EPA Proposes SNURs for Flame Retardants

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EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

DuPont De Nemours Inc. Sues EPA Regarding GenX Test Order

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Earlier this year, the US Court of Appeal for the Third Circuit ordered EPA to provide documentation regarding the Agency’s decision to order DuPont De Nemours Inc. to provide information on GenX chemicals through two section 4 test orders under the Toxic Substances Control Act (TSCA). DuPont brought this case to challenge the testing requirements imposed on the company, asserting that EPA had incorrectly identified the company as a manufacturer of the chemicals identified in the test orders:  hexafluoropropylene oxide (also known as trifluoro(trifluoromethyl)oxirane) and 6:2 Fluorotelomer sulfonamide betaine, two GenX chemicals. The test orders required testing on the inhalation effects toxicity of the chemicals in order to enable EPA to further understand protentional risks posed to human health and the environment. In addition to the cost of the toxicity studies, the manufacturers subject to the orders were assessed a fee of $11,650 to be split evenly amongst them.

After receiving the order to provide documentation, EPA requested several time extensions, but eventually stipulated to an agreement dismissing the case. The motion filed in May 2023 released DuPont from the test orders on 6:2 fluorotelomer sulfonamide betaine and hexafluoropropylene oxide. The Court then dismissed the case.

Audit Finds EPA’s New Chemicals Program Lacks Sufficient Guidance

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On August 2, 2023, EPA’s Office of Inspector General (“OIG”) released a report on its audit of EPA’s New Chemicals Program. The audit identified recordkeeping and quality assurance issues with the program as administered by EPA’s New Chemicals Division (“NCD”). The audit, which began in October 2021, was conducted in response to several internal complaints submitted to OIG.

The New Chemicals Program reviews whether new chemicals or significant new uses of existing chemicals pose an “unreasonable risk” to human health or the environment under the Toxic Substances Control Act (“TSCA”). According to the report, NCD did not have finalized, up-to-date guidance for recordkeeping or for many of the steps in the new chemicals review process, contrary to EPA protocol.  OIG stated that these issues resulted from insufficient staff resources, which prevented NCD from both conducting the chemical reviews within statutory time frames and finalizing guidance for the activities composing the review process. The report also found frequent technical issues with NCD’s TSCA Confidential Business Information systems.

Some of the complaints to OIG alleged that staff were pressured to focus on deadlines rather than chemicals’ potential risks during the new chemical review process. However, OIG found no evidence of this; for example, the report notes that NCD employees were not evaluated on the speed at which they reviewed chemicals.

OIG made the following four recommendations to EPA’s Office of Pollution Prevention and Toxics (“OCSPP”) based on its findings:

  1. Develop a plan to regularly review NCD’s guidance documents,
  2. Develop a plan to periodically assess the effectiveness of NCD’s recordkeeping system,
  3. Develop a plan to identify the root causes of the technical issues, and
  4. Conduct periodic reviews of NCD’s workload.

OCSPP’s response, which was included in the report, agreed with each of OIG’s recommendations and proposed corrective actions in line with the recommendations.

This audit was not the first to find issues with EPA’s implementation of TSCA provisions. A 2019 GAO report identified similar issues, such as insufficient guidance and resources, with the new chemicals review process. In 2020, OIG found that EPA had missed deadlines on existing chemical risk evaluations and that EPA’s ability to meet future deadlines was at risk. EPA has since proposed a fee adjustment designed to increase TSCA fee collections. Most recently, in February 2023, GAO determined that EPA had missed most TSCA deadlines for reviewing new and existing chemicals.  In general, EPA agreed in part or in full when recommendations were made in these reports and corrective actions have been completed or are pending.

EPA Sued Over Herbicide Registration Renewal

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On June 6, 2023, the Center for Food Safety and two other environmental groups sued EPA over the Agency’s decision to renew registrations for Enlist One and Enlist Duo, two herbicides manufactured by Corteva Agrisciences, LLC.  The case is currently pending before the U.S. District Court for the District of Columbia as Center for Food Safety v. EPA.

The lawsuit alleges that EPA failed to properly evaluate the Enlist products’ risks as required by the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) and the Endangered Species Act (“ESA”) when the Agency renewed the herbicides’ registrations until 2027.  According to the plaintiffs, the herbicides cause numerous adverse environmental effects, including harm to crops growing on neighboring properties and drinking water contamination.  The plaintiffs allege that EPA understated these risks in making its decision, while overstating the herbicides’ effectiveness.  In addition, the plaintiffs argue that EPA’s decision harms the survival, growth, and reproduction of exposed plants and animals, including endangered and threatened species.  The plaintiffs ask the court to vacate EPA’s decision and to stop the sale and use of the Enlist products.

