        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 372
        [EPA-HQ-TRI-2019-0375; FRL-10002-70]
        RIN 2070-AK51
        Addition of Certain Per- and Polyfluoroalkyl Substances; Community Right-to-Know Toxic Chemical Release Reporting

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Advance notice of proposed rulemaking.

          SUMMARY:

          In this advance notice of proposed rulemaking (ANPRM), EPA is soliciting information from the public as EPA considers proposing a future rule on adding certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). In this ANPRM, EPA outlines what PFAS are, why the Agency is considering adding certain PFAS to EPCRA section 313, what listing actions are being considered, who may be required to report, the current understanding of hazard concerns for PFAS, EPA's hazard assessments on PFAS, and other information available on these chemicals. In considering a chemical for addition to the EPCRA section 313 list, EPA bases its listing decision on the chemical's hazard (i.e., toxicity), not the risk (i.e., toxicity plus potential exposures) related to that chemical. EPA is requesting comment on which, if any, PFAS should be evaluated for listing, how to list them, and what would be appropriate reporting thresholds given their persistence and bioaccumulation potential. Lastly, EPA asks for any additional data to inform the Agency's evaluation and determination of which PFAS may meet the EPCRA section 313 listing criteria.

          DATES:
          Comments must be received on or before February 3, 2020.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-HQ-TRI-2019-0375, by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
          • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
          • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets#hq.

          All documents in the docket are listed on http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information the disclosure of which 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 electronically through http://www.regulations.gov. Additional instructions on visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets/commenting-epa-dockets.

          FOR FURTHER INFORMATION CONTACT:

            For technical information contact: Daniel R. Bushman, Toxics Release Inventory Program Division (7410M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-0743; email: bushman.daniel@epa.gov.

            For general information contact: The Emergency Planning and Community Right-to-Know Hotline; telephone numbers: toll free at (800) 424-9346 (select menu option 3) or (703) 348-5070 in the Washington, DC Area and International; or go to https://www.epa.gov/home/epa-hotlines.

        SUPPLEMENTARY INFORMATION:

        I. General Information
        A. Does this action apply to me?
        You may be potentially affected by this action if you manufacture, process, or otherwise use PFAS. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
        • Facilities included in the following NAICS manufacturing codes (corresponding to Standard Industrial Classification (SIC) codes 20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 211130*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191, 511199, 512230*, 512250*, 519130*, 541713*, 541715* or 811490*. *Exceptions and/or limitations exist for these NAICS codes.

        • Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 212111, 212112, 212113 (corresponds to SIC code 12, Coal Mining (except 1241)); or 212221, 212222, 212230, 212299 (corresponds to SIC code 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221118, 221121, 221122, 221330 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (limited to facilities previously classified in SIC code 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 424710 (corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); or 562112 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC code 7389, Business Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC code 4953, Refuse Systems).
        • Federal facilities.

        A more detailed description of the types of facilities covered by the NAICS codes subject to reporting under EPCRA section 313 can be found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372, subpart B of Title 40 of the Code of Federal Regulations. Federal facilities are required to report under Executive Order 13834 (https://www.govinfo.gov/content/pkg/FR-2018-05-22/pdf/2018-11101.pdf) as explained in the Implementing Instructions from the Council on Environmental Quality (https://www.sustainability.gov/pdfs/eo13834_instructions.pdf). If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
        B. What action is under consideration by the Agency?
        EPA is considering proposing a rule to add certain PFAS to the list of toxic chemicals subject to reporting under EPCRA section 313 and section 6607 of the PPA (more commonly known as the Toxics Release Inventory (TRI)). EPA is also considering establishing reporting thresholds for PFAS that are lower than the usual statutory thresholds (25,000 pounds for manufacturing or processing and 10,000 pounds for otherwise using listed chemicals) due to concerns for their environmental persistence and bioaccumulation potential.
        C. What is the Agency's authority for this potential action?

        This action is issued under EPCRA sections 313(d) and 328, 42 U.S.C. 11023 et seq., and PPA section 6607, 42 U.S.C. 13106. EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986.
        Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually to EPA and the States. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of the PPA, 42 U.S.C. 13106. Congress established an initial list of toxic chemicals that was comprised of 308 individually listed chemicals and 20 chemical categories.
        EPCRA section 313(d) authorizes EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that EPA may add a chemical to the list if any of the listing criteria in EPCRA section 313(d)(2) are met. Therefore, to add a chemical, EPA must demonstrate that at least one criterion has been met, but need not determine whether any other criterion has been met. Conversely, to remove a chemical from the list, EPCRA section 313(d)(3) dictates that EPA must demonstrate that none of the criteria in ECPRA section 313(d)(2) have been met. The listing criteria in EPCRA section 313(d)(2)(A) through (C) are as follows:
        • The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases.
        • The chemical is known to cause or can reasonably be anticipated to cause in humans: Cancer or teratogenic effects, or serious or irreversible reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects.
        • The chemical is known to cause or can be reasonably anticipated to cause, because of its toxicity, its toxicity and persistence in the environment, or its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administrator, to warrant reporting under this section.
        EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the “acute human health effects criterion;” the EPCRA section 313(d)(2)(B) criterion as the “chronic human health effects criterion;” and the EPCRA section 313(d)(2)(C) criterion as the “environmental effects criterion.”

