The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at providing exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges. EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment. According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years. EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.” EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time. More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations. EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website. More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 

By Lynn L. Bergeson

On December 13, 2019, EPA announced that it has contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “integrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.” EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method. NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020. EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process. EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”