Endocrine Disruptor Screening Program Federal Register Notices
Federal Register (FR) notices related to the Endocrine Disruptor Screening Program (EDSP) are provided below. The notices are presented in chronological order, with the most recently published FR notices first.
Federal Register Notices
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| Date | Title | Summary |
|---|---|---|
| October 27, 2023 | Endocrine Disruptor Screening Program: Near-Term Strategies for Implementation | Near-Term Strategies for Implementation outlined what the EPA EDSP would be doing to meet the congressional mandate for the next few years. With this release, supplemental files were also released, including 1) Use of Existing Mammalian Data to Address Data Needs and Decisions for Endocrine Disruptor Screening Program (EDSP) for Humans under FFDCA Section 408(p) (scientific support for strategies), 2) List of Conventional Registration Review Chemicals for Which an FFDCA Section 408(p)(6) Determination is Needed (prioritization lists), and 3) Status of Endocrine Disruptor Screening Program (EDSP) List 1 Screening Conclusions. |
| January 19, 2023 | Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP) | This white paper describes two NAMs that may be used as alternatives for existing test guidelines and other NAMs that may be used for prioritization and consideration as other scientifically relevant information (OSRI). Future developments for the EDSP are also mentioned. |
| November 28, 2017 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act, Scientific Advisory Panel | EPA convened a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to provide recommendations concerning a proposed Androgen Receptor (AR) pathway model and high throughput (HT) H295R steroidogenesis assay, and provide guidance concerning the Agency’s ongoing development of an approach to detect substances that can perturb thyroid function. |
| August 25, 2015 | Endocrine Disruptor Screening Program Test Guidelines: Three Final Tier 2 Non-Mammalian Tests | EPA is announcing the availability of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines: Medaka Extended One-generation Reproduction Test (MEOGRT), OCSPP Test Guideline 890.2200; Larval Amphibian Growth and Development Assay (LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline 890.2100. These test guidelines are part of a series of test guidelines established by OCSPP for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducting the test and are also used by EPA, the public, and companies that submit data to EPA. |
| August 3, 2015 | Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program | EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)” and identified by EPA ICR No. 2479.01 and OMB Control No. 2070-New. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA has addressed the comments received in response to the previously provided public review opportunity issued in the Federal Register on June 24, 2013, 78 FR 37803. With this submission, EPA is providing an additional 30 days for public review. |
| June 19, 2015 | Endocrine Disruptor Screening Program: Use of High Throughput Assays and Computational Tools | This document describes how EPA is planning to incorporate an alternative scientific approach to screen chemicals for their ability to interact with the endocrine system. This will improve the Agency's ability to fulfill its statutory mandate to screen pesticide chemicals and other substances for their ability to cause adverse effects by their interaction with the endocrine system. The approach incorporates validated high throughput assays and a computational model and, based on current research, can serve as an alternative for some of the current assays in the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery. EPA has partial screening results for over 1800 chemicals that have been evaluated using high throughput assays and a computational model for the estrogen receptor pathway. In the future, EPA anticipates that additional alternative methods will be available for EDSP chemical screening based on further advancements of high throughput assays and computational models for other endocrine pathways. Use of these alternative methods will accelerate the pace of screening, decrease costs, and reduce animal testing. In addition, this approach advances the goal of providing sensitive, specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment. |
| January 30, 2015 | Endocrine Disruptor Screening Program Test Guidelines; Three Draft Tier 2 Non-Mammalian Tests | EPA is announcing the availability of three draft test guidelines for public review and comment that are being added to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screening Program (EDSP): Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. These draft test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA. |
| September 16, 2014 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Integrated Endocrine Activity and Exposure-based Prioritization and Screening. |
| May 30, 2014 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel | There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review New High Throughput Methods to Estimate Chemical Exposure. |
| June 26, 2013 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening. |
| June 24, 2013 | Agency Information Collection Activities; Proposed Collection; Comment Request; Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP) | EPA announces that the agency is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, titled: "Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)” and identified by EPA ICR No. 2479.01 and OMB Control No. 2070-New, represents a new request related to the next phase of an existing program. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying materials are available in the docket for public review and comment. |
| June 14, 2013 | Information Collection Request Submitted to OMB for Review and Approval; Comment Request; ICR Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program | EPA has submitted the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.): “ICR Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)” (EPA ICR No. 2488.01, OMB Control No. 2070-[new]). This is a new ICR that will amend an ICR that is currently approved under OMB Control No. 2070-0176 (EPA ICR No. 2249) and which covers the first list of chemicals. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs. Copies of the ICR and related documents are available in the docket. |
| June 14, 2013 | Endocrine Disruptor Screening Program; Final Second List of Chemicals and Substances for Tier 1 Screening | This document announces the final second list of 109 chemicals identified for Tier 1 Screening under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. |
| June 14, 2013 | Endocrine Disruptor Screening Program; Final Policies and Procedures for Screening Safe Drinking Water Act Chemicals | This document describes EPA’s final policies and procedures for requiring Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP) of chemicals for which EPA may issue EDSP test orders pursuant to section 1457 of the Safe Drinking Water Act (SDWA) and section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 408(p) of the FFDCA directed EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information (OSRI) to determine whether certain chemicals may have hormonal effects. These final policies and procedures supplement the EDSP policies and procedures that were published in the Federal Register on April 15, 2009. |
