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EPA Announces Significant Policy Changes Under TSCA New Chemical Review Program

The Biden Administration has directed the Environmental Protection Agency (EPA) to evaluate policies under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure their compliance with statutory requirements.  This evaluation has resulted in significant changes, announced by EPA on March 29, 2021 as to how EPA will assess and manage the risks associated with new chemicals, including changes to:

  • The introduction of significant new use rules (SNURs),
  • Assumptions about protections afforded by OSHA’s standards as part of New Chemical risk evaluations

SNURs: EPA announced that the agency will no longer exclude conditions of use of a new chemical from their review based on the existence of proposed SNURs. Instead, EPA will review all reasonably foreseen conditions of use. Where a use may present an unreasonable risk, or where there is insufficient information to make a safety determination, EPA will issue an order to address those potential risks, whether or not it is the applicant’s intended or planned use. This new practice will require more information and extend the level of effort and time for EPA New Chemical reviews.

Worker Protection Through Existing OSHA Standards: EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and Safety Data Sheets (SDSs) when evaluating the risks of a new chemical. Instead, EPA will identify the absence of worker safeguards as a reasonably foreseeable conditions of use. Under this approach, if potentially unreasonable risks are identified, then necessary worker protections will be mandated through a TSCA order. Thus, reliance on OSHA standards, personal protective equipment, and knowledge provided by hazard communication programs will no longer be incorporated into New Chemical risk evaluations or the resulting risk management actions. EPA has not clarified whether this policy might result in replacement of OSHA occupational exposure limits (OELs) that could be deemed to not meet EPA risk acceptance criteria. It seems likely that this approach will be also be adopted in EPA high-priority existing chemical risk evaluations. A previous article on the ToxStrategies website discussed the significant differences between EPA TSCA worker risk assessments and OSHA assessments used to establish OELs.