Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
On June 24, 2021, a “unique and broad group” of chemical manufacturers, brand owners, environmental non-governmental organizations (NGO), states, and municipalities sent a letter to the leaders of the House and Senate Appropriations Subcommittees on Interior, Environment, and Related Agencies to express their “strong support” for the U.S. Environmental Protection Agency’s (EPA) Safer Choice Program and to encourage that the program be funded fully. The letter asks that the following language be included in the report:

The Committee supports the Safer Choice program and directs that the program be funded and operated at least at levels consistent with Fiscal Year 2014, adjusted for inflation.

According to the letter, in the last quarter of 2020, EPA reorganized the Office of Chemical Safety and Pollution Prevention (OCSPP), dissolving the Safer Choice branch and reassigning most staff to the areas of OCSPP. The letter states that “[a]s a result, the program is now severely under-resourced with approximately four full-time staff.” The Biden-Harris EPA has taken steps to restore the program, but EPA still faces resource constraints.

The letter describes how companies across the value chain use the Safer Choice brand to advance their individual safer chemical initiatives. Chemical manufacturers invested in developing safer chemicals now listed on the Safer Choice’s Safer Chemicals Ingredients List (SCIL). Brand owners and product manufacturers have reformulated products using the SCIL to obtain Safer Choice certification. Major retailers specify the Safer Choice label as a verifiable way to meet corporate goals laid out in public-facing chemicals policies.

According to the letter, the Safer Choice Program also provides value to entities outside of the supply chain. States and municipalities rely on the Safer Choice Program “because it is the only third-party program that requires all ingredients to be screened for hazards instead of simply using a restricted substances list.” NGOs and consumers “find significant value in an authoritative government program that can be trusted to vet safer chemicals and products.”


By Lynn L. Bergeson and Carla N. Hutton

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists.  EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case).  If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding.  If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register.  The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC.  More information will be available in a forthcoming memorandum that will be posted on our website.


By Christopher R. Blunck
As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  In the comments, linked to in EDF’s May 14, 2020, blog item on the subject (the comments are not yet posted to the EPA dockets), the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require to be included, and then make the revised draft scopes available for public comment.  In their comments, the NGOs note that TSCA Section 6(b)(4)(D) requires that EPA, “not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” (emphasis added) and that under EPA’s risk evaluation rule at 40 C.F.R. Section702.41(c), the scope of a risk evaluation must, among other things, identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
  • The ecological receptors that EPA plans to evaluate;
  • The hazards to health and the environment that EPA plans to evaluate; and
  • The “reasonably available information” on which EPA relies to identify these required scope elements.
The NGOs state that EPA regulations at 40 C.F.R. Section 702.41(c)(7) make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  According to the NGOs, despite the regulatory requirements, EPA has not addressed the specific obligations and “Instead, EPA has only generally described some broad categories of hazards, exposures, and potentially exposed or susceptible subpopulations, and has suggested it will identify the specific hazards, exposures, and subpopulations -- and the reasonably available information it relies on to identify them -- only later, well after the current comment periods have closed and possibly even after the scopes are finalized.”  This, the NGOs state, is not allowed under TSCA and the TSCA risk evaluation rule.
Furthermore, the NGOs state that EPA also refers in each draft scope to “systematic review documentation” that has not yet been made public.  While EPA states it plans to publish this second document prior to issuing the final scope document, and take comment on it, the comments state that “EPA has wholly divorced any public comment opportunity it will provide on that systematic review document from the current public comment opportunity” and “[g]iven that the systematic review document is not yet available, the public is unable to consider its content in preparing comments on the draft scope document.”
The NGOs indicate that given these faults, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  They request EPA simultaneously to publish and take comment on, for a period of no less than 30 days, revised draft scope documents that reflect the planned systematic review, and the systematic review documentation for each scope.
We agree that the faults identified by the NGOs on the draft scope documents and the associated process are significant and that if not remedied, any risk evaluations with scopes founded on the drafts would be legally vulnerable as not comporting with TSCA and EPA’s risk evaluation rule.  EPA may wish to consider taking corrective measures along the lines urged.  This change would include adding into revised draft scopes for comment the reasonably available information EPA has indicated it will identify through the yet-to-be-completed systematic review process, and will identify the specific hazards, exposures, and potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations.