Barley is defined in the U.S. Standards for Barley as grain that, before the removal of dockage, consists of 50 percent or more of whole kernels of cultivated barley ( Hordeum vulgare L.) and not more than 25 percent of other grains for which standards have been established under the USGSA. The term “barley” as used in these standards does not include hull-less barley or black barley.

In 2012, U.S. barley producers harvested 3.2 million acres of barley producing 220.3 million bushels of the grain. Of all the barley planted, more than 60 percent were malting barley types. Beer production in the United States (U.S.) accounts for approximately 55 percent of total domestic use (2008-2012 average), feed and industrial uses account for about 40 percent of domestic use (2008-2012 average), while whiskey, food and seed account for about 6 percent of domestic use (2008-2012 average). Barley is exported for feed and malting purposes, typically accounting for less than five percent of total barley usage.

Under the USGSA (7 U.S.C. 76), GIPSA is authorized to establish and maintain the standards for barley and other grains regarding kind, class, quality, and condition. The barley standards facilitate the marketing of barley, define U.S. barley quality, and define commonly used industry terms in the domestic and global marketplace. Also, the barley standards contain basic principles such as the basis of determination used for a particular quality factor analysis, as well as specifying grades, grade requirements, special grades, and special grade requirements. The barley standards, which were established on August 24, 1926, were last revised in 1997, and appear in the USGSA regulations at 7 CFR 810.201 through 810.207.

On October 4, 2011, GIPSA published an Advance Notice of Proposed Rulemaking (ANPR) in the Federal Register (76 FR 61287) requesting public comment on what revisions, if any, are needed to the current barley standards. GIPSA received four comments from two barley producer associations, one malting industry association, and one beer brewing company. The malting industry association provided a comment stating that two-rowed and six-rowed malting barley are used interchangeably by the malting industry, thus the grades and grade standards should be harmonized for most factors, excluding test weight and thin barley. The comment from a beer brewing company stated that malting quality specifications which are currently applicable only to two-rowed malting barley should be extended to six-rowed malting barley, because the brewing industry uses both types. Additionally, the brewing company stated that they fully supported the comments of the malting barley industry association. Comments from two North Dakota barley producers groups mirrored the comments of the malting barley industry association with regard to harmonizing the standards, and addressed other issues which will be discussed herein.

The malting barley industry association stated that distinctions between two- and six-rowed varieties are not generally warranted, but that distinctions for test weight and percent thin barley are warranted. Two-rowed and six-rowed malting barley have different test weight patterns that are under genetic control and influenced by environment.

All commenters recommended that grade limits for two-rowed and six-rowed malting barley be identical for all grade determining factors except test weight and thin barley, which should remain unchanged. U.S. malting barley manufacturers and users do not distinguish between two-rowed and six-rowed malting barley based on the current barley standards, but view both two-rowed and six-rowed malting barley as functionally equivalent.

All commenters stated that Wild Oats should be included as a grade determining factor for Six-rowed Malting barley. Likewise all commenters stated that Damaged kernels, as well as Other grains, should be included as a grade determining factor for Two-rowed Malting barley. All commenters stated that the grade factors Suitable malting type, Sound barley, and Skinned and broken kernels should all be harmonized for Two-rowed and Six-rowed Malting barley. Further, all commenters agreed that these specific changes are needed in the barley standards.

GIPSA believes that stakeholders in the malting barley industry are well-informed with respect to production, functionality, and quality issues related to malting barley. GIPSA believes the recommended revisions will facilitate the marketing of barley and accordingly, will propose amendments to the malting barley standards to make the recommended revisions. To harmonize two-rowed and six-rowed malting barley grade factors and grade limits, GIPSA recognizes the definitions of Six-rowed Malting barley and Two-rowed Malting barley must be also be consistent. Accordingly, GIPSA will propose revising the definition of Six-rowed Malting barley to mirror the definition of Two-rowed Malting barley, with the exception of test weight and percent thins.

All commenters recommended removing Six-rowed Blue Malting barley as a subclass of malting barley because (1) blue aleurone barley is no longer used by the malting and brewing industry in the U.S. and (2) no blue aleurone malting varieties are being grown for export, and (3) U.S. production of blue aleurone malting barley is minimal. GIPSA agrees and will propose revising the malting barley standards to remove Six-rowed Blue Malting barley as a subclass of malting barley.

GIPSA received identical comments from two North Dakota barley producer groups. Both producer groups questioned why the definitions of Frost-damaged kernels, Heat-damaged kernels, and Mold-damaged kernels included the words “other grains, and wild oats” in their definitions, while the definitions of Injured-by-frost, Injured-by-heat, and Injured-by-mold do not include other grains and wild oats. Both commenters stated that the terminology utilized in malting factors is quasi-redundant and can initiate misunderstanding. They recommended removing other grains and wild oats from all damage definitions, so as to focus attention on heat, frost, or mold damage to barley kernels rather than damage to components other than barley (i.e., other grains and wild oats). Barley is unique in that it is the only grain which has a definition for frost-damaged kernels and mold-damaged kernels in the standard. (In other grains, these damages are determined based on Visual Reference Images.)

The inclusion of “other grains” in the definition of heat-damaged kernels in barley is consistent with the definition of heat-damaged kernels in oats, rye, sorghum, triticale, and wheat. The purpose of including of “other grains” in the damage definition of certain grain standards is to hinder blending of inferior quality grains into the primary grain being presented for inspection. Some grains were more likely to have “other grains” blended into them, which explains why not all grains for which standards exist include “other grains” in the damage definition. The standards should promote increasing quality. Accordingly, GIPSA will not propose any revisions to the barley standards based on the two comments.

GIPSA received comments from the two producer groups recommending that consideration should be given to establishing specific grades for hull-less barley. Hull-less barley is a specialized plant wherein the hull does not adhere to the grain. In the regulations at 810.201, the definition of barley states, “The term “barley” as used in these standards does not include hull-less barley or black barley.” Hull-less barley is considered Not Standardized Grain, counted as “other grain” when encountered in barley, and counted against “sound barley”.

In a comment unrelated to hull-less barley, the malting industry association pointed out that the production of malt for brewing requires barley that is sound, and with an intact hull. The malting and brewing industries are the largest users of U.S. barley. The hull of the barley kernel plays a critical role in the malting process. The malt manufacturing industry would encounter processing problems if hull-less barley was counted as barley, even if only a small percentage of hull-less barley kernels were comingled with malting types. This commenter also addressed “malting factors” that are not part of this rulemaking.

GIPSA's Program Directive 9180.65 provides inspection and certification procedures for hull-less barley, so applicants for service can receive certified results on factors of interest. Given these facts, and absent a market signal from end-users, GIPSA will not propose revisions to the barley standards establishing grades for hull-less barley.

All commenters stated that certain revisions were needed in the inspection instructions in the Barley chapter of Grain Inspection Handbook 2. While inspection instructions are not included in the regulations, GIPSA will review the inspection instructions in Handbook 2, in consideration of the comments, separately from this rulemaking.

GIPSA is issuing this proposed rule to invite comments from all interested persons on how GIPSA can further enhance the barley standards to better facilitate the marketing of barley.

GIPSA proposes to revise Section 810.202 Definition of other terms (c)(1) by amending (i) Six-rowed Malting barley to remove the reference to kernels with white aleurone layers and adding maximum percentages for injured-by-mold and mold-damage kernels, removing (ii) Six-rowed Blue Malting barley, and renumbering (iii) Two-rowed Malting barley to become (ii).

GIPSA proposes to revise Section 810.204 Grade and Grade Requirements for Six-rowed Malting barley and Six-rowed Blue Malting barley by removing references to Six-rowed Blue malting barley, adding Wild Oats as a grade determining factor, increasing the minimum percent of suitable malting type at grades 1 and 2, and increasing the minimum percent of sound barley at all grades.

GIPSA proposes to revise Section 810.205 Grade and Grade Requirements for Two-rowed Malting barley by adding Damaged kernels as a grade determining factor, adding Other grains as a grade determining factor, and reducing the maximum percent of Skinned and broken kernels at grades 1, 2, and 3.

Pursuant to section 4(b)(1) of the USGSA, as amended (7 U.S.C. 76(b)(1)), no standards established, or amendments or revocations of the standards, are to become effective less than 1 calendar year after promulgation unless, in the judgment of the Secretary of Agriculture, the public health, interest, or safety require that they become effective sooner.

This rule has been determined to be exempt for the purposes of Executive Orders 12866 and 13563, and therefore has not been reviewed by the Office of Management and Budget (OMB).

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), GIPSA has considered the economic impact of this action on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened.

The Small Business Administration (SBA) defines small businesses by their North American Industry Classification System Codes (NAICS). 1 This proposed rule affects customers of GIPSA's official inspection and weighing services in the domestic and export grain markets such as grain elevators/merchants (NAICS 424510), those in the malt manufacturing industry (NAICS 311213), and official grain inspection agencies.

GIPSA is proposing to revise the barley standards in the Definitions of Other Terms by removing Six-rowed Blue Malting barley and the reference to kernels with white aleurone layers. In addition, the proposed change will add injured-by-mold and mold-damaged kernels to the definition of Six-rowed Malting barley. The definition change also revises the grade and grade requirements for Two-rowed Malting barley. Further, the grade and grade requirements for Six-rowed Malting barley and Six-rowed Blue Malting barley will be revised.

Under the provisions of the USGSA, grain exported from the U.S. must be officially inspected and weighed. Mandatory inspection and weighing services are provided by GIPSA at 40 export facilities, by delegated States at 11 facilities, and seven facilities for U.S. grain transshipped through Canadian ports. All of these facilities are owned by multi-national corporations, large cooperatives, or public entities that do not meet the requirements for small entities established by the SBA. Further, the regulations are applied equally to all entities. The USGSA (7 U.S.C. 87f-1) requires the registration of all persons engaged in the business of buying grain for sale in foreign commerce. In addition, those persons who handle, weigh, or transport grain for sale in foreign commerce must also register. Section 800.30 of the USGSA regulations (7 CFR 800.30) define a foreign commerce grain business as persons who regularly engage in buying for sale, handling, weighing, or transporting grain totaling 15,000 metric tons or more during the preceding or current calendar year. At present, there are 129 registrants registered to export grain. All are considered to be large businesses.

GIPSA also provides domestic and miscellaneous inspection and weighing services at other than export locations. Such services are provided by 53 official state and private agencies. Approximately 217 different applicants receive domestic inspection services each year and approximately 150 different locations receive track scale tests as a miscellaneous service each year.

Most users of the official inspection and weighing services do not meet the requirements for small entities nor are the agencies that provide such services. Further, GIPSA is required by statute to make services available and to recover, as nearly as practicable, the costs of providing such services. There would be no additional reporting, record keeping, or other compliance requirements imposed upon small entities as a result of this proposed rule. Further, GIPSA has not identified any other Federal rules which may duplicate, overlap or conflict with this proposed rule. GIPSA has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities as defined in the RFA.

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. The USGSA provides in section 87g that no subdivision may require or impose any requirements or restrictions concerning the inspection, weighing, or description of grain under the USGSA. Otherwise, this rule would not preempt any State or local laws, or regulations, or policies unless they present an irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

This proposed rule has been reviewed with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. GIPSA has received no requests for official services for barley from any Tribal Government. Therefore, GIPSA believes that this rule would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements included in this proposed rule previously has been approved by the OMB under control number 0580-0013.

GIPSA is committed to complying with the Government Paperwork Elimination Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to maximum extent possible.

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

For reasons set out in the preamble, GIPSA proposes to amend 7 CFR part 810 as follows:

I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2009-0279 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0279.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ ADAMS Public Documents” and then select “ Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2009-0279 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS, and the NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

The NRC's primary radiation protection regulations are in part 20 of Title 10 of the Code of Federal Regulations (10 CFR). The purpose of these regulations is to establish standards of protection for both members of the public and occupational workers from ionizing radiation resulting from activities conducted under licenses issued by the NRC. These standards are implemented through the radiation protection requirements in the 10 CFR part 20 regulations that NRC licensees must follow. The NRC's predecessor agency, the Atomic Energy Commission (AEC), initially issued its regulations for radiation protection in the Federal Register (FR) on January 29, 1957 (22 FR 548). The regulations substantially followed the recommendations of the first official publication of the then National Committee on Radiation Protection and Measurement, which was renamed in 1964 when it was officially charted by the U.S. Congress (Pub. L. 88-376) and is now known as the National Council on Radiation Protection and Measurements (NCRP). The NCRP report was published in 1953 by the Subcommittee on Permissible Internal Dose, Handbook 52, “Maximum Permissible Amounts of Radioisotopes in the Human Body and Maximum Permissible Concentrations in Air and Water” (NCRP 1953). 1 The ICRP essentially adopted the NCRP 1953 recommendations in “Recommendations of the International Commission on Radiological Protection,” December 1, 1954,” except for one major deviation. The ICRP was the first to recommend limiting radiation doses to persons other than radiation workers, that is, to members of the public. It recommended a dose one tenth of that acceptable for occupational workers, which the NCRP later adopted in 1958. 2

Throughout the mid to late 1950s, the ICRP and the NCRP adopted similar recommendations. For example, in April 1956, the ICRP considered changes to its dosimetry system that included recommendations for accumulated internal dose limits for the critical organs of the human body. The ICRP issued a recommendation of 50 mSv (5 rem) per year for the whole body, gonads, lens of the eye, and active bone marrow of occupational workers. This recommendation was later adopted by both the NCRP and the ICRP (NCRP 1957 and ICRP 1958). 3 The AEC's 1957 final rule that promulgated 10 CFR part 20, and the 1960 amendments to 10 CFR part 20 (25 FR 8595, September 7, 1960; and 25 FR 10914, November 17, 1960), reflect collaborative efforts between the ICRP and NCRP. Therefore, the dose calculation methodology for the AEC's radiation protection standards was based, in part, upon the compilation of the ICRP recommendations developed during the mid to late 1950s and contained in ICRP Publication 1, “Recommendations of the International Commission on Radiological Protection,” 1959; and ICRP Publication 2, “Permissible dose for internal radiation,” 1959.

Following the establishment of the NRC in 1975, the next and last revision of 10 CFR part 20 was published in the Federal Register on May 21, 1991 (56 FR 23360). The purpose of the 1991 revision was to adopt the basic tenets of the ICRP system of radiation dose limitation described in ICRP Publication 26 (1977), “Recommendations of the ICRP.”  4 The 1977 recommendations significantly modified previous radiation protection concepts and principles.

It established a new risk-based system of radiation protection based on three principles: Justification, optimization, and limitation. (1) Justification requires that no new practice or operation involving radiation should be allowed unless it produces a net benefit (i.e., no frivolous use of radiation). (2) Optimization requires all exposures to be kept as low as is reasonably achievable (ALARA) taking into account all relevant social and economic factors. (3) Limitation requires that the effective dose equivalent to individuals shall not exceed the limits (dose limits) as established for appropriate circumstances. The ICRP Publication 26 (1977) also provided for the summation of internal and external exposures for the first time, and eliminated the concept of a threshold effect or tolerance dose and introduced the concept of carcinogenesis as a stochastic effect (i.e., health effects that occur randomly). It provided the foundation and basis for all current Federal and State regulations, except the U.S. Department of Labor's, which is still based upon the ICRP recommendations of the 1950s. (Reference: “A Review of the History of U.S. Radiation Protection Regulations, Recommendations, and Standards,” by C.G. Jones, Health Physics Journal, February 2005, Vol. 88, No. 2, page 113, (ADAMS Accession No. ML050400427), and Radiation Protection, Chapter 4, page 4-3, by J.U. Burnham, et al, 1992)

The majority of the ICRP Publication 26 (1977) recommendations were adopted in NCRP Report No. 91 (1987), “Recommendations on Limits for Exposure to Ionizing Radiation.” The 1987 report replaced NCRP Report 39 (1971), “Basic Radiation Protection Criteria,” and NCRP Report No. 43 (1975), “Review of the Current Status of Radiation Protection Philosophy.” Therefore, the majority of the NCRP Report No. 91 (1987) recommendations were adopted in the 10 CFR part 20 amendments of 1991. The NCRP recommendations were issued after the publication of the proposed 10 CFR part 20 rule; as a result, some of its recommendations were not adopted in the final rule. For more information about ICRP Publication 26 (1977) and NCRP Report No. 91 (1987) recommendations incorporated into 10 CFR part 20 final rule, please see the statement of considerations for the 1986 proposed 10 CFR part 20 rule (51 FR 1092) and the 1991 final 10 CFR part 20 rule (56 FR 23391).

The 1991 revisions to 10 CFR part 20 were also supported by information in ICRP Publication 30 (1979-1988), “Limits for Intakes of Radionuclides by Workers,”  5 including its four parts, four supplements and index, which were published during the period of 1979 through 1988; and ICRP Publication 32 (1981), “Limits for Inhalation of Radon Daughters by Workers.” These documents were used to calculate the inhalation values for the annual limits on intake (ALIs) and derived air concentrations (DACs) for the radionuclides in 10 CFR part 20, appendix B. For more information about the application of these ICRP publications to the 10 CFR part 20 amendments, please see the statement of considerations for the 1986 proposed 10 CFR part 20 rule (51 FR 1092, 1121) and the 1991 final 10 CFR part 20 rule (56 FR 23391).

In ICRP Publication 45 (1985), 6 ICRP issued a statement recommending that the annual dose limit for members of the general public be reduced from 5 mSv (500 mrem) to 1 mSv (100 mrem); this annual dose limit which was adopted in the NRC's 1991 rulemaking. 7 In addition, when the 10 CFR part 20 rulemaking was near completion, the ICRP developed a new series of recommendations as ICRP Publication 60 (1991). 8

The ICRP Publication 60 (1991) recommendations included lowering the occupational dose  9 limit from 50 mSv (5 rem) per year to a 5-year average of 20 mSv (2 rem) per year, with the dose in any given year not to exceed 50 mSv (5 rem); eliminating dose limits for individual organs, except for the skin and the lens of the eye; lowering the exposure limits to an embryo/fetus during the gestation period from 5 mSv (500 mrem) to 4.5 mSv (450 mrem); and changing radiation protection terminology and definitions. The ICRP Publication 60 (1991) recommendations were not considered in the NRC's 1991 rulemaking because they were issued after the rule's public comment period ended. Following the issuance of ICRP Publication 60 (1991), the ICRP issued a series of publications that revised internal dosimetry models. The revised internal dosimetry models superseded many, but not all, of the models described in ICRP Publication 30 (1979-1988) and earlier ICRP publications. As a result, there are differences between 10 CFR part 20 and the dosimetry approaches and occupational dose limits reflected in ICRP Publications 60-61, 66-69, 71-72, and 74. 10

Other than conforming changes to update cross-references to 10 CFR part 20 found in other NRC regulations, the 1991 rulemaking did not substantively revise other NRC regulations (e.g., 10 CFR parts 32, 50, 51, 61, and 72) that had explicit dose criteria. Consequently, some NRC regulations are still based on ICRP Publication 1 (1959), ICRP Publication 2 (1959), and NCRP reports of the 1950s. The differences between the 10 CFR part 20 requirements and the ICRP recommendations issued after ICRP Publication 30 (1979-1988) have created challenges for the NRC and its licensees.

The NRC staff described these challenges in its paper to the Commission, SECY-01-0148, “Processes for Revision of 10 CFR Part 20 regarding Adoption of ICRP Recommendations on Occupational Dose Limits and Dosimetric Models and Parameters,” dated August 2, 2001 (ADAMS Accession No. ML011580363). Specifically, the challenges included licensee requests to use dosimetry methods based upon the recommendations in the various ICRP publications issued after ICRP Publication 30 (1979-1988) for both external (to the body) and internal (within the body) dose assessments; licensees exceeding, or potentially exceeding, dose limits, although the NRC staff had determined that in some cases the 10 CFR part 20 methods for assessing internal and external dose were overly conservative relative to the most current ICRP recommendations; the general areas of differences between radiation protection requirements of the NRC and those nations that relied upon the later ICRP recommendations, including the differences in occupational exposure limits; and the use by some Federal agencies (e.g., U.S. Department of Energy (DOE) and the U.S. Environmental Protection Agency (EPA)) of dosimetry models based upon ICRP recommendations that were either not incorporated in the 1991 rulemaking or were published after that rulemaking.

The SECY-01-0148 paper also discussed options for amending 10 CFR part 20 by adopting the ICRP's recommended occupational dose limits, dosimetric models, and related parameters, and the advantages and disadvantages of the NRC's adoption of the recommendations in ICRP Publication 60 (1991) and the dosimetry models in ICRP Publications 66-69, 71-72, and 74. The paper concluded with an NRC staff recommendation not to amend 10 CFR part 20 at that time, but rather to initiate an effort to study the impacts of adopting the recommended ICRP dosimetry models by through outreach with stakeholders; working with other Federal agencies through the Interagency Steering Committee on Radiation Standards (ISCORS) to ensure a coherent approach within the United States in radiation protection standards and dosimetric models; developing a technical information basis to provide a better understanding of analytical impacts of possible alternative changes to 10 CFR part 20; and monitoring the work of the ICRP as it develops its revision to implement the ICRP Publication 60 (1991) recommendations.

In the staff requirements memorandum (SRM) to SECY-01-0148, dated April 12, 2002, (ADAMS Accession No. ML021050104), the Commission approved the NRC staff's recommendations to continue to work with and monitor the efforts of other Federal agencies to ensure a coherent approach to U.S. radiation protection standards and dosimetric models and to continue to monitor work of the ICRP. The Commission disapproved the development of a communication plan and a technical information basis. The Commission also directed the NRC staff to continue to consider and grant, as appropriate, licensee requests to use the ICRP Publication 60 (1991) revised internal dosimetry models on a case-by-case basis. As a result, the current NRC regulatory framework is a mixture of radiological standards, concepts and quantities, ranging from the 1959 recommendations in ICRP Publication 1 (1959) to the modeling and numeric values of the 1990 recommendations in ICRP Publication 60 (1991). 11

With the issuance of ICRP Publication 103 (2007), 12 the NRC was again presented with the question of whether to update its regulations to reflect the ICRP's recommendations in the area of radiation protection science. This question was addressed in SECY-08-0197, “Options to Revise Radiation Protection Regulations and Guidance with Respect to the 2007 Recommendations of the ICRP,” dated December 18, 2008 (ADAMS Accession No. ML091310193). This paper described and evaluated the ICRP Publication 103 (2007) recommendations along with an NRC staff's recommendation that the Commission approve a closer alignment of the NRC's regulatory framework with the ICRP Publication 103 (2007) recommendations. The NRC staff's recommendation set forth some steps to achieve this alignment, including the development of a technical basis, or the rationale, for a proposed rulemaking to amend the NRC's radiation protection regulations and outreach with stakeholders and interested parties to identify issues, options, and impact information. The NRC staff stated that it would provide the Commission with the results of the stakeholder and interested party interactions, the scope of the proposed rulemaking, including policy and implementation issues, the resources needed for the rulemaking, and the projected rulemaking completion date, which would be dependent on the ICRP's development of essential technical information.

The SECY-08-0197 paper noted that the ICRP Publication 103 (2007) recommendations provided new values for the tissue weighting factors. 13 The paper also noted that ICRP estimated the following dates and deliverables for updated scientific information and guidance for its new dosimetry system: a. A dose conversion factors for calculating occupational exposure from the most commonly used radioisotopes by 2011, b. dose conversion factors for calculating dose limits for members of the public by 2012, and c. dose conversion factors for calculating exposure for all radionuclides by 2014. At present, this information is still being developed. The ICRP's development of biokinetic and dosimetric models and dose coefficients for both worker and public exposure to radionuclides based on the ICRP recommendations was projected for completion by 2014. It is anticipated that this information will not be available until after 2015.

As pointed out in SECY-08-0197, the revised dose conversion factors are crucial to any amendment of the NRC's radiation protection framework. These factors could provide the basis for revising the numeric values of weighting factors, ALIs, and DACs contained in the following 10 CFR part 20 requirements: 10 CFR part 20, appendix B, Table 1, “Occupational Values;” 10 CFR part 20, appendix B, Table 2, “Effluent Concentrations;” and 10 CFR part 20, appendix B, Table 3, “Releases to Sewers.”

In the SRM to SECY-08-0197, “Options to Revise Radiation Protection Regulations and Guidance with Respect to the 2007 Recommendations of the International Commission on Radiological Protection,” dated April 2, 2009 (ADAMS Accession No. ML090920103), the Commission approved the NRC staff's recommended option to begin engagement with stakeholders and interested parties to initiate development of the technical basis for possible revision of the NRC's radiation protection regulations, as appropriate and where scientifically justified, to achieve greater alignment with the ICRP Publication 103 (2007) recommendations. The Commission also directed the NRC staff to continue to participate in national and international forums on radiation protection and to keep them informed of the results of these outreach activities. Notably, the Commission agreed with both the NRC staff and the NRC's Advisory Committee on Reactor Safeguards (ACRS) that “the current NRC regulatory framework continues to provide adequate protection of the health and safety of workers, the public, and the environment.”  14 In this regard, the Commission stated that from “a safety regulation perspective, ICRP Publication 103 (2007) proposes measures that go beyond what is needed to provide for adequate protection.”  15 During the outreach activities associated with the potential alignment with the ICRP Publication 103 (2007) recommendations, the Commission directed the NRC staff to “focus the discussion on discerning the benefits and burdens associated with revising the radiation protection regulatory framework.”  16

The Commission also directed the NRC staff to examine how a lower occupational dose limit of 20 mSv (2 rem) per year has affected the medical and industrial sectors in countries that have implemented the ICRP recommendation when developing the technical basis for the rulemaking. Finally, based on the extent and complexity of the stakeholder comments received, the Commission directed the NRC staff to either (1) provide the Commission with a proposed rule once the technical basis has been developed, or (2) provide a paper to the Commission outlining any substantive policy issues and options for their resolution prior to developing a proposed rule.

In response to the Commission's direction in SRM-SECY-08-0197, NRC staff conducted stakeholder outreach activities on issues about potential changes to the NRC's radiation protection regulations. Three Federal Register notices were issued requesting public feedback and comments (74 FR 32198, July 7, 2009; 75 FR 59160, September 27, 2010; and 76 FR 53847, August 30, 2011). Presentations and discussions were made at a variety of professional societies, licensee organizations, public interest groups, and State organizations (e.g., Conference of Radiation Control Program Directors and the Organization of Agreement States).

In the fall of 2010, the NRC staff conducted a series of facilitated round table workshops in Washington, DC, Los Angeles, CA, and Houston, TX. Each workshop included representatives from a broad range of users of radioactive material; this process provided an opportunity for various groups of stakeholders to have a focused discussion of the technical issues associated with potential changes to the NRC's radiation protection standards. The October 2010 workshop in Washington, DC focused on the nuclear power and fuel cycle industries and the radiation protection programs of other Federal agencies (e.g., EPA, DOE, U.S. Navy, Armed Forces Radiobiology Research Institute, and National Institutes of Health). The November 2010 Los Angeles workshop focused on medical uses of radiation, and the November 2010 Houston, TX workshop focused on industrial radiography. These workshops provided stakeholders the opportunity to discuss the various technical issues with each other and with NRC staff. Transcripts of each workshop and written comments received in response to the Federal Register notices are publicly available through the NRC's public Web site on the page entitled, “Options to Revise Radiation Protection Regulations and Guidance,” http://www.nrc.gov/about-nrc/regulatory/rulemaking/potential-rulemaking/opt-revise.html.

In addition, the NRC staff's outreach activities included participation in the revision of the International Basic Safety Standards by the International Atomic Energy Agency (IAEA) from 2009 through its completion in the second quarter of 2013, and observation of the revision of the Euratom Basic Safety Standards Directive in the European Union. Both the IAEA's and Euratom's revisions focused on aligning their requirements with the ICRP Publication 103 (2007) recommendations.

After extensive stakeholder engagement, the NRC staff determined that an additional paper to the Commission outlining substantive policy issues was needed. This additional policy paper was provided as SECY-12-0064, “Recommendations for Policy and Technical Direction to Revise Radiation Protection Regulations and Guidance,” dated April 25, 2012 (ADAMS Accession No. ML121020108). The SECY-12-0064 paper summarized the NRC staff's interactions with stakeholders as directed by SRM-SECY-08-0197, and provided policy and technical guidance on potential revisions to the NRC's radiation protection regulations.

In SECY-12-0064, the NRC staff recommended that the NRC's regulatory framework be amended to reflect the new terminology and dose calculation methodologies to align with national and international scientific approaches for estimating radiation exposure and risk contained in ICRP Publication 103 (2007). The NRC staff, however, recommended that the NRC not initiate a rulemaking to reflect these changes until the ICRP published its updated dose coefficients and other supporting information, so that a single comprehensive change could be made to the relevant provisions and appendices of 10 CFR part 20. The NRC staff also recommended that the following be explored in greater detail: a reduction in the occupational dose limit to 20 mSv (2 rem) per year, including the mechanisms that would be available to provide some flexibility for licensees to request a higher limit under specified conditions; the impacts of a reduction in the dose limit for the lens of the eye to either 50 mSv (5 rem) or 20 mSv (2 rem), including how the prevention of cataracts should be viewed in comparison with the potential formation of cancer or other adverse impacts; and the impacts of a change in the dose limit for the embryo/fetus to 1 mSv (100 mrem).

Finally, in SECY-12-0064, the NRC staff recommended that: No additional ALARA (as low as is reasonably achievable) planning requirements should be made, however applicable regulatory guidance should be updated to provide additional examples of mechanisms acceptable in the development and implementation of radiation protection programs; the NRC staff should continue to monitor and interact with various international organizations in developing tools and methodologies for assessment of doses in the environment; the NRC staff should explore the implications, benefits, and costs of aligning NRC regulations in 10 CFR part 20 to the NRC metrication policy; and the NRC staff should explore a more detailed examination of the implications, benefits, and costs of requiring additional NRC license categories and Agreement State  17 licensees to report occupational exposures to the NRC's Radiation Exposure Information and Reporting System (REIRS) database.

In SRM-SECY-12-0064, “Recommendations for Policy and Technical Direction to Revise Radiation Protection Regulations and Guidance,” dated December 17, 2012 (ADAMS Accession No. ML12352A133), the Commission approved in part and disapproved in part the NRC staff's recommendations. Specifically, the Commission approved the NRC staff's development of a draft regulatory basis for a revision to 10 CFR part 20 to align with the most recent methodology and terminology for dose assessment in ICRP Publication 103 (2007), including consideration of any conforming changes to all NRC regulations. The Commission directed the NRC staff to develop improvements in the NRC's guidance for those segments of the regulated community that would benefit from more effective implementation of the ALARA strategies and programs to comply with regulatory requirements. The Commission also directed the NRC staff to continue discussions with stakeholders regarding dose limits for the lens of the eye and the embryo/fetus. In addition, the Commission directed the NRC staff to continue discussions with stakeholders on alternative approaches to deal with individual protection at or near the current dose limit. Finally, the Commission directed the NRC staff to improve reporting of occupational exposure by the NRC and Agreement State licensees to the NRC's REIRS database.

In SRM-SECY-12-0064, the Commission disapproved the NRC staff's recommendations to develop a draft regulatory basis to reduce the occupational total effective dose equivalent to 20 mSv (2 rem) per year. The Commission also disapproved the elimination of traditional or “English” dose units to measure radiation exposure from the NRC's regulations. Rather, the Commission directed the continuation of the use of both traditional and International System (SI)  18 units in the NRC's regulations.

