Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

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EPA’s alleged failure to disclose certain information submitted to its New Chemicals Program is subject to judicial review under the Toxic Substances Control Act (TSCA) and the Administrative Procedure Act (APA), the D.C. District Court ruled on August 20, 2024.

In Environmental Defense Fund v. Regan,  No. 1:20-cv-00762-LLA, five environmental organizations allege that EPA engages in a pattern or practice of violating TSCA’s disclosure requirements for premanufacture notices (PMNs) and applications for test marketing exemptions (TMEs).  The suit’s 10 counts include allegations that EPA failed to publish timely and complete notices of receipt of PMNs; failed to make health and safety studies, safety data sheets, and other information contained in PMN submissions available for examination; and failed to disclose information claimed as confidential business information when it facially did not qualify as confidential.

EPA moved for judgment on the pleadings, asserting that the plaintiffs are barred from seeking relief under TSCA for most of their claims.  While TSCA’s citizen suit provisions allow persons to compel the agency to perform nondiscretionary duties, EPA argued that the relevant statutory and regulatory provisions “do not impose a date-certain deadline” on EPA.  The agency also argued that judicial review under the APA would be inappropriate because the claims concern activities that are interlocutory in nature and too minor to meet the APA’s threshold for “agency action.”

The court denied EPA’s motion.  Even in instances where TSCA does not set an explicit deadline, the court said that it is sometimes apparent that activities must be taken in relation to other events.  Three of the plaintiffs’ 10 counts were found to fall in this category.  For example, TSCA directs EPA to provide immediate notice of TME applications for public input and requires EPA to make a determination on each application within 45 days.  Since “[n]otice must precede comment” and “comment must precede the EPA’s decision,” “[t]he only logical conclusion” is that notice is required prior to expiration of the 45-day period, the court held.

For the seven remaining allegations—which all concerned the availability of information submitted with a new chemical notification, and for which a deadline for agency disclosure to interested parties could not be ascertained from the statutory structure—the court was unconvinced by EPA’s argument that the APA could not offer relief.  The APA’s definition of agency action has been interpreted expansively by the courts, and the fact that the challenged activities are merely “interim steps” is not dispositive, the decision states.  Importantly, as part of this analysis, the court held that TSCA section 5(b) creates a “freestanding right to information” submitted as part of a new chemical notification.

Judge Loren L. AliKhan also granted the plaintiffs’ motion to compel the administrative record, rejecting EPA’s arguments that the claims should be understood as “failures to act” rather than actions—meaning that they would not have an administrative record.  However, she did not go so far as to agree with the plaintiffs on the merits.

According to EPA, since the case was filed in 2020, the agency has made “substantial and ongoing improvements to its practices for preparing and publishing public notices and public files as part of its ongoing commitment to improving the administration and transparency” of its New Chemicals Program.

In addition to the Environmental Defense Fund, the plaintiffs include the Center for Environmental Health, the Environmental Health Strategy Center, the Natural Resources Defense Council, and the Sierra Club.

EPA Releases Second Version of Interim Guidance on PFAS Destruction and Disposal

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On April 8, 2024, EPA released the second version of its interim guidance on the destruction and disposal of PFAS and PFAS-containing materials.  The updated interim guidance builds on the initial guidance issued in 2020 by providing new recommendations for the management of PFAS-containing materials.

The updated interim guidance focuses on three categories of large-scale destruction and disposal technologies: underground injection, landfilling, and thermal treatment.  For each category, EPA identifies the technology with a lower potential for environmental release of PFAS when compared to other technologies within their category:

  • Permitted Class I non-hazardous industrial or hazardous waste injection wells (underground injection);
  • Permitted hazardous waste landfills (landfilling); and
  • Permitted hazardous waste combustors (thermal treatment).

However, each technology has drawbacks and is only suitable for certain types of PFAS-containing materials.  For example, EPA notes that new information suggest landfills may release more PFAS into the environment than previously understood, and that transportation logistics may limit the types and amounts of PFAS-containing fluids that can be inserted into Class I wells.

EPA emphasizes the limitations of available data and includes a list of prioritized research needs to inform future guidance.  High-priority research needs include information on releases from landfills and data on releases from thermal treatment units.  EPA describes a new analytical method, OTM-50, that it believes will better characterize the products of incomplete combustion.

In addition, the updated interim guidance presents a new evaluation framework designed to assess emerging technologies and determine their suitability for specific PFAS-containing materials. It also includes an updated list of tools to screen for potentially vulnerable populations living near likely PFAS destruction or disposal sites.

