On November 17, 2010, the U.S. Environmental Protection Agency (EPA) announced the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70248. EPA states that the list of 134 chemicals 'includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This 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 and personal care products (PPCPs).' The 134 chemicals include a significant number of Toxic Substances Control Act (TSCA) chemicals that EPA has identified as priorities under the Safe Drinking Water Act (SDWA) and may be found in sources of drinking water where a substantial number of people may be exposed. The list also includes pesticide active ingredients that EPA is evaluating under its Registration Review Program to ensure they meet current scientific and regulatory standards. Comments are due on or before December 17, 2010. The list is available online.
In a separate notice, EPA also announced its draft policies and procedures for requiring Tier 1 screening under the EDSP. 75 Fed. Reg. 70558.
The Acta Group, L.L.C. (Acta) believes that the issuance of this second list of EDSP screening chemicals and the proposed policies and procedures for obtaining testing is an important development for pesticide registrants and manufacturers of the other substances included in the list. Acta will supplement this memorandum to offer additional analysis and commentary shortly on the draft policies and procedures for requiring Tier 1 screening.
Second List of Chemicals
In selecting chemicals for the second list, EPA first identified candidate chemicals that are either regulated with a national primary drinking water regulation (NPDWR) or are unregulated and listed on the third Contaminant Candidate List (CCL 3). This resulted in a list of 85 regulated drinking water contaminants with existing NPDWRs, and 116 unregulated contaminants listed on CCL 3. EPA next identified candidate chemicals from the Office of Pesticide Programs (OPP) based on pesticides that were scheduled for registration review during fiscal years (FY) 2007 and 2008. EPA states that this selection is part of its intent to expedite efficiently the testing of pesticides, by conducting the testing in parallel or as part of the OPP Registration Review Program. EPA consolidated the lists from the Office of Water (OW) and OPP, resulting in over 200 chemicals. EPA streamlined this list by excluding any chemical that fell into one or more of the following categories:
- Biological agent and naturally-occurring chemicals (e.g., microbials, microbial toxins, inorganics, radionuclides);
- Chemicals for which the manufacturer, importer or registrant cannot be clearly identified (e.g., disinfection byproducts, microbes, microbial toxins, degradate compounds with more than one possible source etc.);
- Chemicals already included on the first EDSP list;
- Chemicals that are hormones with confirmed endocrine effects;
- Chemicals that are 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 (e.g., gases, strongly acidic or basic, solubility, vapor pressure molecular weight); and
- Pesticides that are scheduled for registration review after FY 2008.
Notice Regarding Policies and Procedures
EPA states that it drafted the notice 'with the intent of explaining the policies and procedures relevant to EDSP SDWA chemicals,' and that the draft policies and procedures are intended to supplement the existing EDSP policies and procedures that EPA published in the Federal Register on April 15, 2009. Comments are due on or before January 18, 2011. More information regarding the draft policies and procedures is available online.
In a third Federal Register notice, EPA announced its plan to request an addendum to an existing Information Collection Request (ICR) to the Office of Management and Budget (OMB). 75 Fed. Reg. 70568. According to the notice, the addendum 'simply covers the burden for a new list of chemicals to receive and respond' to EDSP testing orders. EPA is not changing the activities articulated in the original ICR. Comments are due on or before January 18, 2011.
This list builds on the earlier requirements that originated under the 1996 Food Quality Protection Act, which sought to modernize the data sets for pesticides used on food. At the same time, Congress amended the SDWA. EPA's endocrine testing program first broadened to include chemicals used in pesticide formulations that otherwise would be subject to testing under TSCA. This latest list expands the domain of EPA concerning chemicals much further away from EPA's pesticide and toxics programs to reach into other EPA program areas such as drinking water, and also explicitly lists some candidates that are pharmaceuticals that have been found in sources of drinking water. The expansion of the endocrine program's domain indicates that EPA may intend to use its broad authority aggressively to emphasize a concern for the endocrine effect endpoint across EPA programs, and across governmental agency jurisdictions; and to compensate, to some degree, for the shortcomings in testing authority found in other statutes administered by both EPA and other federal agencies. For example, the Food and Drug Administration (FDA) has little organizational or legal capacity to consider the environmental effects of pharmaceuticals, and TSCA expressly exempts pharmaceuticals from its reach. The latest list incorporates some pharmaceuticals that have drinking water exposures as EPA believes they may present endocrine effect risks. This lets EPA take the lead from FDA in this regard. If at a later stage regulation of the drugs appears warranted, it is unclear which authority would be invoked to address uses and/or exposure to the drugs. The list also includes several chemicals listed under the Stockholm Convention, including heptachlor, lindane, hexachlorobenzene, endrin, toxaphene, PFOS, and PCBs, a number of which are not known to be in commerce in the U.S.