In a separate and related activity, the NRC staff will be preparing an ANPR for 10 CFR part 50, appendix I (RIN 3150-AJ38; NRC-2014-0044), which concerns the NRC's design objectives governing dose assessments for radioactive effluents from light-water-cooled nuclear power reactors. The preparation of the 10 CFR part 50, appendix I, ANPR is also in response to the Commission's direction in SRM-SECY-12-0064, which stated that the NRC staff shall, along with the development of the draft regulatory basis for the 10 CFR part 20 regulations, engage in a parallel effort to develop a draft regulatory basis for aligning the 10 CFR part 50, appendix I, design objectives with the most recent methodology and terminology for dose assessment. 19

In accordance with the Commission's direction provided in SRM-SECY-12-0064, the NRC staff is preparing a draft regulatory basis to support a possible amendment to 10 CFR part 20, and with conforming changes to other NRC regulations to align more closely with the ICRP Publication 103 (2007) dose assessment methodology and terminology. The NRC staff is continuing to hold discussions with stakeholders regarding alternative approaches to ensure individual protection at or near the current dose limit are examined, including considerations of whether revised or additional regulatory requirements and guidance may be appropriate to ensure that cumulative occupational exposures  20 are minimized, and whether progressive restrictions should be taken as cumulative exposures increase; whether the dose limits for the lens of the eye should be reduced; whether the dose limits to the embryo/fetus of a declared pregnant occupational worker should be reduced; and whether any undue hardships arise as a result of applying the NRC's metrication policy to any amendment of the 10 CFR part 20 regulations. The results of these discussions with stakeholders will be reflected in the draft regulatory basis. Finally, the 10 CFR part 20 draft regulatory basis will consider improvements in the reporting of occupational exposure by the NRC and Agreement State licensees, including those licensees who currently do not currently submit reports to the NRC's REIRS database.

The NRC staff has identified policy and technical issues to guide the development of a draft regulatory basis for the potential revisions to the NRC's radiation protection regulations and guidance as described in Section III of this ANPR. Sections A through F that follow provide a summary of these policy and technical issues. A more detailed discussion of each issue is contained in a series of six issue papers prepared by NRC staff and identified in Section VIII of this ANPR.

Several revisions are under consideration to more closely align the existing NRC regulations in 10 CFR part 20 with the ICRP Publication 103 (2007) methodology and terminology for dose assessment. During the 30-year period of 1977 to 2007, the ICRP published three key radiological protection recommendations, ICRP Publication 26 (1977), ICRP Publication 60 (1991), and ICRP Publication 103 (2007). The current NRC regulatory framework is a mixture of radiological standards, concepts and quantities ranging from the recommendations in ICRP Publication 1 (1959) to the modeling and numeric values of the recommendations in ICRP Publication 60 (1991).

The current 10 CFR part 20 regulations are based primarily upon the recommendations of ICRP Publication 26 (1977); however, there is one difference in terminology worth noting. The ICRP recommendations used the phrases “the sum of the dose-equivalent from external exposure” and “the committed effective dose equivalent from the intake of radionuclides.” The NRC's regulations use the term “total effective dose equivalent” (TEDE) to represent the summation of dose received from sources external to the body and dose received from the intake of radioactive materials.

In 1991, the ICRP revised its recommendations for dose calculation. The ICRP Publication 60 (1991) recommendations provided changes in the way tissue and radiation weighting factors were defined and used (moving from quality factors to radiation weighting factors). A corresponding change in terminology was also made. For example, ICRP Publication 60 (1991) introduced the term “effective dose,” which was defined as the sum of the weighted equivalent doses in all the tissues and organs of the body.

Additionally, the ICRP Publication 103 (2007) recommendations made revisions to the calculation of dose, including (1) modification of the modeling used for calculation of radiation exposures, (2) changes in values of tissue weighting factors and radiation weighting factors, and (3) substantial modifications of the metabolic models used to represent the movement of radioactive material through the human body. The human body can now be modeled as a more complex set of mathematical and “voxel”  21 phantoms as a result of advances in medical imaging technology since the last substantial amendment of the 10 CFR part 20 regulations in 1991. These technological advances have resulted in the development of reference computational phantoms that are specific models for adult males and females, 15-year-old males and females, and for various other age groups, including infants, 1-year-old, 5-year-old, and 10-year-old children. The reference phantoms for the human body are described in general terms in ICRP Publication 103 (2007) and in ICRP Publication 110 (2009). 22

The availability of models for different age groups provides the opportunity to calculate the numeric values for public exposure to effluents in a more comprehensive manner as compared to the previous calculation methodology of basing assessments primarily on an adult member of the public. A general population includes individuals of both genders and various age groups that range from newborns to senior citizens. Over time, an individual matures from infancy to adulthood, which includes various stages of development. Therefore, the scientific community is evaluating the appropriate approach for a member of the public that would account for the period of time spent at different ages so that the long-term risk of exposure to radiological effluents over a number of years can be properly represented. In particular, the ICRP is considering the use of an age and gender weighted dose coefficient for developing a set of values for environmental intake of radionuclides. Similarly, the NRC is also considering revising the definition of the reference person  23 for its use in environmental dose calculations. The NRC is considering the use of the age and gender averaged approach to provide a more realistic representation of a member of the public that explicitly considers the presence of infants and children within the population.

The concept of a reference person may be like the approach documented in the DOE Technical Standard, DOE-STD-1196-2011, “Derived Concentration Technical Standard,” dated April 2011 (ADAMS Accession No. ML13323B598). The DOE-STD-1196-2011 calculates derived concentration standards using age-specific effective dose coefficients for reference members of the public, along with age and gender dependent intake rates for ingestion of water and inhalation of air. The members of the public are represented by six age subgroups (newborns, 24 1-year-old, 5-year-old, 10-year-old, and 15-year-old children and adults). The analysis weights the effective dose coefficients for each subgroup by their fractional representation in the U.S. population and by their intake of the radionuclide through inhalation, ingestion, or air submersion over their lifetimes. The DOE standard is based on the weighting factors and dose coefficients in ICRP Publication 60 (1991).

As part of its development of the draft regulatory basis, the NRC staff will consider revising the regulations in 10 CFR part 20, as well as making conforming changes to other NRC regulations, to incorporate the ICRP term, “effective dose.” The NRC staff recognizes the preference, from a regulatory stability standpoint, for retaining the term “total effective dose equivalent,” but will analyze, in the draft regulatory basis, the advantages and disadvantages of replacing “total effective dose equivalent” with “effective dose” or “total effective dose” in its regulations.

The same terminology as it is used elsewhere in the world may present qualitative benefits of consistency and ease in communication. With regard to the ICRP's dose assessment methodology recommendations, the NRC staff will consider, in the draft regulatory basis, replacing the definition of “weighting factor” (W T ) in 10 CFR 20.1003 with the tissue weighting factors in Table 3, ICRP Publication 103 (2007), and replacing the quality factors in 10 CFR 20.1004, Tables (B).1 and (B).2, “Units of Radiation Dose,” with the radiation weighting factors in Table 2, ICRP Publication 103 (2007), along with other associated changes (e.g., replacing “dose equivalent” with the term “equivalent dose,” and replacing “effective dose equivalent” with the term “effective dose,” and revising the definition of the term “quality factor”). If approved by the Commission, an update of 10 CFR part 20 to reflect the tissue weighting factors and radiation weighting factors from ICRP Publication 103 (2007) would amend these sections.

In addition, as a part of the development of the draft regulatory basis, NRC staff will consider revising the values in appendix B to 10 CFR part 20, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage;” Table 1, “Occupational Values;” Table 2, “Effluent Concentrations;” and Table 3, “Releases to Sewers,” with new values for ALIs, DACs, effluent concentrations, and sewer concentrations. The current values in appendix B are based on a public dose limit of 0.5 mSv (50 mrem).

The various types of NRC licenses pose different challenges for the use of methodology and terminology for dose assessment. In some instances, exposures to occupational workers and members of the public at a licensed facility are only from sources external to the body. Conversely, other types of licensed facilities have the potential for significant exposures to occupational workers and members of the public due to intake of radionuclides. These types of licenses would be more directly impacted by the revision of the W T , ALI, and DAC values. Therefore, the NRC staff is seeking to understand how various proposals for addressing this issue would affect licensee activities. Likewise, the NRC staff wishes to understand the possible impacts of the proposals, and more specifically, the reasons why certain proposals may be difficult to achieve or may undermine radiation protection. Therefore, the NRC staff is seeking to understand the impacts of adopting the ICRP Publication 103 (2007) methodology and terminology into its regulatory program.

The Issue Paper 1, “Update 10 CFR Part 20 to Align with International Commission on Radiological Protection Publication 103 Methodology and Terminology,” ICRP Publication 103, provides a more detailed discussion and is available in ADAMS under Accession No. ML14084A342. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders.

Q1-1: What are the implications of changing the NRC's regulations to specify “total effective dose” in place of the current term “total effective dose equivalent?” To the extent possible, please provide specific implementation and operational cost information on the impacts of this change relative to licensee procedures, training, recordkeeping, and reporting. This information is necessary for the NRC to determine whether the imposition of such requirements on NRC licensees is justified.

Q1-2: If the NRC adopts the dose assessment terminology and methodology of ICRP Publication 103 (2007) in a future rulemaking, what time period should the NRC consider providing for implementation of the ICRP Publication 103 (2007) methodology and terminology?

Q1-3: How should the calculations of effluent concentration, currently in the 10 CFR part 20 radiation protection regulations, be modified to reflect advances in modeling that are now available? In particular, the NRC is interested in preliminary views on the age and gender averaged approach.

Q1-4: Should the public dose limit of 0.5 mSv (50 mrem) continue to be the basis for the effluent concentration limits for the radionuclides in 10 CFR part 20, appendix B, Table 2, Columns 1 and 2? Should it be reduced or otherwise modified?

The ICRP Publication 26 (1977) provided an occupational dose limit of 300 mSv (30 rem) per year for the lens of the eye. During the 1980's, it became clear from epidemiological studies that the risks from radiation exposure were higher than those anticipated when the ICRP Publication 26 (1977) recommendations were published. As a result, in ICRP Publication 60 (1991), the ICRP recommended reducing the occupational dose limit for the lens of the eye to 150 mSv (15 rem) per year, which is 50 percent of the previously recommended limit of 300 mSv (30 rem) per year in ICRP Publication 26 (1977). In its 1991 rulemaking for 10 CFR part 20, the NRC adopted the ICRP Publication 60 (1991) recommendation in 10 CFR 20.1201(a)(2)(i). In addition, the 1991 amendments added a definition of “lens dose equivalent” (LDE), which is the external exposure of the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm 2 ). 25

As the ICRP continued to re-examine its radiation protection principles, it noted that the eye is one of the most sensitive organs of the body, that the protection of the eye against the effects of ionizing radiation is designed primarily to prevent the formation of cataracts, and that the most sensitive part of the eye for cataract formation is the lens. Cataract formation falls under the class of radiation effects referred to as deterministic (or tissue reactions as used in ICRP Publication 103 (2007)). At doses above a certain threshold, the severity of cataract formation increases with dose, but the radiation-induced incidence of cataract formation below the threshold dose is believed to be essentially zero.

On April 21, 2011, the ICRP issued a statement on tissue reactions indicating that a review of recent epidemiological evidence suggests that there are some tissue reaction effects, particularly those with very late manifestation, where threshold doses are, or might be, lower than previously considered. For the lens of the eye, the threshold absorbed dose is now considered to be 0.50 Gy (50 rad). The ICRP's statement was based on draft report, “Early and Late Effects of Radiation in Normal Tissues and Organs: Threshold Doses for Tissue Reactions and Other Non-Cancer Effects of Radiation in a Radiation Protection Context,” which was published on January 20, 2011, by ICRP. The draft report contained information reviewing the early and late effects of radiation in 36 normal tissues and organs with respect to radiation protection. It also provided new estimates of threshold doses for tissue injury in all organ systems, and for morbidity and mortality, following acute, fractionated, or chronic exposure.

On, August 30, 2011, the NRC solicited public comments on the proposed new ICRP recommendations with the publication, “New International Commission on Radiological Protection Recommendations on the Annual Dose Limit to the Lens of the Eye,” in the Federal Register (76 FR 53847). A summary of stakeholder views on this issue is provided in SECY-12-0064, Enclosure 3, “Assessment of Technical Issues and Feedback,” pages 13 through 17 (ADAMS Accession No. ML121020108).

The ICRP revised the January 2011 draft report based on the comments received during the comment period. Its findings were included in ICRP Publication 118 (2012), “ICRP Statement on Tissue Reactions and Early and Late Effects of Radiation in Normal Tissues and Organs—Threshold Doses for Tissue Reactions in a Radiation Protection Context,” published on August 28, 2012. The ICRP Publication 118 (2012) formalized the new ICRP recommendations for the lens of the eye that are based on the prevention of radiogenic cataracts. For planned occupational exposure situations, the ICRP recommended reducing the limit on equivalent dose for the lens of the eye to 20 mSv (2 rem) per year, averaged over 5 consecutive years (i.e., 100 mSv (10 rem) in 5 years), with no single year exceeding 50 mSv (5 rem), which is significantly lower than ICRP's previous recommendation of 150 mSv (15 rem) per year in ICRP Publication 60 (1991).

The NRC believes that it is appropriate, and scientifically justified, to explore in greater detail the impact of a reduction in the dose limit for the lens of the eye to 50 mSv (5 rem). The NRC also believes that further discussion is warranted on how the prevention of cataracts (which can be corrected by a well-established surgical procedure) compares to efforts to reduce the probability of cancer, a disease posing a far greater health risk. The approaches to be considered include adopting the recommendations in ICRP Publication 118 (2012), moving towards closer alignment with the ICRP recommendations, or retaining the current dose limit. Any new requirements will have implications for measuring occupational exposures and the need to better estimate the dose to the lens of the eye.

The Issue Paper 2, “Occupational Dose Limit for the Lens of the Eye,” provides a more detailed discussion and is available in ADAMS under Accession No. ML14084A341. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders to obtain this information.

Q2-1: Is closer alignment with or adoption of the ICRP Publication 118 (2012) recommendations regarding the dose limits to the lens of the eye appropriate given the scientific information now available?

Q2-2: How should the impact of a radiation-induced cataract be viewed in comparison with other potential radiation effects?

Q2-3: What mechanisms could be applied to keep the cumulative exposure to the lens of the eye below the threshold of 0.50 Gy (50 rad)?

Q2-4: What methods should be allowed for measurement or assessment of the dose to the lens of the eye?

Q2-5: What methods should be allowed for recording dose to the lens of the eye when the eyes are protected?

Q2-6: What are the potential operational impacts of lowering the annual occupational dose to the lens of the eye from the current NRC regulatory standard of 150 mSv (15 rem) to 50 mSv (5 rem)? Would a reduction in the occupational dose limit for the lens of the eye require changes in programs, procedures, practices (e.g., increased use of protective eyewear), or in-room shielding? If so, please describe these changes, including any potential implementation and operational costs.

Q2-7: What are the potential impacts on State regulatory programs of a reduction in the occupational dose limit to the lens of the eye from the current NRC regulatory standard of 150 mSv (15 rem) to 50 mSv (5 rem)?

Currently, the NRC's regulations in 10 CFR 20.1208(a) set the dose limit for the embryo/fetus of a declared pregnant worker at 5 mSv (500 mrem) for the entire pregnancy. Section 20.1208(d) provides allowances for delays in the declaration of pregnancy by workers. If the dose equivalent to the embryo/fetus has exceeded 5 mSv (500 mrem), or is within 0.5 mSv (50 mrem) of this dose, at the time the worker declares the pregnancy to the licensee, then the dose to the embryo/fetus cannot exceed 0.5 mSv (50 mrem) for the remainder of the pregnancy (10 CFR 20.1208(d)). In addition, licensees are to make efforts to avoid substantial variation above a uniform monthly exposure rate to satisfy the dose limit (10 CFR 20.1208(b)). These requirements are based on the ICRP Publication 26 (1977) recommendations. However, ICRP Publication 103 (2007) recommends that the dose limit for the embryo/fetus of a declared pregnant worker be the same as that for a member of the public, which is 1 mSv (100 mrem).

Prior to the 1991 amendments to 10 CFR part 20, the NRC's regulations did not contain a specific dose limit for the embryo/fetus of a declared pregnant occupational worker. Instead, as a matter of policy, the NRC used a single annual limit for both genders and relied on information in Regulatory Guide 8.13, “Instruction Concerning Prenatal Radiation Exposure,” which was first issued in March 1975 (ADAMS under Accession No. ML13350A220) to maintain exposures to the embryo/fetus ALARA.

In developing Regulatory Guide 8.13, the Commission considered the recommendations in NCRP Report No. 39 (1971), “Radiation Protection Criteria.” The NCRP recommended that during the entire gestation period, the maximum permissible dose equivalent to the embryo/fetus from occupational exposure of the worker should not exceed 5 mSv (500 mrem). The ICRP Publication 26 (1977) recommended limiting the working conditions of the declared pregnant worker in such a manner that it is unlikely that the embryo/fetus would receive a dose greater than 5 mSv (500 mrem) for the entire gestation period (51 FR 1092; January 9, 1986).

Thousands of pregnant women are occupationally exposed to ionizing radiation each year. There are radiation-related risks throughout pregnancy that are related to the stage of pregnancy and absorbed dose. Exposure of the embryo/fetus to ionizing radiation could cause adverse health effects, such as cancer and developmental abnormalities. The susceptibility of the embryo/fetus to damage by radiation is well established and data suggests that the period from 10 weeks to 17 weeks in the development of a fetus may be especially critical. Because of this susceptibility, limiting the dose to the embryo/fetus to 5 mSv (500 mrem) or less during the entire pregnancy is generally considered desirable (51 FR 1092; January 9, 1986). Accordingly, the NCRP Report 54 (1977), “Medical Radiation Exposure of Pregnant and Potentially Pregnant Women,” recommended that the total dose equivalent to the embryo/fetus from occupational exposure of the expectant mother not exceed 5 mSv (500 mrem), and that once the pregnancy is known, exposure of the embryo/fetus not exceed 0.5 mSv (50 mrem) in any month.

The ICRP Publication 60 (1991) made clear that the embryo/fetus should be regarded as a member of the public when considering the protection of female workers who are or may be pregnant. In ICRP Publications 60 (1991) and 103 (2007), the ICRP concluded that there is no reason to distinguish between the genders for the purposes of controlling occupational exposures. However, under the ICRP recommendations, if a female worker declares her pregnancy, then additional controls must be considered to protect the embryo/fetus. The ICRP also stated that the methods of radiation protection for occupational workers, who are or may be pregnant, should provide a level of protection for the embryo/fetus equivalent to that provided for a member of the public. The ICRP Publication 103 (2007) recommended approach is that the working conditions of a pregnant worker, after declaration of pregnancy, should be such that it is unlikely that the additional dose to the fetus would exceed about 1 mSv (100 mrem) during the remainder of pregnancy.

On May 24, 2013, NCRP Report No. 174, “Preconception and Prenatal Radiation Exposure: Health Effects and Protective Guidance,” was released. It updated and expanded upon the information in NCRP Report No. 54. The report noted that scientific knowledge has increased and public concerns have changed in the past 36 years since NCRP Report No. 54 was published. Like the findings of ICRP Publication 103 (2007), the report recommended a dose limit of 1 mSv (100 mrem), including dose from the intake of radionuclides, to the embryo/fetus of a declared pregnant worker and recommended applying the concept of ALARA to these exposures.

Although the assessment of doses to the embryo/fetus from exposures to external radiation can be related directly to exposures of the pregnant worker, assessment of doses from intakes of radionuclides is not straightforward. Doses to the embryo/fetus may result from the inhalation or ingestion of radionuclides by the mother during or before pregnancy, and additional doses to the newborn child may result from the transfer of radionuclides in breast milk. The ICRP publications provide dose coefficients for the offspring (embryo/fetus and newborn child) following radionuclide intake by the mother before or during pregnancy and during breast feeding. In many important cases of potential radionuclide intake, doses to the offspring may exceed doses to the mother; such cases should be taken into account in the development of radiation protection programs. 26

To provide adequate radiation protection for the embryo/fetus, and to minimize the restriction on employment, the NRC recognized the importance of female workers voluntarily informing their employers of their pregnancy and the estimated date of conception, so that arrangements can be made to restrict potential exposures. The pregnant worker has the fundamental responsibility for deciding when or whether she will formally declare her condition to her employer. This position is derived from court rulings concerning a woman's rights regarding pregnancy. Having a formal declaration of pregnancy derives from legal, not health protection, considerations (56 FR 23373; May 21, 1991). If an occupational worker chooses not to declare her pregnancy, then the licensee will not be required under the Commission's regulations to limit her dose to the 5 mSv (500 mrem).

The undeclared pregnant occupational women are protected under the NRC's regulations for all workers. The normal occupational dose limits would still be in effect and would have to be complied with, and the dose would also have to be kept “as low as is reasonably achievable.” In addition, as part of her initial employment, the woman, like all occupational workers, should receive instructions in radiation protection (10 CFR 19.12), and a copy of the current version of Regulatory Guide 8.13 (56 FR 23373; May 21, 1991).

The ICRP Publication 103 (2007) recommends that the dose to the embryo/fetus of a declared pregnant worker provide the same general level of protection as that offered for a member of the public, which is 1 mSv (100 mrem). The ICRP recommends applying the 1 mSv (100 mrem) criterion after the declaration of pregnancy by the occupational worker.

The NRC has determined that it is appropriate and scientifically justified to explore whether to change the dose limit for the embryo/fetus to 1 mSv (100 mrem). In its 1991 final rule that amended 10 CFR part 20, the NRC changed the dose limit for a member of the public from 5 mSv (500 mrem) to 1 mSv (100 mrem); however, it did not make the corresponding change to the dose limit for the embryo/fetus. Lowering the dose limit for the embryo/fetus of a declared pregnant occupational worker would align the NRC's regulatory requirements with current scientific data. The data indicate that the embryo/fetus is more sensitive to radiation than initially surmised. This approach would also align the NRC's regulations with the ICRP Publication 103 (2007) recommendations. The option of applying the limit over the entire gestation period, or only to the portion of time following declaration, would need to be explored in greater detail.

The Issue Paper 3, “Dose Limit for the Embryo/Fetus of a Declared Pregnant Occupational Worker,” provides a more detailed discussion and is available in ADAMS under Accession No. ML14084A339. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders to obtain this information.

Q3-1: Are there any significant anticipated impacts associated with reducing the dose limit to the embryo/fetus of a declared pregnant woman, including operational impacts? What are the potential implementation and operational costs?

Q3-2: Are there any benefits or impacts associated with applying the reduced dose limit over the entire gestation period, or only to the period after declaration?

Q3-3: Are there any anticipated implementation impacts on recordkeeping if the dose limit to the embryo/fetus is lowered to 1 mSv (100 mrem)? What are the potential implementation and operational costs?

Q3-4: Are there technological implementation issues, such as limits of detection, which would make adoption of the ICRP Publication 103 (2007) recommendation difficult in certain circumstances?

Q3-5: Are there data on actual dose distributions to the embryo/fetus of a declared pregnant worker? What are the trends for these data?

Each NRC licensee is required to develop, document, and implement a radiation protection program commensurate with the scope and extent of its licensed activities. 27 In addition to meeting expressed dose limits, the NRC requires its licensees to apply the ALARA principle to their licensed operations. Section 20.1003 defines the term ALARA as “making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part [10 CFR part 20] as is practical consistent with the purpose for which the licensed activity is undertaken . . .”  28 The NRC's current ALARA requirements are provided in subpart B of 10 CFR part 20, “Radiation Protection Programs,” and are contained in 10 CFR 20.1101(b) and (d). The current occupational dose limits are provided in subpart C of 10 CFR part 20, “Occupational Dose Limits,” and 10 CFR 20.1201 provides the occupational dose limits for adults.

In the United States, the majority of occupationally exposed individuals receive less than 20 mSv (2 rem) per year as reported to the NRC. 29 However, a small percentage of individuals receive larger exposures up to, and occasionally above, the NRC's current annual occupational limit of 50 mSv (5 rem). While nuclear power reactor operators have been successful in reducing individual exposures, such that only a very limited number of individuals exceed 20 mSv (2 rem) in a year, 30 this is not the case in other segments of the regulated community. For example, industrial radiographers have a somewhat greater percentage of individuals above the average annual dose level of 20 mSv (2 rem) recommended in ICRP Publication 103 (2007). Stakeholder interactions have led the NRC staff to conclude that some of these individuals may be receiving doses close to the 50 mSv (5 rem) limit over multiple years. As described in Section IV.E. of this ANPR and Issue Paper 6, “Reporting of Occupational Exposure” (ADAMS Accession No. ML14084A344), detailed information on these cumulative exposures is difficult to ascertain because some segments of the regulated community are not required to report occupational exposure, therefore making it difficult “to assure that lifetime exposure of workers repeatedly exposed near the limits is minimized” (52 FR 2822; January 27, 1987).

The NRC's regulation in 10 CFR 20.1101(b) provides that each licensee “shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).” The NRC's current regulations in 10 CFR part 20 do not include an explicit requirement to plan activities to optimize radiation protection (ALARA planning) or to establish ALARA planning values as part of the licensee's radiation protection program. With respect to nuclear power reactors, the NRC staff has issued Regulatory Guide 8.8, Revision 3, “Information Relevant to Ensuring that Occupational Radiation Exposures at Nuclear Power Stations Will Be As Low As Is Reasonably Achievable” (ADAMS Accession No. ML003739549), which describes methods to implement the existing ALARA requirements, including detailed ALARA planning for use in the operations of commercial power reactors. However, this level of ALARA planning is not as common in the programs of other types of NRC licensees.

The NRC notes that its implementation and enforcement of its ALARA principles are generally made through specific license conditions instead of through more detailed regulations. Therefore, the NRC staff questions whether additional regulatory requirements are appropriate to foster a clear and consistent approach for all types of licensees versus relying upon license conditions.

In SRM-SECY-12-0064, dated December 17, 2012 (ADAMS Accession No. ML12352A133), the Commission directed the NRC staff to continue discussions with stakeholders on alternative approaches to deal with individual protection at or near the current dose limit. The NRC is currently examining possible mechanisms for addressing individual protection at, or near, the current occupational dose limit of 50 mSv (5 rem) per year. One potential mechanism for achieving this goal is to revise 10 CFR 20.1101, “Radiation Protection Programs,” to include additional requirements for implementing ALARA. Furthermore, reducing exposures through consistent ALARA implementation is a straight forward method for addressing concerns about a worker receiving a cumulative occupational dose, at or near the dose limit, over a number of years.

In addition, the NRC is interested in other proposals for addressing individual protection at or near the current dose limit. During previous public interactions, some stakeholders expressed an interest in strengthening the current ALARA requirements, whereas others expressed opposition to any additional requirements. Some stakeholders who opposed additional ALARA requirements expressed concerns that such additional requirements would become de facto limits and would inhibit the flexibility of licensees to deal with specific operational circumstances.

The NRC staff believes that the objective of any additional regulatory requirements should be to ensure the accurate monitoring of an individual's cumulative occupational dose and to ensure that progressive measures to reduce dose are taken, if necessary, as the cumulative dose increases. If the NRC determines that additional regulatory requirements are necessary to limit the cumulative occupational dose, then this objective could be achieved through either performance-based requirements, such as ALARA, prescriptive requirements, or both. Performance-based requirements express or describe the particular outcomes that must be achieved while leaving some discretion to a licensee on the specific mechanisms used to achieve those outcomes. On the other hand, prescriptive requirements specify a particular methodology or action that is necessary for compliance.

The establishment of ALARA planning values in administrative control levels, relative to the implementation of the ALARA principle, is not a new concept. The “Federal Radiation Protection Guidance for Occupational Exposure” (52 FR 2822, January 27, 1987; ADAMS Accession No. ML13269A320), provides a set of recommendations that incorporates this concept. The NRC and several other Federal agencies developed these recommendations, which were approved by President Reagan on January 20, 1987. The guidance states, “Federal radiation guidance can address only the broad prerequisites of an effective ALARA program . . . authorities may find it useful to establish or encourage the use of . . . administrative control levels specifying, for specific categories of workers or work situations, dose levels below the limiting numerical values recommended in this guidance.”

The current regulations do not require licensees to have a structured ALARA planning process. Therefore, the NRC is considering the development of a requirement for ALARA radiation protection planning. This additional ALARA planning requirement would provide a basis to ensure that licensees have an ongoing process to review radiation exposures, to consider if changes are warranted and practical to reduce exposures, and to ensure the implementation of appropriate programmatic changes.

In conjunction with developing a requirement for ALARA planning, the NRC is considering developing a mechanism to address additional protection when an individual occupational worker nears his or her annual dose limit, and developing cumulative dose criterion that would control doses that an individual worker may receive over a multiple-year period. In this regard, the NRC would require each licensee, as a part of its radiation protection program, to establish mechanisms to examine cumulative occupational doses, and to implement control measures limiting additional doses if an occupational worker approaches his or her cumulative dose criterion. If the NRC ultimately issues such a requirement, it would develop associated guidance to address the various types of licensed activities.

Specifically, regulatory guidance could describe the types of methodologies that the NRC staff could consider acceptable to meet the regulatory requirement of controlling dose as an individual occupational worker approaches the annual dose limit, or his or her cumulative dose criterion. The NRC is considering using various methodologies that are based on national and international recommendations. One potential methodology could be for a licensee to use the ICRP Publication 103 (2007) recommendations for an average dose over a 5-year period of 20 mSv (2 rem) as an administrative control level (ACL). 31 If no individual at the licensed facility exceeded the ACL on an annual basis, then no additional actions would be needed by the licensee other than continued monitoring of exposures. However, if an individual exceeded the ACL in any particular year, the licensee could commit to tracking and limiting the dose of that worker over a 5-year period; the licensee would need to maintain the cumulative occupational dose records during this period.

A second potential methodology for establishing an ACL could be based on the NCRP Report 116, “Limitation of Exposure to Ionizing Radiation,” which recommended an age based cumulative dose restriction. The NCRP Report 116 recommended an occupational dose limit of 50 mSv (5 rem) per year and a cumulative occupational dose limit of 10 mSv (1 rem) times the individual's age in years. Therefore, a licensee could establish an ACL at the 10 mSv (1 rem) level, and if this level is exceeded in any one year, the licensee would apply cumulative dose tracking to ensure that the cumulative age based dose limit for the individual is not exceeded.

In a third potential methodology, a licensee could establish an ACL based on lifetime exposures instead of the yearly approach to dose limits as in ICRP or NCRP recommendations. Under this approach, a licensee could commit to tracking the cumulative occupational doses for each worker and to applying specific additional restrictions if the cumulative occupational dose exceeded a set lifetime cumulative ACL value. Example values of cumulative ACL, such as 0.5 Sv (50 rem) or 0.75 Sv (75 rem), over the worker's lifetime could serve as appropriate fractions of the upper (tolerable) cumulative lifetime dose limit found in ICRP and NCRP recommendations. This approach could work in conjunction with regulations for cumulative occupational dose recordkeeping requirements to ensure that licensees took appropriate actions if dose limits are exceeded.

The preceding methodologies are presented as possible approaches for implementing a general performance requirement. Alternatively, the regulation could specifically incorporate one or more of these methodologies as a new prescriptive requirement. The NRC is interested in obtaining stakeholder input on the use of a performance or prescriptive approach, the rationale as to why one approach is preferable over the other, and any other alternatives that the NRC should consider as acceptable.

