Supreme Court to Debate Overturning Chevron Doctrine

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The U.S. Supreme Court has agreed to consider overturning the Chevron doctrine in the Court’s October 2023 term. Chevron is the legal doctrine that has given federal regulators broad power to define their authority. The appeal in Loper Bright Enterprises v. Raimondo, by four New Jersey fishing companies, asks the court to overturn the watershed 1984 Chevron v. Natural Resources Defense Council ruling. In the Chevron decision, the Supreme Court held that courts should defer to administrative agencies when they offer a reasonable interpretation of an unclear statute.

The case involves a federal requirement that some fishing vessels that are fishing herring off the Atlantic coast hire monitors for conservation and management purposes. The requirement specifically mandates that the fishing companies themselves are expected to pay for the monitors. The fishing companies challenged the requirement, claiming that Congress did not authorize the National Marine Fisheries Service (Service) to require them to pay for the monitors. The fishing companies allege that they could spend as much as 20 percent of their revenues on the monitors. In August 2022, the United States Court of Appeals, District of Columbia Circuit upheld the district court’s “grant of summary judgment [upholding the monitoring requirement] to the Service based on its reasonable interpretation of its authority and its adoption of the Amendment and the Rule through a process that afforded the requisite notice and opportunity to comment” requirement relying upon the Chevron doctrine.

The fishing companies argue that the Court can simply say Chevron does not apply because the law in question (the Magnuson-Stevens Act, which governs the management of marine fisheries in federal waters) does not say anything at all about requiring the industry to fund the cost of monitors. Therefore, there is no ambiguity to be interpreted in favor of the Agency.  On May 1, the Court granted certiorari to hear Question 2 from the fishing companies’ petition, which asked: “Whether the Court should overrule Chevron or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency.”

Overturning Chevron would put more responsibility on Congress to directly address policy issues and give judges more authority to define the limit of agency powers.

EPA Releases Draft National Strategy to Prevent Plastic Pollution

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In April, EPA released the Draft National Strategy to Prevent Plastic Pollution. This strategy document, part of EPA’s Series on Building a Circular Economy for All, outlines voluntary actions aimed at eliminating plastic waste released into the environment from land-based sources by 2040. Under this plan, EPA seeks to reduce, reuse, recycle, collect, and capture plastic waste. The draft strategy comprises three primary objectives, each focusing on different aspects of plastic pollution prevention:

Objective A: Reduce pollution during plastic production

This objective emphasizes minimizing pollution throughout the life cycle of plastic products. It encourages manufacturers and consumers to implement upstream actions such as designing products for reuse and recycling, using less impactful materials, and controlling plastic production facilities. Proposed actions include reducing the production and consumption of single-use, unrecyclable, or frequently littered plastic products, as well as minimizing pollution across the entire life cycle of plastic products.

Objective B: Improve post-use materials management

While the National Recycling Strategy identified actions to enhance recycling, this objective expands the focus to other pathways of circularity, including reuse, refill, and composting. Proposed actions involve conducting a study of existing policies and incentives to evaluate their effectiveness, developing or expanding capacity for maximizing material reuse, facilitating effective composting, increasing solid waste collection, enhancing public understanding of plastic mismanagement, and exploring ratification of the Basel Convention for environmentally sound management of scrap and recyclables.

Objective C: Prevent trash and micro/nanoplastics from entering waterways and remove escaped trash from the environment

Proposed actions include implementing policies, programs, and compliance assurance measures to prevent trash and microplastics from entering waterways, improving water management to capture trash in waterways and stormwater/wastewater systems, increasing awareness of the impacts of plastic products in waterways, and coordinating research on micro/nanoplastics.

The agency aims to gauge the importance of different actions, identify key steps and milestones for successful implementation, determine the roles and actions federal agencies should lead, and evaluate potential unintended consequences on overburdened communities. EPA also seeks input on relevant metrics and indicators to measure progress and invites recommendations for additional actions to include in the strategy.

Congress Enacts Modernization of Cosmetics Regulation

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Last month FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions.  The purpose of the program was to provide an overview of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”). The Act imposes new reporting and registration requirements on cosmetic manufacturers. In addition, under MOCRA, cosmetic manufacturing facilities will be required to implement Good Manufacturing Practices (GMPs).

Under MOCRA, mandatory reporting will be required for serious adverse health events caused by cosmetic products.  Responsible persons (i.e., manufacturers, packers, and distributors) will be required to report such events to FDA within 15 business days of learning about them. MOCRA defines serious adverse health events to include infections, incapacitation, significant disfigurement (e.g., serious rashes, second or third-degree burns, significant hair loss, or alternation of appearance), or any condition of severity that requires professional medical attention. Reports of adverse events must be accompanied by a copy of the label of the product at issue. Records related to adverse events must be maintained for six years. Responsible persons shall make these records to “authorized persons’ during inspections. FDA claims the new requirement aims to help FDA identify potential safety concerns with cosmetic products more quickly and take appropriate action to protect the public.