        In a final rule that added 286 chemicals and chemical categories to the TRI list, EPA published in the Federal Register of November 30, 1994 (59 FR 61432) (FRL-4922-2), a statement clarifying its interpretation of the EPCRA section 313(d)(2) criteria for modifying the EPCRA section 313 list of toxic chemicals. EPA's interpretation of the EPCRA section 313 listing criteria addressed a number of issues including EPA's authority to add chemical categories and EPA's policy on the use of exposure for chemicals that are toxic only at high doses/concentrations.
        II. Background Information
        A. What is TRI?
        EPCRA section 313, 42 U.S.C. 11023, requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to Pollution Prevention Act section 6607, 42 U.S.C. 13106. Note that TRI does not cover all chemicals, facilities, or types of pollution.
        TRI provides information about releases of toxic chemicals from covered facilities throughout the United States; however, TRI data do not reveal whether or to what degree the public is exposed to listed chemicals. TRI data can, in conjunction with other information, be used as a starting point in evaluating such exposures and the risks posed by such exposures. The determination of potential risk to human health and/or the environment depends upon many factors, including the toxicity of the chemical, the fate of the chemical in the environment, and the amount and duration of human or other exposure to the chemical.
        For more information on TRI, visit the TRI website at www.epa.gov/tri. Additionally, via this website, EPA provides a Factors to Consider When Using TRI Data document, which helps explain some of the uses, as well as limitations, of data collected by TRI.
        B. What are PFAS?

        PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon chain on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make them resistant to degradation and thus highly persistent in the environment (Refs. 1 and 2). Some of these chemicals have been used for decades in a wide variety of consumer and industrial products (Ref. 1). Some PFAS have been detected at high levels in wildlife indicating that at least some PFAS have the ability to bioaccumulate (Ref. 2). Some PFAS can accumulate in humans and remain in the human body for long periods of time (e.g., months to years) (Refs. 1, 2, and 3). As noted in EPA's Action Plan (Ref. 1), because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS. As a result, several PFAS have been detected in human blood serum (Refs. 1, 2 and 4).
        C. Why is EPA considering adding PFAS to the TRI?
        Some PFAS may be toxic, persistent in the environment, and accumulate in wildlife and humans. Therefore, releases of some PFAS to the environment and potential human exposure may be of concern. One source of potential exposure to PFAS are releases from industrial facilities that manufacture, process, or otherwise use PFAS. Information on the releases and waste management quantities from such facilities could help EPA and the public identify some potential sources of exposure to PFAS. The TRI is a tool that EPA can use to collect such information. As noted in the EPA Action Plan:

        “Currently, no PFAS chemicals are included on the list of chemicals required to report to TRI; however, the EPA is considering whether to add PFAS chemicals. In considering listing, the EPA must determine whether data and information are available to fulfill the listing criteria and the extent and utility of the data that would be gathered. For example, hazard data required for TRI listing may be readily available for certain PFAS chemicals, but not others. In addition, in considering if TRI will provide useful information to stakeholders, the EPA also will consider if those PFAS are still active in commerce. The process for listing includes notice and comment rulemaking to list PFAS chemicals for reporting prior to adding these chemicals to the TRI for annual reporting.” (Ref. 1)
        As the first step in the process of adding certain PFAS to the TRI, EPA is issuing this ANPRM to allow all stakeholders the opportunity to comment on the various aspects of adding certain PFAS to the TRI toxic chemical list. Note that adding certain PFAS to the TRI could help inform discussions related to risks to human health and the environment but the information collected through TRI, as previously indicated, would not capture all sources of PFAS releases.
        III. What TRI listing actions are being considered?
        Currently, approximately 600 PFAS are manufactured (including imported) and/or used in the United States (Ref. 5). The two PFAS that have been studied the most are perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Due to a voluntary phaseout under the 2010/2015 PFOA Stewardship Program, PFOA and PFOS are no longer produced domestically by the companies participating in the Program. However, PFOA and PFOS may still be produced domestically, imported, and used by companies not participating in the PFOA Stewardship Program (Ref. 6). PFOA and PFOS may also be present in imported articles. PFAS such as hexafluoropropylene oxide (HFPO) dimer acid (Chemical Abstract Service Registry Number (CASRN) 13252-13-6) and its ammonium salt (CASRN 62037-80-3), both commonly referred to as GenX, and perfluorobutane sulfonic acid (PFBS) (CASRN 375-73-5) and its salt potassium perfluorobutane sulfonate (CASRN 29420-49-3)), are some examples of short-chain PFAS that have been developed to replace long-chain PFOA and PFOS, respectively. Compared to PFOA and PFOS, most replacement PFAS tend to have less information available about their potential toxicity to human and ecological populations. Through this ANPRM process, EPA is seeking information to determine which PFAS currently active in commerce have sufficient toxicity information available to meet the EPCRA section 313(d)(2) listing criteria. EPA is considering whether to add any PFAS currently active in commerce for which hazard assessments show that they meet the EPCRA section 313(d)(2) listing criteria. Note that one factor EPA considers when determining whether to add a chemical to the TRI list is whether reporting would occur on the chemical if it were to be added.

