Kelley Green Law Chemical law, emerging contaminants, and regulatory news and insights Tue, 14 Nov 2023 09:54:31 -0500 60 hourly 1 The Prop 65 Annual Conference: Notes from the Front 2023 … “Over-Warning” is Here to Stay Thu, 28 Sep 2023 12:57:00 -0400 (Virtually) Live from San Francisco … Kelley Green Law Blog was delighted again to attend last week’s terrific Prop 65 Clearinghouse 2023 Conference, the largest annual gathering of the movers and shakers in the world of California’s “Proposition 65," including state regulators and legislators, plaintiff enforcers, defense and corporate counsel, tox and risk assessment consultants, product manufacturers, trade associations, and environmental and public health NGOs. With over 200 attendees, the conference’s popularity reflects the broad reach of Prop 65, which affects any business that sells or has a product that is sold in California … in short, most consumer product manufacturers across the globe (particularly with the explosion of internet sales during the pandemic). As I have remarked in prior commentaries (2018, 2020, and 2021), the conference is valuable not only to gain insights into the latest trends, current developments, and future direction of the program, but also as a helpful reminder, for me certainly, of the role and motivations of the other stakeholders in the Prop 65 universe.

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.

Maine Seeks Feedback on Types of Food Packaging Subject to PFAS Prohibition and Availability of “Safer Alternatives” Wed, 16 Aug 2023 00:00:00 -0400 After years of back-and-forth, the Maine Department of the Environment (“MDEP”) is seeking comment (by this coming Monday) on a “concept draft” regulation identifying the types of food packaging that would fall under a 2019 state ban on intentionally added per- and polyfluoroalkyl substances (“PFAS”).

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.

Washington State Adopts Restrictions and Reporting Requirements for PFAS, Flame Retardants, Phthalates and Bisphenols in Wide Range of Consumer Products Thu, 29 Jun 2023 07:05:00 -0400 Joining the ranks of California, Minnesota, Maine, and New York, Washington state has officially finalized a ban on the manufacture, sale, and distribution of a variety of products containing per- and polyfluoroalkyl substances (“PFAS”), as well as several other “high profile” chemicals of concern, including flame retardants, phthalates, and bisphenols.

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.

Draft Model State PFAS Legislation: A More Holistic Approach To Regulating "Forever Chemicals" in Consumer Products Mon, 22 May 2023 12:29:15 -0400 A recent Kelley Drye client advisory summarizes important new draft model state legislation that embodies an expansive approach to the regulation of per- and polyfluoroalkyl substances (PFAS) in consumer products. Crafted by the Northeast Waste Management Officials’ Association, Inc. (NEWMOA) and released earlier this month, the Draft PFAS Prevention Model Act (Draft Model) offers a menu of policy options for state legislatures to address potential PFAS contamination and exposure from consumer products. Most notably, the Draft Model includes a near-total ban on PFAS-containing consumer products within three years, product reporting requirements, "extended producer responsibility" obligations (i.e., product "take back"/recycling programs), and a new multi-jurisdictional “clearinghouse” to assist state environmental agencies with compliance and enforcement of the act.

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.

Maine Readies Proposed Rule on PFAS in Food Packaging Thu, 04 May 2023 14:03:28 -0400 The Maine Department of the Environment (DEP) plans to propose a long-awaited rule later this year aimed at eliminating per- and polyfluoroalkyl substances (PFAS) in food packaging. The proposed rulemaking was announced to state lawmakers by a DEP representative at a legislative hearing in late April, which also included discussions on a slew of recent proposals to amend Maine’s landmark 2021 law to ban PFAS in most other consumer products.

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.

Minnesota Considering Extensive Reporting Requirements and Ban on PFAS in Consumer Products Fri, 28 Apr 2023 06:30:00 -0400 Last week, the Minnesota House passed the state’s largest-ever environmental and natural resources funding bill, including a ban on per- and polyfluoroalkyl substances (“PFAS”) in many consumer products beginning in 2025, with a ban on most such applications in 2032. If passed in the Senate and signed by the Governor, The Gopher State would be the second state, after Maine, to impose near-total restrictions on PFAS in consumer products.

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.

