Endocrine Disruptor Screening Program; Final Second List of Chemicals and Substances for Tier 1 Screening, 35922-35928 [2013-14232]

Download as PDF 35922 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices Environmental Endocrine Disruptor Screening Program; Review of the Endocrine Disruptor Screening Program by a Joint Subcommittee of the Science Advisory Board and Scientific Advisory Panel. July 1999. EPA publication number EPA–SAB–EC–99–013. Available at https://www.epa.gov/endo/ pubs/sab_sap_report.pdf. 15. EPA. U.S. Environmental Protection Agency Endocrine Disruptor Screening Program Comprehensive Management Plan. June 2012. Available at https:// www.epa.gov/endo/pubs/EDSPcomprehensive-management-plan.pdf. 16. EPA. At a Glance: Issuing EDSP Second List Orders. (March 28, 2013). 17. EPA. Chemical Data Reporting Web site at https://www.epa.gov/oppt/cdr. 18. EPA. Status of EDSP Orders/DCIs as of Wednesday, January 2, 2013. 19. EPA. Sample Form: ‘‘FFDCA § 408(p) Order for SDWA § 1457 Chemicals— Initial Response Form for Individual Order Recipients’’ (EPA Form No. 6300– 06). March 27, 2013. Available in Attachment D(3) to the ICR in Docket ID Number EPA–HQ–OPPT–2013–0275. 20. EPA. OCSPP Harmonized Test Guidelines Web site at https://www.epa.gov/ocspp/ pubs/frs/home/testmeth.htm. 21. EPA. Sample Form: ‘‘FFDCA § 408(p) Order for SDWA § 1457 Chemicals— Initial Response Form for Consortium’’ (EPA Form No. 6300–06–C). March 27, 2013. Available in Attachment D(4) to the ICR in Docket ID Number EPA–HQ– OPPT–2013–0275. 22. EPA. Central Data Exchange Web site at https://www.epa.gov/cdx. 23. EPA. Claims of Confidentiality of Certain Chemical Identities Submitted under Section 8(e) of the Toxic Substances Control Act; Notice. Federal Register (75 FR 3462, January 21, 2010) (FRL–8807– 9). List of Subjects Environmental protection, Chemicals, Endocrine disruptors, Pesticides and pests, Safe drinking water, Reporting and recordkeeping. Dated: May 29, 2013. James Jones, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2013–14228 Filed 6–13–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY mstockstill on DSK4VPTVN1PROD with NOTICES [EPA–HQ–OPPT–2009–0477; FRL–9375–8] Endocrine Disruptor Screening Program; Final Second List of Chemicals and Substances for Tier 1 Screening Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 SUMMARY: This document announces the final second list of 109 chemicals identified for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. FOR FURTHER INFORMATION CONTACT: For technical information contact: Hannah Holsinger, Office of Water, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001 (MC–4607M); telephone number: (202) 564–0403, email address: holsinger.hannah@epa.gov, or Pat West, Office of Science Coordination and Policy, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001 (MC– 7201M); telephone number: (202) 564– 1656, email address: west.pat@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCAHotline@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you produce, manufacture, use, or import chemicals (including pesticide chemicals) that may be found in sources of drinking water; if you manufacture or import chemicals that degrade to chemicals found in sources of drinking water; or if you are, or may otherwise be, involved in the testing of chemicals for potential endocrine effects. 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: • Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances. • Pesticide, fertilizer, and other agricultural chemical manufacturers (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals. • Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 of chemical substances for endocrine effects. B. How can I get copies of this document and other related information? The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2009–0477, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at https:// www.epa.gov/dockets. II. Background A. What action is the agency taking? This document announces the final second list of 109 chemicals identified for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. After considering comments received on the draft second list of chemicals and substances published in the Federal Register notice of November 17, 2010 (75 FR 70248) (FRL–8848–7) (Ref. 1), EPA is announcing the final list of the second group of chemicals that will be subject to screening based on the approach described in the notice— ‘‘Endocrine Disruptor Screening Program; Final Policies and Procedures for Screening Safe Drinking Water Act (SDWA) Chemicals,’’ published elsewhere in today’s Federal Register. The EDSP consists of a two-tiered approach to screen and test chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening is to identify substances that have the potential to interact with the endocrine system (specifically the estrogen, androgen, or thyroid hormone systems) using a battery of assays. Substances that have the potential to interact with estrogen, androgen or thyroid systems may proceed to Tier 2, which is designed to identify any adverse endocrine-related effects caused by the E:\FR\FM\14JNN1.SGM 14JNN1 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES substance, and establish a quantitative relationship between the dose and that endocrine effect. This second list should not be construed as a list of known or likely endocrine disruptors. Nothing in the approach for generating the second list provides a basis to infer that by simply being on this list these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so. In a separate notice published elsewhere in today’s Federal Register, EPA describes other aspects of EDSP such as the administrative procedures that EPA will use to require testing. The second group of chemicals to be tested consists of chemicals that section 408(p) of the FFDCA (Ref. 2) requires be screened, i.e., pesticide active ingredients and chemicals used as pesticide inert ingredients (also known as other ingredients) and section 1457 of the 1996 amendment to the SDWA (Ref. 3). EPA developed this final list using the approach outlined in the Federal Register notice announcing the draft second list of chemicals and substances (Ref. 1). More information on EPA’s priority setting approach is available at https://www.epa.gov/scipoly/oscpendo/ pubs/prioritysetting. This document does not describe other aspects of EDSP such as the administrative procedures EPA generally intends to use to require testing, the validated tests and battery that will be included in EDSP, or the timeframe for requiring the testing or receiving the data. The administrative procedures that EPA generally intends to use are described in a separate notice published elsewhere in today’s Federal Register. The remaining topics will be addressed in separate notices that will be subsequently published in the Federal Register. B. What is the agency’s authority for taking this action? FFDCA section 408(p) requires EPA to ‘‘develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate’’ (21 U.S.C. 346a(p)). Section 408(p)(3) generally requires EPA to ‘‘provide for the testing of all pesticide chemicals’’ and gives EPA discretionary authority to ‘‘provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 to such a substance’’ (21 U.S.C. 346a(p)(3)). The statute also authorizes EPA to exempt a chemical upon a determination that ‘‘the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.’’ (21 U.S.C. 346a(p)(4)). Section 1457 of SDWA states that ‘‘in addition to the substances’’ referred to in FFDCA section 408(p)(3)(B), ‘‘the Administrator may provide for testing under the screening program authorized by section 408(p) of such Act, in accordance with the provisions of section 408(p) of such Act, of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance’’ (42 U.S.C. 300j–17). EPA used its authority under SDWA to identify a portion of the chemicals on the second EDSP list. III. History EPA developed EDSP in response to a Congressional mandate in FFDCA ‘‘to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate’’ (21 U.S.C. 346a(p)). Unit II.B. describes the authority for listing a chemical. As part of EDSP, EPA issues orders to collect certain test data on selected chemical substances. In general, EPA intends to use the data collected under EDSP, along with other information, to determine if a pesticide chemical or other substances may pose a risk to human health or the environment due to disruption of the endocrine system. The determination that a chemical does or is not likely to have the potential to interact with the endocrine system will be made on a weight-of-evidence basis taking into account data from the Tier 1 assays and/ or other scientifically relevant information. Chemicals that go through Tier 1 screening and are found to have the potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to the next state of EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect. Further information regarding EDSP and requirements for Tier 1 and Tier 2 testing can be found on the Agency’s EDSP Web site, at https://www.epa.gov/endo/. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 35923 IV. Development of the Second EDSP List The House Appropriations Committee report for EPA’s FY 2010 appropriations (H.R. 2996, H. Rept. 111–180) (Ref. 4), directed EPA to publish within 1 year of enactment a second list of no less than 100 chemicals for screening that includes drinking water contaminants, such as halogenated organic chemicals, dioxins, flame retardants polybrominated diphenyl ethers, polychlorinated biphenyls, perfluorocarbons (PFCs), plastics, bisphenol A, pharmaceuticals and personal care products, and issue 25 orders per year for the testing of these chemicals. This process also should allow for public input. In response, EPA published a draft second list of chemicals for Tier 1 screening on November 17, 2010 and solicited public comments on the list of chemicals. The development of the draft second list is described at length in that Federal Register notice (Ref. 1). EPA received comment letters from approximately 60 organizations or individuals on the November 17, 2010 draft second EDSP list. These organizations/individuals included a water-related association, environmental advocacy groups, chemical industry, consumer and pet advocacy groups, and consultants writing on behalf of the industry. This notice summarizes major comments EPA received, along with the Agency’s response. A complete listing of public comments and EPA’s responses related to the draft second list of chemicals for Tier 1 screening are included in the document entitled ‘‘Final Comment Response Document for the Second Endocrine Disruptor Screening Program List (Categorized Public Comments).’’ The document is available in the docket for this action under docket ID number EPA–HQ–OPPT–2009–0477. A. SDWA 1457 Some commenters stated that EPA had not met the requirements of SDWA 1457 when listing the draft second EDSP list. They stated that a chemical’s inclusion on the third Contaminant Candidate List (CCL3) does not mean that the chemical meets SDWA 1457 requirements. SDWA 1457 states that ‘‘the Administrator may provide for testing under the screening program authorized by section 408(p) of such Act, . . . of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.’’ SDWA section 1457 sets forth the criteria for E:\FR\FM\14JNN1.SGM 14JNN1 35924 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices the selection of substances for EDSP. Section 1457 does not require the Agency to promulgate regulations further defining these criteria. For the EDSP, EPA selected contaminants from the CCL3, for which EPA had evaluated the nature of the occurrence and prevalence information (Ref. 5), and selected contaminants from National Primary Drinking Water Regulations (NPDWRs), which were designated by Congress for regulation due to concerns about occurrence in drinking water and adverse impacts on human health. The scientific basis for EPA’s selection of contaminants on the CCL3 also provides the basis for EPA’s determination that a chemical may be found in sources of drinking water to which a substantial population may be exposed for the purposes of SDWA section 1457. mstockstill on DSK4VPTVN1PROD with NOTICES B. Support for Contaminants Listed in the Draft Second List The Agency received comments supporting the contaminants included on the draft second EDSP list. One commenter stated that the draft second EDSP list was an appropriate starting point since it was developed from existing NPDWRs and the CCL3. Another commenter acknowledged that many of the chemicals included on the draft second EDSP list have already undergone a rigorous review within the Agency for exposure potential in vulnerable populations and noted there is incomplete toxicity data for the general population. The commenter stated that EDSP will contribute important information about endocrine disrupting potential of chemicals which have never been tested for sensitive endpoints in estrogen, androgen, and thyroid hormone disruption. C. Exclusion or Inclusion of Contaminants EPA received comments concerning contaminants that are no longer manufactured or that have been cancelled (banned), indicating these should be removed from the list. EPA also received comments related to chemicals with physiochemical properties that would likely result in test assay incompatibility issues. EPA agrees that contaminants derived from chemicals that have been banned or are no longer manufactured should be removed from the list. EPA has generally determined that it would be reasonable to prioritize testing for those compounds which a manufacturer, importer, or registrant is clearly identifiable and the Agency could order these entities to conduct the testing. Chemicals that have been banned or are VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 no longer manufactured (or imported) do not fit within this category. EPA also agrees that it would be reasonable to exclude chemicals from the second list based on the highly reactive physiochemical properties of the chemicals and test assay incompatibility issues. The exclusion rationales for streamlining the second EDSP list are discussed in the Federal Register notice for the draft second list (Ref. 1). Table 1 of this notice contains a list of chemicals that EPA believes should be removed from the final second list because they are no longer manufactured, are banned chemicals, or the chemicals have physiological properties that make them highly reactive and incompatible with the testing assays. Other chemicals remain on the list as they are still in use and may be found in sources of drinking water (see Unit IV.A. of this notice). Other comments EPA received stated those chemicals with a maximum contaminant level goal of zero should be removed. EPA recognizes that it may not be possible to set more stringent levels for some of these chemicals at this time. However, it is important to note that most of the chemicals with maximum contaminant level goals of zero are based on chronic health endpoints and compounds with endocrine disrupting effects that can be subchronic. Also, it would be important to understand whether a chemical might be an endocrine disruptor with subchronic impacts since this may inform the Agency’s risk assessment and how best to address this contaminant from a regulatory standpoint. In addition, if endocrine effects occur at a level lower than the current maximum contaminant level, the Agency might consider whether improvements in analytical feasibility, which would allow measurements at the level of endocrine effects, have been developed since the promulgation of the existing MCLs. EPA also received comments stating that the Agency should have included some chemicals (e.g., triclosan, alkylphenols and alkylphenol polyethoxylates, bisphenol A, musk fragrances, and pharmaceutical estrogens) with known or suspected endocrine disrupting effects on the second list. When compiling the second EDSP list, EPA focused on priority drinking water contaminants and pesticides previously identified by EPA. These priority chemicals included the CCL3 chemicals, chemicals with NPDWRs, and registration review pesticides. The basis for chemical selection is described in the Federal Register notice for the draft second list (Ref. 1). While the chemicals mentioned PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 in the comments were not included on the current EDSP list, they may be included on future EDSP lists. Several of the chemicals suggested by commenters were evaluated as part of the CCL3 process but did not make the final CCL3 for reasons that are outlined in EPA supporting documents ‘‘Final Contaminant Candidate List 3 Chemicals: Identifying the Universe, Final Contaminant Candidate List 3 Chemicals: Screening to a PCCL,’’ and ‘‘Final Contaminant Candidate List 3 Chemicals: PCCL to CCL’’ (Refs. 6, 7, and 8). As for the current approach for selecting chemicals for the second EDSP list, EPA excluded chemicals that are hormones with confirmed effects as stated in the Federal Register notice for the draft second list (Ref. 1). EPA did not give weight to information on the potential for a chemical to cause endocrine effects as criteria for listing as the purpose of the second EDSP list is to identify substances that have the potential to interact with the endocrine system using appropriate validated test systems and other scientifically relevant information. The final second EDSP list should neither be construed as a list of known or likely endocrine disruptors nor characterized as such. Some commenters also stated that naturally occurring contaminants should be excluded from the draft second EDSP list. EPA sought and used the best available information regarding all substances on the draft second EDSP list, including those that have the potential to naturally occur. Although EPA acknowledges that some substances on the list (e.g., acetaldehyde, acrylamide, methanol, and perchlorate) can occur naturally in the environment, this is not the only known pathway of occurrence for these chemicals to enter into the environment. A basis for chemical selection includes selecting substances that are known or anticipated to occur in public drinking water. Anthropogenic pathways for these chemicals to enter the environment are shown through data from the Toxic Release Inventory (TRI), Chemical Update System/Inventory Update Rule (CUS/IUR), and chemical manufacturing information. Consequently, EPA does not believe that the fact that these chemicals can occur naturally is sufficient reason to exclude the manufacturers and importers of these chemicals from conducting the necessary testing. D. Pesticide Registration Review Issues EPA received comments stating that pesticide active ingredients should not be included on EDSP list and suggesting E:\FR\FM\14JNN1.SGM 14JNN1 35925 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices that issuance of test orders should align with pesticide registration review schedules. The Agency is working toward integrating EDSP and the Registration Review Program, such that the data gathering may be completed in a coordinated manner under these two programs to permit a timely registration review decision inclusive of EDSP and not rely on the fixed chemical list approach for active ingredients. Ultimately, EPA intends that chemicals scheduled for registration review may receive EDSP test orders and the data submitted in response to those orders are coordinated with the submission of data required under registration review. The Agency may then review and evaluate the data submitted for both programs in the same time frame, complete the risk assessment with EDSP outcomes as appropriate, and likely conclude registration review for a given chemical within the schedule, enhancing efficiency. Currently, however, EPA does not have an information collection request (ICR) clearance to issue orders to require EDSP testing generally for registration review chemicals. While the ICR clearance process continues, EPA continues to rely on the chemical list approach for the fiscal year 2007/2008 registration review chemicals in an attempt to begin to address EDSP testing for the early registration review chemicals. V. The Final Second List of Chemicals and Substances for Tier 1 Screening A. Chemicals and Substances Removed From the Draft Second List for Tier 1 Screening EPA removed 25 chemicals and substances from the draft second list based on two of the criteria published in the November 17, 2010 issue of the Federal Register, (Ref. 1): 1. Chemicals for which the manufacturer, importer or registrant cannot be clearly identified (criterion two). 2. Chemicals not likely to be biologically active or which are incompatible with testing assays for various reasons due to one or more of their physiochemical properties (criterion five). EPA reevaluated the draft second list of chemicals and substances based on public comments and determined that sufficient data exist to remove a total of 25 additional contaminants based on criterion two (n=21) and criterion five (n=4). Table 1 presents an alphabetized list of 25 chemicals and substances EPA removed from the original list of 134 proposed for Tier 1 screening and provides the rationale for removal. Although these chemicals have been removed from the second group of chemicals and substances that EPA will screen, it is important to note that the removal of these chemicals and substances does not imply that the Agency has no interest in the potential for endocrine disruption activity for these contaminants. At this time the Agency realizes that there is some difficulty with collecting the information about endocrine effects through EDSP because of the Agency’s inability to identify a manufacturer, importer, or registrant or because the contaminant is incompatible with the testing assays. TABLE 1—CHEMICALS REMOVED FROM DRAFT SECOND EDSP LIST Chemical name CAS Reg No. SDWA PAI Rationale Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Physiochemical properties—highly reactive; incompatible with the testing assays. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Physiochemical properties—highly reactive; incompatible with the testing assays. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. 96–12–8 X ........................ 2. 2, 4, 5–TP (Silvex) ................................... 93–72–1 X ........................ 3. Benzyl chloride ........................................ 100–44–7 X ........................ 4. Chlordane ................................................ 57–74–9 X ........................ 5. Cumene hydroperoxide ........................... 80–15–9 X ........................ 6. Dalapon ................................................... 75–99–0 X ........................ 7. Dimethipin ................................................ 55290–64–7 X ........................ 8. Dinoseb .................................................... 88–85–7 X ........................ 9. Endrin ...................................................... 72–20–8 X ........................ 10. Ethylene dibromide (EDB) ..................... mstockstill on DSK4VPTVN1PROD with NOTICES 1. 1, 2-Dibormo-3-chlorproprane (DBCP) .... 106–93–4 X ........................ 11. Fenamiphos ........................................... 22224–92–6 X X 12. Fenarimol ............................................... 60168–88–9 ........................ X 13. Fenoxycarb ............................................ 72490–01–8 ........................ X VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 35926 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices TABLE 1—CHEMICALS REMOVED FROM DRAFT SECOND EDSP LIST—Continued Chemical name CAS Reg No. SDWA PAI Rationale Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Physiochemical properties—highly reactive; incompatible with the testing assays. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely. Physiochemical properties—highly reactive; incompatible with the testing assays. 14. Heptachlor ............................................. 76–44–8 X ........................ 15. Heptachlor epoxide ................................ 1024–57–3 X ........................ 16. Methoxychlor ......................................... 72–43–5 X ........................ 17. Molinate ................................................. 2212–67–1 X ........................ 18. Oxirane, methyl- .................................... 75–56–9 X ........................ 19. Propetamphos ....................................... 31218–83–4 ........................ X 20. Pyridate .................................................. 55512–33–9 ........................ X 21. Sodium tetrathiocarbonate .................... 7345–69–9 ........................ X 22. Sulfosate ................................................ 81591–81–3 ........................ X 23. Temephos .............................................. 3383–96–8 ........................ X 24. Toxaphene ............................................. 8001–35–2 X ........................ 25. Triethylamine ......................................... 121–44–8 X ........................ Endnotes—Table 1: • TRI contains information on toxic chemical releases from facilities that meet reporting criteria (for most chemicals the thresholds are 25,000 pounds for manufacturing and processing and 10,000 pounds for use). • IUR contains site and manufacturing information for chemicals manufactured (including imported) in amounts of 25,000 pounds or greater at a single site. B. The Final Second List of Chemical and Substances for EDSP Tier 1 Screening Table 2 presents an alphabetized list of the 109 chemicals and substances included in the final second EDSP list of chemicals for Tier 1 screening. As in the draft second list, the final list includes pesticides, two PFCs, and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). The list also consists of an array of other chemicals ranging from those used for industrial manufacturing processes, as plasticizers, or in the production of pharmaceutical, personal care products, and toxic substances. Because this list of chemicals was selected on the basis of exposure potential only, it should neither be construed as a list of known or likely endocrine disruptors nor characterized as such. TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING mstockstill on DSK4VPTVN1PROD with NOTICES Chemical name CAS Reg No. 1. 1,1,1,2-Tetrachloroethane ................................................................................................. 2. 1,1,1-Trichloroethane ......................................................................................................... 3. 1,1,2-Trichloroethane ......................................................................................................... 4. 1,1-Dichloroethane ............................................................................................................ 5. 1,1-Dichloroethylene .......................................................................................................... 6. 1,2,3-Trichloropropane ...................................................................................................... 7. 1,2,4-Trichlorobenzene ...................................................................................................... 8. 1,2-Dichloroethane ............................................................................................................ 9. 1,2-Dichloropropane .......................................................................................................... 10. 1,3-Dinitrobenzene .......................................................................................................... 11. 1,4-Dioxane ..................................................................................................................... 12. 1-Butanol ......................................................................................................................... 13. 2-Methoxyethanol ............................................................................................................ 14. 2-Propen-1-ol ................................................................................................................... 15. 4,4’-Methylenedianiline .................................................................................................... 16. Acetaldehyde ................................................................................................................... VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 630–20–6 71–55–6 79–00–5 75–34–3 75–35–4 96–18–4 120–82–1 107–06–2 78–87–5 99–65–0 123–91–1 71–36–3 109–86–4 107–18–6 101–77–9 75–07–0 E:\FR\FM\14JNN1.SGM 14JNN1 SDWA PAI X X X X X X X X X X X X X X X X ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ 35927 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING—Continued mstockstill on DSK4VPTVN1PROD with NOTICES Chemical name 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. CAS Reg No. Acetamide ........................................................................................................................ Acetochlor ........................................................................................................................ Acetochlor ethanesulfonic acid (ESA) ............................................................................. Acetochlor oxanilic acid (OA) .......................................................................................... Acrolein ............................................................................................................................ Acrylamide ....................................................................................................................... Alachlor ............................................................................................................................ Alachlor ethanesulfonic acid (ESA) ................................................................................. Alachlor oxanilic acid (OA) .............................................................................................. alpha-Hexachlorocyclohexane ......................................................................................... Aniline .............................................................................................................................. Bensulide ......................................................................................................................... Benzene ........................................................................................................................... Benzo(a)pyrene (PAHs) .................................................................................................. Butylated hydroxyanisole ................................................................................................. Carbon tetrachloride ........................................................................................................ Chlorobenzene ................................................................................................................ cis-1,2-Dichloroethylene .................................................................................................. Clethodim ......................................................................................................................... Clofentezine ..................................................................................................................... Clomazone ....................................................................................................................... Coumaphos ..................................................................................................................... Cyanamide ....................................................................................................................... Cyromazine ...................................................................................................................... Denatonium saccharide ................................................................................................... Di(2-ethylhexyl) adipate ................................................................................................... Dichloromethane .............................................................................................................. Dicrotophos ...................................................................................................................... Diuron .............................................................................................................................. Endothall .......................................................................................................................... Epichlorohydrin ................................................................................................................ Erythromycin .................................................................................................................... Ethylbenzene ................................................................................................................... Ethylene glycol ................................................................................................................ Ethylene thiourea ............................................................................................................. Ethylurethane ................................................................................................................... Etofenprox ....................................................................................................................... Fenoxaprop-P-ethyl ......................................................................................................... Flumetsulam .................................................................................................................... Fomesafen sodium .......................................................................................................... Fosetyl-Al (Aliette) ........................................................................................................... Glufosinate ammonium .................................................................................................... HCFC–22 ......................................................................................................................... Hexachlorobenzene ......................................................................................................... Hexachlorocyclopentadiene ............................................................................................. Hexane ............................................................................................................................ Hexythiazox ..................................................................................................................... Hydrazine ......................................................................................................................... Isoxaben .......................................................................................................................... Lactofen ........................................................................................................................... Lindane ............................................................................................................................ Methanol .......................................................................................................................... Methyl tert-butyl ether ...................................................................................................... Metolachlor ethanesulfonic acid (ESA) ........................................................................... Metolachlor oxanilic acid (OA) ........................................................................................ Nitrobenzene ................................................................................................................... Nitroglycerin ..................................................................................................................... N-Methyl-2-pyrrolidone .................................................................................................... N-Nitrosodimethylamine (NDMA) .................................................................................... n-Propylbenzene .............................................................................................................. o-Dichlorobenzene ........................................................................................................... o-Toluidine ....................................................................................................................... Oxydemeton-methyl ......................................................................................................... Oxyfluorfen ...................................................................................................................... Paclobutrazol ................................................................................................................... p-Dichlorobenzene ........................................................................................................... Pentachlorophenol ........................................................................................................... Perchlorate ...................................................................................................................... Perfluorooctane sulfonic acid (PFOS) ............................................................................. Perfluorooctanoic acid (PFOA) ........................................................................................ Picloram ........................................................................................................................... Polychlorinated biphenyls ................................................................................................ VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 60–35–5 34256–82–1 187022–11–3 194992–44–4 107–02–8 79–06–1 15972–60–8 142363–53–9 171262–17–2 319–84–6 62–53–3 741–58–2 71–43–2 50–32–8 25013–16–5 56–23–5 108–90–7 156–59–2 99129–21–2 74115–24–5 81777–89–1 56–72–4 420–04–2 66215–27–8 90823–38–4 103–23–1 75–09–2 141–66–2 330–54–1 145–73–3 106–89–8 114–07–8 100–41–4 107–21–1 96–45–7 51–79–6 80844–07–1 71283–80–2 98967–40–9 108731–70–0 39148–24–8 77182–82–2 75–45–6 118–74–1 77–47–4 110–54–3 78587–05–0 302–01–2 82558–50–7 77501–63–4 58–89–9 67–56–1 1634–04–4 171118–09–5 152019–73–3 98–95–3 55–63–0 872–50–4 62–75–9 103–65–1 95–50–1 95–53–4 301–12–2 42874–03–3 76738–62–0 106–46–7 87–86–5 14797–73–0 1763–23–1 335–67–1 1918–02–1 1336–36–3 E:\FR\FM\14JNN1.SGM 14JNN1 SDWA PAI X X X X X X X X X X X X X X X X X X X ........................ ........................ ........................ ........................ ........................ ........................ X X X X X X X X X X X ........................ ........................ ........................ ........................ ........................ ........................ X X X X ........................ X ........................ ........................ X X X X X X X X X X X X X X ........................ X X X X X X X ........................ X ........................ ........................ X ........................ X ........................ ........................ ........................ ........................ X ........................ ........................ ........................ ........................ ........................ ........................ X X X X X X X ........................ ........................ X X X ........................ ........................ ........................ ........................ ........................ ........................ X X X X X X ........................ ........................ ........................ ........................ X ........................ X X ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ X X X X X ........................ ........................ ........................ X ........................ 35928 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING—Continued Chemical name CAS Reg No. 89. Profenofos ....................................................................................................................... 90. Propionic acid .................................................................................................................. 91. Quinclorac ........................................................................................................................ 92. Quinoline .......................................................................................................................... 93. Quizalofop-P-ethyl ........................................................................................................... 94. RDX ................................................................................................................................. 95. sec-Butylbenzene ............................................................................................................ 96. Styrene ............................................................................................................................ 97. Terbufos ........................................................................................................................... 98. Terbufos sulfone .............................................................................................................. 99. Tetrachloroethylene ......................................................................................................... 100. Thiophanate-methyl ....................................................................................................... 101. Toluene diisocyanate ..................................................................................................... 102. trans-1,2-Dichloroethylene ............................................................................................. 103. Trichloroethylene ........................................................................................................... 104. Triflumizole .................................................................................................................... 105. Trinexapac-ethyl ............................................................................................................ 106. Triphenyltin hydroxide (TPTH) ...................................................................................... 107. Vinclozolin ...................................................................................................................... 108. Xylenes (total) ................................................................................................................ 109. Ziram .............................................................................................................................. 41198–08–7 79–09–4 84087–01–4 91–22–5 100646–51–3 121–82–4 135–98–8 100–42–5 13071–79–9 56070–16–7 127–18–4 23564–05–8 26471–62–5 156–60–5 79–01–6 68694–11–1 95266–40–3 76–87–9 50471–44–8 1330–20–7 137–30–4 Total .................................................................................................................................................................. Dated: May 29, 2013. James Jones, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. VI. References mstockstill on DSK4VPTVN1PROD with NOTICES The following is a list of the documents that are specifically referenced in this document. These references are available at https:// www.regulations.gov. [FR Doc. 2013–14232 Filed 6–13–13; 8:45 am] BILLING CODE 6560–50–P 1. USEPA. 2010. Endocrine Disruptor Screening Program; Second List of Chemicals for Tier 1 Screening; Notice. Federal Register, 75 FR 70248, November 17, 2010. 2. USEPA. 1996. FFDCA section 408(p). Available on-line at https:// epw.senate.gov/FDA_001.pdf. 3. USEPA. 1996. Amendments to the Safe Drinking Water Act. Available on-line at: https://water.epa.gov/lawsregs/guidance/ sdwa/text.cfm. 4. U.S. Congress. House Report 111–180. Available at: https://www.gpo.gov/fdsys/ pkg/CRPT-111hrpt180/pdf/CRPT111hrpt180.pdf. 5. USEPA. 2009. Drinking Water Contaminant Candidate List 3—Final; Notice. Federal Register. Vol. 74. No 194. p. 51850. October 8, 2009. 6. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals: Identifying the Universe, EPA 815–R–09–006. August 2009. 7. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals: Screening to a PCCL, EPA 815–R–05–007. August, 2009. 8. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL, EPA 815–R–09–008. August, 2009. List of Subjects Environmental protection, Chemicals, Drinking water, Endocrine disruptors, Pesticides. VerDate Mar<15>2010 17:03 Jun 13, 2013 Jkt 229001 ENVIRONMENTAL PROTECTION AGENCY [ER–FRL–9009–6] Environmental Impacts Statements; Notice of Availability Responsible Agency: Office of Federal Activities, General Information (202) 564–7146 or https://www.epa.gov/ compliance/nepa/. Weekly receipt of Environmental Impact Statements Filed 06/03/2013 through 06/07/2013. Pursuant to 40 CFR 1506.9. Notice Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA’s comment letters on EISs are available at: https:// www.epa.gov/compliance/nepa/ eisdata.html. EIS No. 20130160, Final EIS, USFS, OR, McKay Fuels and Vegetation Management Project, Review Period Ends: 07/15/2013, Contact: Marcy Anderson 541–416–6463. EIS No. 20130161, Draft EIS, USFS, MT, East Reservoir Project, Comment Period Ends: 07/29/2013, Contact: Denise Beck 406–293–7773, ext. 7504. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 SDWA PAI X ........................ ........................ X ........................ X X X X X X X X X X ........................ ........................ X X X X X X X ........................ X ........................ ........................ ........................ X ........................ ........................ X ........................ ........................ ........................ X X X X X X 88 41 EIS No. 20130162, Final EIS, BLM, NM, SunZia Southwest Transmission Project, Proposed Resource Management Plan Amendments, Review Period Ends: 07/15/2013, Contact: Adrian Garcia 505–954– 2199. EIS No. 20130163, Draft EIS, FERC, AL, Martin Dam Hydroelectric Project, Relicensing, Comment Period Ends: 08/13/2013, Contact: Stephen Bowler 202–502–6861. EIS No. 20130164, Revised Draft EIS, USAF, FL, F–35 Beddown at Eglin Air Force Base, Comment Period Ends: 07/29/2013, Contact: Mike Spaits 850–882–2836. EIS No. 20130165, Draft EIS, BLM, SD, South Dakota Resource Management Plan, Comment Period Ends: 09/11/ 2013, Contact: Mitch Iverson 605– 892–7008. EIS No. 20130166, Final EIS, USFWS, NiSource Multi-Species Habitat Conservation Plan, Review Period Ends: 07/15/2013, Contact: Thomas J. Magnuson 612–713–5467. EIS No. 20130167, Draft EIS, NOAA, MI, Thunder Bay National Marine Sanctuary, Boundary Expansion, Comment Period Ends: 08/14/2013, Contact: Jeff Gray 989–356–8805. EIS No. 20130168, Final EIS, USACE, CA, Feather River West Levee Project Final 408 Permission, Review Period Ends: 07/15/2013, Contact: Jeffery Koschak 916–557–6994. EIS No. 20130169, Final Supplement, NRC, TN, Operation of Watts Bar Nuclear Plant, Unit 2 NUREG–0498, Supplement 2, Review Period Ends: E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35922-35928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14232]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2009-0477; FRL-9375-8]

