The scope of potentially affected companies and products is immense: The reporting obligation extends not only to companies that manufacture or import PFAS chemicals but also to the much wider array of companies that have imported PFAS-containing “articles” in any year since January 1, 2011. A large number of companies will be required to file reports for many consumer products they import for sale that historically often contained PFAS for their heat-, stain-, and water-resistance, non-stick, and other qualities. The scope of potential products in which PFAS have been used is vast and varied, including food packaging, carpets and upholstery, water-resistant clothing and footwear, cookware, cleaning products, dental floss, cosmetics, and paints, among many others.

[The rule] will provide EPA, its partners, and the public with the largest-ever dataset of per- and polyfluoroalkyl substances (PFAS) manufactured and used in the United States.

- EPA Press Release

Companies that have imported such products (“articles”) into the United States now will be required to electronically report information to EPA regarding PFAS uses, production volumes, disposal, exposures, and hazards.

EPA’s definition of covered PFAS is very broad – and confusing: EPA has identified at least 1,462 PFAS that may be covered by the reporting rule. This broad coverage is due to the agency’s decision to define PFAS by chemical structure, rather than issuing a discrete list of chemical names and CAS numbers. For the reporting rule, PFAS include chemicals that have at least one of these three structures:

• R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons;
• R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; and
• CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons

I am a lawyer and not going to pretend to know whether a given chemical qualifies without first consulting a chemical expert. Needless to say this poses a significant challenge to businesses, even those that are accustomed to tracking the inventory of chemicals in their products by name and CAS number.

How do you know if you have to report? Section 8 of the Toxic Substances Control Act (“TSCA”) requires businesses to report information that is “known to or reasonably ascertainable by” them – that is, “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This is the same standard as under EPA’s Chemical Data Reporting (“CDR”) and other Section 8 rules.

In short, EPA emphasizes that meeting the standard requires a careful exercise of “due diligence” and that the extent of expected information-gathering activities will “vary from case-to-case.” EPA expects that, at minimum, companies will “conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees).” In practice, this means that you must consult with sales and marketing personnel, researchers and scientists, as well as any others in your organization that are likely to have information on a given product and/or its chemical composition. For example, companies will be expected to have inquired about and reviewed information in marketing studies, sales reports, or customer surveys, as well as information contained in standard references, such as a Safety Data Sheet (“SDS”) or a supplier notification, and knowledge gained through conferences and technical publications.

Moreover, EPA anticipates that inquiries outside of the company may be needed to fill gaps in their knowledge. This may include contacting upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS-containing product.

EPA specifies that no new customer surveys would be needed to meet the reporting standard. Generally, no new data need to be generated to satisfy the reporting inquiry, which is to be based only on existing information and knowledge that the company would be expected to know about the product. This applies to whether a product contains a PFAS chemical, as well as the other information requested by the agency on uses, exposures, hazards, and production volume.

Here is where I can tell you as a lawyer that it is imperative that you document your information-gathering efforts and responses you receive both from outside and within your organization – even (and perhaps especially) for companies that ultimately determine that reporting is not required or that particular information requested by EPA is not available.

By when must reports be submitted? The final rule takes effect on November 10, 2023, and establishes a “one-year information collection period” for companies to gather their PFAS data since 2011. After this year, companies have a six-month window to submit the information (by May 10, 2025), though “small businesses” that are only subject to the rule because they import PFAS-containing articles have an additional six months to comply (by November 10, 2025).

While 2025 may seem like a long way off, given the extent of the required data collection effort, companies will need every bit of the time provided to conduct and document their due diligence.

Ultimately, countless businesses that previously have never had to file a TSCA report are now facing a complicated data collection and reporting effort. Indeed, the reporting requirements implicate not only companies in the chemical manufacturing industry, but innumerable other consumer product sectors. Though the reporting does not capture domestically produced articles, all product manufacturers should be aware of any PFAS ingredients imported or generated incidentally in the production process.

More information can be found at EPA’s TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances website here. The Federal Register entry for the final rule can be found here.

CPSC is looking for information not only on uses and the presence of PFAS, but also potential exposure and toxicological effects.

Use or Potential Uses of PFAS in Consumer Products

• Definition of PFAS “including which chemical substances should be considered a [PFAS], which chemical substances should be excluded from consideration as a PFAS, and which PFAS are considered in commerce.” This is a critical element of the scope of any CPSC action and has been the subject of debate as states generally have taken a broad view of covered PFAS in their own product-specific regulations, notably including short- and long-chain PFAS. This approach captures thousands of PFAS formulations. While only a relatively small number of PFAS have been the subject of toxicological assessments, the precautionary approach assumes that all or most PFAS share common toxicological characteristics;
• PFAS potentially used or present in consumer products or product categories;
• Specific PFAS and products to prioritize for assessment; and
• Products or materials that may be sources of PFAS, including for “intentional uses” (chemical identity and physical form, functional purpose, and measurements or estimates of levels and concentrations) and incidental occurrence (sources of contaminants, chemical identity and physical form, degradation of substances or materials in products to PFAS, and measurements or estimates of levels/concentration).

Potential Human Exposures to PFAS Associated with Consumer Products Use

• Emissions data from indoor use of PFAS-containing products;

• Migration of PFAS from products into saliva, gastrointestinal fluid, or skin;
• Exposure and risk data, including contact exposures from direct use of consumer products and mediated exposures such as through emission of PFAS from products to surfaces, indoor dust, or indoor air;
• Data related to specific exposure pathways from consumer product sources;
• Data measurements, or estimates on PFAS intake, uptake, clearance, half-life, or occurrence in people;
• Data on the relative source contribution of consumer product(s) or ingestion of indoor dust, or inhalation of indoor air compared with other relevant sources such as drinking water or food associated with estimates of aggregate exposures; and
• “Highly exposed” populations that may use certain consumer products “for a greater than average magnitude, frequency, or duration based on habits, practices, and characteristics specific to that population group.”

