In the wake of the 2016 amendment to the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has been focusing on streamlining new chemical review. On August 7, 2017, the Agency announced several related changes to the new chemical review process. Major reforms include:
- Where a Premanufacture Notice (PMN) raises risk concerns, EPA will allow manufacturers to submit an amended PMN to address those concerns, and will base its judgment on the amended PMN.
- Where EPA has concerns with product uses that can reasonably be foreseen but are not the intended uses described in the PMN, EPA’s concerns can be addressed through significant new use rules (SNURs).
- Identification of reasonably foreseen conditions of use that are not addressed in a PMN will be fact-specific. EPA will find that a use is reasonably foreseeable where facts suggest that the use is not only possible but probable.
- Section 5 testing orders will be confined to cases where they are necessary to reduce uncertainty in “unreasonable risk” findings, and will be structured to reduce or replace animal testing where appropriate.
EPA also announced that it will increase the full-time staff for new chemical review and will streamline related work processes. In addition, to help companies prepare PMNs, EPA will institute a voluntary pre-submission consultation process to provide submitters with a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process. Further support for submitters will be available this fall. EPA announced that it will publish for public comment draft guidance to provide more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations.