EPA Releases Framework for Addressing New PFAS and New Uses Under TSCA

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EPA has released the Framework for Addressing New PFAS and New Uses of PFAS. This document details the Agency’s planned strategy for evaluating Premanufacture Notices  (“PMNs”) for new PFAS compounds and Significant New Use Notices (“SNUNs”) for “new uses” of existing PFAS to ensure they do not pose harm to human health and the environment.

The Agency states that new PFAS substances present challenges for regulators, as there is frequently limited information available to assess their potential risks accurately. Many PFAS compounds are known to persist in the environment, bioaccumulate, and be toxic (known as “PBT”); the framework aims to qualitatively evaluate PFAS based on how likely they truly are to become PBTs in the body and environment.

The framework distinguishes between PFAS uses that may result in environmental releases and potential exposures and those that don’t. For example, PFAS applications that are deemed to have negligible exposure and minimal environmental release, such as in the closed systems used in the manufacture of electronics. EPA generally anticipates allowing the compounds to enter commerce after exposure data is provided.

The framework calls for more comprehensive testing, including toxicokinetic data, for PBT PFAS compounds that are expected to have a low but greater than negligible potential for environmental release and exposure. If initial testing raises concerns about exposure levels and risks, EPA will mandate further testing and risk mitigation before permitting manufacturing. This comprehensive testing would encompass physical-chemical properties, toxicity, and fate analysis. For example, uses of PFAS in spray-applied stain guards inherently involve releases into the environment. If required testing finds potential hazards, EPA has the authority under TSCA section 5 to demand additional testing and risk mitigation strategies or prohibit manufacturing entirely.

If EPA determines a new chemical substance poses an unreasonable risk, lacks sufficient risk information, or involves substantial production with potential exposure, it must issue a section 5(e) order for human health and environmental protection, which may include testing requirements. If PFAS data suggests it’s a PBT chemical and EPA anticipates exposures, the substance or significant new use could be deemed to present an unreasonable risk, therefore requiring either a section 5(f) order or an immediately effective proposed rule under TSCA section 6(a). The section 5(f) order applies to the submitter, while the 6(a) rule covers all users. For a SNUN, the 6(a) rule typically targets the specified new use. The chart below further details the possible EPA determinations and related actions following their review.

Determination Related Action
In the absence of sufficient information to permit a reasoned evaluation of risk from the substance or significant new use, the substance or significant new use may present an unreasonable risk. EPA must issue an order under TSCA section 5(e).
There is insufficient information to permit a reasoned evaluation of risk from the substance or new use. EPA must issue an order under TSCA section 5(e).
The substance or significant new use presents an unreasonable risk. EPA must take action under TSCA section 5(f).
The substance is or will be produced in substantial quantities, and there may be significant or substantial human and/or environmental exposure (exposure-based). EPA must issue an order under TSCA section 5(e).
The substance or significant new use is not likely to present an unreasonable risk. EPA notifies the submitter of its decision and publishes its findings in the Federal Register.

 

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.

New Jersey Reaches Historic Settlement with Solvay Polymers over PFAS Contamination

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On June 28, 2023, New Jersey’s Department of Environmental Protection (NJDEP) announced a proposed settlement with Solvay Specialty Polymers USA, LLC (“Solvay”) over the company’s discharge of PFAS and other hazardous substances from its West Deptford facility.  According to a press release from New Jersey’s Office of Attorney General (NJOAG), the $392.7 million proposed settlement is the “largest single-site natural resource damages and remediation case in New Jersey history.”

In the 2020 complaint that led to the proposed settlement, NJDEP alleged that PFAS discharges and emissions from Solvay’s West Deptford facility had caused “widespread soil, sediment, groundwater, and surface water contamination.”  In particular, NJDEP asserted that levels of PFNA­—a type of PFAS—detected in surface water and public drinking water near the facility were higher than levels reported “anywhere else in the world.”  According to NJDEP, Solvay and the facility’s previous owner knew or should have known about the dangers posed by PFAS but “failed to disclose the impact of their use and releases of PFAS into the environment to the Department and the surrounding community.”

Under the terms of the proposed settlement, Solvay would be required to reimburse NJDEP for previous remediation efforts, pay claims for natural resource damages, and fund additional remedial activities to be undertaken by NJDEP and the company.  Solvay would be responsible for identifying and remediating contaminated natural resources and wells and providing regular reports of its remedial activities to NJDEP.  Funds allocated to NJDEP would primarily be used to address PFAS in drinking water systems.

The settlement comes after a 2019 NJDEP directive for Solvay and four other chemical manufacturers responsible for “significant contamination of New Jersey’s natural resources” to provide financial compensation for PFAS-related contamination and information on their PFAS use and emissions.  NJDEP’s 2020 complaint argued that Solvay did not fully comply with the directive.  According to NJOAG, Solvay is the first company identified by the directive to reach a proposed settlement with NJDEP.

A formal notice of the proposed settlement was published in the New Jersey Register on August 7, 2023.  Public comments on the proposal will be accepted through October 6, 2023.

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.

