        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 52
        [EPA-R04-OAR-2012-0323; FRL-9686-7]
        Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes; Tennessee: Bristol; Determination of Attainment for the 2008 Lead Standards

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          On April 4, 2012, the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), submitted a request to EPA to make a determination that the Bristol nonattainment area for the 2008 lead national ambient air quality standards (NAAQS or standard) has attained the 2008 lead NAAQS. In this action, EPA is proposing to determine that the Bristol nonattainment area (hereafter also referred to as the “Bristol Area” or “Area”) has attained the 2008 lead NAAQS. This proposed determination of attainment is based upon complete, quality-assured and certified ambient air monitoring data for the 2009—2011 period showing that the Area has monitored attainment of the 2008 lead NAAQS. EPA is further proposing that, if EPA finalizes this proposed determination of attainment, the requirements for the Area to submit an attainment demonstration, together with reasonably available control measures (RACM), a reasonable further progress (RFP) plan, and contingency measures for failure to meet RFP and attainment deadlines shall be suspended for so long as the Area continues to attain the 2008 lead NAAQS.

          DATES:
          Comments must be received on or before July 16, 2012.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-R04-OAR-2012-0323, by one of the following methods:
          1. www.regulations.gov: Follow the on-line instructions for submitting comments.
          2. Email: R4-RDS@epa.gov.

          3. Fax: (404) 562-9040.
          4. Mail: EPA-R04-OAR-2012-023, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.
          5. Hand Delivery: Lynorae Benjamin, Chief, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

            Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-2012-0323. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at 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 through www.regulations.gov or email, information that you consider to be CBI or otherwise protected. The www.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 www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

            Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., 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 electronically in www.regulations.gov or in hard copy at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

          FOR FURTHER INFORMATION CONTACT:

          Steve Scofield or Richard Wong, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Scofield may be reached by phone at (404) 562-9034 or via electronic mail at scofield.steve@epa.gov. Mr. Wong may be reached by phone at (404) 562-8726 or via electronic mail at wong.richard@epa.gov.

        SUPPLEMENTARY INFORMATION:

          I. What actions is EPA taking?
          II. What is the background for these actions?
          III. Application of EPA's Clean Data Policy to the 2008 Lead NAAQS
          IV. Does the Bristol area meet the 2008 lead NAAQS?
          A. Criteria
          B. Bristol Area Air Quality
          V. What is the effect of these actions?
          VI. Statutory and Executive Order Reviews

        I. What actions is EPA taking?
        EPA is proposing to determine that the Bristol Area (comprising the portion of Sullivan County bounded by a 1.25 kilometer radius surrounding the Universal Transverse Mercator (UTM) coordinates 4042923 meters E, 386267 meters N, Zone 17, which surrounds the Exide Technologies Facility) has attained the 2008 lead NAAQS. This proposal is based upon complete, quality-assured and certified ambient air monitoring data for the 2009-2011 monitoring period that show that the Area has monitored attainment of the 2008 lead NAAQS.
        Further, EPA is proposing that, if this proposed determination of attainment is made final, the requirements for the Bristol Area to submit an attainment demonstration together with RACM, a RFP plan, and contingency measures for failure to meet RFP and attainment deadlines would be suspended for so long as the Area continues to attain the 2008 lead NAAQS. As discussed below, EPA's proposal is consistent with EPA's regulations and with its longstanding interpretation of subpart 1 of part D of the Clean Air Act (CAA or Act).

        If this proposed rulemaking is finalized and EPA subsequently determines, after notice-and-comment rulemaking in the Federal Register, that the Area has violated the 2008 lead NAAQS, the basis for the suspension of these attainment planning requirements would no longer exist for the Bristol Area, and the Area would thereafter have to address such requirements.
        II. What is the background for these actions?

        On November 12, 2008 (73 FR 66964), EPA established a 2008 primary and secondary lead NAAQS at 0.15 micrograms per cubic meter (μg/m3) based on a maximum arithmetic 3-month mean concentration for a 3-year period. See 40 CFR 50.16. On November 22, 2010 (75 FR 71033), EPA published its initial air quality designations and classifications for the 2008 lead NAAQS based upon air quality monitoring data from those monitors for calendar years 2007-2009. These designations became effective on December 31, 2010.1

           The Bristol Area was designated nonattainment for the 2008 lead NAAQS. See 40 CFR 81.343.

            1 EPA completed a second and final round of designations for the 2008 Lead NAAQS on November 22, 2011. See 76 FR 72097. No additional areas in Sullivan County, Tennessee were designated as nonattainment for the 2008 Lead NAAQS.

        On April 4, 2012, the State of Tennessee, through TDEC, submitted a request to EPA to make a determination that the Bristol Area for the 2008 lead NAAQS has attained that standard based on complete, quality-assured, quality-controlled monitoring data from 2009 through 2011.2

            2 This Area has ambient air monitoring data for forty-seven (47) months for the period of February 2008 through December 31, 2011, which show attainment of the 2008 lead NAAQS. Preliminary 2012 data indicates that this Area is continuing to attain the 2008 lead NAAQS.

        III. Application of EPA's Clean Data Policy to the 2008 Lead NAAQS

        Following enactment of the CAA Amendments of 1990, EPA promulgated its interpretation of the requirements for implementing the NAAQS in the general preamble for the Implementation of Title I of the CAA Amendments of 1990 (General Preamble) 57 FR 13498, 13564 (April 16, 1992). In 1995, based on the interpretation of CAA sections 171 and 172, and section 182 in the General Preamble, EPA set forth what has become known as its “Clean Data Policy” for the 1-hour ozone NAAQS. See Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, “RFP, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard” (May 10, 1995). In 2004, EPA indicated its intention to extend the Clean Data Policy to the PM2.5 NAAQS. See Memorandum from Steve Page, Director, EPA Office of Air Quality Planning and Standards, “Clean Data Policy for the Fine Particle National Ambient Air Quality Standards” (December 14, 2004).

        Since 1995, EPA has applied its interpretation under the Clean Data Policy in many rulemakings, suspending certain attainment-related planning requirements for individual areas, based on a determination of attainment. See 60 FR 36723 (July 18, 1995) (Salt Lake and Davis Counties, Utah, 1-hour ozone); 61 FR 20458 (May 7, 1996) (Cleveland Akron-Lorain, Ohio, 1-hour ozone); 61 FR 31832 (June 21, 1996) (Grand Rapids, Michigan, 1-hour ozone); 65 FR 37879 (June 19, 2000) (Cincinnati-Hamilton, Ohio-Kentucky, 1-hour ozone); 66 FR 53094 (October 19, 2001) (Pittsburgh-Beaver Valley, Pennsylvania, 1-hour ozone); 68 FR 25418 (May 12, 2003) (St Louis, Missouri, 1-hour ozone); 69 FR 21717 (April 22, 2004) (San Francisco Bay Area, 1-hour ozone), 75 FR 6570 (February 10, 2010) (Baton Rouge, Louisiana, 1-hour ozone), 75 FR 27944 (May 19, 2010) (Coso Junction, California, PM10).

