FDA Stance On PFAS: Study Findings and Survey Results

Photo by Gabriel Gurrola on Unsplash

Congress currently is stalling/deciding on the fate of the PFAS class of chemicals.  To remind you, the chemical class Per- or Poly Fluoro Alkyl Substances (PFAS) is incorporated into a wide array of products.  Two such applications involve the resistant properties of the chemicals make them useful to include in plastic liners in food products or fire retardant in furniture products.  Over the last few months (to a year), I have reported on the emergence of the issues associated with the class of compounds (here and here).  But what is the government going to do?


Usually, Congress holds hearings during which the federal agencies (FDA, CDC, EPA) are brought in to deal with the regulation side of the chemical compounds.  That is the reason for all of the recent hearings.  To begin with, the Food and Drug Administration agency needed to do initial testing to make a statement.  The FDA has finally released a statement regarding regulations of PFAS class of chemicals:

For Immediate Release:

June 11, 2019

Statement From:

Acting

Commissioner of Food and Drugs - Food and Drug Administration

Norman E. "Ned" Sharpless MD

Deputy Commissioner for Food Policy and Response - Food and Drug Administration

Frank Yiannas

At the U.S. Food and Drug Administration, increasing our scientific knowledge and capabilities is a cornerstone to ensuring the safety of the foods that Americans consume. We do this by reviewing all available scientific evidence to determine the safety of foods and food packaging and conducting our own research to fill in gaps in the science. As part of these efforts, the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.

Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science.

Background on PFAS

PFAS are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are impermeable to grease, water and oil. For this reason, beginning in the 1940s, PFAS have been used for many different applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, as well as in limited, authorized uses in cookware and food packaging and processing, referred to as food contact substances.

The widespread use of PFAS and their ability to remain intact in the environment means that over time PFAS levels from past and current uses can result in increasing levels of contamination of groundwater and soil. This same accumulation also can occur in humans and animals, with PFAS found in the blood of humans and animals worldwide. While the science surrounding the potential health effects of PFAS is developing, current evidence suggests that the bioaccumulation of certain PFAS may cause serious health conditions. However, with the decrease in production and use of certain PFAS, levels in humans in the U.S. have been declining.

PFAS can occur in food through environmental contamination, including contaminated water and soil used to grow the food. This type of contamination can occur in a specific geographic area; for example, a water well or farm near an industrial facility where PFAS were produced, or an oil refinery, airfield, or other location at which PFAS were used for firefighting. PFAS can also come into contact with food as a result of the limited authorized uses as food contact substances.

FDA Testing

Addressing potential effects of Americans’ PFAS exposure is a national priority and effort and work is underway in this area by several government agencies. The U.S. Environmental Protection Agency, the U.S. Department of Agriculture, the National Institutes of Health, and the Centers for Disease Control and Prevention are advancing knowledge around environmental exposures and potential health risks from PFAS, and the Agency is working on issues related to PFAS contamination with these and other federal partners, including the Department of Defense. State health partners are also investigating exposure and working to reduce exposure in local communities. The FDA recognizes its important role in generating, applying and evaluating the science that is needed to begin to estimate exposures from food. As we continue this research, we will be better able to detect, evaluate, and respond more quickly to potential contamination issues involving food.

The FDA has tested foods for PFAS coming from specific geographic areas with known environmental contamination. Recent limited surveys were conducted on dairy products from certain farms in New Mexico and produce from North Carolina, both of which were from specific areas with known PFAS contamination. For every sample for which PFAS was detected, a safety assessment was performed by FDA scientists. In the case of one dairy farm in New Mexico, milk samples were determined to be a potential health concern and all milk from the farm was discarded and not distributed into the American food supply, and milk production from those cattle has been suspended. The Agency continues to work closely with our regulatory partners in the New Mexico Department of Agriculture on these issues. In the case of the produce samples from North Carolina, the levels of PFAS detected were low and, based on our safety assessment using the best available science, samples were determined not likely to be a health concern at the levels found through testing.

