Regulatory Developments: New Approaches to EPA in Managing New Chemical Polymers

Read the full story in the National Law Journal.

One of the consequences of the new Toxic Substances Control Act (TSCA) is the need for the U.S. Environmental Protection Agency (EPA) to review and make determinations under Section 5(a)(3)(B) on premanufacture notification (PMN) chemicals submitted to EPA, and then to take required actions.  These requirements raise particular and sometimes challenging issues for new chemical polymers because the way polymers are identified allows for multiple different forms of the polymer to be manufactured.  Thus, while the chemical notifier may intend to manufacture a polymer that does not present hazard or risk concerns, because the same cannot be said of other forms of the polymer that could be made (e.g., at a lower molecular weight or with a higher content of reactive functional groups), EPA saw the need to regulate the new polymer to meet the new law’s requirements, including regulating “to the extent necessary” to protect against unreasonable risk.

This is an important issue under Section 5 given that approximately 60 percent of the PMN chemicals submitted under old TSCA were polymers; historically, EPA saw the need to regulate relatively few new polymers based on the polymer intended to be manufactured.  Using Section 5(e) consent orders and/or Significant New Use Rules (SNUR) to regulate so many polymers would have numerous drawbacks, including the significant burden required in developing, enforcing, and complying with the new regulations as well as slowing down the introduction of polymers that are of low regulatory concern when manufactured as intended.  Recognizing that over-regulating “safe” polymers will be a problem for many stakeholders, Bergeson & Campbell, P.C.’s (B&C®) Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D., all former Office of Pollution Prevention and Toxics (OPPT) employees with decades of EPA experience in reviewing and regulating new chemicals, developed and shared with EPA flexible approaches to getting at and resolving the issues that were presented by new polymer cases.

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