        In addition, for any PFAS that meet the listing criteria, EPA is considering adding these compounds to the list of chemicals of special concern (§ 372.28) and establishing lower reporting thresholds. In the past EPA has lowered the reporting thresholds for persistent, bioaccumulative, and toxic (PBT) chemicals (October 29, 1999, 64 FR 58666 (FRL-6389-11)). For PBT chemicals, with one exception, EPA established two reporting thresholds, 100 pounds for PBT chemicals and 10 pounds for highly PBT chemicals (i.e., those PBT chemicals with very high persistence and bioaccumulation values). Certain PFAS may have persistence and bioaccumulation properties similar to other PBT chemicals where even small amounts of release present a concern. To appropriately capture release information of PFAS, EPA is considering establishing reporting thresholds lower than the statutory thresholds of 25,000 pounds for manufacturing or processing and 10,000 pounds for otherwise using listed chemicals.
        PFAS, that meet the ECPRA section 313 listing criteria, could be listed as individual chemicals or as members of PFAS chemical categories. For example, EPA's “Health Effects Support Document for Perfluorooctane Sulfonate (PFOS)” (Ref. 7) states that PFOS (CASRN 1763-23-1) is commonly produced as a potassium salt (CASRN 2795-39-3) and that, while the CASRN given is for linear PFOS, the toxicity studies are commonly based on a mixture of linear and branched PFOS. Therefore, the reference dose (RfD) derived in the 2016 Health Effects Support Document applies to the total linear and branched PFOS. For PFOS it would seem appropriate to create a TRI chemical category that includes all linear and branched isomers of PFOS and any salts of PFOS. PFOA has similar considerations, as may other PFAS that may warrant reporting as a category rather than as individually listed chemicals. EPA may also consider establishing a single chemical category for all PFAS, however, a single category would be of limited use since it would not provide any information about which PFAS are being released and/or managed as waste.
        IV. What are the hazard concerns for PFAS?
        Some PFAS are known to persist in the environment because they are resistant to degradation and have been shown to bioaccumulate in wildlife and humans (Refs. 1 and 2). There are also concerns that some PFAS may cause adverse human health effects, including reproductive, developmental, cancer, liver, immune, thyroid, and other effects (Refs. 1, 2, 8, and 9).
        Based on their physicochemical properties and measured environmental concentrations, some PFAS are considered to be environmentally persistent chemicals (Refs. 1 and 2). In general, most PFAS are resistant to environmental degradation due to their strong carbon-fluorine bonds (Refs. 1 and 2). While PFAS chain length and chemical structure can have implications for environmental fate, PFAS are typically resistant to biodegradation, photooxidation, direct photolysis, and hydrolysis which is consistent with their persistence in soil and water (Ref. 2). Some PFAS, can also degrade or be metabolized to other PFAS such as PFOA or PFOS (Ref. 2). PFAS have been detected in air, surface water, groundwater, drinking water, soil, and food (Ref. 2). The presence of PFAS in many parts of the world, including the Arctic, indicate that long-range transport is possible (Ref. 2).

        Under the TRI, bioaccumulation, to the extent it happens, is part of the hazard concerns and will be considered both in the listing criteria and in considering lower reporting thresholds. Bioconcentration factors (BCFs) estimated from an octanol-water partition coefficient (Kow) or measured in aquatic tests, have typically been used to assess bioaccumulation potential. Kow and the associated BCFs are based on the partitioning of organic chemicals into octanol or lipids. However, for PFAS such as PFOA and PFOS partitioning appears to be more related to their protein binding properties than to their lipophilicity (Refs. 8 and 9). Since Kow does not provide a reliable estimate of bioaccumulation potential for these chemicals, field evidence of bioaccumulation is preferable. Field measured bioaccumulation factors (BAFs), and biomagnification factors (BMFs) or trophic magnification factors (TMFs) are considered more appropriate indicators of the potential for PFAS, such as PFOA and PFOS, to accumulate in fish, other wildlife, and humans (Refs. 8, 9, 10, and 11). The trophic magnification data for PFOA and PFOS was deemed sufficient to consider them to be bioaccumulative by the Stockholm Convention Persistent Organic Pollutants Review Committee in 2015 (Ref. 12).
        While the toxicity of PFOA and PFOS has been studied extensively, there is less data available for other PFAS (Ref. 2). Differences in PFAS chain length and chemical structure can have implications for environmental fate, bioaccumulation, metabolism, and toxicity (Ref. 1). As part of EPA's PFAS Action Plan, the Agency is continuing to collect, systematically review, and evaluate available toxicity data for other PFAS that may help determine whether exposure to structurally similar PFAS results in similar toxic effects (Ref. 1).
        V. What EPA hazard assessments and other toxicity data are available for PFAS?

