(AGENPARL) – lun 30 ottobre 2023 Issued: Oct 30, 2023 (10:13am EDT)
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EPA Rebuilds Endocrine Disrupter Screening Program to Better Assess Human
Endocrine Effects of Pesticides
WASHINGTON (Oct. 26, 2023) – Today, the U.S. Environmental Protection Agency
(EPA) is announcing a strategic plan to ensure that its assessments of
pesticides more closely, quickly, and effectively evaluate the potential for
endocrine effects in humans. These strategies will also improve EPA’s
ability to protect against those effects as part of its pesticide decisions
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to
implement the Endocrine Disruptor Screening Program (EDSP) under section
408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA).   
“This plan is a major milestone in our efforts to ensure that pesticide
decisions continue to protect human health,” said Deputy Assistant
Administrator for Pesticide Programs for the Office of Chemical Safety and
Pollution Prevention Jake Li. “Starting with our highest priority chemicals,
EPA will communicate more transparently our endocrine findings for humans,
pulling from existing data when possible, and requesting new data when
necessary to evaluate potential estrogen, androgen, and thyroid effects.” 
Endocrine systems, also referred to as hormone systems, are found in all
mammals, birds, fish, and many other living organisms. The systems regulate
many biological processes in the body from conception through adulthood and
into old age, including the development of the brain and nervous system, the
growth and function of the reproductive system, and metabolism and blood sugar
levels.  
Endocrine disruptors are chemicals that mimic, block, or disrupt the normal
function of hormones. Following the 1996 amendment of FFDCA, EPA established
EDSP to evaluate how pesticides and other chemicals may affect estrogen,
androgen, and thyroid systems. Since then, EPA has encountered several
challenges with implementing EDSP. For example, the Agency has historically
lacked scientific methods to rapidly and cost-effectively test thousands of
chemicals for endocrine-disrupting effects. Further, EPA’s FIFRA decisions
rarely explained whether or how they fully obtained all needed endocrine data
or complied with FFDCA by protecting humans from potential endocrine effects.
EPA staff also received minimal support and direction from leadership in the
last Administration to implement EDSP. Because of these and other issues, the
Office of Inspector General issued a report in 2021 concluding that the Agency
had made limited progress in implementing EDSP and recommending, among other
things, that the Agency develop an EDSP strategic plan.  
The strategic plan and supporting documents released today advance EDSP in
several unprecedented ways.
EPA will use its FIFRA process to obtain endocrine data and make endocrine
decisions for human health. Going forward, EPA will use its existing FIFRA
data collection authorities to obtain the data it needs to make both FIFRA and
EDSP decisions on whether the pesticide impacts the human estrogen, androgen,
and thyroid systems, and will require any needed protections. Given the large
number of pesticides awaiting these decisions, EPA is prioritizing the
approximately 400 conventional pesticide active ingredients that are being
registered for the first time or undergoing registration review.  
EPA will make endocrine decisions related to human health more expeditiously
by using existing data when possible. EPA routinely obtains data under FIFRA
that are identical or comparable to data that EPA would have obtained through
EDSP. Additionally, other existing studies may also inform EDSP findings.
Where these data are sufficient to support EDSP findings under FFDCA, EPA will
make those findings without seeking additional data. This minimizes
duplicative and expensive animal testing and expedites EPA’s ability to make
those findings without waiting for new studies. To support the strategic plan,
EPA is releasing a science paper that addresses longstanding questions about
which types of existing data can inform endocrine findings under FIFRA and
FFDCA.  
After evaluating available data for 403 conventional pesticides, EPA has
determined it has adequate estrogen and androgen data for 86 of these
chemicals. Thus, as part of registration review, after assessing for potential
thyroid effects, EPA can make final EDSP decisions on the potential for these
chemicals to impact the human estrogen, androgen, and thyroid systems.
Similarly, EPA has determined it has sufficient data for 52 pesticide
chemicals (50 conventional active ingredients and two inert ingredients) it
prioritized in 2009 to assess the potential for these chemicals to impact the
human estrogen, androgen, and thyroid systems. Now, as a supplement to the
strategic plan, the Agency is communicating its final EDSP decisions relating
to impacts on the human estrogen, androgen, and thyroid pathways for these 52
chemicals.  
Because the science on the human endocrine system evolves constantly,
especially for thyroid, EPA anticipates seeking in 2025 scientific peer review
on scientific advancements and on its current approach to thyroid assessments.
The Agency will then determine whether to update its approach.  
In the near-term, EPA will require additional endocrine data for human health
for 30 pesticides. EPA has identified 30 high-priority pesticides that require
additional data on potential human estrogen and/or androgen effects. These
pesticides are considered high priority because preliminary data indicate the
chemicals may cause activity in the endocrine system. EPA is seeking available
data or information on these chemicals for 60 days as part of a public comment
period. Additionally, to fill any remaining data gaps, the Agency intends to
issue FIFRA human health data requests for these chemicals in the spring of
2024. EPA is also seeking available data or other information to evaluate
endocrine data needs for a second group of 126 conventional pesticides for
which the Agency’s initial analysis has found limited endocrine data. For
161 additional conventional pesticides, the Agency will determine which ones
it needs to obtain updated endocrine data for in the coming years as part of
registration review.  
The comment period for this action will open Friday, October 27. Once
available, interested parties can submit data or a comment in docket
EPA-HQ-OPP-2023-0474 at the Regulations page.
    
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