Endocrine Disruptor Screening Program; Final Second List of
Chemicals and Substances for Tier 1 Screening

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This document announces the final second list of 109 chemicals
identified for Tier 1 screening under the Endocrine Disruptor Screening
Program (EDSP). The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to
develop a chemical screening program using appropriate validated test
systems and other scientifically relevant information to determine
whether certain substances may have hormonal effects.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Hannah Holsinger, Office of Water, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001 (MC-4607M); telephone number: (202) 564-0403,
email address: holsinger.hannah@epa.gov, or Pat West, Office of Science
Coordination and Policy, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001 (MC-7201M); telephone
number: (202) 564-1656, email address: west.pat@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you produce,
manufacture, use, or import chemicals (including pesticide chemicals)
that may be found in sources of drinking water; if you manufacture or
import chemicals that degrade to chemicals found in sources of drinking
water; or if you are, or may otherwise be, involved in the testing of
chemicals for potential endocrine effects. 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:
Chemical manufacturers, importers and processors (NAICS
code 325), e.g., persons who manufacture, import or process chemical
substances.
Pesticide, fertilizer, and other agricultural chemical
manufacturers (NAICS code 3253), e.g., persons who manufacture, import
or process pesticide, fertilizer and agricultural chemicals.
Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0477, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

This document announces the final second list of 109 chemicals
identified for Tier 1 screening under the Endocrine Disruptor Screening
Program (EDSP). The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to
develop a chemical screening program using appropriate validated test
systems and other scientifically relevant information to determine
whether certain substances may have hormonal effects. After considering
comments received on the draft second list of chemicals and substances
published in the Federal Register notice of November 17, 2010 (75 FR
70248) (FRL-8848-7) (Ref. 1), EPA is announcing the final list of the
second group of chemicals that will be subject to screening based on
the approach described in the notice--``Endocrine Disruptor Screening
Program; Final Policies and Procedures for Screening Safe Drinking
Water Act (SDWA) Chemicals,'' published elsewhere in today's Federal
Register.
The EDSP consists of a two-tiered approach to screen and test
chemicals for potential endocrine disrupting effects. The purpose of
Tier 1 screening is to identify substances that have the potential to
interact with the endocrine system (specifically the estrogen,
androgen, or thyroid hormone systems) using a battery of assays.
Substances that have the potential to interact with estrogen, androgen
or thyroid systems may proceed to Tier 2, which is designed to identify
any adverse endocrine-related effects caused by the

[[Page 35923]]

substance, and establish a quantitative relationship between the dose
and that endocrine effect. This second list should not be construed as
a list of known or likely endocrine disruptors. Nothing in the approach
for generating the second list provides a basis to infer that by simply
being on this list these chemicals are suspected to interfere with the
endocrine systems of humans or other species, and it would be
inappropriate to do so. In a separate notice published elsewhere in
today's Federal Register, EPA describes other aspects of EDSP such as
the administrative procedures that EPA will use to require testing.
The second group of chemicals to be tested consists of chemicals
that section 408(p) of the FFDCA (Ref. 2) requires be screened, i.e.,
pesticide active ingredients and chemicals used as pesticide inert
ingredients (also known as other ingredients) and section 1457 of the
1996 amendment to the SDWA (Ref. 3). EPA developed this final list
using the approach outlined in the Federal Register notice announcing
the draft second list of chemicals and substances (Ref. 1). More
information on EPA's priority setting approach is available at https://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
This document does not describe other aspects of EDSP such as the
administrative procedures EPA generally intends to use to require
testing, the validated tests and battery that will be included in EDSP,
or the timeframe for requiring the testing or receiving the data. The
administrative procedures that EPA generally intends to use are
described in a separate notice published elsewhere in today's Federal
Register. The remaining topics will be addressed in separate notices
that will be subsequently published in the Federal Register.

B. What is the agency's authority for taking this action?

FFDCA section 408(p) requires EPA to ``develop a screening program,
using appropriate validated test systems and other scientifically
relevant information, to determine whether certain substances may have
an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or such other endocrine effect as [EPA]
may designate'' (21 U.S.C. 346a(p)). Section 408(p)(3) generally
requires EPA to ``provide for the testing of all pesticide chemicals''
and gives EPA discretionary authority to ``provide for the testing of
any other substance that may have an effect that is cumulative to an
effect of a pesticide chemical if the Administrator determines that a
substantial population may be exposed to such a substance'' (21 U.S.C.
346a(p)(3)). The statute also authorizes EPA to exempt a chemical upon
a determination that ``the substance is anticipated not to produce any
effect in humans similar to an effect produced by a naturally occurring
estrogen.'' (21 U.S.C. 346a(p)(4)).
Section 1457 of SDWA states that ``in addition to the substances''
referred to in FFDCA section 408(p)(3)(B), ``the Administrator may
provide for testing under the screening program authorized by section
408(p) of such Act, in accordance with the provisions of section 408(p)
of such Act, of any other substance that may be found in sources of
drinking water if the Administrator determines that a substantial
population may be exposed to such substance'' (42 U.S.C. 300j-17). EPA
used its authority under SDWA to identify a portion of the chemicals on
the second EDSP list.

