This request for comments may seem familiar. In September 2023, MPCA promulgated two Request for Comments (“RFCs”) in furtherance of the state’s Per- and Polyfluoroalkyl Substances (“PFAS”) in Products Ban (also known as “Amara’s Law”). Now, having received over 500 pages worth of comments on these two rules, MPCA plans to combine these two rules and is seeking comments accordingly.

The two previous RFCs focused on implementing the reporting and fees elements of the Minnesota PFAS in Products Ban. In combining these efforts, MPCA is seeking “to ensure that the fee process is directly a part of the reporting system being created for products with intentionally-added PFAS.”

Under Amara’s Law, in addition to banning numerous products containing intentionally-added PFAS, MPCA is authorized to promulgate rules requiring “manufacturers” of a product containing “intentionally-added PFAS” to disclose to the Agency, among other things, a brief description of the product (including a universal product code (“UPC”), stock keeping unit (“SKU”)), the purpose for which PFAS are used in the product (including in any product components), and the amount of each PFAS (identified by its chemical abstracts service registry number) in the product, reported as an exact quantity determined using commercially available analytical methods. In developing a rule to effectuate these disclosure requirements, MPCA sought, and continues to seek, answers to the following questions:

• Are there definitions in the law for which clarification would be useful to understanding reporting responsibilities?
• Are there terms or processes in the law for which clarifications will help reporting entities determine reporting status or data-gathering process?
• How should the MPCA balance public availability of data and trade secrecy as part of the reporting requirements?
• Are there any terms used in the law that should be further defined or where examples would be helpful?
• Are there specific portions of the reporting process that should not be defined through guidance or the development of an application form?
• Other questions or comments relating to reporting or the process of reporting.

Regarding fees, Amara’s Law authorizes the MPCA to require a fee to submit this information “to cover the agency’s reasonable costs to implement” Amara’s Law. In developing the fee rule, the MPCA sought comments on following questions:

• Should the Agency consider tiered fees for different sizes of business?
• Should the Agency consider a per-product or per-company fee?
• Should the Agency consider a per-PFAS or PFAS amount fee?
• Are there other state program fee structures on which the Agency should model the fees?
• Should the Agency consider a fee to be paid when updates to information on previously reported products are submitted? (e.g., decreased amounts or elimination of one or more PFAS)

Now, MPCA simply is combining these rulemaking dockets. There are no draft rules yet, though MPCA is continuing to solicit comments on these two PFAS efforts to inform draft rule development. Thus, this is simply the second of several opportunities for public comment and input on this rulemaking.

Comments submitted to the original RFCs will still be considered along with the responses to this second RFC, so there is no need to resubmit comments. For those entities that missed this first opportunity though, this is an excellent opportunity to have your voice heard prior to MPCA’s drafting rules regarding these reporting and fee requirements.

Comments are due back to the Agency by December 19, 2024.

Enforcement

While penalties are to be assessed on a “case-by-case” basis under AB 347, the minimum penalty for a first-time violation is $10,000. The factors to be considered by the Department of Toxic Substances Control (“DTSC”) in assessing the penalty are common ones: nature and severity of the violation; whether the entity acted in good faith; history of prior violations; evidence that the violation was willful; and the degree of cooperation exhibited by the alleged violator.

The enforcement process will be initiated by DTSC’s issuance of a Notice of Violation (“NOV”), which is to be based on:

(1) Testing: Either testing by the Department or test results submitted by the manufacturer (as part of the registration process discussed below) showing a violation;

(2) Ingredients: The Department determines that “an ingredient identified on a covered product’s label” is a violation of a PFAS restriction; or

(3) Other: The Department finds a violation of AB 347 (including the registration requirement).

AB 347 also provides authority to prohibit the sale of noncompliant products in the state.

While the bill does not expressly allow citizens to initiate enforcement proceedings, citizens are likely to independently test, verify or inspect products and report this information to the Department.

Notably, NOVs are to be made public and published on the DTSC website, including relevant product information.

Manufacturer Registration

On or before July 1, 2029, manufacturers of covered products must register with DTSC, pay a registration fee, and provide a statement certifying compliance with the applicable prohibitions on the use of PFAS to the Department. While the statute does not provide what must be included in this statement, it authorizes the Department specifically to request “technical documentation, including analytical test results, to demonstrate compliance with the applicable covered PFAS restriction.”

The bill does not include any exemptions for small businesses or de minimis sales, which are increasingly common in PFAS bans in sister states. It is possible that such exemptions may be adopted as DTSC establishes implementing regulations.

Testing

As highlighted in a recent court case, a significant PFAS enforcement challenge is the identification and use of appropriate testing methods to determine the presence of PFAS in products. AB 347 directs DTSC, by January 1, 2029, to publish online a list of accepted methods for testing to determine whether a covered product complies with PFAS restrictions and appropriate third-party accreditations for testing laboratories.

In particular, it will be interesting to see how DTSC wrestles with testing for compliance with the 100 ppm “total organic fluorine” (“TOF”) limits for textiles and other products. As TOF testing captures fluorine sources other than PFAS, it is unclear whether a “positive” TOF test result should be considered a violation without further inquiry.

In this case, plaintiffs brought suit against the manufacturer claiming that advertising of the menstrual products as “pure cotton” was untrue given that TOF testing indicated the presence of organic fluorine. While granting the motion to dismiss, the judge has allowed the plaintiffs more time to substantiate their claim that PFAS specifically are present in the product and, if so, at harmful levels. The plaintiffs will now have to do so through a different and more focused testing program.

