Containing linked carbon and fluorine atoms, per- and polyfluoroalkyl substances (aka PFAS) are a diverse group of human-made molecules used in a wide range of consumer and industrial products. Two well-known uses are in the making of non-stick frying/cooking pans and the foam used in fighting primarily aircraft fires (or other petroleum-based fires); hence, PFAS subsurface ground contamination tends to be prevalent around military air bases where foam firefighting has been taught and practiced. Regarding cookware, as of 2015 regulations, cookware must be PFAS free, so other than overheating or braising the PTFE that may be in the cookware’s nonstick coating, at least PFAS isn’t a worry. But groundwater contamination is another story—either caused by fire-fighting foams or other industrial uses/spills.

The good news is that in recent FDA tests on food, PFAS contamination isn’t much of an issue. However, the bad news: Levels found in drinking water have been problematic. A recent article, “PFAS found in 72% of drinking-water samples in Philly’s suburbs,” published on July 28, 2021, by The Philadelphia Inquirer, found that though none of the PFAS samples taken exceeded the current EPA guideline of 70 parts per trillion (ppt)*, even a number of 25 ppt is a potential health issue. One problem is that PFAS compounds accumulate in the human body and don’t go away, and thus, there are no safe levels, according to the Inquirer.

According to the NIH National Cancer Institute, “the International Agency for Research on Cancer (IARC) classified perfluorooctanoic acid (PFOA), the most well-studied per- and polyfluoroalkyl substance (PFAS), as a possible human carcinogen based in part on limited epidemiologic evidence of associations with cancers of the kidney and testis in heavily exposed subjects.”**

PFAS is a family of related chemicals (aka “forever chemicals” because they don’t decompose), and FDA in its analytical testing actually checks for the presence of 16 common PFAS substances using liquid chromatography-tandem mass spectrometry (LC-MS/MS) techniques. In the past, FDA has checked dairy products, produce, cranberries, meat and grain products—and continues to analyze various food and beverage products for the presence of PFAS.


PFAS background

From the 1940s, PFAS chemicals have also been used in stain- and water-resistant fabrics and carpeting, cleaning products, O-rings, gaskets and paints. According to FDA, 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 environmental contamination. Accumulation of certain PFAS has also been shown through blood tests to occur in humans and animals. While the science surrounding potential health effects of this bioaccumulation of certain PFAS is developing, evidence suggests it may cause serious health conditions.

Over the years, FDA has authorized PFAS for use in contact with food in four application categories:

  • Non-stick cookware: PFAS can be used as a coating to make cookware non-stick.
  • Gaskets, O-rings and other parts used in food processing equipment: PFAS may be used as a resin in forming certain parts used in food processing equipment that requires chemical and physical durability.
  • Processing aids: PFAS can be used for making other food contact polymers to reduce buildup on manufacturing equipment.
  • Paper/paperboard packaging: PFAS may be used as grease-proofing agents in fast-food wrappers, microwave popcorn bags, take-out paperboard containers and pet food bags to prevent oil and grease from foods from leaking through the packaging.

The FDA reviews new scientific information on authorized food contact substances to ensure these uses continue to be safe. The extent to which PFAS in the above applications can migrate to food depends on the molecular structure of the substance—though FDA has revamped rules on which PFAS substances can be used where. For more information, visit “Per- and Polyfluoroalkyl Substances (PFAS)” on FDA’s website.


The good news

FDA recently described its efforts to understand the occurrences of PFAS chemicals in the food supply. In its “Total Diet Study” (TDS), FDA tested 94 food samples from the general food supply and found all but one of the samples had no detectable levels of PFAS.

According to FDA, “One sample—cod—had detectable levels of perfluorooctane sulfonate, aka perfluorooctanesulfonic acid (PFOS) and perfluorononanoic acid (PFNA), two types of PFAS. Based on the best available current science, the FDA has no indication that the PFAS levels in the cod sample present a human health concern.”

FDA’s TDS included a broad range of foods, including breads, cakes, fruits, dairy, vegetables, meat, poultry, fish and bottled water, but were not specifically collected from areas of known environmental PFAS contamination. While the sample sizes were relatively small, FDA is not making definitive conclusions, but using the tests to determine if targeted sampling assignments are necessary for certain foods and to help inform the agency’s approach to future surveillance efforts.

However, the FDA also tests for foods grown or produced in areas with known PFAS contamination, which usually occurs at the request of states and before the food enters the market. More good news: Previous analyses have shown that PFAS contamination in the environment where food is grown does not necessarily mean the food itself will contain detectable levels of PFAS. This is because the amount of PFAS taken up by crops/plants depends on several factors, including the specific type of PFAS and characteristics of the food.

According to the posted data, FDA detected PFAS in three samples of seafood—one cod and two tilapia—from three TDS regional collections. Therefore, FDA is conducting a targeted survey of the most commonly consumed seafood in the U.S. The survey will collect and analyze 80 retail seafood samples including shrimp, salmon, canned tuna, tilapia, pollock, cod, crab and clams. The PFAS results from this study will be used to determine if additional sampling and testing is required.


