        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        45 CFR Part 170
        [OCIIO-9983-NC; Docket No. THE SECRETARY-OS-2010-0034]
        RIN 0950-AA19
        Planning and Establishment of Consumer Operated and Oriented Plan Program; Request for Comments Regarding Provisions of Consumer Operated and Oriented Plan Program

          AGENCY:
          Office of Consumer Information and Insurance Oversight, Department of Health and Human Services.

          ACTION:
          Request for comments.

          SUMMARY:
          This document is a request for comments regarding the provisions of section 1322 of the Patient Protection and Affordable Care Act (the Affordable Care Act), enacted on March 23, 2010, which requires the Secretary to establish the Consumer Operated and Oriented Plan program. The Secretary of Health and Human Services invites public comments in advance of future rulemaking and grant and loan solicitations.

          DATES:
          To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 4, 2011.

          ADDRESSES:
          All comments will be made available to the public. WARNING: Do not include any confidential business information that you do not want publicly disclosed. All comments are posted on the Internet exactly as received, and can be retrieved by most Internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records.
          In commenting, please refer to file code OCIIO-9983-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments using any of the following methods (please choose only one of the ways listed):
          • Electronically. You may submit electronic comments to http://www.regulations.gov. Follow the instructions under the “More Search Options” tab.
          • Mail. You may mail written comments to the following address ONLY: Office of Consumer Information and Insurance Oversight, Department of Health and Human Services, Attention: OCIIO-9983-NC, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. Please allow sufficient time for mailed comments to be received before the close of the comment period.
          • Hand or Courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to the following address: Office of Consumer Information and Insurance Oversight, Department of Health and Human Services, Attention: OCIIO-9983-NC, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
          Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the OCIIO drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.
          Comments mailed to the address indicated as appropriate for hand or courier delivery may be delayed and received after the close of the comment period.

          FOR FURTHER INFORMATION CONTACT:

          Catherine Halverson, Office of Consumer Information and Insurance Oversight, Department of Health and Human Services, at (301) 492-4391. Customer Service Information: Individuals interested in obtaining information about the Patient Protection and Affordable Care Act may visit the Secretary of Health and Human Services' Web site (http://www.HealthCare.gov).

        SUPPLEMENTARY INFORMATION:

        I. Background
        Section 1322 of Patient Protection and Affordable Care Act (the Affordable Care Act) requires the Secretary to establish the Consumer Operated and Oriented Plan program (CO-OP program) to foster the creation of “qualified nonprofit health insurance issuers” (qualified nonprofit issuers) that will offer qualified health plans in the individual and small group markets. Such qualified nonprofit issuers must, as directed by the new law, operate with a strong consumer focus and use any profits to lower premiums, improve benefits, or improve the quality of health care delivered to plan members. For purposes of this document, “a CO-OP” refers to a qualified health plan offered by a qualified nonprofit issuer.
        Under the CO-OP program, the Secretary will make loans to assist in funding start-up costs for qualified nonprofit issuers and will award grants (repayable in 15 years) to assist such issuers in meeting State solvency requirements. The Secretary must award the loans and grants and begin funding distribution no later than July 1, 2013. Loans must be repaid within 5 years and grants must be repaid within 15 years, taking into account State reserve requirements and solvency regulations.
        The Affordable Care Act requires the Secretary to convene a Federal advisory board. This advisory board will offer recommendations to the Secretary on the awarding of loans and grants to emerging co-ops under Section 1322.
        II. Solicitation of Comments

        We are inviting public comment to aid in the development of regulations regarding this loan and grant program. To assist interested parties in responding, this request for comment describes various topics about which the Secretary is particularly interested in receiving public comments. Commenters should use the questions below to provide the Secretary with relevant information for the development of regulations regarding the CO-OP program. However, it is not necessary for commenters to address every question below, and commenters may also address additional issues related to the provisions for the CO-OP program in the Affordable Care Act. Individuals, groups, and organizations interested in providing comments may do so by following the instructions in the ADDRESSES section above.
        Below, we summarize relevant statutory provisions and solicit public comment on the topics about which the Secretary is particularly interested.
        A. Section 1322(a) of the Affordable Care Act
        Section 1322(a) of the Affordable Care Act directs the Secretary to establish a program to foster, through grants and loans, the establishment of qualified nonprofit health insurance issuers. Substantially all of the activities of the qualified nonprofit issuers must be in the individual and small group markets. The issuers must be licensed in the State(s) in which they operate. The CO-OP program shall provide for the awarding of loans and grants to provide assistance for the establishment of qualified nonprofit issuers.
        Section 1322(c) of the Affordable Care Act defines a “qualified nonprofit health insurance issuer” as one: (1) That is organized under State law as a nonprofit member corporation, (2) substantially all of the activities of which consist of the issuance of qualified health plans in the individual and small group markets, and (3) that meets other requirements of section 1322(c). To qualify for a loan or grant, the qualified nonprofit issuer (or a related entity or predecessor) must not have been a health insurance issuer on July 16, 2009 and must not be sponsored by a State or local government, any political subdivision thereof, or any instrumentality of such government or political subdivision. Section 1322(c)(4) provides that an organization cannot be a qualified nonprofit health insurance issuer unless any profits made by the organization are required to be used to lower premiums, to improve benefits, and for other programs intended to improve the quality of health care delivered to its members. Section 1322(e) provides that no representative of any Federal, State, or local government (or any political subdivision or instrumentality thereof), and no representative of a health insurance issuer or a related entity, may serve on the board of directors.
        1. What is your assessment of the types of groups or organizations that would meet the criteria outlined above, and be successful in establishing durable qualified plans in the individual and small group markets? Do any organizations currently exist that would satisfy these statutory eligibility criteria for receiving a loan or grant under the CO-OP program? To what extent, and in what way, do funding needs of qualified nonprofit issuers that have already been established differ from the needs of those that have not been? How might funding needs differ for other groups or organizations that do not currently exist, but would be successful in establishing durable qualified plans in the individual and small group markets? How would such differences be considered in determining appropriate financing terms for Federal loans or grants?

        2. What skills, background, and expertise should be required of the loan or grant applicant? What skills, background and expertise should be required of the management team of the qualified nonprofit issuer once the entity is operational (e.g., experience in providing coverage)? What factors are most likely to lead to the successful operation and sustainability of a CO-OP?

        3. What relationship with CO-OP enrollees would promote initial and continued enrollment, e.g., service to a geographic community, a strong provider network, its health care mission, etc.?
        4. What issues might a qualified nonprofit issuer face in developing provider networks in rural or other medical shortage areas?
        5. How much time would a new qualified non-profit issuer need to establish a plan, become operational, begin to accept enrollment and provide health insurance coverage? What factors may affect the timeline necessary to become operational, and how?
        6. What specific details should be required in feasibility studies, business plans, and marketing plans provided by prospective applicants before any loan or grant award is made? What should be included in the scope and content of these studies and plans? What level of detail should be required at the time of application?
        7. What level of investment would be required by a qualified nonprofit issuer to develop sufficient administrative and claims processing information technology (IT) systems? Is there a minimum level of investment that would be required regardless of the size of enrollment? Does it vary according to enrollment size, geographic location, or other factors, and by how much? Are funding needs for this purpose different for any qualified nonprofit issuers that may already be in existence, and if so, in what way?

