Overview of the Endocrine Disruptor Screening Program, including background, phases, history, and general information on the program. Endocrine Disruptor Screening Program (EDSP) Overview . These methods or assays allow EPA to identify and characterize the endocrine activity (specifically, estrogen, androgen and thyroid) of pesticides, commercial chemicals, and environmental contaminants. What will the most massive government-sponsored chemical-testing program in history yield? Reams of uninterpretable data, the waste of an enormous amount of time and money that could instead be spent protecting the public from. ACC offers expertise and resources for industry to comply with the EPA’s Endocrine Disruptor Screening Program through its EDSP Consortia. Overview of USEPA’s Endocrine Disruptors Research Program Elaine Z. Scope of EPA’s EDCs Research Program: Key Questions. Lessons Learned, Challenges, and Opportunities: The US Endocrine Disruptor Screening Program. Tier 1 screening of this initial list of chemicals has now been completed and the data have been submitted to EPA. How do endocrine disruptors work? From animal studies, researchers have learned much about the mechanisms through which endocrine disruptors influence the endocrine system and alter hormonal functions. Endocrine disruptors can. Slide 1 of 15 Endocrine Disruptor Screening Program (EDSP) Presentation for The Pesticide Program Dialogue Committee (PPDC) October 7, 2008.Program History. In the 1. A variety of chemicals have been found to disrupt the endocrine systems of animals in laboratory studies, and compelling evidence shows that endocrine systems of certain fish and wildlife have been affected by chemical contaminants, resulting in developmental and reproductive problems. Based on this and other evidence, Congress passed the Food Quality Protection Act (FQPA), which amended the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Safe Drinking Water Act (SDWA) Amendments in 1. EDSTAC's Final Report. Risk assessments are used to inform risk mitigation measures, as necessary, and regulatory decisions concerning chemicals. As the EDSP screening and testing requirements mature into routine evaluations, the Agency intends to utilize the pesticide registration review process as the framework for managing its responsibilities regarding the endocrine screening of pesticides, and intends to eventually incorporate these requirements routinely into the pesticide registration review process. While EPA has discretionary authority to issue, at any time, testing orders requiring manufacturers to conduct Tier 1 assays, the Agency plans to assess the performance of the Tier 1 battery based on the test data received for the initial list (List 1) of chemicals before beginning to routinely issue orders to test additional chemicals. If EDSP data exist at the time of a pesticide. In October 1. 99. 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. After EDSTAC completed its work and disbanded in 1. EPA organized a Standardization and Validation Task Force (SVTF) consisting of representation from a broad range of sectors, including federal agencies, agrichemical companies, commodity chemical companies, and environmental and public health organizations to coordinate and conduct the scientific and technical work necessary to validate the screens and tests recommended by the EDSTAC. In 2. 00. 1, SVTF was replaced by the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee of an Advisory Council (NACEPT) established under the Federal Advisory Committee Act. As a charter member and co- chair of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), EPA followed 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. In addition to the ICCVAM approach to assay validation in the United States, EPA considered the European approach by the European Center for the Validation of Alternative Methods (ECVAM), as well as the international approach by the Organization for Economic Co- operation and Development (OECD) since some screening assays involved a collaborative validation effort with OECD. In 2. 00. 4, the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) was formed to replace EDMVS. The EDMVAC continued to function like EDMVS by providing advice and recommendations to EPA on scientific and technical aspects of the Tier 1 screens and Tier 2 assays being considered for the Endocrine Disruptor Screening Program. In 2. 00. 7, the EDMVAC was disbanded, and the functions of this advisory committee were taken over by the Federal Insecticide, Fungicide, and Rodenticide Act Science Advisory Panel (FIFRA SAP). The Panel provides scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide related issues as to the impact on health and the environment of regulatory actions. The FIFRA SAP will continue to evaluate relevant scientific issues, protocols, data, and interpretations of the data for the assays during the. EPA Finalizes List of 1. Chemicals To Undergo Endocrine Disruptor Screening. By Patrick Ambrosio. The Environmental Protection Agency has finalized a list of 1. Endocrine Disruptor Screening Program, according to a notice published June 1. Federal Register (7. Fed. 3. 