by Richard Jack, Global Market Development Manager - Food and Environmental, Phenomenex
Per- and polyfluoroalkyl substances (PFAS), known broadly as “forever chemicals,” are a class of approximately 6,000 different man-made compounds that can be found in everything from tap water, to clothing and household items, to fast food wrappers and even human blood. Instead of breaking down, PFAS accumulate in the human body. Health researchers are beginning to understand that PFAS can potentially cause or aggravate health problems such as cancer, birth defects, liver and thyroid diseases and decreased immunity. While there are validated methods and around 35 standards currently available to test for PFAS, difficulty remains in identifying these chemicals in different kinds of products and materials.
Recently, President Biden proposed a 2022 budget that includes $75 million to address PFAS found in drinking water, wastewater and soil, signaling growing interest and scrutiny into the as-yet largely unexplored field of “forever chemicals,” particularly in consumer products and water supply. Concurrently, the Environmental Protection Agency (EPA) separately announced an update to the PFAS Action Plan, devoted to broadening understanding of PFAS. This dual attention from the federal government can potentially bring a new set of regulations for drinking and wastewaters as well as the processing of PFAS-containing products.
What Is at Stake?
While the process is still in the early stages of development, manufacturers and industry leaders should consider the following in anticipating potential regulatory changes in the United States:
Prevalence of PFAS. Currently, the EPA classifies PFAS compounds as “Compounds of emerging concern.” While it cannot yet legally enforce any guidelines around the manufacture, handling, disposal and removal of PFAS, the EPA’s recent announcement of the PFAS Action Plan indicates that it is moving forward in making regulatory determinations. Implications for manufacturers could span the full product life cycle, from raw materials and production to packaging and marketing. To date, the EPA highlights that PFAS can be found in food packaging, household products, workplaces, drinking water and living organisms.
Expanded “Hazardous” environmental designations. The EPA is also taking additional steps to address PFAS contamination in the environment, including designating PFAS chemicals as hazardous substances that would subject them to regulation as hazardous waste. While it is not clear exactly which substances might receive a new designation, likely areas of focus could include the well-studied compounds PFOS and PFOA and, most recently, PFBS. PFBS has received attention following a toxicity assessment in January 2021.
Sensitivity and thresholds for testing. Another change manufacturers are likely to see as an outcome of the regulatory discussions underway is requirements to demonstrate PFAS’ presence more precisely, at extremely low levels in a variety of substances, to meet both private and public sector customer demands.
Labelling and packaging implications. Alongside the EPA regulatory changes, food manufacturers are increasingly being called out on the presence of chemicals in their products, meaning reporting and labelling changes may be required on consumer products.
Preparing for Change
As these discussions unfold, the following should be front and center:
Increased access and availability for testing. Changes to PFAS regulations will drive increased demand for laboratory testing, not just from water utilities, but also Department of Defense sites, Superfund sites and food manufacturers. Regardless of the specific nature of the regulatory changes, stakeholders’ readiness to manage the uptick in testing needs is a critical early consideration. Though the FDA has approved the use of PFAS in certain products since the 1960s, increased knowledge of their toxicity can potentially call into question these early approvals.
Speed and cost considerations. Always a factor for PFAS analysis, sample preparation can be a serious bottleneck for analytical laboratories, given that these compounds are used in a wide variety of consumer products, including paints, clothing, firefighting foams and food packaging material.
To expedite the process for companies who need to get their products to market, laboratories and test-makers should iterate on precise, reliable and effective sample prep cartridges and liquid chromatography columns that can accurately capture and separate the comprehensive suite of PFAS compounds. Such technologies could reduce time in the lab. Precise, reliable, fast and effective PFAS analysis will be an essential component for all stakeholders.
Methodology improvements. Not only should we expect to see a substantial uptick in testing needs as regulations expand, but testing substance-by-substance will no longer be a viable laboratory workflow process. Rather, as we saw with the European Environmental Agency’s work in 2019, it will likely be necessary to recalibrate methodologies to allow for more global PFAS testing, risk assessment and management within a laboratory setting.
What’s Next?
The accurate determination of more PFAS compounds will by necessity increase as suspects are investigated, requiring assessment of newer PFAS compounds and analytical standards that are currently unavailable. In addition, laboratories should monitor the next potential phase of expanded PFAS scrutiny and likely testing needs as the FDA begins to take steps to understand the occurrence of PFAS compounds that may affect the food supply. Ultimately, customer demand is only set to grow as consumers learn more about the potential effects of PFAS and their potential for exposure.
About the Author: Richard Jack, Ph.D., is the Global Market Development manager for the environmental and food markets at Phenomenex corporation. He has over 18 years experience with chromatography and mass spectrometry for the environmental, semiconductor, chemical, and pharmaceutical industries. Richard collaborates with global regulatory agencies to develop validated methods through new applications, instrumentation, column chemistries, and software. Richard is a former EPA Scientific Advisor for the EPA’s panel on Hydraulic Fracturing, a coauthor for EPA 557 and 557.1 along with ASTM D8001 and updates to D4327 and D6919 methods. He is currently the Second Vice Chairman for the ASTM D19 subcommittee on water analysis.