Maine Reexamines PFAS Ban and Reporting Regulations Wed, 26 Apr 2023 12:32:55 -0400 “First movers” in a regulatory field often need to recalibrate their approach. Maine is no exception as it seeks to implement the broadest reporting and use ban in the country addressing per- and polyfluoroalkyl substances (“PFAS”) chemicals in consumer products. With other states watching their experiment carefully, Maine’s legislature and Department of Environmental Protection (“MDEP”) are considering significant adjustments to the ground-breaking program.

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 1st 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.

New York Expands PFAS Apparel Ban Tue, 21 Mar 2023 15:01:58 -0400 The New York state legislature has passed a bill (S.1322/A.994) to modify previous legislation that largely bans per- and polyfluoroalkyl substances (“PFAS”) in clothing and apparel by 2025 that was signed into law by Governor Kathy Hochul in the final hours of 2022.

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 Joins the Growing List of States with Bans on PFAS in Apparel Tue, 07 Mar 2023 12:45:51 -0500 Following in California’s footsteps, New York has recently joined a litany of States banning per- and polyfluoroalkyl substances (“PFAS”) in clothing and apparel.

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.

EU Proposes Ban on PFAS in Most Products Fri, 10 Feb 2023 17:45:45 -0500 The European Union (“EU”) is preparing to adopt the world’s most sweeping ban on per- and poly-fluoroalkyl substances (“PFAS”), including with respect to the presence of the so-called “forever substances” in practically all consumer and commercial products.

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.

Comments Due Soon on EPA Proposed Rule to Eliminate De Minimis Exemption for PFAS Reporting under the Toxic Release Inventory Program Fri, 20 Jan 2023 18:41:11 -0500 Comments are due February 3rd on EPA’s proposed (and much anticipated) rule to eliminate use of the de minimis exemption for reporting on per- and poly-fluoroalkyl substances (“PFAS”) under the Toxic Release Inventory (“TRI”) program.

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.

California Requires New Cookware Chemical Labeling Requirements by January 1st Tue, 29 Nov 2022 21:45:26 -0500 Cookware sold in California will be required to have chemical ingredient information disclosed on the product website by the new year. While part of a wave of legislation focused on per- and polyfluoroalkyl substances (“PFAS”), the California Safer Food Packaging & Cookware Act of 2021, which was signed into law by Governor Newsom in October 2021, requires cookware manufacturers to disclose the presence of thousands of chemicals in their products, starting on January 1, 2023. The legislation also restricts the types of “chemical-free” claims that companies can make in promoting their cookware products.

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.

California Bans PFAS "Forever Chemicals" in Clothing, Textiles, and Cosmetics Tue, 11 Oct 2022 13:01:06 -0400 California joined the growing list of states to ban products containing per- and polyfluoroalkyl substances (“PFAS”) when, on September 29th, Governor Newsom signed into law legislation prohibiting the so-called "forever chemicals" in apparel, textiles, and cosmetics. The ban goes into effect beginning in 2025, and applies to the sale, manufacture and distribution of new cosmetics and textile articles (defined to include apparel, accessories, handbags, backpacks, draperies, shower curtains, furnishings, upholstery, beddings, towels, napkins, and tablecloths) that contain "intentionally added" PFAS.

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.

Maine Makes a Bold Move in Banning Most PFAS-Containing Products Mon, 29 Aug 2022 16:12:08 -0400 Last month, the Maine legislature introduced broad and sweeping restrictions on a range of products containing per- and polyfluoroalkyl substances (“PFAS”). These restrictions are some of the most comprehensive in the country, and, in effect, would ban 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.” Though PFAS have faced heightened public and regulatory scrutiny in the last few years, an outright ban like this is the first of its kind. Unsurprisingly, environmentalists and industry-members are clashing on the merits of the restrictions, with the former heralding it as a guiding light for other states to follow, and the latter fearful that it is the latest contribution to a balkanized regulatory system that will paralyze industry and deprive consumers of essential goods.

