Pacific bluefin tuna; to date its role has been largely limited to reviewing and endorsing the stock assessments prepared by the ISC.

The IATTC and WCPFC first adopted conservation and management measures for Pacific bluefin tuna in 2009, and the measures have been revised five times. The conservation and management measures include harvest limits, size limits, and stock status monitoring plans. In recent years, coordination among both RFMOs has improved in an effort to harmonize conservation and management measures to rebuild the depleted stock. The most relevant resolutions as they relate to recent Pacific bluefin tuna management are detailed below.

In 2012, the IATTC adopted Resolution C-12-09, which set commercial catch limits on Pacific bluefin tuna in the EPO for the first time. This resolution limited catch by all IATTC members to 5,600 mt in 2012 and to 10,000 mt in 2012 and 2013 combined, notwithstanding an allowance of up to 500 mt annually for any member with a historical catch record of Pacific bluefin tuna in the eastern Pacific Ocean (i.e., the United States and Mexico). Resolution C-13-02 applied to 2014 only and, similar to C-12-09, limited catch to 5,000 mt with an allowance of up to 500 mt annually for the United States. Following the advice from the IATTC scientific staff, Resolution C-14-06 further reduced the catch limit by approximately 34 percent—6,000 mt for Mexico and 600 mt for the United States for 2015 and 2016 combined. The IATTC most recently adopted Resolution C-16-08. In accordance with the recommendations of the IATTC's scientific staff, this resolution maintains the same catch limits that were applicable to 2015 and 2016—6,600 mt in the eastern Pacific Ocean during 2017 and 2018 combined. The final rule implementing Resolution C-16-08 was published on April 21, 2017, and had an effective date of May 22, 2017. The most recent regulations represent roughly a 33 percent reduction compared to the average landings from 2010-2014 (5,142 mt). Resolution C-16-08 also outlined next steps in developing a framework for managing the stock in the long-term. This framework included an initial goal of rebuilding the SSB to the median point estimate for 1952-2014 by 2024 with at least 60 percent probability, and further specifies that the IATTC will adopt a second rebuilding target in 2018 to be achieved by 2030. The second Joint IATTC-WCPFC Northern Committee Working Group meeting on Pacific bluefin tuna, that will be held August 28-September 1, 2017, will discuss the development of a rebuilding strategy (second rebuilding target and timeline, etc.) and long-term precautionary management framework (e.g. management objectives, limit and target reference points, and harvest control rules).

The conservation and management measures adopted by the WCPFC have become increasingly restrictive since the initial 2009 measure. In 2009, total fishing effort north of 20° N. was limited to the 2002-2004 annual average level. At this time, an interim management objective—to ensure that the current level of fishing mortality rate was not increased in the western Pacific Ocean—was also established. In 2010, Conservation and Management Measure (referred to as CMM) 2010-04 established catch restrictions in addition to the effort limits described above for 2011 and 2012. A similar measure, CMM 2012-06, was adopted for 2013. In 2014 (CMM 2013-09) all catch of Pacific bluefin tuna less than 30 kilograms (kg) was reduced by 15 percent below the 2002-2004 annual average. In 2015 (CMM 2014-04) the harvest of Pacific bluefin tuna less than 30 kilograms was reduced to 50 percent of the 2002-2004 annual average. The CMM 2014-04 also limits all catches of Pacific bluefin tuna greater than 30 kg to no more than the 2002-2004 annual average level. The measure was amended in 2015 (CMM 2015-04) to include a requirement to adopt an “emergency rule” where additional actions would be triggered if recruitment in 2016 was extremely poor. However, this emergency rule was not agreed to at the 2016 Northern Committee annual meeting. It is expected that it will be discussed again at the Northern Committee meeting in August 2017. Lastly, the measure was amended in 2016 (CMM 2016-04) to allow countries to transfer some of their catch limit for Pacific bluefin tuna less than 30 kg to their limit on fish larger than 30 kg (i.e., increase catch of larger fish and decrease catch of smaller fish); the reverse is not allowed. Unlike the IATTC resolutions for Pacific bluefin tuna, the current WCPFC Pacific bluefin tuna measure does not have an expiration date, although it may be amended or removed. Both the IATTC and WCPFC measures require reporting to promote compliance with the provisions of the measures.

In summary, the WCPFC adopted harvest limits for Pacific bluefin tuna in 2010 and further reduced those limits in 2012, 2014, and 2016. The IATTC adopted harvest limits for Pacific bluefin tuna in 2012 and further reduced those limits in 2014 and 2016. Additionally, both RFMOs addressed concerns about monitoring harvest by adopting monitoring and reporting plans in 2010. Furthermore, the ISC stock assessment predicts that under all scenarios the current harvest limits will allow for rebuilding the abundance of Pacific bluefin tuna to targets by 2030.

After thorough discussion, the SRT members had a range of opinions on the effects of international management on population decline or degradation for Pacific bluefin tuna, ranging from no impact to high impact. The SRT therefore used SEDM to arrive at the conclusion that inadequacy of international management poses a low risk of contributing to population decline or degradation in Pacific bluefin tuna over the short time period (25 years) and a moderate risk over the long time period (100 years).

Domestic fisheries are managed under the MSA. The MSA provides regional fishery management councils with authority to prepare Fishery Management Plans (FMPs) for the conservation and management of fisheries in the U.S. EEZ. The MSA was reauthorized and amended in 1996 by the Sustainable Fisheries Act (SFA) and again in 2006 by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA). Among other modifications, the SFA added requirements that FMPs include measures to rebuild overfished stocks.

The Pacific Fishery Management Council (Pacific Council) has purview over the U.S. West Coast fisheries, which catch the large majority of Pacific bluefin tuna caught by U.S. vessels. The Pacific Council makes recommendations on the implementation of the FMP for U.S. West Coast Fisheries for highly migratory species (HMS FMP) for consideration by NMFS. Additionally, the Pacific Council makes recommendations to NMFS on issues expected to be considered by the IATTC and WCPFC. During its November 2016 meeting, the Pacific Council, in response to a petition that NMFS received by the Center for Biological Diversity, recommended a review of domestic status determination criteria for Pacific bluefin tuna at upcoming meetings in March, June, and September 2017. The domestic status determination criteria, also commonly referred to as reference points, are targets for fishing effort and abundance of the population. At the March 2017 meeting, NMFS provided a report to the Pacific Council that included domestic status determination criteria for Pacific bluefin tuna.

The Pacific Council, in response to NMFS' 2013 determination that the Pacific bluefin tuna stock was overfished and subject to overfishing (78 FR 41033; July 9, 2013), recommended reducing the bag and possession limits for Pacific bluefin tuna in the recreational fishery. The Pacific Council recommended reducing the daily bag limit from 10 to 2 fish and the possession limit from 30 to 6 fish. Based on analyses conducted at the SWFSC, this was projected to reduce landings by 10.4 percent in U.S. waters and 19.4 percent in U.S. and Mexican waters combined (Stohs, 2016). We published a final rule in 2015 implementing the bag limit of two fish per day and possession limit of six fish per trip (80 FR 44887, July 28, 2015).

NMFS coordinates closely with the California Department of Fish and Wildlife (CDFW) to monitor the Pacific bluefin tuna fishery. The State of California requires that fish landed in California have a corresponding receipt, which indicates quantity landed. Together, NMFS and CDFW monitor landings to ensure catch limits agreed to by the IATTC are not exceeded.

In summary, NMFS initially set limits for commercial and recreational harvest limits in 2010 and further reduced those limits in 2012, 2014, and 2016. The CDFW monitors and reports commercial and recreation harvest to NMFS. When U.S. commercial catch limits are met, NMFS closes the fishery. Furthermore, the ISC stock assessment predicts that the current harvest limits will allow for stable or increasing Pacific bluefin tuna SSB. We expect the current harvest limits to be effective at reducing the impact of domestic commercial and recreational fisheries, and we will continue to monitor the effectiveness of those regulations. We find that U.S. domestic management of commercial and recreational fishing poses no or low risk of contributing to population decline or degradation in Pacific bluefin tuna.

The other factors affecting the continued existence of Pacific bluefin tuna that we analyzed are climate change, radiation contamination from Fukushima, and the risks of low abundance levels inherent in small populations.

Over the next several decades climate change models predict changes to many atmospheric and oceanographic conditions. The SRT considered these predictions in light of the best available information. The SRT felt that there were three physical factors resulting from climate change predictions that would have the most impact on Pacific bluefin tuna: Rising sea surface temperatures (SST), increased ocean acidification, and decreases in dissolved oxygen.

Rising SST may affect Pacific bluefin tuna spawning and larval development, prey availability, and trans-pacific migration habits. Pacific bluefin tuna spawning has only been recorded in two locations: Near the Philippines and Ryukyu Islands in spring, and in the Sea of Japan during summer (Okochi et al., 2016; Shimose & Farley 2016). Spawning in Pacific bluefin tuna occurs in comparatively warm waters, and so larvae are found within a relatively narrow temperature range (23.5-29.5 °C) compared to adults (Kimura et al., 2010; Tanaka & Suzuki 2016).

Currently, SSTs within the theoretically suitable range for larvae are present near the Ryukyu Islands between April and June, and in the Sea of Japan during July and August (Caiyun & Ge 2006; Seo et al., 2014; Tanaka & Suzuki 2016). Warming of 1.5-3 °C in the region may shift suitable times to earlier in the year and/or places for spawning northwards. Under the most pessimistic (“business as usual”) CO2 emission and concentration scenarios, SSTs in the North Pacific are likely to increase substantially by the end of the 21st century (Hazen et al., 2013; Woodworth-Jefcoats et al., 2016). However, there is considerable spatial heterogeneity in these projections. The southern Pacific bluefin tuna spawning area is projected to warm 1.5-2 °C by the end of the 21st century, with particularly weak warming in the Kuroshio Current region. In contrast, the Sea of Japan may warm by more than 3 °C compared to recent historical conditions (Seo et al., 2014; Scott et al., 2016; Woodworth-Jefcoats et al., 2016).

The precise mechanisms by which warming waters will affect Pacific bluefin tuna larvae are not entirely clear. Kimura et al. (2010) assumed that the lethal temperature for larvae was 29.5 °C. However, Muhling et al. (2010) and Tilley et al. (2016) both reported larvae of the closely-related Atlantic bluefin tuna in the Gulf of Mexico at SSTs of between 29.5 and 30.0 °C. In addition, tropical tuna larvae can tolerate water temperatures of well above 30 °C (Sanchez-Velasco et al., 1999; Wexler et al., 2011; Muhling et al., 2017). Pacific bluefin tuna larvae may have fundamentally different physiology from that of these other species, or it is possible that the observed upper temperature limit for Pacific bluefin tuna larvae in the field is more a product of the time and place of spawning, rather than an upper physiological limit.