Potential Adverse Human Health Effects

• Reports and data on whether individual PFAS, subclasses, or categories of PFAS have potential for adverse human health effects; and
• Any information on additional sources of data and other information that CPSC should consider not already included in the Docket, available here.

Consumer product manufacturers or retailers should monitor CPSC’s efforts and consider filing comments by the November 30 deadline to help shape a future rule making. In our experience, it is usually best to engage with a regulator early in the process rather than be forced to react later after the agency forms a policy position or proposal. Data can be submitted confidentially - or potentially through an association of companies - to minimize potential adverse public perception.

Given the prominence of PFAS on the regulatory agenda for numerous federal and state agencies, and the high level of media attention being paid to the issue, it is not surprising that CPSC is initiating action.

Maine’s 2019 Toxic Chemicals in Food Packaging Act, codified at MRS Title 32, Section 1733 (3-B), authorizes MDEP to prohibit a manufacturer, supplier or distributor from offering for sale “a food package to which PFAS have been intentionally introduced in any amount greater than an incidental presence.” Prior to imposing such a prohibition, MDEP must issue a determination that a “safer alternative” to the use of PFAS is available. “Safer alternatives” must be readily available in sufficient quantity and at a comparable cost, and perform as well or better than PFAS in the specific food packaging application.

Relying on two assessments by Washington State’s Department of Ecology (the first in May 2021 and the second in May 2022), MDEP concludes that “safer alternatives” to the use of PFAS are available for the nine food packaging applications it received.

Specifically, the prohibition would apply to food packaging:

• Intended for direct food contact (short-term storage or to hold freshly prepared food);

• Comprised in substantial part of paper, paperboard or other materials “originally derived from plant fibers which are intended for short-term storage or to hold freshly prepared food”;

• To which PFAS have been intentionally introduced in any amount greater than an incidental presence; and

• In one of the following categories:

1. Bags and sleeves: containers made from flexible material that can be folded flat and are typically used to transport food from a foodservice establishment. Sleeves include sealed-end bags referred to as pinch-bottom bags.
2. Bowls: an open-topped container with a wide rim opening and a bottom that allows spooning of food. These containers are typically designed to hold foods for serving that have a substantial liquid component; this includes portion cups.
3. Closed containers: a container that encloses food on all sides, with interlocking pieces or overlapping walls which hold the container closed for transport. Examples include clamshells, food pails, bakery boxes, and deli containers.
4. Flat serviceware: shallow, flat-bottomed containers with large surface areas used for serving and transporting food which have one large surface or multiple compartments to separate food items during food service. Examples include, but are not limited to, trays, cafeteria-style trays, and plates.
5. Food boats: a type of tray with tall, lipped edges and no compartments. Examples include, but are not limited to, food service containers for fried clams and lobster rolls. (Very Maine)
6. Open-top containers: containers that enclose food on all but one side and are designed to hold food for serving or transportation. Examples include, but are not limited to, paper cones, cups, bowls, and food boats.
7. Pizza boxes: a folded box used for serving, holding, or transporting various sizes of pizza or calzones.
8. Plates: flat serviceware, whether single or with multiple compartments, used for serving or holding food items during food service.
9. Wraps and liners: sheets used to wrap food for food service or create a lining inside other serviceware to act as an additional barrier.

The regulation would exempt manufacturers that have less than $1,000,000,000 of total annual national sales of food and beverage products.

MDEP is accepting public comment through August 21, 2023 on the draft and anticipates formally proposing the regulation later this year.

The rule was published by Washington’s Department of Ecology (“WDE”) on May 31, pursuant to the state’s Safer Products for Washington (“SPW”) chemical safety law that passed in 2019. The SPW charged WDE with identifying priority chemicals and making regulatory determinations to limit their uses in various categories of consumer products. Priority chemicals WDE determined to lack alternatives for their respective consumer products are instead subject to reporting requirements. The draft rule was originally promulgated in December of last year.

Specifically, the rule prohibits manufacture, sale, and distribution of the following products with intentionally added PFAS:

• Aftermarket stain- and water-resistance treatments
  • Effective January 1, 2025
• Carpets and rugs
  • Effective January 1, 2025
• Leather and textile furniture and furnishings intended for indoor use
  • Effective January 1, 2026
• Leather and textile furniture and furnishings intended for outdoor use
  • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
  • Notification will be due to WDE by January 31, 2025

Interestingly, the regulation includes a novel provision that “presumes the detection of total fluorine indicates the intentional addition of PFAS.” This presumption is rebuttable upon a showing that PFAS were not intentionally added to the product. Notably, fluorine may be detected in some products due to residual or trace contaminant levels of PFAS that are thought to be widespread in the water supply, soil, and in recycled plastics and other materials.

