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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

447 U.S. 557 (1980).

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

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

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

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

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

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

• New specifically-tailored safe harbor warnings for passenger or off-highway motor vehicle parts and recreational marine vessel parts.

OEHHA is accepting public comments on the rulemaking through December 20, 2023. OEHHA will also host a public hearing on December 13, 2023 at 10:00 a.m. (PST) at the CalEPA Headquarters. It can also be accessed remotely. More information will be posted on OEHHA’s website prior to the hearing.

More information on the rulemaking initiative can be found on OEHHA’s website here. The proposed regulatory text can be found here.

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

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

- EPA Press Release

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

Specifically, the prohibition would apply to food packaging:

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

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

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

• In one of the following categories:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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