04
Nov
Deadly Endocrine Disrupting Pesticides Subject to EPA Proposals that Fall Far Short, According to Advocates
(Beyond Pesticides, November 4, 2024) The U.S. Environmental Protection Agency (EPA) last week opened a public comment period on the regulation of endocrine-disrupting pesticides, a proposal that lays out a drawn-out 10-year process that is narrow in evaluating the underlying mechanism that causes endocrine disruption. The proposal, published in the Federal Register as a partial settlement agreement and consent decree, responds to a lawsuit filed by farmworker and health groups challenging the agency’s failure to test and regulate endocrine-disrupting pesticides. Earlier in the year, after over 25 years of delay following the 1996 Congressional mandate to determine whether pesticides disrupt the endocrine system of humans and other organisms, EPA issued a proposal for modifying its approach to the implementation of the Endocrine Disruptor Screening Program (EDSP).Â
The National Institutes of Environmental Health Sciences explains endocrine disruptors this way: “Endocrine-disrupting chemicals (EDCs) are natural or human-made chemicals that may mimic, block, or interfere with the body’s hormones, which are part of the endocrine system. These chemicals are associated with a wide array of health issues. . . Endocrine glands, distributed throughout the body, produce the hormones that act as signaling molecules after release into the circulatory system. The human body is dependent on hormones for a healthy endocrine system, which controls many biological processes like normal growth, fertility, and reproduction. Hormones act in extremely small amounts, and minor disruptions in those levels may cause significant developmental and biological effects.†The Endocrine Society has written, “Many pesticides are designed to be toxic to pests’ nervous or reproductive systems and may act by disrupting endocrine systems. Such chemicals are also EDCs because of the similarities between insect and animal endocrine systems.†The data is available to regulators, who have allowed endocrine-disrupting pesticide exposure for decades to people and families whose lives have been upended and often destroyed by deadly diseases that are preventable and chemicals that can be replaced by alternative practices and products, according to health and environmental advocates. A 2011 article, Effect of Endocrine Disruptor Pesticides: A Review (2011), found: “Many chemicals that have been identified as endocrine disruptors are pesticides. About 105 substances can be listed, and most of them are shown in Table 1. Of these, 46% are insecticides, 21% herbicides, and 31% fungicides; some of them were withdrawn from general use many years ago but are still found in the environment (ex. DDT and atrazine in several countries).†Meanwhile, it is estimated that 90% of breast cancer, the most common form of cancer for women worldwide, is due to nongenetic factors including endocrine-disrupting pesticides. (See Daily News.)Â
EPA’s February 2024 proposal, according to Beyond Pesticides, is an abrogation of the agency’s responsibilities under the 1996 Food Quality Protection Act/Federal Food, Drug, and Cosmetic Act (FQPA/FFDCA) as well as the underlying statute, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Safe Drinking Water Act (SDWA). Limiting the scope of the EDSP to humans, certain pesticide active ingredients only, and limiting the types of data to assess endocrine disruption (ED) effects runs counter to the Congressional intent and requirements in these statutes. It is also a reversal of the Endocrine Disruptor Screening and Testing Advisory Committee’s (EDSTAC) advice and the agency’s original EDSP implementation policy and science decisions.
EPA’s October proposal sets deadlines by which EPA will implement EDSP requirements and assess some of the endocrine-disrupting effects of pesticides. CFS, which serves as counsel for the plaintiffs, including Alianza Nacional de Campesinas, Pesticide Action Network North America, Rural Coalition, Center for Environmental Health, and Organización en California de LÃderes Campesinas, says, “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. To maximize protection of farmworker and public health, the proposed agreement provides opportunities for farmworker input on prioritizing certain pesticides and requires EPA to provide regular public updates on the status of their ongoing assessment. Per the agreement, EPA will complete endocrine-disrupting assessment for 86 pesticides over the next 10 years.â€
While it can be argued that this is the best that can be done under existing federal law, the settlement represents another generation of exposure to endocrine disruptors in air, water, landscapes, and food—chemicals that cause breast cancer, neurological, immunological and reproductive effects, developmental effects, learning disabilities, and a range of effects (many multigenerational) that adversely affect most organ systems. The agreement affirms that the public is not protected and should urgently shift away from a reliance on synthetic pesticides in food production, gardening, and landscape management. For more background, see here, here, here, and here. Also, see the Pesticide-Induced Diseases Database (PIDD) section on endocrine disruptors.