Outside of PFAS, the regulation similarly prohibits the manufacture, sale and distribution of other specified consumer products with non-PFAS priority chemicals. Those priority chemicals and specified products are:

• Ortho-phthalates
  • Fragrances in beauty products and personal care products
    • Effective January 1, 2025
  • Vinyl flooring
    • Effective January 1, 2025
• Organohalogen flame retardants
  • Electric and electronic products with plastic external enclosures, intended for indoor use
    • Effective January 1, 2027 or 2028, depending on the product.
  • Electric and electronic products with plastic external enclosures, intended for outdoor use
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
• Flame retardants
  • Covered wall padding made from polyurethane foam
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
  • Other recreational products made from polyurethane foam
    • Effective January 1, 2025
• Alkylphenol ethoxylates
  • Laundry detergent
    • Effective January 1, 2025
• Bisphenols
  • Drink cans
    • Effective January 1, 2025
  • Food cans
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
  • Thermal paper
    • Effective January 1, 2026

Where prohibitions are not feasible because of a lack of alternatives, reporting is required. The reporting notification for each priority consumer product is due one year from the effective date. They must include the CAS RN of the priority chemical that is intentionally added, the product category or categories that contain the priority chemical, the product component within the product category that contains the priority chemical, a description of the function of the priority chemical, and the concentration range of each intentionally added priority chemical in each product component in each product category.

The new regulations allow manufacturers, sellers and distributors to apply for exemptions to all of the abovementioned prohibitions, and WDE will evaluate exemptions on a case-by-case basis. In considering exemptions, WDE considers the priority chemical’s functional necessity, feasibility of legal compliance, potential alternatives (or the lack thereof), and unforeseen events and circumstances limiting the availability of alternatives.

First-time violators could be subject to civil penalties upwards of $5,000 per violation. Repeat violators are subject to penalties up to $10,000 per violation.

Interestingly, the rule includes language that seeks to avoid future federal preemption of Washington’s new ban and reporting requirements. In particular, the legislation anticipates possible regulation both by the U.S. Environmental Protection Agency (“EPA”) under the Toxic Substances Control Act (“TSCA”) and the Consumer Product Safety Commission (“CPSC”) under the Consumer Product Safety Act (“CPSA”) and/or the Federal Hazardous Substances Act (“FHSA”). TSCA authorizes the EPA to block state-level chemical rules by either issuing federal regulations for the same uses or through a finding establishing the relevant uses of the chemical present no “unreasonable risk” and thus do not require restriction.

It appears WDE sought to sidestep preemption by including provisions in the final rule that transition the program’s outright bans into preemption-immunized reporting requirements should the federal government regulate under TSCA. The final rule extends this language to specified CPSC and FHSA authorities as well.

Though WDE is certainly innovative in their preemption theory, their prohibition and reporting language mirrors the regulatory language employed by other states, including California, New York and Colorado. This language, combined with recent draft legislative language from the Northeast Waste Management Officials’ Association, seem to demonstrate that states are increasingly interested in collaborating with their neighbors to create a consistent, unified regulatory landscape that broadly governs PFAS and other chemicals.

The bill delays the reporting requirement’s effectiveness two years from January 1, 2023 to January 1, 2025. The bill also outlines specific reporting requirements that must now be included in manufacturers’ reports, including “an estimate of the total number of units of the product sold annually in the State or nationally.” Interestingly, the bill also creates two reporting exemptions: one for manufacturers that employ 25 or fewer people, and another for a “used product or used product component.”

Maine’s PFAS law still effectively bans PFAS in almost all products in the state by 2030. Specifically, the law mandates that on January 1, 2030, “a person may not sell, offer for sale or distribute for sale” products where PFAS have been “intentionally added,” except in cases of “unavoidable use.” The law also still requires companies doing business in the state to begin reporting on the presence of PFAS in their products, providing they are not exempt.

In February, MDEP promulgated a proposed rule to provide additional guidance on the reporting requirements and the definition of the magic words “intentionally added” and “unavoidable use,” which govern the scope of the legislation and 2030 ban. MDEP proposed to define “intentionally added” to include PFAS that “provide a specific characteristic, appearance, or quality or to perform a specific function,” as well as “any degradation byproducts of PFAS serving a functional purpose or technical effect within the product or its components.” “Intentionally added” would not include PFAS present in the final product as a contaminant.

The proposal also would restrict “currently unavoidable uses” to PFAS applications “that the Department has determined by rulemaking to be essential for health, safety or the functioning of society and for which alternatives are not reasonably available.” In short, the “unavoidable use” concept would not be up to the product manufacturer to determine but would require future MDEP rulemakings to dole out exemptions.

MDEP has also announced that the Maine Legislature’s Joint Standing Committee on Environment and Natural Resources “is planning to hold public meetings later this year to discuss additional issues, with the possibility of reporting out another bill with further changes in 2024.”

The rule, originally proposed in January 2023, is part of a larger effort by the Biden Administration to effectuate their PFAS Strategic Roadmap and regulate the chemicals. EPA last updated the list of PFAS subject to the TRI reporting program in July 2022.

The additional nine PFAS were added pursuant to the Fiscal Year 2020 National Defense Authorization Act (“NDAA”), which sets forth several mechanisms by which additional PFAS can be added to the list of reportable chemicals. Pursuant to the NDAA, EPA must review confidential business information (“CBI”) claims before adding PFAS to the TRI list if the chemical is subject to a claim of protection from disclosure. After review, EPA determined that the following four PFAS are no longer confidential and thus added them to the TRI:

• Alcohols, C8-16, γ-ω-perfluoro, reaction products with 1,6-diisocyanatohexane, glycidol and stearyl alc. (2728655-42-1);
• Acetamide, N-[3-(dimethylamino)propyl]-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs. (2738952-61-7);
• Acetic acid, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., 2-hydroxypropyl esters (2744262-09-5); and
• Acetamide, N-(2-aminoethyl)-, 2-[(γ-ω-perfluoro-C4-20-alkyl)thio] derivs., polymers with N1,N1-dimethyl-1,3-propanediamine, epichlorohydrin and ethylenediamine, oxidized (2742694-36-4).

