Search results for: pfas

  • FDA recently shared the final results from the testing of domestic and imported bottled water collected at retail locations across the U.S. for per- and polyfluoroalkyl substances (PFAS). Of the 197 samples of purified, artesian, spring, and mineral waters tested, ten samples had detectable levels of PFAS. However, none of those had levels that would have exceeded the EPA’s maximum contaminant levels (MCLs) for PFAS in public drinking water.
  • PFAS are a diverse group of widely used, long lasting chemicals that do not easily break down and can accumulate in the environment and human tissues with negative health consequences. PFAS have been the subject of various testing efforts, lawsuits, and legislation, as we have previously blogged.
  • In the bottled water study, FDA tested for 18 types of PFAS, including the six types with EPA-established MCLs. The ten samples with detectable PFAS levels contained a range of one to four different PFAS in domestic samples and one to two different PFAS in imported samples. Of these, four PFAS were below EPA MCLs for drinking water, and two PFAS detected do not have established MCLs.
  • The Food, Drug, and Cosmetic Act requires FDA to establish a standard of quality regulation for contaminants in bottled water whenever the EPA establishes MCLs for public drinking water as part of a National Primary Drinking Water Regulation. If FDA does not establish a standard for the contaminants or finds that such standards are not necessary to protect public health, then the EPA levels are considered the applicable regulation for bottled water. FDA can then take action against bottled water that presents a safety concern even if there is no standard of quality for a contaminant.
  • Keller and Heckman will continue to monitor activity surrounding PFAS in bottled water and other foods.
  • If passed, Maine’s SB130, titled An Act to Establish the PFAS Response Program and to Modify the Fund To Address PFAS Contamination, would be the first state law to establish PFAS limits in food (PFAS limits have been established for other categories of goods).
  • The bill would formally establish a PFAS response program to “respond to and address PFAS contamination affecting agricultural producers in the State, to assist commercial farms affected by PFAS contamination and to safeguard public health.” We note that the bill would in part codify existing portions of Maine’s PFAS response program, which has already set an action level for PFOS (a type of PFAS) in milk of 210 ppt. 
  • Specifically, under the proposed bill, the PFAS response program would, among other things:
    • Establish maximum levels for PFAS in farm products (defined as “plants and animals useful to humans” and includes, by way of example, products ranging from grains and food crops to Christmas trees).
    • Provide PFAS testing support to help agricultural producers understand the extend of PFAS contamination and provide technical support to assist in mitigation efforts.
    • Provide financial assistance to PFAS-impacted agricultural producers.
    • Establish baseline criteria that agricultural producers would have to adhere to in order to receive technical and financial assistance, including granting property access to conduct PFAS investigations and providing relevant information to program staff.
  • We will continue to monitor and report on PFAS regulation.
  • Last month a lawsuit filed by plaintiffs including the Tucson Environmental Justice Task Force (TEJTF) filed suit against FDA and now former FDA commissioner Robert Califf alleging that FDA had unduly delayed in responding to a petition filed by TEJTF in 2023 which had requested that FDA set tolerances for 30 types of PFAS in lettuce and blueberries and 26 types of PFAS in bread, milk, eggs, salmon, clams, and corn silage.
  • The lawsuit argues that FDA has unduly delayed because it has not acted consistent with its statutory mandate to “promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” (21 USC § 393) and the delay allegedly is to the detriment of the public health. The lawsuit argues that prior decisions holding that courts should defer to FDA on whether to promulgate tolerances is no longer good law post-Chevron and that the “only discretion FDA may exercise for such chemicals [harmful substances] is the level of tolerance to be set.”
  • We will continue to monitor and report on the regulation of PFAS and other chemicals, including any changes in approach that may be implemented by the new administration.

