By Lynn L. Bergeson and Margaret R. Graham
On August 7, 2017, the U.S. Environmental Protection Agency (EPA) issued a press release stating that it has eliminated the new chemical backlog of over 600 chemicals: “[t]he current caseload is back at the baseline and now in line with the typical active workload.” The press release also announces improvements to new chemical safety reviews, which include operating principles, improvement of EPA’s Toxic Substances Control Act (TSCA) new chemicals program, and further transparency, as detailed below.
EPA states it is committing to the following operating principles in its review of new chemicals:
- Where the intended uses in premanufacture notices (PMN) or other TSCA Section 5 notices (such as low volume exemption (LVE) requests) raise risk concerns, EPA will work with submitters, and, if the submitters submit timely amended PMNs addressing those concerns, EPA will generally make determinations based on those amended submissions.
- Where EPA has concerns with reasonably foreseen uses, but not with the intended uses as described in a PMN or LVE application, as a general matter, those concerns can be addressed through significant new use rules.
- As described in the risk evaluation rule released on June 22, 2017, identification of reasonably foreseen conditions of use will be fact-specific. It is reasonable to foresee a condition of use, for example, where facts suggest the activity is not only possible, but, over time under proper conditions, probable.
- The purpose of testing in a Section 5 order is to reduce uncertainty in regard to risk. Specifically, it is to address risk concerns that gave rise to a finding of “may present unreasonable risk” or another Section 5 finding other than “not likely to present unreasonable risk.” In addition, consistent with the statute, any request for testing by EPA will be structured to reduce and replace animal testing as appropriate.
EPA states it will continue to improve of its TSCA new chemicals program in the following ways:
- Redeploying staff to increase the number of Full-Time Equivalent (FTE) staff working on new chemicals;
- Initiating a LEAN exercise (via EPA’s new time-saving and cost-effective tools) to streamline work processes around new chemicals review; and
- Institutionalizing a voluntary pre-submission consultation process so that submitters have 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. While such engagement prior to submission is an additional up-front time and resource commitment by submitters and EPA, it should more than pay for itself with faster, better-informed EPA reviews.
EPA states it needs to be more transparent in how it makes decisions on new chemicals under TSCA, and will be instituting the following to implement that goal:
- In Fall 2017, EPA’s Office of Pollution Prevention and Toxics (OPPT) intends to release, for public comment and stakeholder engagement, draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations;
- EPA will facilitate a public dialogue on its goal of continued improvement in the new chemicals review program; and
- EPA will continue posting weekly web updates of program statistics, so that manufacturers and the public can determine the disposition of cases as quickly as possible.