April 11, 2019
On March 20, 2019, the United States Environmental Protection Agency (EPA) initiated the prioritization process for 40 chemicals under the Lautenberg Chemical Safety for the 21st Century Act (LCSA) amendments to the Toxic Substances Control Act (TSCA). EPA has initiated the prioritization process for designating 20 chemical substances as high priority for risk evaluation, and 20 chemical substances as low priority, meaning that risk evaluation is not warranted for these low priority chemicals at this time. EPA has opened public dockets for each chemical and will be accepting public comments on the prioritization list through July 19th.
TSCA requires that EPA publish this list within three and a half years of the LCSA amendments (enacted in June 2016). The LCSA amendments require that 50% of the chemicals on the list be drawn from the 2014 update of the TSCA Work Plan. The 20 high-priority chemicals include several chlorinated solvents, phthalates, halogenated flame retardants, and formaldehyde previously listed in the 2014 updated TSCA Work Plan. Chemicals were chosen based on potential hazard, exposure, persistence and bioaccumulation, chemical use information, annual Toxics Release Inventory (TRI) information, and other available agency human health and ecological risk assessments (within and outside of the United States). The inclusion of formaldehyde on the high-priority list has stimulated discussion regarding a shift of regulatory focus from EPA’s Integrated Risk Information System (IRIS) to TSCA and what that might mean for future regulatory requirements for formaldehyde.
The 20 low priority chemicals (e.g., 1-butanol, propanol, gluconic acid) were chosen based on low-hazard potential across a range of endpoints determined from interim screening-level evaluations of more than 30,000 chemicals for hazard, use, and exposure for high- and medium- production volume chemicals, considering chemicals with the most available high-quality data. EPA intends to make transparent the documentation that is the basis of its selection of the low-priority chemical substance designations.
EPA also notes that it may use New Approach Methodologies (NAMs) and analogous chemical data to demonstrate suitability for high or low priority designations. EPA intends to update and refine its initial review based on data sources and submission of additional information on these chemicals by stakeholders.
Once the final list is published (December 2019), EPA will initiate risk evaluation for the 20 high-priority chemicals and must publish draft scopes of the risk evaluations within six months (June 2020) and final scopes within the ensuing six months (December 2020). EPA is required to publish the final risk evaluations for these chemicals not more than three years after initiation of the risk evaluations (December 2022).
Gradient staff are well positioned to provide support as you consider preparing comments on the prioritization list or with meeting future TSCA requirements for any of the 40 initiated chemical designations.