Dr. Bruce Jarnot, Regulatory & Sustainability Expert, Product Sustainability, Assent11.08.23
On October 11, 2023, the U.S. Environmental Protection Agency (EPA) released its final ruling on per-and polyfluoroalkyl substances (PFAS) reporting requirements. The new rules require businesses that have imported or manufactured PFAS at any point since 2011 to disclose their PFAS usage.
Medical devices are exempted from this requirement, leading some manufacturers to consider themselves out of the scope of this new rule. However, these companies will still need to conduct due diligence on their internal operations to ensure they don’t have in-scope purchases, in addition to reporting on products that fall outside the medical device category.
This article details the actions medical device manufacturers should take in response to the new ruling.
What arePFAS? PFAS are persistent, bioaccumulative, and toxic, and nearly 97% of Americans have traces of PFAS in their bloodstream because they are commonly used in cookware, dental floss, clothing, furniture, cosmetics, food packaging, and more. PFAS have been linked to a number of negative health effects, including thyroid disease and fertility issues. However, PFAS are essential to the production of medical devices like surgical mesh and catheters, making PFAS regulations and restrictions a complicated affair.
The countdown is now on for medical device manufacturers to collect and submit over a decade’s worth of part and product data from their supplier networks. Any business manufacturing or importing these chemicals must submit a wide range of data, including (but not limited to) uses, production volumes, and import volumes.
Manufacturers have twelve months to collect PFAS information from their own records and their supply chains, and a further six months to submit data to the EPA using the Central Data Exchange (CDX) system. Smaller firms will have an additional six months to report their data since they often have more limited resources and access to data systems.
In addition, importing PFAS for use in manufacturing processes, even in the manufacture of medical devices, is in the scope of the new rule. Therefore, equipment like rubber gaskets or Teflon tubing may need to be reported. Other purchases, like promotional merchandise, also come with PFAS due diligence obligations: importing water-resistant jackets and T-shirts, for example, could put certain medical companies in the scope of TSCA PFAS reporting. Only by conducting due diligence on supply chain purchases since 2011 can medical device manufacturers validate that they have nothing to report under TSCA.
Finally, medical devices are not exempt from PFAS reporting under a number of other regulations. For example, both Maine and Minnesota do not exempt medical devices from PFAS product registration requirements. Similarly, medical devices are in the scope of PFAS regulated under the EU Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation; California Proposition 65; and the Persistent Organic Pollutants (POPs) Regulation.
Because suppliers may need to query their own upstream network, gathering PFAS data will be time-consuming. Manufacturers from any industry should begin collecting data now to take advantage of the full data collection window. To ensure that PFAS data is communicated accurately and in a timely manner, manufacturers will need a systematic approach to supplier education and engagement. Spreadsheets and phone calls will not be enough to collect more than ten years’ worth of data. Instead, medical device manufacturers should turn to automated solutions and machine learning to support their compliance efforts.
Dr. Bruce Jarnot holds a Ph.D. in Biochemistry and Molecular Biology from Wesleyan University. He is a board-certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations, including Whirlpool Corporation, ExxonMobil, the American Petroleum Institute, and the U.S. Air Force. For more information on PFAS compliance management, visit Assent’s website or contact: info@assent.com
Medical devices are exempted from this requirement, leading some manufacturers to consider themselves out of the scope of this new rule. However, these companies will still need to conduct due diligence on their internal operations to ensure they don’t have in-scope purchases, in addition to reporting on products that fall outside the medical device category.
This article details the actions medical device manufacturers should take in response to the new ruling.
Understanding the New TSCA PFAS Rule
Under Section 8(a)(7) of the Toxic Substances Control Act (TSCA), the EPA has an obligation to monitor and phase out hazardous chemicals in the U.S. market. The new PFAS reporting rule provides a definition of PFAS that covers over 1,460 chemicals, though not all of them are currently in use in the U.S. market.What arePFAS? PFAS are persistent, bioaccumulative, and toxic, and nearly 97% of Americans have traces of PFAS in their bloodstream because they are commonly used in cookware, dental floss, clothing, furniture, cosmetics, food packaging, and more. PFAS have been linked to a number of negative health effects, including thyroid disease and fertility issues. However, PFAS are essential to the production of medical devices like surgical mesh and catheters, making PFAS regulations and restrictions a complicated affair.
