Today, as a part of the U.S. Environmental Protection Agency (EPA)’s PFAS Strategic Roadmap, the agency issued the first in a series of Toxic Substances Control Act (TSCA) test orders to require companies to conduct and submit testing on per- and polyfluoroalkyl substances (PFAS). When EPA announced its Strategic Roadmap to confront PFAS contamination nationwide, the agency 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.”
EPA selected 6:2 fluorotelomer sulfonamide betaine (CASRN 34455-29-3) as the first order issued pursuant to the National PFAS Testing Strategy. 6:2 fluorotelomer sulfonamide betaine has been manufactured (defined to include importing) in significant quantities (more than 25,000 pounds in a given year) according to TSCA Chemical Data Reporting (CDR) rule reports. This chemical substance is a surfactant used to make commercial fire-fighting foams and may be found in certain floor finishes. CDR data also indicate that at least 500 workers in a given year could be potentially exposed to this chemical. 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.
The Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc. are the recipients of this first test order. The companies subject to the test order may 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 for existing information. EPA encourages companies to jointly conduct testing to avoid unnecessary duplication of tests. 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 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 are not subject to a valid confidentiality claim will be made publicly available on EPA’s website and in applicable dockets on www.regulations.govEXITEXIT EPA WEBSITE.
PFAS National Testing Strategy
In the PFAS National Testing Strategy, EPA assigned 6,504 PFAS into smaller categories based on similarities in structure, physical-chemical properties, and existing toxicity data. Of these categories, EPA identified 24 that lack 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. As EPA continues to further develop the National PFAS Testing Strategy and following the review of some stakeholder feedback, the agency also plans to increase the weight it places on the potential for exposures when identifying the representative PFAS for each category.
Based on EPA’s experience to date in developing tiered testing strategies for PFAS, it will also be important to have a better, upfront understanding of physical-chemical properties for the wide variety of PFAS included in the National PFAS Testing Strategy. The information from these initial orders will provide the agency with critical information on more than 2,000 similar PFAS that fall within these categories. This information will allow the agency to make better-informed decisions about PFAS as well as guide any future orders. The agency plans to issue the additional Phase I orders in the coming months.
Based on available information and predictive models, testing on 6:2 fluorotelomer sulfonamide betaine will also inform the agency’s understanding of the human health effects of 503 additional PFAS with similar structures as detailed in the Testing Strategy.
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. 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).
Additionally, one order often applies to multiple companies. EPA must identify these companies and their associated points of contacts. To improve the transparency of the process, EPA also tries to resolve confidential business information claims that could prevent EPA from publicly connecting the company to the chemical substance prior to issuing test orders.