EPA was mandated to publish and triennially update the interim guidance by the FY 2020 National Defense Authorization Act.  More information on the updated interim guidance can be found in an EPA fact sheet.

Comments on the updated interim guidance are due October 15, 2024.

Coca-Cola Asks Judge to Dismiss Simply Juice PFAS Suit

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A proposed class action alleging that Coca-Cola’s Simply-brand juices contain PFAS does not state a plausible claim for relief, Coca-Cola told the Southern District of New York on July 31, 2024.

The plaintiff in Lurenz v. The Coca-Cola Co. alleges that laboratory testing revealed “widespread and uniform” PFAS contamination in Simply juices at levels detrimental to human health.  As a result, the claims made on Simply products—including that the beverages are “All Natural” and “made simply” with “all-natural ingredients”—would mislead a reasonable consumer, the most recent complaint asserts.

The court dismissed the initial complaint for lack of standing in June, but allowed the plaintiff to file a new complaint.  In response, Coca-Cola filed a letter requesting a conference before the company files another motion to dismiss.  The letter argues that the new complaint’s allegations are “even vaguer” than those previously dismissed, making it “impossible to tell” when the plaintiff purchased the contested products.  The plaintiff “still cannot show a concrete economic harm needed to establish Article III standing,” Coca-Cola says.

In addition, Coca-Cola argues that the new complaint still provides insufficient factual detail about the testing that revealed PFAS contamination, which was a factor in the earlier dismissal.  Even if the testing allegations are deemed sufficient, Coca-Cola asserts that the all-natural claims are not misleading.  “[N]o reasonable consumer would understand PFAS—a substance that is not intentionally added to the [juices]—to be an ingredient,” the letter states.

The case is similar to an ongoing suit against L’Oréal, the cosmetics company, for alleged PFAS contamination.  A blog post on that case, written after a dismissal due to standing issues, can be found here.

EPA Proposes to Designate Five Substances as High Priority

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On July 25, 2024, EPA published a notice proposing to designate a new batch of existing chemicals as high priority substances under section 6 of the Toxic Substances Control Act (TSCA).  TSCA section 6 requires EPA to continually designate existing chemicals as “high-priority” based on factors including hazard and exposure potential.  Once a high priority designation is made, EPA is required to conduct a risk evaluation and regulate the chemical if it is found to present an unreasonable risk.

If the notice is finalized as proposed, EPA would immediately initiate risk evaluations for the following five substances:

  • Vinyl Chloride (CASRN 75-01-4)
  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

According to an EPA press release, vinyl chloride is a known human carcinogen linked to liver, brain, and lung cancer in exposed workers.  In the release, EPA stated that vinyl chloride’s health hazards helped motivate the passage of TSCA in 1976.

The press release noted that the other four substances are probable human carcinogens and that some pose other types of hazards, such as respiratory and reproductive harms.  All five substances are used to make plastic; vinyl chloride is mostly used to make polyvinyl chloride, better known as PVC.

EPA announced that it was beginning the process of prioritizing these chemicals in December 2023.  In that announcement, EPA also stated that that it “expects to initiate prioritization on five chemicals every year, which will create a sustainable and effective pace for risk evaluations.”

Comments on the notice are due October 23, 2024.

EPA Grants Petition to Address PFAS Created by Plastic Fluorination

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On July 10, 2024, EPA granted a citizen petition from environmental groups encouraging EPA to take Toxic Substances Control Act (TSCA) section 6 action for three PFAS substances produced during the fluorination of plastic containers.

The petition alleges that the three PFAS—PFOA, PFNA, and PFDA—pose a variety of serious human health hazards, even at extremely low exposures.  The petition cites EPA’s December 2023 response to significant new use notices filed by Inhance Technologies (“Inhance”), a fluorination company, for substances including PFOA, PFNA, and PFDA.  As discussed in a previous blog post, EPA found that Inhance’s production of the three PFAS presents an unreasonable risk and ordered Inhance to stop producing the chemicals under TSCA section 5, which allows EPA to regulate new substances and significant new uses.

Inhance challenged EPA’s order.  In March, the Fifth Circuit ruled that EPA could not regulate Inhance under TSCA section 5 because Inhance’s fluorination process had been in place for decades; a blog post on the decision can be found here.  However, the court noted that EPA is free to regulate Inhance’s fluorination process under section 6, which allows EPA to restrict existing substances.  Unlike section 5, section 6 requires EPA to conduct a cost-benefit analysis that considers a substance’s benefits and what the economic consequences of regulation would be.