This should not be a surprising result. While TOF testing may, in fact, be the “gold standard” for screening for potential PFAS presence, as advocated by plaintiffs’ counsel, the test was not designed to be the sole determinative method for identifying PFAS in products. Though a “positive” TOF test often is due to PFAS (roughly 85-95% of the time), because organic fluorine may be present as a result of other non-PFAS chemicals, additional confirmatory testing is necessary to demonstrate that PFAS are actually in a product. Conversely, a “negative” TOF result provides strong confidence that the product/material is PFAS-free. For this reason, the TOF test – which is far cheaper than screening for the thousands of individual PFAS compounds – is an efficient mechanism for businesses to make an initial determination if a product or material should be further investigated for PFAS contamination.

Interestingly, the judge’s decision points to an implementation problem California and other states are grappling with as they begin regulating PFAS chemicals. Citing California Health and Safety Code § 108945, the judge notes that the Golden State defines “regulated PFAS” as either PFAS that are “intentionally added to a product and that have a functional or technical effect in the product,” or “the presence of PFAS in a product or product component at or above 100 parts per million, as measured in total organic fluorine.” Enforcement of the 100 ppm standard as written is complicated given that, at times, a hit for TOF does not mean with any certainty that PFAS are actually present in a product.

Dozens of states now have laws and regulations restricting PFAS in some or all types of products, as well as imposing reporting and other requirements. Six states have banned PFAS specifically in menstrual products, including California, Maine, Vermont, Rhode Island, Colorado, and Connecticut. Many of these jurisdictions are struggling to implement their PFAS product bans citing implementation costs, technological shortcomings, and legislative scoping issues.

In light of this court decision, many state regulators should assess the enforcement implications for alleged violators whose products indicate the presence of organic fluorine via TOF testing, and the role of additional PFAS-specific testing in such actions.

The case is Bounthon v. The Procter & Gamble Company (Case No. 23-cv-00765-AMO) (N.D.Ca. 2024).

The Agency announced that the delay is due to “resource constraints.” In March, EPA’s TSCA program budget was slashed by $5 million compared to what it was for the fiscal year 2023 budget. Given that the Agency is in the process of developing an entirely new online reporting platform for this rule, it is likely that budget cuts impacted the ability for EPA to rollout the platform on time.

The disclosure rule was initially promulgated in response to an amendment to the Toxics Substances Control Act (“TSCA” or “the Act”) that was tucked away in the National Defense Authorization Act for Fiscal Year 2020. The amendment added Section 8(a)(7) to the Act, which directs EPA to require PFAS reporting under TSCA. TSCA generally grants EPA the authority to set use restrictions and reporting, record-keeping, and testing requirements for certain chemical substances and/or mixtures that may pose an unreasonable risk to human health or the environment.

On June 28, 2021, EPA proposed TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. After comments were received and reviewed, EPA published the final rule (“TSCA PFAS Reporting Rule”) on October 11, 2023, effective November 13, 2023. The rule requires any entity that manufacturers, imports, or has manufactured or imported PFAS or PFAS-containing articles in any year since Jan. 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards, among other things. Reporting obligations are less strenuous for entities that only imported articles containing PFAS.

Despite the rule’s seemingly simple reporting requirements, companies will likely spend significant amounts of time, labor and resources ensuring that their mandatory disclosures are compliant. Indeed, there are over 15,000 types of PFAS identified so far, each with their own chemical makeup and profile.

Entities originally had until May 8, 2025 to report, and “small manufacturers” who are subject to the rule exclusively through article imports would have had until November 10, 2025. Now that the rule’s implementation is being delayed, the Agency notes that most reporters will be required to complete all reporting by January 11, 2026, with small manufacturers having until July 11, 2026.

Under HF2310 (also referred to as “Amara’s Law”), manufacturers of products containing PFAS are subject to Minnesota PFAS disclosure requirements. To comply, companies must submit information to MPCA including: a brief description of the product, including a universal product code (“UPC”), stock keeping unit (“SKU”), or other numeric code assigned to the product; the purpose for which PFAS are used in the product, including in any product components; the amount of each PFAS, identified by its CASRN, in the product; the name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer; and any additional information requested by the Agency. Similar reporting requirements are also common under other state PFAS statutes like Maine and Washington. Minnesota’s reports are due in January 2026.

During a July 18 MPCA webinar, Agency staff indicated that the state’s reporting system will heavily borrow from the existing High Priority Chemicals Data System model that is part of the Interstate Chemicals Clearinghouse. MPCA is crafting this system in conjunction with the Northeast Waste Management Officials Association, which last year developed draft model state PFAS legislation. The legislation offers a menu of policy options for state legislatures to address potential PFAS contamination and exposure from consumer products, like a near-total ban on PFAS-containing consumer products within three years, product reporting requirements, ​“extended producer responsibility” obligations (i.e., product ​“take back”/recycling programs), and, relevant here, the new multi-jurisdictional ​“clearinghouse” to assist state environmental agencies with compliance and enforcement of Amara’s Law and others like it.

Speaking broadly, manufacturers are growing increasingly concerned that publicly-accessible PFAS disclosures are going to be used by plaintiffs’ attorneys who will bring false advertising claims against them. Just last month, a proposed class action lawsuit was filed in a California federal court claiming that a razor company’s products contained PFAS and that the plaintiffs would not have purchased the product had they known PFAS were present. The information regarding the products’ PFAS content was discovered via publicly accessible company disclosures filed under the Maine PFAS reporting requirement prior to the law’s amendments.

The case is truly groundbreaking – never before have we seen a case where state-mandated PFAS disclosures have led to allegations of false advertising. Testing ground or not, the case is likely one of many to come as law firms opportunistically scan the environment for cases and plaintiffs.

Turning back to Minnesota, MPCA staff also shared that the Agency expects to finalize draft rules related to associated fee structures and related documents by October of this year.