Similar to other tuna species, larval Pacific bluefin tuna appear to have highly specialized and selective diets (Uotani et al., 1990; Llopiz & Hobday 2015). Smaller larvae rely primarily on copepod nauplii, before moving to cladocerans, copepods such as Farranula and Corycaeus spp. and other zooplankton. In the Sea of Japan region, the occurrence of potentially favorable prey organisms for larval Pacific bluefin tuna appears to be associated with stable post-bloom conditions during summer (Chiba & Saino, 2003). This suggests a potential phenological match to Pacific bluefin tuna spawning. Environmentally-driven changes in the evolution of this zooplankton community, or the timing of spawning, could thus affect the temporal match between larvae and their prey. Woodworth-Jefcoats et al. (2016) project a 10-20 percent decrease in overall zooplankton density in the western Pacific Ocean, but how this may relate to larval Pacific bluefin tuna prey availability is not yet known.

Climate change may affect the foraging habitats of Pacific bluefin tuna. Adult and older juvenile (>1 year) Pacific bluefin tuna disperse from the spawning grounds in the western Pacific and older juveniles can make extensive migrations, using much of the temperate North Pacific. An unknown proportion of 1-2 year old fish migrate to foraging grounds in the eastern North Pacific (California Current LME) and typically remain and forage in this region for several years (Bayliff et al., 1991; Bayliff 1994; Rooker et al., 2001; Kitagawa et al., 2007; Boustany et al., 2010; Block et al., 2011; Madigan et al., 2013; Whitlock et al., 2015).

Sea surface temperatures in the California Current are expected to increase up to 1.5-2 °C by the end of the 21st century (Hazen et al., 2013; Woodworth-Jefcoats et al., 2016). Pacific bluefin tuna tagged in the California Current demonstrate a seasonal north-south migration between Baja California (10° N.) and near the California-Oregon border (42° N.) (Boustany et al., 2010; Block et al., 2011; Whitlock et al., 2015), although some fish travel as far north as Washington State. The seasonal migration follows local peaks in productivity (as measured by surface chlorophyll), such that fish move northward from Baja California after the local productivity peak in late spring to summer (Boustany et al., 2010; Block et al., 2011). Uniform warming in this region could impact Pacific bluefin tuna distribution by moving their optimal temperature range (and thermal tolerance) northward. However, it is unlikely that rising temperatures will be a limiting factor for Pacific bluefin tuna, as appropriate thermal habitat will likely remain available.

The high productivity and biodiversity of the California Current is driven largely by seasonal coastal upwelling. Although there is considerable uncertainty on how climate change will impact coastal upwelling, basic principles indicate a potential for upwelling intensification (Bakun 1990). Bakun's hypothesis suggested that the rate of heating over land would be enhanced relative to that over the ocean, resulting in a stronger cross-shore pressure gradient and a proportional increase in alongshore winds and resultant upwelling (Bakun et al., 2015; Bograd et al., 2017). A recent publication (Sydeman et al., 2014) described a meta-analysis of historical studies on the Bakun hypothesis and found general support for upwelling intensification, but with significant spatial (latitudinal) and temporal (intraseasonal) variability between and within the eastern boundary current systems. In the California Current, a majority of analyses indicated increased upwelling intensity during the summer (peak) months, though this signal was most pronounced in the northern California Current (Sydeman et al., 2014).

To date, global climate models have generally been too coarse to adequately resolve coastal upwelling processes (Stock et al., 2010), although recent studies analyzing ensemble model output have found general support for projected increases in coastal upwelling in the northern portions of the eastern boundary current systems (Wang et al., 2015; Rykaczewski et al., 2015). Using an ensemble of more than 20 global climate models from the IPPC's Fifth Assessment Report, Rykaczewski et al. (2015) found evidence of a small projected increase in upwelling intensity in the California Current north of 40° N. latitude and a decrease in upwelling intensity to the south of this range by the end of the 21st century under RCP 8.5. Pacific bluefin tuna are more commonly found to the south of the 40° N. latitude mark. Perhaps more importantly, Rykaczewski et al. (2015) described projected changes in the phenology of coastal upwelling, with an earlier transition to positive upwelling within the peak upwelling domain. Overall, these results suggest a poleward displacement of peak upwelling and potential lengthening of the upwelling season in the California Current, even if upwelling intensity may decrease. The phenological changes in coastal upwelling may be most important, as these may lead to spatial and temporal mismatches between Pacific bluefin tuna and their preferred prey (Cushing 1990; Edwards and Richardson 2004; Bakun et al., 2015). However, the bluefin tuna's highly migratory nature and plasticity in migratory patterns may help to mitigate shifts in phenology.

The information directly relating to food web alterations that may impact Pacific bluefin tuna is scarce. While changes to upwelling dynamics in foraging areas have been examined, it is still relatively speculative, and literature on the potential impacts of the projected changes is limited. Given their trophic position as an apex predator, and the fact that Pacific bluefin tuna are opportunistic feeders that can change their preferred diet from year to year, alterations to the food web may have less impact on Pacific bluefin tuna than on other organisms that are reliant on specific food sources.

Climate change may affect the Pacific bluefin tuna's migratory pathways. Pacific bluefin tuna undergo trans-Pacific migrations, in both directions, between the western Pacific spawning grounds and eastern Pacific foraging grounds (Boustany et al., 2010; Block et al., 2011). For both migrations, Pacific bluefin tuna remain within a relatively narrow latitudinal band (30-40° N.) within the North Pacific Transition Zone (NPTZ), which is characterized by generally temperate conditions. This region, marking the boundary between the oligotrophic subtropical and more productive subarctic gyres, is demarcated by the seasonally-migrating Transition Zone Chlorophyll Front (TZCF; Polovina et al., 2001; Bograd et al., 2004). Climate-driven changes in the position of the TZCF, and in the thermal environment and productivity within this region, could impact the migratory phase of the Pacific bluefin tuna life cycle.

Under RCP 8.5, SSTs in the NPTZ are expected to increase by 2-3 °C by the end of the 21st century (Woodworth-Jefcoats et al., 2016), with the highest increases on the western side. The increased temperatures within the NPTZ are part of the broader projected changes in the central North Pacific Ocean, including an expansion of the oligotrophic Subtropical Gyre, a northward displacement of the transition zone, and an overall decline in productivity (Polovina et al., 2011). The impacts of these changes on species that make extensive use of the NPTZ could be substantial, resulting in a gain or loss of core habitat, distributional shifts, and regional changes in biodiversity (Hazen et al., 2013). Using habitat models based on a multi-species biologging dataset, and a global climate model run under “business-as-usual” forcing (the A2 CO2 emission scenario from the IPCC's fourth assessment report), Hazen et al. (2013) found a substantial loss of core habitat for a number of highly migratory species, and small gains in viable habitat for other species, including Pacific bluefin tuna. Although the net change in total potential Pacific bluefin tuna core habitat was positive, the projected physical changes in the bluefin tuna's migratory pathway could negatively impact them. The northward displacement of the NPTZ and TZCF could lead to longer migrations requiring greater energy expenditure. The generally lower productivity of the region could also diminish the abundance or quality of the Pacific bluefin tuna prey base.

A recent study of projected climate change in the North Pacific that used an ensemble of 11 climate models, including measures of primary and secondary production, found that increasing temperatures could alter the spatial distribution of tuna and billfish species across the North Pacific (Woodworth-Jefcoats et al., 2016). As with Hazen et al. (2013), this study found species richness increasing to the north following the northward displacement of the NPTZ. They also estimated a 2-5 percent per decade decline in overall carrying capacity for commercially important tuna and billfish species, driven by warming waters and a basin-scale decline in zooplankton densities (Woodworth-Jefcoats et al., 2016). While there is still substantial uncertainty inherent in these climate models, we can say with some confidence that the central North Pacific, which encompasses a key conduit between Pacific bluefin tuna spawning and foraging habitat, is likely to become warmer and less productive through the 21st century.

As CO2 uptake by the oceans increases, ocean pH will continue to decrease (Feely et al., 2009), with declines of between 0.2 and 0.4 expected in the western North Pacific by 2100 under the Intergovernmental Panel on Climate Change's Representative Concentration Pathway (RCP) 8.5 (Ciais et al., 2013). RCP 8.5 is a high emission scenario, which assumes that radiative forcing due to greenhouse gas emissions will continue to increase strongly throughout the 21st century (Riahi et al., 2011). Rearing experiments on larval yellowfin tuna suggest that ocean acidification may result in longer hatch times, sub-lethal organ damage, and decreased growth and survival (Bromhead et al., 2014; Frommel et al., 2016). Other studies on coral reef fish larvae show that acidification can impair sensory abilities of larvae, and in combination with warming temperatures, can negatively affect metabolic scope (Munday et al., 2009a,b; Dixson et al., 2010; Simpson et al., 2011). Surface ocean pH on Pacific bluefin tuna spawning grounds is currently higher than that in the broader North Pacific (8.1-8.2) (Feely et al., 2009). How this may affect the ability of Pacific bluefin tuna larvae (in particular) to adapt to ocean acidification is unknown. Recent studies have shown that future adaptation to rising CO2 and acidification could be facilitated by individual genetic variability (Schunter et al., 2017). In addition, transgenerational plasticity may allow surprisingly rapid adaptation across generations (Rummer & Munday 2017). However, these studies examined small coral reef fish species, so results may not transfer to larger, highly migratory species such as Pacific bluefin tuna. As well as incurring direct effects on Pacific bluefin tuna, ocean acidification is also likely to change the prey base available to all life stages of this species. Different organisms vary substantially in their sensitivity to the combined effects of acidification and warming (Byrne 2011). A shift in the prey assemblage towards organisms more tolerant to acidification is therefore likely in the future.

Current projections estimate a future decline in dissolved oxygen of 3-6 percent by 2100 under RCP 8.5 (Bindoff et al., 2013; Ciais et al., 2013). This may be most relevant for spawning-sized adult Pacific bluefin tuna, which may be subject to greater metabolic stress on spawning grounds. While some studies exist on the effects of temperature on metabolic rates, cardiac function and specific dynamic action in juvenile Pacific bluefin tuna (e.g. Blank et al., 2004; 2007; Clark et al., 2008; 2010; 2013; Whitlock et al., 2015), there are no published studies on larger adults, or on larvae. While future warming and decreases in dissolved oxygen may reduce the suitability of some parts of the Pacific bluefin tuna range (e.g. Muhling et al., 2016), likely biological responses to this are not yet known.