III. History

EPA developed EDSP in response to a Congressional mandate in FFDCA
``to determine whether certain substances may have an effect in humans
that is similar to an effect produced by a naturally occurring
estrogen, or such other endocrine effect as [EPA] may designate'' (21
U.S.C. 346a(p)). Unit II.B. describes the authority for listing a
chemical. As part of EDSP, EPA issues orders to collect certain test
data on selected chemical substances. In general, EPA intends to use
the data collected under EDSP, along with other information, to
determine if a pesticide chemical or other substances may pose a risk
to human health or the environment due to disruption of the endocrine
system. The determination that a chemical does or is not likely to have
the potential to interact with the endocrine system will be made on a
weight-of-evidence basis taking into account data from the Tier 1
assays and/or other scientifically relevant information. Chemicals that
go through Tier 1 screening and are found to have the potential to
interact with the estrogen, androgen, or thyroid hormone systems will
proceed to the next state of EDSP where EPA will determine which, if
any, of the Tier 2 tests are necessary based on available data. Tier 2
testing is designed to identify any adverse endocrine-related effects
caused by the substance, and establish a quantitative relationship
between the dose and that endocrine effect. Further information
regarding EDSP and requirements for Tier 1 and Tier 2 testing can be
found on the Agency's EDSP Web site, at https://www.epa.gov/endo/.

IV. Development of the Second EDSP List

The House Appropriations Committee report for EPA's FY 2010
appropriations (H.R. 2996, H. Rept. 111-180) (Ref. 4), directed EPA to
publish within 1 year of enactment a second list of no less than 100
chemicals for screening that includes drinking water contaminants, such
as halogenated organic chemicals, dioxins, flame retardants
polybrominated diphenyl ethers, polychlorinated biphenyls,
perfluorocarbons (PFCs), plastics, bisphenol A, pharmaceuticals and
personal care products, and issue 25 orders per year for the testing of
these chemicals. This process also should allow for public input. In
response, EPA published a draft second list of chemicals for Tier 1
screening on November 17, 2010 and solicited public comments on the
list of chemicals. The development of the draft second list is
described at length in that Federal Register notice (Ref. 1).
EPA received comment letters from approximately 60 organizations or
individuals on the November 17, 2010 draft second EDSP list. These
organizations/individuals included a water-related association,
environmental advocacy groups, chemical industry, consumer and pet
advocacy groups, and consultants writing on behalf of the industry.
This notice summarizes major comments EPA received, along with the
Agency's response. A complete listing of public comments and EPA's
responses related to the draft second list of chemicals for Tier 1
screening are included in the document entitled ``Final Comment
Response Document for the Second Endocrine Disruptor Screening Program
List (Categorized Public Comments).'' The document is available in the
docket for this action under docket ID number EPA-HQ-OPPT-2009-0477.

A. SDWA 1457

Some commenters stated that EPA had not met the requirements of
SDWA 1457 when listing the draft second EDSP list. They stated that a
chemical's inclusion on the third Contaminant Candidate List (CCL3)
does not mean that the chemical meets SDWA 1457 requirements. SDWA 1457
states that ``the Administrator may provide for testing under the
screening program authorized by section 408(p) of such Act, . . . of
any other substance that may be found in sources of drinking water if
the Administrator determines that a substantial population may be
exposed to such substance.'' SDWA section 1457 sets forth the criteria
for

[[Page 35924]]

the selection of substances for EDSP. Section 1457 does not require the
Agency to promulgate regulations further defining these criteria.
For the EDSP, EPA selected contaminants from the CCL3, for which
EPA had evaluated the nature of the occurrence and prevalence
information (Ref. 5), and selected contaminants from National Primary
Drinking Water Regulations (NPDWRs), which were designated by Congress
for regulation due to concerns about occurrence in drinking water and
adverse impacts on human health. The scientific basis for EPA's
selection of contaminants on the CCL3 also provides the basis for EPA's
determination that a chemical may be found in sources of drinking water
to which a substantial population may be exposed for the purposes of
SDWA section 1457.

B. Support for Contaminants Listed in the Draft Second List

The Agency received comments supporting the contaminants included
on the draft second EDSP list. One commenter stated that the draft
second EDSP list was an appropriate starting point since it was
developed from existing NPDWRs and the CCL3. Another commenter
acknowledged that many of the chemicals included on the draft second
EDSP list have already undergone a rigorous review within the Agency
for exposure potential in vulnerable populations and noted there is
incomplete toxicity data for the general population. The commenter
stated that EDSP will contribute important information about endocrine
disrupting potential of chemicals which have never been tested for
sensitive endpoints in estrogen, androgen, and thyroid hormone
disruption.

C. Exclusion or Inclusion of Contaminants

EPA received comments concerning contaminants that are no longer
manufactured or that have been cancelled (banned), indicating these
should be removed from the list. EPA also received comments related to
chemicals with physiochemical properties that would likely result in
test assay incompatibility issues. EPA agrees that contaminants derived
from chemicals that have been banned or are no longer manufactured
should be removed from the list. EPA has generally determined that it
would be reasonable to prioritize testing for those compounds which a
manufacturer, importer, or registrant is clearly identifiable and the
Agency could order these entities to conduct the testing. Chemicals
that have been banned or are no longer manufactured (or imported) do
not fit within this category. EPA also agrees that it would be
reasonable to exclude chemicals from the second list based on the
highly reactive physiochemical properties of the chemicals and test
assay incompatibility issues. The exclusion rationales for streamlining
the second EDSP list are discussed in the Federal Register notice for
the draft second list (Ref. 1).
Table 1 of this notice contains a list of chemicals that EPA
believes should be removed from the final second list because they are
no longer manufactured, are banned chemicals, or the chemicals have
physiological properties that make them highly reactive and
incompatible with the testing assays. Other chemicals remain on the
list as they are still in use and may be found in sources of drinking
water (see Unit IV.A. of this notice).
Other comments EPA received stated those chemicals with a maximum
contaminant level goal of zero should be removed. EPA recognizes that
it may not be possible to set more stringent levels for some of these
chemicals at this time. However, it is important to note that most of
the chemicals with maximum contaminant level goals of zero are based on
chronic health endpoints and compounds with endocrine disrupting
effects that can be subchronic. Also, it would be important to
understand whether a chemical might be an endocrine disruptor with
subchronic impacts since this may inform the Agency's risk assessment
and how best to address this contaminant from a regulatory standpoint.
In addition, if endocrine effects occur at a level lower than the
current maximum contaminant level, the Agency might consider whether
improvements in analytical feasibility, which would allow measurements
at the level of endocrine effects, have been developed since the
promulgation of the existing MCLs.
EPA also received comments stating that the Agency should have
included some chemicals (e.g., triclosan, alkylphenols and alkylphenol
polyethoxylates, bisphenol A, musk fragrances, and pharmaceutical
estrogens) with known or suspected endocrine disrupting effects on the
second list. When compiling the second EDSP list, EPA focused on
priority drinking water contaminants and pesticides previously
identified by EPA. These priority chemicals included the CCL3
chemicals, chemicals with NPDWRs, and registration review pesticides.
The basis for chemical selection is described in the Federal Register
notice for the draft second list (Ref. 1). While the chemicals
mentioned in the comments were not included on the current EDSP list,
they may be included on future EDSP lists. Several of the chemicals
suggested by commenters were evaluated as part of the CCL3 process but
did not make the final CCL3 for reasons that are outlined in EPA
supporting documents ``Final Contaminant Candidate List 3 Chemicals:
Identifying the Universe, Final Contaminant Candidate List 3 Chemicals:
Screening to a PCCL,'' and ``Final Contaminant Candidate List 3
Chemicals: PCCL to CCL'' (Refs. 6, 7, and 8).
As for the current approach for selecting chemicals for the second
EDSP list, EPA excluded chemicals that are hormones with confirmed
effects as stated in the Federal Register notice for the draft second
list (Ref. 1). EPA did not give weight to information on the potential
for a chemical to cause endocrine effects as criteria for listing as
the purpose of the second EDSP list is to identify substances that have
the potential to interact with the endocrine system using appropriate
validated test systems and other scientifically relevant information.
The final second EDSP list should neither be construed as a list of
known or likely endocrine disruptors nor characterized as such.
Some commenters also stated that naturally occurring contaminants
should be excluded from the draft second EDSP list. EPA sought and used
the best available information regarding all substances on the draft
second EDSP list, including those that have the potential to naturally
occur. Although EPA acknowledges that some substances on the list
(e.g., acetaldehyde, acrylamide, methanol, and perchlorate) can occur
naturally in the environment, this is not the only known pathway of
occurrence for these chemicals to enter into the environment. A basis
for chemical selection includes selecting substances that are known or
anticipated to occur in public drinking water. Anthropogenic pathways
for these chemicals to enter the environment are shown through data
from the Toxic Release Inventory (TRI), Chemical Update System/
Inventory Update Rule (CUS/IUR), and chemical manufacturing
information. Consequently, EPA does not believe that the fact that
these chemicals can occur naturally is sufficient reason to exclude the
manufacturers and importers of these chemicals from conducting the
necessary testing.

