20
Aug
Inspector General Rips EPA for Failure to Test Pesticides for Endocrine Disruption
(Beyond Pesticides, August 20, 2021) The Office of the Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) has issued a damning report on the agency’s progress in protecting the population from potentially damaging endocrine disruption impacts of exposures to synthetic chemical pesticides (and other chemicals of concern). The report’s summary statement says, “Without the required testing and an effective system of internal controls, the EPA cannot make measurable progress toward complying with statutory requirements or safeguarding human health and the environment against risks from endocrine-disrupting chemicals.” This OIG report identifies and details the failings that Beyond Pesticides covered in an April 2021 Daily News Blog article, and many more — the net of which is that “we have yet to see EPA use endocrine disruption findings in pesticide registration decisions.”
The OIG report chronicles a litany of failures. It finds that EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which is responsible for testing all pesticide chemicals for endocrine disrupting activity in humans, has failed to do so. Specifically, it has not implemented a section of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 1996 Food Quality Protection Act — the legislation that requires such testing. In addition, the report states that OCSPP’s Office of Pesticide Programs (OPP) has not implemented a 2015 recommendation that 17 pesticides undergo additional testing for endocrine disruption (ED) in wildlife so that an ecological risk assessment could be effectively conducted.
The report indicates that EPA has not created the tools (e.g., strategic guidance documents or performance measures) necessary to implement effectively the agency’s Endocrine Disruptor Screening Program (EDSP), created in 1998. According to the report, EDSP has not “conducted annual internal program reviews to monitor or assess progress in fulfilling regulatory requirements, and the EDSP has not effectively communicated with internal and external stakeholders. Moreover, previous OCSPP leadership provided acceptable corrective actions to meet the recommendations in a 2011 EPA Office of Inspector General report regarding the EDSP, yet failed to actually implement those corrective actions beyond an initial period of compliance with them. Lastly, some EPA staff indicated that they were instructed to function as if the EDSP was eliminated from the EPA’s budget. Because the EDSP has not had effective internal controls in place since 2015, it cannot have reasonable assurance that the objectives of the program will be accomplished and that resources will be allocated efficiently and effectively. ”
The human body’s endocrine system, comprising a variety of glands and the hormones they produce, is responsible for the activation, regulation, and de-activation of a huge variety of functions in, especially, development, reproduction, growth, metabolism, the cardiac and circulatory system, sleep, mood, and behavior, among others. The hormones secreted by the endocrine glands travel through the bloodstream to various organs and tissues, where they communicate critical regulatory messages.
The ingredients in many pesticides (and in many consumer products) act as endocrine disruptors in humans and other animals in several ways. They may: (1) mimic actions of hormones the body produces (e.g., estrogen or testosterone), causing reactions similar to those generated by the naturally produced hormones; (2) block hormone receptor cells, thereby preventing the actions of natural hormones; or (3) affect the synthesis, transport, metabolism, and/or excretion of hormones, thus altering the concentrations of natural hormones in tissues or at receptor sites. (See a Beyond Pesticides primer on pesticides and ED here.)
As the OIG report notes, “Small disturbances in endocrine function, particularly during certain highly sensitive stages of the life cycle, such as pregnancy and lactation, can lead to profound and lasting effects. Adverse endocrine-related effects in humans may include breast cancer, diabetes, obesity, infertility, and learning disabilities.” Beyond Pesticides would add to that list both direct and indirect implications of ED chemicals, such as other cancers, Parkinson’s disease, multiple reproductive disorders and anomalies (e.g., polycystic ovary syndrome, testicular dysgenesis syndrome, endometriosis, and reduced sperm count), alteration of the gut biome and resultant dysfunction, and metabolic disorders apart from diagnosable diabetes.
See Beyond Pesticides’ Pesticide-Induced Diseases Database’s ED page devoted to diseases and disorders associated with exposures to ingredients in endocrine-disrupting pesticides and in consumer products, such as plastics, disinfectants, linings of canned food containers, toys, cosmetics, flame retardants, detergents. Given the omnipresence of such compounds in pesticides and in the materials stream broadly, exposures to ED chemicals can be frequent and even chronic.
In 2017, Europe’s Pesticide Action Network refined an earlier estimate by the European Union that more than 50 pesticide active ingredients operate as endocrine disruptors. (That earlier list included those identified by TEDX, The Endocrine Disruption Exchange, which was launched by pioneering ED scientist Theo Colborn, PhD.) The update short-listed 37 pesticides of ED concern out of the nearly 500 on the market in Europe in 2015. In 2009, EPA created an EDSP “List 1” of 67 pesticides and “high production volume chemicals” used as pesticide inert ingredients that the agency deemed should be evaluated first for ED impacts. (EPA later reduced this list to 52 chemicals because 15 were subsequently canceled or discontinued.)
EPA’s EDSP uses a tiered testing process. Tier 1 Screening (which looks at high-exposure chemicals) aims to determine if a chemical could interact with the estrogen, androgen, and/or thyroid pathways, the three hormonal pathways in the body’s endocrine system. Tier 2 testing attempts to determine whether a chemical causes adverse effects, and to establish a dose–adverse response metric. EPA has decided that Tier 1 Screening results are insufficient to implicate a chemical as an endocrine disruptor — even when results show that a chemical can or does interact with the endocrine system. But Tier 1 results do determine which chemicals move on to Tier 2 testing — the results of which can influence regulatory decision making.