The NRC is also considering whether an additional requirement is necessary to address the question of concurrent occupational doses of an individual working at multiple licensed facilities. Situations may occur in which workers receive occupational exposures at more than one facility concurrently. One approach could be to expand the scope of 10 CFR 20.2104(a) to cover workers' concurrent employment by two or more licensees during the same period of time (e.g., a weekday shift at one licensee's facility followed by a weekend shift at another licensee's facility). Presently, the regulations require licensees to determine the yearly occupational doses received by its workers. In this regard, 10 CFR 20.2104(c) could be revised to add the phrase “and any concurrent” to statements that now only specify the individual's most recent employer.

As discussed previously, before the 1991 amendments to 10 CFR part 20, the NRC's regulatory framework included the formula D= 5 (N-18), where “N” is the person's age in years, and where “D” is the lifetime dose limit in rems. 32 As part of the implementation of this former regulation, workers were required to provide NRC Form 4, “Cumulative Dose History Report,” when reporting to a new facility. However, the 1991 amendments to 10 CFR part 20 removed this requirement and the lifetime dose limit formula. The statement of considerations for the 1986 proposed rule (which led to the 1991 final rule) explains the lifetime dose limit formula was eliminated as a measure to reduce annual and lifetime doses to occupational workers (51 FR 1092, 1121; January 9, 1986). As a result, there is now no requirement in the NRC's regulations for a licensee to receive a cumulative dose history report (NRC Form 4 or equivalent) from a new employee.

The various types of radioactive material licenses pose different challenges to the control of occupational doses (e.g., industrial radiography, nuclear medicine). In some situations, the design and operation associated with the use of radioactive material limits the occupational dose. Conversely, some uses of radioactive materials can result in significant occupational doses that may be near the annual dose limit. Therefore, the spectrum of radioactive material licenses presents a wide range of challenges and opportunities for reducing occupational doses under ALARA provisions, especially when exposures approach the limits. The NRC is seeking to understand how to ensure that a greater focus is placed on keeping occupational doses ALARA, consistent with the wide range of uses of radioactive material that are licensed. The NRC also seeks to understand the potential impacts of the methodologies that were previously discussed, including any potential difficulties associated with implementation if such methodologies were made requirements by rulemaking.

The Issue Paper 4, “Individual Protection—ALARA Planning,” provides more detailed information and is available in ADAMS under Accession No. ML14084A340. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders to obtain this information.

Q4-1: What are the potential implications of adding specific ALARA planning and implementation requirements to the 10 CFR part 20 regulations? What changes to licensee radiation protection programs could be anticipated? What would be the potential implementation and operational costs?

Q4-2: What regulatory language should be used for an additional ALARA planning requirement and what is the rationale for this language?

Q4-3: How does each of the described methodologies for addressing when an individual occupational worker approaches his or her cumulative dose for the year work for different classes of licensed uses (e.g., a worker at a nuclear reactor power plant versus an industrial radiographer versus medical personnel)? What are the benefits and impacts of the various approaches to ALARA planning on the various types of licenses?

Q4-4: Should licensees be allowed to establish different ACLs for different groups of occupational workers? If so, what should be the basis for the various groupings?

Q4-5: How do the different methodologies previously discussed impact the ability of licensees to best address radiation protection within their programs?

Q4-6: Other than the methodologies discussed in the preceding section, are there other ways to evaluate occupational lifetime cumulative exposures that should be considered?

Q4-7: What are the potential impacts to licensees, contractors, and dosimetry vendors of amending 10 CFR 20.2104 to require a licensee to account for exposure from an occupational worker's concurrent employment with another licensee? Are there any dosimetry vendors that provide concurrent dose records? Should the NRC consider provisions that would require individual occupational workers to provide their occupational dose information in addition to requiring such information from licensees?

Q4-8: Should the Agreement States be allowed to use more restrictive or prescriptive requirements if the NRC decides to use a performance-based approach? What are the benefits and impacts of the various methodologies discussed in the preceding section on Agreement State regulatory programs and Agreement State licensees? If the NRC issues a proposed rule, this information will be important in establishing an appropriate Agreement State compatibility level for any proposed regulatory requirements.

The current 10 CFR part 20 radiation protection regulations were promulgated approximately 1 year before to the publication of the NRC's metrication policy (57 FR 46202; October 7, 1992). The metric system is also known as the International System of Units (SI). Therefore, most NRC dose limits and other units of measurements are listed in the regulations with the traditional or “English” (also known as non-SI) units first followed by the metric units in parentheses. Some NRC regulations list metric units first followed by traditional or “English” units in parentheses. Numerical information in the appendices to 10 CFR part 20 is a mixture of traditional and metric units. For example, the DACs in 10 CFR part 20, appendix B, Table 1, are in units of microcuries per milliliter (μCi/ml); therefore, the activity is in traditional units and the volume is in metric units. By contrast, appendix C of 10 CFR part 20 only displays numerical information using the traditional units of measurement.

In SRM-SECY-12-0064, the Commission disapproved the elimination of traditional units from the NRC's regulations. The SRM further stated that both the traditional and SI units should be maintained. Pursuant to the NRC's 1992 metrication policy, the NRC supports and encourages the use of the metric system of measurement by the nuclear industry. The 1992 policy directed the NRC staff, beginning in 1993, to publish the following documents in dual units of measurement with the SI units listed first followed by the “English” units in parentheses: New regulations, major amendments to existing regulations, regulatory guides, NUREG-series documents, policy statements, information notices, generic letters, bulletins, and all written communications directed to the public. In addition, the NRC's policy provided that licensee-specific NRC documents, such as licensee inspection reports and licensee-specific docketed material, use the system of measurements utilized by the licensee. Furthermore, the policy provided that all event reporting and emergency response communications between licensees, the NRC, and State and local authorities will use the traditional units of measurement. In a 1996 review of its 1992 metrication policy, the Commission stated that it does not intend to revisit the 1992 policy unless it is shown to cause an undue burden or hardship (61 FR 31169, 31171; June 19, 1996).

The implementation of the NRC's metrication policy is not consistent with respect to the units of measurement used in recordkeeping and reporting. The NRC's regulations in 10 CFR 20.2101(a), “Records,” currently require licensees to use the traditional units. Therefore, licensees cannot use the metric units even if they wanted to do so. Section 20.2101(b) allows licensees to record quantities in SI units in parentheses after the traditional units. Section 20.2101(c) requires information recorded on shipping manifests, (e.g., shipments to low-level waste disposal facilities) as required by 10 CFR 20.2006(b), to be listed in SI units or both SI and traditional units. In addition, some NRC regulations require licensee reports to present information with the traditional units first followed by the SI units in parentheses.

The requirement to keep all records in traditional units, or in both sets of units, could be seen as inconsistent with a revised regulation in which the dose criteria are expressed first in SI units followed by the traditional units. One alternative could be to amend the regulations to allow a licensee to maintain records in either set of units as long as only one set of units was used throughout a licensee's recordkeeping system. Another alternative could be to allow a licensee to use either set of units in measurements and calculations; however, the licensee would be required to present the final values that support regulatory compliance in one or both sets of units. These various alternatives have different regulatory burdens and implementation issues. The NRC staff is seeking to gain additional information from stakeholders on the implications of the various alternatives, including the option that no change should be made.

As part of its draft regulatory basis development for a possible revision to the 10 CFR part 20 regulations, the NRC staff is examining the implementation of the Commission's metrication policy about how numerical material could be presented in appendix B of 10 CFR part 20. The NRC staff believes that the unique nature of appendix B, with its detailed numeric information for each radionuclide, may pose a situation in which a deviation from the metrication policy may be needed.

Two issues need to be addressed regarding the application of the Commission's metrication policy to appendix B to 10 CFR part 20. The first issue is the selection of the value that the NRC will consider as the regulatory standard. The values in appendix B are currently given in traditional activity units (microcuries (μCi)) with a certainty of one significant digit. One microcurie is equal to 3.7 × 10 4 becquerels (Bq) in the SI units; therefore, the conversion from microcurie to becquerel is completed by multiplying the activity in microcuries by 3.7 × 10 4 . The resulting values in SI units (becquerels) could be more or less restrictive than the original microcurie values depending on the number of significant digits to which the value is rounded. For example, currently appendix B to 10 CFR part 20 provides the oral ingestion ALI for Actinium-224 as 2 × 10 4 μCi. The corresponding value in the SI units before rounding to one significant digit is 7.4 × 10 7 Bq. If rounded to one significant digit, using the standard rounding conventions, the value in Bq would be smaller than the value in microcurie, and would be more restrictive. Therefore, the NRC staff is exploring the implications of stating the numerical values in appendix B of 10 CFR part 20 like that used in in appendix A to 10 CFR part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Materials.”

In the development of appendix A to 10 CFR part 37, the NRC stated that the SI units provided the regulatory standard and the traditional units were provided for practical use only. Appendix A to 10 CFR part 37 provides in column 1 the name of the radioactive material, column 2 provides the source activity in terabecquerel (TBq), and column 3 provides the source activities in curies. In appendix A to 10 CFR part 37, the NRC also chose to forgo the conventional rounding to the nearest whole number or the rounding to the first significant figure after the decimal point. Rather, appendix A to 10 CFR part 37, column 3 lists curie activity equivalents as three significant figures because many NRC licensees use curies instead of becquerels for source radioactivity. The 10 CFR part 37 -approach of rounding to three significant figures greatly reduces any discrepancies between the two values (the source strength in curies and the source strength in becquerels).

The second issue is the presentation of numerical information in the appendices to 10 CFR part 20. If the NRC staff implements the Commission's metrication policy in appendix B to 10 CFR part 20 (i.e., SI units listed first followed by traditional units in parentheses), the table could become more complicated. At present, appendix B of 10 CFR part 20 consists of three columns providing each radionuclide's name, symbol, and the solubility class, followed by six additional columns providing each radionuclide's ALIs and DACs, concentration limits for airborne and liquid effluents released to the general environment, and concentration limits for discharges to sanitary sewer systems in microcuries or microcuries per milliliter. Implementation of the metrication policy would effectively add six additional columns to provide the traditional unit numeric counterpart for each value in parentheses next to the corresponding values in the SI units. An alternative could be to publish the traditional unit values in a separate guidance document for the convenience of users; this alternative would an exception to the Commission's metrication policy.

The NRC staff is interested in stakeholder views on potential options on the application of the Commission's metrication policy to any potential 10 CFR part 20 revisions. Specifically, the NRC staff is seeking input on: (1) What are some of the potential options; (2) what are the impacts of the option on the format and the usefulness of the NRC's regulations; and (3) what are some of the impacts of the option on licensee operations, especially any benefits, burdens, or undue hardship. Using two units of measurements, traditional and SI units has the potential for causing communication challenges. Therefore, the NRC staff is interested in the implications and impacts of aligning any potential revisions to 10 CFR part 20 with the Commission's existing metrication policy, and with other possible changes that could be considered as aligning to such a change.

The Issue Paper 5 “Metrication—Units of Radiation Exposure and Dose,” provides more detailed information and is available in ADAMS under Accession No. ML14084A343. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders.

Q5-1: Will promulgation of amendments to the 10 CFR part 20 regulations with dose limits and other measurements shown in dual units, with the SI units shown first, followed by the traditional units in parentheses, cause an undue burden or hardship upon any licensee or class of licensees? If so, please explain and provide examples, including any potential implementation or operational costs.

Q5-2. Should 10 CFR 20.2101(a) be revised to allow licensees the option of providing records in SI units or in traditional units? Should licensees be allowed to provide reports in the units used in licensee records? Should licensees be required to record and report in both sets of units? Please provide reasons why or why not.

Q5-3. Should the NRC amend the appendices for 10 CFR part 20 to show values in SI units only, in traditional units only, or in both sets of units? If both SI and traditional units are provided, which set of units should be considered as the regulatory standard? If only one set of units is specified, what would be the most effective means to provide the other set of units (e.g., in a separate guidance publication)? Please provide reasons why or why not.

On December 19, 1968, the AEC published an amendment to 10 CFR part 20 in the Federal Register (33 FR 18926) that added new 10 CFR 20.407, “Personnel exposure and monitoring reports.”  33 This new section required the reporting of occupational radiation exposure information to a central repository at AEC headquarters. The amendment required four categories of licensees to report: (1) Commercial nuclear power reactors, (2) industrial radiographers, (3) fuel processors and fabricators, and (4) manufacturers and distributors of byproduct material. The Commission considered these licensees to have the greatest potential for significant occupational doses. The AEC established this reporting requirement to assist in the following actions: (1) Identifying those individuals who are monitored by more than one licensee or AEC contractor, (2) analyzing radiation exposure experience and identifying general exposure trends from year to year, (3) analyzing the exposure experience of AEC contractors and the four listed categories of licensees, (4) initiating appropriate remedial action where trends or experience in increased radiation exposures indicate the need for more effective controls, and (5) considering and developing appropriate modifications to radiation protection standards and requirements.

On January 19, 1975, the NRC was formed and on May 30, 1975, the NRC published a proposed rule in the Federal Register (40 FR 23478) that would require all NRC-specific licensees to submit personnel monitoring data to the agency. By a letter dated June 2, 1975 (43 FR 44827), a copy of the notice of the proposed rule was mailed to all NRC-specific licensees (e.g., well loggers, medical and academic institutions, industrial radiographers, and portable gauge users). Thirty-six comments were received on the proposed rule. The majority of the comments supported the proposed rule, but offered suggestions for improvement. Medical licensees raised the majority of the opposition to the proposed rule. Their opposition was based on the following issues: (1) Additional paperwork would increase the cost of health care; (2) the personnel monitoring data might have theoretical value, but no practical value; (3) the NRC failed to demonstrate a sufficient cost versus benefit ratio for another administrative requirement; (4) occupational exposures (in medical diagnosis and therapy) are already ALARA; (5) the requirements for reporting overexposures are adequate; (6) only licensees with repeated overexposures should be required to submit annual reports; (7) separating exposures received from NRC-licensed material from exposures received from non-NRC-licensed materials is not possible; and (8) personnel monitoring data contain inherent inaccuracies.

In response to these comments, in a letter dated August 25, 1976, the NRC requested that all NRC-specific licensees voluntarily submit personnel monitoring data for calendar year 1975, along with the total cost for preparing the data in man-hours and dollars-cents. The licensees' responses indicated a total man-hours cost median of 2.75 minutes, and $0.65 per monitored individual to collect the requested information (NUREG-0419, “Occupational Radiation Exposure at NRC-Licensed Facilities 1975, Office of Standards Development, U.S. Nuclear Regulatory Commission”).

After a series of amendments in the 1980s, the occupational reporting requirements in 10 CFR part 20 eliminated the provisions for all NRC-specific licensees to submit reports, and expanded the license reporting categories from four to the current seven, which are: (1) Commercial nuclear power reactors, (2) industrial radiographers, (3) fuel processors and fabricators, (4) manufacturers and distributors of certain byproduct material, (5) geologic repositories for high-level waste (HLW), (6) independent spent fuel storage installations (ISFSIs) and (7) facilities for the land disposal of low-level waste (LLW) (46 FR 13978, February 25, 1981; 46 FR 58282, December 1, 1981; and 47 FR 57480, December 27, 1982).

The current occupational reporting provisions were moved to 10 CFR 20.2206, “Reports of Individual Reporting,” as a part of the 1991 amendments to 10 CFR part 20. Section 20.2206 requires seven categories of licensees to provide an annual report of the monitoring of occupational dose each April 30th (covering the prior calendar year) to the NRC's REIRS database. At present, five categories of NRC licensees report information to the database, namely: (1) Commercial nuclear power reactors; (2) industrial radiographers; (3) fuel processors (including uranium enrichment facilities), fabricators, and reprocessors; (4) ISFSIs; and (5) manufacturers and distributors of certain byproduct material. The NRC's REIRS database does not include occupational information for the two other reporting categories, LLW and HLW facilities, because the NRC has no licensees in those categories. As a result, the database provides a system for maintaining all relevant occupational doses received at nuclear power reactors, fuel processors and fabricators, and ISFSIs in the United States, because all of these facilities are licensed by the NRC regardless of whether they are (even if located in an Agreement State).

Currently, a reporting gap exists because industrial radiographers, and manufacturers and distributors of certain byproduct material, who hold Agreement State licenses, instead of NRC licenses, are not subject to the reporting requirements in 10 CFR 20.2206. As described in the following paragraphs and Section VII.B., Issue Paper 6, “Reporting of Occupational Exposure” (ADAMS Accession No. ML14084A344), Agreement States are not required to adopt the provisions in 10 CFR 20.2206. Consequently, the NRC has experienced significant difficulty in developing reasonable assessments of the overall occupational doses received from industrial radiographers, and manufacturers and distributors of certain byproduct material, since the majority of these licensees are regulated by Agreement States. In addition, as identified in the chart in Section V of Issue Paper 6, several categories of NRC radioactive material licensees are not subject to the 10 CFR 20.2206 reporting requirements. Therefore, the NRC lacks occupational exposure data for several categories of radioactive material licensees.

The NRC's regulations in 10 CFR 20.2206(b) require certain categories of NRC licensees to submit an annual report of the results of the monitoring required by 10 CFR 20.1502 to the NRC's REIRS database. The NRC does not require Agreement States to adopt the 10 CFR 20.2206 provisions. Although an Agreement State can choose not to require their licensees to submit annual reports of occupational radiation dose information to either itself or the NRC, some Agreement State licensees voluntarily report occupational dose information to the REIRS database.

In addition, to expand the Agreement State occupational radiation dose information contained in the NRC's REIRS database, on August 6, 2010, the NRC sent a letter to Agreement State Radiation Control Programs (ADAMS Accession No. ML102100390). This letter requested Agreement State assistance in obtaining occupational radiation dose information from their licensees in the categories of industrial radiography and nuclear pharmacy for the monitoring period of 2000 through 2009.

During the period of 1997 through 2010, the NRC received occupational dose reports from 312 Agreement State licensees. The 312 licensees represented less than 2 percent of the total number of Agreement State licensees, at that time. The NRC staff review of the reports indicated that the 312 Agreement State licensees monitored exposures of 40,622 occupational workers, and 78 percent (31,704) of these occupational workers received a measurable dose. The complete NRC staff review is available in NUREG-2118, Vol.1, “Occupational Radiation Exposure at Agreement State-Licensed Materials Facilities, 1997-2010” (ADAMS Accession No. ML12220A081).

Increased use of the NRC's REIRS database, could serve as a national occupational exposure database for both the NRC and Agreement States. If properly implemented, the database could correlate the occupational exposure of an individual to the licensed facility where the exposure was received. This information would be especially useful for those workers who work concurrently at more than one licensed facility, especially in the radioactive materials area. All of the nuclear power plant licensees are regulated by the NRC, and are required to report occupational exposures to the NRC's REIRS database. Therefore, it is possible to determine the occupational doses of nuclear workers that are employed at more than one nuclear facility, including determining whether a person is exceeding the occupational dose limits. However, there is no mechanism for the NRC or an Agreement State to determine whether an individual is exceeding the occupational dose limits as a result of concurrent employment at multiple licensed facilities, especially if the individual works in jurisdictions regulated by both the NRC and one or more Agreement States.

For example, a physician whose medical practice involves the use of radioactive materials could work concurrently in Washington, DC (an NRC jurisdiction), Alexandria, VA (an Agreement State jurisdiction), and Bethesda, MD (a different Agreement State jurisdiction). If Agreement State licensees provided reports to the NRC's REIRS database, then it would be possible to ensure that an individual who is concurrently employed by licensees in multiple jurisdictions does not exceed the occupational dose limits.

Moreover, increased use of the NRC's REIRS database by NRC and Agreement State licensees, could serve a vital function in evaluating the overall effectiveness of the NRC's regulatory programs, and could be used by the NRC and Agreement States in inspection, enforcement, and incident response activities. It could also assist in assessing cumulative occupational doses on a national basis. The NRC staff is considering if new categories of licensees should be required to report to the database and how to effectively integrate any new reporting from NRC and Agreement State licensees into the system. Therefore, the NRC staff is pursuing that a more detailed examination of the implications, benefits, and costs of requiring additional categories of licensees to report exposures to the NRC's REIRS database. The Issue Paper 6, “Reporting of Occupational Exposures,” provides a more detailed discussion of the background and proposals on the reporting of occupational doses to the database including a chart in Section V that lists several categories of NRC radioactive material licensees where input is needed from the public. In addition, the following questions are intended to elicit information from the public, the regulated community, and other stakeholders.

Q6-1: What criteria should the NRC use to identify additional categories of licensees that should be required to submit annual occupational exposure reports under 10 CFR 20.2206(a)?

Q6-2: What are the benefits of collecting occupational exposure information in one central database to assess the total annual occupational exposure of those individuals who work at more than one licensed facility or contractor facility during the calendar year and receive occupational exposures at these facilities?

Q6-3: Should Agreement States be required to adopt regulations that are compatible with the requirements in 10 CFR 20.2206?

Q6-4: Should the NRC consider a gradual expansion of the 10 CFR 20.2206 licensee reporting categories in a step-wise fashion (e.g., staggered compliance dates for different categories of licensees)? What are the advantages or disadvantages for this option?

Q6-5: What are the potential implementation and operational costs associated with expanding the occupational exposure reporting requirements?

The NRC plans to hold a series of Category 3 public meetings specific to the six issues identified in this ANPR. The public meetings will be held during the ANPR public comment period. The public meetings will provide forums for the NRC staff to discuss the issues and questions identified in the ANPR with external stakeholders and to receive information to support development of a draft regulatory basis for a potential revision of the radiation protection requirements in 10 CFR part 20. The NRC does not intend to provide detailed responses to comments or other information submitted during the public meetings. Each public meeting will be noticed on the NRC's public meeting Web site at least 10 calendar days before the meeting. Stakeholders should monitor the NRC's public meeting Web site for additional information about the public meetings at http://www.nrc.gov/public-involve/public-meetings/index.cfm. The NRC will post the notices for the public meetings and may post additional material related to this action to the Federal rulemaking Web site at www.regulations.gov under Docket ID NRC-2009-0279. The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2009-0279); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

The NRC has implemented a program to address the possible “cumulative effects of regulation” (CER) in the development of regulatory bases for rulemakings. The CER describes the challenges that licensees or other impacted entities (such as Agreement States) may face while implementing new NRC or other agency regulatory requirements. The CER is an organizational effectiveness challenge that results from a licensee or other impacted entity implementing a number of complex positions, programs, or requirements within a prescribed implementation period and with limited available resources, including the ability to access technical expertise to address a specific issue. The NRC is specifically requesting comment on the cumulative effects that may result from a potential amendment to 10 CFR part 20. In developing comments on the possible cumulative effects of any future 10 CFR part 20 rulemaking, please consider the following questions:

(1) In light of any current or projected CER challenges, what could be considered as a reasonable effective date, compliance date, or submittal date(s) from the time any potential final rule is published to the implementation date of any new requirements, including changes to programs, procedures, or facilities?

(2) If there are current or projected CER challenges, what could be done to address them (e.g., if more time is anticipated to implement the potential new requirements, what period of time is estimated to be sufficient, and why would such a proposed time frame be necessary)?

(3) Please identify any current or projected regulatory actions by the NRC or another regulatory agency (such as new or amended regulatory requirements or orders) that could potentially influence the implementation of any potential 10 CFR part 20 rulemaking?

(4) Are there any possible unintended consequences resulting from a potential 10 CFR part 20 rulemaking, such as the possibility that this potential rulemaking could create conditions that would be contrary to the potential action's purpose and objectives? If so, what are the anticipated consequences and how could they be addressed?

(5) Is there any potential costs and benefits information available at this time on a potential 10 CFR part 20 rulemaking?

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this ANPR to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on this ANPR and the draft regulatory basis issues papers (see Section VIII of this ANPR) with respect to the clarity and effectiveness of the language used.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

The NRC will consider comments received or other information submitted in response to this ANPR in the development of the proposed draft regulatory basis or any other documents developed as a part of any potential 10 CFR part 20 rulemaking. The NRC, however, does not intend to provide detailed responses to comments or other information submitted in response to this ANPR. The information obtained through this ANPR process will be used to develop a draft regulatory basis. The draft regulatory basis will be published for public review and comment. If the NRC develops a regulatory basis sufficient to support a proposed rule, then there will be an opportunity for public comment when the proposed rule is published and the NRC will respond to such comments if and when it publishes a final rule. If the NRC develops draft supporting guidance for a proposed 10 CFR part 20 rulemaking, then the public, the regulated community, and other stakeholders will have an opportunity to provide comment on the draft guidance.

If the NRC decides not to pursue a 10 CFR part 20 rulemaking on this topic, the NRC will publish a document in the Federal Register that will generally address public comments and withdraw this ANPR.

Purpose of Meeting

The purpose of the working group will be to discuss and, if possible, reach consensus on a proposed rule for the energy efficiency of manufactured homes, as authorized by section 413 of the Energy Independence and Security Act of 2007 (EISA). Tentative Agenda: (Subject to change):

• Overview of Working Group's Task

• Discussion and formation of a work plan for the MH Working Group to accomplish its objectives.

Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email asrac@ee.doe.gov. In the email, please indicate your name, organization (if appropriate), citizenship, and contact information. Please note that foreign nationals visiting DOE Headquarters are subject to advance security screening procedures. Any foreign national wishing to participate in the meeting should advise ASRAC staff as soon as possible by emailing asrac@ee.doe.gov to initiate the necessary procedures, no later than Monday, July 28, 2014. Anyone attending the meeting will be required to present a government photo identification, such as a passport, driver's license, or government identification. Due to the required security screening upon entry, individuals attending should arrive early to allow for the extra time needed.

Members of the public will be heard in the order in which they request to make a statement at the public meeting. Time allotted per speaker will depend on the number of individuals who wish to speak but will not exceed five minutes. Reasonable provision will be made to include the scheduled oral statements on the agenda. The co-chairs of the Committee will make every effort to hear the views of all interested parties and to facilitate the orderly conduct of business.

Participation in the meeting is not a prerequisite for submission of written comments. ASRAC invites written comments from all interested parties during the course of the negotiations. If you would like to file a written statement with the committee, you may do so either by submitting a hard or electronic copy before or after the meeting. Electronic copy of written statements should be emailed to asrac@ee.doe.gov.

Minutes: All notices, public comments, public meeting transcripts, and supporting documents associated with this working group are included in Docket No. EERE-2009-BT-BC-0021.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

On December 10, 2009, Bombardier Aerospace applied for a type certificate for their new Models BD-500-1A10 and BD-500-1A11 series airplanes (hereafter collectively referred to as “CSeries”). The CSeries airplanes are swept-wing monoplanes with a composite wing fuel tank structure and an aluminum alloy fuselage sized for 5-abreast seating. Passenger capacity is designated as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Aerospace must show that the CSeries airplanes meet the applicable provisions of part 25 as amended by Amendments 25-1 through 25-129.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the CSeries airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the CSeries airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17.

The CSeries airplanes will incorporate the following novel or unusual design features: A fuel tank nitrogen generation system (NGS) that is intended to control fuel tank flammability for all fuel tanks. This NGS is designed to provide a level of performance that applies the more stringent standard for warm day flammability performance applicable to normally emptied tanks within the fuselage contour from § 25.981(b) and appendix M to part 25 to all fuel tanks of the CSeries airplanes. This high level of NGS performance for all fuel tanks is a novel or unusual design feature compared to the state of technology envisioned in the airworthiness standards for transport category airplanes.

The certification basis of the CSeries airplanes includes § 25.981, as amended by Amendment 25-125, as required by 14 CFR 26.37. This amendment includes the ignition prevention requirements in § 25.981(a), as amended by Amendment 25-102, and it includes revised flammability limits for all fuel tanks and new specific limitations on flammability for all fuel tanks as defined in § 25.981(b), as amended by Amendment 25-125.

Section 25.981(a)(3) requires applicants to show that an ignition source in the fuel tank system could not result from any single failure, from any single failure in combination with any latent failure condition not shown to be extremely remote, or from any combination of failures not shown to be extremely improbable. This requirement was originally adopted in Amendment 25-102, and it requires the assumption that the fuel tanks are always flammable when showing that the probability of an ignition source being present is extremely remote. (Amendment 25-102 included § 25.981(c) that required minimizing fuel tank flammability, and this was defined in the preamble as being equivalent to unheated aluminum fuel tanks located in the wing.) This requirement defines three types of scenarios that must be addressed in order to show compliance with § 25.981(a)(3). The first scenario is that any single failure, regardless of the probability of occurrence of the failure, must not cause an ignition source. The second scenario is that any single failure, regardless of the probability of occurrence, in combination with any latent failure condition not shown to be at least extremely remote, must not cause an ignition source. The third scenario is that any combination of failures not shown to be extremely improbable must not cause an ignition source. Demonstration of compliance with this requirement would typically require a structured, quantitative safety analysis. Design areas that have latent failure conditions typically would be driven by these requirements to have multiple fault tolerance, or “triple redundancy.” This means that ignition sources are still prevented even after two independent failures.

Section 25.981(b) states that no fuel tank fleet average flammability exposure may exceed 3 percent of the flammability exposure evaluation time calculated using the method in part 25, Appendix N, or the fleet average flammability of a fuel tank within the wing of the airplane being evaluated, whichever is greater. If the wing is not a conventional unheated aluminum wing, the analysis must be based on an assumed equivalent conventional construction unheated aluminum wing. In addition, for fuel tanks that are normally emptied during operation and that have any part of the tank located within the fuselage contour, the fleet average flammability for warm days (above 80 °F) must be limited to 3 percent as calculated using the method in part 25, Appendix M.

Since the issuance of § 25.981(a)(3), as amended by Amendment 25-102, the FAA has conducted certification projects in which applicants found it impractical to meet the requirements of that regulation for some areas of lightning protection for fuel tank structure. Partial exemptions were issued for these projects. These same difficulties exist for the CSeries project.

The difficulty of designing multiple-fault-tolerant structure, and the difficulty of detecting failures of hidden structural design features in general, makes compliance with § 25.981(a)(3) uniquely challenging and impractical for certain aspects of the electrical bonding of structural elements. Such bonding is needed to prevent occurrence of fuel tank ignition sources from lightning strikes. The effectiveness and fault tolerance of electrical bonding features for structural joints and fasteners is partially dependent on design features that cannot be effectively inspected or tested after assembly without damaging the structure, joint, or fastener. Examples of such features include a required interference fit between the shank of a fastener and the hole in which the fastener is installed, metal foil or mesh imbedded in composite material, a required clamping force provided by a fastener to pull two structural parts together, and a required faying surface bond between the flush surfaces of adjacent pieces of structural material such as in a wing skin joint or a mounting bracket installation. In addition, other features that can be physically inspected or tested may be located within the fuel tanks; therefore, it is not practical to inspect for failures of those features at short intervals. Examples of such failures include separation or loosening of cap seals over fastener ends and actual structural failures of internal fasteners. This inability to practically detect manufacturing errors and failures of structural design features critical to lightning protection results in degraded conditions that occur and remain in place for a very long time, possibly for the remaining life of the airplane.

Accounting for such long failure latency periods in the system safety analysis required by § 25.981(a)(3) would require multiple fault tolerance in the structural lightning protection design. As part of the design development activity for the CSeries, Bombardier has examined possible design provisions to provide multiple fault tolerance in the structural design to prevent ignition sources from occurring in the event of lightning attachment to the airplane in critical locations. Bombardier has concluded from this examination that providing multiple fault tolerance for some structural elements is not practical. Bombardier has also identified some areas of the CSeries design where it is impractical to provide even single fault tolerance in the structural design to prevent ignition sources from occurring in the event of lightning attachment after a single failure. The FAA has reviewed this examination with Bombardier in detail and has agreed that providing fault tolerance beyond that in the proposed CSeries design for these areas would be impractical.

