Kelley Green Law https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law Chemical law, emerging contaminants, and regulatory news and insights Fri, 19 Apr 2024 16:29:24 -0400 60 hourly 1 EPA Announces Drinking Water Standards for Six PFAS https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-drinking-water-standards-for-six-pfas https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-announces-drinking-water-standards-for-six-pfas Tue, 16 Apr 2024 10:51:00 -0400 On April 10, 2024, the United States Environmental Protection Agency (“EPA”) announced the first enforceable federal drinking water standards under the Safe Drinking Water Act (“SDWA”) for six per- and polyfluoroalkyl substances (“PFAS”). PFAS compounds have come to be known as ​“forever chemicals” because of their ability to indefinitely persist in the environment and toxicity at extremely low levels. The final rule, which will go into effect 60 days after its imminent publication in the Federal Register, will set into motion likely legal challenges and wide-ranging consequences for drinking water providers who will need to comply with the stringent new standards, as well as for companies that may have liability for their cleanup.

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.

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EPA Finalizes First-Ever Facility Response Plan Requirements for “Worst-Case” Chemical Discharges to Water https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-finalizes-first-ever-facility-response-plan-requirements-for-worst-case-chemical-discharges-to-water https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-finalizes-first-ever-facility-response-plan-requirements-for-worst-case-chemical-discharges-to-water Fri, 22 Mar 2024 11:45:00 -0400 Echoing recent revisions strengthening the Risk Management Program under the Clean Air Act, the U.S. Environmental Protection Agency (“EPA” or “the Agency”) on March 14, 2024 finalized a rule requiring certain facilities to develop facility response plans ("FRPs") for “worst-case” discharges (or threat of such a discharge) of hazardous substances under the Clean Water Act ("CWA").

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.

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PFAS Grease-Proofing Agents Officially Slip Out of U.S. Market https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-grease-proofing-agents-officially-slip-out-of-u-s-market https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/pfas-grease-proofing-agents-officially-slip-out-of-u-s-market Wed, 06 Mar 2024 14:04:00 -0500 Rest assured, you can stop worrying about ingesting “forever chemicals” when you use fast-food wrappers, microwave popcorn bags, and take-out paperboard containers. Last week, FDA announced here that so-called “grease-proofing” food packaging products containing PFAS will no longer be sold in the U.S. According to FDA, these types of food-contact paper products are the highest contributors of PFAS dietary exposure among all FDA authorized uses of food-contact products containing PFAS.

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.

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California Legislation Seeks to Ban PFAS in Consumer Products Effective 2030 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-legislation-seeks-to-ban-pfas-in-consumer-products-effective-2030 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-legislation-seeks-to-ban-pfas-in-consumer-products-effective-2030 Tue, 27 Feb 2024 13:55:00 -0500 California’s extensive regulatory approach to per- and polyfluoroalkyl substances (“PFAS”) is poised to take a dramatic step forward with a proposed ban on the “forever chemicals” in most consumer products. Following the adoption of similar bans in Maine and Minnesota, California state senator Nancy Skinner (D-Berkeley) introduced bill SB 903 to the state senate last Monday, which would prohibit the distribution, sale, or offering for sale of products containing “intentionally added” PFAS. While the bill does not introduce anything particularly innovative by way of PFAS bans in consumer goods, it does represent one of the most comprehensive instructions to a regulatory agency on how to effectuate such a ban.

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.

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"Green" Claims and Pesticides: EPA Publishes FIFRA Guidance on “Absence of Ingredient” Claims for Bleach, Phosphates and DEET https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/green-claims-and-pesticides-epa-publishes-fifra-guidance-on-absence-of-ingredient-claims-for-bleach-phosphates-and-deet https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/green-claims-and-pesticides-epa-publishes-fifra-guidance-on-absence-of-ingredient-claims-for-bleach-phosphates-and-deet Wed, 07 Feb 2024 00:00:00 -0500 In the final hours of 2023, our colleagues over at Ad Law Access highlighted the numerous regulatory bodies that spent the year clamping down on “greenwashing” advertising practices – such as the Federal Trade Commission’s workshop on “recyclable claims” and California’s carbon disclosure laws – predicting that regulators and consumers will increasingly scrutinize advertising claims alleging environmentally sound business practices and products.