        To date EPA has published two assessments of PFAS: (1) Health Effects Support Document for Perfluorooctane Sulfonate (PFOS) and (2) Health Effects Support Document for Perfluorooctanoic Acid (PFOA) (Refs. 7 and 13). These two documents could be used to determine whether PFOA, PFOS, and related chemicals (e.g., their salts) meet the EPCRA section 313(d)(2) listing criteria. EPA has also developed two new draft PFAS assessments for public comment: (1) Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3) Also Known as “GenX Chemicals” and (2) Human Health Toxicity Values for Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane Sulfonate (PFBS) (CASRN 29420-49-3) (Refs. 14 and 15). Once these documents are finalized, EPA expects these assessments will provide a basis for determining whether GenX chemicals and PFBS meet the EPCRA section 313(d)(2) listing criteria.
        In addition, EPA is working on hazard assessments for the following PFAS containing varying degrees of available toxicity information relevant for human health assessment purposes: Perfluorononanoic acid (PFNA), perfluorobutanoic acid (PFBA), perfluorodecanoic acid (PFDA), perfluorohexanoic acid (PFHxA), and perfluorohexane sulfonic acid (PFHxS) (Ref. 16). Once finalized, EPA expects these assessments will provide a basis for determining whether these chemicals meet the EPCRA section 313(d)(2) listing criteria.

        EPA has also collected scientific literature on approximately 30 PFAS. This list of PFAS and the available scientific literature is posted at https://hero.epa.gov/hero/index.cfm/litbrowser/public/#PFAS. For some of these PFAS, there may be epidemiological and/or experimental animal toxicity data available for review and evaluation of suitability to inform potential human health effects.

        Lastly, EPA is collaborating with the National Toxicology Program (NTP) to study individual PFAS and PFAS as a chemical class. Specifically, the NTP has conducted toxicology studies to evaluate and identify the adverse effects of certain PFAS chemicals including PFBS, PFHxS, PFOS, PFHxA, PFOA, PFNA, and PFDA (https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm). NTP continues to assess the potential health effects of PFAS through a large multi-faceted research effort (https://ntp.niehs.nih.gov/results/areas/pfas/index.html).
        The Agency relies on EPA hazard assessments and externally peer-reviewed hazard assessments from other federal agencies in making determinations as to whether a chemical meets the EPCRA section 313 listing criteria. EPA will consider all PFAS assessments on the human health and environmental effects of PFAS that are available from all sources, including those being conducted by other federal agencies.
        VI. What information is EPA requesting?

        EPA is seeking comments on which of the approximately 600 PFAS currently active in U.S. commerce the Agency should consider evaluating for potential addition to the EPCRA section 313 list of toxic chemicals. EPA would also like to receive comments on whether there are data available to inform how to list PFAS, i.e., as individual chemical listings, as a single category, as multiple categories or as a combination of individual listings and category listings. Note that when chemicals are listed as a category, the TRI reports submitted would include combined data for all members of the category, such that there are no data reported specific to any individual member of the category.
        EPA is also seeking comments on the appropriate reporting thresholds for PFAS. Reporting thresholds should be set at an appropriate level to capture most of the releases of PFAS from the facilities that submit reports under EPCRA section 313. Finally, EPA would like to receive any additional information on human health and environmental toxicity, persistence, and bioaccumulation of PFAS that would help determine if they meet the EPCRA section 313 listing criteria.
        VII. What are the next steps EPA will take?
        EPA intends to carefully review all the comments and information received in response to this ANPRM, as well as previously collected and assembled studies. Once that review is completed, EPA may supplement the collected information with additional hazard assessments to determine whether some PFAS meet the EPCRA section 313(d)(2) criteria. Should EPA decide to move forward with this action, the next step will be to publish a proposed rule to add certain PFAS to the EPCRA section 313 toxic chemical list and set the appropriate reporting thresholds. At that time, the public will have the opportunity to comment on EPA's proposal.
        VIII. References

        The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

          1. USEPA. EPA's Per- and Polyfluoroalkyl Substances (PFAS) Action Plan. EPA 823R18004. U.S. Environmental Protection Agency, Washington, DC. February 2019. Available from: https://www.epa.gov/pfas/epas-pfas-action-plan.

          2. ATSDR. Agency for Toxic Substances and Disease Registry. Toxicological Profile for Perfluoroalkyls—Draft for Public Comment. June 2018. Available from: https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

          3. USEPA. Basic Information on PFAS. U.S. Environmental Protection Agency, Washington, DC. Available from: https://www.epa.gov/pfas/basic-information-pfas.

          4. Department of Health and Human Services, Centers for Disease Control and Prevention. Fourth National Report on Human Exposure to Environmental Chemicals. Pages 247-257, 2009. Available from: https://www.cdc.gov/exposurereport/pdf/fourthreport.pdf.

