Following are some of those “insights," observations and other thoughts from the front lines of Prop 65.

This year, my attention turned heavily to the root causes of the widespread phenomenon known as “over-warning” – i.e., the practice of many businesses to provide a warning for a product out of an abundance of caution, even if one may not technically be necessary. As a result of over-warning, the marketplace (most noticeably in California but increasingly elsewhere as well) is saturated with warnings. Warnings appear on items throughout grocery store aisles, in parking garages and hotels, on restaurant menus, and all over items in “big box” stores. Naturally, consumers start to filter out and ignore such warnings as they become “white noise” in the background. Perhaps more importantly, the sea of unnecessary warnings drowns out the relatively small percentage of warnings that are appropriate and serve meaningful public health ends.

“Including the word ‘California’ on a Prop 65 warning is preferred [by businesses] because … Crazy California!”

My thoughts were struck by the title of one of the slides in the introductory “101” session of the conference: “Our Shared Goal: Public Health.” Great concept, truly, and hard to disagree with. But the statement presents a logical follow up question: Is Prop 65 the best way to achieve that goal of improved public health? I think the answer clearly is no. At minimum, Prop 65 provides incentives that only serve to sow confusion - and perhaps even nonchalance - about what is and is not safe. For example, it is not within a company’s expertise or ability to determine appropriate safe levels or to parse the complexities and ambiguities of toxicological data. And when the penalty is potentially so high - when even if you do a gold-plated risk assessment to demonstrate no warning is needed - you can still lose your case because of the uncertainties of the legal process (the burden of proof is on the business to prove any exposure was “safe,” plaintiffs can muddy the waters with their own experts and nitpick an assessment to raise doubts, and it is hard to predict how a given judge will rule). In short, the most rational option for a business often is to place a warning on your product, instead of taking on the task of making a “public health” determination on your own. Such determinations are not the province of individuals or companies and are best made by, well, the public through the application of publicly agreed upon policies (i.e., a regulatory process).

When the penalty that may be imposed – often by a private plaintiff group that is motivated by fee collection – is based on a moving or unknowable standard (an unknown “safe” level), Prop 65’s ask of a business is practically impossible. In such situations, of course, it makes sense to be overly cautious and put a warning on your product.

So, what is the solution? One thing that would greatly improve the system: California regulators (OEHHA) should establish safe harbor levels for all listed chemicals at the time of listing. Even if such a value may be an initial conservative estimate, having an approved “safe harbor” on the books for every chemical will provide some assurance to companies and minimize one of the most contentious and burdensome elements of the Prop 65 system. Providing such a default “safe harbor” value for every chemical would be one huge step towards minimizing “over-warning.”

Interestingly, a conference panel on the “over-warning” problem directly addressed this idea, with at least one panelist (a plaintiff attorney) noting that the lack of “safe harbor” levels for all chemicals and routes of exposure was “not a big issue.” While I respectfully disagree, there certainly are other, perhaps more effective, ideas to consider to minimize the proliferation of unnecessary warnings. From my perspective as defense counsel, the best idea I heard from the panel was to resurrect an idea from legislation proposed in 2015 that would provide a defense if a business had performed a prior exposure assessment for the product that indicated no warning was needed. While implementation would be tricky, as there could be arguments over whether such a risk assessment was consistent with established criteria, the availability of such a defense would serve the public health goals of Prop 65. Companies would be encouraged to look more seriously at the chemicals in their products and the potential for exposure, and minimize “over-warning” by providing more assurance that a determination that a warning is not needed would not be punished by a private enforcer that knows the burden of proof in court is on the company.

Without shifting the dynamics of the Prop 65 enforcement system – which greatly favor private plaintiffs and practically necessitate over-warning – there will be no reason for businesses to stop providing overly precautionary and unnecessary warnings.

Thanks for joining us at the conference and we hope to be broadcasting live and in person next year from the City by the Bay! As always, for the latest on Prop 65 stay tuned to Kelley Green Law Blog.

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 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.

