Federal Register Vol. 80, No.168,

On December 17, 2014, FSIS published a proposed rule in the Federal Register (79 FR 75073) to add Lithuania to the list of countries eligible to export meat and meat products to the United States (9 CFR 327(b)). This final rule is consistent with the proposed rule.

As is explained in the proposed rule, under the FMIA and implementing regulations, meat and meat products imported into the United States must be produced under standards for safety, wholesomeness, and labeling that are equivalent to those of the United States (21 U.S.C. 620). The FMIA also requires that the livestock from which such imports are produced be slaughtered and handled in connection with slaughter in a manner that is consistent with the Humane Methods of Slaughter Act (7 U.S.C. 1901-1906).

Section 327.2 of Title 9 of the Code of Federal Regulations (CFR) sets out the procedures by which foreign countries may become eligible to export meat and meat products to the United States. Paragraph 327.2(a) requires that a foreign country's meat inspection system provide standards equivalent to those of the United States and to provide legal authority for the inspection system and its implementing regulations that is equivalent to that of the United States. Specifically, a country's laws and regulations must impose requirements equivalent to those of the United States with respect to: (1) Ante-mortem inspection, humane methods of slaughter and handling, and post-mortem inspection by, or under the direct supervision of, a veterinarian; (2) official controls by the national government over establishment construction, facilities, and equipment; (3) direct and continuous official supervision of slaughtering and preparation of product by inspectors to ensure that product is not adulterated or misbranded; (4) complete separation of establishments certified to export from those not certified; (5) maintenance of a single standard of inspection and sanitation throughout certified establishments; (6) requirements for sanitation and for sanitary handling of product at establishments certified to export; (7) official controls over condemned product; (8) a Hazard Analysis and Critical Control Point (HACCP) system; and (9) any other requirements found in the FMIA and its implementing regulations (9 CFR 327.2(a)(2)(ii)).

The country's inspection system must also impose requirements equivalent to those of the United States with respect to: (1) Organizational structure and staffing to ensure uniform enforcement of the requisite laws and regulations in all certified establishments; (2) national government control and supervision over the official activities of employees or licensees; (3) qualified inspectors; (4) enforcement and certification authority; (5) administrative and technical support; (6) inspection, sanitation, quality, species verification and residue standards; and (7) any other inspection requirements (9 CFR 327.2(a)(2)(i)).

In 2004, the government of Lithuania initially requested approval to export meat, poultry, and egg products to the United States. In January 2012, Lithuania amended its request to include only meat and meat products. FSIS then began to evaluate Lithuania's inspection system to determine whether it is equivalent to the United States' system.

FSIS conducted a document review of Lithuania's meat inspection system through information provided on FSIS's Self-Reporting Tool (SRT) 1 to determine whether its system is equivalent to that of the United States. FSIS examined the information submitted by Lithuania to verify that the following equivalence components were addressed satisfactorily with respect to standards, activities, resources, and enforcement: (1) Government Oversight; (2) Statutory Authority and Food Safety Regulations; (3) Sanitation; (4) Hazard Analysis and Critical Control Point Systems; (5) Chemical Residue Testing Programs; and (6) Microbiological Testing Programs. From that review, FSIS concluded that Lithuania's laws, regulations, control programs, and procedures were sufficient to achieve the level of public health protection required by FSIS.

FSIS then proceeded with an initial on-site audit of Lithuania's meat inspection system in September 2012 and concluded that Lithuania's system met each equivalence component except sanitation. Lithuania's State Food and Veterinary Service (SFVS), which is Lithuania's central competent authority in charge of food inspection, took immediate corrective actions to address the audit team's findings and provided a corrective action plan, which included new regulations, procedures, implementation measures, and verification activities. FSIS reviewed the plan and concluded that it addressed all of the audit findings.

FSIS conducted a second on-site audit in September 2013 to verify that all outstanding issues identified during the previous audit had been resolved and that Lithuania had satisfactorily implemented all of the laws, regulations, and instructions to the field that FSIS found to be equivalent during the document review and previous audit. FSIS concluded, on the basis of this audit, that Lithuania had satisfactorily implemented the corrective action plan that it had submitted in response to the 2012 audit.

Consequently, on December 17, 2014, FSIS published a proposed rule to find that Lithuania's meat inspection system is equivalent to the United States' system and, therefore, to add Lithuania to the list of countries eligible to export meat and meat products to the United States. For more detailed information on FSIS's evaluation of the Lithuanian meat inspection system, see the proposed rule (79 FR 75073), and for the full audit reports, go to: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

After considering the comments received on the proposed rule, discussed below, FSIS concludes that Lithuania's meat inspection system is equivalent to the United States' inspection system for meat and meat products. Therefore, FSIS is amending its meat inspection regulations to add Lithuania to the list of countries eligible to export meat and meat products to the United States (9 CFR 327.2(b)). Under FSIS's import regulations, the government of Lithuania must certify to FSIS that those establishments that wish to export meat and meat products to the United States are operating under requirements equivalent to those of the United States (9 CFR 327.2(a)).

Although a foreign country may be listed in FSIS's regulations as eligible to export meat and meat products to the United States, the exporting country's products must also comply with all other applicable requirements of the United States, including those of USDA's Animal and Plant Health Inspection Service (APHIS). These requirements include restrictions under 9 CFR part 94 of the APHIS regulations, which regulate the importation of meat and meat products from countries into the United States to control the spread of specific animal diseases.

Also, under this final rule, all meat and meat products exported to the United States from Lithuania will be subject to reinspection by FSIS at United States ports of entry for, but not limited to, transportation damage, product and container defects, labeling, proper certification, general condition, and accurate count.

FSIS will conduct other types of reinspection activities, such as incubation of canned products to ensure product safety and taking product samples for laboratory analysis to detect any drug or chemical residues or pathogens that may render the product unsafe or any species or product composition violations that would render the product economically adulterated. Products that pass reinspection will be stamped with the official mark of inspection and allowed to enter U.S. commerce. If they do not meet U.S. requirements, they will be refused entry and within 45 days will have to be returned to the country of origin, destroyed, or converted to animal food (subject to approval of the Food and Drug Administration (FDA)), depending on the violation. The import reinspection activities can be found on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures.

In addition, Lithuanian meat and meat products will be eligible for importation into the United States only if they are from animals slaughtered on or after the effective date of this final rule.

FSIS received seven comments in response to the proposed rule. One individual supported the proposed rule. Two individuals, a consumer advocacy organization, and three trade associations representing the pork industry, opposed it. After review and consideration of these comments, FSIS is finalizing the regulation as proposed. The following is a brief summary of the relevant issues raised in the comments and FSIS's responses.

Comment: One individual opposed importing Lithuanian meat and meat products, stating that animal feeding practices in Lithuania would not effectively prevent bovine spongiform encephalopathy (BSE). Three pork industry groups opposed the rule, stating that several cases of African Swine Fever (ASF) reported over the past year in domestic and feral swine populations in Lithuania and adjacent countries would lead to problems in the United States. A consumer advocacy organization stated that allowing Lithuanian products into the United States could lead to the transmission of certain animal diseases into the United States because Lithuania shares common borders with countries that are not free of ASF, Foot-and-Mouth Disease (FMD), Classical Swine Fever (CSF), or Swine Vesicular Disease (SVD) and has trade practices with these countries that are less restrictive than those of the United States.

Agency Response: To export meat and meat products to the United States, countries need to meet the APHIS requirements for animal disease prevention and control. APHIS uses several methods to ensure that harmful animal diseases do not enter the United States. These include actively monitoring the animal disease status of foreign countries and maintaining lists of countries and regions considered to be free (or not free) of certain diseases. If an animal disease is found to exist in a country (or a region within a country) that exports meat, poultry, or egg products to the United States, APHIS requires specific processing steps to ensure that any product from that country or region will not cause the disease to be transmitted to the United States (see 9 CFR part 94).

In addition to these monitoring and processing provisions, APHIS requires imported meat, poultry, and egg products to have accompanying documentation regarding their origin, animal disease status, degree of processing, and intended use. At the U.S. border, CBP officials verify that such documentation is accurate and that the products do not pose an animal disease transmission risk. These steps take place before FSIS reinspects imported product for food safety and other regulatory compliance. All meat and meat products that APHIS restricts from entering the United States because of animal disease concerns will be refused entry by U.S. Customs and Border Protection (CBP).

In the case of BSE, APHIS takes into consideration the risk status recognition as determined by the World Organization for Animal Health (OIE), or conducts its own BSE risk determination upon request. OIE designates countries as having a negligible or controlled BSE risk. Countries that do not meet those designations are considered to have an undetermined risk. OIE and APHIS currently designate Lithuania as a country with controlled BSE risk. The review of Lithuania's food safety system for potential BSE contamination also indicated that SFVS employs effective measures to prevent Specified Risk Materials (SRM) (materials from cattle that scientific studies have demonstrated can contain the BSE agent in cattle infected with the disease) from contaminating the food supply. Removal of SRMs decreases the risk of introduction of BSE to a negligible level. Therefore, FSIS has determined that Lithuania's measures to remove SRMs from its food supply adequately address the potential risk that the BSE agent could contaminate products destined for the United States.

APHIS currently considers Lithuania to be free of SVD, rinderpest, and FMD. APHIS, however, has placed Lithuania in a “special category” because of its common land border with countries that have not been identified to be free of these diseases, and because Lithuania's trade practices are less restrictive than those of the United States. Lithuania's trade practices could, therefore, result in a Lithuanian meat supply that is supplemented with animal products from neighboring countries. Establishments in “special category” countries must certify compliance with specific APHIS regulations, which ensure that animals and animal products received by these establishments, and the products produced by them, are not contaminated through contact with regions where these diseases exist (see 9 CFR 94.11(c)(2) and 94.13(c)(2)).

APHIS recognizes that ASF outbreaks have occurred in wild boar and domestic swine in Lithuania. Lithuania has imposed controls, consistent with European Union legislation, to prevent the spread of this disease. These controls restrict the movement of pigs and pig products, including pork, from areas where the disease has occurred. Were APHIS to add any geographic area of Lithuania to the list of ASF-affected regions, Lithuania would be required to comply with 9 CFR 94.8(b)-(d), which mandates cooking, sealing, cleaning, processing, packing, certification, transportation, and handling requirements.

Under the final rule, Lithuania will be eligible to export meat and meat products to the United States, but will be required to meet APHIS's requirements. Because Lithuania's disease status may change with respect to any animal disease, FSIS will coordinate with APHIS and consider how any change may affect Lithuania's eligibility to export certain types of products to the United States.

Comment: One individual argued that increasing demand for goat meat in the United States should be met through increased local goat production rather than imports. Another individual opposed the rule because the United States already has thousands of meat products in commerce.