          5. USEPA. Toxic Substances Control Act (TSCA) Chemical Substance Inventory. U.S. Environmental Protection Agency, Washington, DC. Available from: https://www.epa.gov/tsca-inventory.

          6. USEPA. Fact Sheet: 2010/2015 PFOA Stewardship Program. Available from: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program.

          7. USEPA. Health Effects Support Document for Perfluorooctane Sulfonate (PFOS). EPA 822-R-16-002. U.S. Environmental Protection Agency, Washington, DC. May 2016. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfos_hesd_final_508.pdf.

          8. USEPA. Drinking Water Health Advisory for Perfluorooctanoic Acid (PFOA). EPA 822-R-16-005. U.S. Environmental Protection Agency, Washington, DC. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.

          9. USEPA. Drinking Water Health Advisory for Perfluorooctane Sulfonate (PFOS). EPA 822-R-16-002. U.S. Environmental Protection Agency, Washington, DC. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfos_health_advisory_final_508.pdf.

          10. USEPA. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000) Technical Support Document Volume 2: Development of National Bioaccumulation Factors. Office of Water, Office of Science and Technology. December 2003 (EPA-822-R-03-030). Available from: https://www.epa.gov/sites/production/files/2018-10/documents/methodology-wqc-protection-hh-2000-volume2.pdf.

          11. Gobas, F.A.P.C., Watze de Wolf, W., Burkhard, L.P., Verbruggen, E., I and Plotzke, K. 2009. Revisiting Bioaccumulation Criteria for POPs and PBT Assessments. Integrated Environmental Assessment and Management—Volume 5, Number 4—pp. 624-637.

          12. UNEP. Proposal to list pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in Annexes A, B and/or C to the Stockholm Convention on Persistent Organic Pollutants. United Nations Environmental Program. 2015. Available from: http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC11/POPRC11Documents/tabid/4573/.

          13. USEPA. Health Effects Support Document for Perfluorooctanoic Acid (PFOA). EPA 822-R-16-003. U.S. Environmental Protection Agency, Washington, DC. May 2016. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_hesd_final-plain.pdf.

          14. USEPA. Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3) Also Known as “GenX Chemicals. Public Comment Draft. EPA-823-P-18-001. U.S. Environmental Protection Agency, Washington, DC. November 2018. Available from: https://www.epa.gov/sites/production/files/2018-11/documents/genx_public_comment_draft_toxicity_assessment_nov2018-508.pdf.

          15. USEPA. Human Health Toxicity Values for Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3). Public Comment Draft. EPA-823-R-18-307. U.S. Environmental Protection Agency, Washington, DC. November 2018. Available from: https://www.epa.gov/sites/production/files/2018-11/documents/pfbs_public_comment_draft_toxicity_assessment_nov2018-508.pdf.

          16. USEPA. IRIS Program Outlook. A Message from the IRIS Program (April 2019). U.S. Environmental Protection Agency, Washington, DC. Available from: https://www.epa.gov/sites/production/files/2019-04/documents/iris_program_outlook_apr2019.pdf.

        IX. Statutory and Executive Order Reviews
        This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Any changes made in response to OMB recommendations have been documented in the docket for this action. Because this action does not propose or impose any requirements, and instead seeks comments and suggestions for the Agency to consider in possibly developing a subsequent proposed rule, the various statutes and Executive Orders that normally apply to rulemaking do not apply in this case. Should EPA subsequently determine to pursue a rulemaking, EPA will address the statutes and Executive Orders as applicable to that rulemaking.

          List of Subjects in 40 CFR Part 372
          Environmental protection, Community right-to-know, Reporting and recordkeeping requirements, and Toxic chemicals.

          Dated: November 25, 2019.
          Andrew R. Wheeler,
          Administrator.

      [FR Doc. 2019-26034 Filed 12-3-19; 8:45 am]
      BILLING CODE 6560-50-P


        POSTAL REGULATORY COMMISSION
        39 CFR Part 3050
        [Docket No. RM2018-9; Order No. 4692]
        Periodic Reporting

          AGENCY:
          Postal Regulatory Commission.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          The Commission is acknowledging a recent filing requesting the Commission initiate an informal rulemaking proceeding to consider changes to an analytical method for use in periodic reporting (Proposal Six). This document informs the public of the filing, invites public comment, and takes other administrative steps.

          DATES:

            Comments are due: August 15, 2018.

          ADDRESSES:

          Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

          FOR FURTHER INFORMATION CONTACT:
          David A. Trissell, General Counsel, at 202-789-6820.

        SUPPLEMENTARY INFORMATION:
        Table of Contents

          I. Introduction
          II. Proposal Six
          III. Notice and Comment
          IV. Ordering Paragraphs

        I. Introduction
        On June 26, 2018, the Postal Service filed a petition pursuant to 39 CFR 3050.11, requesting that the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports.1
           The Petition identifies the proposed analytical changes filed in this docket as Proposal Six.