EPA and PFAS issues in drinking water

There is also good news in that it’s possible to keep PFAS out of water used as an ingredient—or for human consumption. It can be filtered out at the source. So, most food or beverage processors already know if PFAS is a problem in their area, and they know what technologies to use in the pre-treatment stage, as they’ve probably contacted water treatment specialists.

According to the U.S. EPA, certain technologies have been found to remove PFAS from drinking water, especially PFOA and PFOS, which are the most studied of these chemicals. Those PFAS removal technologies include activated carbon adsorption, ion exchange resins and high-pressure membranes. These technologies can be used in drinking-water treatment facilities, in water systems in hospitals or individual buildings, or even in homes at the point-of-entry.

In an April 2021 announcement, EPA Administrator Michael S. Regan issued a memorandum to EPA’s senior leadership calling for the creation of a new “EPA Council on PFAS” (ECP) that is charged with building on the agency’s ongoing work to better understand and ultimately reduce the potential risks caused by these chemicals.

The Council will be directed to:

  • Develop “PFAS 2021-2025 - Safeguarding America’s Waters, Air and Land,” a multi-year strategy to deliver critical public health protections to the American public. To develop the strategy, the ECP will review all ongoing actions, propose any necessary modifications, and identify new strategies and priorities. The ECP shall make initial recommendations within 100 days of its establishment.
  • Continue close interagency coordination on regional specific and cross-media issues to assist states, tribes and local communities faced with significant and complex PFAS challenges.
  • Work with all national program offices and regions to maximize the impact of EPA’s funding and financing programs, and leverage federal and state funds, to support cleanup of PFAS pollution, particularly in underserved communities.
  • Expand engagement opportunities with federal, state, and tribal partners to ensure consistent communications, exchange information, and identify collaborative solutions.

The ECP’s work includes an April 2021 updated PFBS (perfluorobutane sulfonic acid, part of the PFAS family of chemicals) toxicity assessment.*** EPA has also taken action to begin to develop a national primary drinking water regulation, to collect new data critically needed to improve EPA’s understanding of 29 PFAS, and to solicit data on the presence and treatment of PFAS in wastewater discharges. The agency also strongly supports President Biden’s American Jobs Plan, which calls for investing billions of dollars to monitor and treat PFAS in drinking water.

The EPA has a web page dedicated to PFAS-related issues, and can be found at www.epa.gov/pfas.


Resources

* “Drinking Water Health Advisories for PFOA and PFOS,” EPA Health Advisories, web page accessed 7-29-2021.

** “PFAS Exposure and Risk of Cancer,” NIH, National Cancer Institute, Division of Cancer Epidemiology & Genetics, Website, accessed 7-29-2021.

*** “Learn about the Human Health Toxicity Assessment for PFBS,” EPA, Web page accessed July 30, 2021.

Toxicological Profile for Perfluoroalkyls, U.S. Department of Health and Human Services—Agency for Toxic Substances and Disease Registry; May, 2021; 993 pp (PDF).

“Per- and Polyfluoroalkyl Substances (PFAS),” U.S. FDA, Website updated 2/19/21

“Analytical Results of Testing Food for PFAS from Environmental Contamination,” U.S. FDA, Website, updated 6/30/2021.

“Reducing PFAS in Drinking Water with Treatment Technologies,” U.S. EPA, 08-2018, Website

“DOD Officials Discuss Fire-Fighting Foam Replacement, Remediation Efforts,” DOD News, Department of Defense, Sept. 16, 2020, Website


Regulatory Watch

FDA offers dashboards to monitor agency's performance data

FDA-TRACK is FDA’s agency-wide performance management program that monitors, analyzes and reports key performance data and projects for the agency's program offices and cross-cutting initiatives.

Performance data across the agency is analyzed on a quarterly basis and presented to senior leadership to discuss accomplishments and setbacks. The data is then posted to the FDA-TRACK website; the highlights of which are sent to subscribers via the FDA-TRACK Newsletter.

The website provides insights into the daily operations of the agency and how day-to-day work has an impact on FDA’s mission. This allows users to better understand the breadth of the agency’s core responsibilities and how it is addressing high priority initiatives.

The objectives of FDA-TRACK can best be explained through its name:

  • Transparency—communicate FDA’s story to internal and external stakeholders
  • Results—highlight office achievements and cross-agency initiatives that align with FDA’s public health mission
  • Accountability—demonstrate FDA’s contributions to office and agency priorities, plans and results
  • Credibility—encourage the sharing of accurate, reliable performance data to FDA stakeholders
  • Knowledge-sharing—enhance collaboration across program offices and through the FDA

The food safety dashboards have been updated with Q2 data. The Preventive Controls and Current Good Manufacturing Process Dashboard focuses on the FSMA rules entitled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (PC Human Food Regulation) and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC Animal Food Regulation). The first compliance dates for these rules arrived in September 2016 for the largest businesses.

The Imported Food Safety Dashboard focuses on imported human food, imported animal food and the Foreign Supplier Verification Program (FSVP). The first compliance dates for FSVP began in May 2017.

Visit www.fda.gov to subscribe.


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