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.

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.

EPA Tightens Emissions Standards for Chemical Plants

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The synthetic organic chemical manufacturing industry and some polymer manufacturers will face more stringent emissions limitations under a final rule published by EPA on May 16, 2024.  The rule primarily targets emissions from chloroprene and ethylene oxide, which are linked to cancer in humans.

The final rule amends the National Emissions Standards for Hazardous Air Pollutants and New Source Performance Standards for these facilities, which number about 200.  Emissions limitations include requirements to improve flare efficiency and stronger standards for heat exchange systems, process vents, and storage vessels.

According to an EPA fact sheet, covered facilities “must meet risk-based requirements for reducing [ethylene oxide] within two years after the rule becomes effective and must meet risk-based standard for reducing chloroprene within 90 days after” the rule takes effect July 15, 2024.

The final rule also mandates fenceline monitoring for facilities that use, produce, store, or emit chloroprene, ethylene oxide, benzene, 1,3-butadiene, ethylene dichloride, or vinyl chloride.  Neoprene production facilities will be subject to lower action levels for chloroprene and shorter compliance deadlines than other facilities.

Previous EPA regulations had included general exemptions from emission control requirements during periods of startup, shutdown, and malfunction.  The final rule eliminates those exemptions, which courts have deemed impermissible under the Clean Air Act.

In a press release, EPA stated that the final rule will reduce ethylene oxide “and chloroprene emissions from covered processes and equipment by nearly 80%,” reducing “the number of people with elevated cancer risk by 96% in communities near plants that emit” those chemicals.

EPA Finalizes Changes to TSCA Risk Evaluation Procedures

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On May 3, 2024, EPA published a final rule amending the procedures for chemical risk evaluations under the Toxic Substances Control Act (TSCA).  The final rule is largely unchanged from the proposed rule, discussed in a previous Verdant Law blog post.

A key change in the final rule is the requirement that risk determinations end in a single risk determination rather than use-by-use determinations.  EPA previously referred to this approach as a “whole chemical” approach.  However, to address concerns that a single determination of unreasonable risk would mislead the public into believing that all uses present an unreasonable risk, EPA will no longer use the term “whole chemical.”  EPA additionally committed to “identify[ing] the conditions of use that significantly contribute” to the single determination.

Another important change reverts an EPA interpretation of TSCA to a previous interpretation.  EPA proposed that risk evaluations consider all conditions of use in 2017, but determined that the agency had discretion over conditions of use in the final regulation.  However, due to the Ninth Circuit’s 2019 decision in Safer Chemicals, Healthy Families v. EPA, the final rule now mandates the inclusion of all conditions of use in risk evaluations.

Other changes include the removal of the definitions of “best available science” and “weight of the scientific evidence” to allow the agency greater “flexibility to quickly adapt to and implement advancing scientific practices”; EPA’s decision to no longer assume use of personal protective equipment when calculating occupational exposure; and identification of “overburdened communities” as a potentially exposed or susceptible subpopulation.

The final rule, effective July 2, 2024, will apply to ongoing risk evaluations “only to the extent practicable.”

EPA Sets Drinking Water Standards for PFAS

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Concentrations of six PFAS substances in drinking water will be regulated for the first time under new drinking water standards published by EPA on April 26, 2024.

The final rule sets individual maximum contaminant levels (MCLs) for PFOA and PFOS at 4 parts per trillion (ppt).  The agency found no evidence that any level of exposure to either substance is safe, setting aspirational maximum contaminant level goals (MCLGs) of 0 ppt for both.

The final rule also sets individual MCLs (and MCLGs) of 10 ppt for PFHxS, PFNA, and HFPO-DA (known by the trademark GenX).  Mixtures containing two or more of PFHxS, PFNA, HFPO-DA, and PFBS are subject to a hazard index-based limit.

Public water systems are required to conduct initial monitoring by April 2027, be compliant with the MCLs by April 2029, and conduct regular compliance monitoring.  Water systems must include detected PFAS in their annual reports and notify the public if a MCL violation has been detected.

EPA characterizes the regulation as flexible.  The final rule allows reductions in initial monitoring for most small water systems, using previously collected drinking water data to satisfy initial monitoring requirements, and reduced compliance monitoring based on sampling results.  Additionally, the final rule does not dictate how PFAS be removed.

In a press release, EPA said it expects that approximately 6-10% of water systems subject to the final rule may need to take action to meet the standards, reducing PFAS exposure for around 100 million Americans.

A previous Verdant Law blog post on the proposed drinking water standards can be found here.

EPA Publishes Proposed Consent Decrees for Overdue Risk Evaluations

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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.

EPA Proposes to Request Unpublished Studies for 16 Chemicals

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On March 26, 2024, EPA published a proposed rule that would require manufacturers of sixteen chemical substances to submit a wide breadth of unpublished studies to the Agency.

If finalized, the rule would amend the list of chemicals subject to health and safety reporting located at 40 CFR 716.120 by adding the following:

  • 4,4-Methylene bis(2-chloraniline) (CASRN 101–14–4)
  • 4-tert-octylphenol(4-(1,1,3,3- Tetramethylbutyl)-phenol) (CASRN140– 66–9)
  • Acetaldehyde (CASRN75–07–0)
  • Acrylonitrile (CASRN 107–13–1)
  • Benzenamine (CASRN 62–53–3)
  • Benzene (CASRN 71–43–2)
  • Bisphenol A (CASRN 80–05–7)
  • Ethylbenzene (CASRN 100–41–4)
  • Naphthalene (CASRN 91–20–3)
  • Vinyl Chloride (CASRN 75–01–4)
  • Styrene (CASRN 100–42–5)
  • Tribomomethane (Bromoform) (CASRN 75–25–2)
  • Triglycidyl isocyanurate; (CASRN 2451–62–9)
  • Hydrogen fluoride (CARN 7664– 39–3)
  • N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD) (CASRN 793– 24–8)
  • 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428–18– 5).