Another factor to include in considerations of climate change impacts is biogeochemical changes. Driven by upper ocean warming, changes in source waters, enhanced stratification, and reduced mixing, the dissolved oxygen content of mid-depth oceanic waters is expected to decline (Keeling et al., 2010). This effect is especially important in the eastern Pacific, where the Oxygen Minimum Zone (OMZ) shoals to depths well within the vertical habitat of Pacific bluefin tuna and other highly migratory species and, in particular, their prey (Stramma et al., 2010; Moffit et al., 2015). The observed trend of declining oxygen levels in the Southern California Bight (Bograd et al., 2008; McClatchie et al., 2010; Bograd et al., 2015), combined with an increase in the frequency and severity of hypoxic events along the U.S. West Coast (Chan et al., 2008; Keller et al., 2010; Booth et al., 2012), suggests that declining oxygen content could drive ecosystem change. Specifically, the vertical compression of viable habitat for some benthic and pelagic species could alter the available prey base for Pacific bluefin tuna. Given that Pacific bluefin tuna are opportunistic feeders, they could have resilience to these climate-driven changes in their prey base.

The effects of increasing hypoxia on marine fauna in the California Current may be magnified by ocean acidification. Ekstrom et al. (2015) predicted the West Coast is highly vulnerable to ecological impacts of ocean acidification due to reduction in aragonite saturation state exacerbated by coastal upwelling of “corrosive,” lower pH waters (Feely et al., 2008). The most acute impacts would be on calcifying organisms (some marine invertebrates and pteropods), which are not generally part of the adult Pacific bluefin tuna diet. While direct impacts of ocean acidification on Pacific bluefin tuna may be minimal within their eastern Pacific foraging grounds, some common Pacific bluefin tuna prey do rely on calcifying organisms (Fabry et al., 2008).

We find that ocean acidification and changes in dissolved oxygen content due to climate change pose a very low risk to the decline or degradation of the Pacific bluefin tuna on the short-term time scale (25 years), and low to moderate threat on the long-time scale (100 years). The reasoning behind this decision for acidification centered primarily on the disconnect between Pacific bluefin tuna and the lower trophic level prey which would be directly affected by acidification as well as by the lack of information on direct impacts on acidification on pelagic fish. Conclusions by the SRT members on the rising SST due to climate change required SEDM, as the range of values assigned by each SRT member was large. Following the SEDM, the SRT concluded that SST rise poses a low risk of contributing to population decline or degradation in PBF over the short (25 year) and long (100 year) time frames. This decision was reached primarily due to the highly migratory nature of Pacific bluefin tuna; despite likely latitudinal shifts in preferred habitat, it would take little effort for Pacific bluefin tuna to shift their movements along with the changing conditions.

On 11 March, 2011, the Tōhoku megathrust earthquake at magnitude 9.1 produced a devastating tsunami that hit the Pacific coast of Japan. As a result of the earthquake, the Fukushima Daiichi Nuclear Power Plant was compromised, releasing radionuclides directly into the adjacent sea. The result was a 1- to 2-week pulse of emissions of the caesium radioisotopes Caesium-134 and Caesium-137. These isotopes were biochemically available to organisms in direct contact with the contaminated water (Oozeki et al., 2017).

Madigan et al. (2012) reported on the presence of Caesium-134 and Caesium-137 in Pacific bluefin tuna caught in California in ratios that strongly suggested uptake as a result of the Fukushima Daiichi accident. The results indicated that highly migratory species can be vectors for the trans-Pacific movement of radionuclides. Importantly, the study highlighted that while the radiocaesium present in the Pacific bluefin tuna analyzed was directly traceable to the Fukushima accident, the concentrations were 30 times lower than background levels of naturally occurring radioisotopes such as potassium-40. In addition, Madigan et al. (2012) estimated the dose to human consumers of fish from Fukushima derived Caesium-137 was at 0.5 percent of the dose from Polonium-210, a natural decay product of Uranium-238, which is ubiquitously present and in constant concentrations globally.

Fisher et al. (2013) further evaluated the dosage and associated risks to marine organisms and humans (by consumption of contaminated seafood) of the caesium radioisotopes associated with the Fukushima Daiichi accident. They confirmed that dosage of radioisotopes from consuming seafood were dominated by naturally occurring radionuclides and that those stemming directly from Fukushima derived radiocaesium were three to four orders of magnitude below doses from these natural radionuclides. Doses to marine organisms were two orders of magnitude lower than the lowest benchmark protection level for ecosystem health (ICRP 2008). The study concluded that even on the date at which the highest exposure levels may have been reached, dosages were very unlikely to have exceeded reference levels. This indicates that the amount of Fukushima derived radionuclides is not cause for concern with regard to the potential harm to the organisms themselves.

We find that Fukushima associated radiation poses no risk of contributing to population decline or degradation in Pacific bluefin tuna. This was based largely on the absence of empirical evidence showing negative effects of Fukushima derived radiation on Pacific bluefin tuna.

Small populations face a number of inherent risks. These risks are tied to survival and reproduction (e.g. Allee or other depensation effects) via three mechanisms: Ecological (e.g., mate limitation, cooperative defense, cooperative feeding, and environmental conditioning), genetic (e.g., inbreeding and genetic drift), and demographic stochasticity (i.e., individual variability in survival and recruitment) (Berec et al., 2007). The actual number at which populations would be considered critically low and at risk varies depending on the species and the risk being considered. While the Pacific bluefin tuna is estimated to contain at least 1.6 million individuals, of which more than 140,000 are reproductively capable, the SRT deemed it prudent to examine the factors above that are traditionally used to evaluate the impacts of relatively low population numbers. In the paragraphs that follow we discuss how small population size can affect reproduction, demographic stochasticity, genetics, and how it can be affected by stochastic and catastrophic events, and Allee effects.

In small populations, individuals may have difficulty finding a mate. However, the probability of finding a mate depends largely on density on the spawning grounds rather than absolute abundance. Pacific bluefin tuna are a schooling species and individual Pacific bluefin tuna are not randomly distributed throughout their range. They also exhibit regular seasonal migration patterns that include aggregating at two separate spawning grounds (Kitigawa et al., 2010). This schooling and aggregation behavior serves to increase their local density and the probability of individuals finding a mate. This mating strategy could reduce the effects of small population size on finding mates over other strategies that do not concentrate individuals. It is unknown whether spawning behavior is triggered by environmental conditions or densities of tuna. If density of adults triggers spawning, then reproduction could be affected by high levels of depletion. However, the abundance of Pacific bluefin tuna has reached similar lows in the past and rebounded. The number of adult Pacific bluefin tuna is currently estimated to be 2.6 percent of its unfished SSB. The number of adult Pacific bluefin tuna reached a similar low in 1984 of 1.8 percent and rebounded in the 1990s to 9.6 percent, the second highest level since 1952.

Another concern with small populations is demographic stochasticity. Demographic stochasticity refers to the variability of annual population change arising from random birth and death events at the individual level. When populations are very small (e.g., <100 individuals), chance demographic events can have a large impact on the population. Species with low mean annual survival rates are generally at greater population risk from demographic stochasticity than those that are long-lived and have high mean annual survival rates. In other words, species that are long-lived and have high annual survival rates have lower “safe” abundance thresholds, above which the risk of extinction due to chance demographic processes becomes negligible. Even though the percentage of adult Pacific bluefin tuna relative to historical levels is low, they still number in the hundreds of thousands. In addition, the total population size in 2014 as estimated by the 2016 ISC stock assessment was 1,625,837. The high number of individuals, both mature and immature, should therefore counteract a particular year with low survivorship.

Small populations may also face Allee effects. If a population is critically small in size, Allee effects can act upon genetic diversity to reduce the prevalence of beneficial alleles through genetic drift. This may lower the population's fitness by reducing adaptive potential and increasing the accumulation of deleterious alleles due to increased levels of inbreeding. Population genetic theory typically sets a threshold of 50 individuals (i.e., 25 males, 25 females) below which irreversible loss of genetic diversity is likely to occur in the near future. This value, however, is not necessarily based upon the number of individuals present in the population (i.e., census population size, NC) but rather on the effective population size (NE), which is linked to the overall genetic diversity in the population and is typically less than NC. In extreme cases NE may be much (e.g. 10-10,000 times) smaller, typically for species that experience high variance in reproductive success (e.g., sweepstakes recruitment events). NE may also be reduced in populations that deviate from a 1:1 sex ratio and from species that have suffered a genetic bottleneck.

With respect to considerations of NE in Pacific bluefin tuna, the following points are relevant. Although there are no available data for nuclear DNA diversity in Pacific bluefin tuna, the relatively high number of unique mitochondrial DNA haplotypes (Tseng et al., 2014) can be used as a proxy for evidence of high levels of overall genetic diversity currently within the population. With two separate spawning grounds, and adult numbers remaining in the hundreds of thousands, genetic diversity is expected to still be at high levels with little chance for inbreeding, given that billions of gametes combine in concentrated spawning events.

Animals that are highly mobile with a large range are less susceptible to stochastic and catastrophic events (such as oil spills) than those that occur in concentrated areas across life history stages. Pacific bluefin tuna are likely to be resilient to catastrophic and stochastic events for the following reasons: (1) They are highly migratory, (2) there is a large degree of spatial separation between life history stages, (3) there are two separated spawning areas, and (4) adults reproduce over many years such that poor recruitment even over a series of years will not result in reproductive collapse. As long as this spatial arrangement persists and poor recruitment years do not exceed the reproductive age span for the species, Pacific bluefin tuna should be resilient to both stochastic and catastrophic events.

Although Pacific bluefin tuna are resilient to many of the risks that small populations face, there is increasing evidence for a reduction in population growth rate for marine fishes that have been fished to densities below those expected from natural fluctuations (Hutchings 2000, 2001). These studies focus on failure to recover at expected rates. A far more serious issue is not just reducing population growth but reducing it to the point that populations decrease (death rates exceed recruitment). Unfortunately, the reviews of marine fish stocks do not make a distinction between these two important categories of depensation: Reduced but neutral or positive growth versus negative growth. Many of the cases reviewed suggested depensatory effects for populations reduced to relatively low levels (0.2 to 0.5 SSBmsy) that would increase time to recovery, but no mention was made of declining towards extinction. However, these cases did not represent the extent of reduction observed in Pacific bluefin tuna (0.14 SSBmsy). Thus, this case falls outside that where recovery has been observed in other marine fishes and thus there remains considerable uncertainty as to how the species will respond to reductions in fishing pressure.