        8. What level of investment would be required by a qualified nonprofit issuer to develop sufficient health information technology systems necessary to operate a health plan in the health insurance Exchange market, including the use of electronic health records? Is there a minimum level of investment that would be required regardless of the size of enrollment? Does it vary according to enrollment size, enrollee characteristics, or other factors, and by how much? Are funding needs for this purpose different for any qualified nonprofit issuers that may already be in existence, and if so, in what way?
        9. What is the range of funding necessary to capitalize and fund the establishment of a new qualified nonprofit issuer? How much of that amount can be raised privately, or funded through non-Federal government support? What factors should be considered in determining the appropriate amount of Federal loans and/or grants that would be needed to support the establishment of a new nonprofit health insurance issuer? To what extent do the funds needed to capitalize a qualified nonprofit issuer, and the degree of Federal support necessary likely to vary across issuers?
        10. What level of investment is needed to maintain appropriate fiduciary management and oversight, including setting actuarially sound premiums?
        11. Are you aware of any State laws that could create opportunities for or barriers to the formation of qualified nonprofit issuers? Do you think States are likely to create or amend licensure laws to accommodate the formation of qualified nonprofit issuers? Under what circumstances could regional qualified nonprofit issuers serving multiple states be formed? Is there a role for a federation of qualified nonprofit issuers to serve more than one state or region, with risk shared among the issuers? Would this approach be desirable for specific types of communities (for example, agricultural/rural communities)? How would such a federation be organized? How would it be capitalized? What are the advantages and disadvantages of a regional qualified nonprofit issuer or a regional federation of issuers? What barriers would need to be overcome? What would be the advantages of, and barriers to, serving a metropolitan area that crosses State lines?
        12. While “substantially all” of a qualified nonprofit issuer's activities must be in the individual and small group markets, in what other markets or product lines, if any, would it be desirable for qualified nonprofit issuers to participate? For instance, could they participate in Medicaid or the Children's Health Insurance Program (CHIP) and still satisfy the statutory criteria for being a qualified nonprofit issuer? How difficult would it be for a new qualified nonprofit issuer to successfully participate in the small group market? How difficult would it be for a new qualified nonprofit issuer to successfully participate in the individual market? To what extent would participation in other markets affect the viability of new qualified nonprofit issuers or their ability to satisfy the statutory criteria for being a qualified nonprofit issuer? What type of start-up costs are necessary and reasonable for establishing a qualifying CO-OP? What startup costs might be associated with establishing a private purchasing council?
        13. Are there other considerations that should inform what costs would be eligible for a CO-OP loan? Should there be limited time periods for which Federal loans for start-up costs may be available? Are there any start-up costs that would be incurred after the qualified nonprofit issuer begins to provide coverage under one or more plans?
        14. What market factors would most likely affect a qualified nonprofit issuer's durability in the market? What factors should be considered in determining which issuers are likely to be viable in the long-term?
        15. In evaluating applications for loans and grants, what actuarial and minimum plan enrollment criteria should be considered? What is the effect, if any, if providers are anticipated to bear risk? How would such criteria affect the financial soundness of the qualified issuer?
        16. What types of technical assistance, if any, should the Secretary provide to grantees? How should such technical assistance be structured?

        17. In what geographic areas are qualified nonprofit issuers most likely to be successful (e.g., rural or metropolitan areas or certain regions of the country)?
        18. How can qualified nonprofit issuers build provider networks? What strategies have proven effective?
        19. What is the extent of interest in forming qualified nonprofit issuers under Section 1322 of the Affordable Care Act? In what State(s) or geographic region are these entities likely to be established?
        B. Section 1322(b) of the Affordable Care Act
        Section 1322(b) of the Affordable Care Act requires that the Secretary shall give priority to applicants that will offer qualified health plans on a statewide basis, utilize integrated care models, and have significant private support.
        1. How should the term “integrated care model” be defined in the context of section 1322? How should the degree of integration and the degree to which integrated care is used be measured? Should qualified nonprofit issuers formed by primary care networks, even if they contract with secondary and tertiary providers, also be given priority for the award of a grant or loan? To what degree should priority be based on whether providers share risk?
        2. How should “significant private support” be defined in this context?
        3. What options for private support should qualified nonprofit issuers be able to pursue while maintaining nonprofit status? How can such support be structured to avoid inurnment to the benefit of non-members and protect the independence of consumer governance?
        4. What types of organizations are most likely to be successful in meeting any or all of the statutory priority criteria?
        C. Section 1322(b)(2)(a)(iii) of the Affordable Care Act
        Section 1322(b)(2)(A)(iii) of the Affordable Care Act requires the Secretary to ensure that there is sufficient funding to establish at least one qualified nonprofit issuer in each State, except that nothing shall prevent the establishment of multiple issuers in a State if the funding is sufficient. Section 1322(b)(2)(B) provides that if no issuer applies to be a qualified nonprofit health insurance issuer in a State, the Secretary may use the amounts for the awarding of grants to encourage the establishment of an issuer or the expansion of another qualified nonprofit health insurance issuer from another State into the State where no issuer applied.
        1. How can the Secretary best ensure sufficient funding to establish at least one qualified nonprofit issuer in each State?
        2. How might the Secretary encourage the establishment of a CO-OP in a state without a qualified nonprofit issuer?
        D. Section 1322(b)(C)(ii) of the Affordable Care Act
        Section 1322(b)(C)(ii) of the Affordable Care Act restricts the use of loan and grant funds for (i) carrying out propaganda, or otherwise attempting to influence legislation, or (ii) for marketing.
        1. How should the restriction on the use of federal funds for marketing be applied?
        2. What other sources of financing for marketing would be available to qualified nonprofit issuers?

        3. What accounting standards and metrics should be used to determine the sources of funding for marketing activities? If qualified nonprofit issuers did engage in these activities using non-federal funding, what rules should be in place to ensure federal funds are not used?