        EPA also incorporated its interpretation under the Clean Data Policy in implementation rules. See Clean Air Fine Particle Implementation Rule, 72 FR 20586 (April 25, 2007); Final Rule To Implement the 8-Hour Ozone National Ambient Air Quality Standard—Phase 2, 70 FR 71612 (November 29, 2005). The Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upheld EPA's rule embodying the Clean Data Policy for the 1997 8-hour ozone standard. NRDC v. EPA, 571 F.3d 1245 (D.C. Cir. 2009). Other courts have reviewed and considered rulemakings applying EPA's Clean Data Policy, and have consistently upheld them. Sierra Club v. EPA, 99 F. 3d 1551 (10th Cir. 1996); Sierra Club v. EPA, 375 F. 3d 537 (7th Cir. 2004); Our Children's Earth Foundation v. EPA, No. 04-73032 (9th Cir. June 28, 2005 (Memorandum Opinion)), Latino Issues Forum v. EPA, Nos. 06-75831 and 08-71238 (9th Cir. March 2, 2009 (Memorandum Opinion)). EPA sets forth below a brief explanation of the Clean Data Policy. EPA also incorporates the discussions of its interpretation set forth in prior rulemakings, including the PM2.5 implementation rulemaking. See also 75 FR 31288 (June 3, 2010) (Rhode Island, 1997 8-hour ozone), 75 FR 62470 (October 12, 2010) (Knoxville, Tennessee, 1997 8-hour ozone), 75 FR 53219 (August 31, 2010) (Greater Connecticut Area, 1997 8-hour ozone), 75 FR 54778 (September 9, 2010) (Baton Rouge, Louisiana, 1997 8-hour ozone), 75 FR 64949 (October 21, 2010) (Providence, Rhode Island, 1997 8-hour ozone), 76 FR 11080 (March 1, 2011) (Milwaukee-Racine and Sheboygan Areas, 1997 8-hour ozone), 76 FR 31273 (May 31, 2011) (Pittsburgh-Beaver Valley, 1997 8-hour ozone), 76 FR 33647 (June 9, 2011) (St. Louis, Missouri-Illinois, 1997 8-hour ozone), 76 FR 7145 (November 15, 2011) (Charlotte, North Carolina-South Carolina, 1997 8-hour ozone), 77 FR 31496 (May 29, 2012) (Boston-Lawrence-Worchester, Massachusetts, 1997 8-hour ozone). See also, 75 FR 56 (January 4, 2010) (Greensboro-Winston-Salem-High Point, 1997 PM2.5), 75 FR 230 (January 5, 2010) (Hickory-Morganton, Lenoir, 1997 PM2.5), 75 FR 57186 (September 20, 2010) (Birmingham, Alabama, 2006 PM2.5) 76 FR 12860 (March 9, 2011) (Louisville, Kentucky-Indiana, 1997 PM2.5), 76 FR 1850 (April 5, 2011) (Rome, Georgia, 1997 PM2.5), 76 FR 31239 (May 31, 2011) (Chattanooga, Tennessee-Georgia-Alabama, 1997 PM2.5), 76 FR 31858 (June 2, 2011) (Macon, Georgia, 1997 PM2.5), 76 FR 36873 (June 23, 2011) (Atlanta, Georgia 1997 PM2.5), 76 FR 38023 (June 29, 2011) (Birmingham, Alabama 1997 PM2.5), 76 FR 5542 (September 7, 2011) (Huntington-Ashland, West Virginia-Kentucky-Ohio, 1997 PM2.5), 76 FR 60373 (September 29, 2011) (Cincinnati, Ohio-Kentucky-Indiana, 1997 PM2.5), (November 18, 2011) (Charleston, West Virginia, 2006 PM2.5), 77 FR 18922 (March 29, 2012) (Harrisburg-Lebonon-Carlisle-York Allentown, Johnstown and Lancaster, 1997 PM2.5)
        The Clean Data Policy represents EPA's interpretation that certain requirements of subpart 1 of part D of the Act are by their terms not applicable to areas that are attaining the NAAQS.3
           As explained below, the specific requirements that are inapplicable to an area attaining the standard are the requirements to submit a SIP that provides for: Attainment of the NAAQS; implementation of all reasonably available control measures; reasonable further progress; and implementation of contingency measures for failure to meet deadlines for RFP and attainment.

            3 This discussion refers to subpart 1 because subparts 1 and 5 contain the requirements relating to attainment of the lead NAAQS.

        CAA section 172(c)(1), the requirement for an attainment demonstration, provides in relevant part that SIPs “shall provide for attainment of the [NAAQS].” EPA has interpreted this requirement as not applying to areas that have attained the standard. If an area has attained the standard, there is no need to submit a plan demonstrating how the area will reach attainment. In the General Preamble (57 FR 13564), EPA stated that no other measures to provide for attainment would be needed by areas seeking redesignation to attainment since “attainment will have been reached.” See also Memorandum from John Calcagni, “Procedures for Processing Requests to Redesignate Areas to Attainment,” (September 4, 1992), at page 6.

        A component of the attainment plan specified under section 172(c)(1) is the requirement to provide for “the implementation of all reasonably available control measures as expeditiously as practicable” (RACM). Since RACM is an element of the attainment demonstration, see General Preamble (57 FR 13560), for the same reason the attainment demonstration no longer applies by its own terms, RACM also no longer applies. Furthermore, EPA has consistently interpreted this provision to require only implementation of potential RACM measures that could advance attainment.4

           Thus, where an area is already attaining the standard, no additional RACM measures are required. EPA' s interpretation that the statute requires only implementation of RACM measures that would advance attainment was upheld by the United States Court of Appeals for the Fifth Circuit (Sierra Club v. EPA, 314 F. 3d 735, 743-745, 5th Cir. 2002) and by the United States Court of Appeals for the D.C. Circuit (Sierra Club v. EPA, 294 F. 3d 155, 162-163, D.C. Cir. 2002). See also the final rulemakings for Pittsburgh-Beaver Valley, Pennsylvania, 66 FR 53096 (October 19, 2001) and St. Louis, 68 FR 25418 (May 12, 2003).

            4 This interpretation was adopted in the General Preamble, see 57 FR 13498, and has been upheld as applied to the Clean Data Policy, as well as to nonattainment SIP submissions. See
            NRDC v. EPA, 571 F.3d 1245 (D.C. Cir. 2009); Sierra Club v. EPA, 294 F.3d 155 (D.C. Cir. 2002).

        CAA section 172(c)(2) provides that state implementation plan (SIP) provisions in nonattainment areas must require “reasonable further progress.” The term “reasonable further progress” is defined in section 171(1) as “such annual incremental reductions in emissions of the relevant air pollutant as are required by this part or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable NAAQS by the applicable date.” Thus, by definition, the “reasonable further progress” provision requires only such reductions in emissions as are necessary to attain the NAAQS. If an area has attained the NAAQS, the purpose of the RFP requirement has been fulfilled, and since the area has already attained, showing that the State will make RFP towards attainment “[has] no meaning at that point.” General Preamble, 57 FR 13498, 13564 (April 16, 1992).

        CAA section 172(c)(9) provides that SIPs in nonattainment areas “shall provide for the implementation of specific measures to be undertaken if the area fails to make reasonable further progress, or to attain the [NAAQS] by the attainment date applicable under this part. Such measures shall be included in the plan revision as contingency measures to take effect in any such case without further action by the State or [EPA].” This contingency measure requirement is inextricably tied to the reasonable further progress and attainment demonstration requirements. Contingency measures are implemented if reasonable further progress targets are not achieved, or if attainment is not realized by the attainment date. Where an area has already achieved attainment by the attainment date, it has no need to rely on contingency measures to come into attainment or to make further progress to attainment. As EPA stated in the General Preamble: “The section 172(c)(9) requirements for contingency measures are directed at ensuring RFP and attainment by the applicable date.” See 57 FR 13564. Thus these requirements no longer apply when an area has attained the standard.
        It is important to note that should an area attain the lead standards based on 3 years of data, its obligation to submit an attainment demonstration and related planning submissions is suspended only for so long as the area continues to attain the standard. If EPA subsequently determines, after notice-and-comment rulemaking, that the Area has violated the 2008 lead NAAQS, the requirements for the State to submit a SIP to meet the previously suspended requirements would be reinstated. It is likewise important to note that the area remains designated nonattainment pending a further redesignation action.
        IV. Does the Bristol area meet the 2008 lead NAAQS?
        A. Criteria
        Today's proposed rulemaking assesses whether Bristol Area has attained the 2008 Lead NAAQS, based on the most recent 3 years of quality-assured data. The Bristol Area comprises the portion of Sullivan County bounded by a 1.25 kilometer radius surrounding the UTM coordinates 4042923 meters E, 386267 meters N, Zone 17, which surrounds the Exide Technologies Facility.
        Under EPA regulations at 40 CFR 50.16, the 2008 primary and secondary lead standards are met when the maximum arithmetic 3-month mean concentration for a 3-year period, as determined in accordance with 40 CFR part 50, Appendix R, is less than or equal to 0.15 µg/m3 at all relevant monitoring sites in the subject area.
        B. Bristol Area Air Quality

        EPA has reviewed the ambient air monitoring data for the Bristol Area in accordance with the provisions of 40 CFR part 50, Appendix R. All data considered are complete, quality-assured, certified, and recorded in EPA's Air Quality System (AQS) database. This review addresses air quality data collected in 3-year period of 2009-2011 which are the most recent quality-assured data available.
        40 CFR part 58, Appendix D, Section 4.5, states that “At a minimum, there must be one source-oriented State and Local Air Monitoring Station site located to measure the maximum Pb [lead] concentration in ambient air resulting from each non-airport Pb source which emits 0.50 or more tons per year * * *.” The Exide Technologies facility in Bristol is responsible for operating the monitors that meet this requirement. EPA's review shows that Exide has been exceeding the minimum monitoring requirement of one monitor, and is currently operating three Federal reference method (FRM) source-oriented monitors at the facility, which meet the quality assurance requirements of 40 CFR part 58, Appendix A. In addition, the State of Tennessee is also operating one additional source-oriented FRM monitor (AQS ID 47-163-3004, identified in Table 1) at the Exide facility. The State's monitor originally operated from January 1, 2009 through December 31, 2009 (AQS ID 47-163-4002). Beginning January 1, 2010, Tennessee's monitor was relocated 0.3 miles to its current location, approximately 10 feet from Exide's design value monitor (47-163-3001), which is an area of expected maximum concentration at the site.
        Table 1 shows the 2009-2011 design values at the Bristol Area monitors (the metrics calculated in accordance with 40 CFR part 50, Appendix R, for determining compliance with the NAAQS) for the 2008 lead NAAQS. It also shows the maximum 3-month rolling average for each individual year.

