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.

FDA Reaffirms Softening Chemicals are Okay for Food Packaging

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FDA recently denied a citizen petition requesting that the Agency prohibit the use of eight ortho-phthalates and revoke prior sanctioned uses for five additional ortho-phthalates in food packaging. Ortho-phthalates are used to soften plastics. They can be found in plastic film wrap on foods, cap gaskets used on the metal lids of glass jars, beverage caps, and other packaging.

The original petition was submitted by Earthjustice in 2016. FDA responded in May 2022, denying the petition; Earthjustice submitted a petition for reconsideration in June of that same year. Earthjustice stated that it filed the petition for reconsideration because FDA needed to consider the “mounting scientific evidence that phthalates in food cause serious harm,” evidence that has been developed since the petition was originally submitted.  According to Earthjustice, there is now significant scientific evidence that links phthalates to fibroid tumors in women and preterm births.

The petition for reconsideration alleged that FDA ignored the scientific information presented within the original petition, did not take new information into consideration when denying the petition, and failed to take action on the use of phthalates. In its response to the petition for reconsideration, FDA maintained that it did, in fact, assess the scientific information presented in the original petition, which it did not find persuasive enough to change its position on phthalate regulation at this time.

Further, under 21 CFR § 10.33, FDA is only required to grant a petition for reconsideration if all the following criteria apply:

(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.

(2) The petitioner’s position is not frivolous and is being pursued in good faith.

(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.

(4) Reconsideration is not outweighed by public health or other public interests.

The Agency holds that no information was presented in the petition that has not already been presented and is, therefore, in the administrative record. Because all of the above requirements must be met for reconsideration without the presentation of new relevant information in the petition, FDA has no further obligation at this time.

PFAS Action Filed Against The Children’s Place

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In July, a proposed class action lawsuit was filed against the children’s clothing store The Children’s Place, Inc. The complaint states that the company knowingly sells clothing containing per- and polyfluoroalkyl substances (PFAS) despite knowing that these substances are harmful to children’s health. Specifically, the complaint alleges violations of Illinois’ Consumer Fraud and Deceptive Business Practices Act, fraudulent concealment, breach of implied warranty, and unjust enrichment. The allegations are based on the company’s knowledge of the presence of PFAS in their school uniform products and their failure to disclose this fact in its labeling and advertising, knowing parents would not purchase or pay premium prices for the PFAS-containing products.

The Children’s Place products at issue in the case are school uniforms that meet the requirements of Chicago public and private schools. Plaintiff purchased a number of these items for her child. school uniform.  The complaint states that none of the labeling for these items identified the presence of PFAS in the products, and therefore, Plaintiff concluded that PFAS were not present in any of the school uniform items she purchased. However, according to the complaint, independent third-party testing determined many of these school uniform items contained PFAS. Plaintiff additionally claims that the presence of PFAS in these items runs counter to the testing protocols reported in the Children’s Place’s Annual Environment, Social, and Governance Report.  According to the report, the testing protocols help the company avoid unwanted chemical substances in its finished products and provide consumers with confidence that the products they purchase are safe.

The complaint cites to recent studies and reports on the presence of PFAS in children’s school uniforms, stating, “The presence of PFAS in school uniforms is particularly concerning, as uniforms are worn directly on the skin for upwards of eight hours per day, five days per week, by children, who are uniquely vulnerable to harmful chemicals. Due to children’s lower body weight and sensitive development, exposure to PFAS at a young age for prolonged periods of time may result in a greater lifetime threat of adverse health outcomes.” Plaintiff claims that because of the potential harm, she would not have purchased these products for her child had she been aware of the presence of PFAS.

EPA Seeks Input on Expansion of the Safer Choice and Design for the Environment Programs

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EPA recently solicited public comment on its proposed expansion of the Agency’s Safer Choice and Design for the Environment programs. The expansion would include certification of additional product categories; the programs are currently limited to cleaners and disinfectants. Participation in the programs by manufacturers is voluntary. The programs help consumers and businesses acquire products that meet strict criteria for effects on human health and the environment; products certified by the programs do not present a risk of harm to human health or the environment.

The proposed expansion comes as a result of increasing consumer interest in the chemicals used in products and consumers’ desire to make informed purchasing decisions. During the comment period, the Agency seeks input on which new product categories it should add to these programs and how adding these products will benefit the health of humans and the environment. All products in any category that is added will be subject to the human health and environmental toxicology criteria detailed in the Safer Choice Standard. No product containing intentionally added PFAS can be approved for either program.