| April 2, 2013 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review proposed Endocrine Disruptor Screening Program (EDSP) Tier 2 Ecotoxicity Tests. |
| November 16, 2012 | FIFRA Scientific Advisory Panel; Notice of Public Meeting | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review scientific issues associated with Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools. |
| October 21, 2012 | Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of the Tier 1 Screening Battery and Related Test Guidelines | EPA is announcing the availability of the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery of assays and availability of test guidelines (protocols) for conducting the assays included in the battery. The EDSP was established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which directed EPA “to develop a screening program.... 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 the Administrator may designate.” Coordinated by EPA, several in vitro and in vivo screening assays were developed, standardized, and validated to identify the potential of a chemical substance to interact with the estrogen, androgen or thyroid (E, A, or T) hormonal systems. Test chemicals that were thought to be potentially interactive as well as non-interactive with the E, A, or T hormonal systems were used to evaluate feasibility of the protocols, relevance of endpoints and reliability of results within and among independent contract laboratories. Subsequent independent peer review of individual assays helped to clarify the strengths and limitations of each assay and define their modes of action involving the E, A, or T hormonal systems within the context of the EDSP Tier 1 battery. EPA submitted a proposed battery of assays to the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) for external peer review in March 2008. Based on the SAP recommendation, which found the proposed battery adequate to begin screening chemicals to detect the potential for interaction with the E, A, or T hormonal systems, EPA is finalizing the Tier 1 battery as proposed |
| February 29, 2012 | Petition To Demonstrate Paperwork Reduction Act Compliance of the Endocrine Disruptor Screening Program; Notice of Availability | EPA is seeking public comment on a December 7, 2011 petition from the Chemical Producers & Distributors Association (CPDA), the Halogenated Solvents Industry Alliance, Inc., and the People for the Ethical Treatment of Animals (PETA). The petition requested that the Agency abide by the Paperwork Reduction Act and Office of Management and Budget Terms of Clearance for the approved Information Collection Request (ICR) of the first list of 67 chemicals to receive orders under the Endocrine Disruptor Screening Program by demonstrating the information being sought has practical utility and is not duplicative before proceeding with Tier 1 screening orders for additional chemicals. |
| August 10, 2011 | Petition to Maximize Practical Utility of List 1 Chemicals Screened Through EPA's Endocrine Disruptor Screening Program; Notice of Availability | EPA is seeking public comment on a June 21, 2011, petition from CropLife America (CLA), Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) requesting the Agency develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program. |
| February 22, 2012 | Meetings: Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Endocrine Disruptor Screening Program (EDSP) Tier 1 Screening Assays and Battery Performance. |
| December 14, 2010 | Endocrine Disruptor Screening Program: Second List of Chemicals for Tier 1 Screening; Extension of Comment Period | EPA published a notice in the Federal Register issue of November 17, 2010 concerning the Endocrine Disruptor Screening Program's (EDSP) second list of chemicals for Tier 1 screening. This document extends the comment period from December 17, 2010 to January 18, 2011. |
| November 17, 2010 | Endocrine Disruptor Screening Program; Second List of Chemicals for Tier 1 Screening | This document announces the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). EPA established the EDSP in response to section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This second list of chemicals expands the EDSP in an effort to include all pesticides, required by FFDCA, and adds priority drinking water chemicals into the program for screening as authorized by SDWA section 1457. Today’s publication provides public notice of EPA’s tentative decision-making in advance of the actual issuance of EDSP testing orders. |
| November 17, 2010 | Endocrine Disruptor Screening Program; Draft Policies and Procedures for Screening Safe Drinking Water Act Chemicals | This document describes EPA's draft policies and procedures for requiring Tier 1 screening of substances for which EPA may issue testing orders pursuant to section 1457 of the Safe Drinking Water Act (SDWA) and section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). FFDCA section 408(p) directed EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. This document was drafted with the intent of explaining the policies and procedures relevant to EDSP Safe Drinking Water Act chemicals. These draft policies and procedures are intended to supplement the existing EDSP policies and procedures that were published in the Federal Register on April 15, 2009 (74 FR 17560). |
| November 17, 2010 | Agency Information Collection Activities; Proposed Collection; Comment Request; Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.02, OMB Control No. 2070–0176 | In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request an addendum to an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This addendum simply covers the burden for a new list of chemicals to receive and respond to EDSP Orders. The activities articulated in the original ICR are not changing. This ICR addendum, entitled “Addendum for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)” and identified by EPA ICR No. 2249.02 and OMB Control No. 2070–0106. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. |
| November 4, 2010 | Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of a Draft for Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening To Identify Candidate Chemicals for Tier 2 Testing | EPA is announcing the availability for public review and comment of a draft guidance document titled, "Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening to Identify Candidate Chemicals for Tier 2 Testing." This action is in compliance with a directive from the House Appropriations Committee FY 2010 Report directing the EPA to develop and publish criteria by October 30, 2010, for evaluating results of Tier 1 screening and determining whether a chemical should undergo Tier 2 analysis. The purpose of the weight-of-evidence (WoE) document is to set forth some of the general principles, criteria, and considerations EPA generally believes to be relevant under a WoE approach for evaluating data submitted as part of EPA’s two-tiered paradigm for screening and testing chemicals for endocrine activity (i.e., estrogen, androgen, and thyroid hormonal systems; E, A, and T) under the EDSP. This document provides a transparent scientific approach for broadly evaluating Tier 1 screening data to detect an interaction with E, A, and/or T hormonal systems and determine if additional Tier 2 testing is necessary. |