Agency Response: The final rule will list Lithuania as eligible to export meat and meat products derived from cattle, swine, sheep, and goats to the United States (9 CFR 327.2(b)). Although Lithuania will be listed as eligible, it is unlikely to export significant quantities of goat meat or meat products to the United States. Lithuania is a net importer of goat meat and does not have export capacity in this area. In 2014, Lithuania imported about $3,000 worth of such products, less than one metric ton (MT), and did not export any such products. Currently, the United States imports about 19,000 MT of goat meat per year, of which 98% comes from Australia. Lithuania must be export-capable and price-competitive to compete in this market. As is discussed in the economic analysis below, Lithuania has stated that it intends to export only canned, dried, smoked beef and pork products to the United States at this time.

Comment: One individual stated that the FDA was unqualified to certify Lithuanian establishments seeking to export meat or meat products to the United States.

Agency Response: Under 9 CFR 327.2(a)(3), the government of Lithuania must certify to FSIS that those establishments that wish to export meat and meat products to the United States are operating under requirements equivalent to those of the United States. These certifications are subject to review by FSIS. FSIS also conducts periodic equivalence audits of countries eligible to export meat, poultry, or egg products to the United States and will do so for Lithuania. Every imported meat or meat product must enter the United States through an official import inspection establishment and be reinspected by an FSIS import inspector.

Comment: A consumer advocacy organization expressed several concerns regarding the two audits of Lithuania's meat inspection system. The organization stated that: (1) The reports are incomplete because they fail to include establishment checklists used by the FSIS auditor to evaluate how well the Lithuanian inspection program enforced food safety laws and regulations at the plant level; (2) the first audit found that Lithuania's SFVS had inexplicably dropped a requirement that establishments seeking to export to the United States maintain written Sanitation Standard Operating Procedures; (3) the second audit noted that improvement was still needed in Lithuania's inspectors' verification of establishments' compliance with zero tolerance requirements for fecal material, ingesta, and milk on carcasses and meat parts; (4) in the second audit report, audit staff were concerned about the ability of Lithuanian inspection personnel to recognize potential sanitation issues in ready‐to‐eat processing facilities; and (5) neither audit report mentioned what precautions the Lithuanian food safety authorities would take as a consequence of the 2013 horse meat scandal in the European Union, in which Lithuanian products were implicated.

Agency Response: FSIS's evaluation of all the data collected before, during, and after the on-site audits supports the conclusion that the Lithuanian meat regulatory system achieves a level of protection equivalent to that of the United States. FSIS evaluated how well Lithuania's inspection program enforced food safety laws and regulations at the plant level, including audit checklists for specific establishments. The Lithuania establishment checklists are posted at the following link: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

The follow-up audit of Lithuania's meat inspection system confirmed that SFVS adequately and effectively addressed all the findings related to the previous FSIS initial equivalence on-site audit conducted from September 10-26, 2012. The FSIS auditor attested that all corrective actions were implemented in a manner consistent with FSIS's inspection requirements. Additionally, SFVS responded adequately to two areas in need of improvement: Verifying that establishments' HACCP systems ensure that all portions of carcasses were free of visible contamination with fecal material, milk, or ingesta, and requiring that establishments control the movement of personnel and materials in establishments producing Ready-to-Eat (RTE) products. SFVS required immediate adjustments to establishments' HACCP systems and sanitation programs, introduced correlation sessions to reinforce supervisors' understanding of food safety tasks related to export to the United States, and implemented on-going training programs for the inspection program personnel. SFVS implemented its corrective action plan and provided supporting documents during and after its exit meeting with FSIS. These corrective actions improved the performance of official verification activities and demonstrated SFVS's commitment to consistently meeting the requirements for exporting meat and meat products to the United States.

In 2013, a variety of meat products in the European Union were found to contain meat which was not declared on the label, including horse meat and pork. In response, the European Commission and EU Member States, including Lithuania, have pursued efforts to ensure the proper labeling of meat products, including increased communication among food safety agencies regarding food fraud, DNA monitoring, revised registration and identification procedures for horses in the EU, increased penalties for fraudulent activity, and stricter origin labeling. Lithuania, as a Member of the EU, is bound by the EU Regulations under which these actions have been taken.

FSIS also verified that SFVS conducts species verification testing of meat and meat products intended for both domestic production and export, in accordance with the SFVS Director Order No B1-23. This testing will ensure that only eligible species will be exported to the United States. Furthermore, the FSIS auditor verified that Lithuanian establishments are required to ensure that food intended for human consumption is adequately labeled or identified to facilitate its traceability in accordance with Article 18 for Regulation (EC) No 178/2002. The identification and labeling requirements include, at least, the source of food, animal byproduct, or ingredients in a manner that supports effective investigation and traceability. FSIS is confident that the Lithuanian measures in place, along with its reinspection and verification activities at United States ports of entry, will ensure that fraudulently labeled Lithuanian meat products will not enter United States commerce.

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule was designated a “non-significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, this rule was not reviewed by OMB under E.O. 12866.

FSIS is adopting, in its entirety, the proposed regulatory impact analysis from the proposed rule.2 Lithuania expressed an intent to export canned, dried, or smoked beef and pork products to the United States. Lithuania, however, will not be precluded from exporting other meat products in the future if the products meet all applicable APHIS and FSIS requirements for those products. Given the limited market in the United States for Lithuanian meat products and Lithuania's low projected export volume, there is likely to be little, if any, impact on the United States economy.

Lithuania is a small beef producer with limited beef export capacity. Its maximum beef export to the world was achieved in 2011, when it exported $130 million, or 25,000 MT, worth of beef, mainly to the European Union and Russia. Based on analysis of Lithuania's exports to Russia, FSIS estimates that Lithuania has an excess beef export capacity of $26 million ($130 million − $104 million = $26 million) in value, or 3,000 MT (25,000 MT − 22,000 MT = 3,000 MT) in volume, that could be exported to the United States.3

Accordingly, allowing Lithuanian beef exports to enter the 13,050,000-MT 4 United States beef market is expected to have minimal effect (3,000 MT represents a 0.023% increase), leaving the total United States beef supply almost unchanged. Because importing beef from Lithuania is not expected to greatly alter the United States beef supply, it will not contribute to any price change in that market.

Lithuanian data from CY2013 5 shows that this country reached its maximum pork export capacity, meaning it will export little, if any, pork to the United States. Considering that the United States pork supply is 11,212,000 MT (CY2013),6 it is unlikely that imports from Lithuania will result in price changes in the United States pork market.

This cost analysis was based on Lithuania's full export capacity. Currently, however, only six Lithuanian establishments intend to export product to the United States. Four are meat processors only, one is a slaughter facility, and one conducts both meat slaughter and processing. Of the four processing facilities, three process beef and pork, and one processes pork only. The slaughter-only facility and the facility that conducts both slaughter and processing both handle beef and pork. The combined export capacity of these six establishments is much less than Lithuania's total export capacity. With no price change expected in U.S. meat markets, the final rule would not lead to any negative effects on U.S. consumers.

Lithuanian companies that export product to the United States and domestic companies that import products from Lithuania to the United States will incur standard costs such as export fees and freight and insurance costs. They will be willing to bear these costs because of the anticipated financial benefits associated with marketing their products in the United States.

The final rule will increase trade between the United States and Lithuania. The volume of trade stimulated by this rule is likely to be small and is expected to have little or no effect on U.S. meat supplies or meat prices. U.S. consumers, however, are expected to enjoy more choices when purchasing meat and meat products. Lithuanian establishments will export commercially sterile meat products, including canned meat products and ready-to-eat products like salamis and other dried and smoked meats to the United States. The final rule expands choices for U.S. consumers and promotes economic competition.

The FSIS Administrator certifies that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not have a significant impact on a substantial number of small entities in the United States.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule.

No new paperwork requirements are associated with this proposed rule. Foreign countries wanting to export meat and meat products to the United States are required to provide information to FSIS certifying that their inspection systems provide standards equivalent to those of the United States, and that the legal authority for the system and their implementing regulations are equivalent to those of the United States. FSIS provided Lithuania with questionnaires asking for detailed information about the country's inspection practices and procedures to assist that country in organizing its materials. This information collection was approved under OMB number 0583-0153. The proposed rule contains no other paperwork requirements.

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq.) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

FSIS will officially notify the World Trade Organization's Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in Geneva, Switzerland, of this rule and will announce it online through the FSIS Web page located at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.

FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.

Fax: (202) 690-7442.

Email: [email protected].

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

For the reasons set out in the preamble, FSIS amends 9 CFR part 327 as follows:

I. Background

The CDFI Fund, Department of the Treasury, was authorized by the Community Development Banking and Financial Institutions Act of 1994, as amended (12 U.S.C. 4701 et seq.) (the Act). The purpose of the CDFI Fund is to promote economic revitalization and community development through investment in and assistance to Community Development Financial Institutions (CDFIs). The mission of the CDFI Fund is to increase economic opportunity and promote community development investments for underserved populations and in distressed communities in the United States. Its long-term vision is an America in which all people have access to affordable credit, capital, and financial services. The purpose of the CDFI Fund is to promote economic revitalization and community development through investment in and assistance to Community Development Financial Institutions (CDFIs). Through the CDFI Program, the CDFI Fund directly invests in, supports, and trains CDFIs that provide loans, investments, financial services, and technical assistance to underserved populations and communities by providing (i) financial assistance in the form of grants, loans, equity investments, and deposits to CDFIs and (ii) technical assistance grants to CDFIs and entities that propose to become CDFIs, for the purpose of increasing their capacity to serve their Target Markets. The CDFI Fund provides such financial assistance to CDFIs to enhance their ability to make loans and investments, and to provide related services for the benefit of designated Investment Areas, Targeted Populations, or both. Awards are made through a competitive, merit-based application process.

Through the CDFI Program, the CDFI Fund uses Federal resources to invest in CDFIs and to build their capacity to serve low-income people and communities that lack access to affordable financial products and services. Through the CDFI Program, the CDFI Fund provides two types of monetary awards to CDFIs: financial assistance awards and technical assistance awards. Applicants participate in the CDFI Program through a competitive, merit-based quantitative and qualitative application and selection process in which the CDFI Fund makes funding decisions based on pre-established evaluation criteria. An entity may receive a CDFI Program award only after entering into an Assistance Agreement with the CDFI Fund that includes performance goals, matching funds requirements (if applicable), and reporting requirements.

On December 19, 2014, the Department of the Treasury published a final rule, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR part 1000), which adopted the government-wide framework for grants management codified by the Office of Management and Budget (OMB) at 2 CFR 200 (the Uniform Requirements). The Uniform Requirements combine grant-related OMB guidance circulars—reducing the administrative burden for award Recipients and reducing the risk of waste, fraud, and abuse of Federal financial assistance—and establish financial, administrative, procurement, and program management standards for Federal award-making agencies, including the CDFI Fund and its award Recipients.