            1 Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Six), June 26, 2018 (Petition). The Postal Service filed a non-public library reference with Proposal Six. Library Reference USPS-RM2018-9/NP1, Nonpublic Material Relating to Proposal Six, June 26, 2018; Notice of Filing of USPS-RM2018-9/NP1 and Application for Nonpublic Treatment, June 26, 2018.

        II. Proposal Six

          Background. The Postal Service indicates that Proposal Six addresses two issues regarding the treatment of international indemnity payments. Petition, Proposal Six at 1. First, the Postal Service states this proposal “addresses the issue of assigning claims for Priority Mail International (PMI) service to Outbound International Insurance, rather than to the PMI product.” 2

            2 Id. (citing Docket No. ACR2017, United States Postal Service Annual Compliance Report, December 29, 2017, at 71 (FY 2017 ACR)).

        Second, the Postal Service states that Proposal Six responds to a directive in the FY 2017 Annual Compliance Determination report (ACD). Id. In the FY 2017 ACD, the Commission directed the Postal Service to file a report on its “evaluation of Outbound International Insurance cost reporting” within 90 days of the FY 2017 ACD, including a determination of “whether a change in analytical principles is warranted.” 3

            3 Id.; see Annual Compliance Determination Report, Fiscal Year 2017, March 29, 2018, at 88 (FY 2017 ACD).

          Proposal. The Postal Service states that Proposal Six will “expand the distribution of the attributable costs for International Indemnity payments to include International Inbound Indemnity payments.” Petition, Proposal Six at 2. The proposal separates Outbound International Insurance indemnities from Inbound International Insurance indemnities, and “develop[s] separate decision rules for treating the costs relating to Outbound International indemnities and Inbound International indemnities.” Id. Specifically, the Postal Service proposes for Outbound International Insurance indemnities “1) when additional insurance is not purchased, the indemnity cost will be assigned to the base parent product, and 2) when additional insurance is purchased, the indemnity cost will be assigned to the Outbound International Insurance product.” Id. at 4. For Inbound International Insurance, the Postal Service proposes to split these indemnities from Outbound International indemnities and distribute the costs to their respective inbound products. Id. at 5-6.

          Rationale and impact. The Postal Service states that the current cost reporting requires “refinements” which “may not rise to the level of a change in analytical principles.” Id. at 2. It explains that the proposed methodology will correct the prior method of distributing international indemnity payments. Id. The Postal Service identifies the likely effects of Proposal Six on the development of the International Cost and Revenue Analysis (ICRA) report in non-public Library Reference USPS-RM2018-9/NP1. Id. at 2-3. The Petition indicates the proposal shifts costs from Outbound International Insurance to Inbound International Insurance, resulting in an improvement in contribution for Outbound products and a decline in contribution for Inbound products, and provides cell-by-cell differences between the proposed methodology and the data provided in the ICRA as part of the Postal Service's annual compliance report for FY 2017. Id. at 2-6. The Postal Service anticipates the overall net impact would not result in a negative contribution by any product that previously had a positive contribution, but also would not result in a positive contribution by any product that currently has a negative contribution. Id. at 3.
        III. Notice and Comment

        The Commission establishes Docket No. RM2018-9 for consideration of matters raised by the Petition. More information on the Petition may be accessed via the Commission's website at http://www.prc.gov. Interested persons may submit comments on the Petition and Proposal Six no later than August 15, 2018. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is designated as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
        IV. Ordering Paragraphs

          It is ordered:

        1. The Commission establishes Docket No. RM2018-9 for consideration of the matters raised by the Petition of the United States Postal Service for the Initiation of a Proceeding to Consider Proposed Changes in Analytical Principles (Proposal Six), filed June 26, 2018.
        2. Comments by interested persons in this proceeding are due no later than August 15, 2018.
        3. Pursuant to 39 U.S.C. 505, the Commission appoints Kenneth R. Moeller to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

        4. The Secretary shall arrange for publication of this order in the Federal Register.

          By the Commission.
          Ruth Ann Abrams,
          Acting Secretary.

      [FR Doc. 2018-14621 Filed 7-6-18; 8:45 am]
       BILLING CODE 7710-FW-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 679
        RIN 0648-BA18
        Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Management Area; Limited Access Privilege Program

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

          ACTION:
          Notice of availability of fishery management plan amendment; request for comments.

          SUMMARY:
          Amendment 93 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) would amend the Bering Sea and Aleutian Islands Amendment 80 Program to modify the criteria for forming and participating in a harvesting cooperative. This action is necessary to encourage greater participation in harvesting cooperatives, which enable members to more efficiently target species, avoid areas with undesirable bycatch, and improve the quality of products produced. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan, and other applicable law.

          DATES:
          Comments on the amendments must be submitted on or before September 26, 2011.

