On June 6, 2022, the EPA issued the first Toxic Substances Control Act (TSCA) test orders to the Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc. The orders require the companies to conduct and submit testing on per- and polyfluoroalkyl substances (PFAS).
In October 2021, the Agency announced its PFAS Strategic Roadmap, which laid out its actions and timelines to address PFAS contamination. At that time, the EPA also released the National PFAS Testing Strategy to help identify PFAS data needs and require testing to fill those gaps.
“For far too long, families across America, especially those in underserved communities, have suffered from PFAS. High-quality, robust data on PFAS helps EPA to better understand and ultimately reduce the potential risks caused by these chemicals,” said EPA Administrator Michael S. Regan. “Our communities deserve transparency from the companies that use or produce these substances about their potential environmental and human health impacts.”
For the testing strategy, the EPA assigned 6,504 PFAS to smaller categories based on similarities in structure, physical-chemical properties, and existing toxicity data. Within those categories, the EPA identified 24 PFAS that are lacking enough toxicity data “to inform EPA’s understanding of the potential human health effects and contain PFAS with at least one identifiable manufacturer to whom EPA could issue a test order,” states an EPA news release.
The first surfactant selected for the testing strategy is 6:2 fluorotelomer sulfonamide betaine (CASRN 34455-29-3), which has been manufactured (defined to include importing) in significant quantities (more than 25,000 pounds each year), according to TSCA Chemical Data Reporting (CDR) rule reports. It is used to make commercial firefighting foam and is present in some floor finishes.
“CDR data also indicate that at least 500 workers in a given year could be potentially exposed to this chemical,” adds the news release. “Although there is some hazard and exposure information about this PFAS, EPA found there is insufficient data to determine the effects on human health associated with the inhalation route of exposure. This test order will address this data need.”
Tests described in the order include testing of physical-chemical properties and health effects following inhalation. Companies may conduct the tests as described in the order or provide the EPA with existing information that they believe the EPA did not identify in its search for existing information.
Companies subjected to test orders are encouraged to conduct joint testing to avoid duplication, with a tiered process required under TSCA guidelines.
The information gained from the initial test orders will provide the Agency with critical information on more than 2,000 similar PFAS that fall within these categories.
“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,” continues the Agency news release. “With this test order, EPA is for the first time describing the process future PFAS test orders will follow to obtain data on human health effects pursuant to a ‘may present an unreasonable risk’ finding under TSCA section 4(a)(1). This testing comprehensively yet efficiently investigates human health endpoints, applying testing methodologies appropriate for the physical-chemical properties of the subject PFAS. Given the complexity of the testing requirements, a broad spectrum of experts across many offices in the agency worked to determine testing methodology and needs and address other details that go into the process of drafting and issuing an order (e.g., assessing the economic burden of an order).”
The results of all the first-tier testing are required to be submitted to the EPA within 400 days of the effective date of the order and will inform the decision as to whether additional tests are necessary. The orders and any data submitted in response to these orders that is not subject to a valid confidentiality claim will be made publicly available.
The EPA plans to issue additional Phase 1 testing orders over the next few months.