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Daily News Blog

29
Oct

Lawsuit Settlement Tackles EPA’s Dramatic Failure to Regulate Endocrine Disruptors, Despite Fed Mandate

(Beyond Pesticides, October 29, 2024) STARTS TOMORROW—NATIONAL FORUM: IMPERATIVES FOR A SUSTAINABLE FUTURE. A legal victory in federal court is the latest in a series of attempts to force the U.S. Environmental Protection Agency (EPA) to fulfill the mandate given to it by Congress in 1996 to test all pesticides for their endocrine disrupting effects and regulate them accordingly. The case in the U.S. District Court for the Northern District of California was brought by the Center for Food Safety (CFS) and a collection of agricultural workers’ organizations, farmers’ groups, and pesticide activists.

Beyond Pesticides wrote in 2019, EPA’s “Endocrine Disruptor Screening Program (EDSP) began, then virtually stopped, its review and regulation of endocrine disrupting pesticides, despite [its 1996 Congressional mandate] to develop a screening program within two years and then begin regulating.” (See timeline, Figure 2, p11.) After the release of a  a damning 2021 Office of Inspector General (OIG) report (see Beyond Pesticides’ reporting) on the agency’s lack of progress in protecting the population from potentially damaging endocrine disruption impacts of exposures to synthetic chemical pesticides (and other chemicals of concern), CFS wrote: “The 2021 [OIG] report included the shocking revelation that some EPA staff were instructed to function as if the screening program had been eliminated from EPA’s budget, despite a $7.5 million allocation that same year — raising the prospect of EPA’s intentional violation of its statutory duty.”

CFS’ most recent litigation closed with a tentative legal settlement, rather than a judge’s ruling, as did a similar 1999 Natural Resources Defense Council suit. According to the CFS press release, the agreement includes “deadlines by which EPA will implement the EDSP and assess pesticides’ endocrine-disrupting effects. Under the terms of the proposed agreement, over the next five years, EPA will collect data on and assess the effects of endocrine-disrupting pesticides, either as part of the agency’s registration review of registered pesticides or as a part of new pesticide approvals.” EPA also promises to listen to farmworkers’ input on specific pesticides, and to complete assessment of 86 pesticides by 2034.

The case details EPA’s behavior for more than 25 years: a combination of stubborn inaction and a succession of failed promises to do better. In the words of Maricel Maffini, PhD and Laura  Vandenberg, PhD, in Failure to Launch: the Endocrine Disruptor Screening Program at the U.S. Environmental Protection Agency (2022), “[N]ot a single pesticide chemical has been determined to be an endocrine disruptor, and no regulatory actions have been taken.”

The reasoning for EPA’s inaction has been murky and illogical. It has spent most of that time stalled, under chemical industry pressure, on the appropriate testing methods for determining whether a pesticide is an endocrine disruptor (ED), even though there are mountains of academic research demonstrating exactly that for numerous pesticides still in heavy use in the U.S. Currently the agency uses a two-tier system in which, if a chemical meets certain initial criteria in test tube assays, rats, amphibians and fish, it will then be bumped up to a second, more rigorous set of in vivo experiments using a few more species tested over two generations. Other proposed testing protocols have remained under discussion, but not put into practice.

The original legislation mandating establishment of EPA’s Endocrine Disruption Screening Program (EDSP) took effect in 1998 as part of the Food Quality Protection Act of 1996, itself an amendment of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The legislation instructed EPA to implement the EDSP no later than August 1999 and test all registered pesticides. According to the CFS complaint, to date, EPA has begun testing only four percent of those pesticides. Of those, only half are finished and even that remnant requires more testing. EPA published one list of 52 candidate chemicals and a second list of 109 candidates, acknowledging that at least some of them were likely to disrupt hormones. It got through Tier 1 testing for the first 52 chemicals and then stopped. It has completed no testing for the second list. Yet during this same period EPA registered 425 new pesticides without considering their potential endocrine effects. EPA has also acknowledged that more than 87,000 chemicals—not just pesticides—are eligible for EDSP evaluation. There is no way that EPA can ever fulfill the requirements of the enabling legislation with this kind of desultory inaction.