On February 1, 2024, the U.S. Environmental Protection Agency (“EPA” or “the Agency”) joined the fray by publishing a 14-page guidance document titled Guidance on “Absence of an Ingredient” Claims Associated with Federal Insecticide, Fungicide, and Rodenticide Act Regulated Products. The document officially issues guidance on how the Agency will evaluate “absence of ingredient” claims for pesticide products regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Under FIFRA, pesticides must be registered with the EPA before they can be sold or distributed in the United States. To register, applicants are required to meet certain product labeling standards, including the prohibition that a pesticide not be misbranded. A pesticide is misbranded if its labeling contains a statement, design, or graphic representation that is false or misleading.

Under this new Guidance, EPA is advising companies how it will evaluate labeling claims that a pesticide product does not contain an ingredient, and notes that it will do so on a “case-by-case” basis exclusively. The Guidance reiterates that “false or misleading” “absence of an ingredient” claims are not permissible under FIFRA, before going into specific claims proposed by applicants for three common pesticide additives: sodium hypochlorite (commonly referred to as “bleach”), phosphates, and N,N-Diethyl-meta-toluamide (“DEET”).

Specifically, the Guidance represents that the Agency is aware that “bleach-free” claims are not commonly viewed as safety claims and are therefore not misleading in certain products because it indicates to consumers that bleach is in the product so as not to apply it to items that bleach may damage (e.g., clothing). For certain pesticide products however, bleach added to certain chlorinated chemistries break down into free available chlorine, which performs the pesticidal activity. Thus, the Agency believes “absence of bleach” claims generally would be false or misleading on labeling certain pesticide products that contain bleach or bleaching agents. A full list of these chemistries can be found on Page 7 of the Guidance.

The Guidance also shares that EPA will generally not consider “phosphate-free” claims to be misleading when used on pesticide products because phosphates are considered “inert” ingredients with no pesticidal purpose.

For “DEET-free” claims, EPA first acknowledges that consumers may want to have information about whether a pesticide contains DEET for reasons unrelated to safety (e.g., odor, potential damage to elastic on clothing items, rubber, plastic, or vinyl, etc.). Because of this, EPA will generally not consider specific “DEET-free” claims to be false or misleading when accompanied with a qualifying statement such as “Not a safety claim.”

The Guidance also provides information on how registrants may add these claims to their product’s labels.

The new EPA guidance is just the latest indication that federal (and state) regulators are increasingly scrutinizing all sorts of environmental claims - especially claims that relate to chemical content (or absence of certain chemicals) - that aim to make products or companies appear to be more "green."

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EPA Rings in 2024 with Addition of Seven PFAS to Toxic Release Inventory https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-rings-in-2024-with-addition-of-seven-pfas-to-toxic-release-inventory https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-rings-in-2024-with-addition-of-seven-pfas-to-toxic-release-inventory Wed, 10 Jan 2024 13:51:00 -0500 The new year marks the final one of U.S. EPA's Per- and Polyfluoroalkyl Substances (“PFAS”) Strategic Roadmap, and so it is only fitting that the Agency begins 2024 by adding seven additional PFAS to the Toxic Release Inventory (“TRI”).

These PFAS are being added to the TRI pursuant to Section 7321 of the National Defense Authorization Act for Fiscal Year 2020 (“NDAA”), which outlines how the Agency may automatically add certain PFAS to the TRI in annual phases. The NDAA includes a provision that automatically adds individual PFAS to the TRI upon EPA’s finalization of a toxicity value. Because EPA finalized toxicity values for the following six PFAS in 2023, they are now automatically added for Reporting Year 2024:• Ammonium perfluorohexanoate; Chemical Abstract Service Registration Number (“CASRN”) 21615-47-4;• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6;• Perfluorohexanoic acid (PFHxA); CASRN 307-24-4;• Perfluoropropanoic acid (PFPrA); CASRN 422-64-0;• Sodium perfluorohexanoate; CASRN 2923-26-4; and• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CASRN 82113-65-3.Ammonium perfluorohexanoate; Chemical Abstract Service Registration Number (“CASRN”) 21615-47-4;

A seventh PFAS – Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CASRN 2816091-53-7 – also is being added for TRI Reporting Year 2024 after confidentiality claims were rescinded for the substance.