While the consent decree does commit EPA to test for estrogenic effects in conventional pesticide active ingredients, it falls far short of addressing the full range of endocrine disrupting effects of all pesticide ingredients, as is required to protect human health and the environment. The February 2024 comments of Beyond Pesticides detail these requirements. In addition, the only recourse it gives the plaintiffs is to resume the litigation if EPA fails to deliver on its agreement.
Under FIFRA, 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.
OPPORTUNITY FOR TWO ACTIONS
1. Tell EPA that it must consider complete all data concerning endocrine disruption and must not register pesticides without sufficient data to demonstrate no unreasonable adverse endocrine risk.
AND
2. Tell Congress to ensure that EPA follows through! EPA must not register pesticides without sufficient data demonstrating no endocrine disruption.
EPA cannot develop a strategy for evaluating pesticides without understanding the history and status of endocrine disruption research, which are summarized in Beyond Pesticides’ comments and the October 29, 2024 Daily News. Evidence that synthetic chemicals can mimic or otherwise interfere with natural hormones has existed for over half a century. Although early attention was given to estrogen mimics, it soon became apparent that the homeostatic function of the endocrine system—which regulates and balances physiological functions—can be disrupted at many sites and hormone systems.
Endocrine disruption as a phenomenon affecting humans and other species has been critically reviewed by several authors. A common thread weaving across these reviews is the understanding that chemicals that may disrupt the endocrine systems of humans and wildlife may be pervasive in contaminating their habitats. A pandemic of endocrine-related disorders from attention deficit and hyperactivity disorder (ADHD), autism, diabetes, obesity, childhood and breast cancers, testicular cancer in young men, infertility, male dysgenesis syndrome, hypospadias, low sperm count, loss of semen volume and sperm quality, and increased risk of testicular and prostate cancer can be connected with endocrine-disrupting chemicals (EDCs). All these disorders have been increasing in incidence and can be traced back to prenatal exposure to EDCs.
Endocrine pathways are largely conserved across species and, thus, are not species- or taxa- specific. It is well known that thyroid endocrinology in particular is well conserved across vertebrate taxa. This includes aspects of thyroid hormone synthesis, metabolism, and mechanisms of action. Thyroid hormones are derived from the thyroid gland through regulation of the HPT axis, which is controlled through a complex mechanism of positive and negative feedback regulation. Multiple pathways contribute to the synthesis of thyroid-releasing hormone, including thyroid hormone signaling through feedback mechanisms; leptin and melanocortin signaling; body temperature regulation; and cardiovascular physiology. Each pathway directly targets thyroid-releasing hormone neurons. Based on the conservation of endocrine pathways, it is well understood that the ecological assays (the frog assay in particular) are often more sensitive and equally relevant to mammalian assays in informing risk assessors of whether a chemical can perturb and cause adverse endocrine outcomes in the human population and vice versa.
FQPA essentially amends FIFRA and FFDCA to ensure potential endocrine-disrupting effects are considered in EPA risk assessments to fulfill the FIFRA mandate that a pesticide registration will not cause unreasonable adverse effects. This applies to humans, wildlife, and all pesticide chemicals as defined in FIFRA, including “all active and pesticide inert ingredients of such pesticide†(21 U.S.C. 231(q)(1)). SDWA adds drinking water contaminants as well.