          ADDRESSES:
          Send comments to James W. Balsiger, Ph.D., Administrator, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by “RIN 0648-BA18,” by any one of the following methods:
          • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov.
          • Mail: P.O. Box 21668, Juneau, AK 99802.
          • Fax: (907) 586-7557.
          • Hand delivery to the Federal Building: 709 West 9th Street, Room 420A, Juneau, AK.

          All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.
          NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe portable document file (pdf) formats only.

          Copies of Amendment 93, the Environmental Assessment (EA), Regulatory Impact Review (RIR), and the Initial Regulatory Flexibility Analysis (IRFA)—collectively known as the Analysis—for this action are available from the Alaska Region Web site at http://alaskafisheries.noaa.gov.

          FOR FURTHER INFORMATION CONTACT:
          Gwen Herrewig, (907) 586-7091.

        SUPPLEMENTARY INFORMATION:

        The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires that each regional fishery management council submit any fishery management plan amendment it prepares to NMFS for review and approval, disapproval, or partial approval by the Secretary of Commerce (Secretary). The Magnuson-Stevens Act also requires that NMFS, upon receiving a fishery management plan amendment, immediately publish a notice in the Federal Register announcing that the amendment is available for public review and comment.
        The Amendment 80 Program for Bering Sea and Aleutian Islands Management Area (BSAI) groundfish fisheries was recommended by the North Pacific Fishery Management Council (Council) in June 2006 as Amendment 80 to the FMP. NMFS published a final rule to implement Amendment 80 on September 14, 2007 (72 FR 52668), and fishing began under the Amendment 80 Program in 2008.
        The Amendment 80 Program is commonly known as a limited access privilege program. Eligible fishery participants may receive exclusive access to specific fishery resources if specific conditions are met. Under the Amendment 80 Program, NMFS issues a quota share (QS) permit to a person holding the catch history of an original qualifying non-American Fisheries Act trawl catcher/processor that met specific criteria designated by Congress under the Capacity Reduction Program (CRP) (Pub. L. 108-447). NMFS determined that 28 vessels met the criteria specified in the CRP. These vessels comprise the originally qualifying Amendment 80 vessels. Each of the 28 originally qualifying Amendment 80 vessels may be issued a QS permit by NMFS based on their catch history of the six Amendment 80 species (Atka mackerel, Aleutian Islands Pacific ocean perch, flathead sole, Pacific cod, rock sole, and yellowfin sole) in the BSAI, if the Amendment 80 vessel owner applies to NMFS to receive a QS permit.
        Under the Amendment 80 Program, NMFS allocates a specific portion of the BSAI total allowable catch (TAC) for harvest by QS holders, the Amendment 80 sector, for each of the six defined Amendment 80 species. In addition, NMFS allocates a specific portion of the allowable bycatch of BSAI halibut, Bristol Bay red king crab, snow crab, and Tanner crab to the Amendment 80 sector. This allowable bycatch is commonly known as prohibited species catch (PSC) because these species may not be retained, but are known to be incidentally taken in BSAI trawl fisheries.
        Each year, a person assigns each QS permit, Amendment 80 vessel, and any associated license limitation program (LLP) licenses to either an Amendment 80 cooperative, or the Amendment 80 limited access fishery. Generally, the Amendment 80 Program is intended to facilitate the formation of cooperatives that will receive exclusive harvest privileges for a portion of the Amendment 80 species TAC and PSC known as cooperative quota (CQ). A person who does not choose to join a harvesting cooperative must fish in the Amendment 80 limited access fishery, without an exclusive harvest privilege, and must continue to race for fish with other participants in that fishery.
        In order to form a cooperative, the cooperative must apply for a CQ permit by November 1 of the year prior to fishing. The cooperative must be comprised of:
        • At least three unique persons not affiliated with one another through direct or indirect ownership of more than 10 percent; and
        • At least nine (of the 28 potentially available) QS permits in the Amendment 80 sector must be assigned to the cooperative.

        Amendment 93 would result in two modifications to the Amendment 80 Program. First, it would allow a cooperative to form with a minimum of two unique persons holding seven QS permits. The current requirement is that a minimum of three unique persons and nine QS permits must be assigned to a cooperative. Reducing the number of unique persons and number of QS permits can provide additional opportunities for QS holders to establish cooperative relationships that could reduce the number of participants engaged in the race for fish.
        Second, Amendment 93 would require that a person holding multiple QS permits, Amendment 80 vessels, and LLP licenses assign all of those QS permits, vessels, and LLP licenses to either one or more cooperatives or the limited access fishery. Under this proposed change, an Amendment 80 QS permit holder would be prohibited from assigning some QS permits to one or more cooperatives and some to the limited access fishery. Under the current provisions, a vessel owner participating in both a cooperative and the limited access fishery has an incentive to exclude participants in the limited access fishery from joining an existing cooperative or creating an additional cooperative because the vessel owner could lose access to fish that would otherwise be available in the Amendment 80 limited access fishery. This provision would reduce the incentive for a cooperative member to exclude another person from forming a cooperative in order to force them into a race for fish in the limited access fishery. If approved, this provision would not be applicable until the first fishing year 2 years after the effective date of the final rule implementing Amendment 93. For example, if the final rule became effective in October 2011, this requirement would not apply until the start of the 2014 fishing year and QS holders would have to assign all QS permits and vessels to either a cooperative or the limited access fishery by the Amendment 80 annual cooperative application deadline of November 1, 2013.

