Regulatory Developments

EPA and OSHA Sign MOU Regarding EPA’s Review of New Chemicals under TSCA

January 20, 2021 PRINT

The U.S. Environmental Protection Agency (EPA) announced on January 12, 2021, that it signed a memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) “that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).” The goal of the MOU is to improve the combined efforts of the agencies to protect workers who may be exposed to a new chemical substance by providing guidelines for coordination of interface activities between the two agencies, specifically communication as it relates to TSCA Section 5, with the common goal of minimizing workplace exposures. The MOU will remain in effect for three years.

EPA states that highlights of the MOU include:

  • Establishing designated staff and management points of contact to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
     
  • Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
     
  • Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.
     

The MOU notes that under amended TSCA, when a person submits a new chemical notice under Section 5(a)(1), EPA must make a determination under Section 5(a)(3) pertaining to: the likelihood that a new chemical substance or significant new use of a chemical substance presents an unreasonable risk of injury to health or the environment; or the available data on releases and exposures. At the conclusion of the applicable review period, TSCA requires EPA to make one of the following five determinations for each chemical substance or significant new use:

  • Presents unreasonable risk -- TSCA Section 5(a)(3)(A);
     
  • Insufficient information to permit a reasoned evaluation -- TSCA Section 5(a)(3)(B)(i);
     
  • Insufficient information to permit a reasoned evaluation and may present unreasonable risk -- TSCA Section 5(a)(3)(B)(ii)(I);
     
  • Produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities or may be significant or substantial human exposure -- TSCA Section 5(a)(3)(B)(ii)(II); or
     
  • Not likely to present unreasonable risk -- TSCA Section 5(a)(3)(C).
     

The MOU states that “[w]hile EPA, not OSHA, bears the responsibility for making each TSCA Section 5 determination, EPA seeks OSHA input on workplace exposures through regular communication.” These communications may involve any of the determinations listed above, as well as any exemption application made pursuant generally to TSCA Section 5(h). According to the MOU, TSCA Section 5 communication includes, but is not limited to, consultation with OSHA pursuant to TSCA Section 5(f)(5), which requires that, to the extent practicable, EPA consult with OSHA prior to adopting any prohibition or other restriction relating to a chemical substance with respect to which EPA has made a determination under TSCA Section 5(a)(3)(A) or (B) to address workplace exposures.

According to the MOU, as follow-on to consultations initiated in 2016, the MOU formalizes continued engagement by EPA and OSHA in consultation activities pursuant to TSCA Section 5(f)(5). The MOU states that it “remains incumbent upon EPA to identify and notify OSHA of the need for formal consultation.” Under the MOU, EPA intends to make strategic consultation efforts with OSHA pursuant to TSCA Section 5, “recognizing the limited resources of OSHA and that EPA bears sole responsibility to make determinations.” The MOU notes that “EPA and OSHA recognize that consultation will not always be practicable.”

Under the MOU, EPA and OSHA agree to educate appropriate OSHA and EPA employees on applicable standards and regulations that may be implicated by communication under TSCA Section 5, including: 29 C.F.R. Section 1910.1200 (Hazard Communication), 29 C.F.R. Section 1910.132 (Personal Protective Equipment – General), 29 C.F.R. Section 1910.133 (Eye and Face Protection), 29 C.F.R. Section 1910.138 (Hand Protection), 29 C.F.R. Section 1910.134 (Respiratory Protection), 40 C.F.R. Section 721.63 (Significant New Use Rules (SNUR); Protection in the Workplace), and 40 C.F.R. Section 721.72 (SNURs; Hazard Communication Program).

The MOU states that subject to any confidentiality or privilege concerns, OSHA and EPA agree to exchange information necessary to the consultation process established in the MOU. Transfer of specific TSCA confidential business information (CBI) will be handled through the EPA Office of Pollution Prevention and Toxics (OPPT) Document Control Officer (DCO). The TSCA CBI Protection Manual will provide the protocols for the access, use, and storage of TSCA CBI accessed pursuant to the MOU unless alternative arrangements are made consistent with the TSCA CBI Protection Manual. OSHA will protect CBI received from EPA according to the procedures set forth in the TSCA CBI Protection Manual. The MOU requires EPA to provide initial and yearly CBI training to appropriate OSHA staff.

Commentary

In general, we believe the framework created by the MOU will facilitate interaction between and education of EPA and OSHA staff on workplace exposure and regulation-related issues associated with TSCA new chemical reviews. This, we feel, will help EPA and OSHA move towards the agencies’ stated common purpose of minimizing workplace exposures.

EPA’s consultation with OSHA on new chemical reviews prior to EPA’s adoption of prohibitions or restrictions, which are common in TSCA Section 5(e) consent orders and associated TSCA SNURs, however, will not always be practical given resource constraints as well as the general 90-day TSCA new chemical review and determination clock; both TSCA Section 5(f)(5) and the MOU reflect this reality. Nevertheless, it is an opportunity for EPA to ensure its regulations are in line with OSHA requirements and leverage OSHA’s expertise on workplace exposures.

It remains to be seen if the MOU will provide an opportunity for the two agencies to coordinate on broader issues regarding the regulation of new chemicals. This is especially true of chemicals that might be used outside the scope of TSCA jurisdiction. Similarly, the MOU might facilitate opportunities for OSHA to take action across a wider category of substances identified as a concern during TSCA reviews. We note that the provisions related to the sharing by EPA with OSHA and the protection of TSCA CBI are in accordance with existing practices and regulatory procedures in relevant regulations and the TSCA CBI Protection Manual, and those procedures will continue in effect notwithstanding the termination of other provisions of the MOU.


 
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