In its letter granting the petition, EPA said that the agency will initiate “an appropriate proceeding under TSCA Section 6 associated with the formation” of the three PFAS during plastic container fluorination.  As part of the proceeding, “EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.”

EPA Proposes to Restrict Use of N-Methylpyrrolidone

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Multiple occupational uses of n-methylpyrrolidone (NMP) would be banned and others would be restricted under a proposed rule published by EPA on June 14, 2024.  The proposed rule follows EPA’s 2020 determination that NMP presents an unreasonable risk to human health due to health effects including fetal death and reduced fertility.

According to the proposed rule, NMP is a widely used solvent with applications in the manufacturing of lithium-ion batteries, “semiconductors, polymers, petrochemical products, paints and coatings, and paint and coating removers.”  2020 Chemical Data Reporting rule data indicates that total annual production ranged from 100–250 million pounds from 2016 to 2019, EPA says.

The proposed rule would ban the manufacture, processing, distribution, and use of NMP for industrial and commercial use in lubricants, anti-freeze products, automotive care products, and cleaning products, among others.  All industrial and commercial uses not prohibited would be subject to a workplace chemical protection program (WCPP) to minimize direct dermal contact with NMP through incorporation of the hierarchy of controls.  Where controls are insufficient, EPA proposes to require implementation of a PPE program.

The proposed rule would also implement prescriptive controls for certain industrial and commercial uses, such as capping the allowed concentration of NMP in industrial and commercial paints and stains at 45%. Similar concentration maximums would apply to a handful of consumer products, including adhesives.

Although no consumer products would be banned, EPA proposes to implement container size limitations and labelling requirements for some consumer uses, including paint removers, paints, automotive care products, and cleaning products.

EPA proposes that the bans take effect under a staggered schedule, varying from one to two years after publication depending on whether an entity is a manufacturer, processor, distributor, or user of NMP.  Private entities subject to WCPP requirements would have one year to establish the program, and consumer product container size limitations and labelling requirements would also take effect after one year.

Comments on the proposed rule are due on July 29, 2024.

OEHHA Proposes Additional Changes to Prop 65 Warning Requirements

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On June 13, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing changes to Proposition 65’s warning requirements.  The proposed changes revise proposed amendments to Proposition 65 published in October 2023, discussed in a previous blog post.

If implemented, the June 2024 proposal would revise the October 2023 proposal by:

  • Delaying the required use of the new short-form warning content from two years to three years after the amendments take effect.
  • Abandoning many of the proposed changes for internet purchases and catalogues. For example, the June 2024 proposal removes the October 2023 proposal’s requirement that internet retailers provide a warning on the shipped product (in addition to the online warning already required).
  • Including a 60-day grace period for internet retailers to update their online short-form warnings after they are notified that a product will have new warning content.

A document showing the proposed changes to the October 2023 proposal can be found here.  Comments on the proposed changes are due June 28.

Proposition 65, officially known as the as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses in California to warn customers when products contain chemicals known to the state to cause cancer or reproductive harm.

Maine PFAS Law Triggers Class Action Against BIC in California

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Customers in California have filed a class action lawsuit against BIC USA, Inc. (“BIC”), a razor manufacturer, over allegations of PFAS use discovered through BIC’s compliance with a Maine PFAS reporting law.

In 2021, Maine enacted legislation requiring companies to disclose whether their products contain intentionally added PFAS by January 1, 2023.  Although a subsequent law extended this deadline to 2025, some companies had already submitted PFAS information to Maine’s Department of Environmental Protection.  According to the complaint, a Freedom of Access Act request by a public advocacy group revealed that BIC had disclosed the use of PFAS as a lubricant in its razor blades.

The plaintiffs argue that they would not have purchased BIC razors for the price they paid had they known they contained PFAS.  Without a disclosure to the contrary, the complaint asserts that “[n]o reasonable customer would expect that shaving razors would contain dangerous PFAS, which are indisputably linked to harmful health effects in humans.”

The lawsuit alleges violations of California’s Unfair Competition Law and False Advertising Law, among other claims.  The plaintiffs seek injunctive relief, compensatory damages, and punitive damages.

The Maine legislature substantially revised the state’s PFAS reporting requirements in April, discussed in a previous blog post.  Under the amended law, reporting requirements will only apply to “currently unavoidable uses” starting in 2032.

The case is Butler v. BIC USA Inc., N.D. Cal., No. 4:24-cv-02955, filed May 15.

Maine Revises PFAS in Products Legislation

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Maine’s reporting requirements for products containing PFAS will be narrowed, and incremental category-specific bans will be adopted under a new law enacted April 16, 2024.  The law, LD 1537, revises landmark 2021 legislation that implemented a general ban on the sale of products containing intentionally added PFAS starting in 2030 and mandated reporting in the interim.