Cosmetic manufacturing facilities will now be required to register with FDA; existing facilities must register within one year of enactment of the Act, and new facilities must register within 60 days of first beginning cosmetics manufacture. Facilities must renew their registration biennially. Registration requirements include providing all brand names under which cosmetic products manufactured or processed in the facility are sold, a list of all cosmetic products manufactured at the facility, and for each product listed, product ingredients, including ingredients in fragrances and flavors. Manufacturers must also keep records documenting ‘adequate substantiation of safety’ providing competent and reliable evidence that products are safe for use. Further, the Act tasks FDA with establishing Good Manufacturing Practices within 2 years of MOCRA’s passage.

MOCRA also mandates the labeling of fragrance allergens for all cosmetics and ingredient labeling for professional use-only products used by salon workers. Additionally, FDA is to establish a standardized testing method for detecting asbestos in talc-containing products within 1 year of MOCRA’s enactment. MOCRA also requires the FDA to assess the use and safety of PFAS in cosmetics and to publish a report of the assessment to be by December 2025.

In addition, MOCRA allows FDA to request records related to a product’s safety substantiation and ingredients and request a mandatory recall of products that are misbranded and/or adulterated.

MOCRA includes a small business exemption for businesses reporting average gross annual sales for the previous three-year period is less than $1 million. The exemption is limited to small businesses that do not make cosmetics that come in contact with eye mucus membranes, are injected, intended for internal use, or alter the appearance for more than 24 hours. Qualifying businesses are exempt from the core provisions of MOCRA, including facility registration (Section 607) and good manufacturing practice or GMP (Section 606).

MOCRA preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means that cosmetic manufacturers will be subject to a uniform set of regulations across the country.

Community Sues EPA Over Terms for Production of Petrochemical Fuel

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Cherokee Concerned Citizens, on behalf of the Cherokee Forest neighborhood  a fenceline community in Pascagoula, Mississippi, has filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a TSCA section 5(e) consent order. The consent order covers 18 chemicals that were the subject of premanufacture notifications submitted by Chevron in 2021. In its press release announcing the litigation, Earthjustice asserted that the production of these chemicals would result in air pollution that would pose a 1 in 4 cancer risk (25 % of the residents living nearby could develop cancer over their lifetime), 250,000 times greater than what the Agency typically considers unreasonable.

TSCA requires EPA to regulate the manufacturing, processing, and distribution of substances that present an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors. The Statute states that the Administrator shall issue consent orders and significant new use rules “to the extent necessary to protect against such risk.”

EPA identified skin and eye irritation; acute toxicity; systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects); reproductive and developmental toxicity; oral and inhalation portal of entry effects; genetic toxicity; and carcinogenicity as hazards of these New Chemical Substances. These hazards were identified based on the substance’s estimated physical/chemical properties by comparing them to compositionally analogous mixtures for which there is information on human health hazard, using available human hazard information on representative constituents of these New Chemical Substances, and other structural information. As is often the case with PMNs, there were no experimentally derived hazard data for these New Chemical Substances.  For a number of the substances, risks were identified for the general population (infants) for systemic and/or oral portal-of-entry effects via drinking water. Risks to adults for this exposure route were also identified. In addition, risks were identified for the general population for systemic and/or inhalation portal-of-entry effects via fugitive air inhalation for some of the substances at issue.

The consent order imposes worker protection and limitations on the distribution of the new chemical substances. It does not restrict air emissions or wastewater discharges of the substances. The Chevron facility called out by Earthjustice is permitted under the Clean Air and the Clean Water Acts.

EPA Improves ChemView

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EPA uses ChemView as a means for the public to access information about chemicals under the Toxic Substances Control Act (TSCA).  The web application allows searches for information such as volumes reported to the Chemical Data Reporting Rule, Premanufacture Notification determinations, section 5(e) consent orders, health and safety studies submitted under section 8(d) and section 8(e) substantial risk reports.  Only non-confidential business information is accessible.  EPA announced they have also been working to improve ChemView to reduce the delay between when the Agency receives information and when it publishes that information – EPA is trying to achieve near real-time publication.  The Agency is also working to enhance transparency in its processes for evaluating potential risks posed by different chemicals.

EPA is required to publish certain information under TSCA section 5(d), such as the list of new chemical submissions received, microbial commercial activity notices, premanufacture notices, and significant new-use notices. Throughout 2022, EPA used ChemView to make available more than 25,000 new chemical notice records that EPA has received under TSCA section 5.  The 25,000 new chemical notice records include previously unpublished records from 2014 through 2019. EPA plans to continue publishing previously unpublished records into the future and is currently publishing new records within five days of receiving them.

As noted above, EPA also uses ChemView to publish records received under TSCA section 8, including substantial risk reports.  Throughout 2022, EPA published 3,900 substantial risk reports, including over 3,300 reports received from the beginning of 2019 through the end of 2021; all of which were previously unpublished.