With the addition of these seven PFAS to the TRI, 196 PFAS chemicals are now subject to the TRI reporting requirements outlined in Section 313 of the Emergency Planning and Community Right-to-Know Act (“EPCRA”). Facilities that manufacture, process or otherwise use any of these chemicals above the 100 pound annual threshold must report releases and other waste management activities involving these substances for the 2024 reporting year (reports are due July 1, 2025). Hence, facilities should be tracking the use of these chemicals now. For the other, already listed 189 PFAS subject to TRI Reporting Year 2023, reporting is due on July 1, 2024.

Note that EPA classified PFAS as “chemicals of special concern” on October 23, 2023, thereby eliminating applicability of the de minimis exemption which allowed facilities to forego accounting for negligible amounts of PFAS in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process.

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Prop 65 Glyphosate Warnings Violate First Amendment Proscription Against Government-Compelled Speech https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/prop-65-glyphosate-warnings-violate-first-amendment-proscription-against-government-compelled-speech https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/prop-65-glyphosate-warnings-violate-first-amendment-proscription-against-government-compelled-speech Wed, 08 Nov 2023 15:39:00 -0500 In a momentous decision, a federal court of appeals has held that the First Amendment prohibits California from requiring businesses to provide a warning under Proposition 65 for potential exposure to glyphosate. The ruling presents a daunting challenge to the Prop 65 program in situations where the evidence that a chemical causes cancer or reproductive harm (the two toxic endpoints addressed by Prop 65) is subject to meaningful scientific debate, such as is the case with high profile chemicals such as glyphosate, acrylamide, and titanium dioxide, among others.

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.

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California Fiddles with Prop 65 Short-Form Warnings https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-fiddles-with-prop-65-short-form-warnings https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/california-fiddles-with-prop-65-short-form-warnings Tue, 07 Nov 2023 15:57:00 -0500 Whether Nero actually fiddled while Rome burned is historically questionable, though it was undoubtedly true that the mad emperor focused on the trivial during a time of emergency. California leaves no such room for historians to quibble as the Office of Environmental Health Hazard Assessment (OEHHA) takes a third stab in recent years at tinkering with the "short form" warning provisions of Prop 65, justifying the effort in part by asserting that "[n]ot requiring a specific chemical to be included in the short-form warning has led to its over-use, and many businesses are using the short-form warning prophylactically because it protects from potential litigation." Meanwhile, the true cause of "over-warning" is continually ignored by OEHHA: the ridiculous ease of bringing a Prop 65 notice of violation and forcing companies into expensive litigation, even when, in many cases, no such warning was required. (A topic about which we have a lot more to say, most recently with this blog post).

Generally speaking, Prop 65 requires businesses to provide a warning to consumers before they sell a product in California that can cause an exposure to a listed chemical. A widely used option for satisfying Prop 65 chemical warning requirements, the so-called “safe harbor” short-form warning, was initially introduced in the 2016 amendments to Prop 65 as a means for compliance for products with limited label space. The reporting method gained popularity not only for its brevity but also because the current short-form warnings do not mandate identification of a specific chemical.While we still await meaningful Prop 65 reform, OEHHA has initiated yet another rulemaking to amend the Prop 65 “safe harbor” short-form warning provisions, including a new requirement to specify at least one chemical for which the warning is given.

In addition, OEHHA proposes:

• Allowing use of the words “CA WARNING:” or “CALIFORNIA WARNING:” in place of the word “WARNING:” at the beginning of the Prop 65 statement.

• For internet purchases, the Prop 65 warning would be required to be delivered either: on the product display page; with a clearly marked hyperlink on the product display page containing the word “WARNING”, “CA WARNING” or “CALIFORNIA WARNING” that links to the warning; or otherwise prominently displayed on the website in a manner that does not require consumers to “search” for the warning. Moreover, internet purchases would still require the product itself to be labeled in accordance with Prop 65 requirements (or short-form requirements mentioned above) when delivered to the consumer.

• Clarify that warnings for catalogue purchases must appear both in the catalogue and accompany the product when delivered to the consumer.

• Clarify that the short-form warning is available for food products (which was previously ambiguous)

• 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.