Minnesota Passes Legislation Requiring Reporting on Intentionally Added PFAS

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This June, Minnesota became the latest state to pass legislation that will require manufacturers to report intentionally added PFAS in consumer products. It also bans intentionally added PFAS in certain product categories. The legislation will require manufacturers with intentionally added PFAS in consumer products to report the following information to the Minnesota Pollution Control Agency (“MPCA”):

  • A brief description of the product, including a universal product code (UPC), stock-keeping unit (SKU), or other numeric code assigned to the product.
  • The purpose for which PFAS are used in the product, including in any product components.
  • The amount of each PFAS, identified by its Chemical Abstracts Service Registry Number (CASRN), in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by MPCA.
  • The name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer.
  • Any additional information requested by the commissioner as necessary.

Manufacturers will need to submit this information to MPCA on or before January 1, 2026. Furthermore, manufacturers must then receive approval from the Agency before they can sell, offer for sale, or distribute products at issue for sale within the state.

If MPCA does not receive this information and believes a product contains intentionally added PFAS, the Agency can mandate the manufacturer of the product to conduct testing for PFAS. If product testing reveals there are no intentionally added PFAS in the product, the manufacturer must submit a certificate of compliance to MPCA attesting to this fact and including the supporting testing results and any other relevant information. If testing confirms there are intentionally added PFAS in the product, the manufacturer must provide testing results and additional information outlined in the legislation to the Agency.

The legislation bans intentionally added PFAS in a number of products. Such products include:

  • Carpets and rugs
  • Fabric treatments
  • Textile furnishings
  • Upholstered furniture
  • Cleaning products
  • Cookware
  • Cosmetics
  • Dental floss
  • Menstrual products
  • Children’s products
  • Ski wax

The bans on these products will have staggered effective dates between January 1, 2025, and January 1, 2032. The legislation does caveat that MPCA will permit the sale of products with intentionally added PFAS only in instances where the commissioner has determined there is a currently unavoidable use. Product categories that fall under a currently unavoidable use are not detailed in the legislation, but it does specifically state that none of the above product categories are eligible for a currently unavoidable use exemption.

Environment Canada Issues Mandatory Information Request for 850 Chemical Substances

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On June 24, 2023, the Science and Risk Assessment Directorate of Environment Canada published a notice in the Canada Gazette, the Canadian equivalent of the United States Federal Register, that enumerated a mandatory information request for 850 chemical substances for the purpose of assessing whether these substances are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control or the manner in which to control the listed substances under the  Chemicals Management Plan — 2023. The notice details the information that manufacturers, importers, and users of the identified substances will be required to submit.

These 850 substances at issue are divided into four categories:

  • Part 1: Substances for which reporting is required if manufacture, import, or use is 100 kg or more;
  • Part 2: Substances for which reporting is required if manufacture, import, or use is 1,000 kg or more;
  • Part 3: Substances for which reporting is required if import and use for a specific application(s) is 100 kg or more; and
  • Part 4: Substances for which reporting is required if manufacture, import, and use “with additional use activity” is 100 kg or more.

In the notice, Environment Canada grouped reporting requirements by threshold, concentration, and intended use. Reporting is required for substances present at a concentration greater than or equal to 0.1 percent in a mixture or product. In addition, reporting is required for substances present in certain manufactured items (defined as items that are formed into a specific physical shape or design during manufacture and have, for their final use, a function or functions dependent in whole or in part on its shape or design) including products:

  • Intended to be used by or for children under the age of 14 years;
  • Intended to come into contact with the mucosa of an individual other than eyes;
  • Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual;
  • Present in cookware or cooking or serving utensils;
  • Present in food packaging material;
  • Present in clothing or footwear;
  • Present in bedding, sleeping bags, or towels;
  • Present in some furniture, mattresses, cushions, or pillows; and
  • Present in some flooring materials.

Reporting is not required for substances covered by other regulations, including substances that is or is contained in:

  • A pest control product registered under the Pest Control Products Act
  • A fertilizer or supplement registered under the Fertilizer Act
  • A feed registered under the Feeds Act

Additionally, there are exemptions for tetrachloroethylene used in specific situations, such as solvent degreasing and used in dry cleaning. Substances solely in transit through Canada will also be exempt.

Information required includes the concentration, or range of concentrations, of the substance by in goods, where applicable; substance functions; information on commercial and consumer, including use by children; and the title(s) of any unpublished data or studies related to the substance that has not already been provided to the Government of Canada.

Responses are due by January 17, 2024, and must be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window.

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.