As a result of the CSeries and other certifications projects, the FAA has now determined that compliance with § 25.981(a)(3) is impractical for some areas of lightning protection for fuel tank structure, and that application of § 25.981(a)(3) to those design areas is therefore inappropriate. The FAA plans further rulemaking to revise § 25.981(a)(3). As appropriate, the FAA plans to issue special conditions or exemptions, for certification projects progressing before the revision is complete. This is discussed in FAA Memorandum ANM-112-08-002, Policy on Issuance of Special Conditions and Exemptions Related to Lightning Protection of Fuel Tank Structure, dated May 26, 2009.

Section 25.981(b) sets specific standards for fuel tank flammability as discussed above under “Flammability Limits.” Under that regulation, the fleet average flammability exposure of all fuel tanks on the CSeries airplanes may not exceed 3 percent of the flammability exposure evaluation time calculated using the method in part 25, Appendix N, or the fleet average flammability of a wing main tank within an equivalent construction conventional unheated aluminum wing fuel tank, whichever is greater. The typical fleet average fuel tank flammability of fuel tanks located in the wing ranges between 1 and 5 percent. If it is assumed that a CSeries equivalent conventional unheated aluminum wing fuel tank would not exceed a fleet average flammability time of 3 percent, the actual composite airplane wing fuel tank design would be required to comply with the 3 percent fleet average flammability standard, and therefore a means to reduce the flammability to 3 percent would be required. However, the proposed CSeries design includes NGS for all fuel tanks that will also be shown to meet the additional, more stringent warm day average flammability standard in part 25, Appendix M, which is only required for normally emptied fuel tanks with some part of the tank within the fuselage contour. Fuel tanks that meet this requirement typically have average fuel tank flammability levels well below the required 3 percent.

Since the proposed NGS for all fuel tanks on the CSeries provides performance that meets part 25, Appendix M, the FAA has determined that the risk reduction provided by this additional performance will provide compensation for some relief from the ignition prevention requirements of § 25.981(a)(3) while still establishing a level of safety equivalent to that established in the regulations.

In determining the appropriate amount of relief from the ignition prevention requirements of § 25.981(a), the FAA considered the original overall intent of Amendment 25-102, which was to ensure the prevention of catastrophic events due to fuel tank vapor explosion. These proposed special conditions are intended to achieve that objective through a prescriptive requirement that fault tolerance (with respect to the creation of an ignition source) be provided for all structural lightning protection design features where providing such fault tolerance is practical, and through a performance-based standard for the risk due to any single failure vulnerability that exists in the design. In addition, for any structural lightning protection design features for which Bombardier shows that providing fault tolerance is impractical, these proposed special conditions would require Bombardier to show that a fuel tank vapor ignition event due to the summed risk of all non-fault-tolerant design features is extremely improbable. Bombardier would be required to show that this safety objective is met by the proposed design using a structured system safety assessment similar to that currently used for demonstrating compliance with §§ 25.901 and 25.1309.

Given these novel or unusual design features, and the compliance challenges noted earlier in this document, the FAA has determined that application of § 25.981(a)(3) is inappropriate in that it is neither practical nor necessary to apply the ignition source prevention provisions of § 25.981(a)(3) to the specific fuel tank structural lightning protection features of the Bombardier CSeries airplanes. However, without the § 25.981(a)(3) provisions, the remaining applicable regulations in the CSeries certification basis would be inadequate to set an appropriate standard for fuel tank ignition prevention. Therefore, in accordance with provisions of § 21.16, the FAA has determined that, instead of § 25.981(a)(3), alternative fuel tank structural lightning protection requirements be applied to fuel tank lightning protection features that are integral to the airframe structure of the CSeries airplanes. These proposed alternative requirements are intended to provide the level of safety intended by § 25.981(a)(3), based on our recognition, as discussed above, that a highly effective NGS for the fuel tanks makes it unnecessary to assume that the fuel tank is always flammable. As discussed previously, the assumption that the fuel tanks are always flammable was required when demonstrating compliance to the ignition prevention requirements of § 25.981(a)(3).

One resulting difference between these proposed special conditions and the § 25.981(a)(3) provisions they are meant to replace is the outcome being prevented—fuel vapor ignition versus an ignition source. These proposed special conditions acknowledge that the application of fuel tank flammability performance standards will reduce fuel tank flammability to an extent that it is appropriate to consider the beneficial effects of flammability reduction when considering design areas where it is impractical to comply with § 25.981(a)(3).

One of the core requirements of these proposed special conditions is a prescriptive requirement that structural lightning protection design features must be fault tolerant. (An exception wherein Bombardier can show that providing fault tolerance is impractical, and associated requirements, is discussed below.) The other core requirement is that Bombardier must show that the design, manufacturing processes, and Airworthiness Limitations section of the Instructions for Continued Airworthiness include all practical measures to prevent, and detect and correct, failures of structural lightning protection features due to manufacturing variability, aging, wear, corrosion, and likely damage. The FAA has determined that, if these core requirements are met, a fuel tank vapor ignition event due to lightning is not anticipated to occur in the life of the airplane fleet. This conclusion is based on the fact that a critical lightning strike to any given airplane is itself a remote event, and on the fact that fuel tanks must be shown to be flammable for only a relatively small portion of the fleet operational life.

For any non-fault-tolerant features proposed in the design, Bombardier must show that eliminating these features or making them fault tolerant is impractical. The requirements and considerations for showing it is impractical to provide fault tolerance are described in FAA Memorandum ANM-112-08-002. This requirement is intended to minimize the number of non-fault tolerant features in the design.

For areas of the design where Bombardier shows that providing fault tolerant structural lightning protection features is impractical, non-fault-tolerant features will be allowed provided Bombardier can show that a fuel tank vapor ignition event due to the non-fault-tolerant features is extremely improbable when the sum of probabilities of those events due to all non-fault-tolerant features is considered. Bombardier will be required to submit a structured, quantitative assessment of fleet average risk for a fuel tank vapor ignition event due to all non-fault-tolerant design features included in the design. This will require determination of the number of non-fault tolerant design features, estimates of the probability of the failure of each non-fault-tolerant design feature, and estimates of the exposure time for those failures. This analysis must include failures due to manufacturing variability, aging, wear, corrosion, and likely damage.

It is acceptable to consider the probability of fuel tank flammability, the probability of a lightning strike to the airplane, the probability of a lightning strike to specific zones of the airplane (for example, Zone 2 behind the nacelle, but not a specific location or feature), and a distribution of lightning strike amplitude in performing the assessment provided the associated assumptions are acceptable to the FAA. The analysis must account for any dependencies among these factors, if they are used. The assessment must also account for operation with inoperative features and systems, including any proposed or anticipated dispatch relief. This risk assessment requirement is intended to ensure that an acceptable level of safety is provided given the non-fault-tolerant features in the proposed design.

Part 25, Appendix N, as adopted in Amendment 25-125, in conjunction with these proposed special conditions, constitutes the standard for how to determine flammability probability. In performing the safety analysis required by these special conditions, relevant § 25.981(a)(3) compliance guidance is still applicable. Appropriate credit for the conditional probability of environmental or operational conditions occurring is normally limited to those provisions involving multiple failures, and this type of credit is not normally allowed in evaluation of single failures. However, these special conditions would allow consideration of the probability of occurrence of lightning attachment and flammable conditions when assessing the probability of structural failures resulting in a fuel tank vapor ignition event.

The FAA understands that lightning protection safety for airplane structure is inherently different from lightning protection for systems. We intend to apply these proposed special conditions only to structural lightning protection features of fuel systems. We do not intend to apply the alternative standards used under these proposed special conditions to other areas of the airplane design evaluation.

In recognition of the unusual design feature discussed above, and the impracticality of requiring multiple fault tolerance for lightning protection of certain aspects of fuel tank structure, the FAA has determined that a level of safety that is equivalent to direct compliance with § 25.981(a)(3) will be achieved for the CSeries by applying these proposed requirements. The FAA considers that, instead of only concentrating on fault tolerance for ignition source prevention, significantly reducing fuel tank flammability exposure in addition to preventing ignition sources is a better approach to lightning protection for the fuel tanks. In addition, the level of average fuel tank flammability achieved by compliance with these proposed special conditions is low enough that it is not appropriate or accurate to assume in a safety analysis that the fuel tanks may always be flammable.

Section 25.981(b), as amended by Amendment 25-125, sets limits on the allowable fuel tank flammability for the CSeries airplanes. Paragraph 2(a) of these proposed special conditions applies the more stringent standard for warm day flammability performance applicable to normally emptied tanks within the fuselage contour from § 25.981(b) and part 25, Appendix M, to all of the fuel tanks of the CSeries airplanes.

Because of the more stringent fuel tank flammability requirements in these proposed special conditions, and because the flammability state of a fuel tank is independent of the various failures of structural elements that could lead to an ignition source in the event of lightning attachment, the FAA has agreed that it is appropriate in this case to allow treatment of flammability as an independent factor in the safety analysis. The positive control of flammability and the lower flammability that is required by these proposed special conditions exceeds the minimum requirements of § 25.981(b). This offsets a reduction of the stringent standard for ignition source prevention in § 25.981(a)(3), which assumes that the fuel tank is flammable at all times.

Given the stringent requirements for fuel tank flammability, the fuel vapor ignition prevention and the ignition source prevention requirements in these proposed special conditions will prevent “. . . catastrophic failure . . . due to ignition of fuel or vapors” as stated in § 25.981(a). Thus, the overall level of safety achieved by these proposed special conditions is considered equivalent to that which would be required by compliance with § 25.981(a)(3) and (b).

As discussed above, these special conditions are applicable to the Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier Aerospace apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on two model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes.

Most of the terms used in these proposed special conditions either have the common dictionary meaning or are defined in Advisory Circular 25.1309-1A, System Design and Analysis, dated June 21, 1988. The following definitions are the only terms intended to have a specialized meaning when used in these proposed special conditions:

(a) Basic Airframe Structure. Includes design elements such as structural members, structural joint features, and fastener systems including airplane skins, ribs, spars, stringers, etc., and associated fasteners, joints, coatings, and sealant. Basic airframe structure may also include those structural elements that are expected to be removed for maintenance, such as exterior fuel tank access panels and fairing attachment features, provided maintenance errors that could compromise associated lightning protection features would be evident upon an exterior preflight inspection of the airplane and would be corrected prior to flight.

(b) Permanent Systems Supporting Structure. Includes static, permanently attached structural parts (such as brackets) that are used to support system elements. It does not include any part intended to be removed, or any joint intended to be separated, to maintain or replace system elements or other parts, unless that part removal or joint separation is accepted by the FAA as being extremely remote.

(c) Manufacturing Variability. Includes tolerances and variability allowed by the design and production specifications as well as anticipated errors or escapes from the manufacturing and inspection processes.

(d) Extremely Remote. Conditions that are not anticipated to occur to each airplane during its total life, but which may occur a few times when considering the total operational life of all airplanes of one type. Extremely remote conditions are those having an average probability per flight hour on the order of 1 × 10 −7 or less, but greater than on the order of 1 × 10 −9 .

(e) Extremely Improbable. Conditions that are so unlikely that they are not anticipated to occur during the entire operational life of all airplanes of one type. Extremely improbable conditions are those having an average probability per flight hour of the order of 1 × 10 −9 or less.

For lightning protection features that are integral to fuel tank basic airframe structure or permanent systems supporting structure, as defined in Special Condition No. 1, “Definitions,” for which Bombardier shows and the FAA finds compliance with § 25.981(a)(3) to be impractical, the following requirements may be applied in lieu of the requirements of § 25.981(a)(3):

(a) Bombardier must show that the airplane design meets the requirements of part 25, appendix M, as amended by Amendment 25-125, for all fuel tanks installed on the airplane.

(b) Bombardier must show that the design includes at least two independent, effective, and reliable lightning protection features (or sets of features) such that fault tolerance to prevent lightning-related ignition sources is provided for each area of the structural design proposed to be shown compliant with these special conditions in lieu of compliance with the requirements of § 25.981(a)(3). Fault tolerance is not required for any specific design feature if:

(1) For that feature, providing fault tolerance is shown to be impractical, and

(2) Fuel tank vapor ignition due to that feature and all other non-fault-tolerant features, when their fuel tank vapor ignition event probabilities are summed, is shown to be extremely improbable.

(c) Bombardier must perform an analysis to show that the design, manufacturing processes, and the airworthiness limitations section of the instructions for continued airworthiness include all practical measures to prevent, and detect and correct, failures of structural lightning protection features due to manufacturing variability, aging, wear, corrosion, and likely damage.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2014-0483; Directorate Identifier 2014-NM-082-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

On July 31, 2013, we issued AD 2013-16-08, Amendment 39-17546 (78 FR 51055, August 20, 2013). AD 2013-16-08 requires actions intended to address an unsafe condition on certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, and Model CL-600-2D24 (Regional Jet Series 900) airplanes.

Since we issued AD 2013-16-08, Amendment 39-17546 (78 FR 51055, August 20, 2013), we have determined that the MLG dressed shock strut was incorrectly identified as an MLG retraction actuator assembly in paragraph (k)(2) of the “Parts Installation Limitations” section in AD 2013-16-08. We have revised paragraph (k)(2) of this proposed AD accordingly.

In addition, we corrected a typographical error in the service bulletin number specified in paragraph (j)(1)(iii) of AD 2013-16-08, Amendment 39-17546 (78 FR 51055, August 20, 2013), under “Credit for Previous Actions.” Bombardier Service Bulletin “769BA-32-031” was changed to Bombardier Service Bulletin “670BA-32-031.”

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

Since late 2006, we have included a standard paragraph titled “Airworthy Product” in all MCAI ADs in which the FAA develops an AD based on a foreign authority's AD.

The MCAI or referenced service information in an FAA AD often directs the owner/operator to contact the manufacturer for corrective actions, such as a repair. Briefly, the Airworthy Product paragraph allowed owners/operators to use corrective actions provided by the manufacturer if those actions were FAA-approved. In addition, the paragraph stated that any actions approved by the State of Design Authority (or its delegated agent) are considered to be FAA-approved.

In an NPRM having Directorate Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013), we proposed to prevent the use of repairs that were not specifically developed to correct the unsafe condition, by requiring that the repair approval provided by the State of Design Authority or its delegated agent specifically refer to the FAA AD. This change was intended to clarify the method of compliance and to provide operators with better visibility of repairs that are specifically developed and approved to correct the unsafe condition. In addition, we proposed to change the phrase “its delegated agent” to include a design approval holder (DAH) with State of Design Authority design organization approval (DOA), as applicable, to refer to a DAH authorized to approve required repairs for the proposed AD.

One commenter to the NPRM having Directorate Identifier 2012-NM-101-AD (78 FR 78285, December 26, 2013) stated the following: “The proposed wording, being specific to repairs, eliminates the interpretation that Airbus messages are acceptable for approving minor deviations (corrective actions) needed during accomplishment of an AD mandated Airbus service bulletin.”

This comment has made the FAA aware that some operators have misunderstood or misinterpreted the Airworthy Product paragraph to allow the owner/operator to use messages provided by the manufacturer as approval of deviations during the accomplishment of an AD-mandated action. The Airworthy Product paragraph does not approve messages or other information provided by the manufacturer for deviations to the requirements of the AD-mandated actions. The Airworthy Product paragraph only addresses the requirement to contact the manufacturer for corrective actions for the identified unsafe condition and does not cover deviations from other AD requirements. However, deviations to AD-required actions are addressed in 14 CFR 39.17, and anyone may request the approval for an alternative method of compliance to the AD-required actions using the procedures found in 14 CFR 39.19.

To address this misunderstanding and misinterpretation of the Airworthy Product paragraph, we have changed the paragraph and retitled it “Contacting the Manufacturer.” This paragraph now clarifies that for any requirement in this proposed AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the FAA, Transport Canada Civil Aviation (TCCA), or Bombardier's TCCA Design Approval Organization (DAO).

The Contacting the Manufacturer paragraph also clarifies that, if approved by the DAO, the approval must include the DAO-authorized signature. The DAO signature indicates that the data and information contained in the document are TCCA-approved, which is also FAA-approved. Messages and other information provided by the manufacturer that do not contain the DAO-authorized signature approval are not TCCA-approved, unless TCCA directly approves the manufacturer's message or other information.

This clarification does not remove flexibility previously afforded by the Airworthy Product paragraph. Consistent with long-standing FAA policy, such flexibility was never intended for required actions. This is also consistent with the recommendation of the Airworthiness Directive Implementation Aviation Rulemaking Committee to increase flexibility in complying with ADs by identifying those actions in manufacturers' service instructions that are “Required for Compliance” with ADs. We continue to work with manufacturers to implement this recommendation. But once we determine that an action is required, any deviation from the requirement must be approved as an alternative method of compliance.

We estimate that this proposed AD affects 391 airplanes of U.S. registry.

The actions that were required by AD 2013-16-08, Amendment 39-17546 (78 FR 51055, August 20, 2013), that are retained in this proposed AD take up to 16 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $1,018 per product. Based on these figures, the estimated cost of the actions that are required by AD 2013-16-08 is $2,378 per product.

The new requirements of this AD add no additional economic burden.

According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2286) has been filed by BASF Corp., 100 Park Ave. Florham Park, NJ 07932. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of sodium formate as an acidifier in swine feed.

The petitioner has requested a categorical exclusion from preparing an environmental assessment or environmental impact statement under 21 CFR 25.32(r). Interested persons may submit either electronic or written comments regarding this request for categorical exclusion to the Division of Dockets Management (see DATES and ADDRESSES ). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Section 201(g) of SMCRA, 30 U.S.C. 1201(g), provides that any person may petition the Director of OSMRE to initiate a proceeding for the issuance, amendment, or repeal of any regulation adopted under SMCRA. It also specifies that “the Director shall either grant or deny the petition” within 90 days after receipt. On March 13, 1979, OSMRE adopted regulations at 30 CFR 700.12 to further implement this statutory provision.

Under 30 CFR 700.12(c), we will accept a petition for rulemaking only if the Director determines that it sets forth “facts, technical justification and law which may provide a reasonable basis for issuance, amendment or repeal of a regulation.” The rule also states that facts, technical justification or law previously considered in a different petition or rulemaking on the same issue do not qualify as a reasonable basis. Any petition that does not meet this threshold will be rejected without prejudice.

If we accept the petition, we will publish a notice in the Federal Register seeking comments on whether we should grant or deny the petition. At the close of the comment period, the Director will decide to either grant or deny the petition, in whole or in part. We will publish notice of that decision in the Federal Register . If the Director grants the petition, we will initiate rulemaking proceedings in which we again will seek public comment before adopting a final rule. If the Director denies the petition, we will notify the petitioner of the reasons for the decision not to initiate any rulemaking action pursuant to the petition.

In accordance with 30 CFR 700.12(d), the Director's decision on a petition is a final decision for the Department, which means that the petitioner is not entitled to administrative review of the decision. The Director's decision on a petition constitutes the final decision of the Department of the Interior. Accordingly, it is not subject to review by the Office of Hearings and Appeals. However, the petitioner may seek judicial review of a decision to reject or deny the petition.

On April 18, 2014, we received from WildEarth Guardians a petition for rulemaking requesting that OSMRE promulgate rules to prohibit the production of visible nitrogen oxides (NO X ) emissions during blasting at surface coal mining operations in order to protect the health, welfare, and safety of the public and of mine workers, and to prevent injury to persons. The petition requests that we amend our regulations at 30 CFR 816.67 and 817.67 to prohibit visible NO X emissions during blasting and to require that the operator visually monitor all blasting activities and report all instances of visible emissions of NO X to the regulatory authority.

You may view and download the complete text of the petition and accompanying exhibits on our home page at http://www.osmre.gov/programs/rcm/petitions/WEGPetition041414.pdf and http://www.osmre.gov/programs/rcm/petitions/WEGPetitionExhibits.pdf respectively. The petition and exhibits also are available for inspection at the location listed under ADDRESSES.

We are seeking comment on the merits of the petition and the requested rule changes. In addition, we seek comment on the extent to which the decision in In re Permanent Surface Min. Regulation Litig. I, Round II, 1980 U.S. Dist. LEXIS 17660 at *43-44 (D.D.C., May 16, 1980), 19 Env't Rep. Cas. (BNA) 1477, 1491-1492, regarding OSMRE's authority to regulate air quality, should guide the Director in making the decision to grant or deny the petition. In that decision, the court remanded the 1979 version of 30 CFR 816.95 and 817.95, which contained extensive provisions regulating fugitive dust (including fugitive dust from blasting  1 ), because the court found that “the Secretary's authority to regulate [air] pollution is limited to activities related to erosion.” Id. at 1491.

We will review and consider all comments submitted to the addresses listed above (see ADDRESSES ) by the close of the comment period (see DATES ).

Please include the Docket ID “OSM-2014-0003” at the beginning of all written comments. We cannot ensure that comments received after the close of the comment period (see DATES ) or at locations other than those listed above (see ADDRESSES ) will be included in the docket or considered in the development of a proposed rule.

Before including your address, phone number, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

We will not hold a public hearing on the petition. The petitioner did not request a hearing and we have determined under 30 CFR 700.12(c) that no hearing is necessary. However, OSMRE personnel will be available to meet with the public during business hours (8 a.m. to 4 p.m.) during the comment period. Contact the person listed under FOR FURTHER INFORMATION CONTACT if you wish to arrange a meeting.

This notice is not a proposed or final rule, policy, or guidance. Therefore, it is not subject to the Regulatory Flexibility Act, the Small Business Regulatory Enforcement Fairness Act, the Paperwork Reduction Act, the Unfunded Mandates Reform Act, or Executive Orders 12866, 13563, 12630, 13132, 12988, 13175, and 13211. We will conduct the analyses required by these laws and executive orders only if we decide to grant the petition and develop a proposed rule.

In developing this notice, we did not conduct or use a study, experiment, or survey requiring peer review under the Information Quality Act (Pub. L. 106-554, section 15).

This notice is not subject to the requirement to prepare an Environmental Assessment or Environmental Impact Statement under the National Environmental Policy Act (NEPA), 42 U.S.C. 4332(2)(C), because no proposed action, as described in 40 CFR 1508.18(a) and (b), yet exists. This notice only seeks public comment on whether the Director should grant the petition and initiate rulemaking. If the Director ultimately grants the petition, we will prepare the appropriate NEPA compliance documents as part of the rulemaking process.

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Public Participation and Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2014-0541] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number (USCG-2014-0138) in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

This rule involves a fireworks display associated with a televised event that will take place in Baltimore, Maryland, on September 13, 2014 and will attract thousands of spectators. The launch sites for the fireworks display are from discharge barges located in the Patapsco River. The permanent safety zones listed in the Table to 33 CFR 165.506 do not apply to this event.

This rule also involves designated on-water spectator areas associated with the fireworks display. The current regulations under 33 CFR part 100 address safety for reoccurring marine events. This marine event does not appear in the current regulations; however, as it is a regulation to provide effective control over regattas and marine parades on the navigable waters of the United States so as to insure safety of life in the regatta or marine parade area, this marine event therefore needs to be temporarily added.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to ensure safety of life on navigable waters of the United States for designated on-water spectator areas established in support of the Star-Spangled Spectacular Fireworks event.

Fireworks displays are frequently held from locations on or near the navigable waters of the United States. The potential hazards associated with fireworks displays are a safety concern during such events. The purpose of this rule is to promote public and maritime safety during a fireworks display, and to protect mariners transiting the area from the potential hazards associated with a fireworks display, such as the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. This rule is needed to ensure safety on the waterway before, during and after the scheduled event.

The Baltimore Office of Promotion and The Arts, of Baltimore, MD, will sponsor a large fireworks display launched from barges located at seven locations in the Patapsco River at Baltimore, Maryland, scheduled on September 13, 2014 at 9 p.m. A rehearsal of the fireworks show is planned on September 12, 2014 at 9 p.m. If necessary due to inclement weather, the event will be held on September 14, 2014.

Through this regulation, the Coast Guard proposes to establish a safety zone. The safety zone will encompass all waters of the Patapsco River, as follows: (1) Within a 150 foot radius of a fireworks discharge barge in approximate position latitude 39°17′03″ N, longitude 076°36′36″ W, located southeast of Pier 1 Inner Harbor at Baltimore, Maryland; (2) within a 300 foot radius of a fireworks discharge barge in approximate position latitude 39°16′55″ N, longitude 076°36′17″ W, located southwest of Pier 6 Inner Harbor at Baltimore, Maryland; (3) within a 600 foot radius of a fireworks discharge barge in approximate position latitude 39°16′38″ N, longitude 076°35′55″ W, located northwest of the Domino Sugar (ASR Group) refinery wharf at Baltimore, Maryland; (4) within a 500 foot radius of a fireworks discharge barge in approximate position latitude 39°16′42″ N, longitude 076°35′30″ W, located south of the Fells Point Recreation Pier at Baltimore, Maryland; (5) within a 500 foot radius of a fireworks discharge barge in approximate position latitude 39°16′28″ N, longitude 076°34′59″ W, located north of the North Locust Point Marine Terminal at Baltimore, Maryland; (6) within a 600 foot radius of a fireworks discharge barge in approximate position latitude 39°16′15″ N, longitude 076°34′38″ W, located south of the Northwest Harbor Turning Basin at Baltimore, Maryland; and (7) within a 800 foot radius of each of the fireworks discharge barges arranged in a line between approximate position latitude 39°15′47″ N, longitude 076°34′30″ W, and approximate position latitude 39°15′40″ N, longitude 076°34′37″ W, located along the Northwest Harbor (East Channel) at Baltimore, Maryland. The temporary safety zone will be enforced from 7:00 p.m. to 10 p.m. on September 12, 2014, and from 7:30 p.m. to 11 p.m. on September 13, 2014, and if necessary due to inclement weather, from 7:30 p.m. to 11 p.m. on September 14, 2014. The effect of this safety zone will be to restrict navigation in the regulated area during, as well as the set up and take down of, the fireworks display.

This rule requires that entry into or remaining in this safety zone is prohibited unless authorized by the Coast Guard Captain of the Port Baltimore. All vessels underway within this safety zone at the time it is implemented are to depart the zone. To seek permission to transit the area of the safety zone, the Captain of the Port Baltimore can be contacted at telephone number 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Coast Guard vessels enforcing the safety zone can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Federal, state, and local agencies may assist the Coast Guard in the enforcement of the safety zone. The Coast Guard will issue notices to the maritime community to further publicize the safety zone and notify the public of changes in the status of the zone. Such notices will continue until the event is complete.

The Coast Guard also proposes to establish special local regulations on specified waters of the Patapsco River by which spectator vessels may observe the Star-Spangled Spectacular Fireworks on September 13, 2014. This action is necessary to ensure the safety of participants and spectators immediately prior to, during, and following the Star-Spangled Spectacular Fireworks. The regulations will be enforced from 7:30 p.m. to 11 p.m. on September 13, 2014, and if necessary due to inclement weather, from 7:30 p.m. to 11 p.m. on September 14, 2014. The proposed regulated area extends across the entire width of the waterway and will encompass all waters of the Patapsco River, bounded on the east by a line drawn from position latitude 39°15′42″ N, longitude 076°34′48″ W, thence to position latitude 39°15′29″ N, longitude 076°34′34″ W, thence to position latitude 39°15′36″ N, longitude 076°34′12″ W, and bounded on the west by the Inner Harbor western bulkhead, located at Baltimore, MD. Designated spectator areas and an event area exist within this regulated area. Three designated spectator areas, where all vessels are prohibited from transiting in excess of wake speed unless authorized by the Captain of the Port Baltimore or his designated representative and persons and vessels may enter, transit through, anchor in, or remain within, include: (a) All waters of the Patapsco River, within lines connecting the following positions: From latitude 39°16′40″ N, longitude 076°35′10″ W, thence northeasterly to latitude 39°16′45″ N, longitude 076°35′04″ W, thence southeasterly to latitude 39°16′41″ N, longitude 076°34′57″ W, thence northeasterly to latitude 39°16′45″ N, longitude 076°34′50″ W, thence southerly to latitude 39°16′38″ N, longitude 076°34′50″ W, thence southwesterly to latitude 39°16′34″ N, longitude 076°34′55″ W, thence northwesterly to the position of origin. This spectator area is to be used by commercial vessels only; (b) All waters of the Patapsco River, within lines connecting the following positions: From latitude 39°16′27″ N, longitude 076°34′41″ W, thence northerly to latitude 39°16′37″ N, longitude 076°34′37″ W, thence easterly to latitude 39°16′35″ N, longitude 076°34′16″ W, thence southerly to latitude 39°16′18″ N, longitude 076°34′21″ W, thence westerly to the position of origin. This spectator area is to be used by recreational vessels only; and (c) All waters of the Patapsco River, within lines connecting the following positions: From latitude 39°16′53″ N, longitude 076°36′10″ W, thence southerly to latitude 39°16′49″ N, longitude 076°36′17″ W, thence easterly to latitude 39°16′35″ N, longitude 076°36′04″ W, thence northerly to latitude 39°16′48″ N, longitude 076°36′02″ W, thence westerly to the position of origin. This spectator area is to be used by both commercial and recreational vessels. The event area, where all persons and vessels, except those persons and vessels participating in the event, are prohibited from entering, transiting through, anchoring in, or remaining within, includes all waters of the Patapsco River, within the regulated area, excluding the designated spectator areas.

The effect of this proposed rule will be to restrict general navigation in the regulated area during the event. Vessels intending to transit the Patapsco River through the regulated area will be allowed to safely transit the regulated area only when the Coast Guard Patrol Commander has deemed it safe to do so. The Coast Guard will restrict vessel traffic in the event area to provide for the safety of participants, spectators and other transiting vessels. The Coast Guard will provide notice of the special local regulations by Local Notice to Mariners, Broadcast Notice to Mariners, and the official patrol on scene.

The regulations contained within this proposed rule are not intended to effect existing Naval Vessel Protection Zone regulations described in Title 33 CFR Part 165 (Subpart G).

We developed this proposed 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 proposed 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 economic impact of this rule is not significant for the following reasons: The primary impact of these regulations will be on vessels wishing to transit the affected waterways during activities associated with the Star-Spangled Spectacular fireworks display beginning on September 12, 2014 and ending on September 14, 2014. Although these regulations prevent traffic from transiting a portion of the Patapsco River during this event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected area. Moreover, the magnitude of the event itself will severely hamper or prevent transit of the waterway, even absent these regulations designed to ensure it is conducted in a safe and orderly fashion.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this proposed rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Patapsco River encompassed within the special local regulations from 7:30 p.m. on September 13, 2014 to 11 p.m. on September 14, 2014 and encompassed within the safety zone from 7 p.m. on September 12, 2014 to 11 p.m. on September 14, 2014. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

We have analyzed this proposed 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.

This proposed rule involves special local regulations issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES .

Additionally, this proposed rule involves establishing a temporary safety zone for a fireworks display. The fireworks are launched from navigable waters of the United States and may have potential for negative impact on the safety or other interest of waterway users and near shore activities in the event area. The activity includes fireworks launched from barges near the shoreline that generally rely on the use of navigable waters as a safety buffer to protect the public from fireworks fallouts and premature detonations. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary 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 proposed rule.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR parts 100 and 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Public Participation and Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2013-0214] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number (USCG-2014-0214) in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one August 1, 2014, using one of the methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

On January 24, 2014, Sector Northern New England received notice of a proposed replacement of The Gut Bridge in South Bristol, Maine between Rutherford Island and Bristol Neck. A Bridge Permit was awarded to Maine Department of Transportation (MEDOT) on April 15, 2014 to begin in accordance with Plans dated September 24, 2013.