  • On December 18, 2024, the U.S. Food and Drug Administration (FDA) shared its latest test results for per- and polyfluoroalkyl substances (PFAS) in clams as follow up to its findings in the 2022 PFAS in seafood survey.  The results of FDA’s testing are used to help the agency better understand PFAS in commercially available foods and identify foods or types of foods that would benefit from targeted surveys, to help ensure a safe and nutritious food supply.
  • In the 2022 seafood survey, FDA detected high levels of perfluorooctanoic acid (PFOA) in samples of canned clams from China and determined that the estimated exposure was likely a health concern.  Between October 2022 and September 2024, FDA collected and analyzed 12 samples of processed clams with China as the country of origin.  All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples.  Three shipments were refused entry into the US.
  • In 2023, FDA also conducted a survey of domestically acquired clam samples.  All but one of nine samples had PFOA concentrations under the method detection limit and the products remained on the US market.
  • The agency is actively engaging with both imported and domestic clam firms to better understand potential sources of contamination and ways in which PFOA concentrations may be reduced.  FDA also recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood and is conducting two ongoing surveys, focused on molluscan shellfish and other commonly consumed seafood.  FDA will release results of the surveys after completion.
  • On November 19, 2024, FDA issued a request for information on per- and polyfluoroalkyl substances (PFAS) in seafood in an effort to understand the potential for PFAS exposure from seafood and reduce dietary exposure to PFAS that may cause a health concern. According to FDA, seafood presents a unique challenge and opportunity to prevent contamination because many potential hazards can be introduced at the source, such as in growing areas, aquaculture farms, and on fishing vessels.
  • For purposes of this request, FDA defines “seafood” as fresh or saltwater finfish, crustaceans, other forms of aquatic life (e.g., alligator) other than birds or mammals, and all mollusks, which are intended for human consumption. Testing of samples in the general food supply has indicated that seafood may be at higher risk for environmental PFAS compared with other types of food. To expand on the results of these samples, FDA collected additional seafood samples of the most commonly consumed seafood in the United States, including clams, cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna, most of which were imported. Based on perfluorooctanoic acid concentrations in canned clams from China, FDA concluded that their consumption is likely a human health concern, resulting in two voluntary recalls of canned clams from China.  Thus, FDA is requesting information to help enhance the Agency’s knowledge about the types of seafood prone to accumulate PFAS and harvest locations with PFAS contamination, ultimately supporting a comprehensive approach to advance clean air, water, and food.
  • Specifically, FDA is seeking data and information regarding PFAS concentrations in seafood, the environment, and processing water, as well as mitigation strategies for PFAS in seafood. FDA has provided specific questions for each of these categories to help identify where PFAS has been observed. The request for information will be published in the Federal Register on November 20, 2024, with a 90-day comment period ending February 18, 2025.
  • Comments can be submitted electronically on Regluations.gov to docket number FDA02024-N-4604. Keller and Heckman will continue to monitor developments in this area.
  • On March 19, 2024, FDA issued Import Alert 99-49 (“Detention without Physical Examination of Foods Due to Chemical Contamination”), which recommends that FDA field personnel detain without physical examination products offered for import that have previously been found to be contaminated with harmful levels of chemicals, including PFAS.
  • FDA is authorized to refuse admission to food products if the articles appear to violate the Federal Food, Drug, and Cosmetic Act (the “Act”); physical examination is not necessary (21 USC § 381).
  • Companies which have been found to offer violative products for import will have their products added to the import alert’s “Red List,” subjecting future imports of those products to detention without physical examination. Once a product is subject to an import alert, the burden is on the importer to demonstrate to FDA that the product does not violate the Act.
  • It is not clear to what extent FDA will be testing imported food products for chemical contamination, including whether it will focus on particular product types.
  • Keller and Heckman is tracking the regulation of PFAS in various jurisdictions around the world and can assist companies in responding to concerns about PFAS in food and food packaging.
  • About two years have passed since cases were first filed alleging that product marketing deceptively conveyed a lack of PFAS. At this point, many demands have been made, and over 25 cases have been filed. Cases have targeted a variety of products, including fast food packaging, microwave popcorn, juice, waterproof mascara, cosmetic powders and foundation, mouthwash, floss, tampons, waterproof apparel, period underwear, and anti-fog spray for glasses.
  • A handful of cases have targeted claims like “PFAS Free” and “No long-chain PFAS.” Largely, however, plaintiffs argue that claims, such as the following, convey an absence of PFAS: “Safe and comfortable,” “We hold ourselves to the highest quality standards,” “Full of what’s good for you, free of harsh chemicals,” “All the flavors you crave without the ingredients you don’t,” “Ingredients sourced from nature,” “100% Natural,” “Feel good about what’s in this bottle,” “Working toward a sustainable future,” and “Good for you and good for the planet.” Plaintiffs have also targeted claims that products are certified by entities like OEKO-TEX, Forest Stewardship Counsel, and Fair Trade – even where neither the advertising nor the certifiers, themselves, purported to guarantee an absence of PFAS.
  • Most plaintiffs allege that claims are deceptive where testing allegedly showed 100 ppm or more of organic fluorine – which, according to plaintiffs, indicates intentionally added or a “material” amount of PFAS. One case, however, alleged that the threshold was lower, at 20 ppm.
  • So far, over five cases have been dismissed with courts reasoning, for instance, that either the presence of PFAS was disclosed or a company had no duty to disclose PFAS, that migratory chemicals are not “ingredients,” that plaintiffs identified no representations as to PFAS, that plaintiffs failed to test the specific products they purchased, or that organic fluorine does not necessarily indicate the presence of PFAS. Unfortunately, even with such holdings, there is little comfort where courts have not coalesced (and may never coalesce) around how to handle these cases. At least five motions to dismiss remain pending, and at least one motion to dismiss was denied nearly in its entirety. Several cases have settled confidentially, and one settled publicly, with the company agreeing to (1) pay up to $6.5 million in refunds and attorneys’ fees, and (2) take measures to avoid intentionally added PFAS.
  • Keller and Heckman will continue to follow and be available to assist managing risk around PFAS.
  • A class-action lawsuit was filed last week against the manufacturer of a pomegranate juice (and its parent company) for falsely advertising the product (POM) as “all natural” and healthful where it in fact contained non-natural and potentially dangerous PFAS chemicals.  
  • As many of our readers will know, per- and polyfluoroalkyl substances (PFAS) consist of a large group of fluorinated chemicals which bioaccumulate and have been linked to numerous negative health outcomes. Two types of PFAS, perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) have been the subject of most the research on the health effects of PFAS.
  • Plaintiffs independently tested Defendant’s pomegranate juice and found it to contain 2.5 parts per trillion (ppt) of “6:2FTS” PFAS and 6.5 ppt of “PFPeA” PFAS. Defendants claim this amount is “significant” based on EPA’s interim updated health advisories for PFOA and PFOS of 0.004 ppt and 0.02 ppt, respectively.
  • The complaint does not justify application of EPA’s health advisory limits for PFOA and PFOS to different types of PFAS nor does it explain how the PFAS might have entered the juice or how Defendants could have known about the presence of PFAS.
  • Keller and Heckman will continue to monitor and report on this lawsuit and other claims targeting the food industry.
  • Maine’s Department of Environmental Protection (DEP) recently published a second “concept draft” rule to implement Maine’s sweeping PFAS in consumer products legislation; comments are due tomorrow, November 10, on the second “concept draft.” Readers may recall that in July 2021, Maine passed “An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution,” which implements reporting requirements for intentionally added PFAS in consumer products.  The law also prohibits PFAS in carpets, rugs, and fabric treatments, and institutes a total ban on intentionally added PFAS by January 1, 2030.  Once Maine settles on proposed implementing regulations to advance to the Board of Environmental Protection, a formal comment period will open, likely sometime in December based on recent public statements from Maine DEP personnel.  Although the rulemaking process is still ongoing, key updates are provided below:
    • Beginning January 1, 2023, the law requires manufacturers to notify the state of any products sold or distributed in Maine that contain intentionally added PFAS. Products that contain intentionally added PFAS and which are not reported are prohibited from sale or distribution in the state.  Importantly for food companies, DEP has stated that it interprets the statute as applying to food packaging.
    • DEP does not currently have a formal system in place to report products that contain intentionally added PFAS, but DEP will accept notifications via mail or email at PFASProducts@maine.gov. Maine is currently working with the Interstate Chemicals Clearinghouse to develop a reporting database that will ultimately be made public.  The statute provides that the notification must include the following:

(1) A brief description of the product;

(2) The purpose for which PFAS are used in the product, including in any product components;

(3) The amount of each of the PFAS, identified by its CAS registry number, in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by the Maine DEP;

(4) The name and address of the manufacturer, and the name, address and phone number of a contact person for the manufacturer; and

(5) Any additional information established by the department by rule.

  • Exemptions: The statute provides for two exemptions from the reporting requirement. First, “Products for which federal law governs the presence of PFAS in the product in a manner that preempts state authority” are theoretically exempt.  However, DEP has stated that it is not aware of any federal law or regulation that would apply under this exemption.  The second exemption applies to a “product subject to Title 32, chapter 26-A or 26-B” of the Maine Revised Statutes.  Although Chapters 26-A (32 M.R.S. § 1731-1738) and 26-B (38 M.R.S. § 1741-1747) do apply to food packaging generally, DEP has stated that it will interpret this language narrowly.  An FAQ page on DEP’s website states that food packaging is only “subject to” chapter 26-A when the Department prohibits its sale by rule (which it has not yet done) and is only subject to Chapter 26-B if it contains a chemical designated as a “priority food contact chemical” by DEP’s Commissioner (which has not yet happened).  Thus, our readers should be aware that DEP does not interpret these exemptions as applying to food packaging.
  • Waivers and Extensions: Maine’s DEP is accepting requests for extensions to the reporting deadline on a case-by-case basis. Requests for extensions must be made by or on behalf of specific named manufacturers in advance of the January 1, 2023 reporting deadline.  If a manufacturer does not know if their products contain intentionally added PFAS and/or if the manufacturer cannot provide sufficient information to comply with the detailed reporting requirements listed above, that manufacturer can submit an extension request to PFASproducts@maine.gov.  Readers should be aware that all companies that are granted an extension will be listed on a publicly available document.
  • Penalties and Enforcement: Maine’s PFAS prohibition in consumer products directs DEP to adopt rules as necessary for the administration and enforcement of the statutes.  In the concept draft rule, DEP indicated that any violations are subject to DEP’s enforcement authority under 38 M.R.S. §§ 347–349.  A person who violates the provisions of the PFAS statute/reporting obligations may be subject to an investigation resulting in an administrative consent agreement, an enforcement hearing on the alleged violation, or a civil or criminal action brought by the Attorney General.  Civil penalties can be up to $10,000 per day of violation unless the violation relates to hazardous waste, in which case the person shall pay the state a penalty to be determined by a court of not more than $25,000 per day of violation.  In addition, criminal penalties (Section 349) can be up to $25,000 per day of violation.  (Section 349 indicates that violations of the provisions administered by the Maine DEP are considered a Class E crime, which is punishable up to six months incarceration and a $1,000 fine).
  • Keller and Heckman will continue to monitor and provide updates on Maine’s PFAS draft regulations.
  • On February 24, 2022, FDA released PFAS test results from samples that were collected for the FY2021 regional collection of the Total Diet Study (a program to monitor nutrients and contaminant levels in foods). 89 of the 92 tested food samples had no detectable levels of PFAS and, while PFAS was found in three seafood samples (tilapia, cod, and shrimp), given the limited sample size, no conclusions could be drawn about PFAS levels in seafood in the general food supply.
  • PFAS (i.e., per- and polyfluoroalkyl substances) are a diverse group of widely used, long lasting chemicals that do not easily breakdown and can accumulate in the environment and human tissues with potential negative health consequences. They are authorized for certain food contact uses by FDA, although FDA and industry have agreed to voluntarily phase out certain types of PFAS (6:2 FTOH) and a number of states have also passed laws to phase out the use of PFAS.
  • This is the fifth set of general food supply testing conducted by FDA and, of the 532 total samples tested, only 10 have had detectable PFAS. Based on this data, there is currently no evidence that indicates that certain foods should be avoided based on PFAS levels.