          Table 1—Design Value for Monitors in the Bristol Nonattainment Area for the 2008 Lead NAAQS

            Location
            AQS site ID
            2009 Max 3-month rolling avg(µg/m3)

            2010 Max 3-month rolling avg(µg/m3)

            2011 Max 3-month rolling avg(µg/m3)

            2009-2011design value
              (µg/m3)

            364 Exide Drive

              5 47-163-3001
            0.09
            0.08
            0.06
            0.09

            47-163-3002
            0.06
            0.04
            0.04
            0.06

            47-163-3003
            0.06
            0.04
            0.05
            0.06

            47-163-3004

            0.05
            0.08

            47-163-4002
            0.04

        EPA's review of these data indicates that the Bristol Area has attained and continues to attain the 2008 Lead NAAQS, with a design value of 0.09 µg/m3 for the period of 2009-2011. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

            5 According to 40 CFR 58.12(b) “For Pb manual methods, at least one 24-hour sample must be collected every 6 days except during periods or seasons exempted by the Regional Administrator.” All three Exide monitors met and exceeded this requirement, and collected a sample every three days. EPA also publishes an annual recommended national sampling calendar, which contains suggested days of the week for sampling. While this schedule is recommended, it is not a CFR requirement. From March 30, 2011-November 23, 2011, the Exide facility's monitors inadvertently operated on a schedule that deviated from the recommended national schedule by one day of the week. However, since the monitors still collected a sample every six days, the data collection requirements were met by all three Exide monitors for the Area. EPA has thus counted the samples collected using the alternate sampling schedule as creditable samples and calculated valid design values supporting a clean data determination for the Area.

        V. What is the effect of these actions?

        EPA is proposing to determine that the Bristol Area has attained the 2008 lead NAAQS, based on complete, quality-assured and certified data for 2009-2011. Preliminary data available for 2012 indicates that the area continues to be in attainment. EPA further proposes that, if its proposed determination of attainment is made final, the requirements for the Bristol Area to submit an attainment demonstration and associated RACM, a RFP plan, contingency measures, and any other planning SIPs related to attainment of the 2008 lead NAAQS would be suspended for so long as the Area continues to attain the 2008 lead NAAQS. EPA's proposal is consistent and in keeping with its long-held interpretation of CAA requirements, as well as with EPA's regulations for similar determinations for ozone (see 40 CFR 51.918) and fine particulate matter (see 40 CFR 51.1004(c)). As described below, any such determination would not be equivalent to the redesignation of the Area to attainment for the 2008 Lead NAAQS.
        Finalizing this proposed action would not constitute a redesignation of the Area to attainment of the 2008 Lead NAAQS under section 107(d)(3) of the CAA. Further, finalizing this proposed action does not involve approving a maintenance plan for the Area as required under section 175A of the CAA, nor would it find that the Area has met all other requirements for redesignation. Even if EPA finalizes the proposed action, the Bristol Area would remain designated nonattainment for the 2008 Lead NAAQS until such time as EPA determines that the Area meets the CAA requirements for redesignation to attainment and takes action to redesignate the Area.

        If the Bristol Area continues to monitor attainment of the 2008 lead NAAQS, EPA proposes that the requirements for the Bristol Area to submit an attainment demonstration and associated RACM, a RFP plan, contingency measures, and any other planning SIPs related to attainment of the annual PM2.5 NAAQS will remain suspended. If this proposed rulemaking is finalized and EPA subsequently determines, after notice-and-comment rulemaking in the Federal Register, that the Area has violated the 2008 Lead NAAQS, the basis for the suspension of these attainment planning requirements would no longer exist for the Bristol Area, and the Area would thereafter have to address such requirements.
        VI. Statutory and Executive Order Reviews

        Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action proposes to make a determination based on air quality data and to suspend certain Federal requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). Because this rule proposes to make a determination based on air quality data and to suspend certain Federal requirements, it 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). This proposed rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This proposed action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it only proposes to make a determination based on air quality data and suspend certain Federal requirements, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it proposes to determine that air quality in the affected area is meeting Federal standards. The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply because it would be inconsistent with applicable law for EPA, when determining the attainment status of an area, to use voluntary consensus standards in place of promulgated air quality standards and monitoring procedures that otherwise satisfy the provisions of the CAA. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.). Under Executive Order 12898, EPA finds that this rule involves a proposed determination of attainment based on air quality data and will not have disproportionately high and adverse human health or environmental effects on any communities in the area, including minority and low-income.

          List of Subjects in 40 CFR Part 52
          Environmental protection, Air pollution control, Lead, Reporting and Recordkeeping requirements.

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

          Dated: June 5, 2012.
          A. Stanley Meiburg,
          Acting Regional Administrator, Region 4.

      [FR Doc. 2012-14566 Filed 6-13-12; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Centers for Medicare & Medicaid Services
        42 CFR Part 447
        [CMS-2406-P2]
        RIN 0938-AT41
        Medicaid Program; Methods for Assuring Access to Covered Medicaid Services—Rescission

          AGENCY:
          Centers for Medicare & Medicaid Services (CMS), HHS.

          ACTION:
          Proposed rule.

          SUMMARY:
          This proposed rule would remove the regulatory text that sets forth the current required process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist enough providers to assure beneficiary access to covered care and services consistent with the Medicaid statute. States have raised concerns over the administrative burden associated with the current regulatory requirements. While we believe the process described in the current regulatory text is a valuable tool for states to use to demonstrate the sufficiency of provider payment rates, we believe mandating states to collect the specific information as described excessively constrains state freedom to administer the program in the manner that is best for the state and Medicaid beneficiaries in the state.

          DATES:
          To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 13, 2019.

          ADDRESSES:
          In commenting, please refer to file code CMS-2406-P2. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
          Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
          1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
          2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2406-P2, P.O. Box 8016, Baltimore, MD 21244-8016.
          Please allow sufficient time for mailed comments to be received before the close of the comment period.
          3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2406-P2, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

          For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

          FOR FURTHER INFORMATION CONTACT:
          Jeremy Silanskis, (410) 786-1592.

        SUPPLEMENTARY INFORMATION:

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

        Section 1902(a)(30)(A) of the Social Security Act (the Act) requires states to assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area. In the November 2, 2015 Federal Register (80 FR 67576), we published the “Medicaid Program; Methods for Assuring Access to Covered Medicaid Services” final rule with comment period (“2015 final rule with comment period”) that outlined a data-driven process for states to document their compliance with section 1902(a)(30)(A) of the Act. The 2015 final rule with comment period included a new § 447.203(b)(1) through (8), revisions to § 447.204, and a new § 447.205(d)(2)(iv). These regulations established that states must develop and submit to CMS an access monitoring review plan (AMRP), that is updated at least every 3 years, for the following services: (1) Primary care (including those provided by a physician, federally qualified health center, clinic or dental care); (2) physician specialist services (for example, cardiology, urology, radiology); (3) behavioral health services (including mental health and substance use disorder); (4) pre- and post-natal obstetric services, (including labor and delivery); (5) home health services; (6) any additional types of services for which a review is required under § 447.203(b)(6) because of a proposed payment rate reduction or restructuring; (7) additional types of services for which the state or CMS has received a significantly higher than usual volume of beneficiary, provider or other stakeholder access complaints for a geographic area; and (8) additional types of services selected by the state.