MEDOT has held seven public meetings between June 2009 and August 2013. Mariners have expressed no significant concerns.

On November 8, 2013, Public Notice 1-132 was disseminated by the First Coast Guard District Bridge Program Manager. This notice included the official plans being submitted for approval of a bridge permit and solicited comments from the public. Twenty-five comments were received. All comments were in support of burying the existing overhead electrical cables rather than allowing them to remain in place above the water. There were no comments received in opposition of the proposed construction project or potential closures to the channel.

Under the Ports and Waterways Safety Act, the Coast Guard has the authority to establish RNAs in defined water areas that are determined to have hazardous conditions and in which vessel traffic can be regulated in the interest of safety. See 33 U.S.C. 1231 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. The purpose of this proposed rule is to ensure the safe transit of vessels in the area, and to protect all persons, vessels, construction crews, and the marine environment during bridge construction operations on The Gut in South Bristol, ME, between Rutherford Island and Bristol Neck.

MEDOT proposes to replace the existing movable bobtail swing bridge over The Gut, which carries State Route 129 from Bristol Neck to Rutherford Island, with a movable trunnion-style lift bridge on the same alignment. The project is necessary to replace a structurally and operationally deficient bridge that has exceeded its useful life. Before demolition of the existing bridge commences, a temporary fixed detour bridge will be constructed on the east side of the existing bridge to provide for vehicular and pedestrian traffic throughout the project. This temporary bridge will not be movable and will have a fixed vertical clearance of 3 feet 11 inches. The existing bridge has a vertical clearance of 4 feet 2 inches when closed. It is proposed that marine traffic will be restricted from the project vicinity during the removal of the existing bridge and construction of the new bridge. This navigational channel closure is expected to last approximately seven months and marine traffic will be detoured around Rutherford Island during this time frame. Transit time around Rutherford Island is approximately 20-60 minutes for mariners.

Further, all closures will be limited to specific hours of the day. Mariners will be advised of all closure dates and times via Local Notice to Mariners and Broadcast Notice to Mariners in advance of closure times.

We developed this proposed 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 proposed 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 expect the economic impact of this rule to be minimal because mariners are able to make a short transit (approximately 20-60 minutes) around Rutherford Island to reach any destination on the other side of The Gut.

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 proposed rule will not have a significant economic impact on a substantial number of small entities.

This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit under the South Bristol Gut Bridge who cannot clear the fixed temporary bridge of 3 feet 11 inches. The impact to these entities would be minimal because mariners are able to make a short transit (approximately 20-60 minutes) around Rutherford Island to reach any destination on the other side of The Gut and the temporary bridge is estimated to only be in place for about seven months.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

We have analyzed this proposed 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. This proposed rule involves the establishment of an RNA. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary 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 proposed rule.

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

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2013-0215] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number (USCG-2014-0215) in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one on or before August 1, 2014 using one of the methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

On September 11, 2013, Sector Northern New England received notice of potential bridge work being conducted on Bridge 1 between Kittery, ME, and the Portsmouth Naval Shipyard on Seavey Island from September 1, 2014 through April 30, 2017. A Construction Approval Letter will be issued once a contractor is awarded the contract to perform needed repairs.

On February 26, 2014, the U. S. Navy posted a notice in the Portsmouth Herald advising the public of the intent to file applications for approval of structural repairs to be made to Bridge 1. No comments or requests for public meeting were made.

Under the Ports and Waterways Safety Act, the Coast Guard has the authority to establish RNAs in defined water areas that are determined to have hazardous conditions and in which vessel traffic can be regulated in the interest of safety. See 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. The purpose of this proposed rule is to ensure the safe transit of vessels in the area, and to protect all persons, vessels, and the marine environment during structural repairs made to the Portsmouth Naval Shipyard, Bridge 1.

The Coast Guard is proposing to establish an RNA on the navigable waters of the Piscataqua River surrounding Bridge 1 which spans from Kittery, Maine, to Seavey Island, Maine from September 1, 2014 to April 30, 2017. The Portsmouth Naval Shipyard is the bridge owner and is contracting the structural repairs. This bridge is the main entrance to the Portsmouth Naval Shipyard. The existing bridge is a steel girder structure approximately 300 feet long and 50 feet 7 inches wide. Existing vertical clearance is 7 feet at MLW; the proposed vertical clearance is also 7 feet at MLW. Horizontal clearance is currently 57 feet and the proposed clearance would be 56 feet 6 inches. Existing granite block and steel reinforced abutments and piers will remain in place but will be reinforced with cladding around the abutments. As a result, the horizontal clearance would be reduced by six inches.

This proposed RNA would allow the Captain of the Port Sector Northern New England (COTP) to establish speed and wake restrictions and to prohibit vessel traffic on this portion of the river for limited periods when necessary for the safety of vessels and workers during construction work in the channel. The Coast Guard would enforce a five knot speed limit as well as a “NO WAKE” zone and would be able to close the designated area to all vessel traffic under any circumstances, planned or unforeseen, that pose an imminent threat to waterway users or construction operations in the area. At this time, only partial closures of the waterway are anticipated.

We developed this proposed 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 proposed 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 expect the economic impact of this rule to be minimal because this regulated navigation area only requires vessels to reduce speed through a limited portion of the Piscataqua River, therefore causing only a nominal delay to a vessel's transit.

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 proposed rule will not have a significant economic impact on a substantial number of small entities.

This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the vicinity of Bridge 1 from September 1, 2014 to April 30, 2017. These entities would only be required to reduce their speed through a limited portion of the Piscataqua River outside of the main channel.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

We have analyzed this proposed 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. This proposed rule involves the establishment of an RNA. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary 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 proposed rule.

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

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

When submitting comments, remember to:

1. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date, and page number).

2. Follow directions—EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

4. Describe any assumptions and provide any technical information and/or data that you used.

5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

6. Provide specific examples to illustrate your concerns, and suggest alternatives.

7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

8. Make sure to submit your comments by the comment period deadline identified.

This rulemaking addresses submissions from the Ohio Environmental Protection Agency (Ohio EPA). The state submitted its infrastructure SIP for each NAAQS on the following dates: 2008 Pb—October 12, 2011, and supplemented on June 7, 2013; 2008 ozone—December 27, 2012, and supplemented on June 7, 2013; 2010 NO 2 —February 8, 2013, and supplemented on February 25, 2013, and June 7, 2013; and, 2010 SO 2 —June 7, 2013.

Under sections 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure that their SIPs provide for implementation, maintenance, and enforcement of the NAAQS, including the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. These submissions must contain any revisions needed for meeting the applicable SIP requirements of section 110(a)(2), or certifications that their existing SIPs for the NAAQS already meet those requirements.

EPA highlighted this statutory requirement in an October 2, 2007, guidance document entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM 2.5 National Ambient Air Quality Standards” (2007 Memo). On September 25, 2009, EPA issued an additional guidance document pertaining to the 2006 PM 2.5   1 NAAQS entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour Fine Particle (PM 2.5 ) National Ambient Air Quality Standards (NAAQS)” (2009 Memo), followed by the October 14, 2011, “Guidance on Infrastructure SIP Elements Required Under Sections 110(a)(1) and (2) for the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS)” (2011 Memo). Most recently, EPA issued “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and (2)” on September 13, 2013 (2013 Memo).

The SIP submissions referenced in this rulemaking pertain to the applicable requirements of section 110(a)(1) and (2), and address the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. To the extent that the prevention of significant deterioration (PSD) program is comprehensive and non-NAAQS specific, a narrow evaluation of other NAAQS, such as the 1997 8-hour ozone and 2006 PM 2.5 NAAQS will be included in the appropriate sections.

EPA is acting upon the SIP submissions from Ohio that address the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.

This rulemaking will not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (collectively referenced as “director's discretion”); and, (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each one of these substantive areas in separate rulemaking. A detailed history, interpretation, and rationale related to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” ( see 79 FR 27241 at 27242-27245).

EPA's guidance for these infrastructure SIP submissions is embodied in the 2007 Memo. Specifically, attachment A of the 2007 Memo (Required Section 110 SIP Elements) identifies the statutory elements that states need to submit in order to satisfy the requirements for an infrastructure SIP submission. The 2009 Memo was issued to provide additional guidance for certain elements to meet the requirements of section 110(a)(1) and (2) of the CAA, and the 2011 Memo provides guidance specific to the 2008 Pb NAAQS. Lastly, the 2013 Memo identifies and further clarifies aspects of infrastructure SIPs that are not NAAQS specific.

As noted in the 2011 Memo and reiterated in the 2013 Memo, pursuant to section 110(a), states must provide reasonable notice and opportunity for public hearing for all infrastructure SIP submissions. Ohio EPA provided the opportunity for public comment for each NAAQS that ended on the following dates: 2008 Pb—October 11, 2011; 2008 ozone—December 21, 2012; 2010 NO 2 —February 19, 2013; and, 2010 SO 2 —June 5, 2013. The state did not receive any comments during the comment periods.

EPA is also soliciting comment on our evaluation of the state's infrastructure SIP submissions in this notice of proposed rulemaking. Ohio provided detailed synopses of how various components of its SIP meet each of the requirements in section 110(a)(2) for the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS, as applicable. The following review evaluates the state's submissions.

This section requires SIPs to include enforceable emission limits and other control measures, means or techniques, schedules for compliance, and other related matters. However, EPA has long interpreted emission limits and control measures for attaining the standards as being due when nonattainment planning requirements are due. 2 In the context of an infrastructure SIP, EPA is not evaluating the existing SIP provisions for this purpose. Instead, EPA is only evaluating whether the state's SIP has basic structural provisions for the implementation of the NAAQS.

Ohio Revised Code (ORC) 3704.03 provides the Director of Ohio EPA with the authority to develop rules and regulations necessary to meet state and Federal ambient air quality standards. Ohio also has SIP approved provisions for specific pollutants. For example, Ohio Administrative Code (OAC) 3745-71 regulates provides for the direct regulation of Pb emissions, and OAC 3745-18 provides for the direct regulation of SO 2 emissions. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(A) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

As previously noted, EPA is not proposing at this time to approve or disapprove any existing state provisions or rules related to SSM or director's discretion in the context of section 110(a)(2)(A).

This section requires SIPs to include provisions to provide for establishing and operating ambient air quality monitors, collecting and analyzing ambient air quality data, and making these data available to EPA upon request. This review of the annual monitoring plan includes EPA's determination that the state: (i) Monitors air quality at appropriate locations throughout the state using EPA-approved Federal Reference Methods or Federal Equivalent Method monitors; (ii) submits data to EPA's Air Quality System (AQS) in a timely manner; and, (iii) provides EPA Regional Offices with prior notification of any planned changes to monitoring sites or the network plan.

Ohio EPA continues to operate a monitoring network, and EPA approved the state's 2014 Annual Air Monitoring Network Plan for Pb, ozone, NO 2 , and SO 2 on October 30, 2013. Furthermore, Ohio EPA populates AQS with air quality monitoring data in a timely manner, and provides EPA with prior notification when considering a change to its monitoring network or plan. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(B) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

States are required to include a program providing for enforcement of all SIP measures and the regulation of construction of new or modified stationary sources to meet NSR requirements under PSD and NNSR programs. Part C of the CAA (sections 160-169B) addresses PSD, while part D of the CAA (sections 171-193) addresses NNSR requirements.

The evaluation of each state's submission addressing the infrastructure SIP requirements of section 110(a)(2)(C) covers: (i) Enforcement of SIP measures; (ii) PSD program for the 2008 Pb NAAQS; (iii) PSD provisions that explicitly identify oxides of nitrogen (NO X ) as a precursor to ozone in the PSD program; (iv) identification of precursors to PM 2.5 and the identification of PM 2.5 and PM 10   3 condensables in the PSD program; (v) PM 2.5 increments in the PSD program; and (vi) greenhouse gas (GHG) permitting and the “Tailoring Rule.”  4

In this rulemaking, we are evaluating Ohio EPA's submissions with respect to the enforcement of SIP measures. However, we are not taking action on the state's satisfaction of the various PSD and GHG permitting requirements. Instead, EPA will evaluate Ohio's compliance with each of these requirements in a separate rulemaking.

Ohio EPA staffs and implements an enforcement program. ORC 3704.03 provides the Director of Ohio EPA with the authority to implement the enforcement program as well as NSR provisions within OAC 3745-31. Ohio EPA compiles all air pollution control enforcement settlements in the state, and makes them available for public review on its Web site. EPA proposes that Ohio has met the enforcement of SIP measures requirements of section 110(a)(2)(C) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

For the purposes of the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS infrastructure SIPs, EPA reiterates that NSR reform regulations are not in the scope of these actions. Therefore, we are not taking action on existing NSR reform regulations for Ohio. To address the pre-construction regulation of the modification and construction of minor stationary sources and minor modifications of major stationary sources, an infrastructure SIP submission should identify the existing EPA-approved SIP provisions and/or include new provisions that govern the minor source pre-construction program that regulates emissions of the relevant NAAQS pollutants. EPA approved Ohio's minor NSR program on January 22, 2003 (68 FR 2909). Since this date, Ohio EPA and EPA have relied on the existing minor NSR program to ensure that new and modified sources not captured by the major NSR permitting programs do not interfere with attainment and maintenance of the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

Certain sub-elements in this section overlap with elements of section 110(a)(2)(D)(i) and section 110(a)(2)(J). These links will be discussed in the appropriate areas below.

Section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment, or interfering with maintenance, of the NAAQS in another state.

With respect to the 2008 Pb NAAQS, the 2011 Memo notes that the physical properties of Pb prevent it from experiencing the same travel or formation phenomena as PM 2.5 or ozone. Specifically, there is a sharp decrease in Pb concentrations as the distance from a Pb source increases. Accordingly, it may be possible for a source in a state to emit Pb at a location and in such quantities that contribute significantly to nonattainment in, or interference with maintenance by, any other state. However, EPA anticipates that this would be a rare situation, e.g., sources emitting large quantities of Pb are in close proximity to state boundaries. The 2011 Memo suggests that the applicable interstate transport requirements of section 110(a)(2)(D)(i)(I) can be met through a state's assessment as to whether or not emissions from Pb sources located in close proximity to its borders have emissions that impact a neighboring state such that they contribute significantly to nonattainment or interfere with maintenance in that state. One way that a state's conclusion could be supported is by the technical support documents used for initial area designations for Pb.

Ohio's infrastructure SIP submission for the 2008 Pb NAAQS notes that there are three areas designated as nonattainment for the 2008 Pb NAAQS located in portions of Cuyahoga County, Fulton County, and Logan County ( see 75 FR 71033). None of these areas are located in close proximity to any of Ohio's border, and Ohio EPA provided a map of Pb-emitting sources in the state showing that sources emitting 0.5 tpy or above are not in close proximity to any state borders. EPA's final technical support documents for the nonattainment areas located in Ohio support the conclusion that the ambient concentration of Pb are not expected to exceed the NAAQS outside of the nonattainment boundaries. Furthermore, EPA does not believe that the elevated levels of ambient Pb concentrations in Cuyahoga County, Fulton County, or Logan County (or emissions from any other county) would cause or contribute to a violation of the 2008 Pb NAAQS in a neighboring state or create a situation in a neighboring state where maintenance of the 2008 Pb NAAQS was not possible. Therefore, EPA proposes that Ohio has met this set of requirements related to section 110(a)(2)(D)(i)(I) for the 2008 Pb NAAQS.

On February 17, 2012, EPA promulgated designations for the 2010 NO 2 NAAQS, stating, “The EPA is designating areas as “unclassifiable/attainment” to mean that available information does not indicate that the air quality in these areas exceeds the 2010 NO 2 NAAQS” ( see 77 FR 9532). For comparison purposes, EPA examined the design values  5 from NO 2 monitors in Ohio and surrounding states. The highest design value based on data collected between 2010 and 2012 was 65 ppb at a monitor in Philadelphia, Pennsylvania. EPA believes that with the continued implementation of the state's SIP-approved PSD and NNSR regulations found in OAC 3745-31, these low monitored values of NO 2 will continue in and around Ohio. In other words, the NO 2 emissions from Ohio are not expected to cause or contribute to a violation of the 2010 NO 2 NAAQS in another state, and these emissions not likely to interfere with the maintenance of the 2010 NO 2 NAAQS in another state. Therefore, EPA proposes that Ohio has met this set of requirements related to section 110(a)(2)(D)(i)(I) for the 2010 NO 2 NAAQS.

In this rulemaking, EPA is not proposing to approve or disapprove Ohio's compliance with section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone and 2010 SO 2 NAAQS. Instead, we will address the state's satisfaction of these requirements with respect to these two NAAQS in a separate rulemaking.

Section 110(a)(2)(D)(i)(II) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality or to protect visibility in another state. As previously noted, EPA will evaluate Ohio's compliance with the various PSD and GHG infrastructure SIP requirements in a separate rulemaking.

States also have an obligation to ensure that sources located in nonattainment areas do not interfere with a neighboring state's PSD program. One way that this requirement can be satisfied is through an NNSR program consistent with the CAA that addresses any pollutants for which there is a designated nonattainment area within the state.

Ohio's EPA-approved NNSR regulations can be found in OAC 3745-31-21; these regulations contain provisions for how the state must treat and control sources in nonattainment areas, consistent with 40 CFR 51.165, or appendix S to 40 CFR 51. In this rulemaking, EPA is taking no action on this set of requirements under section 110(a)(2)(D)(i)(II). Instead, we will address Ohio's satisfaction of these provisions in a separate rulemaking.

With regard to the applicable requirements for visibility protection of section 110(a)(2)(D)(i)(II), states are subject to visibility and regional haze program requirements under part C of the CAA (which includes sections 169A and 169B). The 2009 Memo, the 2011 Memo, and 2013 Memo state that these requirements can be satisfied by an approved SIP addressing reasonably attributable visibility impairment, if required, or an approved SIP addressing regional haze.

Alternatively, the 2011 Memo states that most, if not all, Pb stationary sources are located at distances from Class I areas such that visibility impacts would be negligible. Although Pb can be a component of coarse and fine particles, it generally comprises a small fraction. When EPA evaluated the extent that Pb could impact visibility, Pb-related visibility impacts were found to be insignificant (e.g., less than 0.10%). Therefore, EPA anticipates that Pb emissions will contribute only negligibly to visibility impairment at Class I areas, and states can include an assessment as to this assumption in their submissions. The closest Class I area (Otter Creek Wilderness, West Virginia) is located approximately 150 miles from the Ohio-West Virginia border, and EPA anticipates that this area (or any other Class I area) would experience less than 0.10% of adverse visibility impact from any Pb-emitting source in Ohio. As previously noted, EPA's final technical support documents for the nonattainment areas located in Ohio support the conclusion that the ambient concentration of Pb are not expected to exceed the NAAQS outside of the nonattainment boundaries. EPA proposes that Ohio has met this set of infrastructure SIP requirements of 110(a)(2)(D)(i)(II) for the 2008 Pb NAAQS.

In this rulemaking, EPA is not proposing to approve or disapprove Ohio's satisfaction of the visibility protection requirements of section 110(a)(2)(D)(i)(II) for the 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQs. Instead, EPA will evaluate Ohio's compliance with these requirements in a separate rulemaking.

Section 110(a)(2)(D)(ii) requires each SIP to contain adequate provisions requiring compliance with the applicable requirements of section 126 and section 115 (relating to interstate and international pollution abatement, respectively).

Section 126(a) requires new or modified sources to notify neighboring states of potential impacts from the source. The statute does not specify the method by which the source should provide the notification. States with SIP-approved PSD programs must have a provision requiring such notification by new or modified sources. A lack of such a requirement in state rules would be grounds for disapproval of this element.

Ohio has provisions in its EPA-approved PSD program that require new or modified sources to notify neighboring states of potential negative air quality impacts. The state's submissions reference these provisions as being adequate to meet the requirements of section 126(a). EPA proposes that Ohio has met the infrastructure SIP requirements of section 126(a) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. Ohio has no obligations under any other section of section 126.

The infrastructure SIP submissions from Ohio affirm that it does not have pending obligations under section 115. Therefore, EPA is proposing that Ohio has the applicable infrastructure SIP requirements of section 110(a)(2)(D)(ii) related to section 115 of the CAA (international pollution abatement) for the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

This section requires each state to provide for adequate personnel, funding, and legal authority under state law to carry out its SIP, and related issues. Section 110(a)(2)(E)(ii) also requires each state to comply with the requirements respecting state boards under section 128.

Sub-element 1: Adequate personnel, funding, and legal authority under state law to carry out its SIP, and related issues. At the time of each of its submissions, Ohio EPA included its most recent biennial budget with its submittal, which details the funding sources and program priorities addressing the required SIP programs. Ohio EPA has routinely demonstrated that it retains adequate personnel to administer its air quality management program, and Ohio's environmental performance partnership agreement with EPA documents certain funding and personnel levels at Ohio EPA. As discussed in previous sections, ORC 3704.03 provides the legal authority under state law to carry out the SIP. EPA proposes that Ohio has met the infrastructure SIP requirements of this portion of section 110(a)(2)(E) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2, and 2010 SO 2 NAAQS.

Sub-element 2: State board requirements under section 128 of the CAA. Section 110(a)(2)(E) also requires each SIP to contain provisions that comply with the state board requirements of section 128 of the CAA. That provision contains two explicit 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.

On June 7, 2013, Ohio EPA provided a supplemental submission to its 2008 Pb, 2008 ozone, and 2010 NO 2 as part of its infrastructure SIP submission for the 2010 SO 2 NAAQS clarifying that the state does not have a board that has the authority to approve enforcement orders or permitting actions as outlined in section 128(a)(1) of the CAA; instead, this authority rests with the Director of Ohio EPA. Therefore, section 128(a)(1) of the CAA is not applicable in Ohio.

Under section 128(a)(2), the head of the executive agency with the power to approve enforcement orders or permits must adequately disclose any potential conflicts of interest. In its June 7, 2013, submission, Ohio EPA notes that EPA has previously approved provisions into Ohio's SIP addressing these requirements ( see 46 FR 57490). Notably, ORC 102: Public Officers—Ethics contains provisions that require the Director of Ohio EPA (and his/her delegate) to file an annual statement with the ethics committee including potential conflicts of interest; furthermore, this annual filing is subject to public inspection. Therefore, EPA proposes that Ohio has met the applicable infrastructure SIP requirements for this section of 110(a)(2)(E) for the 2008 Pb, 2008 ozone, 2010 NO 2, and 2010 SO 2 NAAQS.

States must establish a system to monitor emissions from stationary sources and submit periodic emissions reports. Each plan shall also require the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources. The state plan shall also require periodic reports on the nature and amounts of emissions and emissions-related data from such sources, and correlation of such reports by each state agency with any emission limitations or standards established pursuant to this chapter. Lastly, the reports shall be available at reasonable times for public inspection.

Ohio EPA district offices and local air agencies are currently required to witness 50% of all source testing and review 100% of all tests. EPA-approved rules in OAC 3745-15 contain provisions for the submission of emissions reports, and OAC 3745-77 and OAC 3745-31 provide requirements for recordkeeping by sources. EPA recognizes that Ohio has routinely submitted quality assured analyses and data for publication, and therefore proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(F) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

This section requires that a plan provide for authority that is analogous to what is provided in section 303 of the CAA, and adequate contingency plans to implement such authority. The 2013 Memo states that infrastructure SIP submissions should specify authority, rested in an appropriate official, to restrain any source from causing or contributing to emissions which present an imminent and substantial endangerment to public health or welfare, or the environment.

The regulations at OAC 3745-25 contain provisions which allow the Director of Ohio EPA to determine the conditions that comprise air pollution alerts, warnings, and emergencies. Moreover, the rules contained in OAC 3745-25 provide the requirement to implement emergency action plans in the event of an air quality alert or higher. EPA proposes that Ohio has met the applicable infrastructure SIP requirements for this portion of section 110(a)(2)(G) with respect to the 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

Specific to Pb as indicated in the 2011 Memo, EPA believes that the central components of a contingency plan for the 2008 Pb NAAQS would be to reduce emissions from the source at issue and to communicate with the public as needed. Where a state believes, based on its inventory of Pb sources and historic monitoring data that it does not need a more specific contingency plan beyond having authority to restrain any source from causing or contributing to an imminent and substantial endangerment, then the state could provide such a detailed rationale in place of a specific contingency plan.

EPA has reviewed historic data at Pb monitoring sites throughout Ohio, and believes that a specific contingency plan beyond having authority to restrain any source from causing or contributing to an imminent and substantial endangerment is not necessary at this time. For example, one way to quantify the possibility of imminent and substantial endangerment in this context would be a daily monitored value for Pb that could by itself cause a violation of the 2008 Pb NAAQS. 6 EPA has reviewed data from 2011-2013 (the most recent three calendar year block of complete data) and observes that no such daily monitored value exists.

As described in the section detailing interstate transport of Pb, EPA does not anticipate other areas in Ohio needing specific contingency measures due to low Pb emissions. In conjunction with OAC 3745-25 as described above, EPA proposes that Ohio has met the applicable infrastructure SIP requirements of section 110(a)(2)(G) related to contingency measures for the 2008 Pb NAAQS.

This section requires states to have the authority to revise their SIPs in response to changes in the NAAQS, availability of improved methods for attaining the NAAQS, or to an EPA finding that the SIP is substantially inadequate.

As previously mentioned, ORC 3704.03 provides the Director of Ohio EPA with the authority to develop rules and regulations necessary to meet ambient air quality standards in all areas in the state as expeditiously as practicable, but not later than any deadlines applicable under the CAA. ORC 3704.03 also provides the Director of Ohio EPA with the authority to develop programs for the prevention, and abatement of air pollution. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(H) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

The CAA requires that each plan or plan revision for an area designated as a nonattainment area meet the applicable requirements of part D of the CAA. Part D relates to nonattainment areas.

EPA has determined that section 110(a)(2)(I) is not applicable to the infrastructure SIP process. Instead, EPA takes action on part D attainment plans through separate processes.

The evaluation of the submissions from Ohio with respect to the requirements of section 110(a)(2)(J) are described below.

Sub-element 1: Consultation with government officials. States must provide a process for consultation with local governments and Federal Land Managers (FLMs) carrying out NAAQS implementation requirements.

Ohio EPA actively participates in the regional planning efforts that include both the state rule developers as well as representatives from the FLMs and other affected stakeholders. The FLMs are also included in Ohio EPA's interested party lists which provide announcements of draft and proposed rule packages. OAC 3745-31-06 is a SIP-approved rule which requires notification and the availability of public participation related to NSR actions; notification is provided to the general public, executives of the city or county where the source is located, other state or local air pollution control agencies, regional land use planning agencies, and FLMs. OAC 3704.03(K) is a SIP-approved rule that which requires giving reasonable public notice and conducting public hearings on any plans for the prevention, control, and abatement of air pollution that the Director of Ohio EPA is required to submit to EPA. Additionally, Ohio is an active member of the Lake Michigan Air Director's Consortium (LADCO). Therefore, EPA proposes that Ohio has met the infrastructure SIP requirements of this portion of section 110(a)(2)(J) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

Sub-element 2: Public notification. Section 110(a)(2)(J) also requires states to notify the public if NAAQS are exceeded in an area and must enhance public awareness of measures that can be taken to prevent exceedances.

Ohio EPA maintains portions of its Web site specifically for issues related to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. 7 The information contained in these pages includes background on the health effects of each of these pollutants, the areas of most concern, and the strategies that the state has been taking to address the elevated levels, if any, of the pollutants. Ohio EPA also actively populates EPA's AIRNOW program, and prepares annual data reports from its complete monitoring network. EPA proposes that Ohio has met the infrastructure SIP requirements of this portion of section 110(a)(2)(J) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

Sub-element 3: PSD. States must meet applicable requirements of section 110(a)(2)(C) related to PSD. Ohio's PSD program in the context of infrastructure SIPs has already been discussed in the paragraphs addressing section 110(a)(2)(C) and 110(a)(2)(D)(i)(II). EPA will evaluate Ohio's compliance with the various PSD and GHG infrastructure SIP requirements in a separate rulemaking.

Sub-element 4: Visibility protection. With regard to the applicable requirements for visibility protection, states are subject to visibility and regional haze program requirements under part C of the CAA (which includes sections 169A and 169B). In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus, we find that there is no new visibility obligation “triggered” under section 110(a)(2)(J) when a new NAAQS becomes effective. In other words, the visibility protection requirements of section 110(a)(2)(J) are not germane to infrastructure SIPs for the 2008 Pb, 2008 ozone, 2010 NO 2, and 2010 SO 2 NAAQS.

SIPs must provide for performing air quality modeling for predicting effects on air quality of emissions from any NAAQS pollutant and submission of such data to EPA upon request.

Ohio EPA reviews the potential impact of major and some minor new sources, consistent with 40 CFR part 51, appendix W, “Guidelines on Air Quality Models,” as well as Ohio EPA Engineering Guide 69. These modeling data are available to EPA upon request. The regulatory requirements related to PSD modeling can be found in SIP-approved rule OAC 3745-31-18, and Ohio's authority to require modeling conducted by other entities, e.g., applicants, and the state's authority to perform modeling for attainment demonstrations can be found in SIP-approved ORC 3704.03. The state also collaborates with LADCO and EPA in order to perform modeling. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(K) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

This section requires SIPs to mandate each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing, and enforcing a permit.

Ohio EPA implements and operates the title V permit program, which EPA approved on August 15, 1995 (60 FR 42045); revisions to the program were approved on November 20, 2003 (68 FR 65401). Additional rules that contain the provisions, requirements, and structures associated with the costs for reviewing, approving, implementing, and enforcing various types of permits can be found in ORC 3745.11. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(L) for the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

States must consult with and allow participation from local political subdivisions affected by the SIP.

Ohio EPA follows approved procedures for allowing public participation, consistent with OAC 3745-47, which is part of the approved SIP. Consultation with local governments is authorized through ORC 3704.03(B). Ohio EPA provides a public participation process for all stakeholders that includes a minimum of a 30-day comment period and a public hearing for all SIP related actions. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(M) with respect to the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS.

EPA is proposing to approve most elements of submissions from Ohio EPA certifying that its current SIP is sufficient to meet the required infrastructure elements under sections 110(a)(1) and (2) for the 2008 Pb, 2008 ozone, 2010 NO 2 , and 2010 SO 2 NAAQS. EPA's proposed actions for the state's satisfaction of infrastructure SIP requirements, by element of section 110(a)(2) and NAAQS, are contained in the table below.

In the above table, the key is as follows:

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 Order 12866 (58 FR 51735, October 4, 1993);

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

Throughout this document wherever “we”, “us” or “our” are used, it is intended to refer to the EPA.

The EPA is proposing approval of revisions to Washington's SIP related to major NNSR that were submitted by Ecology on January 27, 2014. The revisions update the general air quality regulations that apply to sources within Ecology's jurisdiction, including the minor new source review permitting program; regulations covering the major source Prevention of Significant Deterioration (PSD); and regulations covering major NNSR. On July 10, 2014 (79 FR 39351) the EPA proposed to approve the general provisions contained in Chapter 173-400 of the Washington Administrative Code (WAC) that apply to all sources under Ecology's permitting jurisdiction, as well as the minor source permitting program. In that first proposal, the EPA stated that we would act separately on the major source permitting programs. In this proposal, the second in the series, the EPA is proposing to approve the major source NNSR regulations contained in WAC 173-400-800 through 173-400-860, as well as other parts of Chapter 173-400 WAC that support major NNSR. In a future proposal, the third in the series, the EPA will act on the remainder of Ecology's January 27, 2014 submittal, covering the Prevention of Significant Deterioration (PSD) and visibility permitting requirements for major stationary sources.

On July 18, 1997, the EPA revised the NAAQS for particulate matter to add new standards for fine particles, using PM 2.5 as the indicator. Previously, the EPA used PM 10 (inhalable particles smaller than or equal to 10 micrometers in diameter) as the indicator for the particulate matter NAAQS. The EPA established health-based (primary) annual and 24-hour standards for PM 2.5 , setting an annual standard at a level of 15 micrograms per cubic meter (μg/m 3 ) and a 24-hour standard at a level of 65 μg/m 3 (62 FR 38652). At the time the 1997 primary standards were established, the EPA also established welfare-based (secondary) standards identical to the primary standards. The secondary standards are designed to protect against major environmental effects of PM 2.5 , such as visibility impairment and materials damage. Washington had no areas violating the annual or 24-hour 1997 PM 2.5 NAAQS at the time the standards were promulgated.

On October 17, 2006, the EPA revised the primary and secondary PM 2.5 NAAQS (71 FR 61236). In that rulemaking, the EPA reduced the 24-hour PM 2.5 NAAQS to 35 µg/m 3 and retained the existing annual PM 2.5 NAAQS of 15 µg/m 3 . In 2009, as a result of the change in the 24-hour PM 2.5 NAAQS from 65 µg/m 3 to 35 µg/m 3 , the EPA designated part of Pierce County as nonattainment based on 2006-2008 monitoring data (74 FR 58688, November 13, 2009). The Tacoma-Pierce County PM 2.5 nonattainment area covers most of the greater Tacoma area and the surrounding communities within Pierce County's urban growth area west of State Route 167 and is currently the only nonattainment area in Washington State. Finally, on December 14, 2012, the EPA reduced the primary annual PM 2.5 NAAQS to 12 μg/m 3 (78 FR 3086). However, the reduced annual PM 2.5 NAAQS will likely have minimal impact on Washington or the Tacoma-Pierce County PM 2.5 nonattainment area because the State's PM 2.5 nonattainment problems are generally dominated by short-term 24-hour spikes associated with residential wood combustion during winter inversions, when stagnant air is trapped in low lying areas.

On May 16, 2008, the EPA finalized a rule to implement the 1997 PM 2.5 NAAQS, including changes to the New Source Review (NSR) program (the NSR PM 2.5 Rule, 73 FR 28321). The 2008 NSR PM 2.5 Rule revised the NSR program requirements to establish a framework for implementing preconstruction permit review for the PM 2.5 NAAQS in both attainment and nonattainment areas. The 2008 NSR PM 2.5 Rule also established the following NSR requirements to implement the PM 2.5 NAAQS: (1) Required NSR permits to address directly emitted PM 2.5 and precursor pollutants; (2) established significant emission rates for direct PM 2.5 and precursor pollutants, including sulfur dioxide (SO 2 ) and oxides of nitrogen (NO X ); (3) established PM 2.5 emission offsets for nonattainment areas; and (4) required states to account for gases that condense to form particles (condensables) in PM 2.5 emission limits. The Ecology regulations, submitted to the EPA on January 27, 2014, were revised to address the requirements of the 2008 NSR PM 2.5 rule, as well as to provide general updates that apply to all NAAQS.

On January 4, 2013, the U.S. Court of Appeals for the District of Columbia Circuit, in Natural Resources Defense Council v. EPA 1 issued a decision that remanded the EPA's 2007 and 2008 rules implementing the 1997 PM 2.5 NAAQS. Relevant here, the 2008 NSR PM 2.5 Rule promulgated NSR requirements for implementation of PM 2.5 in both nonattainment areas and attainment/unclassifiable areas. The Court found that the EPA erred in implementing the PM 2.5 NAAQS in these rules solely pursuant to the general implementation provisions of subpart 1 of part D of title I of the Clean Air Act, rather than pursuant to the additional implementation provisions specific to particulate matter nonattainment areas in subpart 4. The Court ordered the EPA to “repromulgate these rules pursuant to Subpart 4 consistent with this opinion.” Id. at 437.

On June 2, 2014, the EPA published a final rulemaking, Identification of Nonattainment Classification and Deadlines for Submission of State Implementation Plan (SIP) Provisions for the 1997 Fine Particle (PM 2.5 ) National Ambient Air Quality Standard (NAAQS) and 2006 PM 2.5 NAAQS, that begins to address the remand (79 FR 31566). The final rule classified all existing PM 2.5 nonattainment areas as “Moderate” nonattainment areas and set a deadline of December 31, 2014, for states to submit any SIP submissions, including nonattainment NSR SIPs, that may be necessary to satisfy the requirements of subpart 4, part D, title I of the CAA with respect to PM 2.5 nonattainment areas.

In a separate rulemaking process, the EPA is evaluating the requirements of subpart 4 as they pertain to nonattainment NSR for PM 2.5 emissions. In particular, subpart 4 includes section 189(e) of the CAA, which requires the control of major stationary sources of PM 10 precursors “except where the Administrator determines that such sources do not contribute significantly to PM 10 levels which exceed the standard in the area.” Under the Court's decision in NRDC, section 189(e) of the CAA also applies to PM 2.5 .

Ecology's SIP submission included revisions to two definitions in Ecology's nonattainment NSR program. The revised definition of “regulated NSR pollutant” at WAC 173-400-810(24) identifies precursors to both ozone and PM 2.5 in nonattainment areas. With respect to PM 2.5 , the revised definition of “regulated NSR pollutant” at WAC 173-400-810(24) identifies sulfur dioxide and nitrogen oxides as regulated PM 2.5 precursors while volatile organic compounds (VOCs) and ammonia are not regulated PM 2.5 precursors in PM 2.5 nonattainment areas in the State. The revised definition of “significant” at WAC 173-400-810(27) adds significant emission rates for direct PM 2.5 and for sulfur dioxide and nitrogen oxides as PM 2.5 precursors. These revisions, although consistent with the 2008 NSR PM 2.5 Rule developed in accordance with subpart 1 of the Act, may not contain the elements necessary to satisfy the Clean Air Act requirements when evaluated under the subpart 4 statutory requirements. In particular, Ecology's submission does not include regulation of VOCs and ammonia as PM 2.5 precursors, nor does it include a demonstration consistent with section 189(e) showing that major sources of those precursor pollutants would not contribute significantly to PM 2.5 levels exceeding the standard in the area. For these reasons, the EPA cannot conclude at this time that this part of Ecology's nonattainment NSR submission satisfies all of the requirements of subpart 4 as they pertain to PM 2.5 nonattainment NSR permitting.

Although the revisions to Ecology's nonattainment NSR rule may not contain all of the necessary elements to satisfy the CAA requirements when evaluated under the subpart 4 provisions, the revisions themselves represent a strengthening of the currently-approved Washington SIP which does not address PM 2.5 at all. As a result of the June 2014 final rule, Ecology will have until December 31, 2014, to make any additional submission necessary to address the requirements of subpart 4, including addressing the PM 2.5 precursors VOCs and ammonia. For these reasons, the EPA is proposing to approve the major NNSR revisions at WAC 173-400-800 through 173-400-860, as further discussed below, without listing as a deficiency at this time the absence of either the regulation or evaluation of VOCs and ammonia as PM 2.5 precursors.

As described in more detail in the EPA's July 10, 2014 proposal, WAC 173-400-110 through -112 are the starting point for any source seeking to construct a new source or modify an existing source in a nonattainment area under Ecology's rules, whether major or minor. Specific provisions in these sections direct sources constructing a “major” source or making a “major modification” to a “major” source in a nonattainment area to also comply with the requirements of WAC 173-400-800 through -860. See, for example, WAC 173-400-110(1)(d). As also discussed in that July 2014 action, the EPA's review of WAC 173-400-110 through-112 expressly did not include a determination that these revised regulations met requirements for approval of a SIP-approved major NNSR permitting program (40 CFR 51.165). In this action, we are proposing to approve WAC 173-400-110 through -112 for purposes of implementing the major NNSR permitting program because these provisions require compliance with WAC 173-400-800 through -860 (which, as discussed below, are consistent with the CAA requirements for a major NNSR permitting program) and contain other related permit and permit processing provisions that are consistent with CAA requirements.

As described in more detail in the EPA's July 10, 2014 proposal, Ecology shares permitting jurisdiction with seven local clean air agencies and one other state agency, the Energy Facilities Site Evaluation Council (EFSEC). WAC 173-400-800, in conjunction with WAC 173-400-020, describes how Ecology's nonattainment NSR regulations apply in the local and EFSEC jurisdictions. At this time, the EPA is proposing approval of WAC 173-400-800 through 173-400-860 only for those facilities subject to Ecology's direct permitting jurisdiction. This includes all facilities located in Adams, Asotin, Chelan, Columbia, Douglas, Ferry, Franklin, Garfield, Grant, Kittitas, Klickitat, Lincoln, Okanogan, Pend Oreille, San Juan, Stevens, Walla Walla, and Whitman Counties. It also included also includes kraft pulp mills, sulfite pulping mills, and primary aluminum plants, for which Ecology has direct state-wide permitting jurisdiction under the SIP approved provisions of WAC 173-405-012, WAC 173-410-012, and WAC 173-415-012. Ecology's direct permitting jurisdiction includes the largest industrial source in the Tacoma-Pierce County PM 2.5 nonattainment area, the kraft pulp mill owned by RockTenn (formerly Simpson Tacoma Kraft). The remaining facilities in the nonattainment area are subject to the Puget Sound Clean Air Agency's permitting jurisdiction. The EPA intends to review and act upon Puget Sound Clean Air Agency's nonattainment NSR regulations in a separate, future action.

Section 173-400-810 WAC incorporates the definitions contained in 40 CFR 51.165, the regulation that sets forth the requirements for SIPs for major NNSR. This includes important definitional changes made in the EPA's 2008 NSR PM 2.5 Rule establishing SO 2 and NO X as presumptive PM 2.5 precursors, with significant emission rates of 40 tons per year (tpy) for each pollutant. It also includes significant emission rates for PM 10 of 15 tpy and PM 2.5 of 10 tpy, including gaseous emissions from a source or activity which condense to form particulate matter at ambient temperatures. This section makes clear that, in the case of a conflict between the definitions contained in WAC 173-400-810 and other parts of Chapter 173-400 WAC, the definitions of WAC 173-400-810 apply to major NNSR. The EPA reviewed Ecology's submission and is proposing to approve the definitions contained in WAC 173-400-810 as consistent with the EPA's definitions contained in 40 CFR 51.165.

WAC 173-400-820 uses the emission calculations found in 40 CFR 51.165 to determine if a project in a nonattainment area is subject to major NNSR requirements due to an increase in its emissions. The EPA reviewed Ecology's submission and is proposing to approve the emission calculations provisions contained in WAC 173-400-820 as consistent with 40 CFR 51.165(2).

The majority of this section was part of the existing SIP at WAC 173-400-112 (1993), Requirements for New Sources in Nonattainment Areas, which the EPA last approved in 1995 (60 FR 28726, June 2, 1995). Ecology moved the major source nonattainment NSR provisions to a new WAC 173-400-800 thorough 173-400-860 for clarity to the public and regulated community. Ecology also incorporated other 40 CFR 51.165 requirements which were added to regulation since the EPA's last approval in 1995. The EPA reviewed WAC 173-400-830 and is proposing to determine that it is consistent with the SIP-approved provisions formerly contained in WAC 173-400-112 and the EPA's permitting requirements contained in 40 CFR 51.165.

Under CAA section 173, all major sources and major modifications at existing major sources within a nonattainment area must obtain emissions reductions to offset any emissions increases of nonattainment pollutants resulting from the project in an amount that is at least equal to the emissions increase, and that is consistent with reasonable further progress towards attainment. The EPA refers to the proportional difference between the amount of required offsets to the amount of emissions increases as the “offset ratio.” The CAA specifies an offset ratio for several situations. In ozone nonattainment areas subject to subpart 2 (of title 1, part D of the CAA), the ratio is set between 1.1:1 and 1.5:1 depending on the level of classification pursuant to subpart 2. For other nonattainment areas, the CAA establishes a minimum offset ratio of 1:1. The EPA has reviewed Ecology's offset program and ratios and is proposing to approve WAC 173-400-840 as consistent with the CAA.

WAC 173-400-850 adopts by reference the plant-wide applicability limit process and requirements of 40 CFR Part 51, Appendix S, with the minor clarifications to adapt Appendix S to Ecology's permitting program. The EPA has reviewed WAC 173-400-850 and is proposing to determine that it is consistent with 40 CFR Part 51, Appendix S.

This section states that the public participation procedures contained in section 173-400-171 WAC, proposed for approval by the EPA on July 10, 2014, shall be used for any major NNSR permit issued pursuant to WAC 173-400-830 or WAC 173-400-850. Public participation requirements for major NNSR permitting must be consistent with the requirements of 40 CFR 51.160 and 161. See 40 CFR 51.165(f)(5). Having proposed to determine in our previous action that WAC 173-400-171 is consistent with 40 CFR 51.160 and 161 for purposes of minor NSR, we now propose to find that WAC 173-400-171 and -860 meet CAA requirements for major NNSR.

WAC 173-400-131 and 173-400-136 implement a program to issue emission reduction credits (ERC's) useable for offsets required by the major NNSR permitting program and the attainment area offset provisions for major sources in WAC 173-400-113(4). ERC's under this program may also be used as creditable emission reductions for netting purposes in the major NNSR and PSD permitting programs provided they meet the requirements set forth in the definitions of “major modification” in those programs. Since the EPA last approved Chapter 173-400 WAC, Ecology has revised these provisions to make them consistent with the EPA's Final Emissions Trading Policy Statement, (51 FR 43814, December 4, 1986) and 40 CFR 51.165 and 51.166. The EPA is therefore proposing to approve both WAC 173-400-131 and WAC 173-400-136 as consistent with the CAA but only for the purposes of implementing Washington's major NNSR program. The EPA will take action on these provisions for purposes of Ecology's PSD permitting program in a separate, future action.

Consistent with the discussion above, the EPA proposes to approve the major NNSR revisions submitted by Ecology on January 27, 2014. The EPA plans to take action on the remaining provisions related to PSD and visibility permitting requirements for major stationary sources in a separate, future action. This action will result in proposed changes to the Washington SIP in 40 CFR part 52, subpart WW.

The EPA proposes to approve into the SIP at 40 CFR part 52, subpart WW, the Ecology regulations listed in Table 1. The EPA is also affirming that the July 10, 2014 proposed approval of the general air quality regulations contained WAC 173-400-110 through -112 and WAC 173-400-171 meet the EPA's requirements for major NNSR.

As previously discussed in the EPA's July 10, 2014 proposal regarding applicability under section 173-400-020 WAC, the EPA's proposed approval at this time is limited to only those counties or sources where the Department of Ecology has direct jurisdiction. This proposed action excludes sources subject to EFSEC or local clean air agency jurisdiction. The counties where Ecology has direct jurisdiction are: Adams, Asotin, Chelan, Columbia, Douglas, Ferry, Franklin, Garfield, Grant, Kittitas, Klickitat, Lincoln, Okanogan, Pend Oreille, San Juan, Stevens, Walla Walla, and Whitman Counties. The EPA also notes that under the SIP approved provisions of WAC 173-405-012, WAC 173-410-012, and WAC 173-415-012, Ecology has statewide, direct jurisdiction for kraft pulp mills, sulfite pulping mills, and primary aluminum plants, including the RockTenn facility located in the Tacoma-Pierce County PM 2.5 nonattainment area.

Under the CAA, 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 CAA. Accordingly, this proposed action merely approves the state's law as meeting Federal requirements and does not impose additional requirements beyond those imposed by the state's law. For that reason, this proposed action:

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

• 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 the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and

• does not provide the 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not impose substantial direct costs on tribal governments or preempt tribal law. The SIP is not approved to apply in Indian country located in the state, except for non-trust land within the exterior boundaries of the Puyallup Indian Reservation, also known as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and local agencies in Washington authority over activities on non-trust lands within the 1873 Survey Area and the EPA is therefore approving this SIP on such lands. Consistent with EPA policy, the EPA nonetheless provided a consultation opportunity to the Puyallup Tribe in a letter dated February 25, 2014. The EPA did not receive a request for consultation.

In the Final Rules section of this Federal Register , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule, and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this Federal Register .

I. General Information A. Does this action apply to me?

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).

1. Submitting CBI. Do not submit this information to EPA through www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 346a(e), is proposing to establish an exemption from the requirement of a tolerance for residues of acetaldehyde (CAS Reg. No. 75-07-0), acetic acid (CAS Reg. No. 64-19-7), allyl cyclohexyl propionate (CAS Reg. No. 2705-87-5), butryic acid (CAS Reg. No. 107-92-6), butyl alcohol (CAS Reg. No. 71-36-3), citral (CAS Reg. No. 5392-40-5), citronellol (CAS Reg. No. 106-22-9), citronellyl acetate (CAS Reg. No. 150-84-5), β-damascone, (Z)- (CAS Reg. No. 23726-92-3), decanal (CAS Reg. No. 112-31-2), (E)-4-decenal (CAS Reg. No. 65405-70-1), decanoic acid (CAS Reg. No. 334-48-5), 1-decanol (CAS Reg. No. 112-30-1), 2,6-dimethyl-5-heptanal (CAS Reg. No. 106-72-9), 2-dodecanol, (2E)- (CAS Reg. No. 20407-84-5), d-limonene (CAS Reg. No. 5989-27-5), ethyl 2-methylbutyrate (CAS Reg. No. 452-79-1), (E)-geraniol (CAS Reg. No. 106-24-1), (E)-geraniol acetate (CAS Reg. No. 105-87-3), heptanal (CAS Reg. No. 111-71-7), heptanoic acid (CAS Reg. No. 111-14-8), heptyl alcohol (CAS Reg. No. 111-70-6), hexanal (CAS Reg. No. 66-25-1), hexanoic acid (CAS Reg. No. 142-62-1), (Z)-3-hexenol (CAS Reg. No. 928-96-1), (Z)-3-hexenol acetate (CAS Reg. No. 3681-71-8), hexyl acetate (CAS Reg. No. 142-92-7), hexyl alcohol (CAS Reg. No. 111-27-3), lauric acid (CAS Reg. No. 143-07-7), lauric aldehyde (CAS Reg. No. 112-54-9), lauryl alcohol (CAS Reg. No. 112-53-8), methyl-α-ionone (CAS Reg. No. 127-42-4), 3-methyl-2-butenyl acetate (CAS Reg. No. 1191-16-8), 2-methylundecanal (CAS Reg. No. 110-41-8), myristaldehyde (CAS Reg. No. 124-25-4), myristic acid (CAS Reg. No. 544-63-8), neryl acetate (CAS Reg. No. 141-12-8), n-hexanol (CAS Reg. No. 111-27-3), nonanal (CAS Reg. No. 124-19-6), nonanoic acid (CAS Reg. No. 112-05-0), nonyl alcohol (CAS Reg. No. 143-08-8), octanal (CAS Reg. No. 124-13-0), octanoic acid (CAS Reg. No. 124-07-2), 1-octanol (CAS Reg. No. 111-87-5), palmitic acid (CAS Reg. No. 57-10-3), propionic acid (CAS Reg. No. 79-09-4), stearic acid (CAS Reg. No. 57-11-4), 2-tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-trimethylhexanal (CAS Reg. No. 5435-64-3), undecanal (CAS Reg. No. 112-44-7), undecyl alcohol (CAS Reg. No. 112-42-5), valeraldehyde (CAS Reg. No. 110-62-3), and valeric acid (CAS Reg. No. 109-52-4) when used as fragrance components (i.e., inert ingredients) in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at end-use concentrations not to exceed 100 parts per million (ppm).

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. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of FFDCA section 408 and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

Consistent with 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, consistent with FFDCA section 408(b)(2), for an exemption from tolerance for residues of fragrance components listed in Unit II. used as inert ingredients in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at end-use concentrations not to exceed 100 ppm. EPA's assessment of exposures and risks associated with establishing the exemptions from tolerance for the fragrance components listed in Unit II. follows:

In the case of the fragrance components listed in Unit II. above, each of these substances has been approved for use as a synthetic flavoring substance in food under 21 CFR 172.515 based on a substance-specific evaluation conducted by the U.S. Food and Drug Administration (FDA). Additionally, the fragrance components listed in Unit II. above have been evaluated and approved for use as food flavoring agents by the Joint Food and Agricultural Organization of the United Nations/World Health Organization Expert Committee on Food Additives (JECFA) and the European Food Safety Agency (EFSA) as part of their assessment of more than 2,800 food flavoring substances. The EFSA and JECFA food flavoring substance were conducted under an approach titled the Threshold of Toxicological Concern (TTC). Under this approach, generic human exposure threshold values for both non-cancer and cancer endpoints are set at a level below which there would be no appreciable risk to human health. These generic values allow for the safety assessment of substances even in the absence of substance-specific hazard data.

The derivation of TTC human exposure threshold values for non-cancer endpoints is based on an extensive reference database compiled by Munro, (Ref. 1) which included data on chronic, subchronic, reproductive and developmental toxicity studies primarily derived from the reports of the US National Toxicology Program (NTP), the toxicological monographs of JECFA, the EPA Integrated Risk Information System (IRIS), and the Developmental and Reproductive Toxicology (DART) database compiled by the US National Library of Medicine. These sources were considered to contain well-validated toxicological data for well-defined chemical structures, covering pesticides, food additives, industrial and other types of chemicals. Only studies using the oral route of administration (gavage, diet, drinking water, or capsule) were included. In all, the reference database contained 2941 no-observed-adverse-effect levels (NOAELs) from studies conducted on 613 substances, and from these the most conservative (lowest) NOAEL for each substance was entered on the published database. The NOAELs in the reference database were those selected by the original authors of each study, apart from the studies in the IRIS database, for which the NOAELs were selected by the EPA. Munro commented that some authors were highly conservative in their selection of a NOAEL, but such NOAELs were still used for the database to maintain a conservative approach. Munro also stated that, in the calculation of the TTC values, NOAELs from subchronic studies were divided by a factor of 3 to approximate the NOAELs that are likely to be derived from a chronic study.

The chemicals in the Munro database were divided into three structural classes, based on a “decision tree” developed earlier by Cramer et al. (Ref. 2) Cramer Class I are chemicals of simple structure, with efficient modes of metabolism, suggesting low oral toxicity; Cramer Class III are chemicals with structures suggesting significant toxicity or which did not permit any strong initial presumption of safety, and Cramer Class II are chemicals with structures that were less innocuous than Cramer Class I but without features suggesting significant toxicity. Human exposure threshold values were derived by taking the lower 5th percentile value of the distribution of NOAELs for the substances in each of the three Cramer structural classes, multiplying by 60 to convert the values expressed as milligrams/kilograms (mg/kg) of body weight (bw) per day into mg/person per day, and then dividing by a factor of 100 to ensure a margin of safety.

For substances without structural alerts for cancer, the TTC human exposure values for non-cancer risks are considered protective of any potential cancer risk. For substances with a structural alert for cancer, a separate TTC value has been derived. Originally, FDA developed human exposure threshold values to protect against all chronic risks, including the endpoint of cancer, without regard to whether the substance had a structural alert for carcinogenicity (Ref. 3, 4, 5). FDA derived these threshold values using mathematical modeling of risks from animal bioassay data on over 500 known genotoxic and non-genotoxic carcinogens, based on their carcinogenic potency. In 1995, FDA incorporated the threshold value in its threshold of regulation (TOR) policy for substances present in food contact materials. (Ref 6). Under the TOR, substances used in food contact materials that are present in the diet at concentrations below the threshold level are exempted from regulation as food additives. Subsequently, FDA modified this approach by adopting lower threshold values for substances with a structural alert for carcinogenicity. Kroes et al. (Ref. 7) This FDA approach as to substances with structural alerts for carcinogenicity was further refined and adopted by EFSA and JEFCA for use in the TTC approach.

The TTC approach has been incorporated in the evaluations made by JECFA and EFSA in which the organizations both concluded that the each of the substances listed in Unit II. were safe for use as flavoring agents in foods. Under 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles, FDA has issued exemptions from regulation as food additives for a number of substances based on human exposure threshold values.

The human exposure threshold value for threshold (i.e., noncancer) risks is based upon Cramer structural class. In the case of the fragrance components listed in Unit II., all of the substances are included in the Cramer Class I category, which is defined as chemicals of simple structure and efficient modes of metabolism, suggesting low oral toxicity. An EFSA Scientific Committee critical evaluation of the human threshold values for threshold risks concluded that “the use of the 5th percentile No-observed-adverse-effect-level (NOAEL) and an uncertainty factor of 100 to derive the TTC value gives a very low probability (somewhere between 0-5%) of any appreciable non-cancer risk to human health from exposures to substances below the Cramer Class I TTC value of 30 μg/kg/day” (Ref. 8)

Use of TTC values for risk assessment of the fragrance components listed in Unit II. is a more conservative alternative to the chemical-specific Population Adjusted Dose (PAD) or Reference Dose (RfD) approach typically used in Agency risk assessments. For example, in the case of substances having chemical structures described by Cramer Class I for which chemical-specific risk assessments have been performed, these substances have PAD/RfD values which are often orders of magnitude greater than the corresponding TTC values (Ref 9). A summary of the safe exposure levels corresponding to each of the exposure scenarios considered the aggregate exposure assessment of the fragrance components listed in Unit II. is given below:

1. Acute dietary (all populations). There were no effects that could be attributed to a single dose in the database. Therefore, a quantitative acute dietary assessment is not necessary.

2. Chronic dietary (all populations). Concerns for chronic dietary exposures exceeding the TTC value of 30 µg/kg/day.

3. Incidental oral short-term (1 to 30 days). Concerns for incidental oral short-term exposures exceeding the TTC value of 30 µg/kg/day.

4. Dermal short-term (1 to 30 days) and intermediate-term (1 to 6 months). Concern for dermal exposures exceeding the TTC value of 30 µg/kg/day based on oral toxicity data and conservative assumption of 100% dermal absorption.

5. Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months). Concern for inhalation exposures exceeding the TTC value of 30 µg/kg/day based on oral toxicity data. Based on subchronic inhalation data for a number of fragrance substances, including some of fragrance components listed in Unit II., in which no adverse effects were noted at exposure levels up to 1% of ambient air (Ref. 10), it is reasonable to assume that in the case of the fragrance components listed in Unit II. inhalation toxicity would not be observed at doses below which oral toxicity is observed.

6. Cancer (Oral, dermal, inhalation). The Agency used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts for potential genotoxicity/carcinogenicity for any of the fragrance components. No structural alerts for genotoxicity/carcinogenicity relevant to human exposure to these substances as flavoring agents/fragrance components were identified, therefore the use of the TTC human exposure threshold for non-threshold risks for these fragrance components is not applicable. In these circumstances, assessment under the TTC value for non-cancer risks is protective for all risks, including carcinogenicity.

The risk assessment and use of human threshold values for evaluation of food flavoring agents by JECFA and EFSA has focused on oral toxicity and dietary exposure to substances via food and feed. However, the applicability of the TTC approach to substance exposure by routes other than the oral route has been considered by the ESFA Scientific Committee. The Scientific Committee determined that when several routes of exposure are to be taken into account they should be reflected in the exposure assessment used in the application of the TTC approach and that “the application of the TTC approach to routes of exposure other than oral can be done via route-to-route extrapolation, as is often done in conventional risk assessment in cases where only oral toxicity data are available.”

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to the fragrance components listed in Unit II., EPA considered exposure under the proposed tolerance exemptions at a concentration not to exceed 100 ppm for each of the fragrance components listed in Unit II. as well as any other sources of dietary exposure. The use limitation of 100 ppm was incorporated by the Agency to reflect maximum concentrations of these fragrance components in antimicrobial pesticide formulations as well as to ensure that exposures to these fragrance components will be below levels of concern. In conducting the dietary exposure assessment for the fragrance components listed in Unit II., EPA considered dietary exposure from potential residues in or on food resulting from the use as inert ingredients in antimicrobial pesticide product formulations from treated food contact surfaces; and from food that contains the fragrance components as flavoring agents. As to the residue levels in or food resulting from the inert ingredient uses, in the absence of actual dietary exposure data resulting from this use, the EPA has utilized a conservative, health-protective method of estimating dietary intake that is based upon conservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use of the fragrance components in food contact sanitizing antimicrobial pesticide products. This same methodology has been utilized by EPA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. A complete description of the approach used to assess dietary exposures resulting from food contact sanitizing solution uses of the fragrance components can be found at http://www.regulations.gov in document; “Various Fragrance Components: Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations,” pp. 5-8 in docket ID number EPA-HQ-OPP-2013-0821.

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

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, the Agency believes the assumptions used to estimate chronic dietary exposures lead to an extremely conservative assessment of chronic dietary risk due to a series of compounded conservatisms. First, when a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface (residual solution). In the absence of any other data, EPA has used an estimated worst-case concentration of 1 mg of solution per square centimeter (cm) of treated surface area for this quantity. Second, the conservatism of this methodology is compounded by EPA's decision to assume a worst case scenario that all food that an individual consumes will come into contact with 4,000 cm  2 of sanitized non-porous food-contact surfaces. This contact area represents all the surface area from silverware, china, and glass used by a person who regularly eats three meals per day at an institutional or public facility. The surface area of counter tops that comes in contact with food is expected to be smaller than the surface area for food utensils. As a conservative estimate, EPA assumed that 2,000 cm  2 of treated counter top surface area, comes into contact with an individual's food per day. Third, EPA assumes that 100% of the material present on food contact surfaces will migrate to food (Ref 11).

iii. Cancer. Based on the data summarized in Unit III. A., EPA has concluded that the fragrance components listed in Unit II. are not expected to be carcinogenic to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

2. Dietary exposure from drinking water. The proposed use of the fragrance components listed in Unit II. in antimicrobial pesticide products has only a limited opportunity to result in contamination of drinking water because these types of products are used inside of structures. There is the possibility of exposure to drinking water sources via down-the-drain releases and discharges to waste water treatment plants; however, based on the extremely low concentrations of the fragrance components in pesticide formulations, combined with the biodegradability of the fragrance components, there would be at most a negligible exposure to surface water or ground water. Therefore, the use of these fragrance components as inert ingredients is not expected to contribute to dietary exposure from 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, termiticide, and flea and tick control on pets).

The use of the fragrance components in food contact surface antimicrobial pesticide products could result in short- and intermediate-term residential exposures, adult handler dermal and inhalation exposure; post-application dermal and inhalation exposure and child's post- application dermal and incidental oral exposure. In addition, non pesticidal uses of these substances as fragrance components in consumer products may also result in residential dermal and inhalation exposure. However, these pesticidal and non pesticidal non-dietary exposures would be negligible in comparison to the highly conservative estimates of dietary exposure as discussed in Unit III.C.1. above. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

EPA has not found the fragrance components listed in Unit II. to share a common mechanism of toxicity with any other substances, and these fragrance components do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that these fragrance components do 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.

The use of a threshold exposure level as described in Unit II. above is health protective of any toxicity to infants and children and the exposure assumptions utilized in the risk assessment of the fragrance components are highly conservative (protective). These assessments will not underestimate the exposure and risks posed by these fragrance components and no additional safety factor is needed for assessing risk to infants and

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to each of the fragrance components listed in Unit II. from food and water will utilize 23% of the safe exposure level for the U.S. population and all subpopulations.