On April 10, 2015, the CDFI Fund published in the Federal Register an amendment to the interim rule (80 FR 19195) modifying the certification requirements for CDFI Bond Guarantee Program participants seeking to meet the “financing entity” criterion of the CDFI certification requirements. The deadline for the submission of comments on the current rule was June 9, 2015.

As of the close of the June 9, 2015 comment period, the CDFI Fund received no comments on the current rule.

Throughout the rule, the defined term “Awardee” has been replaced by “Recipient.” Further, award funds being transmitted from the CDFI Fund to Recipients are referred to as payments, rather than disbursements. These changes were made to align the terminology in the CDFI Program regulations with the terms used in the Uniform Requirements. Other changes to the rule are specified below:

This section has been revised to clarify that the restrictions on entities applying for, receiving, and using CDFI Program awards, as well as awards through other CDFI Fund programs during the same annual award application cycle, will be described in the corresponding funding notices for those programs.

As indicated above, the defined term “Awardee” has been removed and replaced with the defined term “Recipient”. The defined term “Fund” has been removed and replaced with the defined term “Community Development Financial Institutions Fund” so as to provide clear delineation between the CDFI Fund and the Capital Magnet Fund, another CDFI Fund program. The definition of “Comprehensive Business Plan” has been modified to better reflect the Act's requirements for Comprehensive Business Plans submitted with funding applications. The definition of Development Services has been modified for clarity. The definition of “Financial Product” has been modified to eliminate grants by CDFI Intermediaries to CDFIs and/or emerging CDFIs from the definition. The CDFI Fund believes that this change is necessary to ensure that Recipients apply their financial assistance award funding directly to eligible activities rather than passing their financial assistance awards on to other CDFIs. “Uniform Requirements” has been added as a defined term. In addition, the paragraph numbering has been removed to allow for future modifications to the Definitions section without the need for re-numbering the entire section.

Section 1805.105(a), Uniform Requirements, has been added to affirm that the Uniform Requirements will be applied to all awards made pursuant to this part, as applicable.

Section 1805.201(b)(3)(ii)(B), Geographic Units, has been revised to better conform the description of eligible Investment Areas to the language of the Act. References to “American Indian or Alaska Native area” have been replaced with “Indian Reservation.”

Section 1805.201(b)(4), Development Services, has been revised to permit Development Services to be offered in conjunction with Financial Services in order to meet the certification requirement that CDFIs must provide Development Services. Previously, only Development Services in conjunction with Financial Products met this requirement.

Section 1805.201(b)(5), Accountability, has been revised to require that a CDFI must demonstrate accountability to residents of its Target Market through representation on either its governing board or advisory board. Previously, other means of demonstrating accountability were permitted.

Section 1805.201(c), Records and Review, has been added to clarify that each certified CDFI is subject to periodic review by the CDFI Fund to ensure continued compliance with the CDFI certification requirements in this part, as well as to review the certified CDFI's organizational capacity, lending activity, community impacts, and such other information that the CDFI Fund deems appropriate. CDFIs will be required to provide, upon request, additional information and documentation to the CDFI Fund to facilitate this review.

Section 1805.502(c) has been revised to indicate that the terms of the severe constraints waiver will be set forth in the affected Recipient's Assistance Agreement.

Section 1805.504(a) has been revised to eliminate the restriction on Applicants submitting as matching funds those retained earnings that have been accumulated by the Applicant after the end of the Applicant's most recent fiscal year end prior to the application deadline. The CDFI Fund believes that this change will allow Applicants additional flexibility in attracting and obtaining matching funds.

Section 1805.504(c) has been revised to permit Insured Depository Institutions to use retained earnings that have been accumulated since the inception of the organization as matching funds for financial assistance awards. Previously, this option was only available to Insured Credit Unions and State-Insured Credit Unions.

Section 1805.504(c)(1)(iii)(D) has been revised to eliminate the July 31 date as a specified deadline for the measurement of required increases in member shares, non-member shares, outstanding loans, and other measurable activity. Under the current rule, Insured Credit Union and State-Insured Credit Union Applicants may use the increase in retained earnings since the inception of the organization as matching funds so long as they also demonstrate a required amount of increase in shares, loans, and other activity as described in the applicable Notice of Funds Availability. Due to fluctuations in the timing of the funding rounds, the July 31 date being fixed in the regulations made administration of this requirement challenging. With this revision, the CDFI Fund will have greater flexibility to schedule deadlines in the applicable Notice of Funds Availability relative to the application deadline therein.

Section 1805.701(b) has been revised to more accurately reflect the application and selection requirements of the Act as indicated at 12 U.S.C. 4704, 4705, and 4706.

This section was removed as the CDFI Fund no longer uses Notices of Award (NOAs) that are separate from the Assistance Agreements.

This section has been revised to accommodate the audit requirements of the Uniform Requirements.

Section 1805.803(e)(1)(i) has been revised to conform to the Uniform Requirements. Per the Uniform Requirements and the interim rule, all non-profit organizations that are required to have their financial statements audited pursuant to the Uniform Requirements, must submit their single-audits to the Federal Audit Clearinghouse no later than nine months after the end of the Recipient's fiscal year. Under this rule, as indicated in the applicable Notice of Funds Availability and Assistance Agreement, non-profit organizations that are not required to have their financial statements audited pursuant to the Uniform Requirements may still be subject to additional audit requirements.

Section 1805.803(e)(2)(A) has been revised and simplified to eliminate some outdated report form references in favor of a description of the report types to be collected from Recipients on an annual basis. Specific reporting requirements using OMB Paperwork Reduction Act (PRA) approved information collections will be described in the applicable Notices of Funds Availability and Assistance Agreements.

It has been determined that this regulation is not a significant regulatory action as defined in Executive Order 12866. Therefore, a Regulatory Assessment is not required.

Because no notice of proposed rulemaking is required under the Administrative Procedure Act (5 U.S.C. 553) or any other law, the Regulatory Flexibility Act does not apply.

The collections of information contained in this interim rule have been previously reviewed and approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 and assigned the applicable, approved OMB Control Numbers associated with the CDFI Fund under 1559. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. This document restates the collections of information without substantive change.

This interim rule has been reviewed in accordance with the CDFI Fund's Environmental Quality regulations (12 CFR part 1815), promulgated pursuant to the National Environmental Protection Act of 1969 (NEPA), which requires that the CDFI Fund adequately consider the cumulative impact proposed activities have upon the human environment. It is the determination of the CDFI Fund that the interim rule does not constitute a major federal action significantly affecting the quality of the human environment and, in accordance with the NEPA and the CDFI Fund's Environmental Quality regulations (12 CFR 1815), neither an Environmental Assessment nor an Environmental Impact Statement is required.

Because the revisions to this interim rule relate to loans and grants, notice and public procedure and a delayed effective date are not required pursuant to the Administrative Procedure Act found at 5 U.S.C. 553(a)(2).

Public comment is solicited on all aspects of this interim rule. The CDFI Fund will consider all comments made on the substance of this interim rule, but it does not intend to hold hearings.

Community Development Financial Institutions Program—21.020.

For the reasons set forth in the preamble, 12 CFR part 1805 is revised to read as follows:

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

On June 23, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class E airspace at Tracy Municipal Airport, Tracy, CA (80 FR 35890) . Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace areas extending upward from 700 feet or more above the surface of the earth at Tracy Municipal Airport, Tracy, CA. Decommissioning of the Manteca VOR/DME and further review of the airspace has made this action necessary for the safety and management of standard instrument approach procedures for IFR operations at the airport. Class E airspace extending upward from 700 feet above the surface is modified to within a 3.9-mile radius of Tracy Municipal Airport with segments extending from the 3.9-mile radius to 11 miles northwest, 6.4 miles east, and 9 miles southeast, of the airport.

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

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

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

On May 1, 2015, we published a notice of proposed rulemaking (NPRM) entitled Safety Zones: Oil Exploration Staging Area in Dutch Harbor, AK in the Federal Register (80 FR 24866). We received one comment on the proposed rule. No public meeting was requested, and none was held. On July 10, 2015, the Coast Guard published a temporary final rule (80 FR 39691) which lasted until July 15, 2015. The Coast Guard now believes it will be necessary to maintain the safety zones previous established until August 31, 2015.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule as it would be impracticable, as immediate action is needed to minimize potential hazards to navigation posed by the presence of certain maritime traffic. The presence of large drilling vessels in the staging area was not anticipated by the Coast Guard beyond July 15 when the rulemaking activity began. Any delay in the effective date of this rule would present a safety risk to people and vessels in the vicinity of the staging area.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register for the reasons described above.

Based on the expectation of increased maritime traffic primarily due to the anticipated arrival of approximately twenty eight (28) vessels affiliated with planned offshore drilling operations in the Chukchi and Beaufort Seas, temporary safety zones needed to ensure the safe transit of vessels within the navigable waters of the Port of Dutch Harbor and adjacent waters extending seaward to the limits of the territorial sea. The Coast Guard believes temporary safety zones are needed due to safety concerns for personnel aboard the support vessels, mariners operating other vessels in the vicinity of Dutch Harbor, and to protect the environment. The vessels and equipment anticipated to be staged within these safety zones, due to their size and technical complexity, pose a safety risk to vessels that attempt to navigate too closely to them. Limited rescue capabilities are available in the area. In an effort to mitigate the safety risks and any resulting environmental damage, the Coast Guard is establishing temporary safety zones within the Port of Dutch Harbor and the adjacent territorial sea.

In evaluating this request, the Coast Guard explored relevant safety factors and considered several criteria, including, but not limited to: (1) The amount of commercial activity in and around the Port of Dutch Harbor; (2) safety concerns for personnel aboard the vessels; (3) sensitivity of the environment in the region and potential adverse affects caused by a grounding, allision, or collision; (4) the types and volume of vessels navigating in the vicinity of the Port of Dutch Harbor; and (5) the need to allow for lawful demonstrations without endangering the safe operations of support vessels. Vessels transiting in the vicinity of the safety zones could consist of large commercial shipping vessels, fishing vessels, tugs and tows, and recreational vessels. Any group or individual intending to conduct lawful demonstrations in the vicinity of offshore exploration support vessels must do so outside of the temporary safety zones.

Results from a thorough and comprehensive examination of the five criteria identified above, in conjunction with International Maritime Organization guidelines and existing regulations, warrant establishment of the temporary safety zones. A safety zone would significantly reduce the threat of collisions, allisions, or other incidents which could endanger the safety of all vessels operating on the navigable waters of the Port of Dutch Harbor and the adjacent territorial sea.

For the reasons described above, the Coast Guard is establishing temporary safety zones that would surround the designated vessels while at anchor, moored or underway on the navigable waters of the Port of Dutch Harbor and the adjacent territorial sea in order to mitigate the potential safety risks associated with the increased vessel traffic. The temporary safety zones will encompass the waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit.