The “unavoidable use” exception to the pending ban is the subject of a rulemaking process by the Maine Department of Environmental Protection (“DEP”) and awaits further detail. Depending on the nuances of this exception, the law could very well ban a vast range of products. Compliance for many companies is expected to be difficult, and given already strained supply chains, could result in certain products not being sold in the state altogether. Moreover, the law imposes a heavy administrative burden on the DEP, which will now be tasked with verifying compliance for a massive swath of products, ranging across fabrics, cleaning products, paints, fire-fighting foams, cookware, food packaging, food processing equipment, and cosmetics, among others.

A particularly notable criticism is that all PFAS are not the same. Indeed, there are over 9,000 types of PFAS (identified so far), each with their own unique chemical makeup and profiles. Maine’s bold stroke is therefore scientifically overbroad and will impose unnecessary burdens on many of the product manufacturers and retailers doing business in the state. Moreover, in a state that has ambitions of transitioning to more renewable energy sources, PFAS provide crucial insulation and physical, thermal, and chemical resistance to technologies vital to solar and wind energy.

Science driven and industry sensitive alternatives are certainly prevalent in sister states. In fact, states like California, Colorado, Connecticut, Hawaii, Maryland, Minnesota, New York, Oregon, Rhode Island, Vermont and Washington, have enacted less restrictive PFAS statutes than the total ban Maine proposes. Many of those states too, along with Georgia, Iowa, Massachusetts, Michigan, New Hampshire, New Jersey, North Carolina, Pennsylvania and Wisconsin all have proposed legislation regulating PFAS in some capacity.

That said, current scientific research suggests that exposure to high levels of certain PFAS may lead to adverse health outcomes. This, combined with their presence in various environmental media, consumer goods, and food product packaging, could make them a broad and slow-building threat to human health.

Given the sophistication and complexity behind PFAS regulation, painting with broad prohibitions like Maine’s is certainly bold. No other state in the union, even those with notoriously more rigid regulatory structures for environmental issues, have an outright and total ban on PFAS. A one-size-fits-all solution is simply impractical and overbroad, disrupting economies and industry while reducing consumer’s access to essential goods and services. Of course, when health is at stake, further investigation is warranted. This analysis can and should be conducted in a way that is congruous with the nation’s recovering supply chain and economic apparatus.

The Prop 65 Pandemic: No Covid Slow-Down for Enforcement Tue, 15 Feb 2022 17:53:46 -0500 While the Covid-19 pandemic caused all sorts of disruptions to society and the economy, at least one area of business has thrived over the last two years: private plaintiff enforcement of California Proposition 65. In 2020-2021, over 40% more Prop 65 actions were brought by private plaintiff "bounty hunters" than in the two years prior to the pandemic (2018-2019). Compared to a decade ago, private plaintiff groups now initiate three times more Prop 65 actions each year, and five times more than in 2008.

Unsurprisingly, the most frequently cited chemicals continue to be phthalates (BBP, DBP, DEHP, DIDP, DINP, and DnHP) and lead, which together account for over 70% of cases. Almost half of all cases involve at least one of the six phthalates (1,557 in 2020, 1,374 in 2021), followed slightly by lead (1,134 in 2020, 1,094 in 2021). Acrylamide is the next most commonly noticed Prop 65 chemical (453 in 2020, 264 in 2021) due to its prevalence in a number of different types of food products (it may be formed during heat processing of foods containing sugars), though litigation over the validity of requiring Prop 65 warnings for acrylamide in foods apparently has curtailed the number of such actions, at least for the time being. The decrease in acrylamide cases also likely accounts for some of the difference in total cases between 2020 and 2021. Cadmium (239 in 2020, 224 in 2021), bisphenol A (83/94), and arsenic (88/75) are the other most common chemicals in Prop 65 actions.
YEAR # of 60-Day Notices of Violation* YEAR # of 60-Day Notices of Violation*
2021 3,184** 2014 1,404
2020 3,514 2013 1,097
2019 2,410 2012 908
2018 2,358 2011 1,079
2017 2,711 (2,036)*** 2010 787
2016 1,576 2009 604
2015 1,336 2008 632

* Total number of 60-Day Notices reported on California Attorney General website database (may include amended notices; some notices include multiple businesses not reflected in total).

** Lower total from 2020 likely due to reduced number of acrylamide cases initiated due to court injunction against new acrylamide suits in March 2021 (injunction lifted in May 2021) and ongoing litigation over Prop 65 warnings for acrylamide in food.