EPA proposed to prioritize five of the listed chemicals (underlined above) for TSCA section 6 risk evaluation in December 2023.  The proposed rule also includes 10 chemicals EPA is considering including in its December 2024 initiation of prioritization.  The last substance, a 6PPD transformation product, was included as a result of EPA’s decision to grant a citizen’s petition on 6PPD.

Pursuant to 40 CFR 716.10 and 716.50, the requested information would include studies on health and safety, environmental effects, physical-chemical properties, exposure, and degradation.  Copies of unpublished studies, lists of known unpublished studies not in the submitter’s possession, and lists of ongoing studies would all be required.  Copies of each study previously listed as ongoing would also be required upon completion, regardless of the study’s completion date.

Studies previously submitted to EPA pursuant to a requirement under TSCA would be exempted from the request.  However, EPA proposes not to apply the typical exemption for persons manufacturing one of the 16 substances only as an impurity.

In addition to current manufacturers (including importers), persons who have manufactured or proposed to manufacture a listed substance within the past ten years would be required to submit the requested information.  Comments on the proposed rule are due on May 28, 2024.

Fifth Circuit TSCA Ruling: Established Process Not a “New Use”

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A decades-old manufacturing process cannot constitute a significant new use under TSCA, the US Court of Appeals for the Fifth Circuit ruled on March 21, 2024, in the case Inhance Techs. v. EPA.

Inhance Technologies LLC (“Inhance”) has strengthened plastic containers using the same fluorination process since 1983.  Unbeknownst to Inhance and EPA until March 2022, the fluorination process resulted in the creation of multiple PFAS chemicals that were included in a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate substances, which took effect in September 2020.

When EPA detected PFAS in a container manufactured by Inhance, it issued the Texas-based company a notice of violation of the SNUR because Inhance had not filed significant new use notices (SNUNs) for the PFAS created during the fluorination process.  EPA instructed Inhance to stop or change the fluorination process so that it no longer created PFAS.  Inhance filed two SNUNs in December 2022 but continued fluorinating plastic containers using the same process.  Following review of the SNUNs, in December 2023, EPA issued two orders under TSCA sections 5(e) and 5(f) prohibiting Inhance from manufacturing or processing PFAS through their fluorination process.  In response, Inhance successfully petitioned the Fifth Circuit for expedited review and a stay pending appeal, stating that the company would be forced to shut down if the orders were put into effect.

Inhance argued that EPA’s orders were unlawful for three reasons.  First, Inhance argued that its fluorination technology could not be understood as a “new” use under TSCA because it had been ongoing for over thirty years before EPA finalized the SNUR.  Second, Inhance argued that the PFAS created during the fluorination process constituted impurities, which are exempted from the scope of the SNUR.  Finally, Inhance argued that EPA’s interpretation of the SNUR as applying to all industries is a “reinterpretation” for which Inhance had not received fair notice.

In the end, the court did not address Inhance’s second and third points, finding the first argument sufficient to vacate EPA’s orders.  Though the statute does not define “new,” the court found Inhance’s interpretation, “not previously existing,” more compelling than EPA’s interpretation, “not previously known to the EPA,” for multiple reasons.  But ultimately, the court just did not think EPA’s interpretation was sensible, stating that it “lacks intuitive force.”  Inhance could not have been expected to submit its fluorination process as an ongoing use during the rulemaking process for the SNUR because it did not know that it created PFAS at that time, the court said.

Writing on behalf of the three-judge panel, Judge Cory T. Wilson concluded by stating that EPA is not powerless to regulate Inhance’s fluorination process.  TSCA section 6 allows for regulation of all chemical substances, unlike section 5, which only applies to new substances and significant new uses.  However, unlike section 5 rulemaking, section 6 requires EPA to conduct a cost-benefit analysis, which takes into account the substance’s benefits and economic considerations.  The court stressed that this requirement indicates that Congress wanted EPA to give more thoughtful consideration to the impact of its regulations on preexisting manufacturing processes.

Judge Wilson was joined by Chief Judge Priscilla Richman and Judge James E. Graves Jr., who concurred in the judgment only.

TSCA Test Order Issued for PFAS NMeFOSE

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On March 20, 2024, EPA issued a test order for a PFAS known as NMeFOSE (CASRN 24448-09-7).  The order, issued under section 4(a) of the Toxic Substances Control Act, requires 3M Co. and Wacker Chemical Corp. to conduct tiered testing on NMeFOSE.

NMeFOSE was selected for testing as a representative of a group of similar PFAS.  Although existing information on NMeFOSE was deemed insufficient, EPA “identified hazards for acute toxicity and specific target organ toxicity.”  NMeFOSE is expected to break down into a highly toxic PFAS known as PFOS, which also drove concerns.

In a press release, EPA stated that NMeFOSE “has been used widely in products, including clothing and carpet treatments as well as furniture coatings.”  The press release also noted that NMeFOSE can accumulate and that the PFAS has been found in the air and in biosolids.  No Chemical Data Reporting manufacturing information is available for the substance.

The first round of tests, which focus on physical and chemical properties, are due 365 to 390 days after the order’s effective date of March 25, 2024.  Subsequent testing will include assessments of NMeFOSE’s environmental fate, in vivo health effects, and reproductive toxicity, with specific testing requirements contingent on earlier results.

The order is the fourth issued under EPA’s National PFAS Testing Strategy.  The most recent prior order was for HFPO-DAF in August 2023.