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EPA Requires TRI Reporting of Small Concentrations of PFAS; Expands Supplier Notification for Lead and Other Chemicals of Concern https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-requires-tri-reporting-of-small-concentrations-of-pfas-expands-supplier-notification-for-lead-and-other-chemicals-of-concern https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/epa-requires-tri-reporting-of-small-concentrations-of-pfas-expands-supplier-notification-for-lead-and-other-chemicals-of-concern Mon, 23 Oct 2023 00:00:00 -0400 Earlier today, the U.S. Environmental Protection Agency (“EPA”) finalized elimination of the de minimis exemption for reporting of per- and polyfluoroalkyl substances (“PFAS”) under the Toxic Release Inventory (“TRI”). EPA is officially designating PFAS as Chemicals of Special Concern, for which the de minimis exemption is not applicable and, therefore, tracking and reporting of small concentrations in mixtures and products used at facilities is required.

The de minimis exemption allows facilities to ignore negligible amounts of substances in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process. While PFAS are widely present in numerous products and chemical mixtures due to their heat-, water- and stain-resistant qualities, typically they are present at very low concentrations. As a result, as we have discussed previously, only a relatively small number of TRI reports for PFAS have been filed with the agency in recent years. Indeed, out of the 75,890 total entries reported to TRI for all chemicals in 2021 (from approximately 21,000 facilities), EPA received a mere 92 PFAS reporting forms on 46 different PFAS from 45 facilities. In contrast, there are approximately 650 PFAS are currently in commerce from about 120,000 facilities that involve merely the handling and/or potential release of PFAS.

The final rule also makes the de minimis exemption unavailable for purposes of supplier notification requirements to downstream facilities for all Chemicals of Special Concern, which in addition to PFAS includes a number of persistent, bioaccumulative and toxic (“PBT”) chemicals such as lead, mercury, and dioxins. EPA contends that the change will help “ensure that purchasers of mixtures and trade name products containing these chemicals are informed of their presence in mixtures and products they purchase.” Critics contend however, that this change – particularly for lead, which is naturally occurring and widely present in the environment and raw materials – will dramatically expand the universe of materials for which downstream facilities must track the usage, disposal, and lead content, adding millions of hours to the already labor-intensive reporting burden.

When EPA proposed to eliminate the de minimis exemption, the Agency received mixed feedback. EPA and several environmental organizations argue that the exemption is a “reporting loophole” allowing facilities to avoid reporting listed chemicals, thereby diminishing public trust, reducing transparency, and keeping community members in the dark about chemicals they believe to be hazardous to human health. Industry stakeholders, on the other hand, contend that the de minimis exemption makes the TRI program dramatically more workable by limiting the scope of substances for which reporting is required. Moreover, the exemption is pragmatic and tries to avoid forcing companies to hunt for information on miniscule amounts of substances present in trace quantities that ultimately pose little to no risk.

Interestingly, EPA’s decision to scale back the exemption to the TRI reporting requirement, and thus open the PFAS reporting floodgates, coincides with the Agency’s issuance of a final Toxic Substances Control Act (“TSCA”) rule that similarly requires companies to electronically disclose to EPA information on PFAS uses, production volumes, disposal, exposures, and hazards, dating all the way back to 2011. Together, these two rules will dramatically expand the amount of regulatory reporting industry will conduct related to PFAS.

The new TRI requirements apply starting with the 2024 reporting year (reports due July 1, 2025). A copy of the final rule is available here: Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting.”

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Everything Everywhere All at Once: EPA Reporting Rule Presents Major Challenges for Companies with PFAS-Containing Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/everything-everywhere-all-at-once-epa-reporting-rule-presents-major-challenges-for-companies-with-pfas-containing-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/everything-everywhere-all-at-once-epa-reporting-rule-presents-major-challenges-for-companies-with-pfas-containing-products Thu, 19 Oct 2023 12:39:00 -0400 So-called “forever chemicals,” per- and polyfluoroalkyl substances (“PFAS”) were barely on the regulatory radar screen a decade ago. Now, much like the most recent Best Picture award winner, PFAS are seemingly “Everything Everywhere All at Once.” That is a fairly good, if perhaps slightly exaggerated, summation of the new widely anticipated PFAS reporting rule published last week by the U.S. Environmental Protection Agency (“EPA”).

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.