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 Exposure Rule was first introduced in August 2020, the proposal established that consumption of foods containing acrylamide does not represent an “exposure” requiring a Prop 65 warning so long as the concentrations are “reduced to the lowest level currently feasible using appropriate quality control measures.” Similarly, the proposal adopted specific acrylamide concentration limits for specified food items deemed by OEHHA to be the lowest currently feasible. Thus, concentrations of acrylamide at or below these thresholds would not require a warning.

OEHHA initiated the Exposure Rule rulemaking in August 2020, issuing a series of proposals and revisions in response to comments. After the California Office of Administrative Law ("OAL") rejected a version of the proposed rule in March 2022, OEHHA promulgated further revisions in October. This version was finalized on December 23, 2022.

The final rule – which reflects OAL’s criticisms of earlier versions of the rulemaking, as well as public input – narrows the chemicals covered from all listed chemicals created by cooking or heat processing to only acrylamide in food created by those processes. Additionally, the new text replaces the term “quality control measures,” a vague and unhelpful string of words, and instead incorporates the United Nations’ Codex Alimentarius Code of Practice for the Reduction of Acrylamide in Foods, a helpful (and long) string of words which guide “quality control measures” with dramatically more precision. Notably, the final rule did not change the list of foods/food groups or the exposure levels of acrylamide in such foods that would trigger Prop 65 warning obligations.

The regulation becomes effective on April 1, 2023. The Final Regulation Text is available here. The Notice of Adoption is available here.

In finalizing the Safe Harbor Rule, OEHHA altered the warning language by providing for heightened specificity. The final text of the Safe Harbor Warning Regulation for Exposures to Acrylamide from Food, available online here, requires that the words “CALIFORNIA WARNING” be provided (instead of simply the word “WARNING”) in all capital letters and bold text. That phrase must then be followed by the statement:

Consuming this product can expose you to acrylamide, a probable human carcinogen formed in some foods during cooking or processing at high temperatures. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed. For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide.

The Safe Harbor Rule became effective on January 1, 2023.

Litigation on the acrylamide issue is certain to continue, and, in fact, challenges already have been brought against the Safe Harbor Rule. In early 2022, the Ninth Circuit upheld and extended an injunction issued in 2021 by a federal court judge in the Eastern District of California on the basis that the warning is “compelled speech” that is not “purely factual and uncontroversial” and, therefore, raises First Amendment concerns.

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.

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.

This is the second year that PFAS, known more colloquially as the “forever chemicals” due to their persistence and years-long degradation process, have made an appearance on the TRI, a publicly available database containing information on toxic chemical and waste management activities in the U.S. Their inclusion is relatively new, only being added to the TRI by the 2020 National Defense Authorization Act (“NDAA”).

The information filed for 2021 indicate that the 45 facilities managed over 1.3 million pounds of production-related PFAS waste during the year. These numbers seem odd given that approximately 650 PFAS are currently in commerce (though only 172 are subject to TRI reporting) from about 120,000 facilities that involve merely the handling and/or potential release of PFAS. Though you should seldom trust your lawyers with math, we can confidently say here that these numbers are just not adding up.

The explanation for this gap, though, is simple. The rules allow facilities to disregard certain levels of listed toxic chemicals in mixtures or products that they use. Under this aptly named “de minimis” exception, facilities are not required to report to the TRI certain minimal concentrations of chemicals in the materials they process. Though PFAS are persistent, their quantities in products are often below the de minimis reporting threshold.

EPA has signaled on several different occasions that they intend to eliminate the de minimis exception for PFAS in a forthcoming rulemaking. First, in the Agency’s October 2021 PFAS Strategic Roadmap, EPA stated its intent to categorize PFAS as a “Chemical of Special Concern,” thereby removing its eligibility for de minimis status. Just a few months ago, EPA signaled how it might go about doing that. When EPA published the 2021 TRI dataset last week, it again indicated that it “plans to enhance PFAS reporting under the TRI by proposing a rulemaking this fall that would, among other changes, remove the eligibility of the de minimis exemption for PFAS. If finalized, this proposal would also make unavailable the de minimis exemption with regard to providing supplier notifications to downstream facilities for PFAS and certain other TRI chemicals.” Just three weeks ago, EPA added five new PFAS to the TRI as well.

