On October 14, 2020, EPA received a petition to require health and environmental testing under Section 21 of the Toxic Substances Control Act (TSCA) on certain PFAS manufactured by Chemours in Fayetteville, North Carolina. The petitioners consist of the Center for Environmental Health, the Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance. The petition requests testing on 54 PFAS which Chemours produces. The petition states that the 54 PFAS meet the criteria for testing in section 4(a) of TSCA. It states that,
Based on the known hazards of these analogues, untested PFAS with potential for exposure would meet the criteria for testing in section 4(a)(1)(A) of TSCA because they “may present an unreasonable risk of injury” and have “insufficient information and experience” to determine their effects on health or the environment.
The PFAS produced by Chemours includes both commercial products and byproducts from their manufacturing process. Some of the testing differs based on whether the compound is Tier 1 (detection in human sera, food or drinking water) or Tier 2 (significant potential for human exposure based on detection in environmental media and other evidence). The petition also states that Gen X chemicals have been detected in drinking water and private wells in the vicinity of the Chemours plant. A major point of concern for the petitioners involves the North Carolina consent order, which is the result of a lawsuit against Chemours from the North Carolina Department of Environmental Quality addressing PFAS contamination in the Cape Fear River basin from the Chemours’ facility. The petition states current testing of Gen X chemicals by Chemours has been inadequate to fully evaluate the risks and additional carcinogenicity studies are needed.
The petition proposes testing with animal studies:
- 28-day repeated dose rodent toxicology studies to determine impact on health,
- Multigeneration or extended one-generation and 2-year rodent carcinogenicity studies for Tier 1 substances,
- Testing on both mice and rats using oral routes of administration,
- Inhalation testing used for volatile chemicals, and
- Toxicokinetic studies to characterize relationship between serum concentrations and dermal to evaluate biological half-life and potential for bioaccumulation.
The petition also proposes the following human studies:
- A human health study for the Cape Fear watershed to determine the relationship between exposure in the Cape Fear watershed and health outcomes.
- Testing to determine human half-lives of the listed chemicals through longitudinal biomonitoring and exposure estimation in workers.