Enforcing temporary safety zones for each offshore exploration or support vessel while they are on the navigable waters in the Port of Dutch Harbor or the adjacent territorial sea will help ensure the safety of all vessels, including the diverse commercial fleets of Dutch Harbor.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. The safety zone will have negligible economic impact, as there will be ample room for navigation around it.

This rule is not a significant regulatory action due to the minimal impact this will have on standard vessel operations within the port of Dutch Harbor because of the limited area affected and the limited duration of the rule. The safety zones are also designed to allow vessels transiting through the area to safely travel around the safety zones without incurring additional costs.

The Regulatory Flexibility Act of 1980 (RFA), (5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule could affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit through or anchor in within a portion of the Port of Dutch Harbor or adjacent waters, from June 15, 2015 to July 15, 2015.

This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons: These safety zone restrictions are only effective from July 15, 2015 to August 31, 2015, and are limited only to waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit. The Coast Guard will publish a local notice to mariners (LNM) and will issue broadcast notice to mariners (BNM) alerts via marine channel 16 VHF before the safety zone is enforced.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

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

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

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

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the “For Further Information Contact” section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

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

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

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

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

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

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

The legal basis and authorities for this rule are found in 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

Between 7 a.m. until 10 a.m. on September 12 and 13, 2015, a triathlon/swimming race will be held offshore of Henderson Bay, Lake Ontario, Sackets Harbor, NY. The Captain of the Port Buffalo has determined that a large scale swimming event on a navigable waterway will pose a significant risk to participants and the boating public.

With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Incredboubleman Triathlon event. This zone will be enforced from 7 a.m. until 10 a.m. on September 12 and 13, 2015. This zone will encompass all areas on the waters of Henderson Bay, Lake Ontario, Sackets Harbor, NY within the following positions: 43°53′52.58″ N. and 076°7′40.19″ W., then Northwest to 43°54′4.44″ N. and 076°7′43.89″ W., then Southwest to 43°53′57.19″ N. and 076°8′19.19″ W., then Southeast to 43°53′52.58″ N. and 076°7′40.19″ W. (NAD 83).

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

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

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

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

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Outer Harbor between 7 a.m. to 10 a.m. on September 12 and 13, 2015.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this safety zone would be effective, and thus subject to enforcement, for only 3 hours early in the day. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Coast Guard will enforce the Sister Bay Marinafest Ski Show safety zone listed as item (f)(14) in Table 165.929 of 33 CFR 165.929. Section 165.929 lists many annual events requiring safety zones in the Captain of the Port Lake Michigan zone. This safety zone will encompass waters of Sister Bay within an 800-foot radius of position 45°11.585′ N., 087°07.392′ W. (NAD 83). This zone will be enforced from 1:30 p.m. until 3:15 p.m. on September 5, 2015.

All vessels must obtain permission from the Captain of the Port Lake Michigan, or the on-scene representative to enter, move within, or exit the safety zone. Requests must be made in advance and approved by the Captain of the Port before transits will be authorized. Approvals will be granted on a case by case basis. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated representative.

This document is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the Federal Register, the Coast Guard will provide the maritime community with advance notification for the enforcement of this zone via Broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via Channel 16, VHF-FM.

The Coast Guard will enforce the Sister Bay Marinafest Fireworks safety zone listed as item (f)(15) in Table 165.929 of 33 CFR 165.929. Section 165.929 lists many annual events requiring safety zones in the Captain of the Port Lake Michigan zone. This safety zone will encompass all waters of Sister Bay within an 800-foot radius of the launch vessel in approximate position 45°11.585′ N., 087°07.392′ W. (NAD 83). This zone will be enforced from 8:15 p.m. until 10 p.m. on each day of September 5 and 6, 2015.

All vessels must obtain permission from the Captain of the Port Lake Michigan or the on-scene representative to enter, move within, or exit the safety zone. Requests must be made in advance and approved by the Captain of the Port before transits will be authorized. Approvals will be granted on a case by case basis. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated representative.

This document is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the Federal Register, the Coast Guard will provide the maritime community with advance notification for the enforcement of this zone via Broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via Channel 16, VHF-FM.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows:

Under section 128 of the CAA, each SIP must contain provisions that address two requirements: (i) That any board or body which approves permits or enforcement orders under this chapter shall have at least a majority of members who represent the public interest and do not derive any significant portion of their income from persons subject to permits and enforcement orders under this chapter, and (ii) that any potential conflicts of interest by members of such board or body or the head of an executive agency with similar powers be adequately disclosed. To comply with this statutory provision, MDEQ submitted rules from the Civil Service Rule at 2-8.3(a)(1) for incorporation into the SIP, pursuant to section 128 of the CAA. EPA's June 24, 2015, proposed rulemaking (see 80 FR 36306 at 36312) details how these rules satisfy the applicable requirements of section 128. EPA did not receive any comments regarding its proposal to approve Michigan's state board provisions.

For the reasons discussed in our June 24, 2015, proposed rulemaking, EPA is taking final action to approve MDEQ's submissions addressing the state board requirements under section 128 of the CAA. The specific rule that we are approving as satisfying these requirements is Civil Service Rule at 2-8.3(a)(1). It should be noted that our June 24, 2015, rulemaking contained proposed actions for various additional MDEQ submissions. This final rulemaking, however, is limited only to the state board requirements under section 128 of the CAA.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Michigan Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

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

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 30, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 52 is amended as follows:

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

The background for today's action is discussed in detail in our May 20, 2015 proposal (80 FR 28901). In that notice, we proposed to approve portions of SIP submittals for the State of New Mexico submitted on July 26, 2013, and March 4, 2015, that contained revisions to the Albuquerque-Bernalillo County PSD program. The March 4, 2015 submittal included a request for parallel processing of the submitted 2015 revisions, meaning that the EPA proposed approval of a rule that was not yet finalized at the local level. Our May 20, 2015 proposed approval and accompanying Technical Support Document (TSD) provided the EPA's evaluation of the March 4, 2015 revisions to the New Mexico SIP. We preliminarily determined that the revisions were consistent with the CAA and the EPA's regulations and guidance. As such, we proposed approval of the SIP revisions contained in the March 4, 2015 submittal.

Under the EPA's “parallel processing” procedure, the EPA proposes a rulemaking action on proposed SIP revisions concurrently with the State or Local Agency's public review process. If the proposed SIP revision is not significantly or substantively changed, the EPA will finalize the rulemaking on the SIP revision as proposed after responding to any submitted comments. Final rulemaking action by the EPA will occur only after the final SIP revision has been fully adopted by the State or Local Agency and submitted formally to the EPA for approval as a SIP revision. See 40 CFR part 51, Appendix V.

The City of Albuquerque-Bernalillo County completed their rulemaking process, and the Albuquerque-Bernalillo County Air Quality Control Board adopted revisions to the PSD program on April 30, 2015. These adopted changes were submitted as a revision to the New Mexico SIP on June 11, 2015. The EPA has evaluated the final SIP revision submittal for any changes made from the time of proposal. See “Addendum to the TSD” for EPA-R06-OAR-2013-0616, available in the rulemaking docket. Our evaluation indicates that adopted changes to the Albuquerque-Bernalillo County PSD program are the same as the revisions that we proposed to approve; and therefore, do not alter our rationale presented in the May 20, 2015 proposed approval. As such, the EPA is proceeding with our final approval of the revisions to the New Mexico SIP, consistent with the parallel processing provisions in 40 CFR part 51, Appendix V.

This action to approve the aforementioned revisions to the New Mexico SIP is being taken under section 110 of the Act. We did not receive any comments regarding our proposal.

The EPA is approving revisions to the Albuquerque-Bernalillo County PSD program that were submitted by New Mexico as a SIP revision on July 26, 2013, and June 11, 2015. We are approving the portions of the July 26, 2013, and June 11, 2015 submittals that revised the following sections under 20.11.61:

• 20.11.61.2 NMAC—Scope,

• 20.11.61.5 NMAC—Effective Date,

• 20.11.61.6 NMAC—Objective,

• 20.11.61.7 NMAC—Definitions,

• 20.11.61.10 NMAC—Documents,

• 20.11.61.11 NMAC—Applicability,

• 20.11.61.12 NMAC—Obligations of Owners or Operators of Sources,

• 20.11.61.14 NMAC—Control Technology Review and Innovative Control Technology,

• 20.11.61.15 NMAC—Ambient Impact Requirements,

• 20.11.61.18 NMAC—Air Quality Analysis and Monitoring Requirements,

• 20.11.61.20 NMAC—Actuals Plantwide Applicability Limits (PALs),

• 20.11.61.23 NMAC—Exclusions from Increment Consumption,

• 20.11.61.24 NMAC—Sources Impacting Federal Class I Areas—Additional Requirements,

• 20.11.61.27 NMAC—Table 2—Significant Emission Rates,

• 20.11.61.29 NMAC—Table 4—Allowable PSD Increments, and

• 20.11.61.30 NMAC—Table 5—Maximum Allowable Increases for Class I Variances.

The EPA has determined that these revisions to the New Mexico SIP's Albuquerque-Bernalillo County PSD program are approvable because the submitted rules are adopted and submitted in accordance with the CAA and are consistent with the EPA regulations regarding PSD permitting. The EPA is taking this action under section 110 and part C of the Act.

The EPA is severing from our final approval action the revisions to 20.11.60 NMAC submitted on July 26, 2013, which are revisions to the Albuquerque-Bernalillo County NNSR Program and will be addressed in a separate action.

In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the revisions to the New Mexico regulations as described in the Final Action section above. We have made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the EPA Region 6 office.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

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

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 30, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0531 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 30, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0531, by one of the following methods:

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

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

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

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8281) by BASF Corporation, P.O. Box 13528, Research Triangle Park, North Carolina, 27709. The petition requested that 40 CFR 180.493 be amended by establishing tolerances for residues of the fungicide, dimethomorph in or on strawberry at 1.0 parts per million (ppm) and removing the established tolerances for lettuce, head and lettuce, leaf at 10 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the tolerance for residues of dimethomorph in or strawberry to 0.90 ppm and is correcting the CAS name of dimethomorph in 40 CFR 180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d) to the following introductory tolerance expression text: 40 CFR 180.493(a): Tolerances are established for residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity. 40 CFR 180.493(c): Tolerances with regional registrations are established for residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity. 40 CFR 180.493(d): Tolerances are established for the indirect or inadvertent residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity.

