EPA Updates Safer Choice and Design for the Environment Standard

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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 Proposes Risk Management Rule for 1-Bromopropane

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On August 8, 2024, EPA published a proposed rule to restrict use of the solvent 1-bromopropane (1-BP) (CASRN 106-94-5).  The proposed rule is the result of the agency’s revised 2022 determination that 1-BP presents an unreasonable risk of injury to human health due to effects including neurotoxicity, developmental toxicity, and carcinogenicity.

According to EPA, 1-BP is used in a wide variety of applications, including “vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation.”  Data from the Chemical Data Reporting rule shows that annual production of the substance, also known as n-propyl bromide, increased from 15.4 to 25.8 million pounds between 2012 and 2015.  This increase was because 1-BP is “an alternative to ozone-depleting substances and chlorinated solvents,” according to a 2020 EPA risk evaluation.

Under the proposed rule, all consumer uses of 1-BP would be banned except for use in insulation.  EPA is also proposing to prohibit four industrial and commercial uses, including use in adhesives and sealants, dry cleaning solvents, and automotive care products.  EPA estimates that these banned uses represent about 3% of the current annual production of 1-BP.

Other industrial and commercial uses would be subject to a workplace chemical protection program (WCPP), which would implement an inhalation exposure concentration limit for 1-BP of 0.05 ppm as an eight-hour time weighted average.  Use of chemically resistant gloves would also be required for uses including manufacturing, processing, and disposal.

Notably, in an effort to protect fenceline communities, EPA is proposing to prohibit owners or operators from increasing releases of 1-BP to outdoor air to comply with WCPP requirements.

EPA is proposing staggered compliance dates for the prohibited uses, which would become effective in six months for manufacturers, nine months for processors, and in 12 months for distribution to retailers.  Non-federal entities subject to the WCPP would be required to conduct baseline airborne exposure testing within six months and ensure that the inhalation exposure limit is met within nine months.

1-BP was added to the Toxics Release Inventory list of reportable chemicals in 2015 and became the first addition to the list of hazardous air pollutants in 2022.  More on 1-BP’s addition to the list can be found in a previous blog post.

Comments on the proposed rule are due September 23, 2024.

PFDA IRIS Assessment Finalized Amid Ongoing PFAS Reviews

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This July, EPA released the final Integrated Risk Information System (IRIS) assessment for PFDA.  PFDA’s toxicological review is the third completed IRIS assessment for a PFAS.  Two additional assessments, for PFHxS and PFNA, are still in progress.

Consistent with the draft, the final PFDA assessment concluded that evidence indicates “PFDA exposure is likely to cause liver, immune, developmental, and male and female reproductive effects in humans, given sufficient exposure conditions.”  However, it had a higher maximum acceptable daily dose, known as an oral reference dose (RfD), than the draft assessment.

The draft’s lifetime and subchronic RfD was 4 x 10-10 mg/kg/day.  But the final RfD was 2 x 10-9, partially due to the use of different points of departure (or the dose at which an effect is first observed) for immune and developmental effects.

July also saw the release of the external peer review report for the PFHxS draft IRIS assessment, and external peer review meetings for the draft PFNA assessment took place from July 30 to August 1.  The most recent update to the IRIS Program Outlook, released in June, did not include expected release dates for the final PFHxS or PFNA assessments.

Following external peer review, EPA revises the assessment, conducts a final agency review, and holds a interagency science discussion before releasing the final version.  It took nine months for EPA to finalize the assessment for PFDA after releasing the external peer review report.

EPA finalized drinking water standards for PFAS including PFHxS and PFNA in May; more on that can be found here.  Additional information on the draft IRIS assessment for PFHxS is available in a previous blog post.

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.

Kansas City Grocers Ordered to Stop Selling Illegally-Imported Disinfectants

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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

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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

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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.