History and Timeline
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1996
• The term “endocrine disruptor” is popularized by the
book Our Stolen Future. Co-authored by environmental activist
and now former World Wildlife Fund senior scientist Theo Colborn, the
book sought to implicate synthetic chemicals as the root of problems ranging
from reproductive anomalies in wildlife to neuro-developmental deficits
in human children. However, according to an editorial in the journal Scientific
American: “The book is not scientific. ... The authors present
a very selective segment of the data that have been gathered about chemicals
that might affect hormonal functions. They carefully avoid evidence and
interpretations that are not in accord with their thinking.”
• In response to pressure from environmental groups, the U.S. Congress
enacted the Food Quality Protection Act, which required the Environmental
Protection Agency (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
such other endocrine effect as the [agency] may designate.”
• The EPA establishes an Endocrine Disruptor Screening and Testing
Advisory Committee (EDSTAC) to “provide advice and counsel to the
Agency on a strategy to screen and test chemicals and pesticides that
may be the cause of endocrine disruption in humans, fish, and wildlife.”
According to the EDSTAC
Convening Report, “affected interests” that should be
represented on EDSTAC included the EPA, other federal and state agencies,
industry, water providers, labor/worker health and safety organizations,
environmental, environmental justice, and public health organizations––everyone
except the animal protection community.
1998
• EDSTAC issues its final
report to the EPA.
• On EDSTAC’s advice, the EPA significantly expands the scope
of its Endocrine
Disruptor Screening Program to examine not only “estrogen-like”
effects, but effects on “androgen” and “thyroid”
hormones as well. The EPA further expands the program to include toxicity
testing on birds, fish, amphibians and invertebrates, even though the
law only calls for the determination of possible chemical effects “in
humans.”
1999
• The Natural Resources Defense Council (NRDC) sues the EPA for
failing to implement its endocrine program within a three-year timeframe
(by August 1999) as required by the FQPA.
2000
• At its March 2000 meeting, the U.S. National Toxicology Program’s
former Advisory Committee on Alternative Toxicological Methods (ACATM)
makes a unanimous recommendation that all proposed test methods
for the EPA’s endocrine program should be validated through the
Interagency Coordinating Committee on the Validation of Alternative Methods
(ICCVAM). Although the EPA does indeed require all non-animal tests to
be validated through ICCVAM with very rigorous and thorough standards,
it insists on an arbitrary double standard by not requiring this
same validation of the animal tests.
• The EPA disbands its Endocrine Disruptor Standardization and Validation
Taskforce in response to PETA’s complaints that the panel was not
appropriately balanced (having no representation from the animal protection
community) and that the task force was holding its meetings behind closed
doors––both violations of the Federal Advisory Committee Act.
• The following motion is passed unanimously by the ACATM at its
November 2000 meeting, reiterating its position even more strongly: “The
ACATM expresses grave concern at the bifurcated approach being taken with
review of methods for evaluation of endocrine disruption activity, with
ICCVAM considering in vitro [non-animal] methods and with the
US EPA proposing to review in vivo [animal] methods using an
ICCVAM-like approach. The Committee's primary concern is that both in
vitro and in vivo methods be subjected to the same rigorous
peer review and validation process to ensure the highest likelihood of
acceptance by the regulatory agencies, the scientific community and the
public.”
• PETA intervenes in the endocrine portion of the NRDC’s lawsuit,
challenging the EPA’s expansion of the endocrine program, its almost
total reliance on animal testing, and its plan for a “bifurcated”
validation process.
2001
• The EPA and the NRDC enters into a settlement
agreement under which the EPA agrees, 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.
• The EPA established the Endocrine
Disruptor Methods Validation Subcommittee (EDMVS) to provide technical
advice and counsel on scientific issues associated with test method validation,
including the development and choice of initial protocols, and pre-validation/validation
study designs. The first and second EDMVS plenary meetings are held in
October and December 2001. PETA’s input is reflected in the Pesticide
& Toxic Chemical News article “Endocrine
Panel Tackles Assays and Obstacles.”
2002
• The EDMVS met again in March and June 2002. PETA’s input
is reflected in the Pesticide & Toxic Chemical News article
“PETA Links ‘Body
Counts’ to EPA Endocrine Program.”
• A special session of the Organization for Economic Cooperation
and Development’s (OECD) Task Force on Endocrine Disrupters Testing
and Assessment (EDTA) is held in Tokyo, Japan. Thanks to the strong animal
protection representation at this meeting, the OECD’s “conceptual
framework” for the testing and assessment of chemicals for potential
endocrine disrupting effects is revised to give much greater emphasis
to non-animal screening and testing approaches. The EDTA also endorses
the formation of a “Validation Management Group” to focus
on the development and validation of non-animal screening and testing
methods.
• PETA’s science advisor presents the paper “Ideology
Masquerading as Science: The Case of Endocrine Disrupter Screening Programmes”
at the Fourth World Congress on Alternatives and Animal Use in the Life
Sciences in New Orleans.
• The EPA publishes its proposed approach for selecting the first
group of chemicals to be screened under its endocrine program. PETA presents
its position in the following public
comments and Pesticide & Toxic Chemical News article
“PETA Weighs In
on Endocrine Testing Proposal.”
• The EDMVS holds its fifth plenary meeting in December 2002.
2003
• PETA sends a letter
to the head of the EPA office charged with developing the endocrine program
to urge the Agency to make greater efforts to avoid duplicative testing
of chemicals that may be subject to multiple EPA testing programs.
• The first meeting of the OECD’s Validation Management Group
for Non-Animal Methods (VMG-NA) is held in Paris.
• The EDMVS meets again in June, August, and December 2003. PETA
submitted public comments
on the EPA’s “Detailed Review Paper for an Avian 2-Generation
Reproduction Study.”
• The OECD publishes the results of the uterotrophic
assay peer review that it organized. The journal Alternatives
to Laboratory Animals publishes a critique
of the approach taken by the OECD and its member countries to evaluate
the validity of the uterotrophic assay.
2004
• Instead of renewing the charter for the EDMVS as a subcommittee,
the EPA announces its intent to reconstitute the panel as a full advisory
committee––the Endocrine
Disruptor Methods Validation Advisory Committee (EDMVAC).
• The second meeting of the OECD’s Validation Management Group
for Non-Animal Methods (VMG-NA) is held in Paris in November 2004.
• PETA petitions the EPA to limit the scope of its Endocrine Disruptor
Screening Program to the evaluation of chemical effects in humans, thereby
sparing countless birds, frogs and fish from suffering and death in cruel
chemical-poisoning experiments. Click
here to download PETA's rulemaking petition.