Hutchings et al. (2012) also show that there is no positive relationship between per capita population growth rate and fecundity in a review of 233 populations of teleosts. Thus, the prior confidence that high fecundity provides more resilience to population reduction and ability to quickly recover should be abandoned. These findings, although not providing examples that marine fishes exploited to low levels will decline towards extinction, suggest that at a minimum such populations may not recover quickly. However, Pacific bluefin tuna recently showed an instance of positive growth from a population level similar to the most recent stock assessment. This suggests potential for recovery at low population levels. However, the conditions needed to allow positive growth remain uncertain.

We find that small population concerns pose low risk of contributing to population decline or degradation in Pacific bluefin tuna over both the 25- and 100-year time scales, though with low certainty. This was largely due to the estimated population size of more than 1.6 million individuals, of which at least 140,000 are reproductively capable. This, coupled with previous evidence of recovery from similarly low numbers and newly implemented harvest regulations, strongly suggests that small population concerns are not particularly serious in Pacific bluefin tuna.

As noted previously, the SRT conducted its analysis in a 3-step progressive process. First, the SRT evaluated the risk of 25 different threats (covering all of the ESA section 4(a)(1) categories) contributing to a decline or degradation of Pacific bluefin tuna. The second step was to evaluate the extinction risk in each of the 4(a)(1) categories. Finally, they performed an overall extinction risk analysis over two timeframes—25 years and 100 years.

In step one, the evaluation of the risk of individual threats contributing to a decline or degradation of Pacific bluefin tuna considered how these threats have affected and how they are expected to continue to affect the species. The threats were evaluated in light of the vulnerability of and exposure to the threat, and the biological response. This evaluation of individual threats and the potential demographic risk they pose forms the basis of understanding used during the extinction risk analysis to inform the overall assessment of extinction risk.

Within each threat category, individual threats have not only different magnitudes of influence on the overall risk to the species (weights) but also different degrees of certainty. The overall threat within a category is cumulative across these individual threats. Thus, the overall threat is no less than that for the individual threat with the highest influence but may be greater as the threats are taken together. For example, some of the individual threats rated as “moderate” may result in an overall threat for that category of at least “moderate” but potentially “high.” When evaluating the overall threat, individual team members considered all threats taken together and performed a mental calculation, weighting the threats according to their expertise using the definitions below.

Each team member was asked to record his or her confidence in their overall scoring for that category. If, for example, the scoring for the overall threat confidence was primarily a function of a single threat and that threat had a high level of certainty, then they would likely have a high level of confidence in the overall confidence score. Alternatively, the overall confidence score could be reduced due to a combination of threats, some of which the team members had a low level of certainty about and consequently communicated this lower overall level of confidence with a corresponding score (using the definitions below). Generally, the level of confidence will be most influenced by the level of certainty in the threats of highest severity. The level of confidence for threats with no to low severity within a category that contains moderate to high severity threats will not be important to the overall level of confidence.

The level of severity is defined as the level of risk of this threat category contributing to the decline or degradation of the species over each time frame (over the next 25 years or over the next 100 years). Specific rankings for severity are: (1) High: The threat category is likely to eliminate or seriously degrade the species; (2) moderate: The threat category is likely to moderately degrade the species; (3) low: The threat category is likely to only slightly impair the species; and (4) none: The threat category is not likely to impact the species.

The level of confidence is defined as the level of confidence that the threat category is affecting, or is likely to affect, the species over the time frame considered. Specific rankings for confidence are: (1) High: There is a high degree of confidence to support the conclusion that this threat category is affecting, or is likely to affect, the species with the severity ascribed over the time frame considered; (2) moderate: There is a moderate degree of confidence to support the conclusion that this threat category is affecting, or is likely to affect, the species with the severity ascribed over the time frame considered; (3) low: There is a low degree of confidence to support the conclusion that this threat category is affecting, or is likely to affect, the species with the severity ascribed over the time frame considered; and (4) none: There is no confidence to support the conclusion that this threat category is affecting, or is likely to affect, the species with the severity ascribed over the time frame considered.

Based on the best available information and the SRT's SEDM analysis, we find that overutilization, particularly by commercial fishing activities, poses a moderate risk of decline or degradation of the species over both the 25 and 100-year time scales. While the degree of certainty for this risk assessment was moderate for the 25-year time frame, it was low for the 100-year time frame. This largely reflects the inability to accurately predict trends in both population size and catch over the longer time frame. In addition, management regimes may shift in either direction in response to the population trends at the time.

Over the short and long time frames, we find that habitat destruction, disease, and predation are not likely to pose a risk to the extinction of the Pacific bluefin tuna. Among the specific threats in the Habitat Destruction category, water pollution was ranked the highest (mean severity score 1.5). This was largely due to the fact that any degradation to Pacific bluefin tuna by water pollution is a passive event. That is, behavioral avoidance might not be possible, whereas other specific threats involved factors where active avoidance would be possible.

We also find that based on the best available information and the SRT's SEDM analysis, the inadequacy of existing regulatory mechanisms poses a low risk of decline or degradation to the species over both the 25- and 100-year time scales, given the stable or upward trends of future projected SSB over the short time scale from various harvest scenarios in the 2016 ISC stock assessment. The confidence levels were moderate for the 25-year time frame and low for the 100-year time frame.

Lastly, we find that other natural or manmade factors, which included climate change and small population concerns, pose a low risk of decline or degradation to the species over the 25-year time frame and moderate risk over the 100-year time frame.

As described previously, following the evaluation of the risk of 25 specific threats contributing to the decline or degradation of Pacific bluefin tuna, the SRT then conducted step 2 and step 3 to perform an extinction risk analysis. In step two the SRT used SEDM to evaluate the contribution of each section 4(a)(1) factor to extinction risk. Finally, in step 3 the SRT performed an overall extinction risk analysis over two timeframes—25 years and 100 years.

This final risk assessment considered the threats, the results from the recent stock assessment, the species life history, and historical trends. After considering all factors, team members were asked to distribute 100 plausibility points into one of three risk categories for the short term and long term time frames. The short-term time frame was 25 years and the long-term time frame was 100 years.

The SRT defined the extinction risk categories as low, moderate, and high. The species is deemed to be at low risk of extinction if at least one of the following conditions is met: (1) The species has high abundance or productivity; (2) There are stable or increasing trends in abundance; and (3) The distributional characteristics of the species are such that they allow resiliency to catastrophes or environmental changes. The species is deemed to be at moderate risk of extinction if it is not at high risk and at least one of the following conditions is met: (1) There are unstable or decreasing trends in abundance or productivity which are substantial relative to overall population size; (2) There have been reductions in genetic diversity; or (3) The distributional characteristics of the species are such that they make the species vulnerable to catastrophes or environmental changes. Finally, the species is deemed to be at high risk of extinction if at least one of the following conditions is met: (1) The abundance of the species is such that depensatory effects are plausible; (2) There are declining trends in abundance that are substantial relative to overall population size; (3) There is low and decreasing genetic diversity; (4) There are current or predicted environmental changes that may strongly and negatively affect a life history stage for a significant period of time; or (5) The species has distributional characteristics that result in vulnerability to catastrophes or environmental changes.

The SRT members distributed their plausibility points across all three risk categories, with most members placing their points in the low and moderate risk categories. Over the 25-year time frame, a large proportion of plausibility points were assigned to the low and moderate risk by some team members. Over the 100-year time frame, more points were assigned to the moderate risk category by all members and a few members assigned points to the high risk category. After the scores were recorded, the SRT calculated the average number of points for each risk category under both the 25 and 100-year timeframes. For both timeframes, the greatest number of points were in the low risk category. The average number of points for the low risk category was 68 for the 25-year timeframe and 51 for the 100-year timeframe.

There are a number of factors that contributed to the low ranking of the overall extinction risk over both the 25 and 100-year time frames. The large number of mature individuals, while small relative to the theoretical, model-derived unfished population, coupled with the total estimated population size, was deemed sufficiently large for Pacific bluefin tuna to avoid small population effects. Harvest regulations have been adopted by member nations to reduce landings and rebuild the population, with all model results from the ISC analysis showing stable or increasing trends under current management measures. Also, the SRT noted that over the past 40 years the SSB has been low relative to the theoretical, model-derived unfished population (less than 10 percent of unfished), and it has increased before. While the SRT agreed that climate change has the potential to negatively impact the population, many members of the team felt that the Pacific bluefin tuna's broad distribution across habitat, vagile nature, and generalist foraging strategy were mitigating factors in terms of extinction risk.

After evaluating the extinction risk SEDM analysis conducted by the SRT over the 25-year and 100-year timeframes, we considered the overall extinction risk categories described below:

High risk: A species or DPS with a high risk of extinction is at or near a level of abundance, productivity, spatial structure, and/or diversity that places its continued persistence in question. The demographics of a species or DPS at such a high level of risk may be highly uncertain and strongly influenced by stochastic or depensatory processes. Similarly, a species or DPS may be at high risk of extinction if it faces clear and present threats (e.g., confinement to a small geographic area; imminent destruction, modification, or curtailment of its habitat; or disease epidemic) that are likely to create present and substantial demographic risks.

Moderate risk: A species or DPS is at moderate risk of extinction if it is on a trajectory that puts it at a high level of extinction risk in the foreseeable future (see description of “High risk” above). A species or DPS may be at moderate risk of extinction due to projected threats or declining trends in abundance, productivity, spatial structure, or diversity. The appropriate time horizon for evaluating whether a species or DPS is more likely than not to be at high risk in the foreseeable future depends on various case- and species-specific factors. For example, the time horizon may reflect certain life history characteristics (e.g., long generation time or late age-at-maturity) and may also reflect the time frame or rate over which identified threats are likely to impact the biological status of the species or DPS (e.g., the rate of disease spread). (The appropriate time horizon is not limited to the period that status can be quantitatively modeled or predicted within predetermined limits of statistical confidence. The biologist (or Team) should, to the extent possible, clearly specify the time horizon over which it has confidence in evaluating moderate risk.)