D. Pesticide Registration Review Issues

EPA received comments stating that pesticide active ingredients
should not be included on EDSP list and suggesting

[[Page 35925]]

that issuance of test orders should align with pesticide registration
review schedules.
The Agency is working toward integrating EDSP and the Registration
Review Program, such that the data gathering may be completed in a
coordinated manner under these two programs to permit a timely
registration review decision inclusive of EDSP and not rely on the
fixed chemical list approach for active ingredients. Ultimately, EPA
intends that chemicals scheduled for registration review may receive
EDSP test orders and the data submitted in response to those orders are
coordinated with the submission of data required under registration
review. The Agency may then review and evaluate the data submitted for
both programs in the same time frame, complete the risk assessment with
EDSP outcomes as appropriate, and likely conclude registration review
for a given chemical within the schedule, enhancing efficiency.
Currently, however, EPA does not have an information collection request
(ICR) clearance to issue orders to require EDSP testing generally for
registration review chemicals. While the ICR clearance process
continues, EPA continues to rely on the chemical list approach for the
fiscal year 2007/2008 registration review chemicals in an attempt to
begin to address EDSP testing for the early registration review
chemicals.

V. The Final Second List of Chemicals and Substances for Tier 1
Screening

A. Chemicals and Substances Removed From the Draft Second List for Tier
1 Screening

EPA removed 25 chemicals and substances from the draft second list
based on two of the criteria published in the November 17, 2010 issue
of the Federal Register, (Ref. 1):
1. Chemicals for which the manufacturer, importer or registrant
cannot be clearly identified (criterion two).
2. Chemicals not likely to be biologically active or which are
incompatible with testing assays for various reasons due to one or more
of their physiochemical properties (criterion five).

EPA reevaluated the draft second list of chemicals and substances based
on public comments and determined that sufficient data exist to remove
a total of 25 additional contaminants based on criterion two (n=21) and
criterion five (n=4). Table 1 presents an alphabetized list of 25
chemicals and substances EPA removed from the original list of 134
proposed for Tier 1 screening and provides the rationale for removal.
Although these chemicals have been removed from the second group of
chemicals and substances that EPA will screen, it is important to note
that the removal of these chemicals and substances does not imply that
the Agency has no interest in the potential for endocrine disruption
activity for these contaminants. At this time the Agency realizes that
there is some difficulty with collecting the information about
endocrine effects through EDSP because of the Agency's inability to
identify a manufacturer, importer, or registrant or because the
contaminant is incompatible with the testing assays.

Table 1--Chemicals Removed From Draft Second EDSP List
----------------------------------------------------------------------------------------------------------------
Chemical name CAS Reg No. SDWA PAI Rationale
----------------------------------------------------------------------------------------------------------------
1. 1, 2-Dibormo-3-chlorproprane 96-12-8 X ............... Pesticide not in use;
(DBCP). TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
2. 2, 4, 5-TP (Silvex)........... 93-72-1 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
3. Benzyl chloride............... 100-44-7 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
4. Chlordane..................... 57-74-9 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
5. Cumene hydroperoxide.......... 80-15-9 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
6. Dalapon....................... 75-99-0 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
7. Dimethipin.................... 55290-64-7 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
8. Dinoseb....................... 88-85-7 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
9. Endrin........................ 72-20-8 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
10. Ethylene dibromide (EDB)..... 106-93-4 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
11. Fenamiphos................... 22224-92-6 X X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
12. Fenarimol.................... 60168-88-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
13. Fenoxycarb................... 72490-01-8 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.

[[Page 35926]]

14. Heptachlor................... 76-44-8 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
15. Heptachlor epoxide........... 1024-57-3 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
16. Methoxychlor................. 72-43-5 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
17. Molinate..................... 2212-67-1 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
18. Oxirane, methyl-............. 75-56-9 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
19. Propetamphos................. 31218-83-4 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
20. Pyridate..................... 55512-33-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
21. Sodium tetrathiocarbonate.... 7345-69-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
22. Sulfosate.................... 81591-81-3 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
23. Temephos..................... 3383-96-8 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
24. Toxaphene.................... 8001-35-2 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
25. Triethylamine................ 121-44-8 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
----------------------------------------------------------------------------------------------------------------
Endnotes--Table 1:
TRI contains information on toxic chemical releases from facilities that meet reporting criteria (for
most chemicals the thresholds are 25,000 pounds for manufacturing and processing and 10,000 pounds for use).
IUR contains site and manufacturing information for chemicals manufactured (including imported) in
amounts of 25,000 pounds or greater at a single site.

B. The Final Second List of Chemical and Substances for EDSP Tier 1
Screening

Table 2 presents an alphabetized list of the 109 chemicals and
substances included in the final second EDSP list of chemicals for Tier
1 screening. As in the draft second list, the final list includes
pesticides, two PFCs, and three pharmaceuticals (erythromycin,
nitroglycerin, and quinoline). The list also consists of an array of
other chemicals ranging from those used for industrial manufacturing
processes, as plasticizers, or in the production of pharmaceutical,
personal care products, and toxic substances. Because this list of
chemicals was selected on the basis of exposure potential only, it
should neither be construed as a list of known or likely endocrine
disruptors nor characterized as such.

Table 2--Final Second EDSP List of Chemicals for Tier 1 Screening
----------------------------------------------------------------------------------------------------------------
Chemical name CAS Reg No. SDWA PAI
----------------------------------------------------------------------------------------------------------------
1. 1,1,1,2-Tetrachloroethane............................... 630-20-6 X ...............
2. 1,1,1-Trichloroethane................................... 71-55-6 X ...............
3. 1,1,2-Trichloroethane................................... 79-00-5 X ...............
4. 1,1-Dichloroethane...................................... 75-34-3 X ...............
5. 1,1-Dichloroethylene.................................... 75-35-4 X ...............
6. 1,2,3-Trichloropropane.................................. 96-18-4 X ...............
7. 1,2,4-Trichlorobenzene.................................. 120-82-1 X ...............
8. 1,2-Dichloroethane...................................... 107-06-2 X ...............
9. 1,2-Dichloropropane..................................... 78-87-5 X ...............
10. 1,3-Dinitrobenzene..................................... 99-65-0 X ...............
11. 1,4-Dioxane............................................ 123-91-1 X ...............
12. 1-Butanol.............................................. 71-36-3 X ...............
13. 2-Methoxyethanol....................................... 109-86-4 X ...............
14. 2-Propen-1-ol.......................................... 107-18-6 X ...............
15. 4,4'-Methylenedianiline................................ 101-77-9 X ...............
16. Acetaldehyde........................................... 75-07-0 X ...............