| October 21, 2010 | Endocrine Disruptor Screening Program; Tier 1 Screening Order Issuing Announcement | This action announces the Agency's initiation of the Endocrine Disruptor Screening Program (EDSP) Tier 1 screening for the first group of 67 chemicals by issuing orders between October 29, 2009, and February 26, 2010, pursuant to the authority provided to EPA under section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The EDSP Tier 1 screening data required to satisfy an order are due within 2 years of the date of issuance of the order. This action also provides information for pesticide registrants, manufacturers and importers of inert chemicals used in pesticide products, and the public on how to obtain details about the orders (such as the date of issuance and the recipients), the "Pesticide Inert Ingredients Data Submitters and Suppliers List" (PIIDSSL), and how interested persons other than recipients of test orders may submit other scientifically relevant information on the chemicals subject to the orders |
| October 21, 2009 | Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of the Tier 1 Screening Battery and Related Test Guidelines | EPA is announcing the availability of the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery of assays and availability of test guidelines (protocols) for conducting the assays included in the battery. The EDSP was established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which directed EPA “to develop a screening program. . .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 the Administrator may designate.” Coordinated by EPA, several in vitro and in vivo screening assays were developed, standardized, and validated to identify the potential of a chemical substance to interact with the estrogen, androgen or thyroid (E, A, or T) hormonal systems. Test chemicals that were thought to be potentially interactive as well as non-interactive with the E, A, or T hormonal systems were used to evaluate feasibility of the protocols, relevance of endpoints and reliability of results within and among independent contract laboratories. Subsequent independent peer review of individual assays helped to clarify the strengths and limitations of each assay and define their modes of action involving the E, A, or T hormonal systems within the context of the EDSP Tier 1 battery. EPA submitted a proposed battery of assays to the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) for external peer review in March 2008. Based on the SAP recommendation, which found the proposed battery adequate to begin screening chemicals to detect the potential for interaction with the E, A, or T hormonal systems, EPA is finalizing the Tier 1 battery as proposed. |
| April 15, 2009 | Agency Information Collection Activities; Submission To OMB for Review and Approval; Comment Request; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-New | In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This request involves a new collection activity. The ICR, which is abstracted in this document, describes the nature of the information collection activity and its expected burden and costs. |
| April 15, 2009 | Endocrine Disruptor Screening Program; Policies and Procedures for Initial Screening | This document describes the policies and procedures EPA generally intends to adopt for initial screening of chemicals under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires endocrine screening of all pesticide chemicals and was established in response to growing scientific evidence that humans, domestic animals, and fish and wildlife species have exhibited adverse health consequences from exposure to environmental chemicals that interact with their endocrine systems. In December 2007, EPA sought comment on its draft policies and procedures for initial screening under the EDSP. Following review and revision based on the public comments, EPA is now describing the specific details of the policies and procedures that EPA generally intends to adopt for initial screening under the EDSP, including the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and handling confidential data. |
| April 15, 2009 | Final List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened Under the Federal Food, Drug, and Cosmetic Act | Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. In September 2005, EPA published its approach for selecting the initial list of chemicals for which testing will be required under the Endocrine Disruptor Screening Program (EDSP) and in June 2007, EPA published the draft list of the first group of chemicals proposed for screening in the Agency's EDSP. This document presents the final list of the first group of chemicals that will be screened in the Agency's EDSP. The list was produced using the approach described in the September 2005 notice and considers comments received in response to the June 2007 draft list. The list includes chemicals that the Agency, in its discretion, has decided should be tested first, based upon exposure potential. The Agency deleted 6 chemicals from the original list of 73 based upon recent information showing that the chemicals are no longer expected to be found in 3 exposure pathways. The first group of 67 chemicals identified for testing includes pesticide active ingredients and High Production Volume (HPV) chemicals used as pesticide inert ingredients (also known as other ingredients). 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 by simply being on this list these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so. This document does not describe other aspects of the EDSP such as the administrative procedures EPA will use to require testing, which is addressed in a separate notice published in today's Federal Register. |
| February 13, 2008 | Endocrine Disruptor Screening Program; Second Workshop to Discuss Draft Policies and Procedures; Notice of Public Meeting | EPA is convening a half-day public workshop to discuss the Agency's draft administrative policies and procedures for completing the initial screening and testing under EPA's Endocrine Disruptor Screening Program (EDSP). In the Federal Register issue of December 13, 2007 (72 FR 70842) (FRL-8340-3), EPA announced the availability for public review and comment of the draft policies and procedures EPA is considering adopting for conducting the initial screening and testing under EDSP. A 1-day public workshop was held on December 17, 2007, in Arlington, VA to help the public understand the draft policies and procedures. Subsequently, EPA extended the public comment period for the draft policies and procedures by 30 days in the Federal Register issue of February 6, 2008 (73 FR 6963) (FRL-8351-2). The public comment period now ends March 12, 2008. The purpose of the second public workshop, announced in this notice, is to provide another opportunity for the public to ask questions about the draft EDSP policies and procedures. |
| February 6, 2008 | Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures for Initial Screening; Request for Comment; Extension of Comment Period | EPA issued a notice in the Federal Register of December 13, 2007, announcing the availability of and soliciting public comment on EPA's draft policies and procedures for initial screening under the Agency's Endocrine Disruptor Screening Program (EDSP). The December 13, 2007, notice provided for a 60-day public comment period ending February 11, 2008. EPA received several requests from the public to extend this comment period. This document extends the comment period for 30 days, from February 11, 2008, to March 12, 2008. |
| February 6, 2008 | Agency Information Collection Activities; Proposed Collection; Comment Request; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-new; Extension of Comment Period | EPA issued a notice in the Federal Register of December 13, 2007, announcing EPA's plan to submit a request for a new Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is entitled: "Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)" and identified by EPA ICR No. 2249.01 and OMB Control No. 2070-new. The December 13, 2007 document provided for a 60 day public comment period ending February 11, 2008. EPA received several requests from the public to extend this comment period. This document extends the comment period for 30 days, from February 11, 2008, to March 12, 2008. |
| January 24, 2008 | FIFRA Scientific Advisory Panel; Notice of Public Meeting | There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Endocrine Disruptor Screening Program (EDSP) Proposed Tier-1 Screening Battery. |
| December 28, 2007 | Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period | EPA issued a notice in the Federal Register of June 18, 2007, concerning the draft list of the first group of chemicals that will be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). The draft list was produced using the approach described in the September 2005 notice, and includes chemicals that the Agency, in its discretion, has decided should be tested first, based upon exposure potential. The June 18, 2007 Federal Register notice provided for a 90-day public comment period. EPA extended the comment period an additional 60 days in the Federal Register of September 12, 2007, and later extended the comment period for 45 days in the Federal Register of November 15, 2007. This document is extending the comment period for a third time for an additional 42 days. The new comment period closes February 11, 2008. |
| December 13, 2007 | Endocrine Disruptor Screening Program (EDSP); Draft Policies and Procedures for Initial Screening; Request for Comment | This document announces the availability of and solicits public comment on EPA's draft policies and procedures for initial screening under the Agency's Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires endocrine screening of all pesticide chemicals and was established in response to growing scientific evidence that humans, domestic animals, and fish and wildlife species have exhibited adverse health consequences from exposure to environmental chemicals that interact with their endocrine systems. This document provides specific details on the policies and the related procedures that EPA is considering adopting for initial screening under the EDSP. In general, the Agency has tried to develop policies that could be used in subsequent data collection efforts. However, EPA expects that these policies may be modified as a result of the Agency's experience applying them to the first chemicals to undergo testing. This document also discusses the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and data confidentiality. EPA will also be holding a public meeting to discuss these policies and procedures. A separate Federal Register document announced the details of the public meeting. |
| December 13, 2007 | Agency Information Collection Activities; Proposed Collection; Comment Request; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-new | In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request for a new Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is entitled: "Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)" and identified by EPA ICR No. 2249.01 and OMB Control No. 2070-new. Before submitting the ICR to OMB for review and approval under the PRA, EPA is soliciting comments on specific aspects of the proposed information collection. |
| November 23, 2007 | Endocrine Disruptor Screening Program; Workshop to Discuss Draft Policies and Procedures | EPA is convening a 1-day public workshop to discuss the Agency's draft administrative policies and procedures for completing the initial screening and testing under EPA's Endocrine Disruptor Screening Program (EDSP) and the burden and cost estimates for the related information collection activities. In two forthcoming notices in the Federal Register, EPA will announce the availability for public review and comment of: (1) The draft policies and procedures EPA is considering adopting for conducting the initial screening and testing under the EDSP and (2) the draft Information Collection Request (ICR) for the initial screening and testing. The purpose of the public workshop is to allow the public to ask questions and for EPA to provide further explanation about these aspects of the EDSP, which in turn may facilitate the preparation of comments. |
| November 15, 2007 | Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period | EPA issued a notice in the Federal Register of June 18, 2007, concerning the draft list of the first group of chemicals that will be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). The draft list was produced using the approach described in the September 2005 notice, and includes chemicals that the Agency, in its discretion, has decided should be tested first, based upon exposure potential. The June 18, 2007 Federal Register notice provided for a 90-day public comment period. EPA extended the comment period an additional 60 days in the Federal Register of September 12, 2007. This document is extending the comment period for a second time for 45 days. The new comment period extends to December 31, 2007. |
| September 12, 2007 | Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period | EPA issued a notice in the Federal Register of June 18, 2007, concerning the draft list of the first group of chemicals that will be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). The draft list was produced using the approach described in the September 2005 notice, and includes chemicals that the Agency, in its discretion, has decided should be tested first, based upon exposure potential. This document is extending the comment period for 60 days, from September 17, 2007, to November 16, 2007. |
| July 13, 2007 | Endocrine Disruptor Screening Program; Assay Peer Review Process | The purpose of this notice is to announce the approach EPA intends to take for conducting peer reviews of the Tier 1 screening assays and Tier 2 testing assays that are being validated by the Agency’s Endocrine Disruptor Screening Program (EDSP), as well as EPA’s approach for conducting the peer review of the Tier 1 battery. EPA is also announcing the availability of a listserver (Listserv) that will allow interested parties to sign up to receive email notifications of EDSP peer review updates, including information on the availability of peer review materials to be posted on the EDSP website. These materials may include the documents to be peer reviewed, background documents, the charge to the peer reviewers, and reports that summarize the results of peer reviews. |
