EPA Requests Comment On NAMs To Screen For Endocrine Effects
EPA announced on January 19, 2023, the availability of and solicited public comment on a draft white paper entitled “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” 88 Fed. Reg. 3406. EPA states that it developed the draft white paper pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a screening program to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. The draft white paper announces that certain NAMs have been validated and may now be accepted by EPA as alternatives for certain EDSP Tier 1 assays, while others are useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight of evidence (WoE) evaluations. Comments on the draft white paper are due March 20, 2023. For more information on the draft white paper, please read the full memorandum.