ILMA Attends EPA Meeting on New Chemicals

DECEMBER 7, 2017

ILMA attended EPA’s December 6 public meeting on its implementation of the new chemicals review program under the June 2016 amendments to the Toxic Substances Control Act (TSCA). All meeting materials can be reviewed here. Here are some of the key “takeaways” from the meeting.

Jeff Morris, EPA’s Director of the Office of Pollution Prevention and Toxics (OPPT), discussed the controversial topic of “conditions of use” that the Agency must consider as part of its Pre-Manufacture Notifications (PMN) review process. He stated that EPA will base its required safety determination on the stated, intended uses contained in the PMN submission. 

Mr. Morris added that, if a PMN submitter is notified by EPA of conditions of use issues with the submission and it then submits an amended PMN that removes the troublesome conditions of use, the Agency generally will review the PMN in accordance with the revised conditions of use. 

EPA’s new approach to processing PMNs includes approving the uses contained in the submission if they do not pose an unreasonable risk. The Agency then would proceed to issue a Significant New Use Rule (SNUR) to address any additional, reasonably foreseen uses that may present issues.  

This is significant change, as EPA traditionally has required PMN submitters to agree to a TSCA Section 5 (e) Consent Order as a condition of approval of the PMN. This new approach is somewhat controversial. 

Numerous NGOs, including the Environmental Defense Fund and Earth Justice, stated their concerns at the meeting with the approach outlined by Mr. Morris, noting that nothing in the statute permits EPA to approve only those conditions of use contained in the PMN.  In their reading of the TSCA amendments, EPA must consider reasonably foreseen conditions of use and issue a TSCA Section 5 (e) consent order, if appropriate. 

There also were questions from industry and NGO representatives on the timing between approval of the PMN and the issuance of the SNUR; however, EPA was unable to provide a specific timeline, stating that it was still working on that aspect.

Mr. Morris said that, for the time being, he is personally reviewing every PMN to ensure that the policies and procedures were being consistently applied to all new substance applications. 

His comment drew some criticism and concern from industry, primarily that it will slow down the PMN review and approval process. However, some attendees agreed that uniform application was fundamental and that a “micro-managing” approach was likely good as the Agency implements its new policies. 

Multiple other suggestions were offered to improve the PMN process, including drafting a support document that would allow downstream processors to submit information directly to EPA, as that information is generally the hardest to obtain for a new chemical submission. However, the Agency was non-committal to that proposal. 

EPA will host another public meeting next week regarding the prioritization process for existing chemicals.