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Volume XI, Number 261

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EPA Seeks Additional Public Comment on Final PBT Rules, Announces No Action Assurance for Final Rule on PIP (3:1)

The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;

  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and

  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 68
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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