The U.S. Environmental Protection Agency (EPA) issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy, the latest action taken under EPA’s PFAS Strategic Roadmap to confront contamination from forever chemicals nationwide.
The action orders the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), a substance used as a reactant in organic chemical manufacturing. HFPO-DAF is known to be used to make the chemical Hexafluoropropylene Oxide (HFPO) Dimer Acid (CASRN 13252-13-6), also known by the trade name GenX. HFPO-DA is used in the production of nonstick coatings, stain repellent, and other consumer and industrial products and was widely used to replace PFOA. More than 1 million pounds of HFPO-DAF are manufactured each year, according to TSCA Chemical Data Reporting rule reports.
“We still don’t know enough about the dangers that many PFAS might pose to human health,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “We’re using all the tools at our disposal to rapidly gather data about these substances so that we can better understand the potential environmental and human health impacts of PFAS and take any necessary steps to address them.”
After thoroughly examining existing hazard and exposure data, EPA has concluded that HFPO-DAF may present an unreasonable risk of injury to health or the environment. The potential hazards from exposure to this chemical could include organ damage, including to the eyes and skin, as well as cancer. EPA has also concluded that workers may be exposed to HFPO-DAF. Additionally, EPA’s recent proposal to regulate six PFAS in drinking water, including HFPO-DA and its salts, isomers, and derivatives which includes HFPO-DAF, found there was a meaningful opportunity to reduce health risks to people consuming drinking water contaminated by these PFAS. The test order will help EPA better understand the potential hazards and potential exposures associated with HFPO-DAF.
The information EPA receives under this order will not only improve the Agency’s understanding of human health effects of HFPO-DAF, but also the potential effects of dozens of PFAS that are structurally similar to HFPO-DAF and in the same Testing Strategy category of PFAS, improving the agency’s overall data on PFAS.
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 they believe EPA did not identify in its search, but which satisfies the order requirements.
EPA encourages companies to jointly conduct testing to avoid unnecessary duplication of tests and will also 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 446 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 on EPA’s website and in the applicable docket on www.regulations.gov, subject to confidentiality considerations under TSCA section 14.
PFAS National Testing Strategy
In the National Testing Strategy, EPA assigned PFAS into smaller categories based on similarities in structure, physical-chemical properties, and existing toxicity data. EPA is issuing test orders for PFAS in specific categories that lack toxicity data to inform EPA’s understanding of the potential human health effects.
The first test order was for 6:2 fluorotelomer sulfonamide betaine, a PFAS used in commercial firefighting foam. The second was for HFPO, a PFAS used to manufacture plastics. As EPA continues to further develop the Strategy, refine its universe and categorization of PFAS, and consider stakeholder feedback, the Agency also plans to increase the weight it places on the potential for exposures when identifying which specific PFAS to require testing on.
Section 4 Test Orders
Developing section 4 test orders is a complex and resource-intensive process involving many scientific and regulatory considerations, as explained in this Overview of Activities Involved in Issuing a TSCA Section 4 Order. Given the complexity of the testing requirements, a broad spectrum of experts across the agency worked to determine testing methodology and needs and address other details of drafting and issuing an order, such as assessing the economic burden of an order.
Additionally, one order often applies to multiple companies. EPA must identify these companies and their associated points of contact. To improve the transparency of the process, EPA also works to resolve confidential business information claims that could prevent EPA from publicly connecting the company to the chemical substance prior to issuing test orders.