In summary, the agency cannot limit EDSP to only humans and conventional pesticide active ingredients without violating the statutory requirements enumerated in FIFRA, FQPA, and SDWA. EPA should make use of all available scientifically relevant endocrine disruption research findings and also be wary of deviating from established international efforts for screening/testing endocrine disruptors that incorporate human and wildlife-relevant studies. Recognizing that mammalian data inform potential endocrine disruption in other vertebrate taxa (avian, amphibian, fish) and vice versa, the agency should not decouple the mammalian from other vertebrate assays in EDSP screening. There are more than 50 different ecological and mammalian assays included in the Organization of Economic Cooperation and Development (OECD) Conceptual Framework for screening/testing endocrine disrupting effects, and there are additional assays being developed for consideration as well. So, the agency should not limit the range or types of data to be used, but as FQPA prescribes use “appropriate validated test systems and other scientifically relevant information.â€
Even if currently required data—including the limited data required under this proposed partial settlement—meet the needs of human risk assessment, they are inadequate to evaluate endocrine effects on wildlife species. It should also be understood that under FIFRA, 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. Further, it is not the agency but pesticide registrants that have the burden to demonstrate with adequate data that their products will not pose unreasonable adverse effects, including the inherently presumed endocrine-disrupting effects.
***
With a focus on endocrine disruption, plan now to attend Beyond Pesticides’ 41st National Forum, Imperatives for a Sustainable Future! Thank you to all who attended our launch on October 30—stay tuned for a recording! The second session will continue on Thursday, November 14, 2024, at 1 PM (EST) with Tracey Woodruff, PhD, MPH, the director of the Program on Reproductive Health and the Environment, University of California, San Franisco (UCSF). Dr. Woodruff’s work focuses on uncovering and addressing environmental determinants of disease and health inequities and has written groundbreaking material on endocrine-disrupting chemicals. Registration is complimentary, with contributions appreciated, and is valid for all sessions of the 2024 National Forum!
Letter to the U.S. Environmental Protection Agency
The endocrine disruptor strategy (EDSP) proposed under the consent decree abrogates EPA’s responsibilities under the Food Quality Protection Act/Federal Food, Drug, and Cosmetic Act (FQPA/FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Safe Drinking Water Act (SDWA). While the proposed consent decree commits EPA to test for estrogenic effects in conventional pesticide active ingredients, it falls far short of addressing the full range of endocrine-disrupting effects of all pesticide ingredients, as is required by FIFRA to protect human health and the environment. Limiting the scope of the EDSP to humans, certain pesticide active ingredients only, and limiting the types of data to assess endocrine disruption (ED) effects is contrary to the Congressional intent and requirements in these statutes and reverses Endocrine Disruptor Screening and Testing Advisory Committee advice and EPA’s original EDSP implementation policy and science decisions.
Evidence that synthetic chemicals can interfere with natural hormones has existed for over half a century. Although early attention was given to estrogen mimics, it was soon apparent that the homeostatic function of the endocrine system can be disrupted at many sites and hormone systems.
Many authors have documented the pervasiveness of endocrine-disrupting chemicals (EDCs) in the ecosphere. A pandemic of endocrine-related disorders—ADHD, autism, diabetes, obesity, childhood and breast cancers, testicular cancer in young men, infertility, male dysgenesis syndrome, hypospadias, low sperm count, loss of semen volume and sperm quality, and increased risk of testicular and prostate cancer—may be related to EDCs.
Endocrine pathways are largely conserved across species and thus are not species- or taxa-specific. It is well understood that the ecological assays (e.g., the frog assay) are often more sensitive and equally relevant to mammalian assays in determining whether a chemical can perturb and cause adverse endocrine outcomes in the human population and vice versa.
Thus, EPA cannot limit EDSP to only humans and conventional pesticide active ingredients without violating the statutory requirements of FIFRA, FQPA, and SDWA. EPA must use all available scientifically relevant endocrine disruption research findings and avoid deviating from established international efforts that incorporate human and wildlife studies. Recognizing that mammalian data inform potential endocrine disruption in other vertebrates (avian, amphibian, fish) and vice versa, the agency must not decouple the mammalian from other vertebrate assays in EDSP screening. With more than 50 different ecological and mammalian assays included in the Organization of Economic Cooperation and Development Conceptual Framework for screening/testing endocrine disrupting effects and additional assays in development, EPA must not limit the range or types of data to be used, but as FQPA prescribes, use “appropriate validated test systems and other scientifically relevant information.†Even if currently required data—including the limited data required under this proposed partial settlement—meet the needs of human risk assessment, they are inadequate to evaluate endocrine effects on wildlife species.