Low risk: A species or DPS is at low risk of extinction if it is not at moderate or high level of extinction risk (see “Moderate risk” and “High risk” above). A species or DPS may be at low risk of extinction if it is not facing threats that result in declining trends in abundance, productivity, spatial structure, or diversity. A species or DPS at low risk of extinction is likely to show stable or increasing trends in abundance and productivity with connected, diverse populations.

The SRT evaluation of extinction risk placed the majority of distributed points in the low risk category for both the 25-year and 100-year timeframes. The SRT members explained their assessment of low risk over those timeframes recognizing that the large number of mature individuals, while small relative to the theoretical, model-derived unfished population, coupled with the total estimated population size, was deemed sufficiently large for Pacific bluefin tuna to avoid small population effects. Harvest regulations have been adopted by member nations to reduce landings and rebuild the population, with all model results from the ISC stock assessment analysis (ISC 2016) showing stable or increasing trends under current management measures. Also, the SRT noted that over the past 40 years the SSB has been low relative to the theoretical, model-derived unfished population (less than 10 percent of unfished), and it has increased before. While the SRT agreed that climate change has the potential to negatively impact the population, many members of the team felt that the Pacific bluefin tuna's broad distribution across habitat, its vagile nature, and its generalist foraging strategy were mitigating factors in terms of extinction risk.

Based upon the expert opinion of the SRT and for the reasons described above, we determine that the overall extinction risk to Pacific bluefin tuna is most accurately characterized by the description of the low risk category as noted above.

Section 4(b)(1) of the ESA requires that NMFS make listing determinations based solely on the best scientific and commercial data available after conducting a review of the status of the species and taking into account those efforts, if any, being made by any state or foreign nation, or political subdivisions thereof, to protect and conserve the species. We are not aware of additional conservation efforts being made by any state or foreign nation to protect and conserve the species other than the fishery management agreements already considered, thus no additional measures were evaluated in this finding.

As the definitions of “endangered species” and “threatened species” make clear, the determination of extinction risk can be based on either assessment of the rangewide status of the species, or the status of the species in a “significant portion of its range” (SPR). Because we determined that the Pacific bluefin tuna is at low risk of extinction throughout its range, the species does not warrant listing based on its rangewide status. Next, we needed to determine whether the species is threatened or endangered in a significant portion of its range. According to the SPR Policy (79 FR 37577; July 1, 2014), if a species is found to be endangered or threatened in a significant portion of its range, the entire species is listed as endangered or threatened, respectively, and the ESA's protections apply to all individuals of the species wherever found.

On March 29, 2017, the Arizona District Court in Center for Biological Diversity, et al., v. Zinke, et al., 4:14-cv-02506-RM (D. Ariz.), a case brought against the U.S. Fish and Wildlife Service (FWS), remanded and vacated the joint FWS/NMFS SPR Policy after concluding that the policy's definition of “significant” was invalid. NMFS is not a party to the litigation. On April 26, 2017, the FWS filed a Motion to Alter or Amend the Court's Judgment, which is pending. In the meantime, we based our SPR analysis on our joint SPR Policy, as discussed below.

The SPR Policy sets out the following three components:

(1) Significant: A portion of the range of a species is “significant” if the species is not currently endangered or threatened throughout its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range.

(2) The range of a species is considered to be the general geographical area within which that species can be found at the time NMFS makes any particular status determination. This range includes those areas used throughout all or part of the species' life cycle, even if they are not used regularly (e.g., seasonal habitats). Lost historical range is relevant to the analysis of the status of the species, but it cannot constitute a SPR.

(3) If the species is endangered or threatened throughout a significant portion of its range, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

When we conduct a SPR analysis, we first identify any portions of the range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that are not reasonably likely to be of relatively greater biological significance, or in which a species may not be endangered or threatened. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is endangered or threatened throughout a SPR, rather, it is a step in determining whether a more detailed analysis of the issue is required. Making this preliminary determination triggers a need for further review, but does not prejudge whether the portion actually meets these standards such that the species should be listed.

If this preliminary determination identifies a particular portion or portions that may be significant and that may be threatened or endangered, those portions must then be evaluated under the SPR Policy as to whether the portion is in fact both significant and endangered or threatened. In making a determination of significance under the SPR Policy we would consider the contribution of the individuals in that portion to the viability of the species. That is, we would determine whether the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction or likely to become so in the foreseeable future. Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address the “significant” question first, or the status question first. If we determine that a portion of the range we are examining is not significant, we would not need to determine whether the species is endangered or threatened there; if we determine that the species is not endangered or threatened in the portion of the range we are examining, then we would not need to determine if that portion is significant.

Because Pacific bluefin tuna range broadly throughout their lifecycle around the Pacific basin, there was no portion of the range that, if lost, would increase the population's extinction risk. In other words, risk of specific threats to Pacific bluefin tuna are buffered both in space and time. To be thorough, the SRT examined the potential for a SPR by considering the greatest known threats to the species and whether these were localized to a significant portion of the range of the species. The main threats to Pacific bluefin tuna identified by the SRT were overutilization, inadequacy of management, and climate change. Generally, these threats are spread throughout the range of Pacific bluefin tuna and not localized to a specific region.

We also considered whether any potential SPRs might be identified on the basis of threats faced by the species in a portion of its range during one part of its life cycle. We further evaluated the potential for the two known spawning areas to meet the two criteria for a SPR. The spawning areas for Pacific bluefin tuna are likely to be somewhat temporally and spatially fluid in that they are characterized by physical oceanographic conditions (e.g., temperature) rather than a spatially explicit area. While commercial fisheries target Pacific bluefin tuna on the spawning grounds, spatial patterns of commercial fishing have not changed significantly over many decades. The historical pattern of exploitation on the spawning areas was part of the consideration in evaluating the threat of overexploitation to the species as a whole, and was determined to not significantly increase the species' risk of extinction for the members utilizing that portion of the range for the spawning stage of their life cycle. Given that the species has persisted throughout this time frame and has experienced similarly low levels of standing stock biomass, it has shown the ability to rebound and has yet to reach critically low levels. Therefore, it was determined that this fishery behavior has not significantly increased the species' risk of extinction for this life cycle phase.

Pacific bluefin tuna range broadly throughout their life cycle around the Pacific basin, and there is no portion of the range that merits evaluation as a potential SPR. If a threat was determined to impact the fish in the spawning area, it would impact the fish throughout its range and, therefore, the species would warrant listing as threatened or endangered based on its status throughout its entire range. Based on our review of the best available information, we find that there are no portions of the range of the Pacific bluefin tuna that were likely to be of heightened biological significance (relative to other areas) or likely to be either endangered or threatened themselves.

Section 4(b)(1) of the ESA requires that NMFS make listing determinations based solely on the best scientific and commercial data available after conducting a review of the status of the species and taking into account those efforts, if any, being made by any state or foreign nation, or political subdivisions thereof, to protect and conserve the species. We have independently reviewed the best available scientific and commercial information including the petition, public comments submitted on the 90-day finding (81 FR 70074; October 11, 2016), the status review report, and other published and unpublished information, and have consulted with species experts and individuals familiar with Pacific bluefin tuna. We considered each of the statutory factors to determine whether it presented an extinction risk to the species on its own, now or in the foreseeable future, and also considered the combination of those factors to determine whether they collectively contributed to the extinction risk of the species, now or in the foreseeable future.

Our determination set forth here is based on a synthesis and integration of the foregoing information, factors and considerations, and their effects on the status of the species throughout its entire range. Based on our consideration of the best available scientific and commercial information, as summarized here and in the status review report, we conclude that no population segments of the Pacific bluefin tuna meet the DPS policy criteria and that the Pacific bluefin tuna faces an overall low risk of extinction. Therefore, we conclude that the species is not currently in danger of extinction throughout its range nor is it likely to become so within the foreseeable future. Additionally, we did not identify any portions of the species' range that were likely to be of heightened biological significance (relative to other areas) or likely to be either endangered or threatened themselves. Accordingly, the Pacific bluefin tuna does not meet the definition of a threatened or endangered species, and thus, the Pacific bluefin tuna does not warrant listing as threatened or endangered at this time.

This is a final action, and, therefore, we are not soliciting public comments.

A complete list of all references cited herein is available upon request (see FOR FURTHER INFORMATION CONTACT).

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-34 with attached Policy Justification and Sensitivity of Technology.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-25 with attached Policy Justification and Sensitivity of Technology.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-35 with attached Policy Justification and Sensitivity of Technology.

Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Defense Science Board was unable to provide public notification concerning its meeting on August 9 and August 11, 2017, of the Defense Science Board as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Defense Science Board was unable to provide public notification concerning its meeting on July 31, 2017 through August 4, 2017, and August 7 through August 10, 2017, of the Defense Science Board 2017 Summer Study Task Force on Countering Anti-access Systems with Longer Range and Standoff Capabilities, as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

The mission of the DSB is to provide independent advice and recommendations on matters relating to the Department of Defense's (DoD) scientific and technical enterprise. The objective of the Long Range Effects 2017 Summer Study Task Force is to explore new defense systems and technologies that will enable cost effective power projection that relies on the use of longer stand-off distances than current capabilities. System components may be deployed on manned or unmanned platforms with a range of potential autonomous capabilities. Use of cost reducing technology and advanced production practices from defense and commercial industry may be a major part of the strategy for deploying adequate numbers of weapons. This nine-day session will focus on coalescing all the information from briefings presented during the January, February, March, April, May, June and July meetings of the Long Range Effects 2017 Summer Study Task Force. The four panels (Architecture; Intelligence, Surveillance, and Reconnaissance; Basing, Delivery, and Weapons; and Command, Control, Communications, and Cyber) will meet simultaneously to discuss topics and analyze data in support of the study.

Additionally, the DSB members will attend a working luncheon on August 9, 2017, from 11:00 a.m. to 1:00 p.m. to deliberate and vote on the findings and recommendations from the 2017 DSB Summer Study on Long Range Effects, and on August 11, 2017, from 9:30 a.m. to 12:00 p.m. to present the final outbriefing of the Long Range Effects 2017 Summer Study Task Force to DoD senior leaders.

