EPA Releases Strategic Plan for Endocrine Disruptor Screening Program

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EPA has released a notice requesting comment on its strategic plan to meet its obligations under the Federal Food, Drug, and Cosmetic Act (FFDCA) to screen for and protect against endocrine-disrupting effects in humans. Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of endocrine system hormones and can negatively impact biological processes within the endocrine, immune, and nervous systems. Under the new program, the Agency will assess pesticides more quickly and effectively to evaluate their potential to cause endocrine effects in humans. These assessments will be incorporated into pesticide review efforts made under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).

In the Agency’s press release regarding the program, the Deputy Administrator for Pesticide Programs in the Office of Chemical Safety and Pollution, Jake Li, noted that the program is a major milestone. He also stated that “starting with our highest priority chemicals, EPA will communicate more transparently our endocrine findings for humans.”

EPA review of preliminary data has identified 30 high-priority pesticides that these chemicals affect the endocrine system. The Agency requests additional endocrine data for human health for these chemicals in its request for comment. The Agency intends to fill any remaining data gaps by issuing FIFRA human health data requests for these chemicals in early 2024. These chemicals are identified in EPA’s List of Conventional Registration Review Chemicals, for Which an FFDCA Section 408(p)(6) Determination is Needed, which is available in docket EPA–HQ–OPP–2023–0474 on regulations.gov. FFDCA section 408(p)(6) requires EPA to ‘‘as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health’’ for ‘‘any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.’’ In addition, in the Federal Register notice, EPA requested that stakeholders submit data on the endocrine effects of these pesticides. Data are requested during the notice’s 60-day comment period. After the assessment of the high-priority pesticides is completed, the Agency will request data on a second group of 126 pesticides.

In the strategic plan, EPA explains that the program will pull from existing data when possible.   and request new data if needed. Existing data has been collected under FIFRA and the FFDCA. EPA has chosen 400 conventional pesticide active ingredients that are being registered for the first time or are undergoing registration review for which, through the implementation of its Strategic Plan, the Agency will assess for endocrine effects and determine if additional protections are needed.

The comment period for this notice began on October 27, 2023, and has been extended to February 26, 2024.

EPA Requests Comments on New Approach Methodologies (NAMs) White Paper

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EPA published a draft white paper, New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP) and is requesting public comment. The white paper was developed pursuant to the Federal Food, Drug, and Cosmetics Act (“FFDCA”), which requires EPA to develop a screening program to determine whether certain substances may have effects in humans that is similar to an effect produced by naturally occurring estrogen or other endocrine effects. The white paper states that some NAMs are acceptable alternatives for certain EDSP Tier 1 assays. Other NAMs may be useful for prioritization purposes and weight of evidence evaluations. The EPA press release discussing the draft white paper states that it will “reinvigorate [EPA’s] efforts to meet its requirement for EDSP screening of chemicals and continue to provide transparency of EDSP Tier 1 testing, which is the step in the EDSP that determines the potential for endocrine-disrupting effects and whether there is a need to obtain more data by requiring additional Tier 2 tests.” Tier 1 screenings are used to identify substances that have the potential to interact with the endocrine system, while Tier 2 screenings are used to identify adverse endocrine-related effects caused by a substance.

Currently, each chemical undergoing ESDP Tier 1 methods can take up to six years, and the cost to the industry of each chemical review is roughly $1 million, due significantly to vertebrate testing. Certain validated NAMs included in the white paper will allow EPA to use alternatives to vertebrate animal testing and other in vitro assays, ultimately allowing the Agency to review chemicals faster, more efficiently, and at a lower cost to the Agency.