        Furthermore, under § 447.204(a) through (c), when proposing to reduce or restructure Medicaid payment rates, states must consider the data collected through the AMRP and undertake a public process that solicits input on the potential impact of proposed reduction or restructuring of Medicaid payment rates on beneficiary access to care. States must submit related analysis to CMS along with any proposed rate reduction or restructuring state plan amendment (SPA), and we may disapprove such proposed SPA that does not include documentation supporting compliance with the required AMRP review and public process. Under § 447.204(d), we may take a compliance action against a state to remedy an access issue. The initial AMRP submissions were due to us on October 1, 2016, as provided in the final rule, “Medicaid Program; Deadline for Access Monitoring Review Plan Submissions,” published in the April 12, 2016 Federal Register (81 FR 21479). We received AMRP submissions from all states, and the submissions are available on the Medicaid.gov website at https://www.medicaid.gov/medicaid/access-to-care/review-plans/index.html.

        Finally, under § 447.205(d)(2)(iv), states may provide the required public notice of any significant proposed change in its methods and standards for setting payment rates for services on a state public website that meets the standards specified in that paragraph.
        A number of states expressed concern regarding the administrative burden associated with the regulatory requirements, particularly those states with very high beneficiary enrollment in managed care and a correspondingly limited number of beneficiaries receiving care through a fee-for-service delivery system. States have mentioned that they must utilize a significant amount of staff resources to develop the AMRPs and conduct the required analysis when, because of the relatively small population in fee-for-service, it will result in program data that is not reflective of the state's overall care delivery system and therefore is not well suited to evaluating access for the entire population of Medicaid beneficiaries in the state. For instance, states have discussed that remaining fee-for-service populations are often dually eligible for Medicare and Medicaid with Medicaid only being the secondary payer for most services provided to these individuals. Similarly, remaining fee-for-service populations may reside in long-term care facilities and because Medicaid is often the primary payer of long-term care services, and as such, typically sets the market for these services, the types of data comparisons required by the AMRPs are of limited utility. Other populations remaining in fee-for-service may have reduced packages of services based on specific needs, and these populations are often so small or require such specialized care that their needs may not be meaningfully compared to the general population. Additionally, some states have noted that their managed care contracts require participating providers to also participate in their fee-for-service program. Even states with limited managed care enrollment have raised concerns about what they consider to be burdensome standards and unsustainable processes and, through the National Association of Medicaid Directors, have requested to work with CMS to develop meaningful standards and a process that effectively implements section 1902(a)(30)(A) of the Act.

        In attempt to address some of the states' concerns regarding undue administrative burden, in the March 23, 2018 Federal Register (83 FR 12696), we published a proposed rule that would have exempted states with at least 85 percent of their Medicaid population enrolled in comprehensive, risk-based managed care from the regulatory requirements in §§ 447.203(b)(1) through (6) and 447.204(a) through (c). In addition, the proposed rule would have exempted from the regulatory requirements in §§ 447.203(b)(6) and 447.204(a) through (c) state proposals to reduce rates or restructure payments where the overall reduction is 4 percent or less of overall spending within the affected state plan service category for a single state fiscal year (SFY) and 6 percent or less over 2 consecutive SFYs. In the responses that we received during the public comment period, an overwhelming number of commenters raised concerns that the exemption thresholds were arbitrarily set without data to support them. While we maintain that the thresholds are supportable, we have decided not to finalize the proposed exemptions, and instead to set out a new approach to understanding access and ensuring statutory compliance while eliminating unnecessary burden on states.

        We have relied on states to analyze access to care data and develop procedures to monitor data through updates to the AMRPs. While the AMRPs can serve as an overall structure for states to monitor access data, including after rate reductions or restructurings, similar information can be presented by states through the SPA submission process to demonstrate compliance with the statute without the need to develop and maintain AMRPs as currently required under the regulations. Additionally, apart from the SPA submission process, states continue to be obligated to ensure their rates are sufficient to maintain compliance with section 1902(a)(30)(A) of the Act. If the regulatory amendments in this proposed rule are finalized, we would expect to issue subregulatory guidance concurrently with the publication of the final rule through a letter to State Medicaid Directors to provide information on data and analysis that states will submit with SPAs to support compliance with section 1902(a)(30)(A) of the Act. We anticipate that this guidance would provide states flexibility to select the types of data they would use to demonstrate the sufficiency of payment rates. Such data might include: Rate comparisons; ratios of participating providers to total providers in the geographic area; ratios of participating providers to beneficiaries in the geographic area; available transportation in the geographic area; direct comparisons of access for Medicaid beneficiaries to that of the general population in the geographic area; and provider, beneficiary, and other stakeholder complaints and recommendations for resolution of such complaints. We expect that the guidance would remind states of their ongoing obligation to ensure sufficient payment rates and that they must demonstrate with the information they provide through SPAs that the proposed rates or rate structure would satisfy the requirements of the statute, including section 1902(a)(30)(A) of the Act.

        In addition, in partnership with states, we are renewing our efforts and commitment to develop a data-driven strategy to understand access to care in the Medicaid program across fee-for-service and managed care delivery systems, as well as in home and community-based services waiver programs. This new strategy will focus on developing a more uniform methodology for analyzing Medicaid access data for all states and will be led by us working in partnership with states and other stakeholders. We will use this analysis to inform our approval decisions and to set out new policies, as necessary, to improve beneficiary access to care and services in the Medicaid program. In conjunction with the 2015 final rule with comment period, we also published a Request for Information (RFI) in the Federal Register (80 FR 67377) in which we sought public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. The majority of responses to the RFI were supportive of the concept of more standardized access measures across states and delivery systems, at that time however, we did not believe we had the necessary data at the federal level to move forward with developing such measures. Since 2015, we have improved data available at the federal level through the Transformed Medicaid Statistical Information System (T-MSIS), which is a significant expansion of the previously available information from the Medicaid Statistical Information System (MSIS) and have a better understanding of how such data may be used to monitor access in Medicaid. Additionally, we have been working extensively with states, through a vendor, to identify best practices and develop standardized templates that can be used to analyze access. We hope to build upon these efforts as part of the new strategy.
        II. Provisions of the Proposed Regulations
        We are proposing to remove § 447.203(b), but leave in place the requirement in § 447.203(a) for states to maintain documentation of payment rates and make that available to us upon request. In addition, we propose to remove § 447.204(b) through (c) to remove the regulatory requirements for the process states must follow prior to the submission of a SPA that proposes to reduce or restructure Medicaid service payment rates. We are also proposing to remove § 447.204(d), which specifies actions we could take to remedy an access issue, as this provision was intended to address issues that arose based on the state's access monitoring review procedures that we are now proposing to no longer require. We would continue to have authority to take compliance action or other remedial action if we determine that a state is not in compliance with section 1902(a)(30)(A) of the Act. The proposal would leave in place the opening sentence of the current requirement in § 447.204(a), which is a restatement of the statutory language of section 1902(a)(30)(A) of the Act.
        Although this proposed rule would remove the regulatory process requirements for states to develop and update an AMRP and to submit certain access analysis when proposing to reduce or restructure provider payment rates, states still would be obligated by the statute to ensure Medicaid payment rates are sufficient to enlist enough providers to assure that beneficiary access to covered care and services are available under the plan at least to the extent such care and services are available to the general population in the same geographic area, particularly when reducing or restructuring Medicaid payment rates through SPAs. States would still be required to submit information and analysis to demonstrate compliance with section 1902(a)(30)(A) of the Act when submitting payment SPAs, and as discussed above, we would expect to issue subregulatory guidance to inform states on the types of information and data that we would consider to be acceptable.
        III. Collection of Information Requirements

        Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
        • The need for the information collection and its usefulness in carrying out the proper functions of our agency.
        • The accuracy of our estimate of the information collection burden.
        • The quality, utility, and clarity of the information to be collected.
        • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
        In this proposed rule, we are soliciting public comment on each of these issues for the following sections of this rule that would rescind certain “collection of information” requirements as defined under 5 CFR 1320.3 of the PRA's implementing regulations.
        A. Wage Estimates

        To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2017 National Occupational Employment and Wage Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). Note, this is updated wage information from the currently approved information collection request (CMS-10391; OMB 0938-1134), which used 2015 National Occupational Employment and Wage Estimates. In this regard, Table 1 presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage. This updated adjusted hourly wage information is used for all of the estimated burden calculations in this proposed rule.