In accordance with section 10(d) of the FACA and 41 CFR 102-3.155, the DoD has determined that the Defense Science Board and the Long Range Effects 2017 Summer Study Task Force meetings will be closed to the public. Specifically, the Under Secretary of Defense (Acquisition, Technology, and Logistics), in consultation with the DoD Office of General Counsel, has determined in writing that the DSB meetings and the Long Range Effects 2017 Summer Study Task Force meeting will be closed to the public because matters covered by 5 U.S.C. 552b(c)(1) will be considered. The determination is based on the consideration that it is expected that discussions throughout the DSB meetings and the Long Range Effects 2017 Summer Study Task Force meeting will involve classified matters of national security concern. Such classified material is so intertwined with the unclassified material that it cannot reasonably be segregated into separate discussions without defeating the effectiveness and meaning of the overall meetings. To permit the meetings to be open to the public would preclude discussion of such matters and would greatly diminish the ultimate utility of the DSB's findings and recommendations to the Secretary of Defense and to the Under Secretary of Defense for Acquisition, Technology, and Logistics.

In accordance with section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit a written statement for consideration by the Long Range Effects 2017 Summer Study Task Force members at any time regarding its mission or in response to the stated agenda of a planned meeting. Individuals submitting a written statement must submit their statement to the DSB's DFO—Ms. Karen D.H. Saunders, Executive Director, Defense Science Board, 3140 Defense Pentagon, Room 3B888A, Washington, DC 20301, via email at [email protected] or via phone at (703) 571-0079 at any point; however, if a written statement is not received at least 3 calendar days prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Long Range Effects 2017 Summer Study Task Force. The DFO will review all submissions with the Long Range Effects 2017 Summer Study Task Force Co-Chairs and ensure they are provided to Long Range Effects 2017 Summer Study Task Force members prior to the beginning of this nine-day meeting on July 31, 2017.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-30 with attached Policy Justification and Sensitivity of Technology.

(i) Prospective Purchaser: The Government of Switzerland

(ii) Total Estimated Value:

(iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

The following defense articles and services have been requested as part of a Service Life Extension Program for Switzerland's F/A-18C/D aircraft:

Major Defense Equipment (MDE): Up to fifty (50) Multifunctional Information Distribution System Joint Tactical Radio System (MIDS JTRS) with Concurrent Multi-Net 4 (CMN-4) Capability

Non-MDE includes: Fifty (50) ARC-210 GEN 5 RT-1900A(C) radios w/Second Generation Anti-Jam Tactical UHF Radio for NATO (SATURN) frequency hopping; twenty (20) Joint Helmet Mounted Cueing System (JHMCS) Night Vision Cueing Display (NVCD); CIT Automated Dependence Surveillance-Broadcast (ADS-B) Out; software enhancements to the APG-73 radar; improvements to the F/A-18 Software Configuration Set (SCS) 29C; and sustainment for the ALQ-165 Airborne Self Protection Jammer (ASPJ) system. Operational support for these modifications will be provided through upgrades to the purchaser's unique Mission Data System. Also included are: system integration and testing; software development and integration; support equipment; spare and repair parts; maintenance personnel and pilot familiarization training; software support; publications and technical documents; U.S. Government and contractor technical assistance; and other related elements of logistics and program support.

(iv) Military Department: Navy (XX-P-LAS)

(v) Prior Related Cases, if any: SZ-P-LAN

(vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

(vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex.

(viii) Date Report Delivered to Congress: July 28, 2017.

* As defined in Section 47(6) of the Arms Export Control Act.

The Government of Switzerland has requested the possible sale of a Service Life Extension Program for its F/A-18C/D aircraft to include up to fifty (50) Multifunctional Information Distribution System Joint Tactical Radio System (MIDS JTRS) with Concurrent Multi-Net 4 (CMN-4) capability; fifty (50) ARC-210 GEN 5 RT-1900A(C) radios w/Second Generation Anti-Jam Tactical UHF Radio for NATO (SATURN) frequency hopping; twenty (20) Joint Helmet Mounted Cueing System (JHMCS) Night Vision Cueing Display (NVCD); CIT Automated Dependence Surveillance-Broadcast (ADS-B) Out; software enhancements to the APG-73 radar; improvements to the F/A-18 Software Configuration Set (SCS) 29C; and sustainment for the ALQ-165 Airborne Self Protection Jammer (ASPJ) system. Operational support for these modifications will be provided through upgrades to the purchaser's unique Mission Data System. Also included are: System integration and testing; software development and integration; support equipment; spare and repair parts; maintenance personnel and pilot familiarization training; software support; publications and technical documents; U.S. Government and contractor technical assistance; and other related elements of logistics and program support. The estimated total case value is $115 million.

This proposed sale will contribute to the foreign policy and national security objectives of the United States by helping to improve the security of Switzerland which has been, and continues to be an important force for political stability and economic progress in Europe. Switzerland is also a member of the NATO Partnership for Peace (PfP) program.

The proposed sale will allow the Swiss Air Force to extend the useful life of its F/A-18 fighter aircraft and enhance their survivability. Further, the proposed sale will increase Switzerland's tactical aviation operational capabilities. Switzerland will have no difficulty absorbing this equipment and support into its armed forces.

The proposed sale of this equipment and support will not alter the basic military balance in the region.

The principal contractors will be the Boeing Company, McDonnell Douglas Corporation, St. Louis, MO; Data Link Solutions LLC, Wayne, NJ; Rockwell Collins, Cedar Rapids, IA; Rockwell Collins ESA Vision System LLC, Fort Worth, TX. There are no known offset agreements associated with this potential sale.

Implementation of this proposed sale will not require the assignment of any additional U.S. Government personnel or contractor representatives to Switzerland. However, multiple trips to Switzerland involving U.S. Government and contractor representatives will be required for technical reviews/support, and program management.

There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

(vii) Sensitivity of Technology:

1. The hardware and software being purchased is being used to upgrade Switzerland's existing F/A-18C/D Hornet aircraft. Description and classification of the hardware and software being purchased are detailed in the following paragraphs.

a. The MIDS/JTRS with CMN-4 is a secure, scalable, modular, wireless, and jam-resistant digital information system currently providing Tactical Air Navigation (TACAN), Link-16, and J-Voice to airborne, ground, and maritime joint and coalition warfighting platforms. MIDS provides real-time and low-cost information and situational awareness via digital and voice, communications within the JTRS Enterprise. The MIDS/JTRS hardware is UNCLASSIFIED. The MIDS/JTRS software requires a crypto key be loaded in order to function. The crypto key required for operation is a Controlled Cryptographic Item (CCI).

b. The ARC-210 GEN 5 RT-1990A(C) is a digital radio capable of transmit and receipt of Digital Communication System, Variable Message Format (DCS/VMF) encrypted data messages. The RT-1990 hardware is UNCLASSIFIED. The RT 1900 software requires a crypto key be loaded in order to function. The crypto key required for operation is a Controlled Cryptographic Item (CCI).

c. The AN/AVS-11 Night Vision Cueing Device (NVCD) is UNCLASSIFIED but is capable of high resolution imaging. This capability allows reduced visibility weapon delivery using Switzerland's F/A-18C/D aircraft. While the NVCD hardware is UNCLASSIFIED, this item requires Enhanced End Use Monitoring (EEUM).

2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapons systems effectiveness or be used in the development of a system with similar or advanced capabilities.

3. A determination has been made that the Government of Switzerland can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This proposed sale is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the policy justification.

4. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Switzerland.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Consolidated Annual Report (CAR) for the Carl D. Perkins Career and Technical Education Act of 2006.

OMB Control Number: 1830-0569.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 55.

Total Estimated Number of Annual Burden Hours: 9,020.

Abstract: The purpose of this information collection package—the Consolidated Annual Report (CAR)—is to gather narrative, financial, and performance data as required by the Carl D. Perkins Career and Technical Education Act of 2006 (Perkins IV). Perkins IV requires the Secretary to provide the appropriate committees of Congress copies of annual reports received by the Department from each eligible agency that receives funds under the Act. The Office of Career, Technical, and Adult Education (OCTAE) will determine each State's compliance with basic provisions of Perkins IV and the Education Department General Administrative Regulations [Annual Performance Report] and Part 80.41 [Financial Status Report]. OCTAE will review performance data to determine whether, and to what extent, each State has met its State adjusted levels of performance for the core indicators described in section 113(b)(4) of Perkins IV.

The Privacy Act (5 U.S.C. 552a(e)(4) and (11)) requires each Federal agency to publish in the Federal Register a notice of a new and rescinded system of records. The Department's regulations implementing the Privacy Act are contained in the Code of Federal Regulations (CFR) in 34 CFR part 5b.

The Privacy Act applies to information about an individual that is maintained in a system of records from which information is retrieved by a unique identifier associated with the individual, such as a name or Social Security number (SSN). The information about the individual is called a “record,” and the system, whether manual or computer based, is called a “system of records.”

The Privacy Act requires Federal agencies to publish a notice of a new system of records in the Federal Register and to submit a report to OMB whenever the agency publishes a new system of records or makes a significant change to an established system of records. Each agency is also required to send copies to the Chair of the Senate Committee on Homeland Security and Governmental Affairs and the Chair of the House Committee on Oversight and Government Reform. These reports are intended to permit an evaluation of the probable or potential effect of the proposal on the privacy rights of individuals.

The Privacy Act also requires Federal agencies to publish in the Federal Register a notice of rescindment when an agency stops maintaining a previously established system of records, but the rescission is not within the purview of subsection (r) of the Privacy Act; therefore, it is not required to be reported to OMB and Congress.

The Department identifies the PEPS system of records (18-11-09), as published in the Federal Register on June 4, 1999 (64 FR 30106, 30171-30173), and as amended on December 27, 1999 (64 FR 72384, 72405), to be rescinded because some of the records covered by this system of records will be maintained in the Department's IPM system (18-11-21). The Department takes this action so that it does not maintain duplicate systems of records.

The IPM system is a web-accessible system created by the Department to support eligibility determination and enrollment of entities seeking to participate in student aid programs under title IV of the Higher Education Act of 1965, as amended (HEA), and to oversee those entities' compliance with title IV, HEA's statutory and regulatory requirements.

The IPM system contains information on individuals with substantial ownership interests in, or control over, authorized entities (postsecondary schools, lenders, guaranty agencies, or third-party servicers that participate in title IV, HEA student financial aid programs) regarding the eligibility, administrative capabilities, and financial responsibility of the schools, lenders, guaranty agencies, and third-party servicers. Such information includes, but is not limited to, the names, taxpayer identification numbers, bank account numbers, SSNs, personal identification numbers, personal addresses, personal phone numbers, and personal email addresses of the individuals with substantial ownership interests in, or control over, those entities.

The IPM system also contains information about individuals affiliated with authorized entities who request electronic access to title IV, HEA, Federal Student Aid (FSA) systems. Such information includes, but is not limited to, the individual's name, SSN, date of birth, address, phone number, and authentication information (user ID, password, and security challenge questions and answers).