Additionally, the NDAA automatically adds PFAS to the TRI upon the Agency’s finalization of a toxicity value. EPA finalized toxicity values for the following chemicals in December 2022, thus adding them to the TRI:

• PFBA (375-22-4);
• Perfluorobutanoate (45048-62-2);
• Ammonium perfluorobutanoate (10495-86-0);
• Potassium perfluorobutanoate (2966-54-3); and
• Sodium perfluorobutanoate (2218-54-4)

Now, a total of 189 PFAS chemicals are subject to TRI reporting requirements. The addition of these nine PFAS is effective on January 1, 2023. Accordingly, facilities that manufacture, process or otherwise use any of these chemicals from that date forward must report releases and other waste management activities involving the substances for the 2023 reporting year (reports are due July 1, 2024). Hence, facilities should be tracking the use of these chemicals now. Required PFAS reporting for TRI Reporting Year 2022 is due on July 1, 2023.

The Draft Model reflects a move by states towards a more holistic approach to the regulation of PFAS in products. In recent months, states are trending from product-specific bans (such as for food packaging, cosmetics, textile treatments, cookware, carpets, furniture, etc.) to broad-based bans with limited exceptions, and, increasingly, reporting and labeling requirements (such as in Maine). The Draft Model take this trend a step (or two) further with the groundbreaking "clearinghouse" proposal, which would

maintain a database of all products containing PFAS, including PFAS-added products; a file on all exemptions granted by the participating jurisdictions; a file on alternative labeling plans; and a file of all the manufacturers’ reports on the effectiveness of their collection systems.

Moreover, the Draft Model introduces "end-of-life" EPR requirements into the PFAS regulatory universe.

NEWMOA is taking comments on the Draft Model until June 29.

In 2019, Maine's Toxic Chemicals in Food Packaging Act, in addition to banning phthalates in food packaging by 2022, authorized DEP to pursue a similar ban for PFAS. Before adopting such a ban, the law requires DEP to evaluate the cost and availability of PFAS-free food packaging substitutes. The Department has made several attempts to collect information on PFAS-free substitutes in recent years, but, according to DEP, has not as yet received meaningful industry input. The planned rulemaking will build off a 2022 Washington state report on PFAS-free packaging substitutes and seek formal public comment on the feasibility of a ban.

The announcement comes several months after DEP changed course on whether manufacturers and distributors of PFAS-containing food packaging were subject to the 2021 law requiring reporting on PFAS-containing products by January 1 of this year. Originally, the Department planned to include food packaging within the reporting requirement, but in December decided that the 2019 law provided an exemption.

Meanwhile, DEP is taking comment until May 19 on a proposed rule to clarify implementation of the 2021 law's reporting requirements. A final rule is expected this summer. Maine is the first state to adopt a broad program to report on uses of PFAS in products and other states are watching closely (e.g., California, where the governor recently vetoed a reporting program as premature, and Minnesota, which is set to adopt a program similar to Maine).

In addition, the Maine legislature is considering five different bills that would amend the 2021 law. These bills would redefine the types of PFAS covered by the law, exempt businesses of 10 employees or less, and extend by up to one year the reporting deadlines for manufacturers and users of PFAS. Further coverage of these bills is available here.

HF2310 builds on previous state legislation that never was voted upon. Specifically, the Minnesota Senate introduced SF834 in January earlier this year, which provided for softer PFAS regulations than HF2310. Meanwhile in the Minnesota House, HF1000 also was discussed, but never voted upon. It too would have provided more tempered restrictions on PFAS.

Now paired with an omnibus bill that includes $670 million in funding to various Minnesota agencies, HF2310 would prohibit the sale, offering for sale, or distribution for sale of a wide range of consumer products containing intentionally added PFAS. The following products would be prohibited from containing intentionally added PFAS by 2025: carpets and rugs, cleaning products, cookware, cosmetics, dental floss, fabric treatments, juvenile products, menstruation products, textile furnishings, ski wax, and upholstered furniture.

Additionally, manufacturers of all other products containing PFAS will be required to report their use of these chemicals to the Minnesota Pollution Control Agency by January 1, 2026. A broader ban on the use of PFAS in products would go into effect on January 1, 2032, with exemptions for “unavoidable use” to be determined by the Minnesota Pollution Control Agency based on submitted use data in accordance with an upcoming rulemaking.

The bill echoes legislation adopted by Maine in 2021, which banned PFAS in textiles, carpets and rugs as of January 2023, required manufacturers of other PFAS-containing products to report their PFAS uses by that same date, and imposed a ban on PFAS in most products by 2030. Maine’s Department of Environmental Protection acknowledged last year that a rule would not be in place until later this year, even though businesses were still required to begin reporting by this past January 1. Interestingly, Maine regulators have granted hundreds of company and group-specific extensions on the reporting requirements, despite the Department still working on crafting implementing rules.

HF2310 passed by a vote of 69-59, and has since been passed on to the Minnesota Senate for their review.

Last August, the Maine legislature introduced broad and sweeping restrictions on a range of PFAS-containing products, representing the most aggressive state action to date against the so-called “forever chemicals.” In effect, the law would ban PFAS in most products in the state by 2030. Specifically, the law mandates that on January 1, 2030, “a person may not sell, offer for sale or distribute for sale” products where PFAS have been “intentionally added,” except in cases of “unavoidable use.” The law also required companies doing business in the state to begin reporting on the presence of PFAS in their products as of January 1, 2023.