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        We adjusted our employee hourly wage estimates by a factor of 100 percent. This was necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. We believe that doubling the hourly wage to estimate total cost was a reasonably accurate estimation method.
        B. Proposed Information Collection Requirements (ICRs)
        This rule does not propose any new collection of information requirements. Instead, in the interest of consistency with Executive Order 13771 (January 30, 2017), entitled, “Reducing Regulation and Controlling Regulatory Costs,” this rule proposes to rescind the collection of information requirements and burden that are set out under the 2015 final rule with comment period (80 FR 67576). The requirements and burden (with modification, as explained below) were approved by OMB on April 29, 2016, under control number 0938-1134 (CMS-10391). As noted previously, while we believe the process described in the current regulatory text can be a valuable tool for states to use to demonstrate the sufficiency of provider payment rates, because we have no basis for determining how many states would continue to follow the current AMRP process in whole or in part, we are assuming that all states would opt to provide alternate evidence of compliance with section 1902(a)(30)(A) of the Act and are therefore removing the burden of the current AMRP requirements in its entirety. States were already required to submit information on compliance with section 1902(a)(30)(A) of the Act prior to the 2015 final rule with comment period. As the requirements and burden estimate under control number 0938-1134 (CMS-10391) only accounted for new burden associated with 2015 final rule with comment period, were are not accounting for burden associated overall compliance with section 1902(a)(30)(A) of the Act and information states may submit to demonstrate statutory compliance as part of the SPA submission process if the proposal to rescind the 2015 requirements is finalized. Information and documentation states submit in support of SPAs are covered within the procedural requirements defined in 42 CFR part 430.
        1. ICRs Regarding Access Monitoring Review Plans (§ 447.203(b))
        Current provisions at § 447.203(b) require that states develop and make publicly available an access monitoring review plan that considers: Beneficiary needs, availability of care and providers, and changes to beneficiary utilization of covered services.
        Section 447.203(b)(1) and (2) describes the minimum factors that states must consider when developing an access monitoring review plan, while § 447.203(b)(3) requires that states include aggregate percentage comparisons of Medicaid payment rates to other public (including, as practical, Medicaid managed care rates) or private health coverage rates within their state's geographic areas.
        Section 447.203(b)(4) describes the minimum content that must be in included in the monitoring plan, including: The measures the state uses to analyze access to care issues, how the measures relate to the overarching framework, access issues that are discovered as a result of the review, and the state Medicaid agency's recommendations on the sufficiency of access to care based on the review.
        Section 447.203(b)(5) describes the timeframe for states to develop the access monitoring review plan and complete the data review for the following categories of services: Primary care, physician specialist services, behavioral health, pre- and post-natal obstetric services including labor and delivery, home health, any services for which the state has submitted a state plan amendment to reduce or restructure provider payments which changes could result in diminished access, and additional services as determined necessary by the state or CMS. While the initial access monitoring review plans have been completed, the plan must be updated at least every 3 years, but no later than October 1 of the update year.
        In our currently approved information collection request (CMS-10391; OMB 0938-1134), we estimated that the requirements to develop and make the access monitoring review plans publicly available under § 447.203(b) and (b)(1) through (b)(5) for the specific categories of Medicaid services will affect each of the 50 state Medicaid programs and the District of Columbia (51 total respondents). Using the previously derived estimates of burden hours and updated adjusted hourly wage information, we now estimate that it will take: 80 hr at $47.14/hr for a research assistant staff to gather data, 80 hr at $90.20/hr for an information analyst staff to analyze the data, 100 hr at $89.84/hr for management analyst staff to update the content of the access review monitoring plan, 40 hr at $70.28/hr for business operations specialist staff to publish the access monitoring review plan, and 10 hr at $118.70/hr for managerial staff to review and approve the access monitoring review plan. A demonstrated below in Tables 2A and 2B, we estimate a burden reduction or savings of 15,810 hr (total) at a cost of $1,222,439 (total) or $23,969 (per state).
        Please note that the 2015 final rule with comment period set out a burden of 5,270 hr which divided the total number of respondents (51 states) across 3 years (17 states per year) to equal 17 states × 310 hr per response. In this rule we propose to adjust the number of respondents from 17 to 51 to capture the total number of respondents across the 3 year period, resulting in a difference of −10,540 hr (5,270 hr−15,810 hr).
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        Based on this rule's proposal to rescind the requirement for states to update the access monitoring review plan at least every 3 years, we are also removing the on-going or annual burden associated with the access monitoring review plan. Consistent with our currently approved estimates, we believe that the average ongoing burden is likely to be the same as the average initial burden since states will need to re-run the data, determine whether to add or drop measures, consider public feedback, and write-up new conclusions based on the information they review.

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        2. ICRs Regarding Ongoing Monitoring (§ 447.203(b)(6)(ii))
        Section 447.203(b)(6)(ii) requires that states have procedures within the access monitoring review plan to monitor continued access after implementation of a SPA that reduces or restructures payment rates. The monitoring procedures must be in place for a period of at least three years following the effective date of the SPA. The ongoing burden associated with the requirements under § 447.203(b)(6)(ii) is the time and effort it would take each of the state Medicaid programs to monitor continued access following the implementation of a SPA that reduces or restructures payment rates.
        In our currently approved information collection request (CMS-10391; OMB 0938-1134), we estimated that in each SPA submission cycle, states would submit 22 SPAs to implement rate changes or restructure provider payments based on the number of submissions received in FY 2010.
        Using the previously approved estimates of burden hours and updated adjusted hourly wage information, we now estimate that it will take, on average: 40 hr at $89.84/hr for management analyst staff to develop the monitoring procedures, 24 hr at $89.84/hr for management analyst staff to periodically review the monitoring results, and 3 hr at $118.70/hr for management staff to review and approve the monitoring procedures. As demonstrated below in Tables 4A and 4B, we estimate a burden reduction or savings of 1,474 hr (total) at a cost of $134,329 (total) or $6,106 (per state).

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        3. ICRs Regarding Ongoing Input (§ 447.203(b)(7))
        The current provision at § 447.203(b)(7) requires that states have a mechanism for obtaining ongoing beneficiary, provider, and stakeholder input on access to care issues such as: Hotlines, surveys, ombudsman, or other equivalent mechanisms. States must promptly respond to public input with an appropriate investigation, analysis, and response. They also must maintain records of beneficiary input and the nature of the state response.
        In our currently approved information collection request (CMS-10391; OMB 0938-1134), we estimated that the requirement to develop mechanisms for ongoing feedback would affect each of the 50 state Medicaid programs and the District of Columbia (51 total respondents).
        Using the previously approved estimates of burden hours and updated adjusted hourly wage information, we now also estimate that it would take an average of: 100 hr at $89.84/hr for management analyst staff to develop the feedback effort and 5 hr at $118.70 for managerial staff to review and approve the feedback effort. As demonstrated below in Tables 5A and 5B, we estimate a burden reduction or savings of 5,355 hr (total) at a cost of $488,453 (total) or $9,578 (per state).
        Please note that the 2015 final rule with comment period had set out a burden of 1,785 hr which divided the total number of respondents (51 states) across 3 years (17 states per year) to equal 17 states × 105 hr per response. In this rule, we propose to adjust the number of respondents from 17 to 51 to capture the total number of respondents across the 3-year period, resulting in a difference of −3,570 hr (1,785 hr−5,355 hr).

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        The ongoing burden associated with the requirements under § 447.203(b)(7) is the time and effort it would take each of the 50 state Medicaid programs and the District of Columbia (51 total respondents) to monitor beneficiary feedback mechanisms. The overall effort associated with monitoring the feedback is primarily incurred by the analysts who will gather, review and make recommendations for and conduct follow-up on the feedback. We estimate that it will take an average of: 75 hr at $89.84/hr for management analyst staff to monitor feedback results and 5 hr at $118.70/hr for managerial staff to review and approve the feedback effort. As demonstrated below in Tables 6A and 6B, we estimate a burden reduction or savings of 4,080 hr (total) at a cost of $373,907 (total) or $7,332 (per state).