The reason for these changes are explained in Unit IV.C.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The target organ for dimethomorph is the liver in rats and dogs. No biologically significant effect was observed in the rat subchronic oral toxicity study while decreased body weight and increased incidence of arteritis in male rats and decreased body weights and increased incidence of “ground-glass” foci in livers of female rats were observed in the rat chronic toxicity study. In the dog subchronic oral toxicity study, decreased absolute and relative prostate weights, and slight liver effects were observed. No toxicity was observed at the limit dose in the rat 28-day dermal toxicity study. The developmental toxicity studies showed no increased sensitivity to offspring of either rats or rabbits as demonstrated by the no-observed-adverse-effect-levels (NOAELs) equal to or higher than those producing toxicity in the maternal animals. Likewise, in the 2-generation reproduction study, there was no toxicity to the offspring at any dose lower than that causing parental toxicity. There is no evidence that dimethomorph is a developmental, or reproductive toxicant, and it is not neurotoxic or immunotoxic.

The Agency classified dimethomorph as “not likely to be carcinogenic to humans” based upon lack of evidence of carcinogenicity in rats and mice and no evidence of mutagenicity. A quantitative cancer risk assessment is not necessary. Dimethomorph has low acute toxicity by the oral, dermal, or inhalation route of exposure (Toxicity Category III or IV). It is not an eye or skin irritant, and is not a skin sensitizer.

Specific information on the studies received and the nature of the adverse effects caused by dimethomorph as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Dimethomorph: Human Health Risk Assessment to Support Establishment of a Permanent Tolerance for Residues in/on Strawberry” at pages 29-32 in docket ID number EPA-HQ-OPP-2014-0531.

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

A summary of the toxicological endpoints for dimethomorph used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dimethomorph, EPA considered exposure under the petitioned-for tolerances as well as all existing dimethomorph tolerances in 40 CFR 180.493. EPA assessed dietary exposures from dimethomorph in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for dimethomorph. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WEIA) 2003-2008. The acute analysis assumed 100% crop treated (CT), Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16 default processing factors, and tolerance-level residues for all foods. Drinking water was incorporated directly into the dietary assessment using the surface water concentration and the FIRST (Food Quality Protection Act (FQPA) Index Reservoir Screening Tool) model.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WEIA 2003-2008. The chronic analysis assumed 100% CT, DEEM-FCID Version 3.16 default processing factors, and tolerance-level residues for all foods. Drinking water was incorporated directly into the dietary assessment using the surface water concentration and the FIRST model.

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

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use any anticipated residue or PCT information in the dietary assessment for dimethomorph.

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

Based on FIRST model for surface water and Pesticide Root Zone Model Ground Water (PRZM GW) for ground water, the estimated drinking water concentrations (EDWCs) of dimethomorph for acute exposures for non-cancer assessments are estimated to be 81.1 parts per billion (ppb) for surface water and 20.1 ppb for ground water; and for chronic exposures for non-cancer assessments are estimated to be 24.7 ppb for surface water and 18.8 ppb (post breakthrough avg. ppb) and 14.6 ppb (simulation avg. ppb) for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

For acute dietary risk assessment, the water concentration of 81.1 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of 24.7 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Dimethomorph is not registered for any specific use patterns that would result in residential exposure.

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

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

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

2. Prenatal and postnatal sensitivity. The toxicology data on dimethomorph provides no indication of enhanced sensitivity of infants and children based on the results from rat or rabbit developmental studies as well as a 2-generation rat reproduction study.

3. Conclusion. EPA has determined the 10X FQPA SF be retained for acute dietary exposure scenario for extrapolation of a NOAEL from a LOAEL. For other exposure scenarios, the FQPA SF is reduced to 1x since there is no evidence of increased qualitative or quantitative susceptibility in the young and exposure estimates are unlikely to underestimate risk.

The above decision is based on the following findings:

i. Although the toxicity database of dimethomorph is incomplete because a subchronic inhalation study is not available, the available toxicity database of dimethomorph, including developmental toxicity studies in rats and rabbits, a 2-generation reproduction study in rats, acute and subchronic neurotoxicity study in rats, is adequate to characterize developmental and reproductive effects and to assess the qualitative or quantitative susceptibility in the young.

ii. In an acute neurotoxicity study, functional observational battery (FOB) findings and reduced motor activity were observed at ≥ 250 mg/kg on day 0 only. These findings were considered an impairment of the overall condition of the animals following a single gavage dose, rather than a direct neurotoxic effect of dimethomorph based on the absence of any neurohistopathological changes in the treated animals and the transient nature of the observed FOB and neurobehavioral assessments. In support of this conclusion, no neurotoxic effects were observed in rats fed dimethomorph up to the highest dose tested at 2,400 ppm (178/204 mg/kg/day for males/females, respectively) in a 90-day neurotoxicity study. Additionally, the toxicology database does not reveal evidence of neurotoxic clinical signs, changes in brain weight, or histopathology of the nervous system in any study with dimethomorph.

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

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to dimethomorph will occupy 39% of the aPAD for children 3 to 5 years of age, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to dimethomorph from food and water will utilize 26% of the cPAD for children 1 to 2 years of age, the population group receiving the greatest exposure. There are no residential uses for dimethomorph.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

A short-term adverse effect was identified; however, dimethomorph is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for dimethomorph.

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

5. Aggregate cancer risk for U.S. population. An aggregate cancer risk was not calculated because dimethomorph was classified as “not likely to be carcinogenic to humans”.

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

Adequate enforcement methodology (high performance liquid chromatography with ultraviolet detection (HPLC/UV) method FAMS 002-04 and Method M 2577, a gas chromatographic (GC) method with nitrogen phosphorus detection (NPD)) are available to enforce the tolerance expression.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for dimethomorph in or on strawberry at 0.05 ppm. These MRLs are different than the tolerances established for dimethomorph in the United States. EPA is not proposing to harmonize the U.S. tolerance for residues in strawberry with the Codex due to different application rates (U.S. application rate, 219-237 gram active ingredient/hectare, and Codex countries' application rate, 150 gram active ingredient/hectare).

BASF proposed a tolerance of dimethomorph residues on strawberry at 1.0 ppm. BASF and EPA used the Organization for Economic Cooperation & Development (OECD) spreadsheet calculator and both determined from the data set that a tolerance of 0.90 ppm was the recommended OECD calculator spreadsheet output. However, BASF rounded that value to 1.0 ppm, while EPA's policy is to establish the tolerance at the OECD calculator output level without rounding; therefore, EPA is establishing a tolerance on strawberry at 0.90 ppm. EPA established the tolerance for leafy vegetables (except brassica) crop group 4 in the Federal Register on May 4, 2012 under docket ID number EPA-HQ-OPP-2011-0388. In this ruling, the tolerance for vegetable, leafy, except brassica, group 4 was established at 30.0 ppm. According to 40 CFR 180.493, the individual tolerances for lettuce, head and lettuce, leaf, both at 10.0 ppm, were not removed. Based upon the previous explanation, EPA is removing the tolerances for lettuce, head at 10.0 ppm and lettuce, leaf at 10.0 ppm.

EPA is correcting the CAS name of dimethomorph in 40 CFR 180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d). The CAS name of dimethomorph is currently incorrect (currently is listed as the International Union of Pure and Applied Chemistry (IUPAC) name (E,Z)-4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl) acryloyl]morpholine, and is being revised to the correct CAS name 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine)).

Therefore, EPA is establishing a tolerance for residues of the fungicide, dimethomorph in or on strawberry at 0.90 ppm and removing the established tolerances for lettuce, head and lettuce leaf at 10 ppm. EPA is correcting the CAS name of dimethomorph in 40 CFR 180.493(a), 40 CFR 180.493(c), and 40 CFR 180.493(d) to the following tolerance expressions:

40 CFR 180.493(a): Tolerances are established for residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity.

40 CFR 180.493(c): Tolerances with regional registrations are established for residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity.

40 CFR 180.493(d): Tolerances are established for the indirect or inadvertent residues of the fungicide dimethomorph, 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propen-1-yl]morpholine, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only dimethomorph in or on the commodity.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et se.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et se.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et se.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

This is a summary of the Commission's Memorandum Opinion & Order (MO&O), ET Docket Nos. 10-236 and 06-155, FCC 15-76, adopted July 6, 2015, and released July 8, 2015. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

1. In the Report and Order (R&O) in this proceeding, 78 FR 25138, April 29, 2013, the Commission updated its part 5 ERS rules to add options that provide additional flexibility to keep pace with the speed of modern technological change, and an environment where creativity can thrive. Specifically, the Commission added three new types of ERS licenses to supplement the existing conventional ERS license: the program license, the medical testing license, and the compliance testing license. The Commission also modified its market trial rules to eliminate confusion and more clearly articulate its policies with respect to marketing products prior to equipment certification, including establishing a subpart for product development and market trials.

2. In this MO&O, the Commission responds to petitions for reconsideration of the R&O filed by Marcus Spectrum Solutions LLC (Marcus); Medtronic, Inc. (Medtronic); and Sirius XM Radio Inc. (Sirius XM) and EchoStar Technologies, Inc. (EchoStar).

3. In its petition, Marcus asks that the Commission reconsider a modified provision in § 5.85(a) of the Commission's rules that prohibits all experimental licensees from using bands exclusively allocated to the passive services. Marcus notes that, while the modified rule was proposed in the Notice of Proposed Rulemaking (NPRM) in this proceeding (76 FR 6928, February 8, 2011) and adopted in the rules appendix of the R&O, it is inconsistent with both the text of the R&O and existing policy under which conventional experimental licensees have been allowed to operate in bands allocated to the passive services. Marcus argues that there are legitimate reasons for short-term conventional experiments in some of the bands allocated for passive use. Specifically, Marcus argues that testing new concepts in modulation, high bandwidth, or other technical details in a given non-passive band that might be appropriate as a future home for a new service can be very expensive if that testing requires custom-made equipment. Marcus maintains that there is a valid reason to verify the new technical concepts in a band in which equipment is much less expensive, even though long-term use of that band might not be possible. Therefore, Marcus recommends new language for § 5.85(a) that would prohibit experimental use of the passive bands by the new types of ERS licensees and in product development and market trials, while also specifying that any conventional experimental licensee proposing use of the passive bands for an experiment must include a justification of why non-passive bands are inadequate for that experiment. The Boeing Company (Boeing) and Battelle Memorial Institute (Battelle) support grant of the Marcus Petition, and no commenting parties objects.

4. As Marcus observes, § 5.85(a) of the rules is inconsistent with both the Commission's existing treatment of conventional ERS licenses and the text of the R&O. This inconsistency arose in the NPRM, where the text proposed that only program licenses would be prohibited from using “restricted” bands (including passive service bands) listed in § 15.205(a) of the Commission's rules. In contrast, § 5.85(a) of the rules proposed that all experimental use of “any frequency or frequency band exclusively allocated to the passive services” be prohibited. This inconsistency was not addressed by any commenting party, but the Commission's stated intent in the text of the R&O was to continue previous practice regarding conventional ERS licenses. In addition, the Commission observes that the R&O stated: “Due to the nature of the compliance testing process, the Commission will not impose on them most of the limitations and reporting requirements that it will impose on program licenses. Specifically, because compliance testing often involves emission measurements in restricted bands, compliance testing licensees will be exempt from the prohibition on operating in the restricted bands listed in § 15.205(a) of the rules and from operating in the bands allocated exclusively to the passive services.” Thus, the Commission modifies § 5.85(a) to permit conventional and compliance testing licensees to operate on passive bands.