On this front, the OIG report says, “The OCSPP has not implemented Section 408(p)(3) of the FFDCA to test all pesticide chemicals for endocrine-disruption activity. In June 2015, the EPA recommended that 18 pesticides from List 1 needed additional Tier 2 testing. As of early 2021, the OCSPP has not issued any List 1–Tier 2 test orders for wildlife studies and has only issued test orders for two pesticides for human health studies. Likewise, although the EPA developed and published List 2 with 109 chemicals, the EPA did not issue any List 2–Tier 1 test orders. As a result, the EPA has not made meaningful progress in meeting its statutory obligation to test all pesticide chemicals for endocrine-disruption activity.” The report adds, pointedly, “Endocrine Disruptor Screening Program testing delays are inconsistent with the Federal Food, Drug, and Cosmetic Act, which directs the EPA to take appropriate action to protect public health if a substance is found to have an effect on the human endocrine system.”
Clearly, ED testing has been profoundly stalled. The report indicates that EPA failed to meet a directive from the House Appropriations Committee to publish a List 2 by October of 2010. In reality, the agency did so two and a half years after the deadline (in June 2013). Another directive — to issue, beginning in 2011, 25 test orders per year from List 2 — has been ignored: as of February 2021, EPA had not issued any List 2 / Tier 1 test orders. According to the OIG, responses from OPP staff laid the blame for this faulty record on a lack of overall support and direction for the EDSP from previous OCSPP leadership.
That explanation would appear to comport with some of the evidence unearthed by Sharon Lerner and reported in her The Intercept article, “Whistleblowers Expose Corruption in EPA Chemical Safety Office.” The article evinced not only laxity and managerial allegiance to industry interests, but also, downright corruption on the part of some managers at EPA. Beyond Pesticides reported the comment of Tim White, executive director of PEER (Public Employees for Environmental Responsibility, “It will take new EPA Administrator Michael Regan, [MPA], new Assistant Administrator for Chemical Safety and Pollution Prevention Michal Ilana Freedhoff, [PhD], and Congress to remedy the culture . . . and to rebuild both the science staff at EPA (which was severely eroded during the Trump administration), and the agency’s morale and culture, which were also badly damaged. He noted that as one of his first acts, Administrator Regan issued a memorandum outlining concrete steps to reinforce EPA’s commitment to science.”
The OIG report also cites EPA for: (1) not having adequate internal controls (e.g., strategic guidance documents or performance measures re: meeting statutory requirements) in place to ensure effective program implementation of the EDSP; (2) having conducted no internal review on progress in meeting the dictates of FFDCA; and (3) having no strategic planning document that makes priorities clear or guides program activities. It adds that EDSP needs to improve communication with stakeholders, both internal and external.
The report concludes: “In 1996, Congress directed the EPA to establish the EDSP, and the program received approximately $7.5 million in funding in fiscal year 2021. Yet, the EDSP can show only limited results. Without the required testing and an effective system of internal controls, the EPA cannot make measurable progress toward compliance with statutory requirements or safeguard human health and the environment against risk from endocrine-disrupting chemicals.”
The OIG report issued a series of 10 recommendations, directed to OCSPP Assistant Administrator Freedhoff, that address:
• tiered testing for ED impacts
- timelines for such testing
- strategic planning
- development of performance metrics
- improved communication, including to the public
- internal program review
- improved transparency
The report adds that EPA “generally agreed with our recommendations and provided acceptable corrective actions and estimated completion dates for all ten recommendations. The recommendations are considered resolved with corrective actions pending. We also revised our report where appropriate based on technical comments provided by [EPA].”
A response letter (included in the report) from Dr. Freedhoff confirms that OCSPP is in “general agreement with the 10 recommendations in the Draft Report regarding the Endocrine Disruptor Screening Program.” She outlined several change initiatives, including development of a Strategic Plan and a new organizational structure to ensure management accountability for the EDSP. She also acknowledges “the challenges faced by the EDSP in the past, including efforts from previous OCSPP leadership to not fully implement the EDSP and its funding,” but also pushes back somewhat on the charge of not making “meaningful progress in meeting [EPA’s] statutory obligation to test all pesticides for endocrine-disruption activity.”
Dr. Freedhoff identifies several achievements in that realm, although the items she proffers in her response are not dated, making it difficult to understand which, if any, of the actions she cites might be recent (as opposed to several years old). She did note that EPA has directed considerable effort and funding, over the past decade, to development of NAMs — New Approach Methods for testing chemicals for ED potential that are faster and more efficient, and that provide “more human-relevant and mechanistically driven data for use in the evaluation of estrogen, androgen, and thyroid bioactivity.” She wrote that she and OPP leadership are working on a transition of EDSP so as to make it more responsive, timely, and accountable.
Beyond Pesticides summed up the situation in a recent Daily News Blog that also advocated for members of the public to weigh in with EPA. “EPA is stalled and ignoring its responsibility. EPA now issues Proposed Interim Decisions (PIDs) on pesticide registrations [with] . . . no human health or environmental safety findings associated with the potential for endocrine disruption, or [without] identifying additional data needs to satisfy Endocrine Disruptor Screening Program requirements in the PIDs. EPA cannot make findings of no unreasonable adverse effects without findings concerning endocrine disruption. In the absence of such findings, EPA must cancel and suspend the registration of each pesticide lacking data or findings. Please ensure that your agency meets its responsibility to protect the health of people and wildlife.” EPA must do better.
Source: https://www.epa.gov/system/files/documents/2021-07/_epaoig_20210728-21-e-0186.pdf
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
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August 26th, 2021 at 11:57 pm