Amara’s Law also prohibits a person from selling, offering for sale, or distributing for sale carpets or rugs; cleaning products; cookware; cosmetics; dental floss; fabric treatments; juvenile products; menstruation products; textile furnishings; ski wax; or upholstered furniture, if they contain intentionally added PFAS, beginning January 1, 2025. Beginning January 1, 2032, all products containing PFAS are banned, unless MPCA determines, by rule, that the specific products or product categories for constitute a “currently unavoidable use.” Deliberations on what constitutes a “currently unavoidable use” are ongoing, though a draft rule is likely to be promulgated sometime this year.

As is evident, Minnesota’s PFAS reporting requirements diverges from other states with similar requirements like Maine, Rhode Island, New York, and Washington, creating a complicated landscape for businesses and organizations navigating compliance. This discrepancy will likely lead to considerable confusion for entities that must adhere to dueling sets of regulations. Organizations will need to manage dual reporting systems, each with its own rules and deadlines, complicating compliance efforts and undoubtedly increasing operational costs.

Finding that 1-BP poses an unreasonable risk to human health and that there are safer alternatives available, the proposal bans all uses of 1-BP in consumer products, including spot cleaners, aerosol spray degreasers, stain removers, and automotive care products. However, the Agency is exempting building insulation from the ban as the underlying risk evaluation found that this use does not pose an unreasonable risk to human health.

Regarding commercial and industrial uses, the Agency proposes to ban 1-BP from uses in dry cleaning, stain removers, adhesives, sealants, automotive care products, anti-adhesive agents, functional fluids and craft materials. The rule says these uses make up “an estimated 3% of the current production volume of 1-BP.” The rule provides that uses outside of the ones mentioned may continue to utilize 1-BP, but would be subject to workplace safety controls, including the implementation of a concentration-based inhalation exposure limit. Workers would generally be required to wear “chemically resistant gloves made of supported polyvinyl alcohol or a multiple-layer laminated material,” and undergo 1-BP specific safety training.

The consumer-use bans would become effective six months after the final rule is published in the Federal Register. Industrial and commercial uses will be banned 18 months after the final rule is published. EPA will accept public comments on the proposed rule for 45 days following publication.

This action represents the seventh proposal under TSCA since Congress overhauled the law in 2016, and is the sixth solvent to be targeted by the Agency. The also has outstanding proposals for n-methylperrolidone (“NMP”), trichloroethylene (“TCE”), perchloroethylene (“PCE”) and carbon tetrachloride (“CTC”). A final methylene chloride rule was released earlier this year.

EPA is accepting comments on the proposal through September 23, 2024.

H7356 (a/k/a “Consumer PFAS Ban Act of 2024” or “the Act”) was introduced in the Rhode Island House in late-January earlier this year, and survived numerous amendments and committees before it was successfully approved and sent to the upper chamber in mid-June. The Rhode Island Senate passed the Act quickly, sending it to Governor Daniel McKee’s office on June 21. Governor McKee signed the Act five days later.

Effective January 1, 2027, no person will legally be able to manufacture, sell, offer for sale or distribute in Rhode Island any “covered product” that contains “intentionally added” PFAS. “Covered products” include carpets or rugs, cookware, cosmetics, fabric treatments, juvenile products, menstrual products, ski wax, and textile articles. The same goes for artificial turf and outdoor apparel for severe wet conditions, unless accompanied by a “legible, easily discernable disclosure” including the following statement: “Made with PFAS chemicals.”

The prohibition does not apply to the sale or resale of used products.

Effective January 1, 2025, the Act also prohibits a person, local government, or state agency from discharging class B firefighting foam containing intentionally added PFAS, including for training purposes. The manufacturing or sale of class B firefighting foam containing PFAS is also prohibited on the same date. The bill requires manufacturers/sellers of firefighting personal protective equipment (“PPE”) to provide written notice to the purchaser at the time of sale if the firefighting PPE contains PFAS.

The Rhode Island Department of Environmental Management is responsible for implementing and enforcing the PFAS restrictions. The bill authorizes the Department to seek civil penalties of up to $1,000 for a first violation and $5,000 for subsequent violations.

Meanwhile, in Pennsylvania, HB 2238 similarly stands to ban intentionally added PFAS in covered products effective January 1, 2027, including artificial turf, cleaning products, carpets or rugs, cookware, cosmetics, dental floss, fabric treatment, food packaging, juvenile products, menstrual products, oil and gas products, ski wax, and textile articles. A total ban on products containing PFAS would become effective January 1, 2033, except for where the introduction of PFAS is a currently unavoidable use. Similar exemptions are provided for in Maine’s PFAS ban. Moreover, if passed as drafted, the bill would also require manufacturers whose products contain intentionally added PFAS to register with the Pennsylvania Department of Environmental Protection.

While Rhode Island and Pennsylvania have given themselves a longer runway to implement these prohibitions, “first mover” states like Maine have spent the last several years struggling to implement their PFAS bans. Indeed, two years after Maine passed their initial PFAS-in-products prohibitions, the state significantly overhauled its ban in light of noteworthy implementation difficulties, in turn dramatically shrinking the scope of the reporting requirements and creating a staggered phase-out system for numerous consumer products containing intentionally added PFAS.

Originally introduced by California state senator Nancy Skinner (D-Berkeley), SB 903 would have adopted prohibitions on the manufacturing, distribution, and sale of products containing intentionally added PFAS akin to bans in Maine and Minnesota. The scaling of SB 903 is a noteworthy difference though – California remains the fifth largest economy in the world since 2017.

During deliberations, DTSC told the California Senate Appropriations Committee staff that the bill would create such a large new universe of regulated entities that the Department would have to establish a new branch within the organization to “develop, implement, and administer this new initiative.” DTSC furthered that “the exact magnitude of this bill is unknown; however, the department anticipates it would require at least 44 positions and over $10 million to sufficiently implement this bill as currently written.” Moreover, “[t]o the extent that other state departments use or procure products containing intentionally added PFAS that would be affected by this bill, [there are] unknown but potentially significant state costs for state boards, departments, and organizations to comply with the provisions of this bill.”