5. In making these modifications to § 5.85(a), the Commission observes that a number of conventional experiments have operated in passive service bands without causing harmful interference to passive services, and the Commission concurs with Marcus, Boeing, and Battelle that such conventional experimental use should be permitted to continue under some circumstances. The Commission observes that in those instances in which an experimental applicant had requested use of a passive band, OET staff in coordination with NTIA undertook a case-by-case review of the application and imposed specific conditions on the applicant, as warranted, to minimize the potential that the experiment would cause harmful interference to passive service(s) that use that band. The Commission therefore finds generally appropriate Marcus's recommended new language for § 5.85(a) that would continue to permit conventional ERS use of the passive bands under limited circumstances, and further modifies the language to also permit compliance testing licensees to use those bands.

6. A medical testing experimental radio license (medical testing license) is issued to hospitals and health care institutions that demonstrate expertise in testing and operation of experimental medical devices that use wireless telecommunications technology or communications functions in clinical trials for diagnosis, treatment, or patient monitoring. These licenses are for testing medical devices that would operate under existing rules and use radio frequency (RF) wireless technology for diagnosis, treatment, or patient monitoring for the purposes of, but not limited to, assessing patient compatibility and usage issues, as well as operational, interference, and RF immunity issues. Unlike a conventional experimental license, a medical testing license would allow a health care institution to conduct a wide variety of unrelated clinical trials under a single authorization. The Commission will grant authorizations for a geographic area that is inclusive of an institution's real-property facilities where the experimentation will be conducted and that is under the applicant's control. Applications also may specify, and the Commission will grant authorizations for, defined geographic areas beyond the institution's real-property facilities that will be included in clinical trials and monitored by the licensee.

7. Medtronic's petition raises two issues, which the Commission addresses in turn. First, Medtronic asks that the Commission expand the eligibility for the medical testing license. The second issue pertains to cost reimbursement for clinical trials, which is permitted under Food and Drug Administration (FDA) rules. Medtronic requests that the Commission clarify that such reimbursement does not constitute impermissible marketing under §§ 2.803 or 2.805 of its rules. Medtronic asserts that these changes could greatly facilitate clinical trials because the devices would not need to have first been approved by the Commission under its equipment authorization program. No party filed comments regarding any of the issues raised by Medtronic's petition.

8. Medical testing license eligibility. Medtronic observes that the R&O established this license to meet the needs of the medical community and to allow medical researchers to conduct clinical trials, but limited eligibility for medical testing licenses to health care facilities. Medtronic notes that FDA rules permit a wide range of entities, including non-health care facilities, to sponsor or conduct clinical trial testing. In particular, Medtronic notes that the FDA classifies certain entities involved in medical device research as either “sponsors” or “sponsor-investigators” of clinical trials, with those terms defined as follows:

9. Medtronic observes that under these FDA classifications, a wide-range of entities, including device manufacturers, act as sponsors and sponsor-investigators of clinical trials and engage in real-world patient testing, but that these entities do not always meet the more limited definition of a “health care facility” under the Commission's rules. Thus, Medtronic argues, a “significant portion” of these entities are not eligible to apply for a medical testing license. These entities, it claims, will be subject to testing limitations and added costs and burdens by having to design their tests to comply with the Commission's other experimental authorization rules (or not be able to conduct them in a manner that provides the most utility for device evaluation purposes). Medtronic asserts that the Commission's licensing structure is inconsistent with FDA regulations that permit a wider variety of entities to sponsor or conduct clinical trial testing, and creates regulatory uncertainty, does not meet the development and testing needs of the medical community, and threatens to frustrate the very innovation that this proceeding is intended to promote. Medtronic also asserts that the new program experimental license (program license) is inappropriate for medical testing because that license does not unreservedly cover clinical trials. Medtronic therefore recommends that the Commission extend the eligibility for medical testing licenses to FDA sponsors and sponsor-investigators of clinical trials involving the testing and operation of new medical devices.

10. Medtronic argues that expanding the eligibility to device manufacturers would level the playing field under the rules since the line between device manufacturers and health care facilities is blurring as healthcare providers are among those who develop medical devices. More specifically, given this overlap between the two with respect to their involvement in developing such devices, Medtronic argues that the following two disparities in regulatory treatment unfairly skew the playing field: (1) Medical testing licensees can operate on frequency bands restricted under § 15.205(a) if the device being tested complies with rules in part 18, part 95, Subpart H (Wireless Medical Telemetry Service), or part 95, Subpart I (Medical Device Radiocommunication Service), but program and conventional experimental licensees cannot; and (2) medical testing licensees can conduct clinical trials outside the physical facilities under their control, but program licensees cannot.

11. The Commission addresses separately in a Further Notice of Proposed Rulemaking released simultaneously with this MO&O, whether it should permit program licensees to experiment on frequency bands restricted under § 15.205(a), if the device being tested is designed to comply with all applicable service rules in part 18 (Industrial, Scientific, and Medical Equipment), part 95 (Personal Radio Services), Subpart H (Wireless Medical Telemetry Service), or part 95, Subpart I (Medical Device Radiocommunication Service).

12. After careful consideration, the Commission finds good reason to deny Medtronic's request. In the R&O, the Commission recognized the importance of its experimental licensing program to the development of RF-based medical devices, and its rules provide a variety of authorizations under which medical device experimentation and clinical trials can be conducted, including program licenses, conventional licenses for market trials, and medical testing licenses. The Commission limited the eligibility and scope of a medical testing license to hospitals and health care institutions to address their particular needs in conducting multiple clinical trials, both within their institutions and at defined geographic areas beyond their facilities that will be monitored by the licensee. This license allows a health care institution to assess patient compatibility and use, as well as operational, interference, and RF immunity issues in real use settings. To accomplish this objective, the medical testing license has elements similar to program licenses and to market trial licenses. As with program licenses, a medical testing licensee can conduct multiple unrelated experiments at its own facility that is under its control. As with market trials, the medical testing licensee can request permission to conduct clinical trials at other specified locations that it monitors. The Commission envisions, for example, that a medical testing license would be helpful to those health care institutions when RF-based medical devices used in clinical trials would be operated primarily within the institution by hospital staff who can observe how those devices perform in the presence of other RF equipment. In the R&O, the Commission recognized that, although a health care facility could oversee a clinical trial beyond its facility, it may not want to assume this responsibility in some cases and instead may prefer that the device manufacturer or health practitioner, under a conventional or market trial license, assume responsibility for clinical trials outside the health care facility.

13. The Commission concludes that if it were to expand eligibility for a medical testing licensee to align with the FDA's regulations, it would undermine the Commission's ability to meet its own objectives. Each agency's rules are designed to satisfy different purposes. The Commission's primary concern in authorizing experimentation with RF devices is to ensure that the devices do not cause harmful interference to authorized users of the spectrum and that the devices do not enter into commerce prior to Commission certification. A part 5 licensee is the party that the Commission holds responsible for the proper operation of the experimental RF devices to avoid harmful interference to authorized spectrum users and to take corrective action as necessary. A part 5 license also specifies the locations for experimentation, e.g., a conventional license would specify the locations where the licensee is conducting experimentation, and a program license limits operation to locations directly under the licensee's control. The FDA's Investigational Device Exemption (IDE) rules cited by Medtronic are designed for a different purpose—to determine the safety or effectiveness of a medical device. To accomplish this objective, the FDA's regulations allow for different categories of participation in clinical trials (e.g., sponsors who initiate, investigators who conduct trials, and sponsor-investigators who take on both roles). A sponsor does not necessarily conduct the investigation, and thus would not be directly responsible for the operation of the experimental RF-based devices as intended by the Commission's part 5 rules. Numerous investigators may conduct the clinical trials, often at a variety of locations which are not required to be, and most likely are not, under the sponsor's control. The Commission is concerned that allowing an FDA sponsor or sponsor-investigator to hold a medical testing experimental license would create confusion in determining who is responsible for the proper operation of the experimental RF devices to avoid harmful interference to other spectrum users and to take corrective action as necessary. Also, trials may be conducted by multiple investigators who are not licensees at many different locations that would not be under the licensee's control. This would be contrary to the basic principles underlying the experimental licensing program. The Commission emphasizes that any health care facility that wishes to be eligible for grant of a medical testing license must meet all eligibility requirements contained in its rules, including the requisite RF expertise.

14. The Commission finds it better serves the public interest to maintain the structure that it adopted, wherein a medical testing license is available only to a qualified health care facility that is solely responsible for clinical trials within its institution. The key element here is that the licensee controls the facility—and hence the interference environment—where multiple clinical trials are being conducted. The medical testing license is designed to address the particular needs of health care institutions in conducting multiple clinical trials within its institution under real use conditions, whether the RF-based medical devices being tested are manufactured by themselves or other manufacturers. To expand eligibility for this license to any manufacturer of medical devices, the Commission would have to identify the real-property facilities that they control and where clinical trials would be conducted. It seems unlikely that a manufacturer would conduct clinical trials at its manufacturing facility if this does not provide real use conditions. Moreover, Medtronic does not ask to conduct clinical trials at its own facilities but rather to conduct such trials at multiple other locations as approved under FDA rules on a trial-by-trial basis. This is fundamentally different than how the medical testing license is intended to operate.

15. In declining to modify the rules as requested by Medtronic, the Commission notes that the part 5 rules provide other options for conducting clinical trials that other entities, such as sponsors, investigators and medical device manufacturers, can use. First, entities may evaluate product performance of an experimental wireless medical device under a market trial by obtaining a conventional experimental license. Typically, market trials are conducted prior to the production stage to evaluate product performance and customer acceptability under expected use conditions. As with medical testing licenses, market trials are authorized for devices that are designed to comply with existing Commission rules. However, unlike a regular conventional experimental license, a market trial license can be used to conduct clinical trials in locations not under the licensee's direct control, such as at a patient's home. Second, for instances where a party is developing a device that would not be able to be operated in compliance with existing rules, the Commission envisioned that such devices can be tested under a conventional experimental license. In summary, manufacturers of medical devices, whether associated with a health care facility or not, would have similar opportunities for experimenting with such devices even though they may do so under different types of authorizations. Both health care institutions that qualify for a medical testing license and device manufacturers that do not must obtain either a program or conventional experimental license to conduct basic research and experimentation. Device manufacturers that do not qualify for a medical testing license would need to obtain a market trial license to conduct clinical trials, which provides more flexibility than a medical testing license for specifying the area(s) within which the trial will be conducted. Health care facilities that qualify for a medical testing license could conduct clinical trials under either a medical testing license or a market trial license. Under the medical testing license, the licensee is limited to areas close to the licensee's own facility, and if it wants to conduct a clinical trial in a location not specified in its license, it would do so under a market trial license.

