SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be 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 chemicals.
- Pesticide, fertilizer, and other agricultural chemical manufacturers, importers, and processors (NAICS code 3253), e.g., persons who manufacture, import, or process pesticide; fertilizer; or agricultural chemicals.
- Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemicals for endocrine effects.
To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit III.C., and examine FFDCA section 408(p). If you have any questions regarding the applicability of this action to a particular entity, consult either technical person listed under FOR FURTHER INFORMATION CONTACT.
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-2007-1080, 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?
The Agency is publishing final policies and procedures for issuing EDSP test orders for chemicals pursuant to the Agency's authority under SDWA section 1457 (i.e.,"SDWA chemicals"). Section 1457 of the SDWA authorizes EPA to issue EDSP test orders to manufacturers and importers of chemicals that may be found in sources of drinking water and to which a substantial population may be exposed (42 U.S.C. 300j-17). SDWA chemicals encompass a wide variety of chemicals, including industrial and pesticide chemicals, ingredients in pharmaceuticals and personal care products, and degradates.
These SDWA/FFDCA policies and procedures supplement the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)/FFDCA policies and procedures that were published in the Federal Register issue of April 15, 2009 (FIFRA/FFDCA policies and procedures) (Ref. 1). The FIFRA/FFDCA policies and procedures (Ref. 1) were developed primarily for the issuance of EDSP test orders on pesticide active and inert ingredients, which were the chemicals comprising the first EDSP chemical list (first list). Consequently, some of the FIFRA/FFDCA policies and procedures (Ref. 1) reflect issues uniquely associated with the pesticide market and the specific regulatory context under which EPA regulates pesticide chemicals. In this document, EPA describes the policies and procedures associated with the screening of SDWA chemicals, which include certain modifications to the FIFRA/FFDCA policies and procedures that are intended to address issues that are unique to SDWA chemicals, or to address the circumstances where other competing considerations for SDWA chemicals warrant a modification of the FIFRA/FFDCA policies and procedures.
This document discusses the policy considerations for SDWA chemicals in the following areas:
- Who would receive EDSP test orders for SDWA chemicals? Unit VI.A.
- How will recipients of EDSP test orders for SDWA chemicals be notified? Unit VI.B.
- How will the public know who has received an EDSP test order for a SDWA chemical or who has supplied data? Unit VI.C.
- How will the agency minimize duplicative testing? Unit VI.D.
- What are the potential responses to EDSP test orders for SDWA chemicals? Unit VI.E.
- How can an EDSP test order responses and data be submitted electronically? Unit VI.F.
- How will EPA facilitate joint data development, cost sharing, and data compensation for SDWA chemicals? Unit VI.G.
- What procedures can EPA apply for handling Confidential Business Information (CBI) for SDWA chemicals? Unit VI.H.
- What is the process for contesting an EDSP test order or consequences for failure to respond or comply with an EDSP test order? Unit VI.I.
- What is the informal administrative review procedure? Unit VI.J.
- What are the adverse effects reporting requirements? Unit VI.K.
While the FIFRA/FFDCA policies and procedures (Ref. 1) remain relevant, SDWA chemical EDSP test order recipients are encouraged to refer to this document to fully understand all of the relevant policies and procedures. In addition, a new EDSP test order template for issuance of EDSP test orders under SDWA section 1457 and FFDCA section 408(p)(5) is available in the docket for this document (Ref. 2).
EPA is publishing two related notices elsewhere in this Federal Register issue. One announces the final second EDSP chemical list (second list), which includes both SDWA chemicals and pesticide active ingredients (PAIs). The other announces the submission to the Office of Management and Budget (OMB) of the final Information Collection Request (ICR) Addendum that describes the estimated paperwork burden and costs associated with the second list.
B. What are the statutory authorities for the policies discussed in this document?
SDWA is the primary Federal law that ensures the quality of Americans' drinking water. Under SDWA, EPA sets standards for drinking water and works closely with States, localities, and water suppliers to implement these standards. SDWA authorizes EPA to set national standards for drinking water to protect against both naturally occurring and man-made contaminants that may be found in drinking water (42 U.S.C. 300g-1).
Section 1457 of SDWA authorizes EPA to require testing, under FFDCA section 408(p) (21 U.S.C. 346(a)(p)), of any chemical that may be found in sources of drinking water if the EPA Administrator determines that a substantial population may be exposed to such chemical (42 U.S.C. 300j-17).
Section 408(p)(1) of FFDCA 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 effects as [EPA] may designate" (21 U.S.C. 346a(p)(1)).
Section 408(p)(3) of FFDCA expressly requires that EPA "shall provide for the testing of all pesticide chemicals" (21 U.S.C. 346a(p)(3)). Section 201 of FFDCA defines "pesticide chemical" as "any substance that is a pesticide within the meaning of [FIFRA], including all active and pesticide inert ingredients of such pesticide" (21 U.S.C. 231(q)(1)).
Section 408(p)(5)(A) of FFDCA provides that the EPA Administrator "shall issue an order to a registrant of a substance for which testing is required under [FFDCA section 408(p)], or to a person who manufactures or imports a substance for which testing is required under [FFDCA section 408(p)], to conduct testing in accordance with the screening program . . ., and submit information obtained from the testing to the Administrator, within a reasonable time period that the [Agency] determines is sufficient for the generation of the information" (21 U.S.C. 346a(p)(5)(A)).
The statutes discussed in this unit provide EPA with the discretion to require testing of a pesticide chemical under FFDCA alone, or in any combination of the various authorities (e.g., FIFRA/FFDCA, SDWA/FFDCA, or FIFRA/SDWA/FFDCA).
Section 408(p)(5)(B) of FFDCA requires that, "to the extent practicable, the Administrator shall minimize duplicative testing of the same substance for the same endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures for handling of confidential business information" (21 U.S.C. 346a (p)(5)(B)).
Section 408(p)(5)(D) of FFDCA provides that any person (other than a registrant) who fails to comply with a FFDCA section 408(p)(5) test order shall be liable for the same penalties and sanctions as are provided for under section 16 of the Toxic Substances Control Act (TSCA) (21 U.S.C. 346a (p)(5)(D)). Such penalties and sanctions shall be assessed and imposed in the same manner as provided in TSCA section 16. Under TSCA section 16, civil penalties of up to $37,500 per day may be assessed, after notice and an administrative hearing held on the record in accordance with section 554 of the Administrative Procedure Act (APA) (15 U.S.C. 2615(a)(1)-(2)(A)).
In addition, Congress's House Appropriations Committee Report (H. Rept.) for EPA's FY 2010 appropriations (Ref. 3), 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 (PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals and personal care products, and issue 25 orders per year for the testing of these chemicals."
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