One egregious example is atrazine, which EPA put through Tier 1 tests and found both male and female hormone effects, yet declined to move it up to Tier 2. In its 2015 EDSP Weight of Evidence Conclusions for atrazine, EPA stated, “EDSP Tier 2 testing with mammals, fish, amphibians or birds is not recommended for atrazine at this time because it is not expected to impact current EPA-established regulatory endpoints for human health or ecological risk assessment.” Atrazine, an unambiguous endocrine disrupter, remains on the market in the U.S.

Beyond Pesticides submitted a detailed comment to EPA regarding the agency’s latest proposal to modify its implementation of the EDSP, which would narrow the scope to humans, limit testing to some active ingredients, and limit the data types considered. A Daily News of February 5 details the proposal’s weaknesses. Beyond Pesticides points out that EPA’s mandate is to protect both the environment and humans, and that the elucidation of endocrine disruption came about through observation of chemicals’ effects on animals as much as humans. The thinning of eagles’ eggshells from DDT exposure is an iconic example, which the public became aware of in Rachel Carson’s foundational book, Silent Spring, in 1962—six decades ago. The term “endocrine disruption” emerged from work by the late Theo Colborn, PhD and her 1996 book Our Stolen Future. (See Dr. Colborn’s talk to Beyond Pesticides’ 29th National Pesticide Forum (2011) It soon became apparent that entire ecosystems are affected by chemicals that alter hormonal balances in mammals, birds, fish, reptiles, insects, and even plants. There is no divorcing humans from the rest of the biosphere. It is Beyond Pesticides’ position that “mammalian data inform potential endocrine disruption in other vertebrate taxa (avian, amphibian, fish) and vice versa” and therefore EDSP testing should not “decouple” data on mammals from other vertebrates.

[For a riveting talk by Tyrone Hayes, PhD, professor of Integrative Biology at University of California Berkeley and ground-breaking researcher on endocrine disruptors, see Protecting Life, From Frogs to the Human Family—delivered at Beyond Pesticides’ 36th National Pesticides (2018).]

Beyond Pesticides has further noted that under FIFRA, “[T]here is an inherent presumption of risk, a pesticide is presumed to pose an unreasonable risk until reliable data demonstrate otherwise. If the agency lacks the data and/or resources to fully evaluate endocrine risks to human health and wildlife, then the agency is obliged to suspend or deny any pesticide registration until the agency has sufficient data to demonstrate no unreasonable adverse endocrine risk per the mandate in FIFRA.” This means EPA must assume pesticides are EDs and the companies selling them must prove otherwise to be registered.

EPA has taken the opposite approach all along. It has done very little to protect the public, farmworkers, and wildlife from endocrine-disrupting chemicals despite three lawsuits, at least two sharp admonitions from Congress, and three scathing inspector general reports. The CFS complaint cites the 2021 OIG report, which included interviews with EPA employees from the EDSP who were “ready to go…but EPA lacked the institutional will to follow through with issuing test orders.” In a 2011 report, the Inspector General (IG) attributed EPA’s lack of progress to “lack of management.” And the 2021 IG document reported that EPA instructed some staff to act as if the EDSP did not appear in the agency budget “even though we were fully funded by Congress,” according to one employee.

EPA’s behavior is largely inexplicable to the uninitiated, but it is shaped by the shadowy influence of the pesticide industry, which is like an invisible planet whose existence must be deduced by the behavior of visible objects. In the CFS litigation, CropLife International intervened as a defendant. This gave it status as a party to the litigation, including the right to appeal. CropLife’s filings served to distract the process from the main issue, which was the utter failure of the EDSP. CropLife’s documents contained such ludicrous statements as:

  • “[E]ach of CropLife’s members’ registered pesticide products has been found by EPA, after a rigorous evaluation process, to perform its intended function without “unreasonable risk to man or the environment” or “human dietary risk.”
  • “CropLife has maintained that EPA must take the time to develop validated methods for conducting testing….Rushing through the processes without properly validated methods and protocols risks creating public misperceptions about the chemicals undergoing testing and could result in needless fear and distrust of pesticides.”