*** 2017 totals inflated by ~700 anomalous cases filed in approximately two weeks related to cannabis products.

Data from the fourth quarter of 2021 -- courtesy of the chart below from Scott Dwyer at ToxRisk Consulting, LLC in Washington state -- shows that even the holidays do not significantly curtail plaintiff Prop 65 activity.

One particularly notable addition to the list: the first cases are now emerging involving Perfluorooctanoic Acid (PFOA), one of the PFAS "forever chemicals" that is currently dominating the attention of federal and state regulators. Expect to see the Prop 65 case numbers for PFOA and other PFAS chemicals (several are in line to be listed under Prop 65) rise dramatically in coming months.
Q4 2021 - Notices of Violation
Chemical NOVs Example Products
Phthalates (DEHP, DIDP, DINP, and DBP) 306 Tote bags, tool grips, sporting goods, toy bags, upholstery
Lead 273 Prepared seafoods, dried fruits, dietary supplements, baked goods, ceramic ware, spices
Cadmium 79 Spinach, spaghetti, macaroni, seaweed, frozen and prepared seafoods, dietary supplements
Acrylamide 34 Baked and toasted foods, including chips, cookies, and crackers
Bisphenol A 19 Phone cases, hunting calls, socks
Arsenic 18 Spices, kelp, and seaweed
Benzene 16 Personal care products, including sunscreen and hand sanitizer; crude oil
Diethanolamine 9 Skin and shaving cream, hair gel, sunscreen
Titanium dioxide 7 Cosmetics
Cocamide diethanolamine 7 Shampoo and body wash
Asbestos 6 Cosmetics
Perfluorooctanoic Acid (PFOA) 5 Cosmetics and personal care products
delta-9-Tetrahydrocannabinol 4 CBD oils
Wood dust 3 Sawdust and wood shavings
Chromium (hexavalent compounds) 2 Foundry emissions, apparel belt
Marijuana smoke, Tobacco smoke 2 Marijuana cigarettes
N-Nitrosodiethylamine 2 Latex resistance bands
Carbaryl 1 Olive oil
Formaldehyde (gas) 1 Laminate wood flooring
Methylmercury compounds 1 Edible fungi products
Talc containing asbestiform fibers 1 Cosmetics

California Tweaks Proposed Revisions to Limit Use of Prop 65 "Short Form" Warnings (Updated) Thu, 16 Dec 2021 18:48:26 -0500 Almost a year after initially proposing revisions that would substantially curtail use of the popular "short form" warnings under Proposition 65 (see my prior blog post for more details), the California Office of Environmental Health Hazard Assessment (OEHHA) has issued a modified proposal and requested public comment by January 14, 2022. [UPDATE: OEHHA subsequently extended the comment period to January 21st.] The modifications, which slightly scale back the initially proposed restrictions but would continue to dramatically limit use of the short form warning, include:
  • 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 –

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 -

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] --


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] --

A copy of the proposed revised regulation and OEHHA's explanatory notice are available at: Notice of Modification to Text of Proposed Regulation Title 27, California Code of Regulations Proposed Amendments to Article 6 Clear and Reasonable Warnings – Short Form - OEHHA.

New EPA Nationwide Recycling Strategy Highlights "Extended Producer Responsibility" Programs in Advancing the "Circular Economy" Tue, 16 Nov 2021 16:53:40 -0500 The U.S. Environmental Protection Agency's (EPA's) final National Recycling Strategy, released yesterday, includes prominent mention of "extended producer responsibility" (EPR) as a prime example of programs that advance the "circular economy" by increasing "materials recovery at the state and local levels." The inclusion is notable in that EPR was not mentioned in earlier drafts of the agency's recycling strategy, and is testament to the growing prominence of EPR programs at the state and international levels.

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

While the National Recycling Strategy provides no details on appropriate elements of the design and structure of EPR programs, it emphasizes that "governments need to know when to use them and what conditions make them successful. Efforts under this area aim to increase coordination, availability and accessibility of information on recycling programs and policies at the federal, state, tribal and local levels."

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.

