Ten Things PMN Submitters Need to Know
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:
- What are the new fees and when will they be assessed?
- How does EPA interpret the possible PMN determinations?
- How does EPA interpret “conditions of use”?
- How often does EPA make each determination?
- What is the timeline for EPA to make its determination?
- How can a submitter increase the likelihood of a favorable (or at least faster) determination?
- What is EPA likely to include in a section 5(e) order?
- How likely is EPA to adopt a significant new use rule (SNUR) for a PMN substance?
- What is the timeline for EPA to adopt a SNUR following a section 5(e) order?
- 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.