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

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

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

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

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

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

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

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

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

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

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CPSC Collecting Data on PFAS in Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/cpsc-collecting-data-on-pfas-in-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/cpsc-collecting-data-on-pfas-in-consumer-products Thu, 21 Sep 2023 14:32:00 -0400 The Consumer Product Safety Commission (CPSC) is initiating a wide-ranging data collection effort on the use and presence of per- and polyfluoroalkyl substances (PFAS) in consumer products. As detailed in a September 30 Federal Register Notice and Request for Information (“ROI”), CPSC is requesting public comments by November 30, 2023. The information could provide the basis for a future rulemaking that may restrict or ban PFAS in a broad swath of consumer products.

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.

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Skittles Survive as California Passes Landmark “California Food Safety Act” https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/skittles-survive-as-california-passes-landmark-california-food-safety-act https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/skittles-survive-as-california-passes-landmark-california-food-safety-act Thu, 14 Sep 2023 00:00:00 -0400 The so-called “Skittles Ban” is no more, but earlier this week the California legislature passed a novel bill that would ban four food additives from grocery store shelves starting in 2027. Governor Newsom has until October 14 to sign or veto the legislation.

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.

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Maine Seeks Feedback on Types of Food Packaging Subject to PFAS Prohibition and Availability of “Safer Alternatives” https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-seeks-feedback-on-types-of-food-packaging-subject-to-pfas-prohibition-and-availability-of-safer-alternatives-comments-requested-by-monday-august-21 https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-seeks-feedback-on-types-of-food-packaging-subject-to-pfas-prohibition-and-availability-of-safer-alternatives-comments-requested-by-monday-august-21 Wed, 16 Aug 2023 00:00:00 -0400 After years of back-and-forth, the Maine Department of the Environment (“MDEP”) is seeking comment (by this coming Monday) on a “concept draft” regulation identifying the types of food packaging that would fall under a 2019 state ban on intentionally added per- and polyfluoroalkyl substances (“PFAS”).

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

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

Specifically, the prohibition would apply to food packaging:

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

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

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

• In one of the following categories:

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

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

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

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Washington State Adopts Restrictions and Reporting Requirements for PFAS, Flame Retardants, Phthalates and Bisphenols in Wide Range of Consumer Products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/washington-state-adopts-restrictions-and-reporting-requirements-for-pfas-flame-retardants-phthalates-and-bisphenols-in-wide-range-of-consumer-products https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/washington-state-adopts-restrictions-and-reporting-requirements-for-pfas-flame-retardants-phthalates-and-bisphenols-in-wide-range-of-consumer-products Thu, 29 Jun 2023 07:05:00 -0400 Joining the ranks of California, Minnesota, Maine, and New York, Washington state has officially finalized a ban on the manufacture, sale, and distribution of a variety of products containing per- and polyfluoroalkyl substances (“PFAS”), as well as several other “high profile” chemicals of concern, including flame retardants, phthalates, and bisphenols.

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

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

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


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

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

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


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

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

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

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

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

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

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Maine Delays PFAS Reporting Requirement For Two Years https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-delays-pfas-reporting-requirement-for-two-years https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/maine-delays-pfas-reporting-requirement-for-two-years Tue, 27 Jun 2023 18:48:13 -0400 In the midst of already tumultuous regulatory change, Maine’s Department of Environmental Protection (“MDEP”) has officially delayed the reporting requirements of their landmark per- and polyfluoroalkyl substances (“PFAS”) regulation for two years. The delay was promulgated pursuant to legislation passed by the Maine legislature that not only stalls the reporting rule but similarly creates new reporting exemptions. The bill was the only one of five proposed amendments that passed both chambers and received a signature from Governor Janet Mills.

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.”

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With TRI Reports due July 1, EPA Expands List of Reportable PFAS https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/with-tri-reports-due-july-1-epa-expands-list-of-reportable-pfas https://www.kelleydrye.com/viewpoints/blogs/kelley-green-law/with-tri-reports-due-july-1-epa-expands-list-of-reportable-pfas Sat, 24 Jun 2023 16:28:30 -0400 With the annual July 1 deadline for filing Toxic Release Inventory (“TRI”) reports right around the corner, on June 22nd, the U.S. Environmental Protection Agency (“EPA”) finalized the addition of nine more per- and polyfluoroalkyl substances (“PFAS”) to the list of chemical subject to the reporting program (starting with reports due next year - July 1, 2024 - for the 2023 reporting year).

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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