EPA Proposes Extension Until 2024 for Compliance with Problematic PBT Rule Tue, 26 Oct 2021 17:50:04 -0400 As the U.S. EPA embarks on a full review of regulations addressing the sale, distribution and use of five "persistent, bioaccumulative and toxic" (PBT) substances, the agency already is proposing to extend until 2024 the compliance date with the existing rule for one of the five PBTs - phenol, isopropylated phosphate (3:1) (known as "PIP (3:1)").

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 current proposed extension follows the agency's September announcement that it plans to propose by the Spring of 2023 new rulemakings for all five PBT chemicals addressed in the January 2021 final rule: in addition to PIP (3:1), Decabromodiphenyl ether (DecaBDE), 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP), Hexachlorobutadiene (HCBD), and Pentachlorothiophenol (PCTP).

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.

The Prop 65 Annual Conference: Notes from the Front 2021 Mon, 27 Sep 2021 19:31:38 -0400 (Virtually - once again) Live from San Francisco, Kelley Green Law Blog is reporting today from the Prop 65 Clearinghouse 2021 Conference ... the largest annual gathering of stakeholders from the full spectrum of actors involved with California’s “Proposition 65," including state regulators and legislators, plaintiff enforcers, defense and corporate counsel, tox and risk assessment consultants, product manufacturers, trade associations, and environmental and public health NGOs. The popularity of the conference, with over 250 participants, continues to demonstrate the extensive reach of Prop 65, touching businesses well-beyond the borders of California, particularly with the exponential growth over the last several years in product sales over the internet. As I have remarked in prior commentaries (2018 and 2020), the conference is valuable not only to gain insights into the latest trends, current developments, and future direction of the program, but also as a helpful reminder, for this defense counsel, of the role and motivations of the other stakeholders in the Prop 65 universe.

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


I started my career as a pre-school teacher - which proved to be good preparation for dealing with [Prop 65] stakeholders!

- Carol Monahan Cummings, Chief Counsel of OEHHA and Conference Chair

  • Conference Chair, Carol Monahan Cummings, Chief Counsel of the Office of Environmental Health Hazard Assessment (OEHHA) for the past 18 years, provided the "view from the lead agency" and highlighted OEHHA's work over the last two decades to make warnings more meaningful to consumers and less vague, as well as OEHHA's attempts to reduce the "over-warning" phenomenon. I would argue that the effort on the first issue has proven relatively successful (e.g., adding chemical names to the warnings and establishing webpages to provide more detail on potential exposures), but that OEHHA has been spectacularly unsuccessful in addressing "over-warning."
  • Over-warning was a common theme running through many of the panel discussions. For years, OEHHA and private plaintiff enforcers have bemoaned the proliferation of Prop 65 warnings on products for which a warning technically may not be required (due to no or minimal exposure, for instance) but is provided "prophylactically" to avoid the risk of a lawsuit. As summarized by Eric Somers with Lexington Law Group, which represents the Center for Environmental Health, a prominent Prop 65 enforcement organization: "Over-warning diminishes the impact of warnings over time ... consumers become less risk averse about those warnings and less inclined to take steps to avoid the exposure ... and companies will be less inclined to [do something to] reduce exposures to the chemical."
  • However, "prophylactic" warnings are entirely reasonable from a business perspective. As one defense counsel panelist summed it up: "it is simple cost-benefit analysis ... if the chemical is there, unless your science [showing no exposure] is undisputed" -- something that is very rare -- "then the business is looking to mitigate risks."

If the chemical is there, then I'd be hard-pressed to say that there is not a risk [of being sued].