| June 18, 2007 | Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under the Federal Food, Drug and Cosmetic Act | Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. In September 2005, EPA published its approach for selecting the initial list of chemicals for which testing will be required under the Endocrine Disruptor Screening Program (EDSP). This notice presents the draft list of the first group of chemicals that will be screened in the Agency's EDSP. The draft list was produced using the approach described in the September 2005 Notice, and includes chemicals that the Agency has decided should be tested first, based upon exposure potential. 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. The first group of chemicals identified for testing includes pesticide active ingredients and High Production Volume (HPV) chemicals used as pesticide inerts. After considering comments on this draft list of chemicals, EPA will issue a second Federal Register Notice containing the final list of chemicals. This notice does not describe other aspects of the EDSP such as the administrative procedures EPA will use to require testing, the validated tests and battery that will be included in the EDSP, or the timeframe for requiring the testing or receiving the data. These topics will be addressed in subsequent notices published in the Federal Register. |
| December 13, 2006 | FIFRA Scientific Advisory Panel; Notice of Public Meeting | There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the status of the in utero through lactational assay in the Endocrine Disruptor Screening Program (EDSP). |
| March 29, 2006 | Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) on April 18 through April 20, 2006, in Washington, DC. This meeting, as with all EDMVAC meetings, is open to the public. Seating is on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on: Male and Female Pubertals Assay Interlaboratory Studies, EDSP’s Applied Approach to Validation, Tier 1 Fish Screen Assay Validation Status, updates on Tier 1 Aromatase Assay, and Tier 1 Steroidogenesis Cell Based H295R Assay. |
| November 8, 2005 | Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) on November 30 through December 2, 2005, in Raleigh, NC. This meeting, as with all EDMVAC meetings, is open to the public. Seating is on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on: EPA’s Applied Approach to Validation, OECD Uterotrophic Peer Review Report, Steroidogenesis Using the H295R Cell Line, Avian Studies, and an update on the Pubertal Assays. |
| September 27, 2005 | Endocrine Disruptor Screening Program; Chemical Selection Approach for Initial Screening | This notice describes the approach EPA plans to use for selecting the first group of chemicals to be screened in the Agency’s Endocrine Disruptor Screening Program (EDSP). The Food Quality Protection Act of 1996 (FQPA) amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. In December 2002, EPA sought comment on its approach for selecting the initial list of chemicals for which testing will be required under the EDSP. Following review and revision based on the public comments, EPA is now describing the approach that it intends to use for selecting the chemicals for the initial list. For this initial approach, as recommended by scientific advisory committees, EPA will select 50 to 100 chemicals. The chemicals will be selected based on their relatively high potential for human exposure rather than using a combination of exposure- and effects-related factors. The scope of this first group of chemicals to be tested includes pesticide active ingredients and High Production Volume (HPV) chemicals used as pesticide inerts. This will allow EPA to focus its initial screening efforts on a smaller and more manageable universe of chemicals that emphasizes the early attention to the pesticide chemicals that Congress specifically mandated EPA to test for possible endocrine effects. This notice does not identify the initial list of chemicals, nor does it describe other aspects of the EDSP such as the administrative procedures EPA will use to require testing, the validated tests and battery that will be included in the EDSP, or the timeframe for requiring the testing or receiving the data. The initial chemical list and the details of the EDSP process that will apply to the initial chemical list will be addressed in subsequent notices published in the Federal Register. |
| July 11, 2005 | Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting | There will be a meeting, via teleconference, of the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) on August 2, 2005, in Washington, DC. This meeting, as with all EDMVAC meetings, is open to the public. Due to limited phone lines, we encourage all local participants to join us at RESOLVE. Seating will be on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on the 15-Day Intact Adult Male Assay |
| April 8, 2005 | Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Advisory Committee ( EDMVAC ) on April 26-28, 2005, in Washington, DC. This meeting, as with all EDMVAC meetings, is open to the public. Seating is on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on: Steroidogenesis, Uterotrophic, Fish Screen Studies, and Amphibian Metamorphosis Assays. |
| June 2, 2004 | Establishment of the Endocrine Disruptor Methods Validation Advisory Committee | As required by section 9(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2 section 9(a)(2)), we are giving notice that EPA is establishing the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC). The purpose of this Committee is to provide a forum for a diverse group of individuals representing a broad range of interests and scientific expertise. It will provide advice to the Agency on matters related to the validation of assays under consideration by the Endocrine Disruptor Screening Program (EDSP). The Committee will analyze relevant scientific issues, protocols, review data and interpretations of data for the assays. The major objective of the Committee is to provide advice and recommendations to the EPA Administrator on scientific and technical aspects of the assays as they progress through the validation process. EPA has determined that this advisory committee is in the public interest and will assist the Agency in performing its duties as prescribed by the Food Quality Protection Act of 1996. Copies of the Committee Charter will be filed with the appropriate congressional committees and the Library of Congress. |
| June 1, 2004 | Request for Nominations to the Proposed Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Extension of Time | In the Federal Register of April 26, 2004 (69 FR 22509) (FRL- 7352-9), EPA issued a notice inviting nominations of qualified candidates to consider for appointment to the proposed Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC), which is replacing the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under the National Advisory Council for Environmental Policy and Technology (NACEPT). Due to a low number of submissions of nominations the Agency is extending the request for nomination time period to 4 p.m. eastern time on June 18, 2004. |