Canada Bans Many Single-Use Plastics

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Canada has enacted the Single-use Plastics Prohibition Regulations, SOR/2022-138, prohibiting the manufacture, import, export, and sale of many single-use plastics (SUPs).  The ban will cover the following six types of SUPs by the end of 2025:

  • Checkout bags;
  • Cutlery;
  • Foodservice ware containing expanded polystyrene foam, extruded polystyrene foam (commonly known by the trademark Styrofoam), polyvinyl chloride (PVC), carbon black, or an oxo-degradable plastic;
  • Ring carriers (defined as plastic items “formed in the shape of a series of deformable rings or bands that are designed to surround beverage containers in order to carry them together”);
  • Stir sticks; and
  • Straws.

For ring carriers, the prohibition on manufacture and import takes effect on June 20, 2023, and sale will be prohibited on June 20, 2024.  Manufacture and import of the other five types of SUPs will be prohibited on December 20, 2023, and sale of these items will be prohibited on December 20, 2023.

All six types of SUPs are subject to a temporary exemption for manufacture, import, and sale for the purpose of export; this exemption will be repealed on December 20, 2025.  In the meantime, the regulations institute recordkeeping requirements for persons who manufacture or import SUPs for the purpose of export.

Flexible SUP straws are not subject to the manufacture and import prohibitions for SUP straws, but alternative provisions apply.  For example, retail stores will only be allowed to sell flexible SUP straws if a customer requests straws and the straws are “not displayed in a manner that permits the customer to view the package without the help of a store employee.”

The regulations are the latest in a series of steps taken by Canada to move away from the use of SUPs.  In 2020, Environment and Climate Change Canada (ECCC) released a report on the sources, environmental fate, occurrence, and health effects of plastic pollution, which concluded by stating that “action is needed to reduce macroplastics and microplastics that end up in the environment” in accordance with the precautionary principle.  In 2021, manufactured plastic items were added to the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act.

More information on the regulations can be found in an ECCC guidance document.

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.

Canada Overhauls Assessment of Toxic Substances in CEPA Update

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On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act received royal assent.  The act, which revises Canada’s toxic substances law and enshrines a right to a healthy environment, is the first significant revision to the Canadian Environmental Protection Act (CEPA) since its passage in 1999.

The act implements some, but not all, of the 87 recommendations made by the House of Commons Committee on Environmental and Sustainable Development in 2017.  Key provisions of the act, including a new chemical management plan and implementation of the right to a healthy environment, are unspecified and will be determined by future regulations.

Revisions to Toxic Substances Law

One of the most important changes in the act is the requirement that the government develop a new chemical management plan within the next two years.  The plan must identify substances that should be prioritized for assessment, specify initiatives that should be prioritized by Parliament to control risks posed by substances, promote alternatives to vertebrate testing, and be reviewed at least once every eight years.  To avoid harmful substitutions—when a problem chemical is replaced by a chemical that itself becomes a problem—the ministers are instructed to consider whether it would be more advantageous to assess substances by class than individually.

In 1999, CEPA required the prioritization of substances in commerce for assessment.  According to a backgrounder by Environment and Climate Change Canada, the “resulting process to assess these substances has largely been completed.”  However, a new plan will address “new chemicals being developed, new uses for existing chemicals, increasingly complex supply chains, and emerging science about risks.”

The act also institutes a new classification system for assessed chemicals.  CEPA originally contained two lists of hazardous chemicals: a List of Toxic Substances in Schedule 1 and a Virtual Elimination List.  The act scraps the Virtual Elimination List, which was almost never used, and divides Schedule 1 into Parts 1 and 2.  Part 1 contains 19 chemicals prioritized for total, partial, or conditional prohibition, including PFOS and DDT.  Part 2 contains all other substances deemed toxic, which will be prioritized for pollution prevention.  The 132 substances initially placed in Part 2 include asbestos and manufactured plastic items.

As an alternative to Parts 1 and 2 in Schedule 1, the act creates a watch list for “substances that the ministers have reason to suspect are capable of becoming toxic or that have been determined to be capable of becoming toxic.”  The backgrounder states that the list “will help importers, manufacturers, and Canadian consumers to select safer alternatives and avoid [harmful] substitutions.”  Any person can file a request that the ministers assess a substance’s toxicity or capability to become toxic.

Other changes introduced in the act include requiring the ministers to consider “whether exposure to the substance in combination with exposure to other substances has the potential to cause cumulative effects” and “whether there is a vulnerable population or environment in relation to the substance” when interpreting the results of an assessment; requiring a rationale to support requests for the confidential treatment of business information; and requiring that an explanation be provided if an assessment has not been completed after two years.

Right to a Healthy Environment

Also included in the act, for the first time in Canadian legislative history, is a “right to a healthy environment.”  The government has two years to “develop an implementation framework to set out how the right to a healthy environment will be considered in the administration of this Act.”  The framework must “elaborate on” the act’s principles, such as environmental justice, non-regression, and intergenerational equity.  However, the right is not absolute.  The implementation framework must “determine[e] the reasonable limits to which it is subject.”

Canadian representatives have questioned whether the right to a healthy environment will be enforceable.  The act does not amend section 22 of CEPA, which allows individuals to bring an “environmental protection action” in limited circumstances against persons who commit an offence under CEPA.  The Senate Committee on Energy, the Environment, and Natural Resources stated that “the right to a healthy environment cannot be protected unless it is made truly enforceable,” noting concern that Section 22 “contains too many procedural barriers and technical requirements that must be met to be of practical use” when it comes to enforcement.

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.