Regulatory Developments: New Approaches to EPA in Managing New Chemical Polymers
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. These approaches, involving creative use of chemical identity to assist in managing new chemical polymers, were outlined in a B&C paper and shared with EPA for its consideration. In sharing our thinking, we commended EPA for its recent “not likely” determination on a new polymer that used a new polymer exemption “flag” indicating that the polymer must be made such that it meets the polymer exemption criteria at 40 C.F.R. Section 723.250(e)(1), and encouraged that guidance be developed explaining the purpose and effect of the flag.
The approaches discussed in the B&C paper outline broader and more flexible strategies that could be used as an alternative or a complement to EPA’s polymer exemption flag approach. We believe the approaches and the reasoning discussed in the paper lay a foundation for a more comprehensive scheme that would allow EPA to meet the legal and timing requirements under the new law while speeding commercial innovation and avoiding unnecessary effort and burdensome regulation on “safe” polymers. In particular, we note an approach that, if implemented, would make all of the flexibility present in the polymer exemption available to the PMN notifier, thereby avoiding the need for future PMNs on forms of the polymer that, based on the polymer exemption, will not present an unreasonable risk.
Our report outlining our thinking is available here.