Narrowed reporting requirements

The new law scraps the old law’s “general notification requirement,” which would have required manufacturers to report information on products containing intentionally added PFAS by January 1, 2023 (later delayed to 2025).  Under LD 1537, reporting will only be required for “currently unavoidable uses” beginning in 2032.

As was the case previously, Maine’s Department of Environmental Protection will be tasked with determining what uses are currently unavoidable.  The department solicited requests for proposals from manufacturers seeking currently unavoidable use determinations beginning in January of this year.  However, in light of the new law, the department says on its website that it anticipates currently unavoidable use determinations to begin in 2025.

New timeline for banned products

LD 1537 pushes back the general sales prohibition for products containing intentionally added PFAS from 2030 to 2032.  However, the new law introduces many product category-specific bans.  Certain categories will now be subject to more aggressive deadlines, and a few will not be banned until 2040.

The new sales bans for products containing intentionally added PFAS are as follows:

  • Effective January 1, 2026: cleaning products, cookware, cosmetics, dental floss, juvenile products, menstruation products, textile articles (excluding outdoor apparel for extreme wet conditions and textiles for watercraft, aircraft, or motor vehicles), ski wax, and upholstered furniture.
  • Effective January 1, 2029: artificial turf and outdoor apparel for severe wet conditions (unless it includes a PFAS disclosure).
  • Effective January 1, 2032: all other products containing intentionally added PFAS except for currently unavoidable uses and those subject to a ban in 2040.
  • Effective January 1, 2040: HVAC equipment, refrigeration equipment, refrigerants, foams, and aerosol propellants.

LD 1537 additionally excludes certain product categories from all requirements, including firefighting foams, medical devices/drugs, veterinary products, motor vehicles/motor vehicle equipment, watercraft, and semiconductors.

Other changes

Under the new law, products that do not contain intentionally added PFAS are still subject to the above bans if they are sold in a container that contains intentionally added PFAS.  Importantly, this includes fluorinated containers.

LD 1537 also increases the minimum number of employees for a manufacturer to be subject to reporting requirements from 26 to 101.

More information on LD 1537 can be found at Maine’s Department of Environmental Protection website.

OSHA Revises Hazard Communication Standard

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On May 20, 2024, OSHA published a final rule revising the Agency’s Hazard Communication Standard (HCS), which requires that workers be informed of chemical hazards.  The rule aligns the HCS with Revision 7 (Rev. 7) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), which is updated biennially by the United Nations.

The 318-page final rule includes special labelling provisions for small containers and mandates use of prescribed concentration ranges in safety data sheets (SDSs) when a chemical concentration is claimed as confidential.  The final rule also revises the definitions and classification considerations for various health hazards, adds a new hazard class (desensitized explosives) and three new hazard categories, and makes a number of modifications to the formatting and language that must be used on labels and SDSs.

Though the rule was largely finalized as proposed, OSHA amended one provision in response to industry pushback.  In the proposed rule, OSHA included language requiring that chemical manufacturers and importers evaluate chemical hazards “under normal conditions of use and foreseeable emergencies.”  Many commenters argued that the provision would be overly burdensome, requiring manufacturers to anticipate all possible downstream uses.  In response, OSHA eliminated the language, instead mandating that hazard classifications include “any hazards associated with the chemical’s intrinsic properties,” such as changes to the chemical’s physical form or chemical reaction products associated with reasonably anticipated uses.

The final rule is effective July 19, 2024, and contains staggered compliance deadlines.  Chemical manufacturers, importers, and distributors evaluating substances must update labels and SDSs within 18 months and must make any necessary updates to alternative workplace labelling, hazard communication programs, and trainings within 24 months.  The corresponding compliance dates for mixtures are 36 months and 42 months, respectively.  However, OSHA is not requiring chemicals that have been released for shipment to be relabeled.

GHS Rev. 7 was published in 2017.  Though GHS Rev. 8 was published before OSHA released the proposed rule, OSHA opted to align the HCS with Rev. 7 in large part because major trading partners (including Canada, Europe, and Australia) have adopted or are planning to adopt Rev. 7.  However, OSHA integrated some elements of Rev. 8 that the Agency believes will better protect workers, such as an updated method of classifying skin corrosion/irritation that expands use of non-animal test methods.

The final rule marks the first major update to the HCS since 2012, when the Agency adopted GHS Rev. 3.  A previous Verdant Law blog post on the proposed rule can be found here.