Indeed, the heat is on for EPA to act on PFAS. The Agency is making $1 billion available in grant funding to help communities struggling with PFAS contamination, and has recently updated its Health Advisories on four PFAS chemicals commonly found in drinking water, food packaging and cosmetics. That money comes from the Infrastructure Investments and Jobs Act, which in total, authorizes $5 billion for the Agency to reduce PFAS in environmental justice communities. This newfound financial support, combined with Congressional interest and widespread public scrutiny, all support the Agency’s move towards expanding PFAS reporting requirements and, more generally, the Agency’s aggressive stance towards mitigating PFAS.

It certainly appears that the days of PFAS eligibility under the de minimis exception are coming to a close. And, with that, we can expect a dramatically expanded TRI report in coming years.

While PFAS are subject to a lower reporting threshold (100 pounds per year) than most other TRI-listed substances (the typical thresholds are 25,000 pounds for manufacturing and processing activities, and 10,000 pounds for "otherwise use"), the de minimis exemption allows facilities to disregard certain minimal concentrations of the chemicals in the materials they process. In adding PFAS to the TRI list in June 2020, EPA retained the availability of the de minimis exemption for PFAS — which is 0.1% for perfluorooctanoic acid (PFOA) (due to its cancer classification), and 1% for all other PFAS. Accordingly, the quantity of PFAS in mixtures that contain less than the de minimis concentration do not need to be counted towards the reporting threshold or in release calculations.

Because PFAS are used at low concentrations in many products, the elimination of the de minimis exemption will result in a more complete picture of the releases and other waste management quantities for these chemicals.

- U.S. EPA Press Release, March 3, 2022

Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) requires facilities that manufacture, process or otherwise use TRI-listed chemicals to file annual reports (by July 1) with EPA providing details about their pollution prevention and waste management activities, including releases, of TRI chemicals during the prior calendar year. In June 2020, EPA officially added 172 PFAS to the list of chemicals reportable each year under the TRI program, with subsequent additions to that list, including four new listings in January 2022 for perfluorobutane sulfonic acid (PFBS), potassium perfluorobutane sulfonate, and two chemicals named only by their numeric chemical identifiers: Chemical Abstracts Service registry number (CASRN) 203743-03-7 and CASRN 65104-45-2.

The first reports for PFAS were filed with EPA by the July 1, 2021, deadline for the 2020 reporting year.

EPA's summary report of the 2020 TRI data states that 38 facilities reported for PFAS activities during 2020, managing 800,000 pounds of the chemicals with 9,000 pounds released. Predictably, half of the reports were filed by the chemical manufacturing industry sector, with 11 others from the hazardous waste management sector. The reports addressed 43 different PFAS, most commonly PFOA, perfluorooctanesulfonic acid (PFOS), and hexafluoropropylene oxide dimer acid (HFPO-DA). Of the quantities of PFAS released, over 90 percent were disposed of on site (55%) or transferred off site for disposal (36%), and, therefore, not directly released to the environment. Nine percent of reported "releases" were in the form of water discharges (5%) and air emissions (4%).

A copy of EPA's 2020 TRI National Assessment Report is available on the agency's website.

