As part of the U.S. Environmental Protection Agency's (EPA) PFAS Strategic Pathway, the EPA issued the first in a series of Toxic Substances Control Act (TSCA)-based testing orders on June 6, 2022, requiring companies to Per- and polyfluoroalkyl substances (PFAS) to conduct tests and submit results. When EPA issued its National Integrated Strategic Pathway to address PFAS contamination, it also issued a National PFAS Testing Strategy to help identify PFAS data needs and require appropriate testing to fill those data gaps.

"Families across the United States, especially those in underserved communities, have long suffered from the harmful effects of PFAS. High-quality, reliable PFAS-related data will help EPA better understand and ultimately reduce the potential risks posed by these chemicals." EPA Administrator Michael S. Regan said, "Our communities deserve transparency from the companies that use or produce these substances about their potential environmental and human health impacts."

EPA selected CDPOS (6:2 fluorotelomer sulfonamide betaine, CAS: 34455-29-3) as the substance for the first test order issued under the National PFAS Testing Strategy. According to the TSCA Chemical Data Report (CDR), CDPOS is produced/imported in large tonnages (over 25,000 lbs. in a given year). The substance can be used as a surfactant in firefighting foam and may be present in some floor finishes.CDR data also indicate that at least 500 workers may be exposed to this chemical in a year. Although some hazard and exposure information exists for this PFAS, EPA found that there is insufficient data to determine the human health effects of the exposure pathway by inhalation. This testing requirement will satisfy this data need.

Comu, DuPont, National Foams and Johnson Controls USA Ltd. are the first recipients of the test order. Companies subject to the test order may conduct testing as described in the order, including post-inhalation physicochemical properties and health effects testing, or provide EPA with existing information that they believe EPA has not identified in its search for available information. epa encourages companies to conduct testing jointly to avoid unnecessary duplication of testing. The test order uses a phased testing process in accordance with TSCA requirements. The results of all Tier 1 testing must be submitted to EPA within 400 days from the effective date of the Test Order and will inform the decision as to whether additional testing is required. Test orders and data submitted in response that are not subject to valid confidentiality requirements will be publicly available on the EPA website.

▌PFAS National Testing Strategy

In the PFAS National Testing Strategy, EPA divided the 6504 PFASs into smaller categories based on similarity of structure, physicochemical properties, and available toxicity data. Of these categories, EPA identified 24 categories for which toxicity data on potential human health effects were lacking and for which the presence of a PFAS contained at least one identifiable manufacturer that allowed EPA to issue a test order. As it continues to further develop its national PFAS testing strategy, and after reviewing feedback from a number of stakeholders, EPA plans to add weight to the potential exposure risk of each category when identifying representative PFASs.

Based on EPA's experience to date in developing a PFAS phased testing strategy, it is also important to have a better, upfront understanding of the physicochemical properties of the various PFASs included in the national PFAS testing strategy. The information in these initial test orders will provide EPA with critical information on more than 2,000 such PFASs. This information will enable EPA to make more informed decisions about PFAS and guide the development of future test orders. ePA plans to issue additional Phase I test orders in the coming months.

Testing CDPOS based on available information and predictive modeling will also allow EPA to understand the human health effects of the 503 additional PFASs with similar structures that are detailed in the testing strategy.

▌TSCA Section 4-Testing Order

Developing a test order, according to the test order requirements in TSCA Section 4, is a complex and resource-intensive process that involves many scientific, technical, and regulatory considerations. Based on the "potentially unreasonable risk" finding under TSCA Section 4(a)(1), EPA describes for the first time the process that future PFAS test orders will follow to obtain data on human health effects. The test is a comprehensive and effective investigation of human health data nodes and should use test methods appropriate to the physicochemical properties of PFAS. Given the complexity of the testing requirements, experts in many EPA offices worked to identify test methods and assess needs, and to address other details of the process of drafting and issuing a test order (e.g., the economic cost of a test order).

In addition, a test order is often sent to multiple companies in response. epa must identify information about these companies and their relevant contacts. In order to improve the transparency of the process, EPA will also publicly attempt to resolve issues related to allegations of confidential business information linking the companies involved to chemical substances.