          EP15JY19.009

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        4. ICRs Regarding Corrective Action Plan (§ 447.203(b)(8))
        Current § 447.203(b)(8) requires that states submit to CMS a corrective action plan should access issues be discovered through the access monitoring processes.
        In our currently approved information collection request (CMS-10391; OMB 0938-1134), we estimated that a maximum of 10 states may identify access issues per year. The one-time burden is the time and effort it would take 10 state Medicaid programs to develop and implement corrective action plans.
        Using the previously approved estimates of burden hours and updated adjusted hourly wage information, we estimate that it would take an average of: 20 hr at $89.84/hr for management analyst staff to identify issues requiring corrective action, 40 hr at $89.84/hr for management analyst staff to develop the corrective action plans, and 3 hr at $118.70/hr for managerial staff to review and approve the corrective action plans. As demonstrated below in Tables 7A and 7B, we estimate a burden reduction or savings of 630 hr (total) at a cost of $57,465 (total) or $5,747 (per state).
        Please note that the 2015 final rule with comment period had set out a burden of 208 hr which was corrected in the Supporting Statement (approved by OMB on February 2, 2016) to reflect 630 hr, resulting in a difference of plus 422 hr.

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        5. ICRs Regarding Public Process To Engage Stakeholders (§ 447.204(a)(1) and (2))
        Current § 447.204(a)(1) and (2) require that states consider (when proposing to reduce or restructure Medicaid payment rates) the data collected through current § 447.203 and undertake a public process that solicits input on the potential impact of the proposed reduction or restructuring of Medicaid service payment rates on beneficiary access to care.
        In our currently approved information collection request (CMS-10391; OMB 0938-1134), we estimated that approximately 22 states would develop and implement rate changes that would require a public process. Using the previously approved estimates of burden hours and updated adjusted hourly wage information, we also estimate that it would take an average of: 20 hr at $89.84/hr for management analyst staff to develop the public process and 3 hr at $118.70/hr for managerial staff to review and approve the public process. As demonstrated below in Tables 8A and 8B, we estimate a burden reduction or savings of 506 hr (total) at a cost of $47,364 (total) or $2,153 (per state).
        Please note that the 2015 final rule with comment period had set out a burden of 168 hr which was corrected in the Supporting Statement (approved by OMB on February 2, 2016) to reflect 506 hr, resulting in a difference of plus 338 hr.

          EP15JY19.013

        The ongoing burden associated with the current requirements under § 447.204 is the time and effort it would take 22 state Medicaid programs to oversee a public process. We estimate that it would take an average of: 40 hr at $89.84/hr for management analyst staff to oversee the public process and 3 hr at $118.70/hr for managerial staff to review and approve the public process. As demonstrated below in Tables 9A and 9B, we estimate a burden reduction or savings of 946 hr (total) at a cost of $86,893 (total) or $3,950 (per state).

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        C. Summary of Proposed Collection of Information Requirements and Burden

          EP15JY19.017

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        D. Submission of PRA-Related Comments
        We have submitted a copy of this proposed rule to OMB for its review of the rule information collection and recordkeeping requirements. The requirements are not effective, if finalized, until they have been approved by OMB.
        We invite public comments on these information collection requirements, and particularly on submission frequency and burden hours per response. If you wish to comment, please identify the rule (CMS-2406-P2), the CMS ID number (CMS-10391), and the OMB control number (0938-1134).
        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
        1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

        2. Email your request, including your address, phone number, OMB control number, and CMS document identifier (CMS-10391), to Paperwork@cms.hhs.gov.

        3. Call the Reports Clearance Office at (410) 786-1326.
        See this rule's DATES and ADDRESSES sections for the comment due date and for additional instructions.
        IV. Response to Comments

        Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
        V. Regulatory Impact Statement
        A. Statement of Need

        We are concerned about the unnecessary administrative burden experienced by state Medicaid agencies in meeting the requirements of § 447.203(b)(1) through (8) and § 447.204(b) through (d), when we believe that similar information could be presented by states when necessary to demonstrate compliance with the statute without the need to develop and maintain AMRPs as currently required under the regulations. This proposed rule impacts states' documentation of compliance with section 1902(a)(30)(A) of the Act and would provide burden relief to all states. Although this proposed rule would remove the regulatory process requirements for states to develop and update an AMRP and to submit an access analysis when proposing to reduce or restructure provider payment rates in circumstances that could result in diminished access, states are still obligated by the statute to ensure Medicaid payment rates are sufficient to enlist enough providers to assure that beneficiary access to covered care and services are available under the plan at least to the extent such care and services are available to the general population in the same geographic area, particularly when reducing or restructuring Medicaid payment rates through SPAs. This proposed rule would not remove, or otherwise limit, the states' obligation to comply with the statute, but would allow states greater flexibility in the way in which they demonstrate such compliance.
        B. Overall Impact
        We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, enacted on September 19, 1980) (RFA), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, enacted on March 22, 1995) (UMRA), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
        A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule is not economically significant with an overall estimated reduced reporting burden of $3,633,289.
        C. Anticipated Effects
        1. Effects on State Medicaid Programs
        We anticipate effects on state Medicaid programs as they would no longer be required to maintain and update the access monitoring review plans required under the current regulations. Importantly, the provisions of this proposed rule remove the regulatory procedural requirements for demonstrating access to care. However, states would not be exempt from the statutory requirements under section 1902(a)(30)(A) of the Act and would continue to be required to ensure access is consistent with the Act generally, and especially when seeking to reduce or restructure Medicaid payment rates.
        2. Effects on Small Business and Providers
        We do not anticipate effects on small businesses and providers because states are still required to comply with section 1902(a)(30)(A) of the Act and will need to demonstrate such compliance when they submit a SPA to reduce or restructure payment rates. We do not anticipate our SPA approval decisions will be impacted by removing the process requirements included in these regulations, as states will still need to demonstrate compliance with the Act.
        3. Effects on the Medicaid Program
        The estimated fiscal impact on the Medicaid program from the implementation of the proposed rule is estimated to be a net savings to Medicaid state agencies. This will have an effect on state administrative expenditures, which have been quantified in the collection of information requirements described previously in this proposed rule. While we acknowledge there will still be some level of state administrative burden associated with documenting compliance with the statute, we believe it is likely to be significantly less than the burden associated with carrying out the procedural requirements included in the current regulations, and are seeking comment specifically on this issue. We do not anticipate implementing this proposed rule would have an impact on a state's Medicaid rates.
        The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $7.5 million to $38.5 million in any one year). Individuals and states are not included in the definition of a small entity. As previously stated, we do not anticipate any effect on small entities.
        In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
        Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This rule does not contain mandates that will impose spending costs on state, local, or tribal governments in the aggregate, or by the private sector, in excess of the threshold.
        Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This rule does not have a substantial direct cost impact on state or local governments.
        D. Alternatives Considered

        We considered, and previously proposed, setting a threshold for exemption from certain regulatory requirements for states with at least an 85 percent enrollment rate in comprehensive risk-based managed care. We also considered setting a threshold for proposed payment rate reductions that would be considered “nominal” and not subject to these regulatory requirements. After further consideration of these alternatives, we determined that neither alternative provided sufficient administrative burden relief for states and that implementing the thresholds could be administratively challenging for both states and CMS, particularly in marginal cases where the state's managed care enrollment percentage or the percentage rate change approached the applicable threshold. Therefore, we believe that removing the regulatory requirements is the best course of action as we move forward in the development and implementation of a comprehensive approach to monitoring access across Medicaid delivery systems.
        E. Reducing Regulation and Controlling Regulatory Costs
        Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This proposed rule is expected to be an E.O. 13771 deregulatory action. We estimate that this rule generates $3.63 million in annualized cost savings, discounted at 7 percent relative to year 2016, over a perpetual time horizon. Details on the estimated cost savings of this rule can be found in the preceding analyses.
        G. Conclusion
        In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.

          List of Subjects in 42 CFR Part 447
          Accounting, Administrative practice and procedure, Drugs, Grant programs-health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.

        For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:

          PART 447—PAYMENTS FOR SERVICES

        1. The authority citation for part 447 is revised to read as follows:

          Authority:
          42 U.S.C. 1302.

          § 447.203
           [Amended]

        2. Section 447.203 is amended by removing and reserving paragraph (b).
        3. Section 447.204 is revised to read as follows:

          § 447.204
           Medicaid provider participation and public process to inform access to care.
          The agency's payments must be consistent with efficiency, economy, and quality of care and sufficient to enlist enough providers so that services under the plan are available to beneficiaries at least to the extent that those services are available to the general population in the geographic area.

          Dated: January 28, 2019.
          Seema Verma,
          Administrator, Centers for Medicare & Medicaid Services.

          Dated: February 13, 2019.
          Alex M. Azar II,
          Secretary, Department of Health and Human Services.

          Editorial Note:
          This document was received by the Office of the Federal Register on July 10, 2019.