In an EPA memorandum supporting the Agency’s decision, EPA stated that it had “evaluated the benefits and risks to human health and the environment from these products’ uses, including potential risk to non-target organisms, and conducted effects determinations for federally listed endangered and threatened species.”  According to EPA, the results of its evaluations and assessments were sufficient for the Agency to conclude that granting the registration renewal met the requirements of FIFRA and ESA.  These requirements include FIFRA section 3(c)(5), which directs EPA to register a pesticide when the Agency finds that the pesticide will not generally cause unreasonable adverse effects on human health or the environment, among other criteria; ESA section 7(a)(2), which requires EPA to consult with the Fish and Wildlife Service to ensure that actions taken by EPA do not jeopardize endangered and threatened species; and ESA section 7(d), which prevents EPA from taking irreversible action during 7(a)(2) consultation that eliminates the implementation of reasonable alternatives.

Enlist Duo has previously been the subject of litigation.  In National Family Farm Coalition, et al., v. U.S. EPA, et al., 966 F.3d 893 (9th Cir., 2020), petitioners challenged EPA’s decisions to register the herbicide in 2014, 2015, and 2017 on FIFRA and ESA grounds.  The panel rejected the petitioners’ ESA claims and the majority of the petitioners’ FIFRA claims, allowing Enlist Duo registration, but agreed with the petitioners that EPA did not properly assess harm to monarch butterflies due to the herbicide’s effects on milkweed.  The panel remanded the registration decision to EPA so the Agency could assess this concern and determine whether it presented an unreasonable adverse effect under FIFRA.

According to EPA, Enlist One and Enlist Duo are registered for use in 34 states for a variety of uses on corn, cotton, and soybeans.  Both herbicides contain the active ingredient 2,4-dichlorophenoxyacetic acid choline salt.  Enlist Duo also contains the active ingredient glyphosate.

Walmart and Reynolds Sued Over Recyclable Plastic Bag Marketing Claim

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The State Attorney General of Minnesota has filed a lawsuit against Walmart Inc. and Reynolds Consumer Products Inc. (the owner of the trash bag trademark “Hefty”) for falsely marketing their plastic bags as recyclable. The Complaint alleges violations of Minnesota’s Prevention of Consumer Fraud Protection Act, Deceptive Trade Practices Act, False Statement in Advertising Act, and deceptive environmental marketing claim regulations.

These statutes utilize language explicitly prohibiting the use and dissemination of false, deceptive, or misleading statements. For example, Minnesota’s False Statement in Advertising Act strictly prohibits advertising that contains any material assertion, representation, or statement of fact that is untrue, deceptive, or misleading. Minnesota’s Deceptive Trade Practices Act further states:

“A person engages in a deceptive trade practice when …the person … represents that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that they do not have….” (emphasis added).

Defendants, through their product labeling, advertised their products as recyclable, which was false.  In addition, their actions disqualified the recyclable contents of the plastic bags from being recycled. In Minnesota, when recyclable materials or products are placed in non-recyclable bags on the curb, waste management will render the contents of the entire bag unrecyclable, leading both the bag and its contents to end up in landfills.

Additionally, the Complaint alleges deceptive environmental marketing claims by Walmart, citing the Federal Trade Commission’s (“FTCs”) Guides for the Use of Environmental Marketing Claims (also referred to as the “Green Guides”). The Green Guides state, “it is deceptive to misrepresent, directly or by implication, that a product or package is recyclable. A product or package should not be marketed as recyclable unless it can be collected, separated, or otherwise recovered from the waste stream through an established recycling program for reuse or use in manufacturing or assembling another item.” Minnesota recycling facilities cannot process the Hefty brand plastic trash bags labeled as recyclable); in fact, they can cause machine malfunctions and even serious damage.

The Complaint asked the court to order a stop on the sale of these products as marketed. Further, the Complaint requests that the court order the defendants to fund a program to educate Minnesota residents about recyclable materials.

This is not the only lawsuit related to Hefty’s recycling bags. Last year Connecticut’s Attorney General filed a lawsuit against the manufacturer, Reynolds, alleging the company has falsely and deceptively marketed the same Hefty recycling at issue in the Minnesota case. The Complaint states that Reynolds has marketed and sold these bags “despite full knowledge that their bags were incompatible with recycling facilities in Connecticut.” This case is still being litigated.

EPA Finds TCE as a Whole Chemical Substance an Unreasonable Risk to Human Health

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Earlier this year, EPA announced the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (“TSCA”). EPA found that TCE presents unreasonable risks to the health of workers, occupational non-users, consumers, and bystanders. The risks identified include adverse human health effects unrelated to cancer, such as neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to TCE and risks for cancer from chronic inhalation and dermal exposures to TCE. The revised risk determination supersedes the conditions of use (“COU”) specific “no unreasonable risk” determinations that the EPA previously issued in its 2020 TCE risk evaluation.

