Date: Aug 21, 2020
Keller and Heckman Partner Herb Estreicher, Ph.D., was quoted in the Chemical Watch article, “NGOs Object to Late Addition of Industry Studies in TSCA Review of NMP.” The article discusses how five environmental non-government organization (NGOs) have asked the Environmental Protection Agency (EPA) to disregard a pair of late-submitted reproductive toxicity studies as it works to complete its Toxic Substances and Control Act (TSCA) final risk evaluation of N-methylpyrrolidone (NMP), an issue that could further delay an already overdue evaluation. The EPA has already missed the June statutory deadline to release the final risk evaluation for NMP.
The studies were submitted by a coalition of NMP producers in April, months after the comment period on the draft risk evaluation for NMP had closed. In an August 18 letter to EPA, the NGOs said that any reliance on such material would render the NMP risk evaluation “arbitrary and capricious.” If the EPA does consider the studies, the NGOs said it should then reopen the consultation period on the draft risk evaluation and provide the public with an additional 45 days to comment on the new material.
Anything that the EPA relies on that is significant to its decision has to be open to notice and comment, Dr. Estreicher stated. The EPA may have "no choice" but to allow notice and comment on the studies. That would further delay the release of the final risk evaluation, he noted.
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