In a January 19 Federal Register notice (available at https://www.federalregister.gov/d/2023-00940) the U.S. Environmental Protection Agency (EPA) announced availability of a draft white paper, “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” The white paper states that certain NAMs have been validated and may now be accepted by the EPA as alternatives for certain Tier 1 assays used within the EDSP. Others NAMs may be useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight-of-evidence evaluations. EPA is accepting comment on the draft white paper through March 20; the white paper, other supporting materials and a link to submit comments are available at https://www.regulations.gov/document/EPA-HQ-OPP-2021-0756-0001.

The EDSP was established by the Federal, Food, Drug and Cosmetic Act, which required EPA to develop a screening program to determine whether certain substances may have effects in humans similar to effects produced by naturally occurring estrogens or other endocrine effects. The purpose of Tier 1 EDSP screening is to identify chemicals that have potential biological activity in the estrogen, androgen, or thyroid hormone pathways. Recent EPA research efforts have focused on the development and evaluation of high-throughput in vitro assays and in silico methods as NAMs, including databases and computational models, for use as alternatives to the current suite of assays in the EDSP Tier 1 battery, to accelerate the pace of screening, add efficiencies, decrease costs, and reduce animal testing. More information about use of NAMs in the EDSP is available at https://www.epa.gov/endocrine-disruption/use-high-throughput-assays-and-computational-tools-endocrine-disruptor.