The IPM system will integrate a number of core partner management functions to deliver significant improvements from both a cost and customer satisfaction perspective. The partner management functions include enrollment, eligibility, and oversight processes used to manage partner entities as they administer title IV financial assistance. The IPM system will integrate the services currently provided by legacy systems into a single IPM solution. This integration will take an end-to-end view of FSA's entire partner eligibility and oversight business, which includes the following legacy systems: Postsecondary Education Participants System (PEPS), Electronic Application for Approval to Participate in Federal Student Financial Aid Programs (eApp), eZ-Audit, Integrated Partner Management Document Management (IPM DM), and Lender's Application Process (LAP). The benefits of integrating these legacy systems will include:

• Improved workflow automation to ensure timely completion of partner eligibility and enrollment processes;

• Improved efficiency in case management;

• A seamless repository of information;

• A scalable and configurable platform that will provide maximum flexibility to meet future needs;

• Reduced risks from leveraging current technologies to replace outdated and unsupported technologies;

• An established base of secure and accessible information;

• More efficient processes to meet internal and external reporting requirements;

• Improved overall program quality by reducing errors; and

• Reduction of the risk of FSA failing to detect a non-compliant partner.

Upon implementation of the IPM system, the PEPS legacy systems will be retired. However, some legacy systems may be kept alive for a short period of time to ensure the continued operation of our business until the new IPM system is fully functional.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

For the reasons discussed in the preamble, the Acting Chief Operating Officer of Federal Student Aid (FSA) of the U.S. Department of Education (Department) publishes a notice of a new and a rescinded system of records to read as follows:

Agenda: Commissioners will hold a public meeting to receive updates on the following topics: (1) Cybersecurity in Elections; (2) Help America Vote Act Payments and Grants; and (3) the Election Administration and Voting Survey. Commissioners will receive a project update from the Inspector General. Commissioners will consider and vote on a commission organization chart. Commissioners will announce upcoming 2017 EAC Elections Awards.

Status: This Meeting Will Be Open to the Public.

This information collection request contains:

1. OMB No.: 1910-5175;

2. Information Collection Request Title: Office of Energy Efficiency and Renewable Energy (EERE) Environmental Questionnaire;

3. Type of Request: Extension, with changes;

4. Purpose: The DOE's EERE provides Federal funding through Federal assistance programs to businesses, industries, universities, and other groups for renewable energy and energy efficiency research and development and demonstration projects. The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.) requires that an environmental analysis be completed for all major Federal actions significantly affecting the environment including projects entirely or partly financed by Federal agencies. To effectively perform environmental analyses for these projects, the DOE's EERE needs to collect project-specific information from Federal financial assistance awardees. DOE's EERE has developed its Environmental Questionnaire to obtain the required information and ensure that its decision-making processes are consistent with NEPA as it relates to renewable energy and energy efficiency research and development and demonstration projects. Minor changes have been made to the Environmental Questionnaire that help to clarify certain questions, but do not change the meaning of the questions being asked;

5. Annual Estimated Number of Total Responses: 300;

6. Average Hours per Response: 1; and

7. Annual Estimated Number of Burden Hours: 300.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On July 19, 2017, the Illinois Environmental Protection Agency (IEPA) submitted an application titled “NPDES e-Reporting Tool” for revision to its EPA-approved program under title 40 CFR to allow new electronic reporting. EPA reviewed IEPA's request to revise its EPA-authorized Part 123—EPA Administered Permit Programs: The National Pollutant Discharge Elimination System program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision/modification set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Illinois's request to revise its Part 123—EPA Administered Permit Programs: The National Pollutant Discharge Elimination System program to allow electronic reporting under 40 CFR parts 122 and 125 is being published in the Federal Register.

IEPA was notified of EPA's determination to approve its application with respect to the authorized program listed above.

Auction 1000, which was conducted pursuant to Title VI of the Middle Class Tax Relief and Job Creation Act of 2012, was completed on April 13, 2017, and the Commission initiated a transition period during which broadcast television stations that received new channel assignments in the April 13, 2017 Closing and Channel Reassignment Public Notice will be reauthorized and relicensed. The deadline for applications for construction permits consistent with the requirements of that Public Notice were due July 12, 2017.

The first priority filing window, which opens on Wednesday, August 9, 2017 and closes at 11:59 p.m. EDT on Friday, September 8, 2017, is limited to: (1) 25 reassigned stations that were granted a waiver of the July 12, 2017 filing deadline because they were “unable to construct” the specified facilities assigned to them in the Closing and Channel Reassignment Public Notice; (2) stations entitled to protection in the repacking process that are predicted to experience a loss of population served in excess of one percent as a result of the auction repacking process; and (3) Class A stations that did not receive protection and were displaced in the repacking process. Applications filed by stations that received a waiver of the July 12, 2017 filing deadline and displaced Class A stations are exempt from a filing fee.

Eligible stations may file applications for expanded facilities that qualify as a minor change under the Commission's rules, or for alternate channels which will be treated as major change applications under the Commission's rules. Applicants must protect the construction permit facilities of stations assigned to new channels, whether those stations' applications have been granted or remain pending, and must also protect the facilities specified in applications that were filed before the April 2013 freeze on applications proposing to extend a station's contour. Applications filed by displaced Class A stations must also demonstrate that the proposal would not cause interference to a low power television or translator facility previously authorized or proposed. A station that files an application that is incomplete or defective will be afforded an opportunity to submit an amendment to correct any defects, and failure to correct will result in dismissal of the application. If an application filed by (1) a station that was unable to construct the facilities specified in the Closing and Channel Reassignment Public Notice or (2) a displaced Class A station is dismissed, then the station must file a new application within 15 days of dismissal and pay the requisite filing fee.

Applications filed during the first priority filing window will be treated as filed on the last day of the window for purposes of determining mutual exclusivity. Stations with mutually exclusive applications will be notified and given a 90-day period to resolve their mutual exclusivity by proposing a technical solution or settlement in an amendment to their pending applications.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Hospice Request for Certification and Supporting Regulations; Use: The Hospice Request for Certification Form is the identification and screening form used to initiate the certification process and to determine if the provider has sufficient personnel to participate in the Medicare program. Form Number: CMS-417 (OMB Control number: 0938-0313); Frequency: Annually; Affected Public: Private Sector—Business or other for-profits; Number of Respondents: 851; Total Annual Responses: 851; Total Annual Hours: 213. (For policy questions regarding this collection contact Sarah Fahrendorf at 410-786-3112.)

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use issued, on November 15, 2012, the ICH harmonized tripartite guideline entitled “Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)” (the PBRER guideline) (available at https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html). The PBRER guideline is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions, to enhance efficiency and reduce burden by reducing the number of reports generated for submission to the regulatory authorities. The PBRER is intended to provide a common standard for periodic reporting on approved drugs or biologics among the ICH regions.

FDA currently has OMB approval for the required submission of periodic adverse drug experience reports (PADER) for drugs subject to a new drug application (NDA) or an abbreviated new drug application (ANDA) (§  314.80(c)(2) (21 CFR 314.80(c)(2)) (OMB control number 0910-0230), and for the required submission of periodic adverse experience reports (PAER) for drugs subject to a biologics license application (BLA) (§  600.80(c)(2) (21 CFR 600.80(c)(2)) (OMB control number 0910-0308).

There is considerable overlap in the information required under §§  314.80(c)(2) and 600.80(c)(2) and the information requested in a periodic safety report using the ICH E2C(R2) PBRER format. Applicants subject to periodic safety reporting requirements under FDA regulations could choose to continue to submit the reports as specified in those regulations, and would be permitted to submit reports in the PBRER format and submit reports as specified in FDA regulations with an approved waiver. Companies who submit periodic reports on the same drug to multiple regulators, including not only the United States, but, also the European Union, Japan, and regulators in other countries who have elected to adopt the ICH standards, may find it in their interest to prepare a single PBRER, rather than preparing multiple types of reports for multiple regulators. As a result, FDA, in the Federal Register of November 29, 2016 (81 FR 85976), announced the availability of the guidance for industry entitled “Providing Post-marketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)” to indicate its willingness to accept post-market periodic safety reports using the ICH PBRER format in lieu of the specific reports described in FDA regulations.

Because FDA regulations in §§  314.80(c)(2) and 600.80(c)(2) include specific requirements for periodic safety reports, in order for an applicant to submit an alternative report, such as the PBRER, for a given product, FDA must grant a waiver. Existing regulations permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under existing control numbers. (See §  314.90(a), waivers for drugs subject to NDAs and ANDAs, approved under OMB control number 0910-0001, and §  600.90(a), waivers for products subject to BLAs, approved under OMB control number 0910-0308.) The November 29, 2016, guidance both explains conditions under which applicants that have previously received waivers to submit reporting information in the format of the previous ICH guidance would be permitted to apply those existing waivers to the submission of PBRERs, and also advises how applicants that have not previously obtained a waiver may submit waiver requests to submit the PBRER.

There are information collections proposed in the November 29, 2016, guidance that are related to waivers specifically to enable the submission of PBRERs, and these information collections are not already addressed under the approved control numbers covering waiver submissions and periodic safety reports generally. FDA has previously granted waiver requests, submitted under §§  314.90(a) and 600.90(a), that allow applicants to prepare and submit reports using the periodic safety update report (PSUR) format described in FDA's 1996 and 2004 ICH E2C guidance. In accordance with the recommendations of the November 29, 2016, guidance, if an applicant already has a PSUR waiver in place for a given approved application, FDA will consider the existing PSUR waiver to allow the applicant to submit a PBRER instead of a PSUR because the PBRER replaces the PSUR for post-marketing periodic safety reporting for that application. The applicant would not need to submit a new waiver request unless the applicant wishes to change the frequency of reporting. FDA will consider requests to be waived of the quarterly reporting requirement but will not waive applicants of the annual reporting requirement.

If an applicant submits a PBRER in place of the PSUR and uses a different data lock point, the applicant should submit overlapping reports or submit a one-time PADER/PAER in order to cover the gap in reporting intervals. The applicant should submit notification to the application(s), indicating the change in data lock point and should include a description of the measures taken to ensure that there are no resulting gaps in reporting.

If an applicant submits a PBRER in place of the PSUR and uses a different reporting frequency for the PBRER than was used for the PSUR, the continued validity of the waiver will be conditioned on the submission of a PADER/PAER as needed to fulfill the reporting frequency requirement under FDA regulations. The applicant should submit a notification to the application(s), describing this change and the measures taken to ensure that the periodicity requirements are being met.