| April 26, 2004 | Request for Nominations to the Proposed Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) | EPA is inviting nominations of qualified candidates to consider for appointment to the proposed Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC), which is replacing the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under the National Advisory Council for Environmental Policy and Technology (NACEPT). EPA will consider nominations submitted in response to this notice as well as nominations received from other outreach efforts in selecting EDMVAC members. The purpose of the proposed EDMVAC will be to provide 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 (EDSP). The proposed Committee will evaluate relevant scientific issues, protocols, data and interpretations of the data for the assays during the validation process. The proposed EDMVAC will provide advice on the composition of the Tier I screening battery as well. Nominations will be accepted until 4 p.m. eastern time on May 26, 2004. |
| November 21, 2003 | Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), on December 10-12, 2003. The purpose of this meeting is to receive advice and input from the EDMVS on: The Pubertals assay and Aromatase assay prevalidation results; receive the introductory presentation on Adult Intact Male assay; and receive updates on: The Androgen Receptor Binding assay, efforts to finalize reference chemicals, and the Organization for Economic Cooperation and Development (OECD) fish drafting Group |
| July 30, 2003 | Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a Subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), on August 18-20, 2003. This meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. |
| May 30, 2003 | Endocrine Disruptor Screening Program; Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Request for Nominations for Membership | As mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA), amended by the Food Quality Protection Act (FQPA) of 1996, EPA implemented an Endocrine Disruptor Screening Program (EDSP). As part of the EDSP, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) was established in 2001, is a Subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT). The members of the EDMVS may serve up to three 2-year terms. This notice is a request for nominations for new members of the EDMVS from interested organizations. NACEPT is a chartered federal advisory committee subject to the provisions of the Federal Advisory Committee Act (FACA). Through NACEPT, the EDMVS provides technical advice and recommendations to EPA regarding validation of the Tier I screening and Tier II testing methods for the EDSP. |
| May 21, 2003 | Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a Subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), on June 5-6, 2003. This meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. |
| February 26, 2003 | Proposed Chemical Selection Approach for Initial Screening; Extension of Comment Period | In a Federal Register notice published on December 30, 2002, EPA set forth for public comment the approach EPA intends to use for selecting the first group of chemicals to be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). EPA requested that comments be submitted on or before March 1, 2003. In response to several requests to extend the deadline for submitting comments, EPA is extending the comment period to April 1, 2003. |
| December 30, 2002 | Proposed Chemical Selection Approach for Initial Screening; Request for Comment | This notice sets forth for public comment the approach EPA plans to use for selecting the first group of chemicals to be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). Following consideration of comments on this draft approach, EPA will issue a second Federal Register notice setting forth its approach for selecting the first group of chemicals and the chemicals it proposes for this initial list. Following comment on the draft list of specific chemicals, EPA will issue the final list. |
| November 14, 2002 | Endocrine Disruptor Methods Validation Subcommittee Under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | EPA is announcing a 2-hour teleconference meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal advisory committee, on December 4, 2002. The EDMVS will provide technical advice on a fish lifecycle assay detailed review paper presented by the Endocrine Disruptor Screening Program (EDSP). The upcoming teleconference meeting is open to the public. |
| July 10, 2002 | Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal Advisory Committee, on July 23-24, 2002. The EDMVS will provide technical advice on screening and testing methods for the Endocrine Disruptor Screening Program (EDSP). This meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. |
| May 28, 2002 | Endocrine Disruptor Method Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | There will be a meeting, via teleconference, of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal Advisory Committee, on June 11, 2002, to discuss the steroidogenesis detailed review paper. The meeting is open to the public. Due to limited phone lines, we encourage all local participants to join us at RESOLVE. Seating will be on a first-come basis. The EDMVS meeting originally scheduled for June 10-12, 2002, has been postponed. That meeting will be rescheduled for late July. |
| March 8, 2002 | Endocrine Disruptor Method Validation Subcommittee Under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal Advisory Committee, on March 25th - 27th, 2002. The EDMVS will provide technical advice on screening and testing methods for the Endocrine Disruptor Screening Program (EDSP). The upcoming meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. |
| November 21, 2001 | Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | As mandated by the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, EPA is implementing an Endocrine Disruptor Screening Program (EDSP). As part of the implementation of EDSP, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under the National Advisory Council for Environmental Policy and Technology, a Federal Advisory Committee NACEPT, has been established. There will be a 3-day meeting of the EDMVS, December 10 - 12, 2001. EDMVS will provide technical advice on the Tier 1 screening and Tier 2 testing methods for its EDSP. The meeting is open to the public. Seating is on a first-come basis. |
| October 11, 2001 | Endocrine Disruptor Methods Validation Subcommittee Under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting | As mandated by the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality protection Act of 1996, EPA is implementing an Endocrine Disruptor Screening Program (EDSP). As part of the implementation of EDSP, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) has been established under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal Advisory Committee. EDMVS will have their first 2-day meeting, October 30-31, 2001. EDMVS will provide technical advice on the Tier 1 screening and Tier 2 testing methods for EPA's EDSP. The meeting is open to the public. Seating is on a first-come basis. |
| May 16, 2001 | National Toxicology Program: Release of the NTP final report from the Endocrine Disruptors Low-Dose Peer Review for public comment | The National Toxicology Program (NTP)/National Institute of Environmental Health Sciences (NIEHS) organized and conducted a scientific peer review at the request of the EPA to evaluate reported low-dose reproductive and developmental effects and dose-response relationships for endocrine disrupting chemicals. The NTP is soliciting public comment prior to transmitting the final report to the EPA. Public comments received in response to this solicitation will be included in the final transmittal. The final report is available on the NTP web site at http://ntp-server.niehs.nih.gov or by contacting the NTP Office of Liaison and Scientific Review; 919-541-0530 (phone); 919-541-0295 (fax); liaison@starbase.niehs.nih.gov ; 111 T.W. Alexander Drive, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709. Comments are being accepted through July 16, 2001. Instructions on how to submit comments are in the Federal Register notice. |
| May 7, 2001 | Endocrine Disruptor Screening Program; Establishment of an Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Request for Nominations for Membership | As mandated by the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, EPA is implementing an Endocrine Disruptor Screening Program (EDSP). This notice proposes the establishment of an Endocrine Disruptor Methods Validation Subcommittee (EDMVS) as a Subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), and requests nominations for members of the EDMVS from interested organizations. NACEPT is a chartered federal advisory committee subject to the provisions of the Federal Advisory Committee Act. Through NACEPT, the EDMVS will provide technical advice an recommendations to EPA regarding validation of the Tier 1 Screening and Tier 2 Testing methods for its Endocrine Disruptor Screening Program (EDSP). |
| March 26, 2001 | Endocrine Disruptor Screening Program; Proposed Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Meeting | There will be a meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT), a Federal Advisory Committee, on April 24, 2001. The EDMVS will provide technical advice on screening and testing methods for the Endocrine Disruptor Screening Program (EDSP). The upcoming meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. |
| July 13, 2000 | Priority-Setting Workshop for the Endocrine Disruptor Screening Program (EDSP); Extension of Comment Period | EPA is extending the comment period, announced in the May 19, 2000, Federal Register, for issues discussed at the June 5-7 Priority-Setting Workshop for the Endocrine Disruptor Screening Program (EDSP), from July 7, 2000 to August 25, 2000. |
| May 19, 2000 | Priority-Setting Workshop for the Endocrine Disruptor Screening Program; Notice of Public Meeting | The National Toxicology Program (NTP) is organizing a Peer Review to evaluate dose-response relationships for endocrine disrupting chemicals. In particular, the panel will evaluate whether chemicals can cause hormone-related effects at doses lower than those typically used in the standard toxicological dose-setting paradigm. The U.S. Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program will use the results from this peer review to assist in determining how to identify and characterize potential low-dose effects that may arise during endocrine disruptor screening, testing, and hazard assessment. If the review panel concludes that the current data on low-dose effects are inconclusive, it will be asked to describe specific research that would resolve the ambiguities. The Peer Review will take place October 10-12, 2000 at the Sheraton Imperial Hotel and Convention Center, Research Triangle Park, NC. This meeting is open to the public. |
| September 27, 2000 | National Institute of Environmental Health Sciences, NIH; National Toxicology Program; Peer Review Meeting on Low-Dose Issues for Endocrine Disruptors; Update on Meeting Scope; Meeting Agenda; and Registration Information | The National Toxicology Program (NTP) is organizing a Peer Review to evaluate whether chemicals can cause hormone-related effects at doses lower than those typically used in the standard toxicological dose-setting paradigm. On January 6, 2000 the NTP published a Federal Register notice outlining plans for the Peer Review meeting and soliciting public input into the process. This notice broadens the request for research studies and data to be considered and extends previously announced deadlines for receipt of research information for use in this peer review. |
| April 17, 2000 | National Toxicology Program: Peer Review Meeting on Low-Dose Issues for Endocrine Disruptors; Scope of Information Considered for Review Broadened, Deadline for Receipt of Information Extended, and Date for Meeting Delayed | NTP is soliciting comments on the planned scope and process for a proposed peer review of studies bearing on the question of whether endocrine disruptors may cause effects at doses lower than are tested using standard toxicological testing procedures. Nominations for peer reviewers, as well as nominations for studies to be reviewed, are also being solicited. Results from the peer review will help the U.S. Environmental Protection Agency (a member agency of the NTP) and, in particular the EPA's Endocrine Disruptor Screening Program, determine how to address low-dose questions in endocrine disruptor screening, testing, and hazard assessment. |
| January 6, 2000 | National Toxicology Program: Solicitation of Comments on Proposed Peer Review of Low-Dose Issues for Endocrine Disruptors | NTP is soliciting comments on the planned scope and process for a proposed peer review of studies bearing on the question of whether endocrine disruptors may cause effects at doses lower than are tested using standard toxicological testing procedures. Nominations for peer reviewers, as well as nominations for studies to be reviewed, are also being solicited. Results from the peer review will help the U.S. Environmental Protection Agency (a member agency of the NTP) and, in particular the EPA's Endocrine Disruptor Screening Program, determine how to address low-dose questions in endocrine disruptor screening, testing, and hazard assessment. |
| December 28, 1998 | Endocrine Disruptor Screening Program: Statement of Policy Notice | In this notice, EPA is providing additional details and an opportunity for public comment on its Endocrine Disruptor Screening Program (EDSP). The Agency first set forth the basic components of the EDSP in the August 11, 1998, Federal Register. The EDSP is required by the Federal Food, Drug, and Cosmetics Act (FFDCA), as amended by the Food Quality Protection Act (FQPA). In developing the EDSP, EPA considered recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), a panel chartered pursuant to the Federal Advisory Committee Act. EDSTAC recommended expansion of the screening program beyond the statutory minimum to include not only pesticides but commercial chemicals regulated under the Toxic substances Control Act (TSCA), certain natural products, non-pesticide food additives, and cosmetics. EDSTAC also recommended that EPA screen for effects on the androgen and thyroid systems and for effects on fish and wildlife. This notice describes the major elements of EPA's EDSP, as well as its implementation. |
