A snapshot of the changing regulatory framework for PFAS

Background

The term PFAS represents thousands of chemicals with a wide range of chemical structures and physical properties. A basic distinction can be drawn based on the chain length of the molecule. It is believed that short-chain PFAS are less toxic, however, there is a growing debate as to whether that is true. On the other hand, there have been many studies linking two types of long-chain PFAS – perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) to certain health effects. PFOA and PFOS are no longer manufactured in the United States, but because PFAS are resistant to degradation, there may still be trace levels of PFOA and PFOS present in the environment. As a potential consequence, the public may be exposed to low-levels of PFAS chemicals in different ways, including through food, which may come from (1) the environment – typically in geographical regions near a facility where PFAS are manufactured or used; or (2) migration from food packaging. While regulators and industry have made strides toward eliminating PFAS from food packaging, potential environmental contamination remains the more pressing issue for food companies. 

PFAS Contamination in Foods

PFAS may find their way into foods through environmental contamination. Yet, there are no federal standards or a national threshold for PFAS relating to the food supply. With respect to drinking water, the Environmental Protection Agency (EPA) established a health advisory (but not a regulatory standard) for PFAS in drinking water at 70 parts per trillion.  

FDA

Although the U.S. Food and Drug Administration (FDA) does not have a threshold for PFAS contamination in foods, the FDA has conducted risk assessments of foods found in certain geographical regions with known environmental contamination, as well as a limited assessment of foods from the general food supply.  To conduct these safety assessments, FDA reviews information including: (1) the levels of PFAS found in the food, (2) average consumption of the food; and, (3) the most current toxicological information for PFAS.¹ The FDA uses this information to determine whether the levels of PFAS found in the food may pose a health concern, especially to vulnerable populations. The FDA has published the results of these assessments on its website,² and continues to monitor PFAS levels in coordination with the relevant states’ departments of health. 

For example, in June 2019 the FDA announced the results of recent limited surveys conducted on dairy products from certain farms in New Mexico and produce from North Carolina, both of which were areas with known PFAS contamination.³ For every sample for which PFAS was detected, the FDA performed a safety assessment. In the case of one dairy farm in New Mexico, FDA scientists determined that milk samples posed a potential health concern, leading to discarding all milk from the farm so it would not be distributed into the American food supply, and suspending milk production from those cattle. In North Carolina, the levels of PFAS detected were low and, based on the agency's safety assessment, the FDA concluded the samples were not likely to be a health concern.  

In addition, the FDA has an ongoing study testing for PFAS in foods typically eaten by Americans, but not associated with specific “contamination areas.” The samples analyzed so far are from foods originally collected as part of FDA’s Total Diet Study (TDS) in 2017.⁴ Although the FDA found some levels of PFAS in 14 of 91 samples, the safety assessment determined the products were not likely to be a health concern. 

Maine

Unlike the FDA, Maine has established a defined PFAS action level – the PFOS action threshold in cow’s milk is 210 parts per trillion (ppt).⁵ The Maine Department of Agriculture, Conservation and Forestry (DACF) has conducted two state-wide retail milk testing surveys for PFAS, with the most recent survey concluding in July 2020.⁶ The survey resulted in the detection of PFOS exceeding the threshold in milk from a central Maine dairy farm.⁷ According to the state’s press release, the farm is no longer producing milk for consumption and is not contributing to the milk supply.

California

PFOA and PFOS also are listed chemicals under Proposition 65 (Prop 65), a California law implemented by the Office of Environmental Health Hazard Assessment (OEHHA).⁸ Their inclusion on the list indicates that OEHHA considers them to be chemicals “known to cause cancer, birth defects or other reproductive harm.” Prop 65 requires businesses to inform Californians about exposures to such listed chemicals. Failure to do so may expose businesses to risk of a Prop 65 enforcement action.   

PFAS Testing Standards

Currently, there are no uniform or consistent standards used for PFAS testing. In an effort to address this issue, the EPA published the PFAS Action Plan in 2019, which outlines the long-and-short-term actions the EPA plans to take surrounding PFAS.⁹ One action is developing and validating laboratory methods to detect and quantify selected PFAS in air, water, and soil; the EPA publishes those validated methods to a dedicated website.¹⁰

Regarding PFAS testing in foods, the FDA announced in October 2019 the first single-lab validated scientific method for testing 16 different types of PFAS in a diverse sample of foods, using Liquid Chromatography-Tandem Mass Spectrometry.¹¹ The FDA also has 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. 

Finally, certain states, such as Maine, have published their own sampling protocols and have listed approved laboratories for PFAS analysis on the state website.¹²

Food Packaging & Food Contact Substances

Although PFAS have historically been used for grease-proofing in paper and paperboard for food packaging, there are federal and state efforts underway to remove PFAS from these food contact substances.  

At the federal level, as of November 2016, long-chain PFAS were no longer used in food contact applications sold in the United States.¹³ On 31 July 2020, FDA announced an agreement with manufacturers of PFAS used in food packaging to voluntarily phase-out their sales of certain short-chain PFAS (6:2FTOH) used in food contact substances in the United States over the course of three years, beginning in January 2021.¹⁴ After the phase-out period (ending January 2024), manufacturers will no longer sell food contact substances made with short-chain (6:2FTOH) PFAS. The FDA estimates that it may take up to 18 months to exhaust existing stocks of paper products containing the PFAS food contact substances from the market.  

Meanwhile, state legislatures have been active in this space as well. A host of states have recently proposed laws prohibiting the manufacture, distribution, or sale of food packaging containing intentionally added PFAS. However, so far only two states have adopted the initiative into law: Maine and Washington.¹⁵

Importantly, as summarized above, the prohibitions in each law will not go into effect until two years after a safer alternative is identified by the respective health departments, but no sooner than January 2022. Below are examples of states that have proposed food packaging legislation pending.

Next steps

We will continue to monitor developments related to PFAS.  If you have any questions about PFAS, the relevant regulations, or need help with conducting a PFAS compliance assessment, please don’t hesitate to contact us. 

References

1    FDA does not currently have toxicity reference values for dietary exposure for PFAS other than PFOA and PFOS (0.02 μg/kg bw/day).

2    See Analytical Results of Testing Food for PFAS from Environmental Contamination (20 October 2020) https://www.fda.gov/food/chemicals/analytical-results-testing-food-pfas-environmental-contamination. 

3    Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys (11 June 2019) https://www.fda.gov/news-events/press-announcements/statement-fdas-scientific-work-understand-and-polyfluoroalkyl-substances-pfas-food-and-findings.  

4    Id. 

5    Maine PFAS Screening Levels (November 2020) https://www.maine.gov/dep/spills/topics/pfas/Maine-PFAS-Screening-Levels-11-2020.pdf.  

6    DACF retail milk testing for PFAS confirms Maine milk supply is safe; high PFOS level detected on one central Maine Farm, Maine Department of Agriculture, Conservation and Forestry, (24 July 2020),  https://www.maine.gov/dacf/about/news/news.shtml?id=2980438. 

7    Three on-farm milk samples detected PFOS at 12,700, 14,900, and 32,200 ppt.

8    Chemicals Listed Effective November 10, 2017 as Known to the State of California to Cause Reproductive Toxicity: Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) (9 November 2017) https://oehha.ca.gov/proposition-65/crnr/chemicals-listed-effective-november-10-2017-known-state-california-cause. 

9    EPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan (February 2019) https://www.epa.gov/sites/production/files/2019-02/documents/pfas_action_plan_021319_508compliant_1.pdf.  

10    Methods to Detect and Quantify PFAS  (Last updated 17 July 2020) https://www.epa.gov/chemical-research/status-epa-research-and-development-pfas.  

11    FDA Makes Available Testing method for PFAS in Foods and Final Results from Recent Surveys (31 October 2019)href="https://www.engage.hoganlovells.com/knowledgeservices/insights-and-analysis/china-promises-clampdown-on-debt-evaders-as-bond-defaults-shake-market" id="linkColor" rel="RecentPublicationLink" title="China promises clampdown on "> https://www.fda.gov/food/cfsan-constituent-updates/fda-makes-available-testing-method-pfas-foods-and-final-results-recent-surveys. 

12    Maine Department of Environmental Protection, PFAS https://www.maine.gov/dep/spills/topics/pfas/index.html. 

13    See 81 Fed. Reg. 5 (4 January 2016) and 81 Fed. Reg. 83672 (22 November 2016); see also Market Phase-Out and Revocation of Authorization of Long-Chain PFAS (last updated 20 October 2020) https://www.fda.gov/food/chemicals/authorized-uses-pfas-food-contact-applications#5fbc0e4aded19.

14    FDA Announces voluntary agreement with manufacturers to phase out certain short-chain PFAS used in food packaging (31 July 2020) https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-agreement-manufacturers-phase-out-certain-short-chain-pfas-used-food.  

15    Maine Toxics in Food Packaging, Public Law c. 277, HP 1043 (June 2019), https://www.mainelegislature.org/legis/bills/bills_129th/billtexts/HP104301.asp; Washington ACT Relating to the use of perfluorinated chemicals in food packaging, HB 2658 (March 2018) https://app.leg.wa.gov/billsummary?Year=2017&BillNumber=2658. 

Authored by Elizabeth Fawell, Xin Tao, and Anneke Altieri.