To conduct these safety assessments, the FDA reviews relevant information, such as the levels of PFAS found in that food, consumption of that food and the most current toxicological information for PFAS, which we use to determine whether the levels of PFAS found in that food may pose a health concern, especially to vulnerable populations.

Over the last year, we have expanded our testing to analyze for PFAS in foods typically eaten by Americans, and not associated with specific contamination areas. The samples analyzed were from foods originally collected as part of the FDA’s Total Diet Study (TDS) in 2017 and analyzed in 2019. This is the first time the FDA has tested for PFAS in such a highly diverse sample of foods. While no PFAS compounds were detected in the majority of the foods sampled, varying levels of PFAS were found in 14 samples out of 91, but our safety assessment determined the products were not likely to be health concern at the levels that were detected. We plan to continue this testing and currently have new TDS samples in the lab for analysis. Combined with our other sampling, the testing will help us calculate the risks of exposure through food.

Next Steps

Our findings on dairy, produce, and the samples from the TDS were recently presented by FDA scientists at this year’s annual meeting of the Society of Environmental Toxicology and Chemistry (SETAC) in Helsinki, Finland. The purpose of this scientific presentation was to share, with the scientific community, the new methodologies being advanced by the FDA for measuring concentrations of these substances across a wide variety of foods, and the early findings generated from the application of these methods. The FDA has published information on PFAS testing in other foods in the past, but FDA scientists also shared information on its recent limited PFAS testing.

Since PFAS contamination is not specific to the U.S., sharing the FDA’s knowledge and analytical advances with scientists from across the world working on this issue is an important part of our work to begin to address this problem globally. Overall, the FDA’s testing to date has shown that very few foods contain detectable levels of PFAS. However, we know that levels may not be uniform and there is more work to be done. To ensure we are taking the best approach to this complex issue, we have established an internal agency PFAS workgroup with representatives from the human and animal foods programs. A key objective of this workgroup is to establish base-line levels for PFAS in foods, which requires data from these initial and future surveys, and will be used to then estimate overall PFAS exposure. The workgroup will use a systematic, risk-based approach to identify and prioritize FDA activities to reduce exposure to PFAS in human and animal food, guided by available data.

Measuring PFAS concentrations in food, estimating dietary exposure and determining the associated health effects is an emerging area of science. Although the FDA’s scientists are at the forefront of developing new and more sensitive testing methods to measure PFAS in foods, this work does not occur in isolation. We’re also working closely with our federal and state partners to advance the science of PFAS detection and better understand the potential health risks associated with PFAS exposure.

As the FDA continues to evaluate the food supply, we are committed to using the advanced analytical capabilities of FDA labs to generate and share new scientific information, such as our testing methodologies. By working closely with our state partners and helping them to develop their own testing capacities, we can work together to increase the baseline knowledge of PFAS occurrence in foods. We will also continue to support response to local requests about known or possible contamination events.

Federal and state partners each have important roles to play to better understand PFAS exposures and potential health effects, and the FDA will continue to work with these partners to help inform appropriate next steps to protect and promote public health. As part of an era of smarter food safety, the FDA is committed to testing more foods, collaborating with other federal agencies, helping states develop their own testing capacities, and continuing to support responses to contamination events. It is critical that we continue to share our knowledge and leverage existing and new resources as local, state and federal agencies work together to study this emerging public health issue.

We remain committed to sharing further updates as our ongoing surveillance work into PFAS exposure in foods continues.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The initial findings indicate that no dangerous detectable levels were found in foods.  Except for milk in New Mexico.  FDA regulators reached out immediately and stopped milk sales/distribution.  For the broader class of PFAS chemicals, the danger has been reduced for the moment.  Testing in foods (which are different from liquids) presents different challenges.



Namely, matrix effects.  The presence of spectator chemicals (not being analyzed) could interfere with measurements of chemicals of interest. Currently, the Cannabis industry is plagued with matrix effects which distorts method development at each stage.  Which is why the FDA states above that method development are emerging for such tests.



Regardless, I will update you on the progress of the testing along with the regulations which emerge as a result of the current hearings.  Stay tuned!



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