The countdown is now on for medical device manufacturers to collect and submit over a decade’s worth of part and product data from their supplier networks. Any business manufacturing or importing these chemicals must submit a wide range of data, including (but not limited to) uses, production volumes, and import volumes.
Manufacturers have twelve months to collect PFAS information from their own records and their supply chains, and a further six months to submit data to the EPA using the Central Data Exchange (CDX) system. Smaller firms will have an additional six months to report their data since they often have more limited resources and access to data systems.
Reportable PFAS Can Be Found in Medical Device Manufacturing
Notably, the EPA has created a reporting exemption for PFAS in medical devices. However, this exemption only covers PFAS that make their way into finished medical device products — it isn’t a blanket “get out of jail free” card for businesses that manufacture medical devices as part of their product lines. For example, many dental equipment manufacturers include laboratory equipment in their portfolios, which does not fall under the medical device exemption. Because there is not a de minimis reporting threshold for PFAS under the new rule, even a company with a product line made up of 90% medical devices is still obligated to report on PFAS use in the other 10%.In addition, importing PFAS for use in manufacturing processes, even in the manufacture of medical devices, is in the scope of the new rule. Therefore, equipment like rubber gaskets or Teflon tubing may need to be reported. Other purchases, like promotional merchandise, also come with PFAS due diligence obligations: importing water-resistant jackets and T-shirts, for example, could put certain medical companies in the scope of TSCA PFAS reporting. Only by conducting due diligence on supply chain purchases since 2011 can medical device manufacturers validate that they have nothing to report under TSCA.
Finally, medical devices are not exempt from PFAS reporting under a number of other regulations. For example, both Maine and Minnesota do not exempt medical devices from PFAS product registration requirements. Similarly, medical devices are in the scope of PFAS regulated under the EU Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation; California Proposition 65; and the Persistent Organic Pollutants (POPs) Regulation.
Multidimensional Risk: It’s Not Just About Compliance
For medical device manufacturers, the PFAS story is not just about regulatory compliance. There are several non-regulatory risks that present threats to business continuity:- Part obsolescence: As in-scope manufacturers pull out of PFAS manufacturing, the availability of many PFAS-dependent products will come to an end. For example, 3M, one of the world’s largest PFAS chemical manufacturers, is ceasing production of PFAS by 2025. Any medical device containing PFAS parts is now at risk for supply chain disruption.
- Process disruptions: Any maintenance, repair, or operational (MRO) process that uses PFAS parts or products not only carry reporting risk, but also expose manufacturers to disruption risk as parts become scarcer and more expensive.
- Insurance and liability issues: Since 2005, there have been approximately 6,400 PFAS-related lawsuits, and the legal landscape is shifting away from focusing on chemical manufacturers to those who make product safety claims while still using PFAS. Insurers are taking notice and starting to ask their customers for PFAS disclosures.
Act Now
The EPA has given manufacturers 18 months to collect and report PFAS data from their supply chains, with an expectation of documented due diligence that includes supplier inquiries. Even businesses focusing on medical device manufacturing have a range of activities and imported parts that require, at a minimum, data collection to validate whether in-scope PFAS are present.Because suppliers may need to query their own upstream network, gathering PFAS data will be time-consuming. Manufacturers from any industry should begin collecting data now to take advantage of the full data collection window. To ensure that PFAS data is communicated accurately and in a timely manner, manufacturers will need a systematic approach to supplier education and engagement. Spreadsheets and phone calls will not be enough to collect more than ten years’ worth of data. Instead, medical device manufacturers should turn to automated solutions and machine learning to support their compliance efforts.
Dr. Bruce Jarnot holds a Ph.D. in Biochemistry and Molecular Biology from Wesleyan University. He is a board-certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations, including Whirlpool Corporation, ExxonMobil, the American Petroleum Institute, and the U.S. Air Force. For more information on PFAS compliance management, visit Assent’s website or contact: info@assent.com