5,9. 22). The listed chemicals, the second group of substances selected for inclusion in the EDSP, will undergo Tier 1 screening, a battery of tests designed to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems. EPA said it focused on priority drinking water contaminants and pesticides, including substances included on the third Contaminant Candidate List, a set of contaminants that are not currently subject to any national primary drinking water regulations but may require regulation under the Safe Drinking Water Act. The finalized List 2 includes the chemicals perchlorate, benzene, and methanol, as well as 4. The notice specifies that List 2 should not be interpreted as a list of known or likely endocrine disruptors. The agency developed the EDSP after Congress passed authorizing legislation in 1. The first test orders for the program were issued in October 2. EPA to Consider Advisory Panel Report. The Environmental Protection Agency told BNA in a June 1. Tier 1 test orders for the new list of chemicals until it has received a report from the FIFRA Scientific Advisory Panel. The federal advisory panel met in May to discuss the performance of the Tier 1 battery in the screening of the initial list of 5. EDSP (3. 7 CRR 6. EPA said a final report from the SAP is due to the agency in September. The agency will fully consider the recommendations included in that report prior to issuing any additional Tier 1 test orders. Steven Bennett, senior director of scientific affairs and sustainability at the Consumer Specialty Products Association, told BNA in a June 1. EPA will “apply lessons learned” from the initial round of tests before issuing test orders for the List 2 substances. CSPA is one of the three industry organizations that filed a 2. EPA complete a full analysis of data generated for the List 1 pesticides before moving ahead with test orders on additional substances (3. CRR 6. 65, 7/4/1. The American Chemistry Council said in a statement June 1. EPA to “fully evaluate” the performance of the Tier 1 tests and make adjustments before testing additional chemicals. Any tests that do not perform as intended should either be revised or replaced with validated approaches before additional testing is conducted, ACC said. Industry Group Urges Pesticide Removal. Clare Thorp, senior director of human health policy at Crop. Life America, issued a June 1. EPA should refrain from issuing additional test orders until reviewing the SAP recommendations on List 1. Thorp said testing the List 2 substances before completing a full evaluation of the SAP's recommendations on the Tier 1 battery could result in “excessive, unnecessary practices that afford no additional benefits to the protection of human health and the environment.”Thorp also said pesticides that do not pose a concern under the Safe Drinking Water Act should not be included in List 2, since EPA stated the focus was on drinking water contaminants. Including the pesticides on List 2 could indicate to the public that the pesticides present a drinking water concern, even though the pesticides have been tested under the Federal Insecticide, Fungicide, and Rodenticide Act, according to Thorp. Crop. Life America also suggested that pesticides included on List 2 because of their status in the registration review process should be removed, Thorp said.“It would make more sense to issue the test orders for these compounds at the end of their individual registration review process, whenever that falls due,” she said. The document includes information on how EPA will determine who will receive a test order, how recipients can respond to test orders, and how test orders can be contested. The agency said it will attempt to identify and issue orders to “all significant manufacturers and importers” of List 2 substances. OPP Database to be Used. The Office of Pesticide Programs' information network, an internal database, will be used to identify technical registrants who hold a registration for a product containing a listed chemical as an active ingredient. Test orders will be issued to all identified technical registrants, according to the notice. Additionally, EPA will rely on information reported under the Toxic Substances Control Act inventory update reporting rule and information in the Toxic Release Inventory database to identify test order recipients for List 2 chemicals that are not used as pesticide active ingredients. EPA added that it plans to post a list of all List 2 test order recipients on its website once the orders are sent out. The White House Office of Management and Budget will need to approve an information collection request authorizing EPA's data collection activity before the test orders can be issued, according to EPA. The agency has submitted requests to collect additional data under the EDSP, according to a separate notice (7. Fed. 3. 5,9. 03). The notice finalizing the second list of chemicals to undergo Tier 1 screening is available at https: //s. The notice outlining EPA's policies and procedures for screening the chemicals is available at https: //s.
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