Does your company plan to submit a premanufacture notice (PMN) under section 5 of the Toxic Substances Control Act (TSCA)?  Has it done so recently?  If so, you need to know the answers to ten key questions:

1. What are the new fees and when will they be assessed?
2. How does EPA interpret the possible PMN determinations?
3. How does EPA interpret “conditions of use”?
4. How often does EPA make each determination?
5. What is the timeline for EPA to make its determination?
6. How can a submitter increase the likelihood of a favorable (or at least faster) determination?
7. What is EPA likely to include in a section 5(e) order?
8. How likely is EPA to adopt a significant new use rule (SNUR) for a PMN substance?
9. What is the timeline for EPA to adopt a SNUR following a section 5(e) order?
10. What are the prospects for a “not likely” determination and a non-order SNUR?

This alert provides answers to those questions based on what EPA has said and done since enactment of the TSCA amendments on June 22, 2016.

For a full text of The Ten Things PMN Submitters Need to Know, click here.

Beveridge & Diamond’s Chemicals Regulation practice group and Chemicals industry group provide strategic, business-focused advice to the global chemicals industry. We work with large and small chemical companies whose products and activities are subject to EPA’s broad chemical regulatory authority under TSCA and state chemical restrictions. For more information, please contact the authors.