On March 25, 2024, the EPA announced it issued its fourth Toxic Substances Control Act (TSCA) test order to 3M Company and Wacker Chemical Corporation to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical Abstract Service (CAS) Reference Number: 24448-09-7), including testing on the health effects following inhalation of this chemical.
NMeFOSE is used in products such as clothing, carpet treatments, and furniture coatings like paint and varnish. It has been found in the air and in biosolids, which are a byproduct of the water treatment processes often used on agricultural fields as fertilizer. Studies have also demonstrated that NMeFOSE can accumulate in indoor dust and air, as well as in outdoor environmental media.
“In the National [per-and polyfluoroalkyl substances (PFAS)] 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 effects on human health and the environment,” an Agency news release says. “As EPA continues to further develop this 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 specific PFAS that would require testing.”
The Agency has determined that NMeFOSE may present an unreasonable risk of injury to health or the environment. The potential health issues include damage to the nervous system and immune system, as well as cancer.
Companies subject to TSCA test orders may either conduct the tests as described in the order or provide the EPA with existing information they believe the Agency didn’t identify in its search but that satisfies the order requirements. Companies are encouraged to jointly conduct testing to avoid unnecessary duplication of tests. The Agency 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 order is effective today, March 25, 2024,” the EPA news release adds. “The results of all the first-tier testing are required to be submitted to EPA within one year 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 the Regulations.gov page, subject to confidentiality considerations under TSCA section 14.”
Information received under this test order not only improves the Agency’s understanding of NMeFOSE's human health effects but also increases its understanding of potential health effects of more than 100 PFAS that are structurally like NMeFOSE and add to the agency’s overall knowledge of this category of PFAS.
“Communities across the country need information about whether or not PFAS are in our air and water, and any health risks caused by these chemicals,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff in the EPA release. “This year, we’re continuing to use test orders to gather data about the health effects of PFAS so that we can take any necessary action to protect people and the environment.”
Developing test orders is complex for the Agency. The process involves many scientific and regulatory considerations and uses a broad spectrum of experts across the agency working to determine testing methodology and needs, as well as address other details of drafting and issuing an order, such as assessing the economic burden of an order.
As in this case, test orders often involve more than one company. Each company must be identified, along with each company’s point of contact. To improve the transparency of the process, the EPA also works to resolve confidential business information claims that could prevent the EPA from publicly connecting the company to the chemical substance before issuing test orders.
See the EPA TSCA Section 4 Test Orders and the National PFAS Testing Strategy websites for additional information.