  • In discussing the future of the current "short-form warning," panelists were in agreement that OEHHA's contention that proposed amendments are needed in part because the short-form warning contributes to over-warning was a "red herring." The over-warning phenomenon long-preceded adoption of the short-form option in 2016. Eric Somers, with the plaintiff-side Lexington Law Group, summarized: "Over-warning is caused by aggressive enforcement and the business desire to mitigate risk."
  • Over-warning is not the result of specific regulatory safe-harbor warning text or mechanisms of delivery; rather, it is directly related to the practical reality that to avoid being forced into a settlement the only other option for a business is to go to trial, with all its related uncertainties and costs. As I wrote at the time the 2016 amendments were adopted: "By focusing exclusively on the question of how to provide 'clear and reasonable' warnings, ... the amendments fail to address perhaps the most important question facing businesses confronted with Proposition 65 compliance: the issue of when warnings are required is not addressed at all. Hence, businesses will remain challenged by the paramount issue of whether a warning is required, particularly for a product that may contain a listed chemical but for which the company believes, based on its own due diligence and proper science, that exposure is below a safety threshold.... While a business rightfully should develop data on potential exposures to a listed chemical in a product, and assess the safety of that exposure, plaintiffs remain free to challenge such exposure/safety assessments and drag businesses into the expensive and time-consuming Proposition 65 enforcement process."
  • OEHHA earlier this year proposed to limit the use of "short-form" warnings to situations where space is constrained (products with 5 square inches of label space or less); to eliminate their use for internet and catalog warnings; and to require identification of a chemical for which the warning is being provided.
  • Objections from the business community are focused more on the process than the content/details of the short-form warning: after going through a multi-year regulatory process that resulted in the current "short form" option in 2016, and having now implemented those label changes, it is frustrating to have to "go through this again" only a few years later. "Changing a label on a product is expensive."
  • Factors that plaintiffs consider in assessing whether to bring a case:
    • The potential for harm if nothing is done, particularly with respect to chemicals with adverse impacts at low exposure levels (such as lead)
    • Opportunities for reformulation to reduce or eliminate exposures to a listed chemical in a product
    • The potential for a broad industry-wide impact by provoking change in a manufacturing process or inputs
    • Whether a warning would be effective if reformulation is not viable
    • Environmental justice (EJ) impacts - seek to address marketing of certain products to EJ communities (based on input from those living in and actively working with EJ communities)
  • Great discussion of the pending First Amendment case involving warnings related to acrylamide in foods (CalChamber vs Bonda, 9th Circuit): does compelling a "safe harbor" warning violate the First Amendment rights of a business? By way of legal background, such "compelled speech must be purely factual and non-controversial." How does this standard apply for a chemical, such as acrylamide (or, in a prior case, glyphosate) where there remains robust scientific debate about the risk of cancer or reproductive harm from exposure to a given chemical?
  • Ideas for addressing the explosion of food cases that do not address realistic risks: reform the certificate of merit process to make the plaintiff's initial showing more robust for chemicals in food; adopt more "safe harbor" levels for acrylamide and other chemicals that form in specific foods to provide more certainty for industry; require a "meet and confer" process prior to litigation for the parties to determine what the appropriate level of the substance should be in food.
  • As a lawyer that has represented many new and often smaller companies in navigating the waters of Prop 65, it was great to see a panel session dedicated to the challenges "small businesses" face in complying with Prop 65. Small companies typically lack the resources that larger businesses have to assess compliance with Prop 65 (testing, risk assessment), implement appropriate warning and labeling, or to defend a case when a plaintiff comes calling (or even to "call their bluff"). While there is a "small business" exemption (for companies with less than 10 employees), in practice, the exemption often is of little utility due to indemnity provisions commonly found in contracts between small business producers and downstream distributors and retailers. Panelists cited strong arm tactics by some plaintiffs to "buffalo" small businesses into a settlement. Others cited the impact of broader industry-wide settlements (put together by larger players in an industry or trade associations) that are onerous for small businesses to comply with.
  • The good news is that (once again) reform legislation is being developed in the California Assembly ... however, amendments to a voter-adopted initiative require a two-thirds super-majority of both houses of the state legislature. Historically, Prop 65 reform legislation has struggled to pass due to the multiple stakeholders involved with diverging interests -- and, if passed, been too watered-down to provide meaningful relief to businesses.
  • The proposed cannabis "safe harbor" warnings will provide new and unique warnings for cannabis smoke and THC products (and different modes of consumption; ingestion, inhalation, topical). Question whether these products are truly sufficiently unique to warrant distinct warning language from other consumer products. The more specified warnings are consistent with OEHHA's goal of making warnings increasingly tailored to provide more detailed information to consumers.
  • The conference concluded with a spirited discussion on the topic of the "Divide Between Businesses and Environmentalists Over What Prop. 65 Has Accomplished." From my own perspective, every day I see Prop 65 cases that are charitably described as frivolous, and the vast majority of cases seem to target chemicals that are present at trivial levels and simply do not pose any sort of meaningful risk. Hence, the "over-warning" phenomenon. But it is undeniably true that Prop 65 has been highly successful in focusing the attention of companies and the public on the chemicals that are in products manufactured, used, consumed and purchased every day. In this respect, Prop 65 remains perhaps the single most consequential state-level environmental/public health regulatory program in the US, with global reach.