[[Page 35927]]

17. Acetamide.............................................. 60-35-5 X ...............
18. Acetochlor............................................. 34256-82-1 X X
19. Acetochlor ethanesulfonic acid (ESA)................... 187022-11-3 X ...............
20. Acetochlor oxanilic acid (OA).......................... 194992-44-4 X ...............
21. Acrolein............................................... 107-02-8 X X
22. Acrylamide............................................. 79-06-1 X ...............
23. Alachlor............................................... 15972-60-8 X X
24. Alachlor ethanesulfonic acid (ESA)..................... 142363-53-9 X ...............
25. Alachlor oxanilic acid (OA)............................ 171262-17-2 X ...............
26. alpha-Hexachlorocyclohexane............................ 319-84-6 X ...............
27. Aniline................................................ 62-53-3 X ...............
28. Bensulide.............................................. 741-58-2 X X
29. Benzene................................................ 71-43-2 X ...............
30. Benzo(a)pyrene (PAHs).................................. 50-32-8 X ...............
31. Butylated hydroxyanisole............................... 25013-16-5 X ...............
32. Carbon tetrachloride................................... 56-23-5 X ...............
33. Chlorobenzene.......................................... 108-90-7 X ...............
34. cis-1,2-Dichloroethylene............................... 156-59-2 X ...............
35. Clethodim.............................................. 99129-21-2 X X
36. Clofentezine........................................... 74115-24-5 ............... X
37. Clomazone.............................................. 81777-89-1 ............... X
38. Coumaphos.............................................. 56-72-4 ............... X
39. Cyanamide.............................................. 420-04-2 ............... X
40. Cyromazine............................................. 66215-27-8 ............... X
41. Denatonium saccharide.................................. 90823-38-4 ............... X
42. Di(2-ethylhexyl) adipate............................... 103-23-1 X ...............
43. Dichloromethane........................................ 75-09-2 X ...............
44. Dicrotophos............................................ 141-66-2 X X
45. Diuron................................................. 330-54-1 X X
46. Endothall.............................................. 145-73-3 X X
47. Epichlorohydrin........................................ 106-89-8 X ...............
48. Erythromycin........................................... 114-07-8 X ...............
49. Ethylbenzene........................................... 100-41-4 X ...............
50. Ethylene glycol........................................ 107-21-1 X ...............
51. Ethylene thiourea...................................... 96-45-7 X ...............
52. Ethylurethane.......................................... 51-79-6 X ...............
53. Etofenprox............................................. 80844-07-1 ............... X
54. Fenoxaprop-P-ethyl..................................... 71283-80-2 ............... X
55. Flumetsulam............................................ 98967-40-9 ............... X
56. Fomesafen sodium....................................... 108731-70-0 ............... X
57. Fosetyl-Al (Aliette)................................... 39148-24-8 ............... X
58. Glufosinate ammonium................................... 77182-82-2 ............... X
59. HCFC-22................................................ 75-45-6 X ...............
60. Hexachlorobenzene...................................... 118-74-1 X ...............
61. Hexachlorocyclopentadiene.............................. 77-47-4 X ...............
62. Hexane................................................. 110-54-3 X ...............
63. Hexythiazox............................................ 78587-05-0 ............... X
64. Hydrazine.............................................. 302-01-2 X ...............
65. Isoxaben............................................... 82558-50-7 ............... X
66. Lactofen............................................... 77501-63-4 ............... X
67. Lindane................................................ 58-89-9 X ...............
68. Methanol............................................... 67-56-1 X ...............
69. Methyl tert-butyl ether................................ 1634-04-4 X ...............
70. Metolachlor ethanesulfonic acid (ESA).................. 171118-09-5 X ...............
71. Metolachlor oxanilic acid (OA)......................... 152019-73-3 X ...............
72. Nitrobenzene........................................... 98-95-3 X ...............
73. Nitroglycerin.......................................... 55-63-0 X ...............
74. N-Methyl-2-pyrrolidone................................. 872-50-4 X ...............
75. N-Nitrosodimethylamine (NDMA).......................... 62-75-9 X ...............
76. n-Propylbenzene........................................ 103-65-1 X ...............
77. o-Dichlorobenzene...................................... 95-50-1 X ...............
78. o-Toluidine............................................ 95-53-4 X ...............
79. Oxydemeton-methyl...................................... 301-12-2 X X
80. Oxyfluorfen............................................ 42874-03-3 X X
81. Paclobutrazol.......................................... 76738-62-0 ............... X
82. p-Dichlorobenzene...................................... 106-46-7 X X
83. Pentachlorophenol...................................... 87-86-5 X X
84. Perchlorate............................................ 14797-73-0 X ...............
85. Perfluorooctane sulfonic acid (PFOS)................... 1763-23-1 X ...............
86. Perfluorooctanoic acid (PFOA).......................... 335-67-1 X ...............
87. Picloram............................................... 1918-02-1 X X
88. Polychlorinated biphenyls.............................. 1336-36-3 X ...............

[[Page 35928]]

89. Profenofos............................................. 41198-08-7 X X
90. Propionic acid......................................... 79-09-4 ............... X
91. Quinclorac............................................. 84087-01-4 ............... X
92. Quinoline.............................................. 91-22-5 X ...............
93. Quizalofop-P-ethyl..................................... 100646-51-3 ............... X
94. RDX.................................................... 121-82-4 X ...............
95. sec-Butylbenzene....................................... 135-98-8 X ...............
96. Styrene................................................ 100-42-5 X ...............
97. Terbufos............................................... 13071-79-9 X X
98. Terbufos sulfone....................................... 56070-16-7 X ...............
99. Tetrachloroethylene.................................... 127-18-4 X ...............
100. Thiophanate-methyl.................................... 23564-05-8 X X
101. Toluene diisocyanate.................................. 26471-62-5 X ...............
102. trans-1,2-Dichloroethylene............................ 156-60-5 X ...............
103. Trichloroethylene..................................... 79-01-6 X ...............
104. Triflumizole.......................................... 68694-11-1 ............... X
105. Trinexapac-ethyl...................................... 95266-40-3 ............... X
106. Triphenyltin hydroxide (TPTH)......................... 76-87-9 X X
107. Vinclozolin........................................... 50471-44-8 X X
108. Xylenes (total)....................................... 1330-20-7 X X
109. Ziram................................................. 137-30-4 X X
----------------------------------------------------
Total..................................................................... 88 41
----------------------------------------------------------------------------------------------------------------

VI. References

The following is a list of the documents that are specifically
referenced in this document. These references are available at https://www.regulations.gov.

1. USEPA. 2010. Endocrine Disruptor Screening Program; Second List
of Chemicals for Tier 1 Screening; Notice. Federal Register, 75 FR
70248, November 17, 2010.
2. USEPA. 1996. FFDCA section 408(p). Available on-line at https://epw.senate.gov/FDA_001.pdf.
3. USEPA. 1996. Amendments to the Safe Drinking Water Act. Available
on-line at: https://water.epa.gov/lawsregs/guidance/sdwa/text.cfm.
4. U.S. Congress. House Report 111-180. Available at: https://www.gpo.gov/fdsys/pkg/CRPT-111hrpt180/pdf/CRPT-111hrpt180.pdf.
5. USEPA. 2009. Drinking Water Contaminant Candidate List 3--Final;
Notice. Federal Register. Vol. 74. No 194. p. 51850. October 8,
2009.
6. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Identifying the Universe, EPA 815-R-09-006. August 2009.
7. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Screening to a PCCL, EPA 815-R-05-007. August, 2009.
8. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Classification of the PCCL to the CCL, EPA 815-R-09-008. August,
2009.

List of Subjects

Environmental protection, Chemicals, Drinking water, Endocrine
disruptors, Pesticides.

Dated: May 29, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-14232 Filed 6-13-13; 8:45 am]
BILLING CODE 6560-50-P

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