EPA Issues Test Order for PFAS Used in Manufacturing Under National Testing Strategy

EPA Issues Test Order for PFAS Used in Manufacturing Under National Testing Strategy

October 9, 2024

This action orders Innovative Chemical Technologies, The Chemours Company, Daikin America, Inc., Sumitomo Corporation of Americas, and E.I. Du Pont de Nemours and Company to conduct and submit testing on 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl prop-2-enoate, also known as 6:2 fluorotelomer acrylate or 6:2 FTAc. 6:2 FTAc is used to manufacture plastics, resins, textiles, apparel, leather and other chemicals. Between one million and 20 million pounds are produced per year.

"PFAS in our air, water, and in our bodies cause serious health effects like cancer and heart and liver problems," said Michal Freedhoff, the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. "That's why it's so important for us to collect as much information as we can on these chemicals - to learn more about the potential environmental and human health impacts of PFAS and take any necessary steps to address them."

Summaries of studies of 6:2 FTAc exposures to rodents suggest it causes changes in blood cell counts, liver and kidney size, and animal behavior. Further, the chemical structure of 6:2FTAc suggests that it may cause cancer.

PFAS such as 6:2FTAc can build up in our bodies and the environment over time. Even small amounts can significantly contribute to people's long-term exposure and health risk for cancers, impacts to the liver and heart, and immune and developmental damage to infants and children.

EPA finds that 6:2 FTAc may present an unreasonable risk of injury to health or the environment, given the hazard and exposure concerns for this chemical specifically and for PFAS generally. The information EPA receives under this order, especially toxicity information, will improve the agency's understanding not only of human health effects of 6:2 FTAc, but also of the potential effects of over a hundred PFAS that are structurally similar to 6:2 FTAc. The information will also add to EPA's overall knowledge of this category of 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 exposure, 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 several required endpoints to reduce time, costs and the use of animal subjects.

The order employs a tiered testing process, as TSCA requires. The results of all but one of the first-tier tests are required to be submitted to EPA within one year of the effective date of the order. Hydrolysis as a function of pH is a first-tier test and its completion is required within 390 days of the effective date of the order. The results of these first-tier tests will inform the decision as to which additional tests are necessary or how they may need to be conducted. 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 the Regulations.gov page, subject to confidentiality considerations under TSCA section 14.

PFAS National Testing Strategy

In the National PFAS Testing Strategy, EPA assigned PFAS into smaller categories based on similarities in structure and physical-chemical properties. EPA is issuing test orders for PFAS in specific categories that lack toxicity data to inform the agency's understanding of the potential human health effects.

As EPA continues to further develop the strategy, refine its universe and categorization of PFAS, and consider stakeholder feedback, the agency has also increased the weight it places on the potential for exposures when identifying specific PFAS on which to require testing.

Section 4 Test Orders

Developing TSCA 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, as well as to address other details of drafting and issuing an order, such as assessing the order's economic burden.

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.

View the test order issued today and other section 4 test orders.

Learn more about the PFAS National Testing Strategy.