Endocrine Disruptor Screening Program, United States
Contents
The Endocrine Disruptor Screening Program
Endocrine Disruptor Screening Program timeline. (Source: U.S. EPA) The science related to measuring and demonstrating endocrine disruption is in its infancy, so validated methods of testing that indicate specific effects of an endocrine disruptor are still being developed. The Endocrine Disruption Screening Program (EDSP) is mandated to use validated methods for the screening and testing chemicals to identify potential endocrine disruptors, determine adverse effects, dose-response, assess risk and ultimately manage risk under current laws. These methods or assays once developed and validated should allow EPA to identify and characterize the endocrine activity (specifically, estrogen, androgen and thyroid) of pesticides, commercial chemicals, and environmental contaminants. While EPA has some data on endocrine-disrupting pesticides, currently insufficient scientific data are available on most of the estimated 87,000 chemicals produced today to allow for an evaluation of of endocrine-associated risks.
To address this issue, EPA is developing a two-tiered screening and testing process. In Tier 1, EPA hopes to identify chemicals that have the potential to interact with the endocrine system. In Tier 2, EPA will determine the specific effect caused by each endocrine disruptor and establish the dose at which the effect occurs. This approach will enable EPA to gather the information needed to identify endocrine disruptors and take appropriate regulatory action, as mandated by Congress. In 2001, EPA chartered the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under Federal Advisory Committee Act (FACA) and National Advisory Council for Environmental Policy and Technology (NACEPT). EDMVS provides people and organizations the opportunity to express their concerns and work to ensure that scientifically-sound validation processes are developed for animal- and non-animal-based screens and tests. EDMVS' mission is to critically examine every step of the validation process, provide advice to EPA, and suggest or consider new assays, or chemical tests. See the Assay Status Table[1] for the current status of the Tier 1 and Tier 2 assays.
Validated Methods Development
EPA's Endocrine Disruptor Screening Program (EDSP) Team is currently conducting the studies needed to validate the endocrine disruptor screening and testing methods. To this end, EPA is using the general principles and process developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). EPA tasks include:
- Method Development
- Comprehensive literature review
- Develop initial protocol
- Prevalidation
- Demonstration of relevance
- Preliminary data on reliability
- Standardization of protocol
- Validation on multiple laboratories
- Proof of relevance and reliability
- Scientific Peer Review
- Regulatory Acceptance and Implementation
Statutory Authorities
The 1996 Food Quality Protection Act (FQPA) and the 1996 Amendments to the Safe Drinking Water Act (SDWA) require EPA to:
Develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effect as the Administrator may designate.
The two acts target different sets of chemical substances. Section 304 of the FQPA states that in carrying out the program, the Administrator shall:
(A) Provide for the testing of all pesticide chemicals; and (B) provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.
Section 136 of the SDWA Amendments states that:
In addition to the substances referred to in (FQPA), the Administrator may provide for testing under the screening program authorized by (FQPA) for any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.
In addition, the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act provide testing authority that might be applicable to endocrine disruption. A brief summary of the applicable sections of other statutes is provided below.
FFDCA
The Federal Food, Drug, and Cosmetics Act (FFDCA) section 408(p) provides EPA authority to require testing of all pesticide chemicals. It also provides EPA authority to require testing of any other substance that might have an effect that is cumulative to an effect of a pesticide chemical if EPA determines that a substantial population might be exposed to the substance. 21 U.S.C. 346(a)(p).
SDWA
The Safe Drinking Water Act (SDWA) provides EPA with authority to require testing of any substance that might be found in sources of drinking water if EPA determines that a substantial population might be exposed to the substance. 42 U.S.C.§ 300j-17.
TSCA
The [[Toxic Substances Control Act] (TSCA)] provides authority for EPA to require testing of TSCA chemicals, provided certain hazard and/or exposure-based findings are made. 15 U.S.C. § 2603. In addition, EPA has authority to issue consent orders to require testing when interested parties agree on an acceptable testing program. 51 Fed. Reg. 23706 (June 30, 1986).
FIFRA
The [[Federal Insecticide, Fungicide, and Rodenticide Act] (FIFRA)] provides EPA with authority to require testing of pesticides if EPA determines that additional data are required to maintain in effect an existing registration. 7 U.S.C. § 136a(c)(2)(B).
Endocrine Disruptor Screening Program History
August 1996: Statutory Authorities
In August 1996, Congress passed both the Food Quality Protection Act (FQPA) and amendments to the Safe Drinking Water Act (SDWA), both containing provisions calling for the screening and testing of chemicals and pesticides for possible endocrine disrupting effects. These laws require EPA to develop a screening program that uses appropriate validated test systems and other scientifically relevant information and determine if the effect that certain substances have in humans is similar to the effect produced by a naturally occurring hormone.
- Read more about the Food Quality Protection Act[2].
- Read more about the Federal Food, Drug, and Cosmetic Act Amendments[3].
- Read more about the Safe Drinking Water Act Amendments[4].
October 1996: EDSTAC Convenes
The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), a federal advisory committee, was formed in 1996 to make recommendations on how to develop the screening and testing program called for by Congress. Representatives from industry, government, environmental and public health groups, worker safety groups, and academia comprised EDSTAC. The members of EDSTAC were tasked with developing consensus-based recommendations for a screening program that would provide EPA with the information needed to make regulatory decisions about chemicals that disrupt endocrine system.
