Proactive Steps May Help Pharma, Medtech Mitigate PFAS Risk | Deloitte US has been saved
By Oliver Steck, principal, and Mayura Gill, senior manager, Deloitte & Touche LLP
More than 70 million people might be drinking water contaminated by per- and polyfluorinated substances (PFAS), according to the Environmental Protection Agency (EPA), which evaluated 30% of water supplies in the United States.1 PFAS is a class of chemicals commonly used in cleaning products, food packaging, clothing, cookware, pharmaceuticals, and medical devices.2
PFAS are often described as “forever chemicals” due to their inability to degrade naturally in the environment. They have been linked to a variety of health problems, including liver and immune system damage and some cancers. These chemicals accumulate not only in the environment but also our bodies.3 They can have a disproportionate impact on vulnerable populations as well as on women and children, impacting fertility, fetal growth, and child development.4
Over the past year, there has been a flurry of global activity around PFAS, including litigation,5 a proposed blanket restriction in the European Union (EU),6 and state and federal actions in the U.S. Lawsuits have already forced some manufacturers to phase out PFAS and pay large fines.7 This, combined with growing scrutiny from regulators around the world, has prompted some pharmaceutical and medical device manufacturers to take a close look at their products, materials, supply chains, and suppliers.
We lead Deloitte’s chemicals of concern risk-management strategy. Deloitte helps clients identify and mitigate the risks these chemicals could pose to consumer safety and their product portfolios. This is an important topic for corporations, but also for consumers who rely on pharmaceuticals and medical devices for their health and well-being. Deloitte recently conducted a webinar where we outlined steps companies can take to identify forever chemicals and remediate them throughout their portfolios and supply chains (click here to access a recording of Chemicals of Concern: Evolving regulations and their impact to portfolios).
Keeping up with regulations
A proposed EPA rule would make it illegal for manufacturers to release the most common PFAS into the environment without disclosing the quantity in their regulatory reporting.8 Last year, the EU proposed a gradual phase-out of all PFAS following a joint proposal from Germany, the Netherlands, Denmark, Norway, and Sweden. This could take effect as early as next year.9
Europe has already banned the use of another forever chemical—titanium dioxide (TiO2)—from food products,10 and there is a proposed ban for pharmaceuticals.11 However, TiO2 is still used in the U.S. for a wide range of products including candy, toothpaste, and in pills and capsules where it serves a variety of purposes including reducing blotchiness and giving pills their signature bright white appearance.12 If federal or state regulators were to ban TiO2, manufacturers would likely need to quickly pivot and find suitable alternatives for that ingredient.
In a blog last summer, we highlighted nitrosamines, another chemical of concern, which can be found in everything from grilled foods to cosmetics and pharmaceuticals (see Impurity regs may affect life sciences pipelines). While nitrosamines are considered safe in small quantities, high levels or prolonged exposure could increase the risk of cancer. They have been found in medications used to treat a wide range of conditions (e.g., hypertension, heartburn, and type 2 diabetes), which led to the recall of at least 10 widely use drugs.13
While there is no one-size-fits-all approach to assessing and remediating the risk that forever chemicals can pose to product portfolios, we urge our clients to consider the framework and governance structure below, which can be applied to almost all scenarios:
Conclusion
There seems to be a lot of interest in PFAS and other forever chemicals by trade groups and the mainstream media. This has led to heightened awareness, and scrutiny, among some consumers. In the absence of a regulation, companies should try to be proactive and transparent about their efforts to remove potential risks associated with their products and brand. Taking a leading role in developing products that are safe for consumers and the environment is important to maintaining consumer trust and helping to ensure continued positive brand reputation.
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Endnotes:
1The EPA is proposing that 'forever chemicals' be considered hazardous substances, NPR, February 2, 2024
2What are PFAS?, National Institute of Environmental Health Sciences
3PFAS exposure and risk of cancer, National Cancer Institute
4Higher rate of PFAS in water in communities of color, Harvard T.H. Chan School of Public Health, May 15, 2023
5Forever chemicals’ were everywhere in 2023. Expect more litigation in 2024, Reuters, December 28, 2023
6US food faces PFAS challenge as European rules, policies expand, Bloomberg Law, September 12, 2023
7Chemical companies’ PFAS payouts are huge, but the problem is even bigger, The Guardian, August 3, 2023
8Biden-Harris Administration announces new steps to protect communities from PFAS, EPA press release, February 1, 2024
9US food faces PFAS challenge as European rules, policies expand, Bloomberg Law, September 12, 2023
10The EU bans titanium dioxide as a food additive, European Commission press release, January 18, 2022
11Pharma groups fight proposed ban on titanium dioxide in Europe, Regulatory Affairs Professional Society (RAPS), November 27, 2023
12Health advocates urge US regulators to ban common food coloring additive, The Guardian, June 2, 2023
13Information about nitrosamine impurities in medications, U.S. Food & Drug Administration, August 4, 2023
14Recommended acceptable intake limits for nitrosamine drug substance-related impurities, U.S. Food & Drug Administration, August 2023
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Deloitte shall not be responsible for any loss sustained by any person who relies on this publication.
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