The biggest accomplishment of Prop 65 is the extent of the law's general deterrence function ... reformulation that occurs behind the scenes, using the Prop 65 list as a check, outside of enforcement, and is completely invisible to the public."

- Claudia Polsky, Clinical Professor of Law and Director, Environmental Law Clinic, UC Berkeley

  • Panel debate centered on the role of the private enforcement mechanism. Supporters cite the actions of private plaintiffs as the engine that drives companies to pay attention to Prop 65 and the list of chemicals. Without this mechanism, it would be similar to TSCA at the federal level, dealing only with a small subset of listed chemicals and providing minimal incentive to companies outside of that small group of chemicals. Critics maintain that the private enforcement mechanism is an incredibly inefficient means of achieving the same regulatory results, with little relationship between the penalty paid and the extent of the public benefit achieved. The system has resulted in widespread over-warning, due to the threat of relatively unrestrained private enforcement, and misallocation of public health resources towards minimal or non-existent risks.
  • Would a program like "Safer Products" (under the California Department of Toxic Substances Control) be more appropriate? On one hand, government regulatory programs "move like molasses" and are not cost-effective ... though private enforcement focuses costs on one segment of society, businesses that may or may not be primarily responsible for an exposure risk. A government-directed regulatory program, however, would target meaningful risks and weed out the large majority of current cases that are trivial and not truly in the public interest.
  • More active public enforcement, with the attorney general and/or district attorneys taking more Prop 65 cases, would be one possible solution ... though resources may not be available to do so.
  • Ultimately, the future of Prop 65 relies on the ability to impose proper limits on private enforcement while preserving the core function of plaintiffs as putting teeth into Prop 65.
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.

Maine Law Heralds Wave of "Extended Producer Responsibility" Mandates for Product Packaging Wed, 11 Aug 2021 16:57:47 -0400 Signaling a notable advance in "extended producer responsibility" (EPR) policies, on July 13, Maine became the first U.S. state to require companies to pay fees related to the type and quantity of packaging for products sold in the state, in order to fund state recycling programs. The new law (LD 1541) is the first EPR law to be enacted among many similar provisions under consideration by different states. If similar laws are adopted in additional jurisdictions, the prevailing model for funding recycling in the United States will shift from a municipal-funded model to a business-funded model.

Under the new law, "producer" companies will be required to file annual reports on their product packaging with the state, the information from which will be used as the basis for assessing annual fees. The program will be operated by a "packaging stewardship organization" that will be formed by the Maine Department of Environmental Protection (DEP), with reporting and fee obligations coming into effect one year after the organization is established. Fees will be based on the net weight of each type of packaging the company reports, and a fee schedule developed by DEP based on collection and processing costs per ton. The collected fees will help fund local government recycling and waste management costs.

"Producers" subject to the law include companies that own a brand sold or distributed within Maine, or, if the brand-owner does not have a presence in the state, the company that imports the product into Maine.

The law covers packaging material "used for the containment, protection, delivery, presentation or distribution of a product, including a product sold over the Internet, at the time that the product leaves a point of sale with or is received by the consumer of the product." There are exceptions for packaging material intended to be used for long-term storage or protection, beverage containers, and certain paint containers, as well as for producers of small amounts of packaging waste.

The clear goal of the program, like other EPR initiatives, is to incentivize companies to reduce the quantity of packaging materials, establish "take back" programs, and move to more "sustainable" product design and packaging options.

Maine is at the forefront of the "EPR for packaging" movement, with at least half a dozen other states considering similar legislation, most notably in Oregon (where the state legislature has passed a bill that awaits the governor's signature), California, Hawaii, Maryland, Massachusetts and New York.

A copy of the Maine law is available here.