Navigating New PFAS Regulations: How to Prepare for What We Know
Brent Kobielush (TAG)
During a FSMA presentation covering updates to PFAS regulations, the Director of Food Safety at the Acheson Group, Dr. Brent Kobielush, shared updates to PFAS regulations in an effort to equip attendees with the information needed to operate their companies proactively and feel prepared for the future.
Understanding Perfluoroalkyl Substances (PFAS)
As more state authorities regulate PFAS, it’s important to understand the complexity of these chemical compounds and how new research may affect your manufacturing processes. Perfluoroalkyl Substances (PFAS) are widely used, long-lasting chemicals which break down very slowly over time. More than 9,000 PFAS have been identified and used across many industries for decades, including:
Stain-resistant textiles
Food handling and packaging materials
Firefighting foam
Medical devices
Paint
The most studied substances are Perfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA), more commonly known as “forever chemicals.” These substances are typically used in food packaging because they prevent grease from leaking. Regulators focus on PFOS and PFOA because of their long half-lives in the environment and in the body. Many of these substances are no longer produced, but still contaminate soil and groundwater, which has prompted the EPA to recently deem “forever chemicals,” as hazardous substances.
Not All PFAS Compounds Are The Same
Understanding which PFAS exist across your supply chain is important to assessing your manufacturing risk. There are toxicological differences in the chemical makeup of PFAS that define their levels of impact. These differences are characterized by:
Different levels of exposure: PFAS can be present in our water, soil, and food. Health effects may be subject to the amount of interaction.
Different routes of exposure: Oral and inhalation exposure may depend on whether you’re a manufacturer or consumer.
Bioavailability: Dietary exposure to PFAS may be impacted by its ability to bind with certain food compounds, which can make the chemicals inert.
At certain doses, PFAS compounds may be linked to multiple health effects, including:
Increased cholesterol
Decreased vaccine response
Decreases in birth weights
Changes to liver enzymes
Increase in blood pressure
In fact, the EPA recently found PFOS AND PFOA to be more dangerous than previously believed and have lowered their health risk thresholds to nearly zero; levels so low they cannot currently be detected.
It’s important to note that association and causation can seem deceptively similar, but recognizing their differences is crucial to understanding the relationships between chemicals. Association measures a relationship between two variables, however, that doesn’t automatically mean that the change in one is the cause of the change in the other.
More research is needed to determine whether certain health effects are the direct result of PFAS exposure or a mix of environment and eating habits. Staying informed on new findings is critical to determining how to move forward and operate your company proactively.
U.S. Regulatory Agencies Taking Action
Federal and State regulators are taking a very proactive approach to PFAS limitation, and it’s important to remain focused on facts and evidence.
EPA Announces Interim Guidance
When evaluating the health risk that PFAS present, the EPA uses Reference Doses (RfD). This measurement refers to the dose that someone at a certain weight could be exposed to for a lifetime, without any appreciable toxicological health risk. In response to PFAS health concerns, the EPA has updated PFOA and PFOS guidance for water to exceedingly low levels:
PFOA RfD = 1.5 x 10-9 mg/kg/day, a health advisory level of 4 parts per quadrillion (ppq).
PFOS RfD = 7.9 x 10-9 mg/kg/day, a health advisory level of 20 parts per quadrillion (ppq).
To put ppq into context, one part per quadrillion is one mile on a journey of 170 light years. These levels are significantly lower than 2016’s RfDs and aren’t even detectable in water. The FDA’s advisory level of Aflatoxin, one of the most potent liver carcinogens known, pales in comparison, measuring at 20 parts per billion.
The FDA’s Involvement
The FDA is requesting information on food contact materials. Specifically, they’ve released a request for information on the uses of fluorinated Polyethylene, first authorized for use in 1983. Once they’ve gathered enough data, the FDA will likely set guidance values on this substance.
The FDA has conducted tests for PFAS since 2019 on a variety of products, such as chocolate cake and fish, which will likely lead to future guidance levels.
As a result, in July 2022, a few food manufacturers took voluntary action over smoked baby clams due to levels of PFAS found by the U.S. FDA.
The USDA’s Involvement
USDA Food Safety and Inspection Service (FSIS) will continue to test. They’re collecting data on a variety of products, including meat, fish, and derivatives of these products. Stay on top of findings by reviewing their most recent screening papers.
U.S. State PFAS Regulations
State-by-state regulations are in place or taking shape. Similar to GMO regulations, PFAS limits will affect the supply chain and federal regulation will take its lead for state rulings. It’s important for your manufacturing plant to follow ongoing state regulation changes to ensure compliance. You can do this by regularly checking each state’s regulations.
Preparing for Inevitable PFAS Regulation Changes
Short Term
Focus on susceptibility, monitoring, and determining risk within your supply chains. The concept of monitoring your supply chains may feel overwhelming, but regulators have already elevated their surveillance. Understanding where risks may lie up and down your supply chain will be very important.
A couple of steps to mitigate issues within your supply chain include:
Checking with your packaging suppliers to see if they have alternatives in place for grease-proofing agents and paper board washing methods.
Implementing a makeshift risk assessment to evaluate PFAS levels from a regulatory standpoint. Eliminating these compounds may not be realistic, but having written risk assessments helps regulators see that you’ve taken a proactive approach to removing contamination in your products.
Long Term
Regulatory and perceived health risks will continue to increase and enter mainstream media, which will prompt more regulation.
It’s imperative that food manufacturers continue to be proactive. Secure alternatives to packaging when it becomes available. Analyze your water supply and scrutinize your supply chain to uncover places where there are higher risks. Incorporate regular monitoring to help inform risk and share with regulators to influence future PFAS limits.
Conclusion
Elimination of PFAS will not be easy and may not be possible, but proactive management and risk assessment will characterize the success of your company as global regulators take more stringent action on PFAS.
There are more than 9,000 PFAS, but the good news for manufacturers is that new technological advancements may help mitigate these compounds in your supply chain. In fact, chemists at Northwestern University recently found a relatively simple way to break down PFAS in the environment which may inform alternative substances and methods in your supply chain
Bottom line, the more educated you and your suppliers are on PFAS and the increased scrutiny of how it is (and will be) regulated, the far more prepared you’ll be to act, rather than experience disruption.