16. Also, as acknowledged by Medtronic, the Commission may declare a specific geographic area an innovation zone for the purpose of conducting a clinical trial. Such a declaration, which could be made on the Commission's own motion or in response to a public request—such as from a health care facility lacking the RF expertise necessary for obtaining a medical testing licensee—would permit the Commission to designate a defined geographic area and frequency range(s) for specific types of experiments by program licensees within guidelines that the Commission may establish on a case-by-case basis. These innovation zones can include geographic areas beyond a program licensee's authorized area without the licensee having to apply for a new license to cover a new location. Thus, they can serve to effectively extend a program license without the licensee being required to modify its license to cover a new location. Accordingly, innovation zones will provide opportunities for program licensees, including FDA sponsors and sponsor-investigators, to test potentially innovative wireless devices in real world operating environments, such as testing medical devices in health care institutions. In the R&O, the Commission stated that this approach “may be particularly useful for manufacturers who want to test medical or other types of equipment that will be used in a health care setting while it is in the product development stage, but who will not be eligible for the medical testing license. A manufacturer of medical devices would be able to continue its product testing for clinical trials under its program license at a designated innovation zone without having to apply for a separate market trial license.”

17. As the Commission concluded in the R&O, the different licensing options represent a multi-faceted approach to facilitate robust medical RF experimentation that responds to the record developed in this proceeding. The medical testing experimental license complements the types of medical RF experimentation that parties will be able to conduct under a conventional, program, or market trial experimental license. Accordingly, the Commission discovered that limiting eligibility for a medical testing license to hospitals and health care facilities is not detrimental to medical innovation and product development. The Commission's goal in this proceeding is to facilitate bringing ground-breaking new technologies and services to consumers more rapidly, and it finds that its current rules provide the proper incentives toward achieving that goal to both FDA-approved sponsors/sponsor-investigators and to health care facilities. Accordingly, the Commission denies Medtronic's request to expand the eligibility for the medical testing license at this time. As licensees take advantage of the new flexible licenses, the Commission will gain valuable insight as to whether it could modify the rules in the future without sacrificing its objective of ensuring that each clinical trial is conducted in a way that minimizes the potential for harmful interference to authorized services.

18. Cost reimbursement for clinical trials. The second issue raised by Medtronic pertains to cost reimbursement for clinical trials of experimental medical devices. Medtronic explains that, while manufacturers of medical devices are not permitted by the FDA to profit from clinical trials, they are allowed to recover certain manufacturing, research, development and handling costs associated with FDA-defined “investigational devices.” Medtronic further states that the FDA typically allows sponsors to charge investigators for such devices, and that the costs are usually passed on to the clinical trial subjects. The FDA rules permit a sponsor or investigator to charge subjects for an investigational device, but those entities may not commercialize that device by charging a price larger than that necessary to recover the costs of manufacture, research, development, and handling. Medtronic requests that the Commission clarify that such reimbursement does not constitute impermissible marketing under §§ 2.803 or 2.805 of its rules. Medtronic argues that the requested clarification will ensure consistency between the regulatory regimes of the Commission and the FDA, simplify manufacturers' compliance, and encourage medical device testing and innovation. Medtronic maintains that the purposes of FDA's cost recovery mechanism align with the Commission's marketing restrictions, and that permitting cost recovery in clinical trials will encourage medical device research and development that will ultimately benefit consumers.

19. The Commission's rules generally prohibit the operation and marketing of RF products prior to equipment authorization except under certain specified conditions. § 2.805 (“Operation of radio frequency devices prior to equipment authorization”) lists conditions under which RF devices may be operated prior to equipment authorization, including operation under an experimental radio license issued under part 5 of the rules, and states that an RF device that may be operated prior to equipment authorization “may not be marketed (as defined in § 2.803(a)) except as provided elsewhere in this chapter.” § 2.803 (“Marketing of radio frequency products prior to equipment authorization”) defines marketing as “sale or lease, or offering for sale or lease, including advertising for sale or lease, or importation, shipment, or distribution for the purpose of selling or leasing or offering for sale or lease.” These restrictions on marketing are intended to prevent the unchecked dissemination of experimental devices into the stream of commerce, where they may not always be easily recalled. The Commission concludes here that accepting reimbursement payments under the FDA's rules for the use of an unauthorized RF device in a clinical trial falls within this definition of “marketing.” However, § 2.803 includes a number of exceptions to the general prohibition against marketing unauthorized equipment. One of those exceptions is for market trials conducted under a part 5 experimental license. Accordingly, and, as explained below, the Commission clarifies that the marketing advocated by Medtronic is permitted on a limited basis under the § 2.803 exception for market trials conducted by part 5 experimental licensees.

20. In the R&O, the Commission modified its part 5 rules to provide more flexibility for market trials, including some forms of cost recovery, while continuing to provide safeguards to protect the public. Section 5.602 (“Market Trials”) permits marketing of devices (as defined in § 2.803) and provision of services for hire prior to equipment authorization, provided that the devices included in the market trial are authorized under this rule section and will be operated under the current rules; could be authorized under waivers of such rules that are in effect at the time of marketing; or could be authorized under rules that have been adopted by the Commission, but that have not yet become effective. The rule stipulates that the experimental licensee must own all transmitting and/or receiving equipment, but also permits the experimental licensee to: (1) Sell equipment to other licensees (e.g. manufacturer to licensed service provider), and (2) lease equipment to trial participants for purposes of the study. Equipment must be retrieved or rendered inoperable after the trial.

21. The Commission finds that, for devices that necessitate an experimental license for the conduct of a clinical trial, the market trial rule allows for some cost recovery for investigational devices used in those trials consistent with the Commission's purpose to prevent the unchecked dissemination of experimental devices into the stream of commerce. While the Commission's market trial rules differ from the FDA rules, they do provide manufacturers of experimental medical devices a mechanism for offsetting costs associated with the development of those devices. For example, FDA rules allow sponsors to charge investigators for medical devices and these costs may be passed on to the clinical trial participants, and a part 5 market trial licensee may sell devices to another licensee (e.g., a health care facility that is a medical testing licensee) or lease medical devices to trial participants, which may permit full or partial cost recovery. The Commission believes that this structure generally accommodates Medtronic's request, and serves the public interest by providing medical device manufacturers an incentive to develop innovative, but potentially costly, devices for use in clinical trials.

22. The Commission also observes that not all clinical trials occur under part 5 experimental rules. The Commission's experience has been that clinical trials, especially those involving implanted devices which cannot be easily returned to the licensee as the rules require, occur after the FCC has issued an equipment authorization grant for the device. In those cases, there is no FCC marketing restriction that conflicts with FDA rules.

23. The Commission also clarifies that a medical testing licensee conducting clinical trials that wants to seek reimbursement under the FDA's rules should follow the requirements for market trials in § 5.602. In establishing the medical testing license, the Commission observed that the license will allow for “clinical trials of medical devices that have already passed through the early developmental stage and are ready to be assessed for patient compatibility and use, as well as operational, interference, and RF immunity issues in real world situations.” This is conceptually analogous to a market trial, which “com[es] later in the development process” and is a “program designed to evaluate product performance and customer acceptability prior to the production stage.” Also, both medical testing licenses and market trials licenses are used for devices that will be operated under the current rules; could be authorized under waivers of such rules that are in effect at the time of marketing; or could be authorized under rules that have been adopted by the Commission, but that have not yet become effective. In the R&O the Commission stated that it would require a market trial to be authorized under a conventional, rather than a program, license “in recognition of the inherent difference between market trials and `regular' experimentation and testing—the most prominent difference being the necessity to prevent an experimental licensee from creating a de facto service through the experimental licensing process.” As discussed above, clinical trials are analogous to market trials, and should be treated like market trials for cost recovery purposes by the experimental license rules. Accordingly, the Commission modifies § 5.402 to make clear that medical testing licensees may recover their costs to the extent they are permitted by the market trial rule.

24. The Commission also clarifies that, under a conventional license issued for a product development trial, a licensee conducting a clinical trial could not be reimbursed for its costs, and the Commission takes this opportunity to correct a contradiction in its current rules regarding product development trials. Although § 2.803 exempts product development trials from the marketing rule for equipment operated prior to certification, the product development trial rule (§ 5.601) expressly prohibits marketing of devices as defined in § 2.803 or the provision of services for hire. This prohibition in the rule is consistent with the Commission's statement in the R&O that licensees conducting a product development trial must not market devices or offer services for hire. The Commission differentiated product development trials, which occur very early in the development process, from market trials for marketing purposes. Market trials, which occur later in the development process, can engage in marketing activity if they use equipment that could be operated under the current rules; could be authorized under waivers of such rules that are in effect at the time of marketing; or could be authorized under rules that have been adopted by the Commission, but that have not yet become effective. Product development trials have no such restrictions and thus restricting marketing is important to prevent the unchecked dissemination of experimental devices into the stream of commerce. Clearly, the Commission's intent was to prohibit marketing for product development trials and erred in its drafting of the marketing exceptions in § 2.803. Accordingly, the Commission herein corrects § 2.803(c)(1) to refer only to market trials and remove the reference to product development trials. Thus, the Commission notes that reimbursement under the FDA's rules for clinical trials would not be permitted for a product development trial.

25. Thus, the Commission concludes that Medtronic's requests are best accommodated under the existing rules. To the extent that cost recovery for medical devices used in clinical trials is done under the market trial rules set forth in § 5.602, the Commission grants Medtronic's request and clarifies that such cost recovery does not constitute impermissible marketing under §§ 2.803 and 2.805 of its rules.

26. In their petition, Sirius XM and EchoStar request that the Commission add a definition of “emergency notifications” to its rules to clarify that all participants in the Emergency Alert System are emergency notification providers, and are therefore entitled to notification of program experiments that might affect them, as well as protection from harmful interference that such experiments might cause to them. The R&O specified that for program license experiments that may affect critical service bands (i.e. bands used for the provision of commercial mobile services, emergency notifications, or public safety purposes), the program licensee must take the additional steps of developing a specific plan to avoid causing harmful interference to operations in those bands prior to commencing operations and providing notice to those critical service licensees who might be affected by the planned experiment.