FDA expects approximately 187 waiver requests and notifications to include the additional information described previously in this document for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 55 applicants to make these submissions, and we estimate that the time for submitting the additional information described previously would be on average approximately 1 hour for each waiver request or notification.

If an applicant does not have a PSUR waiver in place for an approved application, the applicant may submit a waiver request under §  314.90(a) or §  600.90(a) to submit a PBRER instead of the PADER/PAER. The applicant should submit a request to FDA for each approved application for which a waiver is requested, and a single waiver request letter can include multiple applications. Waiver requests should be submitted to each of the application(s) in the request, and may be submitted electronically or by paper as described in the November 29, 2016, guidance. Each PBRER waiver request should include the following information:

• The product name(s) and application number(s);

• a brief description of the justification for the request;

• the U.S. approval date for the product(s) and current reporting interval used;

• the reporting interval of the last PADER/PAER submitted for the product(s); and

• the data lock point that will be used for each PBRER. If a data lock point other than one aligned to the U.S. approval date is proposed, the applicant should describe how he/she will ensure that there are no gaps in reporting intervals (e.g., by submitting overlapping reports; submitting a one-time PADER/PAER to cover the gap period; or, if the gap is less than 2 months, extending the reporting interval of the final PADER/PAER to close the gap).

• The frequency for submitting the PBRER, as described in section IV.C of the April 8, 2013, draft guidance.

• The email address and telephone number for the individual who can provide additional information regarding the waiver request.

As explained earlier, existing regulations at § 314.90(a) or 600.90(a) permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under OMB control numbers 0910-0001 and 0910-0308. FDA believes that the information submitted under numbers 1-4 and number 7 in the list in the previous paragraph is information that is typical of any waiver request regarding post-marketing safety reporting and is accounted for in the existing approved collections of information for waiver requests and reports. Concerning numbers 5 and 6, FDA expects approximately 67 waiver requests to include the additional information for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 29 applicants to make these submissions, and we estimate that the time for submitting the additional information described in the previous paragraph would be on average approximately 2 hours for each waiver request.

In the Federal Register of May 23, 2017 (82 FR 23578), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received.

We therefore estimate the burden of this collection of information as follows:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the Fair Packaging and Labeling Act (the FPLA) require that cosmetic manufacturers, packers, and distributors disclose information about themselves or their products on the labels or labeling of their products. Sections 201, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the labeling of cosmetic products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the FD&C Act or misbranded under section 602 of the FD&C Act.

FDA's cosmetic labeling regulations are published in part 701 (21 CFR part 701). Four of the cosmetic labeling regulations have information collection provisions. Section 701.3 requires the label of a cosmetic product to bear a declaration of the ingredients in descending order of predominance. Section 701.11 requires the principal display panel of a cosmetic product to bear a statement of the identity of the product. Section 701.12 requires the label of a cosmetic product to specify the name and place of business of the manufacturer, packer, or distributor. Section 701.13 requires the label of a cosmetic product to declare the net quantity of contents of the product.

In the Federal Register of May 23, 2017 (82 FR 23576), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received which described ingredients used in the creation of cosmetics but was not PRA-related and will not be addressed here.

FDA estimates the burden of this collection of information as follows:

The hour burden is the additional or incremental time that establishments need to design and print labeling that includes the following required elements: A declaration of ingredients in decreasing order of predominance, a statement of the identity of the product, a specification of the name and place of business of the establishment, and a declaration of the net quantity of contents. These requirements increase the time establishments need to design labels because they increase the number of label elements that establishments must take into account when designing labels. These requirements do not generate any recurring burden per label because establishments must already print and affix labels to cosmetic products as part of normal business practices.

The estimated annual third-party disclosure is based on data available to the Agency, our knowledge of and experience with cosmetic labeling, and our communications with industry. We estimate there are 1,518 cosmetic product establishments in the United States. We calculate label design costs based on stock keeping units (SKUs) because each SKU has a unique product label. Based on data available to the Agency and on communications with industry, we estimate that cosmetic establishments will offer 94,800 SKUs for retail sale in 2017. This corresponds to an average of 62 SKUs per establishment.

One of the four provisions that we discuss in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including non-retail professional-use-only products. We estimate that including professional-use-only cosmetic products increases the total number of SKUs by 15 percent to 109,020. This corresponds to an average of 72 SKUs per establishment.

Finally, based on the Agency's experience with other products, we estimate that cosmetic establishments may redesign up to one-third of SKUs per year. Therefore, we estimate that the number of disclosures per respondent will be 21 (31,878 SKUs) for § 701.3 and 24 each (36,432 SKUs) for §§ 701.11, 701.12, and 701.13.

We estimate that each of the required label elements may add approximately 1 hour to the label design process. We base this estimate on the hour burdens the Agency has previously estimated for food, drug, and medical device labeling and on the Agency's knowledge of cosmetic labeling. Therefore, we estimate that the total hour burden on members of the public for this information collection is 141,174 hours per year.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the health security of the Nation (see the PHS Act, 42 U.S.C. 247d-6b). This collection of medical products for use during national health emergencies, known as the Strategic National Stockpile (SNS), is to “provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.” It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).

Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (§§ 201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center Director may grant a request for an exception or alternative to certain regulatory provisions pertaining to the labeling of human drugs, biological products, medical devices, and in vitro diagnostics that currently are or will be included in the SNS if certain criteria are met. The appropriate FDA Center Director may grant an exception or alternative to certain FDA labeling requirements if compliance with these labeling requirements could adversely affect the safety, effectiveness, or availability of products that are or will be included in the SNS. An exception or alternative granted under the regulations may include conditions or safeguards so that the labeling for such products includes appropriate information necessary for the safe and effective use of the product given the product's anticipated circumstances of use. Any grant of an exception or alternative will only apply to the specified lots, batches, or other units of medical products in the request. The appropriate FDA Center Director may also grant an exception or alternative to the labeling provisions specified in the regulations on his or her own initiative.

Under §§ 201.26(b)(1)(i) (human drug products), 610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human use), an SNS official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores such products that are or will be included in the SNS may submit, with written concurrence from a SNS official, a written request for an exception or alternative to certain labeling requirements to the appropriate FDA Center Director. Except when initiated by an FDA Center Director, a request for an exception or alternative must be in writing and must:

• Identify the specified lots, batches, or other units of the affected product;

• Identify the specific labeling provisions under the regulations that are the subject of the request;

• Explain why compliance with the specified labeling provisions could adversely affect the safety, effectiveness, or availability of the product subject to the request;

• Describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product given the anticipated circumstances of use of the product;

• Provide copies of the proposed labeling of the specified lots, batches, or other units of the affected product that will be subject to the exception or alternative; and

• Provide any other information requested by the FDA Center Director in support of the request.

If the request is granted, the manufacturer may need to report to FDA any resulting changes to the new drug application, biologics license application, premarket approval application, or premarket notification (510(k)) in effect, if any. The submission and grant of an exception or an alternative to the labeling requirements specified in the regulations may be used to satisfy certain reporting obligations relating to changes to product applications under §§ 314.70, 601.12, 814.39 and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices subject to premarket approval), or 21 CFR 807.81 (medical devices subject to 510(k) clearance requirements)).

The information collection provisions in §§ 314.70, 601.12, 807.81, and 814.39 have been approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-0231, respectively. On a case-by-case basis, the appropriate FDA Center Director may also determine when an exception or alternative is granted that certain safeguards and conditions are appropriate, such as additional labeling on the SNS products, so that the labeling of such products would include information needed for safe and effective use under the anticipated circumstances of use.

Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute, or store affected SNS products. Based on data from fiscal years 2014 and 2015, FDA estimates an average of one request annually for an exception or alternative received by FDA. FDA estimates an average of 24 hours preparing each request. The average burden per response for each submission is based on the estimated time that it takes to prepare a supplement to an application, which may be considered similar to a request for an exception or alternative. To the extent that labeling changes not already required by FDA regulations are made in connection with an exception or alternative granted under the regulations, FDA is estimating one occurrence annually in the event FDA would require any additional labeling changes not already covered by FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes. The average burden per response for each submission is based on the estimated time to develop and revise the labeling to make such changes.

In the Federal Register of May 23, 2017 (82 FR 23584), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received.

We therefore estimate the burden of this collection of information as follows:

When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

Information Collection Request Title: Office of Patient Advocacy/Be The Match® Patient Services Survey, OMB No. 0906-0004—Revision.

Abstract: The National Marrow Donor Program®/Be The Match® is a HRSA contractor dedicated to helping patients and families get the support and information they need to learn about their disease and treatment options, prepare for a blood stem cell transplant, and thrive after a transplant procedure. The information and resources provided help individuals navigate the bone marrow or cord blood transplant process. Participant feedback is essential to understand the needs for transplant support services and educational information across a diverse population. This information is used to determine helpfulness of existing services and resources. Feedback is also used to identify areas for improvement and develop future programs.

Need and Proposed Use of the Information: Barriers to access to bone marrow or cord blood transplant related care and educational information are multi-factorial. Feedback from participants is essential to better understand the changing needs for services and information as well as to demonstrate the effectiveness of existing services. The primary use for information gathered through the survey is to determine helpfulness of participants' initial contact with Be The Match® Patient Services Coordinators (PSC) and to identify areas for improvement in the delivery of services. In addition, stakeholders use this evaluation data to make program and resource allocation decisions.

The survey includes items to measure the following: (1) Reason for contacting Be The Match®, (2) if the PSC was able to answer questions and was easy to understand, (3) if the contact helped the participant to feel better prepared to discuss transplants with their care team, (4) increase in awareness of available resources, (5) timeliness of response, and (6) overall satisfaction.

The proposed changes to the survey instrument include minor changes to both selected survey questions and the instructions. The updated survey questions include simplified language and the references to race and ethnicity are updated to better match preliminary U.S. Census Bureau question format and statements from the U.S. Department of Education. The question format changes will better allow individuals to self-identify their ethnicity and race and permit individuals to select more than one race and/or ethnicity. These changes will not increase respondent burden.

Likely Respondents: Respondents will include all patients, caregivers and family members who have contact with Be The Match Patient Services Coordinators via phone or email for transplant navigation services and support. The decision to survey all participants was made based on historic evidence of patients' unavailability due to frequent transitions in health status as well as between home and the hospital for initial treatment and care for complications.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.