• Setting the maximum label size for short form warnings at 12 square inches (an increase from the originally proposed 5 square inches). OEHHA contends that the change addresses concerns that the original proposed limit was too small to be meaningful and that "a 12 square inch limit would accommodate these concerns, while still limiting use of the short-form warnings to packages with limited available label space for consumer product information that would not easily accommodate the full warning."
• Removing the originally proposed prohibition on use of the short form in online warnings or catalogs. Accordingly, the current regulatory language allowing on-line and catalog use of the short form warning for products that have the short form warning on package would remain in place. This shift responds to concerns about having "varying warning language for the same products," as well as the possibility of potential retailer liability for providing the incorrect warning language.
• Adding new signal word options “CA WARNING” or “CALIFORNIA WARNING” in lieu of the generic "WARNING" phrase at the start of the warning text. This shift follows an increasing trend in companies providing warning statements by referring to the California program explicitly in an effort to make clear to consumers that the warning is a product of California law (which may, perhaps, signal to sentient human beings that the warning is rooted in an oddball requirement coming out of the "Left Coast"; though, while a nod towards reality, not likely OEHHA's intended purpose).
• Including more warning options that "more directly address exposure to carcinogens or reproductive toxicants to provide an additional safe harbor warning that can be used on the product label." Currently, short form warnings look like:

WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov

If finalized, the new short form warnings options would include:

WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Risk of Cancer [and/or Reproductive Harm] From [Name of one or more chemicals known to cause cancer and reproductive toxicity] Exposure - www.P65Warnings.ca.gov

WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Risk of Cancer [and/or Reproductive Harm] from exposure to [Name of one or more chemicals known to cause cancer and reproductive toxicity] -- www.P65Warnings.ca.gov

or

WARNING [OR CA WARNING OR CALIFORNIA WARNING]: Exposes you to [Name of one or more chemicals known to cause cancer and reproductive toxicity], a [carcinogen/reproductive toxin] -- www.P65Warnings.ca.gov

EPR is a broad policy concept that covers a range of programs that, as defined by EPA, "place a shared responsibility for end-of-life product management on producers and other entities involved in the product chain." Notable examples include the European Union End-of-Life Vehicles Directive, and various U.S. state requirements that govern products such as appliances, electronics, vehicle switches, batteries, paint, pesticides, pharmaceuticals, and, of most recent note, product packaging. (See my blog post on a recent EPR product packaging laws in Maine, Oregon, and elsewhere.)

A circular economy is an industrial system that is restorative or regenerative by design. It is a change to the linear model from which resources are mined, made into products, and then thrown away. A circular economy reduces materials use, redesigns materials and products to be less resource intensive, and recaptures “waste” as a resource to manufacture new materials and products.

- EPA National Recycling Strategy

The strategy is likely to provide impetus for further adoption of EPR programs nationwide.

More information on EPA's National Recycling Strategy is available here.

Originally finalized this past January, the PBT rules immediately drew widespread criticism, particularly with regard to PIP (3:1) and the broad prohibition on the processing, import, and other distribution in commerce of components and products containing the substance, initially scheduled to come into effect on March 8, 2021. PIP (3:1) is a widely used plasticizer and flame retardant that is present in a wide range of components, particularly electronics including cell phones, laptop computers, wiring harnesses, and other equipment used across a broad spectrum of industries. With only limited exemptions in the current PBT rule, many companies were faced with a major compliance dilemma that could prevent access to and import of critical parts or materials. In response, EPA adopted a "no action assurance" policy that paused enforcement of certain provisions of the PIP (3:1) rule for six months. In September, EPA further extended the enforcement pause until March 8, 2022.

Now, EPA is proposing a further extension until October 31, 2024 of the compliance deadline for the provisions related to PIP (3:1) in articles.

EPA is proposing to further extend the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted.

- EPA Press Release, October 21, 2021

The latest proposed rule seeks to further extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, along with associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles.

In the proposal, EPA describes specific kinds of information the agency is seeking to support finalizing the proposed compliance date extension, including:

• Specific uses of PIP (3:1) in articles throughout their supply chains;
• "Concrete steps taken" to identify, test, and qualify substitutes for those uses;
• Specific product certifications that would require updating (such as flammability standards);
• An estimate of the time that would be required to remove the substance; and
• Documentation of specific needs for replacement parts, including the service life of the equipment and the identification of any applicable regulatory requirements for the assurance of replacement parts.

The provisions of the January 2021 rules remain in effect while EPA works on the new rulemaking effort, with the exception of PIP (3:1) as noted above.

Further information on the proposed PIP (3:1) rulemaking is available at EPA's website.