      [FR Doc. 2019-14943 Filed 7-11-19; 11:15 am]
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        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [Docket No. FWS-HQ-ES-2012-0094; FXES111309F2130-123-FF09E22000]
        Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist the Wood Bison

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Notice of 90-day petition finding.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to delist the wood bison (Bison bison athabascae) under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition does not present substantial information indicating that delisting the wood bison subspecies may be warranted. Therefore, we are not initiating a status review in response to this petition. However, we ask the public to submit to us any new information that becomes available concerning the status of, or threats to, the wood bison or its habitat at any time.

          DATES:
          The finding announced in this document was made on April 19, 2013.

          ADDRESSES:
          This finding is available on the Internet at http://www.regulations.gov at Docket Number FWS-HQ-ES-2012-0094. Supporting documentation we used in preparing this finding is available for public inspection, by appointment, during normal business hours at the U.S. Fish and Wildlife Service, Alaska Regional Office, 1011 East Tudor Road, Anchorage, AK 99503; (907) 786-3856. Please submit any new information, materials, comments, or questions concerning this finding to the above street address.

          FOR FURTHER INFORMATION CONTACT:
          Marilyn Myers at U.S. Fish and Wildlife Service, Fisheries and Ecological Services, 1011 E. Tudor Road, Anchorage, AK 99503; or by telephone at 907-786-3559; or by facsimile at (907) 786-3848. If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800-877-8339.

        SUPPLEMENTARY INFORMATION:

        Background
        Section 4(b)(3)(A) of the Act (16 U.S.C. 1531 et seq.) requires that we make a finding on whether a petition to list, delist, or reclassify a species presents substantial scientific or commercial information indicating that the petitioned action may be warranted. We are to base this finding on information provided in the petition, supporting information submitted with the petition, and information otherwise available in our files. To the maximum extent practicable, we are to make this finding within 90 days of our receipt of the petition, and publish our notice of the finding promptly in the Federal Register.
        Our standard for substantial scientific or commercial information within the Code of Federal Regulations (CFR) with regard to a 90-day petition finding is “that amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted” (50 CFR 424.14(b)). If we find that substantial scientific or commercial information was presented, we are required to promptly conduct a species status review, which we subsequently summarize in our 12-month finding.
        Petition History
        On April 3, 2012, we received a petition, dated April 3, 2012, from the Western Bison Association, the Rocky Mountain Buffalo Association, the Minnesota Buffalo Association, the Oklahoma Buffalo Association, the North Dakota Buffalo Association, the Northwest Buffalo Association, the Missouri Buffalo Association, the Kansas Buffalo Association, and W. Michael Gear and Kathleen O'Neal Gear requesting that the wood bison be removed from the Federal List of Endangered and Threatened Wildlife as threatened under the Act. The petition clearly identified itself as such and included the requisite identification information for the petitioners, as required at 50 CFR 424.14(a). In a letter to the petitioners sent April 24, 2012, we stated that we anticipated that we would review the petition and make a finding within the coming year. This finding addresses the petition.
        Previous Federal Action(s)

        The listing history for wood bison is extensive and was reconstructed in the proposed rule to reclassify wood bison from endangered to threatened, which published February 8, 2011 (76 FR 6734). Please refer to that document for the complete listing history. Here we present only the most pertinent facts.

        Wood bison became listed in the United States under the 1969 Endangered Species Conservation Act when it was included on the first List of Endangered Foreign Fish and Wildlife, which was published in the Federal Register on June 2, 1970 (35 FR 8491). In 1974, the first list under the 1973 Endangered Species Act appeared in the Code of Federal Regulations (CFR); the wood bison was listed as an endangered species based on its inclusion on the original 1969 list. Because the wood bison was listed under the 1969 Endangered Species Conservation Act, there is not a separate Federal Register notice that defined the population(s) and their range, or analyzed threats to the subspecies.
        On May 14, 1998, the Service received a petition from a private individual requesting that the Service remove the wood bison from the List of Endangered and Threatened Wildlife, primarily because it had been downlisted from Appendix I to Appendix II under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). In a 90-day finding published on November 25, 1998 (63 FR 65164), we found that the petitioner did not provide substantial information to indicate that the delisting may be warranted.
        On November 26, 2007, we received a petition from the co-chairs of Canada's National Wood Bison Recovery Team requesting that we reclassify the wood bison from endangered to threatened. On February 3, 2009, we published a 90-day finding (74 FR 5908) acknowledging that the petition provided sufficient information to indicate that reclassification may be warranted and that we would initiate a status review. On February 8, 2011, we published a proposed rule to reclassify wood bison (76 FR 6734), and on May 3, 2012, we published a final rule reclassifying wood bison as threatened under the Act (77 FR 26191).
        Status in Canada

        In Canada, the Species at Risk Act (SARA) is the Canadian counterpart to the U.S. Endangered Species Act. Under the SARA, the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) was established as the scientific body that identifies and assesses a species' status. The wood bison was recognized by the COSEWIC as an endangered subspecies of Canadian wildlife in 1978. Wood bison was reclassified to threatened in June 1988, based on a status report prepared by the National Wood Bison Recovery Team. The National Wood Bison Recovery Team published a national recovery plan in 2001 (Gates et al. 2001), which has guided recovery actions in Canada since that time.
        Species Information

        Wood bison is the largest native extant terrestrial mammal in North America (Reynolds et al. 2003, p. 1015). Average weight of mature males (age 8) is 910 kilograms (kg) (2,006 pounds (lb)) and the average weight of mature females (age 13) is 440 kg (970 lb) (Reynolds et al. 2003, p. 1015). They have a large triangular head, a thin beard and rudimentary throat mane, and a poorly demarcated cape (Boyd et al. 2010, p. 16). In addition, the highest point of their hump is forward of their front legs; they have reduced chaps on their front legs; and their horns usually extend above the hair on their head (Boyd et al. 2010, p. 16). These physical characteristics distinguish them from the plains bison (Reynolds et al. 2003, p. 1015; Boyd et al. 2010, p. 16). Detailed information on the biology of wood bison is provided in our February 8, 2011, proposed rule to reclassify wood bison as threatened (76 FR 6734) and in our May 3, 2012, final rule (77 FR 26191). Please refer to those documents for a detailed account of the species' biology.
        Taxonomy

        In the proposed and final rules (76 FR 6734, 77 FR 26191), we adopt the widely accepted notion that wood bison is a valid subspecies, a point which the petitioners contest. The petitioners assert that wood bison and plains bison (Bison bison bison) are not significantly different and that they should be considered a single species. Therefore, we discuss taxonomic classification and our rationale for accepting wood bison as a valid subspecies below.
        Taxonomy is the theory and practice of classifying organisms. Traditionally, physical characteristics of an organism were used to describe a species. However, from an evolutionary perspective, appearances can be deceptive; animals that look alike may not be closely related and animals that appear different from one another may actually be closely related. With the advent of sophisticated molecular tools, taxonomists can now examine various aspects of a species genetic code to help them determine how closely animals are related to one another. Although molecular techniques have added another tool in the taxonomist's toolbox, they also have limitations and do not necessarily give an unambiguous picture of the relationship among species. Sample size (number of animals sampled, number of genes sampled, or the number of loci on a gene sampled), type of DNA examined (mitochondrial DNA vs. nuclear DNA), the techniques used, and the populations selected for sampling are among a few of the reasons that variable or ambiguous results may arise. In addition, how a species (or subspecies) is defined, which on its face is a simple concept, is in reality very complex, and several definitions for “species” exist (Mayr and Ashlock 1991, pp. 24-28; de Queiroz 2007, pp. 879-885). Consequently, the intersection of incomplete knowledge of exactly how animals are related to one another, combined with the human concept of what a species is, often culminates in controversy over whether certain groups of animals should be lumped together or split apart. Such is the case for wood bison.

