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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

447 U.S. 557 (1980).

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

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

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

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

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

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

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.

It would mark the first time a state has banned food items containing additives that are otherwise permitted by the U.S. Food and Drug Administration (“FDA”).

The California Food Safety Act, AB 418, prohibits a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product for human consumption containing any of the following substances:

• Brominated vegetable oil (CAS no. 8016-94-2)
• Potassium bromate (CAS no. 7758-01-2)
• Propylparaben (CAS no. 94-13-3)
• Red dye 3 (CAS no. 16423-68-0)

These additives are commonly found in orange and citrus sodas, baked goods, candies, marshmallows, and processed foods. They are added to food for texture and aesthetic purposes as well as to extend shelf-life.

The FDA has already banned red dye 3, an artificial coloring agent derived from petroleum, from cosmetics. But, it is still authorized for use in foods and medicines to give them bright red coloring and sheen.

Titanium dioxide — the ingredient that would have required a Skittles reformulation — was dropped from the final bill over industry objections. Common in ice creams, chocolates, creamers, chewing gum, dressing, cakes, and all types of candies, titanium dioxide is added to provide whiteness and opacity. Critics of the original bill noted that titanium dioxide is approved for use and widely used in pharmaceuticals, which have a practically identical exposure and risk pattern as food consumption. The European Union is currently wrestling with this dichotomy.

The effective date of the ban also was amended to achieve bipartisan support for the bill, which was originally proposed to begin in 2025. With these compromises, the bill cleared the state Senate on a 33-3 vote and the Assembly on a 65-6 vote.

AB 418 will have national implications: large manufacturers likely will remove these additives from their products entirely, rather than narrowly tailoring distribution to California. Such a strategy may be even more appealing as the New York state legislature debates bill A6424, which mirrors the California law banning all the same chemicals plus titanium dioxide. The use of these additives in food is already banned in the European Union.

The bill authorizes the California Attorney General, a city attorney, a county counsel, or a district attorney to enforce the ban. Civil penalties may not exceed $5,000 for first-time violations. For repeat violations, civil penalties may not exceed $10,000 per violation.

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.

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.