2023-00940: Availability of New Approach Methodologies in the Endocrine Disruptor Screening Program; Notice of Availability and Opportunity for Comment
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The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on a draft White Paper entitled "Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP)." This draft White Paper was developed 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. This draft White Paper announces that certain NAMs have been validated and may now be accepted by the 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 evaluations.
The agency’s own summary, as published.
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