FQPA amends FIFRA to ensure potential endocrine-disrupting effects are considered in risk assessments to fulfill the FIFRA mandate that pesticide use will not cause unreasonable adverse effects. This applies to humans and wildlife and to all pesticide chemicals as defined in FIFRA including all active and inert ingredients. Under FIFRA, a pesticide is presumed to pose an unreasonable risk until reliable data demonstrate otherwise. If EPA is unable to fully evaluate endocrine risks to human health and wildlife, then the agency must suspend or deny any pesticide registration until the agency has sufficient data to demonstrate no unreasonable adverse endocrine risk.
Thank you.
Letter to Congress
Plaintiffs and the Environmental Protection Agency have tentatively agreed on a consent decree describing an endocrine disruptor strategy (EDSP) to meet EPA’s responsibilities under the Food Quality Protection Act/Federal Food, Drug, and Cosmetic Act (FQPA/FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Safe Drinking Water Act (SDWA). While the proposed consent decree commits EPA to testing for estrogenic effects in conventional pesticide active ingredients, it falls far short of addressing the full range of endocrine disrupting effects of all pesticide ingredients, as is required by FIFRA to protect human health and the environment. Limiting the scope of the EDSP to humans, certain pesticide active ingredients only, and limiting the types of data to assess endocrine disruption (ED) effects is contrary to the Congressional intent and requirements in these statutes and reverses Endocrine Disruptor Screening and Testing Advisory Committee advice and EPA’s original EDSP implementation policy and science decisions.
Evidence that synthetic chemicals can interfere with natural hormones has existed for over half a century. Although early attention was given to estrogen mimics, it was soon apparent that the homeostatic function of the endocrine system can be disrupted at many sites and hormone systems.
Many authors have documented the pervasiveness of endocrine-disrupting chemicals (EDCs) in the ecosphere. A pandemic of endocrine-related disorders—attention deficit and hyperactivity disorder (ADHD), autism, diabetes, obesity, childhood and breast cancers, testicular cancer in young men, infertility, male dysgenesis syndrome, hypospadias, low sperm count, loss of semen volume and sperm quality, and increased risk of testicular and prostate cancer—may be related to EDCs.
Endocrine pathways are largely conserved across species and thus are not species- or taxa- specific. It is well understood that the ecological assays (e.g., the frog assay) are often more sensitive and equally relevant to mammalian assays in determining whether a chemical can perturb and cause adverse endocrine outcomes in the human population and vice versa.
Thus, EPA cannot limit EDSP to only humans and conventional pesticide active ingredients without violating the statutory requirements of FIFRA, FQPA, and SDWA. EPA must use all available scientifically relevant endocrine disruption research findings and avoid deviating from established international efforts that incorporate human and wildlife studies. More than 50 different ecological and mammalian assays are included in the Organization of Economic Cooperation and Development Conceptual Framework for screening/testing endocrine disrupting effects and additional assays in development, so EPA must not limit the range or types of data to be used, but as FQPA prescribes, use “appropriate validated test systems and other scientifically relevant information.†They must be adequate to evaluate endocrine effects on wildlife species as well as humans.
FQPA amends FIFRA to ensure potential endocrine-disrupting effects are considered in risk assessments to fulfill the FIFRA mandate that pesticide use will not cause unreasonable adverse effects. This applies to humans and wildlife and to all pesticide chemicals as defined in FIFRA including all active and inert ingredients. Under FIFRA, a pesticide is presumed to pose an unreasonable risk until reliable data demonstrate otherwise. If EPA is unable to fully evaluate endocrine risks to human health and wildlife, then the agency must suspend or deny any pesticide registration until the agency has sufficient data to demonstrate no unreasonable adverse endocrine risk.
Please ensure that EPA carries out its statutory responsibilities.
Thank you.