EDSTAC thoroughly reviewed and discussed the scientific information available about endocrine disruptors and sought the opinion of other experts and members of the public during its 2-year deliberations. EDSTAC presented its final report to EPA in September 1998.
August 1998: Federal Register Notice - EDSP
EPA outlined into the Endocrine Disruptor Screening Program (EDSP), which incorporated many of EDSTAC's recommendations, in an August 1998 Federal Register Notice. This notice provides operational details regarding the major elements of EPA's Endocrine Disruptor Screening Program.
- Read the August 1998 FR Notice[7].
December 1998: Federal Register Notice - Proposed Statement of Policy
In this notice, EPA provides additional details on the Endocrine Disruptor Screening Program. This notice describes the major elements of EPA's EDSP, as well as its implementation.
- Read the December 1998 FR Notice[8].
July 1999: Federal Register Notice - Proposed Statement of Policy
At the request of EPA, a joint subcommittee of the EPA Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP) reviewed a set of scientific issues related to the development of the Agency’s EDSP.
- Read the 1999 SAB/SAP Report: Review of the EPA's Proposed Environmental Endocrine Disruptor Screening Program[9].
December 1999: NRDC Settlement Agreement
EPA and the Natural Resources Defense Council (NRDC) entered into an agreement to settle part of a lawsuit that NRDC filed against EPA regarding implementation of the Endocrine Disruptor Screening Program. In the settlement agreement, EPA agreed, among other things, to use best efforts to complete validation of certain screening and testing methodologies that are proposed for use in the program by specific dates, and to use best efforts to start requiring screening and testing of certain chemicals by specific dates.
- Read the Signed NRDC Settlement Agreement[10].
August 2000: Report to Congress - EDSP Implementation Progress
EPA presented a Report to Congress in August 2000 summarizing endocrine disruptor issues and describing the Endocrine Disruptor Screening Program. EPA also described its progress in implementing the program, ongoing studies relating to endocrine disruptors, and the measures being taken to address animal welfare concerns under the EDSP.
- Read the 2000 Report to Congress[11].
October 2001: EDMVS/FACA Convenes
The Endocrine Disruptor Methods Validation Subcommittee (EDMVS) was established under the EPA's National Advisory Council for Environmental Policy and Technology (in accordance with the Federal Advisory Subcommittee Act (5 U.S.C. App. 2 Section 9c)). EDMVS provides advice and counsel to EDSP on scientific issues associated with the validation of Tier 1 and Tier 2 assays on topics including the development and choice of initial protocols; prevalidation study designs, validation study designs, and the integration of prevalidation and validation study results into EDSP Tier 1 and Tier 2 methods documents suitable for external peer review (63 FR 71542).
- Read the EDMVS Mission Statement[12].
May 2002: Report to Congress - EDVMS Progress
In a Report to Congress, EPA provided an update on the progress of EDVMS and described validation processes that incorporated the advice of the EDMVS. It also summarized recent subcommittee meetings and presented a list of subcommittee members.
December 2002: Federal Register Notice - Proposed Chemical Selection Approach for Initial Screening
EPA set forth for public comment the Proposed Chemical Selection Approach for Initial Screening[15] which presents the approach EPA intends to use for selecting 50 to 100 chemicals for initial screening under the Federal Food, Drug and Cosmetic Act.
June 2004: EDMVAC Established
The Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC)[16] was established in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2 Section 9c)) and 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. The committee will evaluate relevant scientific issues, protocols, data, and interpretations of the data for the assays during the validation process. EDMVAC will also provide advice on the composition of the Tier I screening battery.
- Read the EDMVAC Charter[17].
September 2005: Federal Register Notice - Chemical Selection Approach for Initial Screening
EPA published the Chemical Selection Approach for Initial Screening[18] which presents the approach EPA intends to use for selecting 50 to 100 chemicals for initial screening under the Federal Food, Drug and Cosmetic Act.
June 2007: Federal Register Notice - Draft List of Chemicals for Initial Screening
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[19]. 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 system]s] of humans or other species.
December 2007: Federal Register Notice - Draft Policies and Procedures
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[20] 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.
- How to Submit Comments[21]
- The other seeks public comment on the draft Information Collection Request (ICR)[22] 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[23]
- Draft Template for EDSP Test Orders
- Draft EDSP Order Initial Response Form[26]
- Detailed Workflow for Respondent Activities Under the EDSP's Tier 1 Screening For the First 73 Chemicals[27]
- Calculations for Paperwork Burden and Costs for Data Generation Activities[28]
- List of Agency Activities[29]
- Draft List of Initial Pesticide Active Ingredients and Pesticide Inert[30]
- How to Submit Comment[31]
Today
EPA is currently implementing EDSP on three fronts:
- Developing protocols to conduct specific assays, evaluating their effectiveness, and ensuring that the assay can be performed reliably and consistently in different laboratories.
- Prioritizing chemicals for screening and testing.
- Establishing policies and procedures to require testing.
More information on each of the three fronts is available through the following links:
- Read more about EDSP Policies and Procedures
- Read more about Priority Setting
- Read more about Assay Development and Validation
Notes (Endocrine Disruptor Screening Program, United States)
References
- EPA Endocrine Disruptor Screening Program
- Campbell, Neil A. Biology, third edition. California: The Benjamin/Cummings Publishing Company, Inc., 1993.
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