27. Sirius XM and EchoStar observe that the NPRM explicitly recognized that EAS participants provide emergency notifications, and that the R&O required that any program licensee seeking to undertake an experiment in a band used for emergency notifications must develop a plan to avoid interference to emergency notification providers, but that the R&O failed to specify that such providers include all EAS participants. Sirius XM and EchoStar contend that this failure will create confusion on the part of program license applicants and undermine the Commission's goal of avoiding interference threats to the EAS network. Therefore, to avoid the possibility that program licensees may fail to notify EAS participants of their planned experiments or cause harmful interference to EAS participants, Sirius XM and EchoStar recommend that the Commission set forth a definition of emergency notification providers that includes all EAS participants. No party filed comments regarding the Sirius XM/EchoStar Petition.

28. The Commission's goal throughout this proceeding has been to foster new experimental uses of the RF spectrum, while protecting authorized radio services from any harmful interference that these new uses might cause. Moreover, the Commission has recognized that an additional measure of protection must be afforded to bands used by services that are crucial to the public safety and well-being. The Commission's clear intent in this proceeding has been to include all EAS participants as emergency notification providers. For example, the Commission included this discussion in the NPRM: “. . . Television and radio broadcast bands are used in support of the Emergency Alert System (EAS). In recognition of these vital interests, the Commission proposes to require that, for tests that affect bands use for the provision of commercial mobile services, emergency notifications, or public safety purposes on the institution's grounds, the licensee first develop a specific plan that avoids interference to these bands.” As Sirius XM and EchoStar observe, the R&O adopted the NPRM's proposal that the program licensee must develop a specific plan to avoid harmful interference to operations in these critical service bands, but failed to explicitly state that emergency notification providers include all EAS participants. Accordingly, and to avoid any confusion, the Commission is adding to § 5.5 of the rules a definition of emergency notification providers as inclusive of all EAS participants.

29. Regulatory Flexibility Certification. The Regulatory Flexibility Act (RFA) requires that agencies prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not have a significant economic impact on a substantial number of small entities.” The Commission hereby certifies that the rule revisions set forth herein will not have a significant economic impact on a substantial number of small entities for the following reasons: (1) The modification of § 5.85(a) essentially restores that rule to what existed prior to initiation of this proceeding, but with the further modification that permits use of passive service bands by compliance testing licensees, as was explicitly authorized in the R&O. As explained above, the prohibitions adopted in the rules appendix of the R&O was over-inclusive—the stated intent in this proceeding was to prohibit experimental use of the passive bands only by program and medical testing licensees and in product development and market trials. Restoring the rule to allow for the grant of conventional experimental licenses that use the passive bands, which had been permitted for many years prior to adoption of the R&O, as well as permitting use of these bands by new compliance testing licensees, will not have an adverse impact on any small entities. (2) Denying FDA sponsors and sponsor-investigators eligibility for medical testing licenses in § 5.402 of the Commission's rules will not adversely impact small entities, as they will still have the ability to conduct clinical medical trials under the auspices of a product development trial, or under a program license in cases in which the Commission establishes an innovation zone for a clinical trial. (3) Clarifying that some cost reimbursement for medical devices used in clinical trials is permissible under the § 5.602 market trial rules may benefit some small entities, without adversely impacting any such entities. (4) Clarifying in § 5.5 of the rules that all participants in the Emergency Alert System are emergency notification providers simply codifies what was adopted in the R&O, and will not adversely impact any small entities. The Commission will send a copy of this Memorandum Opinion and Order, including this certification, to the Chief Counsel for Advocacy of the Small Business Administration.

30. Paperwork Reduction Act Analysis. This document contains no new or modified information collection requirement that are subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), it previously sought specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees.

31. Congressional Review Act. The Commission will send a copy of this Memorandum Opinion and Order in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

32. Pursuant to section 4(i), 301, 303 and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 303, and 405 and § 1.1, 1.2, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.2, and 1.429, this Memorandum Opinion and Order is adopted.

33. The petitions for reconsideration filed by Marcus Spectrum Solutions LLC; Medtronic, Inc.; and Sirius XM Radio Inc. and EchoStar Technologies Inc. Are granted, to the extent indicated above, and otherwise are denied.

34. Parts 2 and 5 of the Commission's rules are amended, as set forth in the Final Rules. These revisions will be effective September 30, 2015 of this Memorandum Opinion and Order.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 2 and 5 as follows:

NMFS is specifying the 2015 ACLs and AMs for bottomfish, crustacean, precious coral, and coral reef ecosystem fishery management unit species (MUS) in American Samoa, Guam, the CNMI, and Hawaii. NMFS proposed these specifications on July 21, 2015 (80 FR 43046), and the final specifications do not differ from those proposed. The 2015 fishing year began on January 1 and ends on December 31, except for precious coral fisheries, for which the fishing year began on July 1, 2015, and ends on June 30, 2016.

NMFS is not specifying ACLs for MUS that are currently subject to Federal fishing moratoria or prohibitions. These MUS include all species of gold coral, the three Hawaii seamount groundfish (pelagic armorhead, alfonsin, and raftfish), and deepwater precious corals at the Westpac Bed Refugia. The current prohibitions on fishing for these MUS serve as the functional equivalent of an ACL of zero.

Additionally, NMFS is not specifying ACLs for bottomfish, crustacean, precious coral, or coral reef ecosystem MUS identified in the Pacific Remote Islands Area (PRIA) FEP. This is because fishing is prohibited in the EEZ within 12 nm of emergent land of the PRIA, unless authorized by the U.S. Fish and Wildlife Service (USFWS), in consultation with NMFS and the Council. Additionally, there is no suitable habitat for these stocks beyond the 12-nm no-fishing zone, except at Kingman Reef, where fishing for these resources does not occur. To date, the USFWS has not consulted with NMFS for any fishing that the USFWS may authorize within 12 nm of the PRIA. NMFS will continue to monitor authorized fishing within 12 nm of the PRIA in consultation with the USFWS, and may develop additional fishing requirements, including catch limits for species that may require them.

NMFS is also not specifying ACLs for pelagic MUS at this time, because NMFS previously determined that pelagic species are subject to international fishery agreements or have a life cycle of approximately 1 year and are, therefore, statutorily excepted from the ACL requirements.

Tables 1-4 list the ACL specifications for 2015.

Federal logbook and reporting from fisheries in Federal waters is not sufficient to monitor and track catches towards the proposed ACL specifications accurately. This is because most fishing for bottomfish, crustacean, precious coral, and coral reef ecosystem MUS occurs in state waters, generally 0-3 nm from shore. For these reasons, NMFS will apply a moving 3-yr average catch to evaluate fishery performance against the proposed ACLs. Specifically, NMFS and the Council will use the average catch during fishing year 2013, 2014, and 2015 to evaluate fishery performance against the appropriate 2015 ACL. At the end of each fishing year, the Council will review catches relative to each ACL. If NMFS and the Council determine the three-year average catch for the fishery exceeds the specified ACL, NMFS and the Council will reduce the ACL for that fishery by the amount of the overage in the subsequent year.

You may find additional background information on this action in the preamble to the proposed specifications published on July 21, 2015 (80 FR 43046).

The comment period for the proposed specifications ended on August 5, 2015. NMFS received comments from a commercial bottomfish fisherman on the proposed specifications for non-Deep 7 bottomfish in the main Hawaiian Islands (MHI), and from the U.S. Air Force on the applicability of annual catch limits for recreational fishing at Wake Atoll in the Pacific Remote Island Areas. NMFS responds to these comments as follows:

Comment 1: The proposed ACL should account for changes in the historical landings of non-Deep 7 bottomfish in the MHI that resulted from changes in market conditions and regulatory actions. The commenter suggested that, in the past, MHI fishermen limited their catch of certain non-Deep 7 bottomfish species because they were associated with ciguatera (a toxin) and because fishermen received low prices for their catch due to higher volume of fish provided by the bottomfish fishery in the Northwestern Hawaiian Islands (NWHI). The commenter noted, however, that the closure of the NWHI fishery in 2010 and restrictions on landing MHI Deep 7 bottomfish upon reaching the annual catch limit in past fishing season have resulted in MHI fishermen targeting non-Deep 7 bottomfish, and landing more fish in recent years.

Response: NMFS and the Council considered changes in the historical landing when specifying the ACL and AMs for MHI non-Deep 7 bottomfish. The Biomass Augmented Catch Maximum Sustainable Yield (MSY) model, which generates the estimate of MSY which is used as the basis for the overfishing limit, acceptable biological catch, and ACL, uses the historical catch record for MHI non-Deep 7 bottomfish from 1966-2013. Thus, in estimating MSY, the model includes the period of time when changes occurred in the landings of MHI non-Deep 7 bottomfish. NMFS and the Council continue to work on improving the scientific, commercial, and other information that provide the basis for management decisions, and are exploring fishery-independent methods and technologies for assessing bottomfish resources. As information becomes available, NMFS will accommodate such data in future models and stock assessments.

Comment 2: The commenter asserts that, because the ACL for MHI non-Deep 7 bottomfish is based on imperfect data, NMFS should allow more leeway in applying the AMs if the fishery exceeds the ACL.

Response: Under federal regulations at 50 CFR 600.310 implementing the ACL requirement, the ACL serves as the basis for invoking the AM. AMs are management controls to prevent a fishery from exceeding an ACL and to correct or mitigate any overage of the ACL. While the data may be imperfect, the Council and NMFS established the ACLs using the best available information, and NMFS must adhere to the established ACL and AM process. See 50 CFR 665.4 and 50 CFR 600.310.

Comment 3: The U.S. Air Force requested confirmation that the proposed ACLs and AMs for Pacific Island bottomfish, crustacean, precious coral and coral reef fisheries at Wake Island take into account the annual recreational harvest levels described in the Air Force Fishing Management Plan for Wake Atoll.

Response: In the proposed specifications (80 FR 43046, July 21, 2015), NMFS explained that we did not propose ACLs for bottomfish, crustacean, precious coral, or coral reef ecosystem MUS regulated under the PRIA FEP. In the Supplementary section of this final rule, NMFS again clarifies that it is not specifying ACLs for PRIA bottomfish, crustacean, precious coral, or coral reef ecosystem MUS. This is because fishing is currently prohibited within 12 nm of emergent land, unless authorized by the USFWS in consultation with NMFS and the Council (See 50 CFR 665.933). Also, there is no coral reef habitat seaward of the 12-nm prohibited fishing area. To date, the USFWS has not consulted with NMFS for any fishing that the USFWS may authorize within 12 nm of the PRIA. Consultation with the USFWS would provide information that NMFS and the Council need to monitor catch and effort in the PRIA, and to develop any future catch limits that would be necessary.

The Regional Administrator, NMFS PIR, determined that this action is necessary for the conservation and management of Pacific Island fishery resources, and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. NMFS published the factual basis for the certification in the proposed rule and does not repeat it here. NMFS received no comments on this certification; as a result, a regulatory flexibility analysis is not required, and none has been prepared.

This action is exempt from review under E.O. 12866 because it contains no implementing regulations.