        Public comments are being solicited on proposed Amendment 93 through the end of the comment period (see DATES). NMFS intends to publish a proposed rule in the Federal Register for public comment that would implement Amendment 93, following NMFS evaluation under the Magnuson-Stevens Act procedures. Public comments on the proposed rule must be received by the close of the comment period on Amendment 93 to be considered in the approval/disapproval decision on Amendment 93. All comments received by the end of the comment period on Amendment 93, whether specifically directed to the FMP amendment or the proposed rule, will be considered in the approval/disapproval decision on Amendment 93. Comments received after the end of the public comment period for Amendment 93, even if received within the comment period for the proposed rule, will not be considered in the approval/disapproval decision on the Amendment. To be considered, comments must be received by NMFS, not just postmarked or otherwise transmitted, by the close of business on the last day of the comment period.

          Authority:
           16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447.

          Dated: July 25, 2011.
           Margo Schulze-Haugen,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 2011-19126 Filed 7-27-11; 8:45 am]
      BILLING CODE 3510-22-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 660
        [Docket No. 160617540-6540-01]
        RIN 0648-XE695
        Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Annual Specifications; Correction

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

          ACTION:
          Proposed rule; correction.

          SUMMARY:
          This document corrects a typographical error in the ADDRESSES section to a proposed rule published on June 23, 2016.

          DATES:
          Comments on the proposed rule must be submitted on or before July 25, 2016.

          ADDRESSES:
          You may submit comments on this document identified by NOAA-NMFS-2016-0048, by any of the following methods:
          • Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0048, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.
          • Mail: Submit written comments to William W. Stelle, Jr., Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070; Attn: Joshua Lindsay.

            Instructions: Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Copies of the report “Pacific Mackerel (Scomber japonicus) Stock Assessment for USA Management in the 2015-2016 Fishing Year” may be obtained from the West Coast Region (see ADDRESSES).

          FOR FURTHER INFORMATION CONTACT:
          Joshua Lindsay, West Coast Region, NMFS, (562) 980-4034, Joshua.Lindsay@noaa.gov.

        SUPPLEMENTARY INFORMATION:
        Need for Correction
        In the ADDRESSES section of a proposed rule (81 FR 40844, June 23, 2016) on page 40845, in the first column, NMFS used an incorrect year, “2015” rather than “2016”, in the document identifier and Federal e-Rulemaking Portal hyperlink. The ADDRESSES section has been corrected in this document.

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

          Dated: July 14, 2016.
          Samuel D. Rauch III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

      [FR Doc. 2016-17130 Filed 7-19-16; 8:45 am]
       BILLING CODE 3510-22-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        [Docket: CDC-2012-0010]
        42 CFR Part 73
        Influenza Viruses Containing the Hemagglutinin From the Goose/Guangdong/1/96 Lineage

          AGENCY:
          Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

          ACTION:
          Request for information; reopening of comment period.

          SUMMARY:
          With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the re-opening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.

          DATES:
          Written or electronic comments must be received on or before March 11, 2013.

          ADDRESSES:
          You may submit comments, identified by Docket Number CDC-2012-0010, by any of the following methods
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
          • Mail: Centers for Disease Control and Prevention, Select Agent Program, 1600 Clifton Road NE., Mailstop A-46, Atlanta, Georgia 30333, ATTN: Docket No. CDC-2012-0010.

            Instructions: All submissions received must include the agency name and RIN for this rulemaking. All relevant comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

            Docket Access: For access to the docket to read background documents or comments received or to download an electronic version of the NPRM, go to http://www.regulations.gov. Comments will be available for public inspection Monday through Friday, except for legal holidays, from 9 a.m. until 5 p.m. at 1600 Clifton Road NE., Atlanta, GA, 30333. Please call ahead to 1-866-694-4867 and ask for a representative in the Division of Select Agents and Toxins to schedule your visit. Our general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet as they are received and without change.

          FOR FURTHER INFORMATION CONTACT:
          Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS A-46, Atlanta, Georgia 30333. Telephone: (404) 718-2000.

        SUPPLEMENTARY INFORMATION:

        On October 17, 2012, the Centers for Disease Control and Prevention(CDC), located within the Department of Health and Human Services (HHS) published a request for information and comment in the Federal Register (77 FR 63783) to obtain information and comments from the public to questions concerning highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We have re-opened the comment period to allow interested persons additional time to prepare and submit comments. We will also accept comments received between December 18, 2012 (the day after the close of the original comment period) and the date of this notice.

          Dated: February 4, 2013.
          Kathleen Sebelius,
          Secretary.

      [FR Doc. 2013-02828 Filed 2-7-13; 8:45 am]
      BILLING CODE 4163-18-P