The U.S. Environmental Protection Agency (EPA) has issued the next Toxic Substances Control Act (TSCA) test order requiring certain manufacturers to conduct testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s the National PFAS Testing Strategy.
The action orders companies to conduct and submit testing on trifluoro(trifluoromethyl)oxirane (HFPO), a perfluoroalkyl substance used in making plastics. This is the second test order under the strategy.
The information EPA receives under this order improve the Agency’s understanding of human health effects of both HFPO and dozens of PFAS that are structurally similar to HFPO. These other substances are in the same Testing Strategy category of PFAS as HFPO.
“PFAS can pose a serious risk to communities, especially those overburdened with pollution, but many of these chemicals have limited or no toxicity data,” says Michael Freedhoff, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “That’s why we’re working quickly to establish stronger, more robust data on PFAS to better understand and ultimately reduce the potential risks.”
HFPO (CASRN 428-59-1) is used in making plastics and in organic chemical manufacturing. More than 1,000,000 pounds of HFPO are manufactured each year, according to TSCA Chemical Data Reporting rule reports.
EPA issues the test order to multiple manufacturers: the Chemours Company FC LLC, DuPont De Nemours Inc., E. I. du Pont de Nemours and Company, and 3M Company.
The companies subject to the test order may either conduct the tests as described in the order, including testing of physical-chemical properties and health effects following inhalation, or provide EPA with existing information that they believe EPA did not identify in its search.
The agency encouraged companies to jointly conduct testing to avoid unnecessary duplication of tests. The agency also says that it will consider possible combinations of tests that cover all required endpoints to diminish the amount of time, animal subjects, and costs required.
The order employs a tiered testing process, as TSCA requires. The results of all the first-tier testing are required to be submitted to EPA within 415 days of the effective date of the order and will inform the decision as to which additional tests are necessary. The order and any data submitted in response to this order will be made publicly available , subject to confidentiality considerations.
Prior to issuing the test order, EPA engaged in discussions with the recipient companies to encourage them to voluntarily submit existing data on HFPO to EPA. Based on information in existing studies provided by cooperating companies, EPA determined that certain data were no longer needed and thus excluded the relevant testing requirements from the issued order.
EPA has made the data voluntarily provided by these companies publicly available in docket EPA-HQ-OPPT-2021-0910 on www.regulations.gov.
EPA previously concluded that HFPO may present an unreasonable risk of injury to health or the environment. The potential hazards from exposure to this chemical could include neurotoxicity, reproductive effects and cancer. EPA also found there is insufficient information to determine the effects on human health from inhalation of HFPO (which is a gas at room temperature). This test order will address this data need.