        E. Section 1322(b)(2)(D) of the Affordable Care Act
        Section 1322(b)(2)(D) of the Affordable Care Act requires the Secretary to award and begin the distribution of loans and grants not later than July 1, 2013.
        1. To what extent is it necessary for new qualified nonprofit issuers to be operational by 2014 in order to be successful? How soon should grants or loans be distributed to establish qualified nonprofit issuers that can be operational in 2014?
        2. How might funds be best allocated and, to what extent should distribution of loan funds be front-loaded to meet the statute's goal of establishing a CO-OP in each state?
        3. Given the limited funding for this program, how long should draw down on grants and loans be permitted after the award date if loans and grants are not being utilized?
        F. Section 1322(b)(3) of the Affordable Care Act
        Section 1322(b)(3) of the Affordable Care Act requires that regulations regarding the repayment of loans and grants be “consistent with State solvency regulations and other similar State laws that may apply.” Loans shall be repaid within 5 years and grants shall be repaid within 15 years, taking into consideration any appropriate State reserve requirements, solvency regulations, and requisite surplus note arrangements that must be constructed to provide for repayment prior to awarding loans/grants.
        1. When developing a repayment schedule, how should HHS take into consideration state reserve requirements?
        2. What factors will determine the ability of qualified nonprofit issuers to generate sufficient revenues to repay the loans and grants? How and when will such issuers likely develop sufficient revenues to start the repayment of grants provided to fund reserves?
        3. What interim benchmarks after initial funding should the Secretary use to determine an issuer's ongoing likelihood of success and whether corrective actions, or other protective measures might be necessary with respect to loan and grant funds?
        4. What data are available about the potential success and failure rate of nonprofit health plans who may apply for grants and loans? If data are not available, what proxy data would be useful to inform benchmarks, or other performance standards?
        G. Section 1322(c)(2) of the Affordable Care Act
        Section 1322(c)(2) of the Affordable Care Act provides that an organization shall not be treated as a qualified nonprofit issuer (and therefore shall not be qualified to apply for loans and grants under the CO-OP program) if the organization or a related entity (or a predecessor of either) was a health insurance issuer on July 16, 2009. Section 1322(c)(2) of the Affordable Care Act also provides that an organization shall not be treated as a qualified nonprofit issuer if it is sponsored by a State or local government, political subdivision thereof, or an instrumentality of such government or political subdivision.
        1. What should and should not constitute a “related entity” or “predecessor” of a health insurance issuer for purposes of Section 1322 of the Affordable Care Act?
        H. Section 1322(c)(3) of the Affordable Care Act
        Section 1322(c)(3) of the Affordable Care Act requires that a qualified nonprofit issuer must be a nonprofit, member corporation and meet a number of governance requirements including the following:
        • The governance of the organization must be subject to a majority vote of its members;
        • Its governing documents must incorporate ethics and conflict of interest standards against insurance industry involvement and interference; and
        • The organization is required to operate with a strong consumer focus, including timeliness, responsiveness, and accountability to members.
        1. How can prospective applicants demonstrate a commitment to operating with a strong consumer focus, including responsiveness and accountability to members? How can prospective applicants demonstrate a commitment to responsiveness and accountability to members from diverse populations?
        2. What type(s) of governance structure(s) should be required? What criteria should be used in determining who is eligible to be members of the organization and of the governing body? What type of characteristics should the governing body have to ensure consumer representation and involvement? What are the options for consumer governance, beyond electing the board of directors, that would most promote ongoing consumer engagement and responsiveness of the qualified nonprofit issuer to consumer needs?
        I. Section 1322(c)(4) of the Affordable Care Act
        Section 1322(c)(4) of the Affordable Care Act provides that an organization cannot be a qualified nonprofit health insurance issuer unless any profits made by the organization are required to be used to lower premiums, to improve benefits, and for other programs intended to improve the quality of health care delivered to its members.
        1. How could the governance structure and type of organization help ensure that excess revenues are used for the benefit of members? What accounting standards and metrics should be used to determine how such funds are applied? Should such funds in one year be used to lower premiums in a subsequent year? What types of benefits might be considered? Should excess funds be used to prepay loans or grants, to allow for greater revenues/benefits to the members over time? Is this preferable to giving refunds to members for the year in which the profit was earned?
        2. How should programs intended to improve the quality of care be defined and measured in this context?
        J. Section 1322(c)(5) of the Affordable Care Act
        Section 1322(c)(5) of the Affordable Care Act requires qualified nonprofit issuers to meet all the requirements that other issuers of qualified health plans are required to meet, including solvency and licensure requirements, rules on payments to providers, network adequacy rules, rate and form filing rules, any applicable State premium assessments and any other State laws described in section 1324(b).
        1. Do any States permit newly-formed issuers (or plans) to meet these requirements incrementally over a period of time after enrollment and provision of health insurance coverage?
        K. What other considerations should be addressed relating to the CO-OP program?
        Please include in your comment letter any additional questions or comments you have about the CO-OP program.

          Dated: January 26, 2011.
          Marilyn Tavevnner,
          Principal Deputy Administrator and Chief Operating Officer.

      [FR Doc. 2011-2254 Filed 1-28-11; 4:15 pm]
      BILLING CODE 4150-03-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 180
        [EPA-HQ-OPP-2005-0253; FRL-9329-8]
        Propylene Oxide; Proposed Tolerance Actions

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA is proposing to establish the tree nut crop group tolerance and separate tolerances on pistachio and pine nuts for both the fumigant propylene oxide and the reaction product from the use of propylene oxide, known as propylene chlorohydrin, to cover all registered uses on raw and processed nuts. Also, in accordance with current Agency practice, EPA is proposing minor revisions to tolerance expressions and specific tolerance nomenclatures for propylene oxide and propylene chlorohydrin.

          DATES:
          Comments must be received on or before February 21, 2012.

          ADDRESSES:
          Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0253, by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
          • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
          • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

            Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2005-0253. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

            Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

          FOR FURTHER INFORMATION CONTACT:

          Joseph Nevola, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; email address: nevola.joseph@epa.gov.

        SUPPLEMENTARY INFORMATION:

        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. Potentially affected entities may include, but are not limited to:
        • Crop production (NAICS code 111).

        • Animal production (NAICS code 112).
        • Food manufacturing (NAICS code 311).
        • Pesticide manufacturing (NAICS code 32532).

        This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
        B. What should I consider as I prepare my comments for EPA?
        1. Submitting CBI. Do not submit this information to EPA through 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.
        II. Background
        A. What action is the agency taking?
        In this action, EPA is proposing to amend the propylene oxide tolerance regulation at 40 CFR 180.491 to add the crop group for tree nuts (nut, tree, group 14). In the Reregistration Eligibility Decision (RED) for propylene oxide, the Agency recommended that a tree nut crop group tolerance be established for two separate reasons:
        1. As a technical correction to conform the existing tolerance on “nutmeat, processed, except peanuts” with current Agency commodity terms; and

