Another Busy Year Planned for Implementation of TSCA Requirements
TSCA Risk Evaluation Process
In our 2021 Forecast, we predicted that the Biden administration would look for opportunities to reopen the Toxic Substances Control Act (TSCA) risk evaluation process required by the 2016 TSCA amendments as implemented by the Trump EPA. The Biden EPA did not disappoint, announcing at the end of June that it would revisit the risk evaluations for the “first ten” high priority substances completed by the Trump EPA. According to EPA’s announcement, these risk assessments incorrectly excluded certain exposure pathways, in particular for susceptible subpopulations and—consistent with EPA’s renewed focus on environmental justice— “fenceline communities” located near industrial facilities. Subsequently, in December 2021, EPA released for public comment a draft TSCA Systematic Review Protocol, ostensibly designed to address a review by the National Academies of Sciences, Engineering and Medicine of the protocol the Trump EPA put in place in 2018. Notably, in its press release EPA said the draft protocol was used instead of the 2018 protocol to evaluate the “next 20” risk evaluations underway pursuant to the 2016 amendments. Comments on the protocol are due February 18, 2022.
TSCA Fee Rule
In addition, EPA has indicated that based on public comment, in early 2022 it will issue a supplemental proposal to the changes to the TSCA fee rule first proposed in January 2021. Ultimately this rule will govern the fees manufacturers, importers, and certain processors are required to pay to fund EPA’s costs to implement TSCA. The January 2021 proposed rule included new exemptions for certain manufacturers and importers that are analogous to the current Chemical Data Rule (CDR) exemptions. EPA has indicated that in April 2022 it intends to issue a notice of proposed rulemaking for rules on submitting and supporting confidential business information claims.
New Section 6(a) Rulemakings
The EPA also plans roll out a series of proposed Section 6(a) Rulemakings addressing chemicals which require EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. The proposed Rulemakings, as identified in the EPA’s Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions, include pending actions on the following chemicals: Cyclic Aliphatic Bromide Cluster (HBCD), 1-Bromopropane; Carbon Tetrachloride, Trichloroethylene (TCE), and asbestos (chrysotile).
Finally, the EPA announced in late December 2021 that it would be granting the TSCA Section 21 petition submitted by several North Carolina NGO’s compelling a manufacturer to conduct testing of a group of per- and polyfluoroalkyl substances (PFAS). The first phase of testing, authorized under Section 4 of TSCA, will include up to 24 PFAS substances. The EPA plans to then extrapolate this information to 2,950 PFAS that belong to the same categories as the 24 individual substances being tested. This testing and other PFAS testing proposed as part of the Section 21 petition are expected to have wide reaching implications for potential future regulation of PFAS exposures in air, water, and soils.