TCE is a volatile organic compound (“VOC”) used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings, and automotive care products like brake cleaners. EPA determined that 52 of the 54 COUs evaluated drive the unreasonable risk determination.

EPA states that it used the whole chemical risk determination approach for TCE because there are benchmark exceedances for multiple COUs spanning across most aspects of TCE’s life cycle, from manufacturing (including import), processing, commercial use, consumer use, and disposal for health of workers occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA holds that this approach is appropriate because the health effects associated with TCE exposures are “severe and potentially irreversible,” including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer. EPA notes that the revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). EPA states that as it moves forward with a risk management rulemaking for TCE, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.

Additionally, EPA stated it is conducting a screening-level approach to assess potential risks from the air and water pathways for several of the first 10 risk evaluation chemicals, including TCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for TCE that were excluded from the 2020 risk evaluation and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for TCE.

Hearing Announced on EPA’s Intent to Cancel Chlorpyrifos Pesticide Registrations

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On June 21, 2023, EPA announced that a public hearing will be held in response to objections and hearing requests following EPA’s issuance of a Notice of Intent to Cancel (“NOIC”) pesticide registrations for three products containing chlorpyrifos. The hearing will begin at 9 a.m. on January 8, 2024, and will continue as necessary through January 11, 2024.

The objections and hearing requests following the NOIC came from a collection of grower groups and a producer of chlorpyrifos products. The petitioners are currently challenging EPA’s 2021 final rule, which revoked all tolerances for chlorpyrifos, in the Eighth Circuit case Red River Valley Sugarbeet Growers Association et al. v. Regan. The petitioners argue that EPA should stay or withdraw the NOIC until the pending case is decided.

EPA’s NOIC was the result of over a decade of efforts to ban chlorpyrifos use. In 2007, two non-profit organizations filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos, pointing to studies showing neurotoxic, developmental, endocrinal, and carcinogenic effects in humans and animals as a result of exposure. EPA did not take final action on the petition until it denied the petition in 2017, concluding that the science behind the effects of exposure remained unresolved.  In 2021, the Ninth Circuit vacated EPA’s decision in League of United Latin Am. Citizens v. Regan. The court held that EPA had abdicated its statutory duty under the Federal Food, Drug, and Cosmetic Act by failing to update the tolerances for chlorpyrifos despite its inability to conclude, to the statutory standard of reasonable certainty, that present tolerances caused no harm. The court ordered EPA to grant the 2007 petition and modify or revoke the tolerances accordingly. EPA opted to revoke all tolerances in the final rule.

In the ongoing case, Red River Valley Sugarbeet Growers Association et al. v. Regan, the grower groups and the chlorpyrifos producer argue that the final rule was arbitrary and capricious due to EPA’s disregard for safe chlorpyrifos uses. The petitioners observe that shortly before the final rule was published, EPA completed a human health assessment that found that chlorpyrifos use on eleven crops in select regions was safe. By refusing to act on its own evidence, the petitioners assert that EPA disregarded its statutory mandate to review the safety of tolerances using current science.

According to EPA, chlorpyrifos was registered for use in the U.S. beginning in 1965. At the time of the final rule, chlorpyrifos was registered for use on fruit and nut trees, many types of fruits and vegetables, and grain crops.

FTC Finalizes Made in the USA Enforcement Action Against Motocross Parts Maker

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Last month the Federal Trade Commission (“FTC”) took enforcement action against an ATV and motocross parts maker, Cycra, and one of its officers for falsely claiming the company’s products were manufactured in the United States. FTC’s complaint alleged Cycra made false or misleading Made in the United States (MUSA”) advertising claims in violation of the Made in USA Labeling Rule. The rule strictly prohibits marketers from labeling products as “Made in USA” unless (1) the final assembly or processing of the product occurs in the United States; (2) all significant processing that goes into the product occurs in the United States; and (3) all or virtually all ingredients or components of the product are made and sourced in the United States.

Between 2019 and 2022, Cycra advertised and sold motocross and ATV products, which it claimed were all or virtually all made in the United States. More than 150 of the company’s products displayed labels containing the wording “Made in the USA” (what FTC refers to as a “MUSA Label”) along with images of American flags. Additionally, the company’s website and social media made numerous Made in the USA claims, including that products were “[p]roudly designed, developed and manufactured in Lexington, North Carolina” and “[p]roudly made in the USA.”

Cyrca products were, in actuality, not being produced in the United States. Cycra imported at least 30 shipments of parts or accessories from Asia and Europe and additionally imported shipments of finished products already packaged, some already including MUSA Labels.

FTC’s order details a variety of requirements limiting the claims Cycra can make regarding its products going forward. First, there will be restrictions on unqualified claims; the company will be prohibited from making unqualified MUSA claims for any product unless it can show that the final assembly and all significant processing of the product take place in the United States and that all, or virtually all, ingredients or components of the product are made and sourced in the United States. Additionally, FTC has ordered requirements for qualified claims, requiring that for any qualified MUSA claims, there must be clear disclosure about the extent to which the product contains foreign parts, ingredients, components, or processing. Lastly, FTC has ordered requirements for assembly claims which require the company to ensure that when a product is claiming to be assembled in the United States, its principal assembly takes place in the United States and that those assembly operations are substantial.

The order also included a monetary judgment of $872,577. The monetary judgment has been partially suspended based on the company’s inability to pay.  However,  the company has been required to pay $221,358.66 of the penalty.

Microplastics and PPD Derivatives Proposed for Regulation in California

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California state regulators recently announced plans to potentially regulate two additional groups of chemicals under the state’s Safer Consumer Products Program (“SCP”). The California Department of Toxic Substances Control (“DTSC”) has proposed adding microplastics and para-Phenylenediamine (“PPD”) derivatives to its Candidate Chemicals List (“CCL”) due to their reported impacts on human health and the environment. Regulators are beginning a public comment process in the hopes of gathering valuable input and feedback from stakeholders to help inform a potential regulatory proposal.

Scientific evidence has been growing regarding the harmful effects of microplastics on both human health and the environment. These minuscule plastic particles, released directly or through the breakdown of larger plastic items, persist and spread throughout the ecosystem. DTSC detailed this issue and identified products that release microplastics into the environment as one of their top five policy priorities in the 2021-2023 Priority Product Work Plan.

PPD derivatives, a family of chemicals widely used in various industrial applications, have also come under scrutiny. Specifically, 6PPD, a member of the PPD derivative family, is extensively used in motor vehicle tires to prevent degradation over time. DTSC is finalizing regulations to include motor vehicle tires containing 6PPD on its Priority Product List. This regulation will require tire manufacturers to identify and assess potential alternatives to 6PPD that ensure tire safety and performance. By adding the entire PPD derivative class to the CCL, manufacturers will be prompted to thoroughly evaluate the tradeoffs involved before switching from 6PPD to another PPD derivative.

Adding chemicals to the CCL does not automatically impose new requirements. Instead, it enables the SCP Program to select consumer products containing these chemicals for evaluation and potential regulation as Chemicals of Concern in Priority Products.

Public workshops are scheduled for June and July, providing an opportunity for interested parties to contribute to the discussion and share their expertise. Information on the upcoming workshops can be found here.

Oral Arguments in Monsanto “Roundup” Case

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On June 13, 2023, the full Eleventh Circuit heard oral arguments in the case Carson v. Monsanto Co.  The case hinges on whether a Georgia law that requires Monsanto to warn consumers about risks the company knows about or has reason to know about is preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The appellant, John D. Carson Sr., alleges that he developed cancer due to regular use of Roundup, a glyphosate-based pesticide manufactured by Monsanto. Carson claims that Monsanto “has known for decades” that Roundup use can cause cancer and failed to label their products in a way that notified consumers of this risk as required by Georgia law.

FIFRA requires pesticide manufacturers to include warning labels on products that adequately protect consumer health, but EPA has concluded that glyphosate is “not likely to be carcinogenic” to humans.  FIFRA prohibits state labelling laws that are “in addition to or different from” FIFRA requirements (7 U.S.C. § 136v(b)). Monsanto argues that this language expressly preempts the Georgia law, while Carson contends that the Georgia law merely “parallels” FIFRA’s provisions. Carson cites Bates v. Dow AgroSciences LLC, interpreting the ruling to mean that claims “equivalent to” or narrower than FIFRA provisions are not preempted (544 U.S. 431, 447 (2005)).

Also at issue in the case is the question of whether EPA’s actions with regard to Roundup constitute “force of law.” Carson asserts that EPA’s registration of Roundup does not have the force of law necessary to preempt Georgia law.  Monsanto argues that no force-of-law analysis is required because “EPA determinations define the scope of preemption as a matter of statutory construction,” but also argues that EPA’s actions constitute force of law even if such an analysis is undertaken.

During oral arguments the court posed questions to Carson’s attorney regarding whether a force-of-law analysis is necessary and questioned the attorney representing Monsanto on whether the grounds for an impossibility preemption were met. In addition, both attorneys were asked whether the appeal was “collusive” due to the type of settlement the parties reached in the case.

Carson’s suit was initially dismissed by a Georgia court, which held that FIFRA expressly preempted the Georgia law. In July 2022, it was reinstated by a three-judge Eleventh Circuit panel which ruled in favor of Carson. The panel reached the same result in a new opinion in October 2022. Last December, the full Eleventh Circuit vacated the opinion, ordering that the case be heard en banc.