        2. To address the lack of a tolerance for registered uses on raw nuts. U.S. EPA, RED for Propylene Oxide (August 2006). In the Federal Register of September 24, 2008 (73 FR 54954) (FRL-8382-2), EPA addressed the commodity conformity issue by replacing the “nutmeat, processed, except peanuts” with a tree nut crop group. However, a propylene oxide registrant objected to this action pointing out that this was not merely a technical correction to commodity terms but actually a substantive change to the tolerance because the tree nut crop group did not cover all nuts falling within the generic term “nutmeat, processed.” Accordingly, EPA, on its initiative, corrected its error and replaced the tree nut crop group with the pre-existing tolerance for “nutmeat, processed, except peanuts” in the Federal Register of June 29, 2011 (76 FR 38036) (FRL-8877-7). Unfortunately, at the time of that action, EPA failed to recognize that the RED had found that a tree nut crop group was needed both as a technical, conforming change and to cover registered uses on raw nuts. Today, EPA is addressing the second reason by once again proposing to establish a tree nut group tolerance for propylene oxide in 40 CFR 180.491(a)(1) for residues of propylene oxide in or on nut, tree, group 14 at 300 ppm and in 40 CFR 180.491(a)(2) for residues of propylene chlorohydrin in or on nut, tree, group 14 at 10.0 ppm. However, because the current tree nut group tolerance does not cover all registered uses on nuts, EPA is also proposing to establish individual tolerances on these use sites (pistachios, pine nuts) in 40 CFR 180.491(a)(1) for residues of propylene oxide in or on pistachio at 300 ppm and nut, pine at 300 ppm, and in 40 CFR 180.491(a)(2) for residues of propylene chlorohydrin in or on pistachio at 10.0 ppm and nut, pine at 10.0 ppm. Establishment of tolerances for pistachios, pine nuts, and the nut, tree, group 14, would complete the actions recommended by the Agency in the RED.
        In order to conform to current Agency practice, EPA is proposing to revise the commodity terminology in 40 CFR 180.491(a)(1) from “herbs and spices, group 19, dried” to “herbs and spices, group 19, dried leaves” and in 40 CFR 180.491(a)(2) from “herbs and spices, group 19, dried, except basil” to “herbs and spices, group 19, dried leaves, except basil.”
        Also, in accordance with current Agency practice to describe more clearly the measurement and scope or coverage of tolerances, including applicable metabolites and degradates, EPA is proposing minor revisions to tolerance expressions for propylene oxide and propylene chlorohydrins. The revisions will not substantively change the tolerance or, in any way, modify the permissible level of residues permitted by the tolerance.
        The Agency is proposing to revise the introductory text containing the tolerance expressions in 40 CFR 180.491(a)(1) and (a)(2).

        EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each RED for the active ingredient. REDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: (800) 490-9198; fax number: (513) 489-8695; Internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: (800) 553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. An electronic copy of the propylene oxide RED and its addendums are available on the Internet in the docket for this proposed rule, ID number EPA-HQ-OPP-2005-0253, at http://www.regulations.gov and at http://www.epa.gov/pesticides/reregistration/status.htm.

        Copies of the Residue Chemistry Chapter and other documents (such as the dietary exposure analysis of October 2011 for use of propylene oxide on pine nuts and comprehensive dietary exposure analysis of June 2006) which support the propylene oxide RED are found in the Administrative Record. An electronic copy of the Residue Chemistry Chapter and addendum as well as other support documents for propylene oxide are available through EPA's electronic docket and comment system, regulations.gov at http://www.regulations.gov. You may search for docket ID number EPA-HQ-OPP-2005-0253, then click on that docket ID number to view its contents.
        EPA has determined that the aggregate exposures and risks are not of concern for the above mentioned pesticide active ingredients based upon the data identified in the RED which lists the submitted studies that the Agency found acceptable.
        B. What is the agency's authority for taking this action?

        A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.
        The Agency's evaluation of the database for pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, are contained in REDs, as are the Agency's conditions under which these uses and products will be eligible for reregistration. In REDs, the Agency recommends the establishment, modification, and/or revocation of specific tolerances. The Agency's tolerance recommendations, such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs do not need such assessment when the tolerances are no longer necessary.
        C. When do these actions become effective?

        EPA is proposing that the establishment of tolerances, and revision of tolerance expressions and nomenclatures become effective on the date of publication of the final rule in the Federal Register. If you have comments, please submit comments as described under SUPPLEMENTARY INFORMATION.
        Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
        1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and
        2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.
        III. International Residue Limits
        In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
        The Codex has not established a MRL for propylene oxide or propylene chlorohydrin.
        IV. Statutory and Executive Order Reviews

        In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e). The Office of Management and Budget (OMB) has exempted this type of action (e.g., establishment of a tolerance) 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) (Pub. L. 104-4). Nor does it require any special considerations as required by 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 other 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, or expansion of exemptions might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis for tolerance establishments and modifications was published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticide involved in this proposed rule, the Agency hereby certifies that this proposed rule will not have a significant negative economic impact on a substantial number of 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 section 408(n)(4) of FFDCA. 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.

          List of Subjects in 40 CFR Part 180
          Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

          Dated: December 14, 2011.
          Steven Bradbury,
          Director, Office of Pesticide Programs.

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

          PART 180—[AMENDED]
          1. The authority citation for part 180 continues to read as follows:

            Authority:
            21 U.S.C. 321(q), 346a and 371.

          2. Section 180.491 is amended by revising paragraphs (a)(1) and (a)(2) to read as follows:

            § 180.491
            Propylene oxide; tolerances for residues.
            (a) General. (1) Tolerances are established for residues of the fumigant propylene oxide, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only propylene oxide, when used as a postharvest fumigant, in or on the commodity.

                Commodity
                Parts per million

                Cacao bean, dried bean
                200

                Cacao bean, cocoa powder
                200

                Fig
                3.0

                Garlic, dried
                300

                Grape, raisin
                1.0

                Herbs and spices, group 19, dried leaves
                300

                Nut, pine
                300

                Nut, tree, group 14
                300

                Nutmeat, processed, except peanuts
                300

                Onion, dried
                300

                Pistachio
                300

                Plum, prune, dried
                2.0

             (2) Tolerances are established for residues of the reaction product, propylene chlorohydrin, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of propylene chlorohydrin (1-chloro-2-propanol), and its isomer 2-chloro-1-propanol, calculated as the stoichiometric equivalent of propylene chlorohydrin (1-chloro-2-propanol), that results from the use of propylene oxide as a postharvest fumigant, in or on the commodity.

                Commodity
                Parts per million

                Basil, dried leaves
                6000

                Cacao bean, dried bean
                20.0

                Cacao bean, cocoa powder
                20.0

                Fig
                3.0

                Garlic, dried
                6000

                Grape, raisin
                4.0

                Herbs and spices, group 19, dried leaves, except basil
                1500

                Nut, pine
                10.0

                Nut, tree, group 14
                10.0

                Nutmeat, processed, except peanuts
                10.0

                Onion, dried
                6000

                Pistachio
                10.0

                Plum, prune, dried
                2.0

      [FR Doc. 2011-32655 Filed 12-20-11; 8:45 am]
      BILLING CODE 6560-50-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 81
        [EPA-R04-OAR-2017-0390; FRL-9978-59-Region 4]
        Air Plan Approval and Air Quality Designation; KY; Redesignation of the Kentucky Portion of the Louisville Unclassifiable Area

          AGENCY:
          Environmental Protection Agency.

          ACTION:
          Proposed rule.