Despite SB 903’s failure to pass through the California Legislature, the Golden State’s existing efforts to restrict the use of PFAS in consumer goods remain evident. For example, AB 1817 and AB 2771 passed through the legislature easily and were both signed by Governor Gavin Newsom on September 29, 2022. These bills respectively prohibit the manufacturing, distribution, sale, or offering for sale of textile articles or cosmetic products containing PFAS beginning January 1, 2025.

Nevertheless, California seems to have picked up on something by observing the implementation struggles that “first mover” states like Maine are dealing with. Indeed, two years after Maine passed their initial PFAS-in-products prohibitions, the state significantly overhauled its ban in light of noteworthy implementation difficulties, in turn dramatically shrinking the scope of the reporting requirements and creating a staggered phase-out system for numerous consumer products containing intentionally added PFAS.

• Increase the time for implementation of revised short-form warning content from two years to three years;

• Revert to the original regulation text for most of the internet and catalog warning content; and

• Include a new provision which, during the three-year implementation period of the proposed amendments, would provide internet retailers a 60-day grace period to update online short-form warnings from the date they receive a warning or written notice from a manufacturer or distributor changing the warning content.

While OEHHA proposes to extend the implementation period, the revised proposal does not alter the fundamental changes the agency is pursuing with regard to the short form warning. In particular, the amendments would require the “short-form” warning to be significantly less short by requiring the identification of at least one specific chemical for which the warning is being provided and to utilize lengthier text than required for the current short-form warning. Our write-up of the rulemaking proposed revised short-form warnings can be found here.

In contrast for internet and catalog warnings, OEHHA is reversing course and largely reverting back to the original 2016 regulatory text. The updated proposal would clarify that internet warnings comply with Prop 65 if they use one or more of the following methods:

• A warning on the product display page;
• A clearly marked hyperlink using the word “WARNING” or the words “CA WARNING” or “CALIFORNIA WARNING” on the product display page that links to the warning; or
• Otherwise prominently displayed warning provided to the purchaser prior to completing the purchase.

The proposal also emphasizes that “a warning is not prominently displayed if the purchaser must search for it in the general content of the website.”

Interestingly, the proposed revisions would do away with language previously proposed to “clarify” that internet “safe harbor” warnings must also be included “on or with the product when delivered to the consumer.”

Finally, OEHHA would allow three years to implement the revised warning content. In addition, for retailers, the proposal would provide a 60-day grace period to provide updated warning language on websites after receiving a warning or written notice of changes.

Speaking broadly, Prop 65 requires businesses to provide warnings to consumers prior to selling a product in California that could cause an exposure to a listed chemical. The law does not specify required warning text or methods, other than that the warning be “clear and reasonable” and provided to the consumer prior to exposure. However, OEHHA regulations specify warning language and methodology for various product categories which, if utilized, are deemed de facto compliant (a/k/a “saf- harbor” warnings). To avoid challenge, companies routinely utilize these “safe-harbor” warnings, including “short-form” versions that were originally introduced in the 2016 Prop 65 amendments for use with products with limited label space. The brevity of this method, combined with this label’s ability to comply with Prop 65 without disclosure of a specific chemical, has resulted in its widespread popularity with manufacturers, distributors, and retailers.

Comments are due on this proposal by June 28, 2024. More information can be found on OEHHA’s website here.

The seven chemicals are:

• Perfluorohexanoic acid (“PFHxA”); Chemical Abstracts Service Registry Number (“CASRN”) 307-24-4;
• Perfluoropropanoic acid (“PFPrA”); CASRN 422-64-0;
• Sodium perfluorohexanoate; CASRN 2923-26-4;
• Ammonium perfluorohexanoate; CASRN 21615-47-4;
• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide (“TFSI”); CASRN 82113-65-3;
• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6; and
• Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CASRN 2816091-53-7.

As discussed at proposal earlier this year, the first six PFAS were added pursuant to the 2020 National Defense Authorization Act, which outlines how the Agency may automatically add certain PFAS to the TRI in annual phases once a toxicity value has been finalized. Because EPA finalized toxicity values for those PFAS in 2023, they are automatically added for Reporting Year 2024. The last PFAS, Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl), is being added for TRI Reporting Year 2024 after confidentiality claims were rescinded for the substance.

Reports for these chemicals will first be July 1, 2025, covering the 2024 calendar year. For the 189 PFAS previously on the TRI list reports for the 2023 reporting year are due by July 1, 2024.

Note that EPA classified PFAS as ​“chemicals of special concern” on October 23, 2023, thereby eliminating applicability of the de minimis exemption which allowed facilities to forego accounting for negligible amounts of PFAS in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process.

The designation of PFOA and PFOS as CERCLA hazardous substances also is expected to trigger multiple legal challenges, as well as administrative and legislative efforts to narrow the universe of potentially responsible parties (“PRPs”) subject to potential liability in connection with the substances, and to provide protection to so-called ​“passive receivers” of them such as public water systems, publicly owned treatment works, airports, firefighting agencies, farmers who have applied biosolids to agricultural soils, among others. The rule specifically recognizes potentially affected entities, naming, among others, manufacturers of textiles, leather, petroleum, printing, plastics, rubber, glass, cement, steel, aluminum, vehicle parts, medical equipment, and home furnishings.

The rule goes into effect 60 days upon publication in the Federal Register.

CERCLA and PFAS: A Comprehensive Liability Scheme Meets a Pervasive Contaminant

The designation of two PFAS as hazardous substances is significant in part because of the nature of the chemicals involved: widely (and legally) used for decades across a broad swath of industries – from food packaging, clothing, cookware and numerous other consumer products to fire firefighting foams, machining fluids, and a host of industrial uses – with relatively minimal awareness, until recently, by users or the Agency of potential environmental or human health risks. Given the scope of usage and the prevalence of PFAS in soil and water at sites across the country, the introduction of PFAS to CERCLA’s liability scheme will no doubt expand liability for entities that previously have not been targeted in PFAS litigation.

Passed in 1980, CERCLA was designed to provide broad federal authority to respond to releases or threatened releases of ​“hazardous substances” that may endanger public health or the environment, and to broadly encompass multiple classifications of statutory ​“responsible parties” subject to liability to ensure timely cleanups and their funding. CERCLA is well known for its far-reaching retroactive, and strict liability scheme. Strict liability means that response costs may be imposed upon all parties that meet the statutory definition of a ​“responsible party,” including parties who own or operate contaminated property, caused the release or threatened release of hazardous substances, or who otherwise arranged for the disposal of hazardous substances at other sites. EPA can force PRPs to either cleanup the polluted site or reimburse the government for the full remediation of the contaminated site. Because of CERCLA’s joint and several liability scheme, any one PRP can be held liable for the full amount of the cost. Parties held liable are permitted to seek contribution costs from other PRPs. CERCLA PRPs may also be liable for Natural Resource Damages, as defined in the statute and associated regulation, and which include the often multi-million dollar efforts to assess those costs.

PFAS, an umbrella term for thousands of fluorinated chemicals, are commonly referred to as ​“forever chemicals” because of their persistence in the environment. Once PFAS are released to the environment, they resist breakdown, bioaccumulate and biomagnify through ecosystems, and permeate the environment. Since the 1950s, PFAS have been entrenched in everyday product use and manufacturing, present in aircrafts, textiles, water- or fire-resistant products, cookware, paint, bathroom products, most technology like cell phones, and many other items. PFAS are now understood by EPA and state regulatory authorities to be toxic at extremely low concentrations, with links being discovered between the chemicals and increased risks of birth defects, decreased fertility, thyroid disease and several forms of cancer, specifically testicular and kidney cancer.

Given their broad use in products and industrial processes cross many sectors of the economy, PFAS have been found in many water systems throughout the U.S., and have been detected as far as the Arctic Circle. The U.S. Centers for Disease Control reported in 2015 that 97% of Americans have PFAS in their blood and tissue, and additional, large-scale biomonitoring efforts are underway globally. The extent of the contamination is not fully known, as substantial testing only began in the last decade. Until recently, PFAS were largely unregulated, except by states that adopted their own regulations in the absence of action at the federal level.

Industry Impacts, Strict Liability, and Litigation

While environmental groups generally have praised EPA’s efforts to bring PFAS into to the CERCLA liability scheme, industry groups have expressed concern about the far-reaching consequences that potential liability across so many sectors that the listings will trigger. Accordingly, there has been significant effort to obtain liability carve-outs, particularly for downstream ​“passive receivers” of PFAS (i.e., entities that unknowingly received PFAS in material used or processed at a facility, such as municipal landfills and drinking water and wastewater treatment facilities).

EPA’s announcement about the rule was accompanied by its release of an enforcement discretion policy, in which the Agency said it will likely decline to pursue cases against community water systems, publicly owned treatment works (“POTW”), municipal separate storm sewer systems, publicly owned/operated municipal solid waste landfills, publicly owned airports, local fire departments, and farms that apply biosolids to land. Additionally, EPA announced that they will apply ​“fairness and equitable factors” to other entities in deciding whether to pursue a case.

Despite those assurances, neither CERCLA nor the rule prohibit private parties from initiating lawsuits to recover costs spent in conducting response and remediation actions against entities who EPA may decline to pursue. While the enforcement policy notes that the Agency will seek to require settling parties to waive their rights to sue parties that satisfy equitable factors, and may in fact mitigate some litigation risk concerns, the policy is not absolute and private parties may not be interested in including such a provision as part of their own settlement. Thus, even parties who do not manufacture PFAS, nor utilize them in their products, may find themselves before a court having to explain their relationship to the PFAS contamination.

On the legislative side, the Senate and House are considering bills seeking to address the expansive liability the CERCLA designation would impose on vast numbers of possible PRPs. Just two months after the ANPRM, the U.S. Senate Committee on Environment & Public Works (“EPW”) published a bipartisan draft bill that narrowed the definition of PFAS, but did not include any liability exemptions for passive receivers or other sectors.

Nevertheless, enough pressure was put on the Senate EPW Committee to convene a March 2024 hearing on the matter. Across the board, the Senators seemed interested in creating a statutory liability carve-out for those who do not use PFAS or benefit from their presence but instead encounter them in operations incidentally from upstream inputs, also known as ​“passive receivers.” There appears to be bipartisan interest in ensuring that PFAS manufacturers and polluters pay for remediation costs, but it is unclear whether any legislation will be forthcoming.

EPA’s decision markedly expands the scope of PFAS liability, both in terms of retroactivity and by creating a nearly limitless class of PRPs from whom litigants can now bring action against. For inquiries on how this rule may affect you, please contact a member of the Kelley Drye environmental team.

On April 18, Senate Majority Whip Dick Durbin (D-IL) and Rep. Betty McCollum (D-MN) of the House Appropriations Committee, introduced companion versions of Forever Chemical Regulation and Accountability Act (“FCRAA”) in their respective Congressional chambers. The Senate bill, S.4187, has been referred to the Environment & Public Works Committee while the House companion, H.R.8074, has been referred to five different House committees: (1) Energy and Commerce; (2) Oversight and Accountability; (3) Science, Space, and Technology; (4) Transportation and Infrastructure; and (5) Armed Services.

As written, the bill would task the National Academies of Sciences with reviewing and evaluating the available scientific evidence to determine “categories” of “essential uses” of PFAS, and provide guidance on designating PFAS uses as either “essential” or “non-essential.” Then, the bill would set a four year deadline to eliminate non-essential uses of PFAS in certain classes, and a 10-year national deadline to eliminate non-essential PFAS uses in all non-essential classes, while providing exemptions for currently unavoidable and certain critical purposes. The bill provides a petition process “to designate a use of PFAS as essential or non-essential.”

The bill also takes a page out of Maine and Minnesota’s PFAS reporting laws. Specifically, FCRAA would require all PFAS manufacturers and users to file reports with the U.S. Environmental Protection Agency (“EPA”) to disclose certain information relating to PFAS, as well as to submit their own phase-out schedule.

Beyond the phase-out and notification requirements, the bill would update CERCLA to toll state statutes of limitations and statutes of repose for newly-designated hazardous substances, like PFAS, until the later of either: the date on which it was designated as a hazardous substance; or when the plaintiff knew or reasonably should have known of their injury related to the substance. According to a section-by-section summary of the bill, FCRAA will also “prevent large corporations from exploiting bankruptcy procedures to avoid persistent, bioaccumulative, and toxic chemicals, including PFAS, claims.”

The full-text of the 107-page bill is available here. A section-by-section summary of the bill is available here.

[1] New State Ice Co. v. Lieberman, 285 U.S. 262 (1932).

Under the rule, individual enforceable limits, or Maximum Contaminant Levels (“MCLs”), for PFOA, PFOS, PFHxS, PFNA, and HFPO-DA, as well as a combined MCL for mixtures containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS using a Hazard Index (“HI”) approach. In addition, the rule will establish health-based, non-enforceable Maximum Contaminant Level Goals (“MCLGs”) for these PFAS. The MCLs and MCLGs are summarized in the table below.

EPA determined that there is no level of PFOA and PFOS, which it has determined are likely carcinogens, that is without risk of adverse health effects. Therefore, the MCLs for these two contaminants are being set at 4.0 ppt, the lowest feasible level that can be detected and the most stringent in the nation. The rule also uses a risk-based standard for mixtures of PFHxS, HFPO-DA and its ammonium salt (also known as a GenX chemicals), PFNA, and PFBS. For these compounds, the rule will require the use of a formula to determine if any mixture of these chemicals in drinking water, taken together, has an ​HI score of 1.0 or greater, which indicates potential risk of adverse health effects. HI calculations account for the fact that, although certain PFAS may not be harmful at low levels, mixtures of PFAS can have additive adverse health effects.

The individual MCLs and MCLGs for PFHxS, PFNA, and HFPO-DA, are being set at 10 ppt to ensure protection of public health when only one of these PFAS is present. EPA also finalized an HI of 1.0 for any mixture containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS to address health concerns related to the co-occurrence of these PFAS.

Pursuant to the final rule, public water systems that do not already monitor for PFAS will need to begin doing so. By 2027, public water systems must have completed the prescribed initial monitoring and will need to conduct ongoing compliance monitoring going forward. Systems must also include PFAS test results in consumer confidence reports and alert the public of any monitoring procedure violations beginning in 2027.

Beginning in 2029, the rule will require public water systems to be in compliance with all PFAS MCLs and to provide public notifications of any exceedances. Should exceedances occur, systems must then take action to reduce PFAS levels.

EPA also announced $1 billion in need-based funding through the Bipartisan Infrastructure Law (“BIL”) to help states and territories implement PFAS testing and treatment at public water systems and to help owners of private wells address PFAS contamination. This is included in the $9 billion that the BIL already provides to invest in communities with drinking water impacted by PFAS and other emerging contaminants, including $4 billion to the Drinking Water State Revolving Fund and $5 billion through EPA’s Emerging Contaminants in Small or Disadvantaged Communities Grant Program.

More frequent sampling and testing will impose high costs on water systems, especially those with MCL exceedances. To reduce costs for systems, EPA said that previously collected monitoring data may satisfy some or all the initial monitoring requirements if the sampling was conducted as part of the data collection program known as UCMR 5 or other appropriate monitoring campaigns.

Some industry groups and local officials are dissatisfied with EPA’s new rules, questioning the economic burden placed on water systems and manufacturers and predicting that certain manufacturing industries will seek residence in countries with less stringent environmental protections. Advocates of the rule argue that the health risks posed by PFAS are dangerous enough to warrant the cost of compliance.

The new MCLs are likely to be adopted into remedial actions performed pursuant to the federal Comprehensive Environmental Response, Compensation, and Liability Act (CERLCA), especially if EPA also finalizes its pending proposed rule to list PFOA and PFOS as hazardous substances under CERCLA. In addition, in states and/or U.S. territories that employ federal and state MCLs as a driver for remediation cleanup standards, EPA’s promulgation of the new MCLs may affect remedial activities required under state environmental remedial programs, such as state equivalents of CERCLA.

According to the text of the pre-publication version of the final rule, these FRP requirements would apply to facilities that, “because of their location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or exclusive economic zone.” Thus, facilities with an onsite quantity of a CWA hazardous substance that meets or exceeds threshold quantities (i.e., 1,000 times the Reportable Quantity identified in 40 CFR 117.3), are located within half a mile radius of a navigable water or conveyance into such water, or that meet one of following substantial harm criteria will be expected to comply:

• Whether the facility has had a reportable discharge of a CWA hazardous substance that reached a navigable water within the last five years;
• Whether it has the ability to “adversely impact a public water system;”
• Whether it has the ability to cause injury to fish, wildlife and “sensitive environments;” and
• Whether it has the ability to cause injury to public receptors.

The new rule also provides a process by which EPA Regional Administrators may assess facilities on a case-by-case basis, and if supported, can require a facility to develop a FRP based on, among other things, factors related to potential impacts of worst-case discharges on environmental justice communities.

In a press release on the matter, EPA estimates that approximately 5,400 facilities will be required to submit FRPs under the new rule. These facilities will have 36 months to submit FRPs to EPA once the rule is published in the Federal Register.

For further background on the rulemaking, which dates back to at least 2016, please see our prior posts here, here and here.

Other FDA-authorized categories, such as non-stick pots and pans, rubber O-rings and gaskets used in food processing equipment, and manufacturing aids added to other food contact polymers remain in place at the federal level. FDA determined that PFAS in these products would not be available to migrate at more than negligible amounts under the intended conditions of use and would, therefore, not pose a safety risk.

The recent phase-out of PFAS-containing grease-proofing food packaging was a result of a series of FDA determinations and industry action. In the early 2000s, FDA first raised safety concerns with certain PFAS substances commonly referred to as “C8 compounds” or “long-chain” compounds. This category was phased out of the U.S. market between 2011 and 2016 voluntarily and through FDA authorization revocations. In their stead, industry began to use “short-chain” PFAS replacements that had been authorized for use as grease-proofing agents.

In 2020, FDA found that a short-chain PFAS – 6:2 fluorotelomer alcohol (“6:2 FTOH”) – also may pose a safety risk. FDA found that under certain conditions, the smaller PFAS “sidechain” can detach from the polymerized molecule. As a result, there is potential for PFAS to migrate to food at levels that may result in a potential safety concern. FDA sought and obtained market-phase-out commitment letters from each of the manufacturers of PFAS grease-proofing agents that contain this substance. And in 2023, FDA received confirmation from manufacturers of all remaining authorized grease-proofing substances containing different types of PFAS (not the subject of the safety review) that those manufacturers had voluntarily stopped producing and selling these products for business reasons unrelated to safety.

FDA indicated that it will continue to test foods from the general food supply this year and next to accurately estimate U.S. consumers’ exposure to PFAS from foods. This includes testing samples from the Total Diet Study (see more on this study here) as well as a survey of bottled water. The agency will also conduct additional seafood testing. If the testing supports an FDA finding of a health concern relating to a particular food based on PFAS exposure, FDA has indicated it will take action.

As we have discussed here and here, several states have laws regulating PFAS exposure from food packaging products that are in place or moving rapidly through legislatures. Please continue to watch this space as “forever chemicals” continue to consume ever greater attention from regulators.

The “Ending Forever Chemicals Act” (SB 903) builds on the Golden State’s existing efforts to restrict the use of PFAS in consumer goods. For example, AB 1817 and AB 2771 passed through the legislature easily and were both signed by Governor Gavin Newsom on September 29, 2022. These bills respectively prohibit the manufacturing, distribution, sale, or offering for sale of textile articles or cosmetic products containing PFAS beginning January 1, 2025.

SB 903 proposes to apply this prohibition to all “products,” which the bill defines as “an item manufactured, assembled, packaged, or otherwise prepared for sale in California, including, but not limited to, its components, sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products.” It further defines “component” as “an identifiable ingredient, part, or piece of a product, regardless of whether the manufacturer of the product is the manufacturer of the component.” The prohibition would be effective January 1, 2030. Interestingly, the bill gives the California Department of Toxic Substances Control (“DTSC”) the authority to, via rulemaking, prohibit intentionally added PFAS in a product or product category before the 2030 effective date.

Like Maine and Minnesota’s ban of PFAS in consumer goods, California also creates exemptions for products where DTSC finds via rulemaking that the presence of PFAS in the consumer good constitutes a “currently unavoidable use” (“CUU”). To qualify, the bill authorizes DTSC to solicit petitions for individual products and product categories that may qualify for a CUU waiver. The Maine Department of Environmental Protection is accepting individual CUU proposals until this Friday, March 1, for products that may fit within the standard. Meanwhile, the comment period for the Minnesota Pollution Control Agency’s proposed definition of CUU also closes on March 1.

California’s bill would statutorily codify the requirements to satisfy a CUU at HSC, Division 104, Part 3, Chapter 18, 109030.2(a). A CUU would be found where:

1. There are no safer alternatives to PFAS that are reasonably available.
2. The function provided by PFAS in the product is necessary for the product to work.
3. The use of PFAS in the product is critical for health, safety, or the functioning of society.

Note that the third criterion here is borrowed from the definition of “CUU” under Maine’s prohibition exemption at 38 M.R.S. § 1614.1.B.

SB 903 further outlines what CUU petitions must contain, and how DTSC must evaluate such petitions. This includes a requirement that all petitions be subject to public comment.

Moreover, the bill provides that CUU petitions expire five years after issuance. The bill authorizes DTSC to revoke petitions prior to expiration if it can determine that the information used to justify the issuance is no longer relevant. And, importantly, the bill requires manufacturers to renew determination petitions no later than six months prior to their expiration. DTSC must also publish an online list on their website of each determination of a CUU, its expiration date, and the products and uses exempt from the prohibition.

If DTSC has reason to believe that a product contains intentionally added PFAS in violation of the bill, SB 903 authorizes DTSC to require the manufacturer to test the product and send DTSC results demonstrating compliance. Violators would be subject to a civil penalty not to exceed $1,000 per day for each violation, with repeat violations raising that penalty to a $2,500 maximum. The bill also authorizes the judiciary to enjoin sale of violating products.

While California is not the first state to issue such a ban, and has indeed borrowed almost all of these provisions from Maine or Minnesota, SB 903 represents the most realized version of such a prohibition introduced to date. It provides robust language and demarcated instructions to DTSC on how to effectuate the ban and its numerous exemptions. It also allows public comment for individual CUU petitions and explains how the CUU exemption must be renewed over time.

