Search results for: pfas

  • 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.
  • FDA released per- and polyfluoroalkyl substances (PFAS) testing results yesterday from its first survey of nationally-distributed processed foods collected for the Total Diet Study (TDS). 164 of the 167 tested foods did not contain detectable levels of PFAS. FDA’s update states that the three samples that do contain detectable PFAS levels do not present a human health concern.
  • The comprehensive analysis of the results published online provides more information on the tested foods that did contain detectable levels of PFAS: perfluorooctanesulfonic acid (PFOS) and perfluorononanoic acid (PFNA) were found in frozen fish sticks/patties, PFOS and perfluorodecanoic acid (PFDA) in canned tuna, and PFOS in protein powder. The substances were detected at concentrations below 150 ppt.
  • While the sample sizes are limited and the results do not provide an accurate description of PFAS levels in the general food supply, FDA’s TDS studies will help the agency determine if additional sampling is needed for any foods. As we reported last month, FDA has also published results from its testing of 94 food samples, including in raw fruits and vegetables, meats, poultry, and fish. Of these PFAS were detected in a single sample of cod but not at levels that indicated a human health concern. FDA has stated it plans to conduct a targeted survey of PFAS in commonly-consumed seafoods.
  • The House of Representatives passed the PFAS Action Act to regulate the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) on July 21, 2021. The bill’s passing follows FDA’s recently published update on testing of PFAS in food to better understand the presence of PFAS in the food supply. As our readers know, PFAS are known for their grease, water, and oil-resistant properties. They are used in a variety of consumer products, including food-contact materials.
  • As passed by the House, the bill would (1) require the Environmental Protection Agency to add two PFAS, perfluorooctanoic acid (PFOA) and perfluoroactanesulfonic acid (PFOS), to the list of hazardous substances within one year and assess all other PFAS within five years to determine whether they should be designated as hazardous substances; and (2) require EPA to determine whether PFAS should be designated as toxic pollutants under the Clean Water Act. Designation as a hazardous substance under the Comprehensive Environmental Response, Liability, and Compensation Act (CERCLA) triggers remediation for and cleanup of sites impacted by the substances but does not regulate use of hazardous substances. The bill would also require the EPA Administrator to monitor PFAS in drinking water and permit a “PFAS-free” indication on nonstick cookware.
  • The bill passed 241-183, with 23 Republican members joining Democrats, and will now move to the Senate. The Act is a revived version of a 2020 bill of the same name that passed the House in January 2020 but died in a Republican-led Senate.
  • On June 30, the U.S. Food and Drug Administration (FDA) published a constituent update notifying the public of recent test results from a study it conducted to better understand the presence of per- and polyfluoroalkyl substances (PFAS) in the food supply.  PFAS are known for their grease, water, and oil-resistant properties and are used in a variety of consumer products, including food-contact materials.
  • FDA’s most recent testing detected PFAS in only one of 94 food samples.  FDA tested a variety of breads, cakes, fruits, dairy, vegetables, meats, poultry, fish, and bottled water and detected PFAS in a single sample of cod, which contained detectable levels of two PFAS compounds, perfluorooctane sulfonate (PFOS) and perfluorononanoic acid (PFNA).  Based on current and reliable food science, the Agency indicated that the PFAS levels detected in cod do not present a human health concern.
  • FDA’s testing was conducted as part of the Total Diet Study (TDS), a program the Agency began in 1961 to monitor the levels of nutrients, toxic elements, pesticide residues, and other chemicals in food. The Agency’s testing of TDS samples for PFAS is intended to determine if targeted sampling assignments are necessary for certain food items and to help inform its approach to future surveillance efforts.
  • The most recent testing is the third dataset released on PFAS in food.  Given that PFAS has been detected in past analysis of tilapia, FDA plans to conduct a targeted survey of PFAS in the most commonly consumed seafood items in the U.S.
  • PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.
  • FDA has been engaged in working to develop new methods to quantify PFAS in foods and has conducted test samples of foods Americans typically consume for certain types of PFAS. In June, FDA released a statement highlighting the Agency’s efforts and outlining some of the initial results of the testing.   At that time, FDA reported that 14 of the 91 samples evaluated contained PFAS.
  • In its October 31 statement, FDA made available a scientifically validated method for testing for 16 types of PFAS in a variety of food.  After applying the validated method to the initial results, FDA said that detectable levels of certain PFAS chemicals were found in only two of 91 samples, ground turkey and tilapia. The agency will continue to analyze additional samples and make those results available this year.
  • On June 11, Acting FDA Commissioner Ned Sharpless released a statement highlighting recent agency efforts to better understand the impact of per- and polyfluoroalkyl substances (PFAS) in food and providing findings from recent tests of food samples in the United States.  In presenting the initial results of the testing, which focused on foods from specific geographic areas with known environmental contamination, Sharpless affirmed that 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.”
  • PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.  PFAS have been the subject of increased scrutiny among environmental groups and certain states.
  • Of the 91 samples evaluated from the 2017 FDA Total Diet Study (TDS), 14 contained PFAS. The safety assessments undertaken for these 14 samples indicated no human health concern, based on analysis of the level of PFAS found in that food, consumption of that food, and the most current toxicological information available for PFAS.  Sharpless’ announcement comes one week after FDA updated its website to include information on PFAS in the food supply and the agency’s newly formed PFAS working group.  The agency plans to continue to work with states to develop testing methods and capacities and to increase the baseline knowledge of PFAS levels in foods.
  • On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in the United States. As part of Operation Stork Speed and the agency’s broader Closer to Zero initiative, FDA analyzed more than 300 retail products, generating over 120,000 data points across a wide range of potential chemical contaminants. The testing covered powdered, ready-to-feed, and concentrated liquid formulas and included analysis for heavy metals, pesticides, PFAS, phthalates, and other substances that may be present due to environmental or agricultural factors.
  • Overall, FDA’s findings reinforced that all infant formula products on the U.S. market meet a high safety standard, with most samples showing undetectable or very low levels of the contaminants tested. Agency leadership emphasized that these results are encouraging and affirm the general safety of the U.S. infant formula supply.
  • Specifically, all samples tested contained levels of lead, mercury, cadmium, and arsenic that were significantly below U.S. Environmental Protection Agency drinking water standards when prepared for feeding. Pesticides were not detected in 99 percent of samples tested, and none of the 25 out of 30 tested most commonly assessed PFAS compounds were detected in any sample. Among the remaining PFAS analytes, 95 percent of products had total PFAS levels at or below 28 parts per trillion, while 95 percent of samples showed phthalate concentrations at or below 116 parts per billion.
  • FDA plans to continue targeted and routine surveillance, expand testing to additional contaminants, and work with manufacturers to push contaminant levels as low as reasonably achievable. The agency also indicated it will continue developing formal action levels where appropriate.
  • Keller and Heckman will continue to monitor regulatory and policy developments affecting infant formula safety and supply.
  • Yesterday FDA released its fiscal year (FY) 2027 budget request of approximately 7.2 billion, an increase of 3.3% as compared to the FY 2026 enacted budget. FDA’s budget consists of budget authority—money allocated out of the Congressional budget— and user fees. The FY 2027 budget represents a 1.4 decrease with respect to budget authority, but a 7.7% increase with respect to user fees.
  • The Human Foods Program’s (HFP) proposed budget is approximately $1.29 billion, representing an increase of 9.2% from FY 2026 enacted. Only 1.0% of the proposed HFP budget is from user fees. The proposed FDA budget includes $9.0 million to HFP to support transitioning of routine domestic food safety inspections to states. It also includes at least $50 million across FDA programs “to support the Secretary’s vision to remove harmful chemicals from the food supply by addressing unsafe chemical additives used in food.” (The budget provides conflicting numbers, $50 million and $57 million, for this purpose). This allocation includes expansion of the Closer to Zero program, the development of models to predict PFAS levels in food-producing animals, and the exploration of legislative changes “to close the GRAS loophole.”
  • However, no legislative changes specifically relating to self-determined GRAS status are included in the legislative proposal section. FDA’s proposed GRAS rule is currently expected to be published by late spring or early summer.  
  • A legislative proposal under the heading “Ensure FDA Access to Industry Data to Strengthen Food Chemical Safety” would require post-market reassessments of chemicals added to food and submission of certain data and results to FDA. Another legislative proposal would establish a biennial registration user fee for all foreign human and animal food facilities (there is no cost currently associated with food facility registrations, whether foreign or domestic). Other food related legislative proposals encompass expanded oversight of infant formula (including expanded testing and reporting requirements), the required destruction of FDA-regulated imports refused entry and which present a public health concern (with no re-export option), and increased food-related information sharing with state, local, Tribal, and U.S. territorial authorities.
  • The U.S. Environmental Protection Agency (EPA) has published its proposed Sixth Contaminant Candidate List (CCL 6) for drinking water, adding per- and polyfluoroalkyl substances (PFAS), microplastics, and other hazards.
  • The drinking water CCL lists contaminants that are not currently subject to primary drinking water regulations but are known or anticipated to be in public water systems. Substances added to the list are not subject to any immediate requirements but instead are identified as priority contaminants for potential future regulation.
  • CCL 6 includes four chemical groups—including PFAS and microplastics—75 chemicals, and nine microbes. According to the Federal Register Notice, the PFAS group includes chemicals that contain at least one of three specific structures; listing the PFAS group is intended to signify EPA’s “commitment to prioritizing and building a strong foundation of science on PFAS.”
  • The Notice also states that inclusion of microplastics on the list is a “first step toward defining and better understanding potential public health risk from exposure via drinking water” and identifies four data gaps requiring further research.
  • Both PFAS and microplastics received public nominations for inclusion on CCL 6. EPA is seeking comments on the proposed CCL 6 at regulations.gov under docket number EPA-HQ-OW-2022-0946.
  • In addition to EPA’s announcement of CCL 6, the Department of Health and Human Services (HHS) has announced the Systematic Targeting of MicroPlastics (STOMP) initiative to “create the definitive toolbox for measuring, researching, and affordably removing microplastics and nanoplastics (MNPs) in the human body. STOMP will focus on developing measurement methods to understand microplastics in the human body and mitigate any harm caused.
  • Keller and Heckman will continue to monitor updates related to PFAS and microplastics.