In February, MDEP announced a highly anticipated proposed rule to provide not only additional guidance on the reporting requirements, but also seeking to define the magic words “intentionally added” and “unavoidable use” which govern the scope of the legislation and 2030 ban. MDEP proposed to define “intentionally added” to include PFAS that “provide a specific characteristic, appearance, or quality or to perform a specific function, as well as “any degradation byproducts of PFAS serving a functional purpose or technical effect within the product or its components.” “Intentionally added” would not include PFAS present in the final product as a contaminant.

The proposal also would restrict “currently unavoidable uses” to PFAS applications “that the Department has determined by rulemaking to be essential for health, safety or the functioning of society and for which alternatives are not reasonably available.” In short, the “unavoidable use” concept would not be up to the product manufacturer to determine but would require future MDEP rulemakings to dole out exemptions.

Now, at a public hearing last week, MDEP announced that, while it intends to proceed with the current proposed rulemaking, the agency is anticipating the need for further revisions due to pending legislation. Five different PFAS bills have been introduced in both chambers of Maine’s legislature, each of which could prompt MDEP to revisit the regulatory process and overhaul the pending rule, which is already months behind the January 1^st deadline that required companies to begin reporting.

The pending bills, taken as a whole, would redefine the types of PFAS covered by the law, exempt businesses of 10 employees or less, and extend by up to one year the reporting deadlines for manufacturers and users of PFAS. The five currently pending bills are:

• LD 217, HP0138: An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances - Rep. Dick Campbell of Orrington
• LD 304, HP0202: An Act to Establish Statewide Standards for Perfluoroalkyl and Polyfluoroalkyl Substances - Rep. Benjamin Hymes of Waldo
• LD 1214, SP0495: An Act to Clarify the Laws to Combat Perfluoroalkyl and Polyfluoroalkyl Substances Contamination - Sen. Joseph Baldacci of Penobscot
• LD 1273, SP0510: An Act to Exempt Some Businesses from Certain Laws Relating to Perfluoroalkyl and Polyfluoroalkyl Substances in Accordance with the Size of the Business - Sen. Trey Stewart of Aroostook
• LD 1537, SP0610: An Act to Amend the Laws Relating to the Prevention of Perfluoroalkyl and Polyfluoroalkyl Substances Pollution and to Provide Additional Funding - Sen. Henry Ingwersen of York

Comments on Maine’s proposed regulations are due May 19, 2023.

In agreeing to the ban, Governor Hochul called upon the legislature to amend the law to provide clarity on several specifics, including the scope of products covered, timing and enforcement mechanisms.

Accordingly, the amended legislation expands the scope of the ban to capture the use of intentionally added PFAS in a broader range of apparel, including clothing items intended for “regular wear or formal occasions including, but not limited to, undergarments, shirts, pants, skirts, dresses, overalls, bodysuits, vests, dancewear, suits, saris, scarves, tops, leggings, leisurewear, formal wear,” outdoor apparel and children’s clothes, including onesies, bibs and diapers. Previously, outdoor apparel and outerwear had been exempt.

Notably, the bill does not include professional uniforms worn to protect the wearer from health or environmental hazards. However, PFAS would be banned in high-performance outerwear for severe wet conditions starting in 2028.

The new bill also adds penalties and creates timelines for banning the use of PFAS in most clothing. In terms of penalties, the bill requires the state Department of Environmental Conservation to set a threshold for PFAS, including unintentionally added chemicals, which would take effect by 2027. Initial violations would be subject to a civil penalty of up to $1,000 a day, and continued violations would be subject to a penalty of up to $2,500 per day.

According to the TRI Analysis, in 2021, 44 facilities reported managing 1.3 million pounds of PFAS as waste, compared to 800,000 pounds reported in 2020. While most such waste is recycled, facilities reported 108,000 pounds in releases of PFAS containing waste, significantly more than the roughly 20,000 pounds of releases reported in 2020. Unsurprisingly, the hazardous waste management sector accounted for nearly 80 percent of these releases, primarily through regulated landfills, and the boost is largely attributable to one facility. Direct releases to the environment are a fraction of the reported numbers.

The spike in these numbers is likely attributable to updated reporting requirements required by the 2020 National Defense Authorization Act, which mandated PFAS reporting starting in 2021 (for the 2020 reporting year). Specifically, new reporting requirements under this Act included the addition of four PFAS to the list of 172 PFAS reported for 2020. EPA admits in the Analysis that the increase in PFAS managed as waste in 2021 is primarily due to reporting for one PFAS, perfluorooctyl oxide, one of the four chemicals added to the list for 2021.

In the Agency’s Press Release, EPA opines that

“Because PFAS are used at low concentrations in many products, this rule [to eliminate the de minimis exemption] would ensure covered industry sectors and federal facilities that make or use TRI-listed PFAS will no longer be able to rely on the de minimis exemption to avoid disclosing their PFAS releases and other waste management quantities for these chemicals.”

It certainly appears that EPA is poised to eliminate the exemption in its anticipated final rulemaking on the matter.

Many industry stakeholders, however, emphasize that the de minimis exemption is necessary to make the TRI program more workable in practice by limiting the need for reporting entities to hunt for information on miniscule amounts of substances that generally pose little to no risk.

