Important Updates on EPA’s TSCA New Chemicals Program
For Release: March 29, 2021
The Environmental Protection Agency (EPA) is conducting an evaluation of its policies, guidances, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they adhere to statutory requirements, the Biden-Harris administration’s executive orders, and other directives. The agency has identified several instances where the approach for making determinations and managing risks associated with new chemicals can more closely align with the requirements of TSCA to ensure protections for human health and the environment, including the use of significant new use rules (SNURs) and assumptions related to worker exposures.
EPA remains committed to meeting statutory deadlines for review and determinations on new chemicals submissions under TSCA section 5 and will continue to engage with submitters to ensure the agency is moving as expeditiously as possible to come to a resolution on their submissions. Additionally, EPA will provide timely communication for any changes to stakeholders and the public through the normal distribution lists used to announce TSCA developments.
Use of SNURs
EPA will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. Rather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA’s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks.
As has been the long-standing practice, EPA intends to continue issuing SNURs following TSCA section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufacturers or processes the chemical in the future. This ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA section 5(e) or 5(f) order. A SNUR requires manufacturers to submit a significant new use notification to EPA for assessment before the chemical substance can be manufactured or processed for the new use described in the SNUR.
EPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. Where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and updated Safety Data Sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.