EDSP Chronology
The following graphic depicts the Endocrine Disruptor Screening Program
(EDSP) chronology. Click on any of the events to view a brief description
of each.
You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.
August 1996: Statutory Authorities
In August 1996, Congress passed both the Food
Quality Protection Act (FQPA) [PDF, 50pp., 253KB, About PDF] 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 required EPA to develop a screening program
that uses appropriate validated test systems and other scientifically
relevant information to determine if the effect that certain substances
have in humans is similar to the effect produced by a naturally occurring
hormone.
The Food Quality Protection Act amends the Federal Food, Drug, and Cosmetic
Act. Read more about the Federal
Food, Drug, and Cosmetic Act Amendments.
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 the 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-years of deliberations. EDSTAC presented
its final report to EPA in September 1998. Read
more about the creation of EDSTAC
and it's participants.
August 1998: Federal Register Notice - EDSP
EPA outlined the Endocrine Disruptor Screening Program (EDSP), which incorporated
many of EDSTAC's recommendations, in an August
1998 Federal Register Notice [PDF, 4pp., 34KB, About PDF]. This notice provides operational
details regarding the major elements of EPA's Endocrine Disruptor Screening
Program.
December 1998: Federal Register Notice - Proposed
Statement of Policy
EPA provided additional details on the Endocrine Disruptor Screening Program
(EDSP), including the major elements of the Program and its implementation,
in a December 1998 Federal Register
Notice [PDF, 28pp., 228KB, About PDF].
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. The results of the review are summarized in the 1999 SAB/SAP Report: Review of the EPA's Proposed Environmental Endocrine Disruptor Screening Program [PDF, 48pp., 1MB, About PDF].
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 (EDSP). 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 [PDF, 16pp., 873KB, About PDF]
2000: Report to Congress - EDSP Implementation Progress
EPA presented a Report to Congress
in August 2000 [PDF, 20pp., 88KB, About PDF] summarizing endocrine disruptor issues and
describing the Endocrine Disruptor Screening Program (EDSP). 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.
2001: EDMVS Formed
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 Committee Act (5 U.S.C.
App. 2 Section 9c)). EDMVS provides technical advice and counsel to EPA
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; and validation study designs. All of the
study results generated during protocol development, prevalidation and
validation will be combined into EDSP method-specific documents suitable
for external peer review. External scientific peer review of the EDSP
methods will be arranged by EPA through an Agency-approved external scientific
peer review panel (63 FR 71542).
Read the EDMVS Mission Statement [PDF, 2pp., 8KB, About PDF]
2002: Report to Congress - EDMVS Progress
EPA provided an update
on the progress of EDMVS [PDF, 6pp., 19KB, About PDF] and described validation processes
that incorporated the advice of the EDMVS. It also summarized recent subcommittee
meetings and presented a list of subcommittee members. Read Attachment
A to the report [PDF, 9pp., 24KB, About PDF].
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 [PDF, 19pp., 119KB, About PDF]
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) 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 [PDF, 3pp., 20KB, About PDF]
September 2005: Federal Register Notice - Chemical Selection Approach for Initial Screening
EPA published the Chemical Selection Approach for Initial Screening [PDF, 17pp., 125KB, About PDF] 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 [PDF, 18pp., 131KB, About PDF].
How to comment.
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 (PDF) (21 pp, 144K) the Agency intends to use for the initial screening of pesticide chemicals under the Agency's Endocrine Disruptor Screening Program (EDSP). EPA is also seeking comment on the draft template for the 408(p) Order that will be issued to require testing of the pesticide chemical.
- The other seeks public comment on the draft Information Collection Request (ICR) (PDF) (3 pp, 58K) that describes the information collection activities associated with Tier 1 screening of the first group of chemicals under the EDSP and provides EPA's estimates for the related paperwork burden and costs.
- Information Collection Request Supporting Statement
- Draft Template for EDSP Test Orders
- Draft EDSP Order Initial Response Form
- Detailed Workflow for Respondent Activities Under the EDSP's Tier 1 Screening For the First 73 Chemicals
- Calculations for Paperwork Burden and Costs for Data Generation Activities
- List of Agency Activities
- Draft List of Initial Pesticide Active Ingredients and Pesticide Inert
- How to Submit Comments
You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.