The bill will likely gain support in the California legislature. The real question moving forward is whether Gov. Newsom, who has vetoed several PFAS prohibition bills (see here and here) in the past for vagueness and overreach surrounding applicability and enforcement, will be satisfied with the legislation.

Accordingly, in addition to voiding the need for glyphosate-related Prop 65 warnings, the ruling highlights First Amendment “free speech” rights as a potential defense for businesses subject to Prop 65. The ruling also should have repercussions for Prop 65 chemical-listing decisions by the Office of Environmental Health Hazard Assessment (“OEHHA”).

For a more “legalese” discussion of the case, read on ….

The U.S. Court of Appeals for the Ninth Circuit has held that California cannot enforce a Proposition 65 rule requiring cancer labels on products containing glyphosate, the most commonly used herbicide in the world and best known as the active ingredient in popular weed-killer Roundup. The case was decided on First Amendment grounds, with the Court ruling that the Golden State’s carcinogen warning requirement as applied to glyphosate forces companies using the chemical to “convey a controversial, fiercely contested message that they fundamentally disagree with,” and therefore cannot be enforced by state regulators.

The suit was initially brought in the U.S. District Court for the Eastern District of California by a coalition of agricultural producers and business entities that use glyphosate in their herbicide products. They filed the lawsuit in late 2017 in response to the OEHHA decision to list the chemical under Prop 65, which requires businesses to provide a warning to consumers before they sell a product in California that can cause an exposure to a listed chemical. The coalition claimed that mandating glyphosate warnings under Prop 65 violated their First Amendment right to be free from compelled speech because the scientific conclusiveness of glyphosate being a carcinogen remains hotly contested. In listing the chemical in 2015l, California relied on the International Agency for Research on Cancer (“IARC”) classification of glyphosate as “probably carcinogenic.” However, that conclusion has not been adopted by any other scientific body, including the U.S. Environmental Protection Agency, which has found that “glyphosate is not likely to be carcinogenic in humans.”

Consistent with the First Amendment, some commercial speech (i.e., speech that promotes a business or commercial activity, in contrast to private or political speech) may be restricted or compelled via government regulations. The constitutionality of these regulations is assessed based upon differing levels of scrutiny which apply depending on the type of regulation the government seeks to promulgate and enforce. Relevant here, the lowest level of scrutiny was established by the Supreme Court in Zauderer v. Office of Disc. Counsel, where the Court held that states may compel “purely factual and uncontroversial” commercial speech "as long as disclosure requirements are reasonably related to the State's interest in preventing deception of consumers." 471 U.S. 626, 628 (1985). An “intermediate” standard of scrutiny was established by the Supreme Court in Central Hudson v. Public Svn. Comm’n where the Court created a four-part test to determine whether governmental regulation of commercial speech is constitutional:

1. To be protected, the commercial speech must concern lawful activity and may not be misleading. If this step is satisfied, courts will use the following steps to determine whether the governmental regulation is constitutional:
2. The governmental interest in regulating speech must be “substantial;”
3. The regulation must advance the interest asserted; and
4. The regulation may not be any more extensive than necessary to serve the interest asserted in Step 3.

447 U.S. 557 (1980).

Shortly after the lawsuit was initiated in the Eastern District of California, OEHHA spun their wheels and generated several glyphosate-specific “safe harbor” warnings, two of which it presented to the Eastern District for review under Zauderer. Both of these warnings were rejected by the Eastern District, which held that one warning was “not significantly different” from previously rejected warnings, and the other was deficient because it improperly “conveys the message that there is equal weight of authority for and against the proposition that glyphosate causes cancer, or that there is more evidence that it does… when the heavy weight of evidence in the record is that glyphosate is not known to cause cancer.” Thus, the statement was too controversial to pass muster under Zauderer.

Both parties filed for motions for summary judgment in September 2019. In June 2020, the District court granted summary judgment for the Plaintiffs and granted their application for a permanent injunction of Prop 65 enforcement of warning requirements for glyphosate. In granting this motion, the District Court determined that the appropriate standard of review for the compelled commercial speech at issue in the glyphosate warning was “intermediate scrutiny” under Central Hudson rather than the lowest level of scrutiny under Zauderer. Applying intermediate scrutiny, the District Court found that although California did have a substantial interest in informing consumers of cancer risks under the second prong of Central Hudson, the misleading nature of the warning about glyphosate’s carcinogenicity did not directly advance that interest, as required by the third prong. Accordingly, the District Court permanently enjoined enforcement of the Prop 65 warning label for glyphosate.

California appealed to the Ninth Circuit, claiming the lower court erroneously rejected one of the proposed alternative warnings and that such judicial review should have been subject only to the lowest form of scrutiny under Zauderer. The Ninth Circuit disagreed, finding intermediate scrutiny to be the appropriate level of review because the proposed alternative warning at issue was still not “purely factual and uncontroversial.” The Court noted that

The proposed warning that ‘glyphosate is known to cause cancer’ was not purely factual because the word ‘known’ carries a complex legal meaning that consumers would not glean from the warning without context and thus the word was misleading. Moreover, saying that something is carcinogenic or has serious deleterious health effects -- without a strong scientific consensus that it does -- is controversial.

Hence, applying the intermediate scrutiny standard, the Ninth Circuit declared that “[b]ecause none of the proposed glyphosate Prop 65 warnings are narrowly drawn to advancing California's interest in protecting consumers from carcinogens, and California has less burdensome ways to convey its message than to compel Plaintiffs to convey it for them, the Prop 65 warning as applied to glyphosate is unconstitutional.”

A copy of the Ninth Circuit decision in Nat’l Association of Wheat Growers v. Bonta (9th Cir., No. 20-16758, 11/7/23) is available here.