The progress EPA has made in the area of endocrine disruptors is important and likely to impact many businesses.

A few months ago the U.S. Environmental Protection Agency (EPA) released a draft list of the 73 pesticide active ingredients and high-production volume (HPV)/pesticide inert chemicals selected for so-called “Tier 1” screening under the Endocrine Disruptor Screening Program (EDSP). While this development may not sound all that relevant to Manufacturing Today readers, the progress EPA has made in the area of endocrine disruptors is important and likely to impact many businesses.

EPA believes evidence suggests that endocrine systems of certain fish and wildlife have been affected by chemical contaminants, resulting in developmental and reproductive problems. Based on such evidence, Congress passed the Food Quality Protection Act (FQPA) in 1996, requiring EPA to screen pesticide chemicals and environmental contaminants that might affect human or animal endocrine systems.   

Endocrine disruptor screening initiatives at EPA are underway in three areas: EPA is performing scientific and technical testing needed to validate the endocrine disruptor screens and tests; EPA is setting priorities by selecting chemicals for initial screening and testing; and EPA is developing the policies and procedures it will use to compel mandatory testing. The June 2007 notice announced the draft list of the initial 73 active pesticide ingredients and pesticide “inerts” (non-active chemicals added to pesticide formulations) to be considered for Tier I screening.

EPA’s Chemical Selection Process
EPA produced the draft list of chemicals using the approach described in its Sept. 27, 2005, Federal Register notice, and included chemicals that EPA, in its discretion, decided should be tested first based upon each chemical’s exposure potential. The exposure pathways identified for pesticide active ingredients include food, drinking water, residential use and occupational exposure. The exposure pathways identified for HPV pesticide inert chemicals include human biological monitoring, ecological biomonitoring, drinking water and indoor air. Because there were a large number of chemicals on one or more of these candidate lists, EPA decided it needed to establish priorities.   

EPA identified an initial list of 64 pesticide active ingredients and nine HPV/pesticide inert chemicals to undergo Tier 1 screening in the EDSP. EPA gave priority in this selection process to those chemicals that appeared most often in the exposure pathway databases. The Tier I screening tests consist of a variety of endocrine test methods. These include an estrogen receptor binding assay, androgen receptor binding assay, steroidogenesis assay, aromatase assay, uterotrophic assay, Hershberger assay, pubertal assay and fish reproductive screening. EPA hopes to complete peer review by the middle of 2008.

In the initial list of chemicals, EPA identified 64 pesticide active ingredients to undergo Tier 1 screening in the EDSP. In choosing which pesticide active ingredients to include on the initial screening list, EPA gave priority to those that appeared in four exposure pathways and appeared in three exposure pathways where the food and occupational exposure pathways were represented.

EPA identified an initial list of nine HPV/pesticide inert chemicals to undergo Tier 1 screening. In choosing which HPV/pesticide inert chemicals to include on the initial screening list, EPA gave priority to those that appeared in four exposure pathways and appeared in three exposure pathways where the human biological monitoring exposure pathway was represented.

Deferred From Screening
In its September 2005 Federal Register notice, EPA stated the following types of chemical substances may be deferred from initial screening:  (1) certain Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) List 4 pesticide inerts (i.e., “inerts of minimal concern”); (2) most polymers with number average molecular weight greater than 1,000 daltons; (3) strong mineral acids and bases; and (4) chemicals that are being used as “positive controls” to validate the screening assays.

EPA examined the 73 chemicals identified for initial screening in light of the criteria for deferral. According to EPA, none of the chemicals selected for initial screening are categorized as List 4 inerts, high molecular weight polymers or strong mineral acids or bases. Several of the 73 chemicals have been used as “positive controls” in the validation of individual assays by the EDSP, however. EPA states that none of the selected chemicals identified as EDSP “positive controls” were used in a full battery of Tier 1 screening assays. As a result, none of the chemicals qualify as “positive controls” for Tier 1 screening, as a whole.

As noted in the September 2005 Federal Register notice, any company subject to a testing requirement under Tier 1 may assert (supported by appropriate data) during the comment period for the draft list that the chemical is an endocrine disruptor and that the Tier 1 EDSP screening is unnecessary. EPA does not intend to permit chemicals on this list to bypass Tier 1 screening and move directly to Tier 2 testing without appropriate data to support such an action.

Implications
Any chemical testing program invites uncertain results, and endocrine testing is no exception. Chemicals believed to pose adverse health or environmental effects can be compromised commercially as the pressure to deselect them intensifies. Endocrine testing requirements could inspire reporting under Toxic Substances Control Act Section 8(e) and/or FIFRA Section 6(a)(2). EPA takes these reporting obligations very seriously. The potential for toxic tort liability must also be considered if a chemical is believed to inspire adverse health effects. Once a chemical is believed to cause or contribute to an adverse effect, the ripple effect for chemical producers, and particularly for consumer products containing the tested chemical, are significant. Product deselection campaigns are waged in various venues — through the submission of petitions that seek cancellation of certain chemical uses, in the board room through shareholder campaigns, and in legislative contexts through proposed legislation. Readers with interest in the endocrine testing area are urged to monitor and participate actively in these matters, and be mindful of the business implications of endocrine testing.

Lynn L. Bergeson is a managing director of Bergeson Campbell P.C., a Washington, D.C., law firm focusing on chemical, pesticide and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation and associated business issues. She is also president of The Acta Group L.L.C. and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, UK. Bergeson is legal counsel to the American Chemistry Counsel Nanotechnology Panel. She can be reached at 202-557-3800.