          SUMMARY:

          On May 4, 2018, the Commonwealth of Kentucky, through the Kentucky Energy and Environment Cabinet, Division for Air Quality (KDAQ), submitted a request for the Environmental Protection Agency (EPA) to redesignate the portion of Kentucky that is within the bi-state Louisville, KY-IN fine particulate matter (PM2.5) unclassifiable area (hereinafter referred to as the “bi-state Louisville Area” or “Area”) to unclassifiable/attainment for the 2012 primary annual PM2.5 national ambient air quality standard (NAAQS). The bi-state Louisville Area consists of Jefferson County and a portion of Bullitt County in Kentucky as well as Clark and Floyd Counties in Indiana. EPA now has sufficient data to determine that the bi-state Louisville Area is in attainment of the 2012 primary annual PM2.5 NAAQS. Therefore, EPA is proposing to approve Kentucky's request and redesignate the Area to unclassifiable/attainment for the 2012 primary annual PM2.5 NAAQS based upon complete, quality-assured, and certified ambient air monitoring data showing that the PM2.5 monitors in the bi-state Louisville Area are in compliance with the 2012 primary annual PM2.5 NAAQS.

          DATES:
          Comments must be received on or before June 29, 2018.

          ADDRESSES:

          Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0390 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

          FOR FURTHER INFORMATION CONTACT:

          Madolyn Sanchez, Air Regulatory Management Section, in the Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW, Atlanta, Georgia 30303-8960. Madolyn Sanchez may be reached by phone at (404) 562-9644 or via electronic mail at sanchez.madolyn@epa.gov.

        SUPPLEMENTARY INFORMATION:
        I. Background

        The Clean Air Act (CAA or Act) establishes a process for air quality management through the establishment and implementation of the NAAQS. After the promulgation of a new or revised NAAQS, EPA is required to designate areas, pursuant to section 107(d)(1) of the CAA, as attainment, nonattainment, or unclassifiable. On December 14, 2012, EPA revised the primary annual NAAQS for PM2.5 at a level of 12 micrograms per cubic meter (μg/m3), based on a 3-year average of annual mean PM2.5 concentrations. See 78 FR 3085 (January 15, 2013). EPA established the standard based on significant evidence and numerous health studies demonstrating that serious health effects are associated with exposures to particulate matter.
        The process for designating areas following promulgation of a new or revised NAAQS is contained in section 107(d)(1) of the CAA. On December 18, 2014, EPA designated the majority of areas across the country as nonattainment, unclassifiable/attainment, or unclassifiable 1
           for the 2012 PM2.5 NAAQS based upon air quality monitoring data from monitors for calendar years 2011-2013. See 80 FR 2206 (January 15, 2015). EPA's January 15, 2015, rulemaking also described a process by which EPA would evaluate any complete, quality-assured, certified air quality monitoring data from 2014 that a state submitted for consideration before February 27, 2015. EPA stated that it would evaluate whether, with the inclusion of certified 2014 data, the 3-year design value for 2012-2014 suggests that a change in the initial designation would be appropriate for an area. If EPA agreed that a change in the initial designation would be appropriate, EPA would withdraw the designation announced in the January 15, 2015, document for such area before the effective date and issue another designation reflecting the inclusion of 2014 data.

            1 For the initial PM area designations in 2014 (for the 2012 annual PM2.5 NAAQS), EPA used a designation category of “unclassifiable/attainment” for areas that had monitors showing attainment of the standard and were not contributing to nearby violations and for areas that did not have monitors but for which EPA had reason to believe were likely attaining the standard and not contributing to nearby violations. EPA used the category “unclassifiable” for areas in which EPA could not determine, based upon available information, whether or not the NAAQS was being met and/or EPA had not determined the area to be contributing to nearby violations. EPA reserves the “attainment” category for when EPA redesignates a nonattainment area that has attained the relevant NAAQS and has an approved maintenance plan.

        In a follow-up designation action published on April 7, 2015 (80 FR 18535), EPA designated five areas as unclassifiable/attainment in Georgia, including two neighboring counties in the bordering states of Alabama and South Carolina, that were initially deferred in EPA's January 15, 2015, rulemaking. In the same action, EPA changed the designations for one area in Ohio, two areas in Pennsylvania, and one bi-state area with portions in Kentucky and Ohio from nonattainment to unclassifiable/attainment. The bi-state Louisville Area was changed from nonattainment to unclassifiable.

        EPA initially designated the bi-state Louisville Area as nonattainment in its January 15, 2015, rulemaking based on ambient air quality data collected from 2011-2013. In that time period, a monitor in Clark County, Indiana, showed a violation of the 2012 PM2.5 NAAQS. Per its policy, EPA explained that it would change the designation for the Area if data showed that the monitor in Clark County, Indiana, met the 2012 PM2.5 NAAQS for the design value period 2012-2014, and Indiana elected to early certify 2014 ambient air quality data. Indiana submitted complete, quality-assured, and certified 2014 data from the ambient air quality monitor in Clark County, Indiana, by the prescribed deadline of February 27, 2015, showing that the monitor was attaining the NAAQS. However, as noted in the final technical support document (TSD) for the Area included in the docket for the January 15, 2015, rulemaking,2

           EPA explained that because air quality data in the Jefferson County, Kentucky portion of the Area were invalid due to issues with the collection and analysis of PM2.5 filter-based samples, EPA could only change the designation to unclassifiable. Therefore, EPA changed the designation of the Area from nonattainment to unclassifiable in the action published on April 15, 2015.

            2 Available in the January 15, 2015, rulemaking docket as document number EPA-HQ-OAR-2012-0918-0322.

        II. What are the criteria for redesignating an area from unclassifiable to unclassifiable/attainment?
        Section 107(d)(3) of the CAA provides the framework for changing the area designations for any NAAQS pollutants. Section 107(d)(3)(A) provides that the Administrator may notify the Governor of any state that the designation of an area should be revised “on the basis of air quality data, planning and control considerations, or any other air quality-related considerations the Administrator deems appropriate.” The Act further provides in section 107(d)(3)(D) that even if the Administrator has not notified a state Governor that a designation should be revised, the Governor of any state may, on the Governor's own motion, submit a request to revise the designation of any area, and the Administrator must approve or deny the request.
        When approving or denying a request to redesignate an area, EPA bases its decision on the air quality data for the area as well as the considerations under section 107(d)(3)(A).3
           In keeping with section 107(d)(1)(A), areas that are redesignated to unclassifiable/attainment must meet the requirements for attainment areas and thus must meet the relevant NAAQS. In addition, the area must not contribute to ambient air quality in a nearby area that does not meet the NAAQS. The relevant monitoring data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in the EPA Air Quality System (AQS) database. The designated monitors generally should have remained at the same location for the duration of the monitoring period.4

            3 While CAA section 107(d)(3)(E) also lists specific requirements for redesignations, those requirements only apply to redesignations of nonattainment areas to attainment and therefore are not applicable in the context of a redesignation of an area from unclassifiable to unclassifiable/attainment.

            4 See Memorandum from John Calcagni, Director, EPA Air Quality Management Division, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” (September 4, 1992).