        We recognize, as the petitioners assert, that differences in opinion exist regarding the division of Bison into two subspecies (B. b. athabascae and B. b. bison) (e.g., Bork et al. 1991, pp. 43, 47; Geist 1991, p. 283). However, quantified differences in pelage (e.g., distribution of mane, chaps, and cape) and structure (e.g., overall body size, location of hump, length of horns) have been described (van Zyll de Jong et al. 1995, pp. 394-400). These differences, and the fact that wood bison and plains bison are physically separated by a great distance, led Boyd et al. (2010, p. 16 (American Bison Specialist Group)) to conclude separation into two subspecies is consistent with the subspecies concept. As noted in our final rule to downlist wood bison (77 FR 26209), the introduction of plains bison into Wood Buffalo National Park in Canada, the only place where wood bison remained in the 1920s, led to some degree of hybridization. However, genetic analysis has indicated that although the wood bison had limited contact with plains bison, it was minimal enough that the animals exhibit predominantly wood bison traits. Wood bison originating from founders with minimal contact with plains bison are genetically more similar to one another than they are to plains bison (van Zyll de Jong et al. 1995, pp. 394-404; Wilson and Strobeck 1999, p. 493). Hybridization did not lead to a phenotypically homogenous population (one population that looks the same) (van Zyll de Jong et al. 1995, pp. 394-404).

        As described above, molecular tools can be used to evaluate the relatedness of individuals, populations, species, and genera. The work of Wilson (2001) and Wilson and Strobeck (1999, pp. 493-494) using DNA microsatellites indicate that the genetic differences between plains bison and wood bison are greater than those within either of the two subspecies. These results support maintaining the subspecific designation. Results of studies that sequence only mitochondrial DNA are of limited value in answering questions about subspecific designation because mitochondrial DNA is inherited only from the maternal side (Avise 1994, pp. 62, 99). In the case of Douglas et al. (2011), which the petitioners use as support for their argument of lumping the subspecies together, mitochondrial DNA from only two wood bison were sequenced, further limiting the authors' ability to draw general conclusions about the relatedness of wood and plains bison. As Boyd et al. (2010, p. 17) note, the inability to detect a difference with a molecular test comparing limited sequences of genomic material does not necessarily mean that there is no difference. It is possible that in the future refined genetic analysis with appropriate sample design and sample size will provide a more compelling reason to lump the two subspecies together. Until that time, we will continue to follow the accepted separation of North American bison into two subspecies.
        The Canadian National Recovery Plan (Gates et al. 2001, p. 28) provides this summary about American bison subspecies:
        (1) Historically, wood bison differed from other bison populations with regard to multiple morphological and genetic characteristics.
        (2) The intrusion of plains bison into the range of wood bison in 1925-1928 was entirely human-caused.
        (3) The two North American bison subspecies continue to be morphologically and genetically distinct, despite some hybridization in the 1920s.
        (4) Wood bison and their descendants continue to constitute populations of a subspecies of bison.

        In a recent evaluation of the subspecific separation of wood bison from plains bison, Boyd et al. (2010 pp. 15-18) also conclude that there appears to be sufficient justification for the formal recognition of the two subspecies. In addition, they point out that regardless of the formal designation for wood bison, all forms of geographic and ecological variation contribute to biodiversity and that variants of a species may have evolutionarily important ecological adaptations (Boyd et al. 2010, p. 18). This reality is reflected in the Service's ability to recognize and provide protection to “distinct population segments” at a taxonomic level below subspecies. In addition, COSEWIC also considers and includes subspecies, varieties, or geographically or genetically distinct populations in its definition of wildlife species (http://www.cosewic.gc.ca/eng/sct2/sct2_5_e.cfm, viewed June 26, 2012). Both the Act and SARA recognize that conservation of biological diversity requires protection for taxonomic entities below the species level whether at the subspecific level or less (e.g., distinct populations). Therefore, regardless of how we name the populations we now call wood bison, since its description in 1897 (Rhoads 1897) wood bison in Canada have been recognized as a unique subspecies and managed as such. Consequently, even if we were to consider wood bison and plains bison as one species, that would not automatically lead to the delisting of the wood bison.
        The International Code of Zoological Nomenclature (Code) provides guidance to zoologists worldwide regarding naming species. In the Preface to the Code it states, “Nomenclatural rules are tools that are designed to provide the maximum stability compatible with taxonomic freedom.” A published “revision” or “monograph” is the standard method used to examine all the species within a group and present a unified synopsis of all of the information available (Mayr and Ashlock 1991, p. 348). Recognizing the taxonomic controversy that exists for the subspecific designation of wood bison, a reasonable, defensible, and conservative approach is to follow the naming conventions that are in place. The petition does not provide compelling, convincing, or unambiguous information that would cause the Service to consider wood bison and plains bison as a single species, nor can we authoritatively resolve this issue with the information available.

        In summary, based on the historical physical separation, and quantifiable behavioral, morphological, phenological (appearance), and genetic differences between the two subspecies, the best available scientific information indicates that subspecific designation is appropriate (FEAP 1990, p. 24; Bork et al. 1991, p. 47; van Zyll de Jong et al. 1995, pp. 403-404; Wilson and Strobeck 1999, pp. 492-494; Reynolds et al. 2003, p. 1010; Boyd et al. 2010, pp. 15-18). The established management of bison as two subspecies and the long-standing recognition of the two subspecies by the scientific community provide additional justification for treating wood bison and plains bison as two distinct subspecies.
        Evaluation of Information for This Finding
        Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations at 50 CFR part 424 set forth the procedures for adding a species to, or removing a species from, the Federal Lists of Endangered and Threatened Wildlife and Plants. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act:
        (A) The present or threatened destruction, modification, or curtailment of its habitat or range;
        (B) Overutilization for commercial, recreational, scientific, or educational purposes;
        (C) Disease or predation;
        (D) The inadequacy of existing regulatory mechanisms; or
        (E) Other natural or manmade factors affecting its continued existence.
        We must consider these same five factors in delisting a species. We may delist a species according to 50 CFR 424.11(d) if the best available scientific and commercial data indicate that the species is neither endangered nor threatened for the following reasons:
        (1) The species is extinct;
        (2) The species has recovered and is no longer endangered or threatened; or
        (3) The original scientific data used at the time the species was classified were in error.

        In the case of this petition, the petitioners have not discussed threats to the species (or subspecies) that remain or have been eliminated. They focus instead on the success of recovery efforts for wood bison “ecotype,” the increase in the number of animals, and the establishment of new herds. We agree that significant strides have been made towards recovery of wood bison, and we discussed the success of recovery efforts in our proposed and final rules for the reclassification of wood bison (76 FR 6734, 77 FR 26191). Although we acknowledge that wood bison are no longer endangered, we conclude in our final rule that threats to wood bison remain and that the wood bison should be listed as threatened. In particular, we identified loss of habitat, disease, and hybridization as ongoing threats. The conclusions made in the May 3, 2012, final rule to reclassify the subspecies are still valid. The petitioners have not provided, and we have not received, any new information regarding threats to, or recovery of, wood bison that was not considered in the final reclassification rule.

        Finding
        The petition does not present substantial information to indicate that delisting of wood bison is warranted. Although we recognize that controversy exists around the subspecific designation for wood bison, nomenclature stability, management history, and the acceptance of two subspecies by the American Bison Specialist Group, the Canadian National Wood Bison Recovery Team, and other zoologists lead us to the conclusion that retaining the current nomenclature is appropriate and defensible.
        Although the petitioners argue that wood bison and plains bison should be considered as one species, they did not indicate that all or most threats to bison have been ameliorated. Instead, they focus on the success of recovery efforts for wood bison. We agree that the status of wood bison is more secure today than it once was. However, in our final rule to reclassify wood bison as threatened, which published earlier this year, we identified threats that remain to the species. The petitioners did not provide any new information about the status of the species that we were not already aware of and had evaluated in our final rule.

        On the basis of our determination under section 4(b)(3)(A) of the Act, we conclude that the petition does not present substantial scientific or commercial information to indicate that delisting the wood bison under the Act may be warranted at this time. Although we will not conduct a thorough review of the status of the species at this time, we encourage interested parties to continue to gather data that will assist with the conservation of the wood bison. If you wish to provide information regarding the wood bison, you may submit your information or materials to Marilyn Myers, Endangered Species Biologist, Alaska Regional Office (see FOR FURTHER INFORMATION CONTACT), at any time.
        References Cited

        A complete list of references cited is available on the Internet at http://www.regulations.gov and upon request from the Alaska Regional Office (see FOR FURTHER INFORMATION CONTACT).
        Author

        The primary author of this notice is Marilyn Myers of the Alaska Regional Office (see FOR FURTHER INFORMATION CONTACT).
        Authority

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

          Dated: November 7, 2012.
          Daniel M. Ashe,
          Director, U.S. Fish and Wildlife Service.

      [FR Doc. 2013-09241 Filed 4-18-13; 8:45 am]
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