Court Finds EPA’s Transparency in New Chemicals Disclosures Reviewable

/in , , ,

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 Updates Safer Choice and Design for the Environment Standard

/in , , ,

On August 8, 2024, EPA finalized updates to the Safer Choice and Design for the Environment Standard.  The revised standard implements sustainable packaging criteria and introduces a Safer Choice Cleaning Service Certification for cleaning service providers.

Created in 2009, the Safer Choice program allows products such as cleaners and detergents to carry a special label if they meet human and environmental health requirements.  Products must meet both holistic and component-level requirements to be approved for partnership with EPA, which is renewable and lasts three years.  Design for the Environment operates under the same standard and applies specifically to antimicrobial products.

Under the updated standard, primary packaging for certified products can no longer contain intentionally added PFAS.  The revisions also require packages to either be 1) designed to be reused or 2) recyclable and made of a certain percentage of recycled content.

The update also inaugurates a certification program for cleaning services that use certified products “to the maximum extent practicable.”  The agency says that it will consider exceptions on a case-by-case basis, including in situations where limited certified products are available for a certain product class.

Other changes include stricter requirements for pet care products and voluntary criteria aimed at reducing carbon-based energy consumption.  The new standard does not alter the master criteria for ingredients or any of the supplemental requirements for certain product classes.

The update is the first revision to the standard since 2015 and the fourth in its history.  New products must comply with the updated standard immediately.  Existing partnership products must comply within a year after they are notified of the updates.

 

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

/in , ,

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

/in ,

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.

Kansas City Grocers Ordered to Stop Selling Illegally-Imported Disinfectants

/in , , ,

On May 6, 2024, EPA Region 7 announced that 17 grocery stores in the Kansas City area had been ordered to stop the sale and use of certain Fabuloso-brand cleaners and other disinfectants because of potential health risks.  The orders, issued by the Kansas and Missouri Departments of Agriculture in partnership with EPA, require the stores to immediately remove the illegal products from their shelves.

According to EPA’s press release, the products contain glutaraldehyde, an active ingredient not approved for household disinfectant use in the U.S. due to its potential health risks. These risks include “throat and lung irritation, asthma and difficulty breathing, dermatitis, nasal irritation, sneezing, wheezing, burning eyes, and conjunctivitis.”

EPA says that the products were illegally imported.  The press release states that their labels are primarily in Spanish and that the affected grocers “serve Hispanic communities.”

It is important to note that not all Fabuloso products are unsafe.  There is also an EPA approved US version of Fabuloso which does not contain glutaraldehyde.  According to the press release, some stores subject to the orders sold both the illegal and the approved US versions of the disinfectants.

Class Action Against Coca-Cola for “100% Recyclable” Claims Advances

/in , ,

A proposed class action against Coca-Cola and other companies selling bottled water can proceed after the plaintiffs provided survey results indicating that consumers may be misled by Coca-Cola’s recyclability claims, the Northern District of California ruled in the case Swartz v. The Coca-Cola Co., No. 3:21-cv-04643.

Crucial to the case are the Federal Trade Commission’s Green Guides, which provide guidance for environmental marketing claims and are codified into California law.  The Green Guides allow marketers to make unqualified recyclable claims “if the entire product or package, excluding minor incidental components, is recyclable” by facilities available to “at least 60 percent” of Californians.

The plaintiffs initially alleged that the defendants’ “100% Recyclable” claims are false and misleading because most of the bottles are not recycled in practice.  The judge rejected that argument, stating that reasonable consumers would not understand the claims “to mean that the entire product will always be recycled.”  The plaintiff’s next complaint placed greater emphasis on the bottles’ caps and labels, which are allegedly not recyclable.  However, the court found inadequate factual support for their claims, which were also undermined because bottle caps and labels constitute minor components under the Green Guides.

The plaintiffs’ newest complaint overcomes those shortfalls, Judge James Donato ruled on April 8, 2024.  The survey results indicate that consumers understand the defendant’s claims to mean the entire bottle (including bottle caps and labels) are recyclable, and the defendants “expressly qualify” their recyclability as “100%.”  As a result, the plaintiffs can plausibly allege that “these representations to consumers are different from” unqualified claims protected by the Green Guides, he said.

The court also determined that there was sufficient factual support for the plaintiffs’ deception claims to move forward.  Because the defendant’s product labels are “disposed of as refuse” by facilities responsible for over 40% of the relevant type of bottle recycling in California, it is plausible that the “defendant’s products are not capable of being ‘100%’ recycled by plants in California,” the court ruled.

The lawsuit consolidates actions brought separately by consumers and the Sierra Club.  In addition to Coca-Cola, the suit names BlueTriton Brands and Niagara Bottling as defendants.  Between the three companies, water bottles are sold under the brand labels Dasani, Deer Park, Poland Spring, Niagara, Kirkland Signature, and others.

 

EPA Grants Petition to Address PFAS Created by Plastic Fluorination

/in , , , ,

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.”

Maine PFAS Law Triggers Class Action Against BIC in California

/in , ,

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

/in ,

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.

EPA Publishes Proposed Consent Decrees for Overdue Risk Evaluations

/in , , ,

EPA would be required to complete overdue risk evaluations by new deadlines if two proposed consent decrees, announced by EPA on April 26, 2024, are adopted.

Section 6(b)(4)(G) of the Toxic Substances Control Act (TSCA) requires EPA to complete risk evaluations within three years of initiation, with a six-month extension possible.  EPA has missed this 3.5-year deadline for 22 ongoing risk evaluations.  Twenty of these risk evaluations were initiated in December 2019 as a result of amended TSCA’s requirement that EPA designate 20 existing substances as “high-priority,” which automatically initiated risk evaluations.  The other two, which concern the substances DIDP and DINP, were requested by manufacturers.

The proposed consent decrees would resolve two consolidated lawsuits against the agency.  The first, brought by environmental groups, challenges EPA’s failure to complete all 22 overdue risk evaluations; a previous blog post on that case can be found here.  The American Chemistry Council filed the second, which only concerns the two manufacturer-requested risk evaluations.

Under the proposed consent decrees, linked here and here, EPA would be required to complete:

  • Draft risk evaluations for at least seven of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for DIDP, DINP, TCEP, formaldehyde, and 1,1-dichloroethane by December 31, 2024;
  • Final risk evaluations for seven of the remaining substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

Under the proposed decrees, EPA could file a motion to extend a deadline if the agency deems it necessary.  The proposed consent decrees also include a provision automatically extending these deadlines if the agency undergoes a lapse in appropriations.

Since the first lawsuit was filed in September 2023, EPA has completed draft risk evaluations for TCEP (more on that here) and formaldehyde.  However, EPA has yet to release draft risk evaluations for any of the other 22 overdue evaluations.

Comments on the proposed consent decrees are due May 28, 2024.