        III. What is EPA's rationale for proposing to redesignate the area?

        In order to redesignate the Area from unclassifiable to unclassifiable/attainment for the 2012 primary annual PM2.5 NAAQS, the 3-year average of annual arithmetic mean concentrations (i.e., design value) over the most recent 3-year period must be less than or equal to 12.0 µg/m3 at all monitoring sites in the Area over the full 3-year period, as determined in accordance with 40 CFR 50.18 and Appendix N of Part 50. EPA reviewed PM2.5 monitoring data from monitoring stations in the bi-state Louisville Area for the 2012 primary annual PM2.5 NAAQS for the 3-year period from 2014-2016. These data have been quality-assured, certified, and recorded in AQS by Kentucky and Indiana, and the monitoring locations have not changed during the monitoring period. As summarized in Table 1, the design values for all monitors in the Area for the 2014-2016 period are below the 2012 primary annual PM2.5 NAAQS.

          Table 1—2012 Annual PM2.5 Design Values for Monitors in the Bi-State Louisville Area for 2014-2016

            County
            Monitoring site

            2014-2016 design
              value
              (μg/m3)

            Clark County, IN
            180190006180190008

            10.68.7

            Floyd County, IN
            180431004
            9.3

            Jefferson County, KY
            211110043211110051
              211110067
              211110075

            10.410.3
              9.5
              10.4

        Because the 3-year design values, based on complete, quality-assured data, demonstrate that the Area meets the 2012 primary annual PM2.5 standard, EPA is proposing to redesignate the Kentucky portion of the Louisville Area from unclassifiable to unclassifiable/attainment for this NAAQS.5

            5 The State of Indiana has not yet submitted a redesignation request for its portion of the Louisville Area.

        IV. Proposed Action

        EPA is proposing to approve Kentucky's May 4, 2018, request to redesignate the Kentucky portion of the bi-state Louisville Area from unclassifiable to unclassifiable/attainment for the 2012 primary annual PM2.5 NAAQS. If finalized, approval of the redesignation request would change the legal designation, found at 40 CFR part 81, of the portion of Bullitt County located in the Area and Jefferson County, Kentucky, from unclassifiable to unclassifiable/attainment for the 2012 primary annual PM2.5 NAAQS.
        V. Statutory and Executive Order Reviews
        Under the CAA, redesignation of an area to unclassifiable/attainment is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to unclassifiable/attainment does not in and of itself create any new requirements. Accordingly, this proposed action merely proposes to redesignate an area to unclassifiable/attainment and does not impose additional requirements. For that reason, this proposed action:
        • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
        • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because redesignations are exempted under Executive Order 12866;

        • 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
        • Will not have disproportionate human health or environmental effects under Executive Order 12898 (59 FR 7629, February 16, 1994).
        The proposed action is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

          List of Subjects in 40 CFR Part 81
          Environmental protection, Air pollution control.

          Authority:
          42 U.S.C. 7401, et seq.

          Dated: May 15, 2018.
          Onis “Trey” Glenn, III,
          Regional Administrator, Region 4.

      [FR Doc. 2018-11567 Filed 5-29-18; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [FWS-R1-ES-2009-0043; MO 92210-0-0008 B2]
        Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Mountain Whitefish in the Big Lost River, Idaho, as Endangered or Threatened; Correction

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Notice of 12-month petition finding; correction.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service), announced in our 12-month finding on a petition to list the mountain whitefish (Prosopium williamsoni) in the Big Lost River, Idaho, under the Endangered Species Act of 1973, as amended (Act), that listing was not warranted. Our finding published in the Federal Register on April 6, 2010, but two figures were omitted from the document. We now provide those two figures.

          ADDRESSES:
          Our finding is available on the Internet at http://www.fws.gov/idaho, and also at http://www.regulations.gov at Docket No. FWS-R1-ES-2009-0043. Supporting documentation we used in preparing the finding is available for public inspection, by appointment, during normal business hours at the U.S. Fish and Wildlife Service, Idaho Fish and Wildlife Office, 1387 S. Vinnell Way, Room 368, Boise, ID 83709. We will accept any new information, materials, comments, or questions concerning this finding at any time at this address.

          FOR FURTHER INFORMATION CONTACT:
          Acting State Supervisor, Idaho Fish and Wildlife Office (see
            ADDRESSES); by telephone at 208-378-5243; and by facsimile at 208-378-5262. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

        SUPPLEMENTARY INFORMATION:

        Our announcement of a 12-month finding on a petition to list the mountain whitefish (Prosopium williamsoni) in the Big Lost River, Idaho, under the Act (16 U.S.C. 1531 et seq.) published in the Federal Register on April 6, 2010 (75 FR 17352), with minor errors we now correct in this document.

        In the published notice, Figure 1 is mentioned two-thirds the way down the first column of page 17353, but the figure itself is omitted. Under the header Species Distribution and Habitat, the figure should be inserted at the end of the first paragraph.

        In the published notice, Figure 2 is mentioned two-thirds the way down the second column of page 17353, but the figure itself is omitted. Under the header Distribution and Habitat Within the Big Lost River Basin, the figure should be inserted at the end of the paragraph.
        Both figures are provided below.
        BILLING CODE 4310-55-P

          EP22AP10.000

          EP22AP10.001

          Dated: April 16, 2010.
          Sara Prigan,
          Federal Register Liaison, U.S. Fish and Wildlife Service.

      [FR Doc. 2010-9247 Filed 4-21-10; 8:45 am]
      BILLING CODE 4310-55-C


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 622
        [Docket No. 101124579-1088-01]
        RIN 0648-BA51
        Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery Off the Southern Atlantic States; Red Snapper Management Measures

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments.

          SUMMARY:
          NMFS issues this proposed rule that would implement a regulatory amendment (Regulatory Amendment 10) to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP), as prepared by the South Atlantic Fishery Management Council (Council). This proposed rule would remove the snapper-grouper area closure implemented through Amendment 17A to the FMP. The intended effect of this proposed rule is to help achieve optimum yield (OY) for the fishery and minimize socio-economic impacts to snapper-grouper fishermen, without increasing the risk of the red snapper resource experiencing overfishing.

          DATES:
          Written comments must be received on or before March 21, 2011.

          ADDRESSES:
          You may submit comments on the proposed rule identified by 0648-BA51 by any of the following methods:
          • Electronic submissions: Submit electronic comments via the Federal e-Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
          • Mail: Rick DeVictor, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.

            Instructions: All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

          To submit comments through the Federal e-rulemaking portal: http://www.regulations.gov, enter “NOAA-NMFS-2010-0249” in the keyword search, then check the box labeled “Select to find documents accepting comments or submissions”, then select “Send a comment or submission”. NMFS will accept anonymous comments (enter N/A in the required field if you wish to remain anonymous). You may submit attachments to electronic comments in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.
          Comments received through means not specified in this rule will not be considered.

