Summary (source)
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.
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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 athttp://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 http://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 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 athttp://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 http://www.epa.gov/endo/.
See full at the Federal Register's full text.
