The 1996 Food Quality Protection Act, which amended the Federal Food, Drug, and Cosmetic Act, directed EPA to develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have hormonal effects in humans. The 1996 amendments to the Safe Drinking Water Act authorize EPA to screen substances that may be found in sources of drinking water for endocrine disruption potential. In October 1996, under the authority of the Federal Advisory Committee Act (FACA ), EPA chartered a scientific advisory committee -- the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) -- to advise EPA on establishing a program to carry out Congress's directives.
EPA is developing requirements for the screening and testing of pesticides, commercial chemicals, and environmental contaminants for their potential to disrupt the endocrine system. Although EPA has some data on endocrine-disrupting pesticides, insufficient scientific data are available for most of the chemicals produced today to allow for an evaluation of endocrine associated risks. The science related to measuring and demonstrating endocrine disruption is relatively new and validated testing methods are still being developed.
As a charter member and co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), EPA is following the interagency validation framework in the development and refinement of assays to reduce animal use, refine procedures involving animals to make them less stressful, and replace animals where scientifically appropriate. When complete, EPA will use these validated methods or assays to identify and characterize the endocrine activity of pesticides, commercial chemicals, and environmental contaminants, specifically in relation to estrogen, androgen, and thyroid hormones.
EPA will use the assays in a two-tiered screening and testing process:
- Through Tier 1, EPA hopes to identify chemicals that have the potential to interact with the endocrine system.
- Through Tier 2, EPA will determine the endocrine-related effects caused by each chemical and obtain information about effects at various doses.
EPA will use this two-tiered approach to gather information needed to identify endocrine-active substances and take appropriate action, as mandated by Congress.
EPA is currently implementing EDSP in three major parts:
- Develop and validate Tier 1 screening level assays; select the appropriate
screening assays for the Tier 1 battery based on the validation data;
and develop and validate Tier 2 tests. In 2001, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) was established by EPA's National Advisory Council for Environmental Policy and Technology (NACEPT). The mission of EDMVS was to provide technical input to EPA for the assays recommended by EDSTAC, and critically examine each step of the validation process for the assays. NACEPT and its EDMVS worked to ensure that scientifically-sound assays are developed for animal- and non-animal-based endocrine disruptor screens and tests during the validation process. NACEPT and EDMVS also ensured that people and organizations have the opportunity to comment and express their concerns and issues associated with the assays and processes.
The Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) was formed to replace EDMVS. The EDMVAC will continue to function like EDMVS by providing advice and recommendations to EPA on scientific and technical aspects of the Tier I screens and Tier II assays being considered for the Endocrine Disruptor Screening Program. More recently, the Agency has obtained independent scientific advice on assay validation from EPA's FIFRA Scientific Advisory Panel (SAP).
Implement an approach to select an initial set of chemicals to go through Tier 1 screening. The available laboratories and resources for screening and testing cannot handle the large number of potential endocrine disrupting chemicals at one time. Therefore, EPA developed a strategy for prioritizing chemicals for screening. EPA initially published the proposed chemical selection approach for comment, a Chemical Selection Approach for Initial Tier 1 Screening in an FR Notice (PDF) (19 pp, 119K, About PDF), in December 2002. EPA published a final approach for selecting the initial 50 to 100 chemicals for Tier 1 Screening, Chemical Selection Approach for Initial Screening in an FR Notice (PDF) (17pp, 125K, About PDF), in September 2005.EPA published the draft list of initial pesticide active ingredients and pesticide inerts to be considered for screening under the Federal Food, Drug and Cosmetic Act for public notice and comment in a 2007 Federal Register Notice (PDF) (18pp, 131K, About PDF). This list is based on the methodology described in the September 2005 FR Notice. After considering comments on this draft list of chemicals, EPA will issue a second Federal Register Notice containing the final list of chemicals.
- Develop the procedures EPA will use to require screening. EPA has issued two Federal Register (FR) notices seeking public comment on the Endocrine Disruptor Screening Program:
- One seeks public comment on the draft policies and procedures (PDF) (21 pp, 144K) the Agency intends to use for the initial screening of pesticide chemicals under the Agency's Endocrine Disruptor Screening Program (EDSP). EPA is also seeking comment on the draft template for the 408(p) Order that will be issued to require testing of the pesticide chemical.
- The other seeks public comment on the draft Information Collection Request (ICR) (PDF) (3 pp, 58K) that describes the information collection activities associated with Tier 1 screening of the first group of chemicals under the EDSP and provides EPA's estimates for the related paperwork burden and costs.
- Information Collection Request Supporting Statement
- Draft Template for EDSP Test Orders
- Draft EDSP Order Initial Response Form
- Detailed Workflow for Respondent Activities Under the EDSP's Tier 1 Screening For the First 73 Chemicals
- Calculations for Paperwork Burden and Costs for Data Generation Activities
- List of Agency Activities
- Draft List of Initial Pesticide Active Ingredients and Pesticide Inert
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