| December 28, 1998 | Endocrine Disruptor Screening Program: Priority-Setting Workshop | This notice invites public participation in a workshop to discuss the development of a priority-setting system for the selection of chemicals for testing in the Endocrine Disruptor Screening Program (EDSP). The recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) and the Agency's subsequent Statement of Policy contain a set of principles and a general strategy for setting priorities for testing. The Agency is now commencing the detailed design phase of the priority-setting system and seeks public input on the design of the system. |
| August 11, 1998 | Endocrine Disruptor Screening Program | As mandated by the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, EPA is setting forth its screening program for determining which pesticide chemicals and other substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. In developing the screening program, EPA considered recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee, a panel chartered pursuant to the Federal Advisory Committee Act. EPA refers to this program as the "Endocrine Disruptor Screening Program" or the "Screening Program." This document describes the major elements of EPA's Endocrine Disruptor Screening Program. EPA will provide operational details regarding the Screening Program, its regulatory implementation, and provide an opportunity for public comment in a later Federal Register document. After public comment and before implementation, EPA will submit the Screening Program for review to a joint panel of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel and the EPA Science Advisory Board. |
| June 12, 1998 | EPA's Endocrine Disruptor Screening and Testing Advisory Committee; Notice of Public Meeting | EPA is announcing the final meeting of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on developing a strategy to screen and test chemicals, including pesticides, for their potential to disrupt endocrine functions in humans, fish, and other wildlife. |
| April 9, 1998 | FIFRA Scientific Advisory Panel and Science Advisory Board; Open Meeting | There will be a joint two-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) and the Agency Science Advisory Board (SAB) to review a set of scientific issues being considered by the Agency concerning the development of the Agency's endocrine disruptor screening and testing program as required by the 1996 Food Quality Protection Act and the Safe Drinking Water Act. This meeting will focus on scientific issues identified by the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC) in their draft report. Agenda items include the conceptual framework for the operation of the EDSTAC, the endocrine disruptors priority setting process, the proposed endocrine disruptors screening battery and testing scheme, and a discussion of the near-term endocrine disruptors program implementation activities. Information from the draft EDSTAC report and from this meeting as well as public comments will be used by the Agency to develop the endocrine disruptors program. |
| March 2, 1998 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the eighth meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| January 23, 1998 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the seventh meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| November 25, 1997 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the sixth meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| September 3, 1997 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the fifth meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| July 7, 1997 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the fourth meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| April 28, 1997 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the third meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| March 14, 1997 | Special Report on Environmental Endocrine Disruption: An Effects Assessment and Analysis | EPA is announcing the availability of the ``Special Report on Environmental Endocrine Disruption: An Effects Assessment and Analysis.'' The report provides an overview of the current state of the science for endocrine disruption. The report's major components are an introduction to the endocrine system and the endocrine disruption hypothesis; a review of potential human health and ecological risks; and an analysis section, including an overview of research needs. The report represents an interim assessment pending a more extensive review expected to be issued by the National Academy of Sciences later in 1997. |
| January 27, 1997 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the second meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Advisory Committee Act (FACA) to advise EPA on a strategy for screening chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. |
| November 27, 1996 | Endocrine Disruptors; Notice of Public Meeting | EPA is announcing the first meeting of the Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC), a committee established under the provisions of the Federal Committee Advisory Act (FACA) to advise EPA on a strategy for screening and testing chemicals and pesticides for their potential to disrupt endocrine functions in humans and wildlife. |
| Oct 17, 1996 | Endocrine Disruptors; Notice of Public Meeting | EPA is holding a public meeting with interested stakeholder groups to assist the Agency in forming a committee under the provisions of the Federal Advisory Committee Act (FACA) to provide advice on the screening and testing of chemicals and pesticides for their potential to disrupt endocrine function in humans and wildlife. This is the second of such meetings. The first meeting was held May 15-16, 1996, in Washington DC. Persons who attended the first meeting or placed their names on a list to be kept informed of further developments will be notified of this meeting by letter, and will receive additional information regarding the formation of the committee and nominees for committee membership. |
| May 8, 1996 | Endocrine Disruption by Chemicals: Next Steps in Chemical Screening and Testing; Open Meeting | Recent research indicates that environmental endocrine disruptors need more attention by chemical and pesticide regulators. The EPA will hold a meeting on May 15 and May 16, 1996 in the Washington, DC metropolitan area to discuss how EPA can work cooperatively with industry, the environmental community, academia and others to develop a screening and testing strategy to identify chemicals that may pose significant risks through endocrine disruption. This notice announces the location and times for the meeting and sets forth tentative agenda topics. EPA has invited 20 representatives of industry, the environmental community, academia, and government to this meeting. The meeting is open to the public, but space for observers is limited. The meeting is structured to allow the invited participants to discuss items on a predetermined agenda. However, at the end of the first day, there will be thirty minutes of open discussion. |