But overall, CropLife’s argument starkly pitted property and economic rights against the continued viability of human life and the environment without which life cannot exist. The judge accepted CropLife’s assertion that its interests should be given considerable weight in the process.

It is always worth pushing back on egregious environmental failures and it is encouraging to see the CFS settlement set out very worthy goals in writing. But EPA’s history does not bode well for real change. That will likely require agency restructuring and stronger pressure from Congress. You can help bring this about by voting in the most consequential election of our lifetimes and by telling your elected representatives to support effective reform, realistic funding, and EPA’s forward momentum toward fulfilling its statutory mandates.

Don’t Miss This!: Hear from world renowned researcher on endocrine disruptors and their connection to petrochemical pesticide exposure, Tracey Woodruff, PhD (Director of the Program on Reproductive Health and the Environment, and Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California San Francisco) at Beyond Pesticides’ 41st National Forum, Imperatives for a Sustainable Future—Reversing the existential crises of pesticide-induced illness, biodiversity collapse, and the climate emergency. The Forum begins on October 30 at 2-4pm (EDT) and then continues on November 14 at 1pm (EST). The Forum provides an opportunity to discuss with scientists from Germany and the United States, both (i) the hazards that define the urgency of threats associated petrochemical toxicants, with a focus on chemicals that disrupt the endocrine system (including pesticides) and lead to life-threatening diseases, and (ii) the strategy for adopting a path forward that tackles the problem holistically, rather than one chemical at a time.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Sources:

Alianza Nacional de Campesinas, Pesticide Action Network North America, Rural Coalition, Center for Environmental Health, Organición en California de Líderes Campesinas, and Center for Food Safety v. USEPA
United States District Court for the Northern District of California
December 20, 2022
Case No. 22-cv-9030, Complaint for Declaratory and Injunctive Relief
http://www.centerforfoodsafety.org/files/2022-12-20-doc-01–pltf-complaint_89752.pdf

Victory! EPA Ends Decades of Inaction on Assessing Endocrine-Disrupting Harms of Pesticides Pursuant to Legal Settlement with Farmworker and Environmental Health Groups
Center for Food Safety
October 15, 2024
https://www.centerforfoodsafety.org/andrew-kimbrell/2440/andrew-kimbrell/press-releases/6963/victory-epa-ends-decades-of-inaction-on-assessing-endocrine-disrupting-harms-of-pesticides-pursuant-to-legal-settlement-with-farmworker-and-environmental-health-groups

Failure to Launch: The Endocrine Disruptor Screening Program at the U.S. Environmental Protection Agency
Maricel V. Maffini and Laura N. Vandenberg
Front. Toxicol., 29 May 2022
https://www.frontiersin.org/journals/toxicology/articles/10.3389/ftox.2022.908439/full

EPA Proposal for Endocrine Disruption Testing of Pesticides Is Too Narrow in Scope
https://www.beyondpesticides.org/action-of-the-week/epa-proposal-for-endocrine-disruption-testing-of-pesticides-is-too-narrow-in-scope

While France Bans a Common Endocrine Disrupting Pesticide, EPA Goes Silent: U.S. ignores statutory mandate to review pesticides that cause deadly illnesses at minute doses, defying classical toxicology
Pesticides and You, Summer 2019
https://www.beyondpesticides.org/assets/media/documents/Feature%20–%20Endocrine%20disruptor%20review%2039.2.pdf

Inspector General Rips EPA for Failure to Test Pesticides for Endocrine Disruption
Beyond Pesticides, August 20, 2021
https://beyondpesticides.org/dailynewsblog/2021/08/inspector-general-rips-epa-for-failure-to-test-pesticides-for-endocrine-disruption/

EPA’s Failure to Regulate Endocrine-Disrupting Pesticides before a Federal Court. . . Again
Beyond Pesticides, January 6, 2023
https://beyondpesticides.org/dailynewsblog/2023/01/epas-failure-to-regulate-endocrine-disrupting-pesticides-before-a-federal-court-again/

Take Action: Male Fertility Harmed by Pesticides and EPA Dysfunction
Beyond Pesticides, July 18, 2022

Take Action: Male Fertility Harmed by Pesticides and EPA Dysfunction

 

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