If adopted, the proposed National Primary Drinking Water Regulation (NPDWR) would set legally enforceable individual Maximum Contaminant Levels (MCLs) for two of the best known PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), at 4.0 parts per trillion (ppt). 4.0 ppt is understood as the current laboratory detection limit for PFOA and PFOS, and signals that EPA intends for the limits to be set at the most stringent possible level. If adopted at 4.0 ppt, the MCLs for PFOA and PFOS would be the most restrictive in the nation, and states and U.S. territories will be required to adopt MCLs at or below the same standard within two years.

EPA also proposes using a risk-based standard for mixtures of four additional PFAS compounds in drinking water: perfluorohexane sulfonic acid (PFHxS), hexafluoropropylene oxide dimer acid (HFPO-DA) and its ammonium salt (also known as a GenX chemicals); perfluorononanoic acid (PFNA); and perfluorobutane sulfonic acid (PFBS).^[1] For these compounds, the regulation would require use of a formula to determine if any mixture of these chemicals in drinking water, taken together, has a “Hazard Index” (HI) score of 1.0 or greater, which indicates potential risk of adverse health effects.

To understand how all three of these proposed standards would impact their operations, public water systems should immediately review past sampling results to determine whether they exceed the proposed limits. Public water systems should also begin planning and evaluating costs to comply, despite the lack of an immediate deadline to do so, with the proposed standards.

SDWA also requires the Administrator of the EPA to propose a maximum contaminant level goal (MCLG) simultaneously with the NPDWR.^[2] The MCLG is a non-enforceable public health goal that represents a level at which no known adverse health effects are expected to occur. Because EPA determined PFOA and PFOS are likely carcinogenic to humans, the agency proposes MCLGs of 0.0 ppt. The proposed MCLG for any mixture of PFNA, PFHxS, PFBS, and GenX Chemicals is HI 1.0.

The proposed rule is the latest in a series of actions EPA is taking to address PFAS pollution. In March 2021, pursuant to its “PFAS Strategic Roadmap: EPA’s Commitments to Action,” EPA issued a final determination to regulate PFOA and PFOS as contaminants under SDWA. As mandated by SDWA, the proposed rule comes 24 months after determination.^[3] Once published in the Federal Register, the public will have the opportunity to provide verbal or written comments to EPA on the proposed rule.^[4] Following the public comment period, EPA expects to issue the final regulation by the end of 2023. It is important for any entity that seeks to modify or influence the proposed standards to fully participate in EPA’s administrative process.

If adopted, in concert with EPA’s pending proposed rule to list PFOA and PFOS as hazardous substances under the federal Comprehensive Response, Compensation, and Liability Act (CERLCA), the MCLs for PFOA and PFOS may be expected to be adopted into remedial actions performed pursuant to 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 MCLs for PFOA and PFOS may affect remedial activities required under state environmental remedial programs, such as state equivalents of CERCLA.

EPA is authorized to promulgate an NPDWR under SDWA based on its determination that these six PFAS may have adverse health effects, occur in public water systems with a frequency and at levels of public health concern, and that, in the sole judgment of the Administrator, their regulation presents a meaningful opportunity for health risk reduction for persons served by public water systems.^[5] EPA anticipates that, if fully implemented, the rule will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses.

[1] In the proposed rule, EPA issues a preliminary regulatory determination to regulate PFNA, PFHxS, PFBS, and GenX Chemicals.

[2] SDWA 1412(a)(3); 42 U.S.C. 300g-1(a)(3).

[3] SDWA 1412(b)(1)(E); 42 U.S.C. 300g-1(b)(1)(E).

[4] EPA, in its proposal, specifically requests comment on whether water systems should be permitted to apply to the relevant state agency for monitoring waivers and whether the identification of possible alternatives to traditional vulnerability assessments should be considered to identify risk.

[5] SDWA 1412(b)(1)(A); 42 U.S.C. 300g-1(b)(1)(A).

New York Governor Kathy Hochul signed the bill into law on December 30, 2022, which will officially eliminate the use of PFAS in all apparel by December 31, 2023. The law follows on the heels of New York’s PFAS ban in food packaging that became effective on December 31, 2022.

In September of last year, California enacted a similar ban on PFAS in clothing. The Golden State’s law prohibits the distribution, sale, or offering for sale of any new textiles that contain PFAS beginning on January 1, 2025. While New York clearly drew upon the California law, and similar laws in other states, the New York law is less detailed. For example, while California prescribes a compliance process by which manufacturers are to provide retailers and distributors with a "certificate of compliance," no such provision is included in New York. Similarly, California also includes a provision, absent in New York, requiring the use of the "least toxic alternative" when substituting for PFAS.

Perhaps the most interesting difference in the two state laws, however, is that while both ban the intentional use of PFAS in apparel (i.e., chemicals with an intended function or technical effect in the product), California also attempts to address residual PFAS levels by including a ban on total organic fluorine content above 100 ppm by 2025 and 50 ppm by 2027.

“Other state are considering action on PFAS in garments, including Washington and California, which will address the problem via their existing regulatory processes. States such as Vermont and Massachusetts have pending legislation that could effect the use of PFAS in garments.”

Notably, the New York law does not apply to “professional uniforms or outerwear intended for extreme conditions.” Presumably, further guidance will be forthcoming to further define this exemption, which is intended to address both severe wet-weather and dangerous fire fighting or similar conditions. For instance, PFAS serve a dual function in apparel worn by firefighters: PFAS aid in flame-suppression foams and fire-suppressive clothing, and they are water resistant, meaning the material does not become soaked and heavy during use.

The bill eliminates the use of PFAS in all apparel by December 31, 2023.