          Copies of the regulatory amendment, which includes an environmental assessment and a regulatory impact review, may be obtained from the South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; telephone 843-571-4366; fax 843-769-4520; e-mail safmc@safmc.net; or may be downloaded from the Council's Web site at http://www.safmc.net/.

          FOR FURTHER INFORMATION CONTACT:
          Rick DeVictor, 727-824-5305.

        SUPPLEMENTARY INFORMATION:
        The snapper-grouper fishery of the South Atlantic is managed under the FMP. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
        Background
        The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the OY from Federally managed fish stocks. These mandates are intended to ensure fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems. To further this goal, the Magnuson-Stevens Act requires fishery managers to end overfishing of stocks while achieving OY from the fishery, and to minimize bycatch and bycatch mortality to the extent practicable.

        In the South Atlantic, the red snapper stock is currently overfished and undergoing overfishing. The stock status was determined through a Southeast Data Assessment and Review (SEDAR) benchmark stock assessment for red snapper, SEDAR 15, which was completed in February 2008. Based on this stock assessment, Amendment 17A to the FMP was developed to end the overfishing of red snapper and rebuild the stock. The final rule to implement Amendment 17A was published in the Federal Register on December 9, 2010 (75 FR 76874). The management measures implemented through the final rule included a prohibition on the harvest and possession of red snapper in or from the South Atlantic exclusive economic zone (EEZ) (and in State or Federal waters for a vessel with a Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper), a requirement for the use of non-stainless steel circle hooks when fishing for snapper-grouper species with hook-and-line gear north of 28° N. latitude in the South Atlantic EEZ, and an area closure for South Atlantic snapper-grouper. The snapper-grouper area closure includes 4,827 square miles (7,768 square km) off the coasts of southern Georgia and northeast Florida where the harvest and possession of snapper-grouper species would be prohibited, except when fishing with black sea bass pot gear or spearfishing gear for species other than red snapper.
        Through the SEDAR 24 benchmark stock assessment, updated information on the status of the red snapper stock became available in late October 2010. The SEDAR 24 assessment incorporated the high landings from recent years, as well as new information regarding the selectivity of older and larger red snapper to hook-and-line gear, post-release mortality data, and methodologies for estimating historic landings of red snapper. The Council's Scientific and Statistical Committee (SSC) reviewed the new assessment in November 2010 and endorsed model runs in the assessment that suggest the snapper-grouper area closure could be modified without compromising the objective of ending red snapper overfishing. Modifying the area closure would also minimize negative socio-economic effects on snapper-grouper fishing communities. The SEDAR 24 assessment has determined, similar to SEDAR 15, that the red snapper stock is overfished and undergoing overfishing, however, the rate of overfishing found in SEDAR 24 is less than the rate of overfishing found in the previous stock assessment (SEDAR 15).
        Given the information in the new stock assessment, an emergency rule to delay the effective date of the snapper-grouper area closure was published on December 9, 2010 (75 FR 76890). The emergency rule delayed the effective date of the area closure from January 3, 2011, until June 1, 2011, with a possible 186-day extension, unless superseded by subsequent rulemaking. A correction to the emergency rule was published on December 20, 2010, to correct a previous error (75 FR 79309). The delayed effective date provided the Council time to respond to the new scientific information from the SEDAR 24 benchmark stock assessment. The Council voted to approve Regulatory Amendment 10 to modify the area closure implemented through Amendment 17A to the FMP, based upon the new stock assessment information.
        Regulatory Amendment 10 evaluates alternatives to the snapper-grouper area closure approved in Amendment 17A to the FMP. These alternatives include decreases in the size of the area closure, decreases in the duration of the area closure, and the removal of the area closure entirely.
        At its December 2010 meeting, the Council voted to remove the snapper-grouper area closure entirely as their preferred alternative in Regulatory Amendment 10.
        Regulatory Amendment 10 presents information from SEDAR 24 that suggests the red snapper fishing moratorium in the South Atlantic has been more effective in reducing the mortality of red snapper than previously determined from the results of SEDAR 15. The analysis contained in the regulatory amendment also evaluates fishing effort reduction, in addition to the reduction in red snapper removals in 2010 as reported through the Marine Recreational Fishing Statistics Survey (MRFSS). Evidence provided by MRFSS suggests effort has been reduced by 33 percent and total red snapper removals in pounds have been reduced by 81 percent when 2010 data are compared to the 2007-2009 baseline data. The required reduction in removals of red snapper to end overfishing has been determined to be 70 to 75 percent.
        When recent reductions in fishing effort are considered, the red snapper moratorium, implemented through Amendment 17A to the FMP, is projected to end red snapper overfishing and rebuild the stock without the additional implementation of the snapper-grouper area closure. Therefore, the proposed action in Regulatory Amendment 10 to remove the snapper-grouper area closure approved in Amendment 17A to the FMP seeks to prevent significant direct economic loss to snapper-grouper fishermen and achieve OY for the fishery, without subjecting the red snapper resource to overfishing.
        Classification
        Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the regulatory amendment, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
        This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

        NMFS prepared an initial regulatory flexibility analysis (IRFA), as required by section 603 of the Regulatory Flexibility Act, for this proposed rule. The IRFA describes the economic impact that this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the objectives of, and legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A copy of the full analysis is available from the Council (see
          ADDRESSES). A summary of the IRFA follows.

        The rule proposes to remove the snapper-grouper area closure provision implemented through Amendment 17A to the FMP. This provision is a year-round closure, i.e., prohibition of harvest, retention, and possession of any species in the snapper-grouper fishery management unit, except for snapper-grouper harvested with spearfishing gear or allowed to be harvested with a sea bass pot, within an area corresponding to commercial logbook grids (cells) 2880, 2980, and 3080 for depths from 98 ft (30 m) to 240 ft (73 m).
        The Magnuson-Stevens Act provides the statutory basis for the proposed rule.
        No duplicative, overlapping, or conflicting Federal rules have been identified.
        The proposed rule would not establish any new reporting, record-keeping, or other compliance requirements.

        This proposed rule is expected to directly affect commercial harvesting and for-hire fishing operations. The Small Business Administration has established size criteria for all major industry sectors in the U.S. including fish harvesters and for-hire operations. A business involved in fish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $4.0 million (NAICS code 114111, finfish fishing) for all its affiliated operations worldwide. For for-hire vessels, the other qualifiers apply and the annual receipts threshold is $7.0 million (NAICS code 713990, recreational industries).