3. From non-dietary exposure. The fragrance components listed in Unit II. may be utilized in antimicrobial pesticide products with uses that could result in residential exposure such as hard surface cleaning products. For residential handler exposure, the Agency assumed that most residential use will result in short-term (1 to 30 days) dermal and inhalation exposures.

The Agency assumed that post-application exposure in residential settings is expected to be short-term in duration only but antimicrobial products used as cleaning agents may be used in facilities where cleaning activities can occur on an intermediate-term basis. Therefore, these post-application scenarios were included in the intermediate-term aggregate assessment. The scenarios evaluated were short- and intermediate term post-application dermal and inhalation (indoor), short- and intermediate-term incidental oral ingestion from treated indoor surfaces (hand-to-mouth vinyl/hard surfaces).

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

4. 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).

These fragrance components may be utilized as inert ingredients in pesticide formulations registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to the fragrance components listed in Unit II.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate exposures for each of the individual fragrance components listed in Unit II. do not exceed 24% of the safe exposure level (i.e., a level equivalent to a PAD or RfD) and therefore are not of concern.

5. 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).

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate exposures that do not exceed 24% of the safe exposure level for each of the fragrance components listed in Unit II. and not of concern.

6. Aggregate cancer risk for U.S. population. Based on the lack of structural alerts for carcinogenicity and the lack of exceedance of the chronic TTC value, the fragrance components listed in Unit II. are not expected to pose a cancer risk to humans.

7. 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 residues of each of the fragrance components listed in Unit II. Therefore EPA is proposing to exempt from the requirement of a tolerance under 40 CFR 180.940(a) the residues of acetaldehyde, acetic acid, allyl cyclohexyl propionate, butryic acid, butyl alcohol, citral, citronellol, citronellyl acetate, β-damascone, (Z)-, decanal, (E)-4-decenal, decanoic acid, 1-decanol, 2,6-dimethyl-5-heptanal, 2-dodecanol, (2E)-, d-limonene, ethyl 2-methylbutyrate, (E)-geraniol, (E)-geraniol acetate, heptanal), heptanoic acid, heptyl alcohol, hexanal, hexanoic acid, (Z)-3-hexenol, (Z)-3-hexenol acetate, hexyl acetate, hexyl alcohol, lauric acid, lauric aldehyde, lauryl alcohol), methyl-α-ionone, 3-methyl-2-butenyl acetate, 2-methylundecanal, myristaldehyde, myristic acid, neryl acetate, n-hexanol, nonanal, nonanoic acid, nonyl alcohol, octanal, octanoic acid, 1-octanol, palmitic acid, propionic acid, stearic acid, 2-tridecanal, 3,5,5-trimethylhexanal, undecanal, undecyl alcohol, valeraldehyde, and valeric acid.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. The use limitation of 100 ppm will be enforced through the pesticide registration process under the FIFRA, 7 U.S.C. 136 et seq. EPA will not register any food-contact use antimicrobial pesticide for sale or distribution containing any of the fragrance components listed in Unit II. at concentrations exceeding 100 ppm.

An exemption from the requirement for a tolerance is proposed for residues of acetaldehyde, acetic acid, allyl cyclohexyl propionate, butryic acid, butyl alcohol, citral, citronellol, citronellyl acetate, β-damascone, (Z)-, decanal, (E)-4-decenal, decanoic acid, 1-decanol, 2,6-dimethyl-5-heptanal, 2-dodecanol, (2E)-, d-limonene, ethyl 2-methylbutyrate, (E)-geraniol, (E)-geraniol acetate, heptanal), heptanoic acid, heptyl alcohol, hexanal, hexanoic acid, (Z)-3-hexenol, (Z)-3-hexenol acetate, hexyl acetate, hexyl alcohol, lauric acid, lauric aldehyde, lauryl alcohol), methyl-α-ionone, 3-methyl-2-butenyl acetate, 2-methylundecanal, myristaldehyde, myristic acid, neryl acetate, n-hexanol, nonanal, nonanoic acid, nonyl alcohol, octanal, octanoic acid, 1-octanol, palmitic acid, propionic acid, stearic acid, 2-tridecanal, 3,5,5-trimethylhexanal, undecanal, undecyl alcohol, valeraldehyde, and valeric acid when used as inert ingredients (fragrance components) in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at end-use concentrations not to exceed 100 ppm.

This document proposes to establish exemptions from tolerances under FFDCA section 408(d). 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), or impose any enforceable duty or contain any unfunded mandate as described under Title II. of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ). Nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note). The Agency hereby certifies under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) that this proposed action will not have significant negative economic impact on a substantial number of small entities. Establishing an a pesticide tolerance or an exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities.

In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects 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.” This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

In 1998, we, the U.S. Fish and Wildlife Service (Service), published in the Federal Register a final rule that established a nonessential experimental population of Mexican wolves in Arizona and New Mexico (63 FR 1752, January 12, 1998; Figure 1). We took this action in accordance with section 10(j) of the Endangered Species Act (16 U.S.C. 1531 et seq.) (Act), which allows us to designate as an “experimental population” a population of endangered or threatened species that has been or will be released into suitable natural habitat outside the species' current natural range. Experimental populations are treated as threatened species for purposes of section 9 of the Act. The general regulations that extend most section 9 prohibitions to threatened species do not apply to these populations, and we may use our discretion to devise management programs and special regulations for them.

We established the Mexican wolf nonessential experimental population in consideration of the 1982 Mexican Wolf Recovery Plan, which has the primary objective of establishing a viable, self-sustaining population of at least 100 Mexican wolves in the wild. In March of 1998, we released 11 Mexican wolves from the captive-breeding program to the wild. Many additional individuals and family groups have been released or translocated since that time.

Through project reviews, annual reports, monitoring, and communication with our partners and the public, we now recognize that elements of the 1998 final rule need to be revised to help us enhance the growth, stability, and success of the nonessential experimental population. Accordingly, to improve implementation and conservation of the Mexican wolf nonessential experimental population, on June 13, 2013, we published a proposed rule in the Federal Register to make several changes to the 1998 section 10(j) rule and management regulations for Mexican wolves (78 FR 35719).

We are now revising the provisions in the June 2013 proposed rule based on information received during the public comment period and our scoping process for the draft environmental impact statement. We solicit public comment as described below.

We will accept written comments and information during this reopened comment period on our proposed revisions to the existing nonessential experimental population designation of the Mexican wolf ( Canis lupus baileyi ), our draft environmental impact statement, and the amended required determinations provided in this document. Any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other concerned governmental agencies, Native American tribes, the scientific community, industry, general public, and other interested parties concerning the revised proposed revision. We are particularly interested in comments concerning the following revisions to our proposed rule:

(1) Moving the southern boundary of the Mexican Wolf Experimental Population Area (MWEPA) in Arizona and New Mexico from Interstate Highway 10 to the United States-Mexico international border (Figure 2).

(2) Identifying Zones 1, 2, and 3 as different management areas within the MWEPA and discontinuing the use of the term Blue Range Wolf Recovery Area (BRWRA) part of (Figure 2).

Zone 1 is an area within the MWEPA in Arizona and New Mexico where Mexican wolves may be initially released or translocated, and includes all of the Apache, Gila, and Sitgreaves National Forests; the Payson, Pleasant Valley, and Tonto Basin Ranger Districts of the Tonto National Forest; and the Magdalena Ranger District of the Cibola National Forest.

Zone 2 is an area within the MWEPA where Mexican wolves will be allowed to naturally disperse into and occupy, and where Mexican wolves may be translocated. On Federal land in Zone 2, initial releases of Mexican wolves are limited to pups less than 5 months old, which allows for the cross-fostering of pups from the captive population into the wild, as well as enables translocation-eligible adults to be re-released with pups born in captivity. On private and tribal land in Zone 2, Mexican wolves of any age, including adults, can also be initially released under a Service- and State-approved management agreement with private landowners or a Service-approved management agreement with tribal agencies. The northern boundary of Zone 2 is Interstate Highway 40; the western boundary goes south from Interstate Highway 40 and follows Arizona State Highway 93, Arizona State Highway 89/60, Interstate Highway 10, and Interstate Highway 19 to the United States-Mexico international border; the southern boundary is the United States-Mexico international border heading east, then follows New Mexico State Highway 81/146 north to Interstate Highway 10, then along New Mexico State Highway 26 to Interstate Highway 25; the boundary continues along New Mexico State Highway 70/54/506/24; the eastern boundary follows the eastern edge of Otero County, New Mexico, to the north and then along the eastern edge of Lincoln County, New Mexico, until it intersects with New Mexico State Hwy 285 and follows New Mexico State Highway 285 north to the northern boundary of Interstate Highway 40. Zone 2 excludes the area in Zone 1.

Zone 3 is an area within the MWEPA where neither initial releases nor translocations will occur, but Mexican wolves will be allowed to disperse into and occupy. Zone 3 is an area of less suitable Mexican wolf habitat and where Mexican wolves will be more actively managed under the authorities of this rule to reduce human conflict. We expect Mexican wolves to occupy areas of suitable habitat where ungulate populations are adequate to support them and conflict with humans and their livestock would be low. If Mexican wolves move outside areas of suitable habitat, they will be more actively managed. Zone 3 is two separate geographic areas on the east and west sides of the MWEPA. One area of Zone 3 is in western Arizona and the other in eastern New Mexico. In Arizona, the northern boundary of Zone 3 is Interstate Highway 40; the eastern boundary goes south from Interstate Highway 40 and follows State Highway 93, State Highway 89/60, Interstate Highway 10, and Interstate Highway 19 to the United States-Mexico international border; the southern boundary is the United States-Mexico international border; the western boundary is the Arizona-California State border. In New Mexico, the northern boundary is Interstate Highway 40; the eastern boundary is the New Mexico-Texas State border; the southern boundary is the United States-Mexico international border heading west, then follows State Highway 81/146 north to Interstate Highway 10, then along State Highway 26 to Interstate Highway 25, the southern boundary continues along State Highway 70/54/506/24; the western boundary follows the eastern edge of Otero County to the north and then along the eastern edge of Lincoln County until it follows State Highway 285 north to the northern boundary of Interstate Highway 40.

(3) Adding definitions for the terms cross-fostering; designated agency; disturbance-causing land-use activity; domestic animal; Federal land; feral dog; in the act of biting, killing, or wounding; initial release; intentional harassment; non-Federal land; Service-approved management plan; translocate; tribal trust land; ungulate herd; wounded; and Zones 1, 2, and 3.

(4) Revising the due care criteria with regard to trapping activities. With regard to trapping activities, due care includes: Following the regulations, proclamations, recommendations, guidelines, and/or laws within the State or tribe where the trapping takes place; modifying or utilizing appropriate size traps, chains, drags, and stakes to reasonably expect to prevent a wolf from either breaking the chain, or escaping with the trap on the wolf, or utilizing sufficiently small traps (less than Victor 2) to reasonably expect the wolf to either immediately pull free from the trap, or span the jaw spread when stepping on the trap; reporting the capture of a Mexican wolf (even if the wolf has pulled free) within 24 hours to the Service; not taking a Mexican wolf via neck snares; and if a Mexican wolf is captured, trappers can call the Interagency Field Team (1-888-459-WOLF [9653]) as soon as possible to arrange for radio-collaring and releasing of the wolf. Per State regulations for releasing nontarget animals, trappers may also choose to release the animal alive and subsequently contact the Service or Interagency Field Team.

(5) On non-Federal lands anywhere within the MWEPA, domestic animal owners or their agents may take (including kill or injure) any Mexican wolf that is in the act of biting, killing, or wounding a domestic animal provided that evidence of a freshly wounded or killed domestic animal by a Mexican wolf is present. This take must be reported to the Service's Mexican Wolf Recovery Coordinator or a designated agency of the Service within 24 hours. The take of any Mexican wolf without evidence of biting, killing, or wounding a domestic animal may be referred to the appropriate authorities for investigation.

(6) Based on the Service's or a designated agency's discretion and during or after a removal action authorized by the Service or a designated agency (provided the Service's or designated agency's actions were unsuccessful), the Service or designated agency may issue permits to domestic animal owners or their agents (e.g., employees, land manager, local officials) to allow domestic animal owners or their agents to take (including intentional harassment or killing) any Mexican wolf that is present on non-Federal land where specified in the permit. Permits issued under this provision will specify the number of days for which the permit is valid and the maximum number of Mexican wolves for which take is allowed. Take by permittees under this provision will assist the Service or designated agency in completing control actions. Domestic animal owners or their agents must report this take to the Service's Mexican Wolf Recovery Coordinator or a designated agency of the Service within 24 hours.

(7) Based on the Service's or a designated agency's discretion and during or after a removal action authorized by the Service or a designated agency (provided the Service's or designated agency's actions were unsuccessful), the Service or designated agency may issue permits to domestic animal owners or their agents (e.g., employees, land manager, local officials) to allow livestock owners or their agents to take (including intentional harassment or killing) any Mexican wolf that is in the act of biting, killing, or wounding livestock on Federal land. Permits issued under this provision will specify the number of days for which the permit is valid and the maximum number of Mexican wolves for which take is allowed. Take by livestock owners or their agents under this provision will assist the Service or designated agency in completing the authorized control action. Livestock owners or their agents must report this take to the Service's Mexican Wolf Recovery Coordinator or a designated agency of the Service within 24 hours.

(8) Allowing for take of Mexican wolves response to impacts to wild ungulates and in accordance with certain stipulations. If Arizona or New Mexico determines, based on established ungulate management goals, that Mexican wolf predation is having an unacceptable impact on a wild ungulate herd (pronghorn, bighorn sheep, deer, elk, or bison), the respective State may request approval from the Service that Mexican wolves be removed from the area of the impacted ungulate herd. Upon written approval from the Service, the State (Arizona or New Mexico) or any designated agency may be authorized to remove (capture and translocate in the MWEPA, move to captivity, transfer to Mexico, or lethally take) Mexican wolves. Because tribes are able to request the capture and removal of Mexican wolves at any time, take in response to wild ungulate impacts is not applicable on tribal trust lands.

We will consider all comments and information received during the public comment period in preparation of the final rule to revise the existing nonessential experimental population designation of the Mexican wolf and the final environmental impact statement. Accordingly, the final rule and final environmental impact statement may differ from this proposal and the draft environmental impact statement.

Please note that comments merely stating support for or opposition to the actions under consideration without providing supporting information, although noted, will not be considered in making a determination for the final rule.

If you submitted comments or information on the June 13, 2013 (78 FR 35719), proposed revision to the existing nonessential experimental population designation of the Mexican wolf or the August 5, 2013 (78 FR 47268), publication of a notice of intent to prepare an environmental impact statement in conjunction with the proposed rule, please do not resubmit them. We will incorporate them into the public record as part of this comment period, and we will fully consider them in the preparation of our final rule.

You may submit your comments and materials concerning this proposed revision to the nonessential experimental population designation of the Mexican wolf, the draft environmental impact statement, and the amended required determinations provided in this document by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES .

If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. We will post all hardcopy comments on http://www.regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as some of the supporting documentation we used, will be available for public inspection on http://www.regulations.gov at Docket No. FWS-R2-ES-2013-0056, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

This document discusses only those topics directly relevant to the modifications we are making to our proposal to revise existing nonessential experimental population designation of the Mexican wolf and the associated draft environmental impact statement. For more information on previous Federal actions concerning the Mexican wolf, refer to the proposed revision to the existing nonessential experimental population designation of the Mexican wolf, which published in the Federal Register on June 13, 2013 (78 FR 35719), and is available online at http://www.regulations.gov (at Docket Number FWS-R2-ES-2013-0056) or from the Mexican Wolf Recovery Program, U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

On June 13, 2013 (78 FR 35719), we published a proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf. That proposal had a 90-day comment period ending September 11, 2013. On August 5, 2013 (78 FR 47268), we published a notice of intent to prepare an environmental impact statement in conjunction with the proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf. That notice of intent to prepare an environmental impact statement had a 45-day comment period ending September 19, 2013. On September 5, 2013 (78 FR 54613), we extended the public comment period on the proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf to end on October 28, 2013, and announced public hearings. On October 28, 2013 (78 FR 64192), we once again extended the public comment period on the proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf to end on December 17, 2013, and announced public hearings on the proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf. We will submit for publication in the Federal Register a final rule revising the existing nonessential experimental population of the Mexican wolf on or before January 12, 2015.

Based on information received during the public comment period and our scoping process for the draft environmental impact statement, we are proposing several modifications to our June 13, 2013, proposal to revise the existing nonessential experimental population designation of the Mexican wolf. Under section 10(j) of the Act and our regulations at 50 CFR 17.81, the Service may designate as an experimental population a population of endangered or threatened species that has been or will be released into suitable natural habitat outside the species' current natural range. When designating an experimental population, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the section 10(j) rule contains the prohibitions and exemptions necessary and appropriate to conserve that species. In order to improve implementation and conservation, we are proposing several changes to our proposed rule to revise the section 10(j) rule and management regulations for the Mexican wolves.

In the June 13, 2013 (78 FR 35719), proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf, we proposed that Mexican wolves on State-owned lands within the boundaries of the MWEPA be regulated in the same manner as on lands owned and managed by other public land management agencies. In this modification to our proposal, we have removed any reference that the Service will consider State-owned lands within the boundaries of the MWEPA in the same manner as we consider lands owned and managed by other public land management agencies. In the 1998 final rule that established a Mexican wolf nonessential experimental population (63 FR 1752, January 12, 1998) (1998 Final Rule), management of Mexican wolves on all State-owned lands within the boundary of the MWEPA, but outside of designated wolf recovery areas, were subject to the provisions of private lands. Henceforth, the Service will consider the management of Mexican wolves on State-owned lands within the boundaries of the MWEPA in the same manner and subject to the same provisions of this rule as on non-Federal lands, which is consistent with the 1998 Final Rule.

Additionally in the June 13, 2013 (78 FR 35719), proposed rule, we proposed to modify the provision “six breeding pairs” to a requirement that at least 100 Mexican wolves must be present in the MWEPA before a permit to take Mexican wolves can be issued to livestock owners or agents on public land grazing allotments. The 1998 Final Rule included a definition of breeding pair as one of the conditions for take of Mexican wolves by livestock owners or agents on public land grazing allotments (i.e., that there must be six breeding pairs present in order for a permit to take wolves to be issued by the Service). In the June 13, 2013 (78 FR 35719), proposed rule we considered overall population size to be a better metric for evaluating the appropriateness of providing such permits because it provided a more consistent measure of the population's status. However, based on scientific information that was submitted during public comment, we are no longer using six breeding pairs or at least 100 Mexican wolves as conditions for issuing a permit to livestock owners or their agents on Federal lands. Now, we are proposing to allow livestock owners or their agents to take (including intentional harassment or killing) any Mexican wolf that is in the act of biting, killing, or wounding livestock on Federal land be based on the Service's or a designated agency's discretion and during or after a removal action has been authorized by the Service or a designated agency (provided the Service's or designated agency's actions were unsuccessful).

Also in the June 13, 2013 (78 FR 35719), preamble to our proposed rule to revise the existing nonessential experimental population designation of the Mexican wolf, we considered several additional revisions. One of the considerations was to change the term “depredation” to “depredation incident” and revise the definition to mean, “The aggregate number of livestock killed or mortally wounded by an individual Mexican wolf or single pack of Mexican wolves at a single location within one 24-hour period, beginning with the first confirmed kill or injury.” We considered this change in order to provide consistency with terms used in our management documents (standard operating protocol, management plans, etc.), in which we consider all of the depredations that occur within one 24-hour period as one incident in our determination of what management actions to apply to a given situation. However, we received public comment, particularly from the ranching community, that this term does not appropriately communicate individual depredations (e.g., a wolf may have depredated three times in one 24-hour period). In addition, we are using the term “depredation” only in our definition of problem wolves. Therefore, we will no longer consider changing the term “depredation” to “depredation incident” and will use the term “depredation” only as defined in the rule portion of this document.

Below, we discuss the additional modifications to our proposal to revise the existing nonessential experimental population designation of the Mexican wolf.

We are adding or revising several definitions to our June 13, 2013 (78 FR 35719), proposed rule to provide additional clarification; definitions for these terms are laid out in the rule portion of this document:

We are proposing to expand the MWEPA by moving the southern boundary from Interstate Highway 10 to the United States-Mexico international border across Arizona and New Mexico (Figure 2). Expanding the MWEPA was a recommendation in the Mexican Wolf Blue Range Reintroduction Project 5-Year Review (AMOC and IFT 2005, p. ARC-3). We are proposing this modification because the reintroduction effort for Mexican wolves now being undertaken by the Mexican Government has established a need to manage Mexican wolves that may disperse into southern Arizona and New Mexico from reestablished Mexican wolf populations in Mexico. An expansion of the MWEPA south to the international border with Mexico would allow us to manage all Mexican wolves in this area, regardless of origin, under the experimental population 10(j) rule. The regulatory flexibility provided by our proposed revisions to the 1998 Final Rule would allow us to take management actions within the MWEPA that further the conservation of the Mexican wolf while being responsive to needs of the local community in cases of problem wolf behavior.

Also, we are identifying Zones 1, 2, and 3 as different management areas within the MWEPA and discontinuing the use of the term BRWRA. Zone 1 is where Mexican wolves may be initially released or translocated, and includes all of the Apache, Gila, and Sitgreaves National Forests; the Payson, Pleasant Valley, and Tonto Basin Ranger Districts of the Tonto National Forest; and the Magdalena Ranger District of the Cibola National Forest. Zone 2 is an area within the MWEPA where Mexican wolves will be allowed to naturally disperse into and occupy, and where Mexican wolves may be translocated. On Federal land in Zone 2, initial releases of Mexican wolves are limited to pups less than 5 months old, which allows for the cross-fostering of pups from the captive population into the wild, as well as enables translocation-eligible adults to be re-released with pups born in captivity. On private and tribal land in Zone 2, Mexican wolves of any age, including adults, can also be initially released under a Service- and State-approved management agreement with private landowners or a Service-approved management agreement with tribal agencies. Translocations in Zone 2 will be focused on suitable Mexican wolf habitat that is contiguous to occupied Mexican wolf range. Zone 3 is where neither initial releases nor translocations will occur, but Mexican wolves will be allowed to disperse into and occupy. Zone 3 is an area of less suitable Mexican wolf habitat and where Mexican wolves will be more actively managed under the authorities of this rule to reduce human conflict.

We are also proposing the expansion of initial release sites to include the entire Sitgreaves National Forest in Arizona; the Payson, Pleasant Valley, and Tonto Basin Ranger Districts of the Tonto National Forest in Arizona; and the Magdalena Ranger District of the Cibola National Forest in New Mexico (Figure 2). This expansion would include the proposed modification that would allow for initial releases and translocations throughout Zone 1. Our proposed modification to eliminate the primary and secondary recovery zones within Zone 1 and our consideration of expanding Zone 1 to include the entire Sitgreaves and three Ranger Districts of the Tonto National Forests in Arizona and one Ranger District of the Cibola National Forest in New Mexico are consistent with recommendations in the Mexican Wolf Blue Range Reintroduction Project 5-Year Review (AMOC and IFT 2005, p. ARC-4). These revisions will provide additional area and locations for initial release of Mexican wolves to the wild from captivity beyond that currently allowed by the 1998 Final Rule.

In the rule portion of this document, we have clarified take provisions for intentional harassment, opportunistic harassment, take for research purposes, take by Service personnel or designated agency, and unintentional take. In restructuring these allowable forms of take, we have not added more forms of take. Rather, we restructured to clarify take provisions provided in the 1998 Final Rule. We have also revised the due care criteria in regard to trapping activities. And we have provided language to clarify that personnel of the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Wildlife Services will not be in violation of the Act or this rule for take of a Mexican wolf that occurs while conducting official duties associated with predator damage management activities for species other than Mexican wolves.

Furthermore, we have modified provisions in the 1998 Final Rule to allow for removal of Mexican wolves in response to impacts to wild ungulates. Under this provision, if Arizona or New Mexico determines, based on ungulate management goals, that Mexican wolf predation is having an unacceptable impact on a wild ungulate herd (pronghorn, bighorn sheep, deer, elk, or bison), the respective State may request approval from the Service that Mexican wolves be removed from the area of the impacted ungulate herd. Upon written approval from the Service, the State (Arizona or New Mexico) or any designated agency may be authorized to remove (capture and translocate in the MWEPA, move to captivity, transfer to Mexico, or lethally take) Mexican wolves. These management actions must occur in accordance with § 17.84(k)(7)(iv)(A).

One of the additional provisions we are now proposing is to allow take of a Mexican wolf on non-Federal lands anywhere within the MWEPA by domestic animal owners or their agents when any Mexican wolf is in the act of biting, killing, or wounding a domestic animal provided that evidence of a freshly wounded or killed domestic animal by Mexican wolves is present.

We are also proposing provisions for the issuance of permits on non-Federal land anywhere within the MWEPA, and under particular circumstances, to allow domestic animal owners or their agents to take (including intentional harassment or kill) any Mexican wolf that is present on non-Federal land. Permits issued under this provision specify the number of days for which the permit is valid and the maximum number of Mexican wolves for which take is allowed. Take by permittees under this provision will assist the Service or designated agency in completing control actions. Domestic animal owners or their agents must report this take to the Service's Mexican Wolf Recovery Coordinator or a designated agency of the Service within 24 hours.

Lastly, we have added reporting requirements which clarify that, unless otherwise specified in this rule or in a permit, any take of a Mexican wolf must be reported to the Service or our designated agency within 24 hours.

In accordance with our joint policy published in the Federal Register on July 1, 1994 (59 FR 34270), we conducted peer review on our June 2013 rule. Due to the revisions, we will again seek expert opinions from previous reviewers and independent specialists regarding this revised proposed rule. The purpose of such review is to ensure that our final rule for this species is based on scientifically sound data, assumptions, and analyses. We will send peer reviewers copies of this document immediately following publication in the Federal Register . We will invite these peer reviewers to comment, during the reopening of the public comment period, on our use and interpretation of the science used in developing our proposed rule.

We will consider all comments and information we receive during the comment period on the June 13, 2013 (78 FR 35719), proposed rule and this revised proposed rule during preparation of a final rulemaking. Accordingly, the final decision may differ from this proposal.

In our June 13, 2013, proposed rule (78 FR 35719), we indicated that we would defer our determination of compliance with several statutes and executive orders until the information concerning potential economic impacts of the designation and potential effects on landowners and stakeholders became available in the draft environmental impact statement. We have now made use of the draft environmental impact statement data to make these determinations. In this document, we affirm the information in our proposed rule concerning Executive Order (E.O.) 12866 (Regulatory Planning and Review), E.O. 13132 (Federalism), E.O. 12988 (Civil Justice Reform), E.O. 13211 (Energy, Supply, Distribution, and Use), the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), and E.O. 12630 (Takings). However, based on the draft economic analysis data, we are amending our required determinations concerning the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), and the National Environmental Policy Act (42 U.S.C. 4321 et seq. ).

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 801 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include such businesses as manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and forestry and logging operations with fewer than 500 employees and annual business less than $7 million. To determine whether small entities may be affected, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

Importantly, the impacts of a rule must be both significant and substantial to prevent certification of the rule under the RFA and to require the preparation of an initial regulatory flexibility analysis. If a substantial number of small entities are affected by the proposed rule, but the per-entity economic impact is not significant, the Service may certify. Likewise, if the per-entity economic impact is likely to be significant, but the number of affected entities is not substantial, the Service may also certify.

In the 1998 Final Rule, we found that the nonessential experimental population would not have significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act. The 1998 Final Rule set forth management directions and provided for limited allowable legal take of Mexican wolves within the MWEPA. We concluded that the rule would not significantly change costs to industry or governments. Furthermore, the rule produced no adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. enterprises to compete with foreign-based enterprises in domestic or export markets. We further concluded that no significant direct costs, information collection, or recordkeeping requirements were imposed on small entities by the action and that the rule was not a major rule as defined by 5 U.S.C. 804(2) (63 FR 1752, January 12, 1998).

If this proposed revision to the nonessential experimental population of the Mexican wolf is adopted, the area affected by this rule includes the portion of the States of Arizona and New Mexico from Interstate Highway 40 south to the United States-Mexico international border. This rule proposes activities that have, in part, already been taking place within the BRWRA. However, it expands many of those activities to larger portions of the MWEPA.

In addition, section 7(a)(4) of the Act requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species. However, because a nonessential experimental population is, by definition, not essential to the survival of the species, conferencing will unlikely be required within the MWEPA. Furthermore, the results of a conference are strictly advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. In addition, section 7(a)(1) requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the nonessential experimental population area. As a result, and in accordance with these regulations, some modifications to the proposed Federal actions within the nonessential experimental population area may occur to benefit the Mexican wolf, but we do not expect projects on Federal lands to be halted or substantially modified as a result of these regulations.

On the other hand, this proposed revision would allow Mexican wolves to occupy anywhere within the MWEPA, which has the potential to affect small entities in the area outside the initial release areas. Specifically, small businesses involved in hunting and animal production, such as outfitters, guides, and beef cattle and sheep ranching, may be affected by Mexican wolves preying on wild native ungulates or depredating on domestic animals. We have further assessed these types of impacts to small entities in the area outside the initial release areas in the draft environmental impact statement.

Small businesses involved in ranching and livestock production may be affected by Mexican wolves depredating on domestic animals. Direct effects to small businesses could include foregone calf or cow sales at auctions due to depredations. Indirect effects could include impacts such as increased ranch operation costs for surveillance and oversight of the herd, and weight loss of livestock when wolves are present. Ranchers have also expressed concern that a persistent presence of wolves may negatively impact their property and business values. We do not foresee a significant economic impact to a substantial number of small entities in the ranching and livestock production sector based on the following information.

The Department of Agriculture reported a national estimate of 89.3 million cattle and calves in 2013, which implies that together, Arizona and New Mexico contribute approximately 2.5 percent to the overall national supply (NASS: http://quickstats.nass.usda.gov ). Over 90 percent of the ranches in Arizona (approximately 6646 out of 7384 ranches) and 80 percent of the ranches in New Mexico (approximately 5336 out of 6670 ranches) could be classified as small with a total number of less than 100 cattle. We estimate there are fewer than 12,000 small ranches in Arizona and New Mexico below Interstate 40 (the project area), based on 2007 Census of Agriculture data by county. This is a significant overestimate of the number of small ranches in the project area because it includes data for counties that are split by Interstate 40 (i.e., only a portion of the counties' ranches occur in the study area), as well as ranches that may occur in Zone 3 where we do not expect wolf occupancy over the project time period. While small ranches represent the majority of the number of ranches in the two States, they produce less than 10 percent of the states' total cattle and calf inventory, or a quarter of one percent of the national inventory. The largest operations, those with an inventory greater than 2,500 cattle, account for over 50 percent of the total states' livestock.

Between 1998 and 2013, on average there were about 56 total depredations (confirmed and unconfirmed) by Mexican wolves in any given year, which equates to about 1.2 cow/calves killed for every Mexican wolf (or 118 depredations for every 100 Mexican wolves). Compared to the 2007 total inventory of cattle (123,124) for the 5 county area of the Mexican wolf initial release area (Graham, Greenlee, and Apache Counties, Arizona, and Catron and Grant Counties, New Mexico) both confirmed and unconfirmed depredations per 100 Mexican wolves account for less than 0.01 percent of the herd size. The economic cost of Mexican wolf depredations in this time period has been a small percentage of the total value of the livestock operations. The average number of cattle killed (both confirmed and unconfirmed) in any given year is estimated to be 118.2 per 100 Mexican wolves. The expected value of these cattle (118.2 cattle killed per 100 Mexican wolves on average for any year) at auction using 2012 prices (most current data available at the time of the analysis) would be about $98,000 dollars. Prices will be updated for the final EIS.

We recognize that annual depredation events have not been, and may not be uniformly distributed across the ranches operating in occupied wolf range. Rather, wolves seem to concentrate in particular areas and to the extent that livestock are targeted by the pack for depredations, some ranch operations will be disproportionately affected. However, while a depredation could disproportionately impact a small ranch compared to a larger ranch (e.g., in lost market value), it is more likely that a depredated cow will belong to a large ranching operation than a small one based on the proportion of cattle associated with ranch size. The annual number of depredations (both confirmed and unconfirmed) is expected to grow from 97 to 335 cows/calves as the Mexican wolf population also grows from 83 to 285 individuals during the period 2013 through 2026. The total economic impact to the ranching community during this period is calculated to be $2.3 million with a net present value of $1.4 million. We would expect to compensate 100 percent of the market value of confirmed depredated cattle and 50 percent of market value for probably kills with payments to affected ranchers from our Mexican Wolf Interdiction Fund, which provides for proactive conservation measures to decrease the likelihood of depredation and for compensation of verified livestock depredations. This impact, spread over a 12-year period, is not both significant and substantial. That is, if impacts are disproportionately felt, the number of affected ranches will be small but the impact to those affected may be significant. If the impacts are more evenly spread across a greater number of ranches the economic impact to those entities will not be significant.

Small businesses involved in ranching and livestock production may be affected by weight loss of livestock due to the presence of Mexican wolves. For example, livestock may lose weight because wolves force them off of suitable grazing habitat or away from water sources. Livestock may try to protect themselves by staying close together in protected areas where they are more easily able to see approaching wolves and defend themselves and their calves. A consequence of such a behavioral change would likely be weight loss, especially if the wolves are allowed to persist in the area for a significant amount of time. The weight loss would be associated with the cattle's fear of roaming away from the herd to forage. Using a mid-point estimate of 6 percent weight loss for calves at the time of auction (based on available data), we calculated the impact on 2012 model ranches assuming that wolf presence pressures were allowed to persist throughout the foraging year. Based on available studies and reports and under current market prices, a six percent weight loss for calves at the time of sale could result in a total loss of profit for a small ranch and reduce profits for a medium and large ranch on the equivalent of losing five and ten calves for auction from the baseline (an estimated loss of profit of $9,269 for a large ranch). We estimate that only a small proportion of ranches in the project area could be affected by weight loss, given that wolves may not occupy areas near some ranches' livestock during any point of the project time frame (12 years), wolves may not be in the vicinity of some ranches' livestock for the entire foraging season (as assumed in our calculations), and landowners and the Service and our designated agencies have a variety of harassment and take mechanisms available to address wolf-livestock conflicts. Furthermore while such an impact could be significant to an individual small ranch, for the purposes of this certification we do not consider the impact significant because small ranches account for less than 10 percent of the states' total cattle and calf inventory, or a quarter of one percent of the national inventory. Therefore, we do not foresee a significant economic impact to a substantial number of small entities in the ranching and livestock production sector associated with indirect effects of weight loss of livestock when wolves are present.

Small businesses associated with hunting in Arizona and New Mexico could also be affected by implementation of our proposed action. Direct effects to small businesses in this section could occur from impacts to big game populations due to Mexican wolf predation (primarily on elk); loss of hunter visitation to the region, or a decline in hunter success, leading to lost income or increased costs to guides and outfitters. However, we do not have information suggesting that these impacts will occur. Between 1998 and 2012, Arizona Game and Fish Department conducted a study to determine the impact that Mexican wolves have had on deer and elk populations in the Blue Range Wolf Recovery Area. The study found that while Mexican wolves do target elk as their primary prey source, including elk calves during the spring and summer season, there was no discernable impact on the number of elk calves that survive through early fall periods. A similar finding was made for mule deer. The study also reported that the number of elk permits authorized by AGFD has varied since Mexican wolves were reintroduced into Arizona. The study reports that the variation is attributable to a variety of management-related objectives. Elk availability for hunters, however, was not the reason for the decline.

During the project time period, we expect the Mexican wolf density in the MWEPA to be no higher (and more likely, lower) than it is currently and wolf to elk ratios (an indicator of predation pressure) to occur at levels resulting in less than significant biological impacts, suggesting that ungulate populations will not be impacted by Mexican wolves. Furthermore, information suggests that wolves tend to prey on unproductive calf elk and older cow elk, whereas hunters are seeking elk with high reproductive potential. Trends in hunter visitation and success rates since 1998 in the areas where Mexican wolves have been introduced are stable or increasing based on the number of licensed hunters and hunter success rates. We do not have information suggesting these trends would change during the project time period. Therefore, we do not foresee a significant economic impact to a substantial number of small entities associated with hunting activities.

We also considered impacts to the tourism industry from implementation of our proposed action. In this case, impacts to small businesses would be positive, stemming from increased profits associated with wolf-related outdoor recreation opportunities, such as providing eco-tours in Mexican wolf country. However, we do not have information suggesting that wolf presence will create significant (positive) economic impacts to a substantial number of small entities, as very few eco-tours or other ventures have been identified since 1998. Therefore, we do not foresee a significant economic impact to a substantial number of small entities associated with tourism activities.

In summary, we have considered whether the proposed designation would result in a significant economic impact on a substantial number of small entities. Information for this analysis was gathered from the Arizona Game and Fish Department, cooperating agencies, New Mexico Game and Fish Department, stakeholders, published literature and reports, and the Service. For the above reasons and based on currently available information, we certify that, if promulgated, the proposed revision to the existing nonessential experimental population designation of the Mexican wolf would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.

We may not conduct or sponsor and the public is not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. The OMB has reviewed and approved our collection of information associated with reporting the taking of experimental populations (50 CFR 17.84) and assigned OMB Control Number 1018-0095. The OMB has also approved the collection of information associated with endangered and threatened species permit applications and reports and assigned OMB Control Number 1018-0094, which expires January 31, 2017. This proposal contains a requirement to prepare a science based document in order to obtain Service authorization to remove Mexican wolves in response to impacts to wild ungulates. Because this requirement applies only to two States, OMB approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) is not required.

The purpose of the draft environmental impact statement, prepared under the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq. ), is to identify and disclose the environmental consequences resulting from the proposed action of revising the existing nonessential experimental population designation of the Mexican wolf. In the draft environmental impact statement, four alternatives are evaluated: Alternative One (BRWRA Expansion; MWEPA Expansion with Management Zone; Modified Provisions for Take of Mexican Wolves); Alternative Two (MWEPA Expansion with Management Zones; Modified Provisions for Take of Mexican Wolves); Alternative Three (BRWRA Expansion; MWEPA Expansion with Management Zones); and Alternative Four (No Action).

The no action alternative is required by NEPA for comparison to the other alternatives analyzed in the draft environmental impact statement. Our preliminary determination is that revising the existing nonessential experimental population designation of the Mexican wolf will not have significant impacts on the environment. However, we will further evaluate this issue as we complete our final environmental impact statement.

As we stated earlier, we are soliciting data and comments from the public on the draft environmental impact statement, as well as all aspects of the proposed rule. We may revise the proposed rule or supporting documents to incorporate or address information we receive during the comment period on the environmental consequences resulting from our revision of the existing nonessential experimental population designation.

For Mexican wolves that occur outside the MWEPA, the Act (16 U.S.C. 1531 et seq. ) prohibits activities with endangered and threatened species unless a Federal permit allows such activities. Along with our implementing regulations at 50 CFR part 17, the Act provides for permits, and requires that we invite public comment before issuing these permits. A permit granted by us under section 10(a)(1)(A) of the Act authorizes activities with U.S. endangered or threatened species for scientific purposes, enhancement of survival or propagation, or interstate commerce. Our regulations regarding implementation of section 10(a)(1)(A) permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

As part of this rulemaking process, we have drafted a section 10(a)(1)(A) permit to allow for certain activities with Mexican wolves that occur outside the MWEPA. In compliance with NEPA (42 U.S.C. 4321 et seq. ), we have included analysis of the environmental effects of the draft permit as part of our draft EIS. This draft section 10(a)(1)(A) permit is attached as an appendix in the draft EIS. Both the Act and the National Environmental Policy Act require that we invite public comment before issuing these permits. Therefore, we invite local, State, tribal, and Federal agencies, and the public to comment on the draft section 10(a)(1)(A) permit.

The primary authors of this document are the staff members of the New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq. ) and the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ).

Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as proposed to be amended at 78 FR 35719 (June 13, 2013) set forth below:

Background on the Convention

A map showing the boundaries of the area of application of the Convention (Convention Area), which comprises the majority of the western and central Pacific Ocean (WCPO), can be found on the WCPFC Web site at: www.wcpfc.int/doc/convention-area-map . The Convention focuses on the conservation and management of highly migratory species (HMS) and the management of fisheries for HMS. The objective of the Convention is to ensure, through effective management, the long-term conservation and sustainable use of HMS in the WCPO. To accomplish this objective, the Convention established the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC). The WCPFC includes Members, Cooperating Non-members, and Participating Territories (hereafter, collectively “members”). The United States is a Member. American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands (CNMI) are Participating Territories.

As a Contracting Party to the Convention and a Member of the WCPFC, the United States is obligated to implement the decisions of the WCPFC. The WCPFC Implementation Act (16 U.S.C. 6901 et seq. ) authorizes the Secretary of Commerce, in consultation with the Secretary of State and the Secretary of the Department in which the United States Coast Guard is operating (currently the Department of Homeland Security), to promulgate such regulations as may be necessary to carry out the obligations of the United States under the Convention, including the decisions of the WCPFC. The WCPFC Implementation Act further provides that the Secretary of Commerce shall ensure consistency, to the extent practicable, of fishery management programs administered under the WCPFC Implementation Act and the Magnuson-Stevens Fishery Conservation and Management Act (MSA; 16 U.S.C. 1801 et seq. ), as well as other specific laws (see 16 U.S.C. 6905(b)). The Secretary of Commerce has delegated the authority to promulgate regulations under the WCPFC Implementation Act to NMFS.

At its Tenth Regular Session, in December 2013, the WCPFC adopted CMM 2013-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean.” CMM 2013-01 is the most recent in a series of CMMs for the management of tropical tuna stocks under the purview of the WCPFC. It is a successor to CMM 2012-01, adopted in December 2012. These and other CMMs are available at: www.wcpfc.int/conservation-and-management-measures .

CMM 2013-01's stated general objective is to ensure that the stocks of bigeye tuna ( Thunnus obesus ), yellowfin tuna ( Thunnus albacares ), and skipjack tuna ( Katsuwonus pelamis ) in the WCPO are, at a minimum, maintained at levels capable of producing their maximum sustainable yield as qualified by relevant environmental and economic factors. The CMM includes specific objectives for each of the three stocks: For each, the fishing mortality rate is to be reduced to or maintained at levels no greater than the fishing mortality rate associated with maximum sustainable yield.

CMM 2013-01 went into effect February 4, 2014, and is generally applicable for the 2014-2017 period. Some of its provisions apply to specific periods within the 2014-2017 period, and some of its provisions are contingent on whether the WCPFC makes certain decisions in the future. The CMM includes provisions for purse seine vessels, longline vessels, and other types of vessels that fish for HMS. The CMM's provisions for purse seine vessels include limits on the allowable number of fishing vessels, limits on the allowable level of fishing effort, restrictions on the use of fish aggregating devices, requirements to retain all bigeye tuna, yellowfin tuna, and skipjack tuna except in specific circumstances, and requirements to carry vessel observers. This proposed rule is limited to implementing CMM 2013-01's provisions on allowable levels of fishing effort by purse seine vessels on the high seas and in the U.S. EEZ in the Convention Area, and only for 2014. The CMM's other provisions would be implemented through one or more separate rules, as appropriate.

Currently there is a limit on the amount of fishing effort that U.S. purse seine vessels may collectively spend between the latitudes of 20° N. and 20° S. on the high seas and in the U.S. EEZ in the Convention Area in 2014 (50 CFR 300.223(a)). The areas of high seas and U.S. EEZ between the latitudes of 20° N. and 20° S. in the Convention Area are referred to in the regulations as the Effort Limit Area for Purse Seine, or ELAPS, and the limit applies within the ELAPS as a whole. The limit in the ELAPS for 2014 is 2,588 fishing days, which is identical to the limit for 2013. The 2013 and 2014 limits were established in a final rule published May 23, 2013 (78 FR 30773; “2013 rule”), and are consistent with the CMM for tropical tunas that was in effect at that time, CMM 2012-01. CMM 2012-01 has a provision that was applicable to the high seas portion of the ELAPS and a separate provision that was applicable to the U.S. EEZ portion of the ELAPS. For reasons explained in the preamble to the proposed rule (78 FR 14755, published March 7, 2013) that preceded the May 23, 2013, final rule, NMFS established the 2013 and 2014 fishing effort limits (following the practice in previous rules for earlier years) so that a single limit applies in the entire ELAPS rather than separate limits for the two areas. Limits on U.S. purse seine fishing effort in the ELAPS have been in place since 2009, when NMFS issued a final rule (74 FR 38544, published August 4, 2009; “2009 rule”) to establish the limits required under the then-in-effect CMM for tropical tunas, CMM 2008-01.

NMFS stated in the preamble to the March 7, 2013, proposed rule that if the WCPFC adopted a new CMM with purse seine provisions that differ from those in CMM 2012-01, NMFS would take any steps necessary to implement the WCPFC's new decision. Because the allowable level of purse seine fishing effort on the high seas has changed under CMM 2013-01, this proposed rule would make the necessary changes to the 2014 purse seine fishing effort limit in the ELAPS.

This proposed rule is limited to implementing the provisions in CMM 2013-01 for 2014 on allowable levels of fishing effort by purse seine vessels on the high seas and in the U.S. EEZ. The CMM's fishing effort limit provisions for subsequent years would be implemented through one or more separate rules. NMFS is implementing the 2014 purse seine effort limits separately from other provisions of the CMM to ensure that the limits go into effect in U.S. regulations before the prescribed limits are exceeded by the fleet, which has a moderate likelihood of occurring before the end of 2014.

The purse seine fishing effort provisions of CMM 2013-01 apply only in the Convention Area between the latitudes of 20° N. and 20° S. The proposed action as described below would therefore be limited to that area.

With respect to the U.S. EEZ, CMM 2013-01 requires coastal members like the United States to “establish effort limits, or equivalent catch limits for purse seine fisheries within their EEZs that reflect the geographical distributions of skipjack, yellowfin, and bigeye tunas, and are consistent with the objectives for those species.” CMM 2013 further requires, “Those coastal States that have already notified limits to the Commission shall restrict purse seine effort and/or catch within their EEZs in accordance with those limits.” The United States has regularly notified the WCPFC of its purse seine effort limits for the U.S. EEZ since the limits were first established in 2009 (in a final rule published August 4, 2009; 74 FR 38544). Accordingly, CMM 2013-01 does not change the applicable limit for the U.S. EEZ.

With respect to the high seas, CMM 2013-01 requires flag members to restrict the fishing effort of their purse seine vessels to specified levels, which for the United States is 1,270 fishing days per year.

This proposed rule would continue to implement the applicable limits for the U.S. EEZ and the high seas such that they apply to a single area, without regard to the boundary between the U.S. EEZ and the high seas; that is, to the ELAPS as a whole. As in the previous rules that established purse seine fishing effort limits in the ELAPS, NMFS has determined that combining the high seas and the U.S. EEZ limits would accomplish the objective of controlling the fishing mortality rates of the tuna stocks as required under the CMM, and, moreover, would provide greater operational flexibility to affected purse seine vessels and result in lesser adverse economic impacts than if separate limits were established in the two areas.

The existing purse seine fishing effort limit for the ELAPS was determined as follows: The U.S. EEZ portion of the ELAPS limit was 558 fishing days per year, and the high seas limit was 2,030 days per year, resulting in a combined limit of 2,588 fishing days per year, which is currently in place for 2014. CMM 2013-01 changes the high seas portion to 1,270 fishing days per year, so the new combined limit is 1,828 days per year (558 + 1,270). Accordingly, this proposed rule would change the existing 2014 purse seine fishing effort limit for the ELAPS from 2,588 fishing days to 1,828 fishing days.

The Administrator, Pacific Islands Region, NMFS, has determined that this proposed rule is consistent with the WCPFC Implementation Act and other applicable laws, subject to further consideration after public comment.

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

An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the RFA. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained in the SUMMARY section of the preamble and in other sections of this SUPPLEMENTARY INFORMATION section of the preamble. The analysis follows:

The proposed rule would apply to owners and operators of U.S. purse seine vessels used for fishing in the Convention Area. The number of affected vessels is the number licensed under the Treaty on Fisheries between the Governments of Certain Pacific Island States and the Government of the United States of America (South Pacific Tuna Treaty, or SPTT). The current number of licensed vessels is 40, which is the maximum number of licenses available under the SPTT (excluding joint-venture licenses, of which there are five available under the SPTT, none of which have ever been applied for or issued).

On June 12, 2014, the Small Business Administration (SBA) issued an interim final rule revising the small business size standards, effective July 14, 2014 (79 FR 33647). The rule increased the size standard for Finfish Fishing to $20.5 million. Based on (limited) available financial information about the affected fishing fleets and the SBA's definition of a small finfish harvester (i.e., gross annual receipts of less than $20.5 million, independently owned and operated, and not dominant in its field of operation), and using individual vessels as proxies for individual businesses, NMFS believes that all the affected fish harvesting businesses are small entities. As indicated above, there are currently 40 purse seine vessels in the affected purse seine fishery. Neither gross receipts nor ex-vessel price information specific to the 40 vessels are available to NMFS, so average annual receipts for each of the 40 vessels during the last 3 years for which reasonably complete data are available, 2010-2012, were estimated as follows: The vessel's reported retained catches of each of skipjack tuna, yellowfin tuna, and bigeye tuna in each year was multiplied by an indicative Asia-Pacific regional cannery price for that species and year (developed by the Pacific Islands Forum Fisheries Agency and available at https://www.ffa.int/node/425#attachments ). The products were summed across species for each year, and the sums were averaged across the 3 years. The estimated average annual receipts for each of the 40 vessels were less than $20.5 million.

The proposed rule would not establish any new reporting or recordkeeping requirements (within the meaning of the Paperwork Reduction Act). Affected vessel owners and operators would have to comply with all the proposed requirements, as described earlier in the SUPPLEMENTARY INFORMATION section of the preamble. Fulfillment of these requirements is not expected to require any professional skills that the affected vessel owners and operators do not already possess. The costs of complying with the proposed requirements are described below to the extent possible:

If and when the purse seine fishery is closed to fishing in the ELAPS as a result of the annual fishing effort limit being reached in 2014, owners and operators of U.S. purse seine vessels would have to cease fishing in that area for the remainder of the calendar year. Closure of the fishery in the ELAPS could thereby cause foregone fishing opportunities and associated economic losses if the ELAPS contains preferred fishing grounds during such a closure. The likelihood of the fishery being closed in the ELAPS in 2014 under the proposed rule is greater than under the no-action alternative, because the proposed limit (1,828 days) is smaller than the existing limit (2,588 fishing days). Historical fishing patterns suggest a moderate likelihood of the fishery being closed before the end of 2014. The most recent 10 years for which estimates are available, but omitting 2010-2012, during which two important areas of high seas were closed to fishing, are used to determine the likelihood of the limit being reached. In order to make the data comparable among years, historical fishing effort, as well as the proposed ELAPS limit, are expressed here in terms of fishing days per year per active vessel, on average. Assuming 40 active vessels in 2014, the existing limit, 2,588 fishing days per year, is equivalent to 65 fishing days per year per vessel, on average (this level is termed the “existing threshold” in the following discussion, to distinguish it from the fleet-wide limit for 2014). The proposed limit, 1,828 fishing days, is equivalent to 46 fishing days per vessel per year, on average (“proposed threshold”). Among the 10 years 2001-2009 and 2013, fishing effort in the ELAPS ranged from 31 to 64 fishing days per vessel per year, exceeding the existing threshold in none of the 10 years and exceeding the proposed threshold in 4 of the 10 years, or 40 percent of the time. Based on this history, the likelihood of the proposed limit being reached in 2014 is substantial—roughly 40 percent, whereas the existing limit is unlikely to be reached.

Other factors that could influence the likelihood of the proposed limit being reached are the status of vessels with respect to whether they have fishery endorsements and are allowed to fish in the U.S. EEZ, El Niño-Southern Oscillation (ENSO) conditions, and recent changes to SPTT-related arrangements. Regarding the first factor, if the proportion of the fleet that has fishery endorsements changes from the proportion during the baseline period, the likelihood of the ELAPS limit being reached would change accordingly (if the proportion increases, the likelihood would increase). However, because fishing in the U.S. EEZ makes up a relatively small portion of all fishing in the ELAPS, this is a relatively minor factor, and is not examined any further here. Regarding the second factor, the eastern areas of the WCPO have tended to be comparatively more attractive to the U.S. purse seine fleet during El Niño events (versus other times), when warm surface water spreads from the western Pacific to the eastern Pacific and large, valuable yellowfin tuna become more vulnerable to purse seine fishing. Consequently, the ELAPS, much of which is situated in the eastern range of the fleet's fishing grounds, is likely to be more important fishing grounds to the fleet during El Niño events (as compared to neutral or La Niña events). According to the National Weather Service (see http://www.cpc.ncep.noaa.gov/products/analysis_monitoring/enso_advisory/index.shtml ), as of May 2014, conditions were ENSO-neutral and the forecast was that the chance of El Niño conditions will exceed 65 percent by the summer of 2014. To put this into perspective, the operational definition of El Niño as used by the National Weather Service is one such that El Niño events—which by definition last no fewer than five months and typically last less than 2 years—have occurred four times since 2001, and seven times since 1988. During this period, El Niño conditions have prevailed during much less than half the time. Thus the more-than-65 percent chance of an El Niño developing in the summer of 2014 suggests a slightly higher likelihood (than indicated by historical fishing effort alone) of the proposed 2014 ELAPS limit being reached. Regarding the third factor, effective June 15, 2013, while certain SPTT instruments are being renegotiated, there is an interim arrangement in place between U.S. purse seine vessel owners and the members of the Pacific Islands Forum Fisheries Agency (FFA) that stipulates that the U.S. fleet may collectively spend no more than 12,000 fishing days in the EEZs of the Parties to the Nauru Agreement (PNA, a subset of eight FFA members in whose waters most WCPO tropical purse seine fishing occurs), and no more than 450 fishing days in the EEZs of the other FFA members during the period of the interim arrangement, which is 18.5 months). Assessing the likelihood of the FFA members' EEZs “limit” (in quotation marks because it is not a federal regulatory limit) being reached before the end of 2014 is difficult because the meaning of a fishing day under that arrangement is different than the meaning as used for the ELAPS limit, and NMFS does not have access to reliable measures of fishing days as used in the arrangement. The following discussion is based on fishing days as defined for the purpose of the ELAPS limit. The “limit” of 12,000 + 450 fishing days over 18.5 months means that there are 202 fishing days in the FFA members' EEZs available to each of the 40 expected U.S. vessels per 12 months, on average. Over the life of the SPTT through 2013, this level of 202 fishing days per vessel in the FFA members' EEZs was exceeded in only one calendar year, 2010, which saw 208 fishing days per vessel in the EEZs of the FFA members. The second highest level was in 2011, when there were 194 fishing days per vessel. 2010 and 2011 were two of the three years during which the two westernmost high seas pockets were closed to purse seine fishing, so they are probably not very indicative of likely fishing effort in 2014. Thus, it appears that there is a relatively small likelihood of the EEZs of the FFA members becoming unavailable to the U.S. fleet before the end of 2014. Furthermore, it is possible that U.S. vessels will obtain access to additional 2014 fishing days in the EEZs of one or more FFA members, which would further lessen the likelihood of the FFA members' EEZs “limit” being reached.

In summary, based on the available information, there is a moderate likelihood of the proposed ELAPS limit being reached before the end of 2014 (about 40-percent likelihood based solely on historical patterns, and slightly greater taking into account forecasted ENSO conditions).

The costs associated with a closure of the ELAPS would depend greatly on the length of the closure. Given the moderate likelihood of a closure, its duration would likely be relatively brief. The costs of a closure would also depend greatly on whether the EEZs of other nations, particularly the typically most favored fishing grounds, the EEZs of the PNA, are still open to fishing. As indicated above, there is relatively small likelihood of the EEZs of the FFA members being unavailable for fishing before the end of 2014. Assuming they do remain available as fishing grounds, the impacts of a closure of the ELAPS would likely be minor. Nonetheless, the closure of any fishing grounds for any amount of time would be expected to bring impacts to affected entities (e.g., because the open area might, during the closed period, be less optimal than the closed area, and vessels might use more fuel and spend more time having to travel to open areas). If the ELAPS is a relatively preferred fishing ground during the closure (e.g., because of oceanic conditions or other factors), then the losses would be accordingly greater than if the ELAPS is not preferred relative to other fishing grounds. If the EEZs of the PNA and other FFA members are not available during an ELAPS closure, the costs of an ELAPS closure could be substantial. In the event the entire WCPO is closed to fishing during an ELAPS closure, possible next-best opportunities include fishing outside the Convention Area in the eastern Pacific Ocean (EPO), and not fishing. The EPO tends to be fished very little by the fleet, indicating it contains less favorable fishing grounds (although, as indicated above, it tends to become more favorable during El Niño events). Furthermore, unless on the IATTC Vessel Register, which very few of the SPTT-licensed purse seine vessels currently are, an SPTT-licensed vessel is allowed to make only one fishing trip in the EPO each year, not to exceed 90 days in length, and there is an annual limit of 32 trips for the entire SPTT-licensed fleet (50 CFR 300.22(b)(1)). The alternative of not fishing at all during an ELAPS closure would mean a loss of any revenues from fishing. However, many of the vessels' variable operating costs would be avoided in that case, and for some vessels the time might be used for productive activities like vessel and equipment maintenance. U.S. purse seine vessel operating costs are not known, so estimates of economic losses cannot be made. But information on revenues per day can give an indication of the magnitude of possible economic costs to affected entities. Average annual gross revenues for the 40 affected purse seine vessels during 2010-2012 were approximately $11 million per vessel, on average. This equates to about $30,000 per calendar day, on average.

The proposed 2014 ELAPS limit could affect the temporal distribution of fishing effort in the U.S. purse seine fishery. Since the limits would apply fleet-wide; that is, they would not be allocated to individual vessels, vessel operators might have an incentive to fish harder in the ELAPS earlier in a given year than they otherwise would. Such a “race-to-fish” effect might also be expected in the time period between when a closure of the fishery is announced and when it is actually closed, which would be at least seven calendar days. To the extent such temporal shifts occur, they could affect the seasonal timing of fish catches and deliveries to canneries, and conceivably affect prices. However, because most of the traditional fishing grounds are outside the ELAPS, the intensity of any race-to-fish in the ELAPS is likely to be low if it occurs at all. The small likelihood of the EEZs of the FFA being closed to fishing before the end of 2014, as discussed above, might also influence the behavior of fishermen earlier in the year, but it is not clear how it would influence fishing in the ELAPS. If fishermen are more concerned about the FFA members' EEZs closing at some point, they might fish harder in those waters earlier in the year; if, on the other hand, they are more concerned about the ELAPS closing, they might fish harder in the ELAPS earlier in the year. In any case, the timing of cannery deliveries by the U.S. fleet alone (as it might affected by a race to fish in the ELAPS) is unlikely to have an appreciable impact on prices, since many canneries buy from the fleets of multiple nations at any given time. A race to fish could bring costs to affected entities if it causes vessel operators to forego vessel maintenance in favor of fishing or to fish in weather or ocean conditions that they otherwise would not. This could bring costs in terms of the health and safety of the crew as well as the economic performance of the vessel.

In summary, there is a moderate likelihood of the limit being reached before the end of 2014, and if it is reached before the end of 2014, the impacts to affected entities could be minor or substantial, depending on such factors as the length of the closure, whether the EEZs of the FFA members remain available for fishing, and oceanic conditions.

There would be no disproportionate economic impacts between small and large entities operating vessels as a result of this proposed rule. Furthermore, there would be no disproportionate economic impacts based on vessel size, gear, or homeport.

NMFS has not identified any Federal regulations that duplicate, overlap with, or conflict with the proposed regulations.

In previous rulemakings to establish or revise U.S. purse seine fishing effort limits in the ELAPS in accordance with WCPFC decisions, NMFS considered a number of alternatives. The alternatives had to do, firstly, with the time scales for the limits (e.g., single-year versus multiple-year limits); secondly, with whether separate limits would be established in the U.S. EEZ and high seas portions of the ELAPS or they would be combined; thirdly, with whether the limit(s) would be allocated to individual vessels; and fourthly, with the magnitude of the limit(s).

The first category, time scales, is not relevant here because the objective is to implement the required fishing effort limit for 2014 only.

The second category, whether to break up the ELAPS limit into separate limits for the U.S. EEZ and the high seas portions of the ELAPS, would provide less operational flexibility for affected purse seine vessels, and thus be more constraining and costly than the proposed limit. It is not preferred for that reason.

The third category, allocating the limit among individual vessels, would likely alleviate any adverse impacts of a race-to-fish that might occur as a result of establishing the competitive fishing effort limits as in the proposed rule. As described in the previous paragraphs, those potential impacts include lower prices for landed product and risks to performance and safety stemming from fishing during sub-optimal times. Those impacts, however, are expected to be minor, so this alternative is not preferred.

Regarding the fourth category, the magnitude of the limits, NMFS could, as it did for the 2013 rule that established the 2013 and existing 2014 ELAPS limit, consider both smaller and larger limits for the ELAPS. Smaller limits, being more constraining and costly to affected fishing businesses, are not considered further here. CMM 2013-01 includes an explicit limit for the United States for the high seas, 1,270 fishing days per year, so NMFS is not afforded any discretion there. Like its predecessor, CMM 2012-01, CMM 2013-01 is less explicit with respect to the U.S. EEZ, so NMFS could consider a more expansive limit for that aspect of the total ELAPS limit. For example, in the 2013 rule, NMFS considered an alternative that would be based in part on the fleet's greatest annual level of fishing effort in the U.S. EEZ (on an average per-vessel basis, then expanded to a 40-vessel-equivalent) during the 1997-2010 time period. Using that approach here, the U.S. EEZ aspect of the limit would be 1,655 fishing days, and when combined with the high seas aspect of 1,270 fishing days, the total ELAPS limit would be 2,925 fishing days. Because this alternative limit is greater and thus less constraining than the proposed limit of 1,828 fishing days (as well as the existing limit of 2,588 fishing days), the costs of complying with this alternative would be less than or equal to those of the proposed limit. This alternative is not preferred because it would depart from the effort limits established for the period 2009-2013. The approach used in formulating the limit proposed in this rule is consistent with the precedent set by the 2009 rule and the 2013 rule, and affected entities have been exposed to the impacts of those limits for the past five years.

The alternative of taking no action at all, which would leave the existing 2014 ELAPS limit of 2,588 fishing days in place, is not preferred because it would fail to accomplish the objective of the WCPFC Implementation Act or satisfy the international obligations of the United States as a Contracting Party to the Convention.

For the reasons set out in the preamble, 50 CFR part 300 is proposed to be amended as follows: