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Overview of the June 2007 Draft List of Chemicals for Initial Tier 1 Screening
Highlights
Federal Register Notice Extending the Comment Period for the Draft List of Chemicals
Draft List of Chemicals for Initial Screening - Federal Register Notice (PDF) (18 pp, 131K, About PDF)
EPA is seeking public comment on a draft list of 73 pesticide chemicals that was published in a June 2007 Federal Register Notice (PDF) (18 pp, 131K, About PDF). The chemicals selected are the first to be considered for screening under the Federal Food, Drug and Cosmetic Act. This list should not be construed as a list of known or likely endocrine disruptors. Nothing in the approach for generating the initial list provides a basis to infer that any of the chemicals selected interfere with or are suspected to interfere with the endocrine systems of humans or other species.
Comments are due to EPA February 11, 2008. How to comment.
- Background Information
- Applying the Chemical Selection Approach
- Chemical Substances Deferred from Screening
- Bypassing Tier 1 Screening
- How to Comment
Background Information
The EDSP was established in response to a Congressional mandate in the Federal Food, Drug, and Cosmetic Act (FFDCA), to screen pesticides, chemicals and environmental contaminants for their potential to affect the estrogen, androgen or thyroid hormone systems. The core elements of the EDSP are:
- Assay development and validation for Tier 1 screening and Tier 2 testing;
- Priority setting and selection of chemicals to be tested; and
- Development of program policies and procedures to require testing.
For more information on endocrine disruptors and the core elements of the screening program see the "Endocrine Primer."
Applying the Chemical Selection Approach
As described in the September 2005 Federal Register Notice (PDF) (17pp, 125K, About PDF), EPA analyzed data for four exposure pathways for pesticide active ingredients and data for four exposure pathways for High Production Volume (HPV) chemicals used as pesticide inerts. The four exposure pathways identified for pesticide active ingredients include: food, drinking water, residential use, and occupational exposure. The four exposure pathways identified for HPV/pesticide inert chemicals include: human biological monitoring, ecological biomonitoring, drinking water, and indoor air.
The Agency evaluated the data sources for each pathway to produce four candidate lists of chemicals of pesticide active ingredients and four candidate lists of HPV/pesticide inert chemicals for potential screening. Because there were a large number of chemicals on one or more of these candidate lists, it was necessary to establish priorities for selecting chemicals for initial screening.
Integration of Pathway Priorities for Pesticide Active Ingredients
EPA identified an initial list of 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.
Integration of Pathway Priorities for High Production Volume/Pesticide Inerts
EPA identified an initial list of 9 HPV/pesticide inert chemicals to undergo Tier 1 screening in the EDSP. 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.
Chemical Substances Deferred from Screening
In September 2005, EPA indicated that the following types of chemical substances may be deferred from initial screening:
- Certain FIFRA List 4 pesticide inerts (i.e., List 4 inerts are described as "inerts of minimal concern");
- Most polymers with number average molecular weight greater than 1,000 daltons;
- Strong mineral acids and bases; and
- Chemicals that are being used as a "positive controls" to validate the screening assays.
EPA examined the 73 chemicals identified for initial screening in light of the criteria for deferral. None of the chemicals selected for initial screening were categorized as List 4 inerts, high molecular weight polymers, or strong mineral acids or bases. Several of the 73 chemicals, however, have been used as "positive controls" in the validation of individual assays by the EDSP. 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.
Bypassing Tier 1 Screening
As indicated 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.
How to Comment
Comments will be accepted until February 11, 2008. All comments should be identified by docket identification (ID) no. EPA-HQ-OPPT-2004-0109.
Publicly available docket materials are available in the electronic docket, Regulations.gov.
Comments may be submitted by one of the following methods:
- Follow the on-line instructions for submitting comments found in the electronic docket, Regulations.gov.
- E-mail: oppt.ncic@epa.gov.
- Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
For further information contact Linda Phillips (phillips.linda@epa.gov or 202-564-1264).