        From 2007-2009, an average of 895 vessels-per-year had valid permits to operate in the commercial snapper-grouper fishery. Of these vessels, 751 held transferable permits and 144 held non-transferable permits. On average, 797 vessels landed snapper-grouper species, generating dockside revenues of approximately $14.514 million (2008 dollars). Each vessel, therefore, generated an average of approximately $18,000 annually in gross revenues from snapper-grouper. Gross dockside revenues by State are distributed as follows: $4.054 million in North Carolina, $2.563 million in South Carolina, $1.738 million in Georgia/Northeast Florida, $3.461 million in central and southeast Florida, and $2.695 million in the Florida Keys. Vessels that operate in the snapper-grouper fishery may also operate in other fisheries, the revenues of which cannot be determined with available data and are not reflected in these totals.
        Based on revenue information, all commercial vessels affected by the proposed rule can be considered small entities.
        From 2007-2009, an average of 1,797 vessels had valid permits to operate in the snapper-grouper for-hire fishery, of which 82 are estimated to have operated as headboats. The for-hire fleet is comprised of charterboats, which charge a fee on a vessel basis, and headboats, which charge a fee on an individual angler (head) basis. The charterboat annual average gross revenue is estimated to range from approximately $62,000-$84,000 for Florida vessels, $73,000-$89,000 for North Carolina vessels, $68,000-$83,000 for Georgia vessels, and $32,000-$39,000 for South Carolina vessels. For headboats, the corresponding estimates are $170,000-$362,000 for Florida vessels, and $149,000-$317,000 for vessels in the other States.
        Based on these average revenue figures, all for-hire operations that would be affected by the proposed rule can be considered small entities.
        Some fleet activity, i.e., multiple vessels owned by a single entity, may exist in both the commercial and for-hire snapper-grouper sectors but its extent is unknown, and all vessels are treated as independent entities in this analysis.
        The proposed rule is expected to directly affect all Federally permitted commercial vessels that operate in the South Atlantic snapper-grouper fishery as well as for-hire vessels operating out of northeast Florida and Georgia. All directly affected entities have been determined, for the purpose of this analysis, to be small entities. Therefore, it is determined that the proposed action will affect a substantial number of small entities.
        Because all entities that are expected to be affected by the proposed rule are considered small entities, the issue of disproportional effects on small versus large entities does not arise in the present case.
        The economic analysis done for the proposed rule estimated the changes in net operating revenues to commercial and for-hire vessels. These changes were estimated assuming the closure provision, within Amendment 17A to the FMP, commenced on January 3, 2011, although its implementation has been delayed via emergency rule until June 1, 2011, unless superseded by subsequent rulemaking. For the current analysis, net operating revenue was equated to profit.
        The proposed action to eliminate the area closure that was adopted in Amendment 17A to the FMP is estimated to have a non-uniform change in the short-term profits of commercial vessels operating in the South Atlantic snapper-grouper fishery. Annual profits would increase approximately by $358,000 for vessels in northeast Florida and Georgia and by $103,000 for vessels in southeast Florida. On the other hand, annual profits would decrease approximately by $241,000 for vessels in North Carolina, by $129,000 in South Carolina, and by $2,000 for vessels in the Florida Keys. The net effect of the proposed action on commercial vessels as a whole would be an average increase in annual profits of approximately $88,000. Vessels fishing with vertical-line gear are the ones most affected by the proposed action.
        The differential effects of the proposed action on commercial vessels in various geographic areas in the South Atlantic are mainly determined by the manner in which quotas for certain snapper-grouper species, such as gag, red grouper, black grouper, and vermilion snapper, would be met. Although the proposed action would not close very specific areas off the coasts of Georgia and northeast Florida, commercial vessels operating in other areas would also be affected via the possible quota closures of some snapper-grouper species. Opening the areas closed under Amendment 17A would allow commercial vessels from southeast Florida, northeast Florida, and Georgia to harvest more snapper-grouper species than they may have under the closure, such as vermilion snapper, gag, and red grouper, and this would tend to increase their profits. Such a harvest increase, however, may lead to reaching certain snapper-grouper quotas sooner, which could result in lower harvest by vessels in North Carolina, South Carolina, and the Florida Keys. These vessels would then experience reductions in their profits. The more restrictive quotas are those for vermilion snapper and gag. The quota for gag is especially critical, because it also serves as a trigger mechanism for closing the harvest of all shallow-water groupers.
        For-hire vessels operating in northeast Florida and Georgia are expected to be the only for-hire vessels affected by the proposed action. This is based on the extent of for-hire vessel fishing activities in the subject three statistical areas set for closure under Amendment 17A to the FMP. As a result of the proposed action in this regulatory amendment, annual profits are expected to increase by $300,000 for charterboats and $1,000,000 for headboats.
        Eleven alternatives, including the proposed action, were considered for the area closure. The first alternative to the proposed action is the no action alternative. Among the alternatives, this would result in the largest negative economic effects on small entities. The second alternative to the proposed action is a May-October closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m). This alternative would result in lower profit increases for both the commercial and for-hire vessels than the proposed action. The third alternative to the proposed action is a May-August closure of cells 2880, 2980, and 3080 in depths from 98 ft (30 m) to 240 ft (73 m). This alternative would result in a lower profit increase to the for-hire vessels and a slightly higher profit increase to commercial vessels than the proposed action. The overall net effect of this alternative would be a lower profit increase than that under the proposed action.

        The fourth alternative to the proposed action is a July-December closure of cells 2880, 2980, and 3080 in depths from 98 ft (30 m) to 240 ft (73 m). This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action. The fifth alternative to the proposed action is a May-December closure of cells 2880, 2980, and 3080 in depths from 98 ft (30 m) to 240 ft (73 m). This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action. The sixth alternative to the proposed action is a May-December closure of cells 2880, 2980, and 3080 in depths from 66 ft (20 m) to 240 ft (73 m) for the first year and a May-October closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the second and consecutive years. This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action.
        The seventh alternative to the proposed action is a May-October closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the first year and a June-July closure of cell 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the second and consecutive years. This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action. The eighth alternative to the proposed action is a May-October closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the first year and a July closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the second and consecutive years. This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action. The ninth alternative to the proposed action is a July-December closure of cells 2880, 2980, and 3080 in depths from 98 ft (30 m) to 240 ft (73 m) for the first year and a January-April closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the second and consecutive years. This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action.
        The tenth alternative to the proposed action is a May-December closure of cells 2880, 2980, and 3080 in depths from 98 ft (30 m) to 240 ft (73 m) for the first year and a January-April closure of cells 2880 and 2980 in depths from 98 ft (30 m) to 240 ft (73 m) for the second and consecutive years. This alternative would result in lower profit increases to the for-hire and commercial vessels than the proposed action.

          List of Subjects in 50 CFR Part 622
          Fisheries, Fishing, Puerto Rico, Reporting and recordkeeping requirements, Virgin Islands.

          Dated: February 14, 2011.
          Samuel D. Rauch III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

        For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

          PART 622—FISHERIES OF THE CARIBBEAN, GULF, AND SOUTH ATLANTIC
          1. The authority citation for part 622 continues to read as follows:

            Authority:
            16 U.S.C. 1801 et seq.

            § 622.35
            [Amended]
            2. In § 622.35, the suspension on paragraph (l) is lifted and paragraph (l) is removed and reserved.

      [FR Doc. 2011-3733 Filed 2-17-11; 8:45 am]
      BILLING CODE 3510-22-P