In April 2019, the EPA proposed significant new use rules (SNURs) for 13 chemicals subject to premanufacture notice (PMN) review without consent orders. The SNURs require the submission of a significant new use notice for EPA review for the use of the chemical under certain conditions. The EPA will then issue a finding for significant new use under the Toxic Substances Control Act (TSCA).
While the EPA is forging ahead to finalize SNURSs, there has been significant pushback from certain groups concerning the EPA’s approach. NGOs have raised questions about the lawfulness of the EPA’s rules proposed last October. Historically, when the EPA expressed concerns in reviewing a PMN that the “chemical is not likely to present an unreasonable risk of harm” but another use might present an unreasonable risk of harm, the EPA would impose a Section 5(e) consent order on the PMN submitter that would limit the alternate use as it applied to that submitter. Thereafter, a SNUR for that substance would be issued, so that the same restrictions would apply to other manufacturers of that same substance. This is the first time under the amended TSCA that the EPA has decided to employ a “SNUR-only” approach to evaluate concerns about foreseeable applications of a new chemical.
The EPA previously summarized the “SNUR-only” approach in a policy document in 2017 entitled “New Chemicals Decision-Making Framework” that was later challenged. In connection with potential concerns about unreasonable risks of harm resulting from uses other than those described in a PMN, the EPA stated “[t]he expectation is that SNURs will generallybe effective vehicles to address such concerns and that, as a general matter, EPA will address such concerns through SNURs.”
The use of non-consent order SNURs led the Natural Resources Defense Council (NRDC) to formally challenge EPA’s approach. In the action, the NRDC and other groups maintained that this approach is prohibited under the current law because EPA’s new chemical review would essentially be limited to the PMN submitter’s intended uses rather than foreseeable uses. The lawsuit was later withdrawn without court review, based on EPA’s representations that it had not employed that SNUR approach. Nevertheless, it appears likely that the EPA will face future legal challenges in how it evaluates the implementation of SNURs.
So far, the EPA has largely ignored criticisms about issuing SNURs without first imposing consent orders. It has stated that rather than targeting the use of SNURs, criticism of its approach actually focuses on safety determinations for new chemicals under TSCA 5(a)(3).
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis of your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].