On February 7, the EU Chemical Agency (“ECHA”) issued the plan – known as the “Universal Restriction Proposal” – that would ban the use of PFAS in many of the most common applications (such as clothing, food packaging, cookware, and cosmetics) within 18 months of enactment. For products where PFAS-free alternatives are known but not widely available (e.g., technical textiles for medical applications, industrial food and feed production, hard chrome plating), a five-year phase-in ban would apply. For products where alternatives are currently unknown (e.g., professional protective apparel, certain specialty textiles, laboratory refrigerants), the ban would be phased-in over 12 years. The ban would apply to imports as well as domestically-produced goods.

The proposed ban would apply to nearly 10,000 different PFAS chemical formulations, with few exceptions, and is intended to cover the vast majority of PFAS uses. The chemical scope of the restriction proposal is broadly defined as: “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).”

The proposal – which was crafted by Germany and the Netherlands with support from Norway, Sweden and Denmark, after the countries compiled a “dossier” reflecting several years of research – recommends that the chemicals be restricted under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) regulation.

“This proposal is actually the broadest restriction proposal that has ever been prepared and submitted.”

- Frauke Averbeck, German Federal Institute of Occupational Safety and Health, February 7

Following release of the proposal, ECHA’s two scientific subdivisions, the Risk Assessment Committee (“RAC”) and the Socio-Economic Analysis Committee (“SEAC”), will now conduct their own scientific evaluation. This process usually takes about a year, but, given the complexity of the matter, some experts anticipate an even longer review period.

A six month public comment process (“open consultation” period in EU parlance) is scheduled to start on March 22. During this process, interested parties can submit comment on the proposed restrictions to ECHA, as well as provide information on the availability of PFAS-free alternatives or lack thereof. An online information session will be held April 5.

Once ECHA reviews the committees’ scientific evaluations and stakeholder comments, the agency will finalize recommendations to submit to the European Commission, which, together with the EU Member States, will then vote on the potential restriction. The proposal is expected to be issued as a final rule sometime in 2025, potentially going into effect in 2026 or 2027.

The proposed restrictions will have global ramifications. In addition to EU-based product manufacturers and end-users, imported products also are covered by the ban. Such a broad ban will necessitate careful supply chain communication and oversight to ensure that product components and raw materials do not contain banned PFAS. Such supply chain management can be particularly challenging given the widespread historical use of PFAS and their presence as impurities or residuals in a wide variety of recycled materials and other raw materials. Further, demand for PFAS-free alternatives is likely to become intense and lead to potential shortages of needed production inputs.

While the ban is not likely to come into force for several years, companies are advised to start planning now to evaluate the presence of PFAS in their products and throughout their supply chain, as well as to develop and secure PFAS-free alternatives.

When the 2021 TRI data were published last year, those following the ever evolving world of PFAS were initially surprised to see such a small PFAS presence represented. Indeed, of the 75,890 total entries reported to TRI for all chemicals in 2021 (from nearly 21,000 facilities), EPA received merely 92 PFAS reporting forms on 46 different PFAS from 45 facilities. This information seems even more jarring considering that approximately 650 PFAS are currently in commerce (though only 172 are currently subject to TRI reporting) from about 120,000 facilities.

The reason for this gap was the vast employment of an aptly named “de minimis” exemption, a long-standing TRI policy that allows facilities to ignore amounts of substances in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens). The Agency has signaled since 2020 that it planned to do away with the exemption for PFAS, and the December 5 proposal follows through on that pledge.

In announcing the rule, EPA asserted that it “would ensure that covered industry sectors and federal facilities that make or use TRI-listed PFAS will no longer be able to rely on the de minimis exemption to avoid disclosing their PFAS releases and other waste management quantities for these chemicals.”

By removing this reporting loophole, we’re advancing the work set out in the Agency’s PFAS Strategic Roadmap and ensuring that companies report information for even small concentrations of PFAS. We will make this information available to the public so EPA and other federal, state and local agencies can use it to help best protect health and the environment.

EPA Administrator Michael Regan

The Agency and several environmental organizations have argued in the past that the so-called “reporting loophole” of the de minimis exemption allows facilities to avoid reporting releases of potentially significant amounts of TRI-listed chemicals, thereby diminishing public trust, obfuscating transparency, and keeping community members in the dark about chemicals they believe to be hazardous to human health. The Sierra Club alongside other organizations, for example, have sued EPA claiming that the exemption is not statutorily permitted. The case, National PFAS Contamination Coalition, et al. v. EPA, is currently pending in the United States District Court for the District of Columbia.

However, as pointed out by the reporting community of industry stakeholders, the de minimis exemption helps make the TRI program more workable in practice by limiting the scope of substances for which reporting is required and not requiring companies to chase down information on miniscule amounts of substances present at trace quantities that generally pose little to no risk.

For certain chemicals of “special concern” – such as mercury, dioxins, lead, and other “persistent, bioaccumulative, and toxic” substances – EPA previously has eliminated availability of the exemption, as well as the TRI short-form (Form A) reporting option. The proposed rule would add PFAS to the category of chemicals of “special concern.”

In order to ensure that downstream users are informed of the presence of “special concern” chemicals in mixtures and products they purchase, the proposed rule also would make the exemption unavailable for supplier notification requirements.

