- EPA to Expand Chemicals Testing for Endocrine Disruption
- November 18, 2010 | Authors: Bridget E. Calhoun; Warren Lehrenbaum
- Law Firm: Crowell & Moring LLP - Washington Office
On Wednesday, November 17th, the Environmental Protection Agency (EPA) will publish in the Federal Register a list of 134 additional chemicals being considered for "Tier 1 screening" tests under the Endocrine Disruptor Screening Program (EDSP). The list of chemicals being proposed for testing includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). The list also includes 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 complete list of 134 chemicals can be found at the bottom of this alert.
You may be potentially affected by this notice if you produce, manufacture, use, consume, work with, or import any of the 134 chemicals on the list. EPA is allowing for a 30 day comment period to receive information that may inform the exclusion or inclusion of the chemicals on the second EDSP list.
EPA developed EDSP in response to a Congressional mandate in the Federal Food, Drug, and Cosmetic Act (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)). As part of EDSP, EPA issues orders to collect certain test data on listed chemical substances. Test data requirements are derived from specific test assays, which are divided into two tiers. Tier I test assays (the subject of the November 17th notice) are used to "screen" the chemicals for interaction with the estrogen (E), androgen (A) or thyroid (T) hormonal systems. Tier II test assays may be required for some of the chemicals listed and are intended to test for more specific chemical effects on the endocrine system, and are currently in the process of being developed and validated.
EPA issued the first list of chemicals of 67 chemicals under the EDSP on April 15, 2009. This list included 58 pesticides and 9 high production volume chemicals and/or inert ingredients of pesticide products. The test screens are estimated to cost approximately $1,000,000/chemical. Industry has raised numerous concerns about the EDSP including:
- Test guidelines that are overly prescriptive and inflexible;
- Overly stringent test validation criteria that could lead to repeating otherwise technically sound studies;
- Screening tests with highly variable test endpoints that could easily result in false positive test results.
- Inadequate guidance on the criteria that will be applied in deciding whether a substance will be required to complete Tier II testing following the initial screen.
Final data submissions for the first 67 chemicals undergoing screening are not due until October 2011 (unless extensions are granted), and EPA is not likely to complete its evaluation of these Tier I data until sometime in 2012. Based on this schedule, EPA will not have an opportunity to apply "lessons learned" from the initial Tier I testing program as it finalizes its list of additional chemicals that will be subject to testing.
Second EDSP List of Chemicals for Tier 1 Screening
1 ,2-Dibromo-3-chloropropane (DBCP)
Acetochlor ethanesulfonic acid (ESA)
Acetochlor oxanilic acid (OA)
Alachlor ethanesulfonic acid (ESA)
Alachlor oxanilic acid (OA)
cis- 1 ,2-Dichloroethylene
Methyl tert-butyl ether
Metolachlor ehtanesulfonic acid (ESA)
Metolachlor oxanilic acid (OA)
Perfluorooctane sulfonic acid (PFOS)
Perfluorooctanoic acid (PFOA)
Triphenyltin hydroxide (TPTH)
CAS Number = Chemical Abstract Services Registry Number