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EPA - Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program

NAMs refer to any technology, methodology, approach, or combination of these that can provide information on chemical hazard and risk assessment while limiting/optimizing the use of animal testing.

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 in silico methods mentioned are QSAR consensus models for estrogen and androgen receptor available in the OPERA tool, a freely available tool that is discussed and demonstrated in our tutor-assisted eLearning course "NAMs - Use and application of QSAR and read-across". They can be used as "NAMs Acceptable for Priority Setting and WoE Analysis".

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