The Act creates two new requirements for cookware manufacturers. First, they must disclose the presence of “hazardous chemicals,” including PFAS, bisphenol A (“BPA”), and over 3,000 other substances included on the California Department of Toxic Substances (“DTSC”) Candidate Chemical list. The Act applies to cookware manufacturers "whose name appears on the product label, or person who the cookware is manufactured for or distributed by (as identified by the product label).” “Cookware” includes “durable houseware items that are used in homes and restaurants to prepare, dispense, or store food, foodstuffs, or beverages. ‘Cookware’ includes pots, pans, skillets, grills, baking sheets, baking molds, trays, bowls, and cooking utensils.”

By January 1, 2023, cookware manufacturers must post on the internet website for the cookware product: (1) a list of all chemicals “intentionally added” to the cookware (i.e., chemicals that have a functional or technical effect in the product) that are also present on the DTSC Candidate Chemical list; (2) the names of the authoritative list or lists referenced by the DTSC; and (3) a link to the internet website for the authoritative list or lists.

By January 1, 2024, similar information must be disclosed on the product packaging, as well as third party retail websites where the product is sold. There is an exception to the on-product disclosure requirement if the surface area of the cookware cannot fit a product label of at least two square inches and the cookware does not have either (1) an exterior container or wrapper on which a product label can appear or be affixed; or (2) a tag or other attachment with information about the product attached to the cookware.

Second, the Act prohibits manufacturers from advertising that a product is “free” of a chemical when other chemicals from the same chemical class are present. For example, a pan labeled as “PFOA-free” would be non-compliant if it contains other PFAS, such as PTFE. While this is primarily targeted at PFAS claims, the ramifications extend to other classes of chemicals (such as phthalates).

Cookware manufacturers should promptly review the ingredients in their products to determine if any appear on the DTSC list and, if so, prepare the required website disclosure. Given the extent of the chemical list, it is likely that many cookware products will be subject to the disclosure requirements.

Released on October 11th, the paper, “Presumptive Contamination: A New Approach to PFAS Contamination Based on Likely Sources” (published in Environmental Science & Technology Letters), aims to fill existing data gaps by positing that

[I]n the absence of high-quality data to the contrary, PFAS contamination is probable near facilities known to produce, use, and/or release PFAS, and to protect public health, the existence of PFAS in these locations should be presumed until high-quality testing data is available.

(1) Fluorinated aqueous film-forming foam ("AFFF") discharge sites: military sites, airports, firefighting training sites, and "high-hazard flammable liquid fire" sites such as those associated with oil and gas extraction, petroleum refineries, bulk storage facilities, and chemical manufacturing, as well as railroad crashes.

(2) Industrial facilities that produce or use PFAS: Identified largely through the limited scope of facilities that reported PFAS use under the U.S. Environmental Protection Agency ("EPA") Toxic Release Inventory ("TRI") program.

(3) Sites related to PFAS-containing waste: Including PFAS-contaminated effluent and sludge from wastewater treatment plants ("WWTPs"), as well as solid waste disposal sites.

The authors note that "State and federal agencies can use a presumptive contamination approach to identify and prioritize locations for monitoring, regulation, and remediation."

The information from this study is particularly notable on the heels of EPA's August 2022 proposal to add two PFAS chemicals (PFOA and PFOS) to the list of hazardous substances under the Superfund program. Clearly, the magnitude of PFAS contamination in the United States is extraordinary, and raises the potential for thousands of clean up actions (and regulatory enforcement) at sites across the country.

For textiles, the law requires manufacturers to provide retailers and distributors with a certificate of compliance stating that the product does not contain any "regulated PFAS," which are defined as PFAS "that have a functional or technical effect in the product." Further, the ban applies to PFAS present in textile articles present above certain minimum thresholds, as measured by total organic fluorine content: 100 parts per million as of January 1, 2025, with a reduction to 50 parts per million in 2027.

The law also requires a manufacturer to use the "least toxic alternative" when replacing regulated PFAS in textile articles. The term "least toxic alternative" is not defined in the legislation but presumably envisions a process similar to the "Alternatives Analysis" required for manufacturers of products subject to the state's Safer Consumer Products (SCP) program.

Notably, the PFAS prohibition is delayed until 2028 for "outdoor apparel for severe wet conditions." Such products, however, must be clearly labeled as “Containing PFAS chemicals” starting January 1, 2025. Full exemptions from the ban are provided for “personal protective equipment” (PPE) and “clothing items for exclusive use by the United States military.” Carpets and rugs are excluded from the ban as they are currently regulated under the SCP program.

The cosmetics ban extends a previous California law prohibiting 13 specific PFAS chemicals to all of the thousands of different PFAS substances in existence. No minimum PFAS content threshold is provided in the law, which may present a challenge to companies seeking to demonstrate that PFAS have not been intentionally added to a cosmetics product and that any amount identified is from contamination in raw materials, water or other unknown sources.

While the California ban is among the most aggressive legal prohibitions related to PFAS in products, the scope of the ban does not go as far as recent legislation adopted in Maine, which applies to all products containing intentionally added PFAS (unless for "unavoidable uses" which have yet to be defined). The California prohibition, however, goes into effect much sooner (starting in 2025) than the 2030 ban in Maine. (Maine has banned PFAS in carpets and rugs as of 2023.)

Governor Newsom also declined to further extend California's PFAS regulations by vetoing legislation that would have required consumer product manufacturers to submit annual reports on intentionally added PFAS in all products and product components beginning in 2026. In 2021, Maine adopted a similar reporting requirement that goes into effect January 1, 2023.

With the final adoption of the California PFAS prohibitions, all eyes now turn to New York, where Governor Hochul is weighing signature of legislation passed earlier this year to ban intentionally added PFAS in apparel starting in 2024.