ASTM International Publishes Case Study on Standards for Biodegradable Plastic

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ASTM International, in celebration of its 125th anniversary, solicited case studies from committee members to showcase standards that have had a significant impact on society. One of the winning entries highlights a set of standards for biodegradable plastic from Committee D20 on Plastics. Two companion specification standards for compostable plastics and paper coatings have been established to promote environmentally responsible end-of-life solutions. These ASTM standards, D6400 and D6868, respectively, are crucial for gaining acceptance in the marketplace and regulatory bodies in states such as California, Washington, Minnesota, Rhode Island, and Connecticut. The plastics industry exclusively uses D6400 and D6868 for making biodegradability claims under industrial composting conditions, and these standards also serve as the basis for certifications issued by U.S. and European organizations. Many stakeholders require that compostable products meet D6400 for plastics and D6868 for coatings on paper, and industrial composters also demand adherence to these standards for the products applicable to composting

EPA Proposes Methylene Chloride Ban

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On April 20, 2023, EPA released a proposed rule under Section 6(a) of the Toxic Substances Control Act (“TSCA”) that would drastically limit the use of methylene chloride. Section 6(a) of the statute provides EPA authority to ban or restrict the manufacture, processing, distribution, and use of chemical substances that pose an unreasonable risk of injury to human health or the environment. EPA explains that its decision is driven by concerns about the risks posed to workers, occupational non-users, consumers, and individuals in close proximity to consumer usage. The Agency stated that it is particularly concerned about adverse health effects such as neurotoxicity, liver damage, and cancer resulting from inhalation and dermal exposure to methylene chloride.

EPA’s proposed rule seeks to “rapidly phase down” the manufacturing, processing, and distribution of methylene chloride for consumer use, as well as most industrial and commercial uses. The phase down is expected to be completed within 15 months of the effective date of the final rule. EPA’s analysis indicates that alternative products with similar cost and effectiveness to methylene chloride are generally available for most of the that the Agency intends to prohibit.

According to EPA, methylene chloride poses an unreasonable health risk, without considering costs or other non-risk factors, including an unreasonable risk to potentially exposed or vulnerable subpopulations identified as relevant in the 2020 methylene chloride risk evaluation, under specific conditions of use (“COU”). (EPA defines COU as the circumstances in which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.) To address the unreasonable risk, EPA proposes the following restrictions:

  • Prohibit the manufacture, processing, and distribution of methylene chloride for all consumer use.
  • Prohibit most industrial and commercial uses of methylene chloride.
  • Enforce a workplace chemical protection program (“WCPP”) that includes inhalation exposure concentration limits, workplace exposure monitoring, and exposure controls for ten specific conditions of use of methylene chloride.
  • Require recordkeeping and downstream notification requirements for the manufacturing, processing, and distribution of methylene chloride in commerce.

The rule does provide an exemption to the prohibition on industrial uses for ten years for civilian aviation uses to prevent significant disruptions to critical infrastructure. This exemption will be subject to conditions such as compliance with the WCPP.  An exemption is also provided for emergency use of methylene chloride in support of the National Aeronautics and Space Administration’s mission. The exemption is limited to specific critical or essential conditions when no technically and economically feasible safer alternatives are available. This exemption will also require compliance with the WCPP. It too is time-limited to ten years.

EPA clarified that all COUs of methylene chloride under TSCA (except its use in consumer paint and coating removers, which was previously addressed under TSCA Section 6) will be covered by this proposal.

Regarding the WCPP for methylene chloride, EPA’s press release states that the agency collaborated with the Occupational Safety and Health Administration (OSHA) during the development of the proposed rule, taking into account existing OSHA requirements to ensure comprehensive worker protections. The Agency asserts that the proposed risk-based limits are based on up-to-date data and fulfill the TSCA mandate to eliminate unreasonable risks. If the rule is finalized, employers would have one year to comply with the WCPP and would be obligated to periodically monitor the workplace to ensure that workers are not exposed to methylene chloride at levels that pose an unreasonable risk.

In the Federal Register notice, EPA particularly requested comments on the feasibility and effectiveness of the proposed worker protection requirements from parties that would be responsible for implementing the program. (The comment period closed on July 3.) Additionally, EPA hosted a public webinar on June 7 to present overview of the proposed regulatory action and provide an opportunity for participation in discussion on the proposed WCCP. Materials from the webinar are available on EPA’s website.

New Tech Being Developed to Remove PFAS from Drinking Water

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Canadian researchers have developed a potentially revolutionary method of filtering and eliminating poly-fluoroalkyl and perfluoroalkyl substances (PFAS) from water. Limiting and removing PFAS has been a national focus and is particularly important because the substances are highly durable. They persist in the environment and the body for years and have been linked to infertility, thyroid problems, and several types of cancer.

Existing methods of removing PFAS from water have limitations, with activated carbon, for example, filtering long-chain PFAS but not effectively trapping the shorter-chain variants of the chemicals. Existing methods also typically create waste products that contain high concentrations of PFAS, which often end up in landfills or are incinerated, potentially causing further harm to the environment.

The new technology developed by the University of British Columbia involves tiny, porous plastic beads that can remove long- and short-chain chemicals at rates that match or exceed industry standards. These PFAS could be stripped away, making the beads potentially reusable or recyclable. The team has also engineered techniques to break the leftover PFAS down into harmless compounds. While the technology is promising, it has yet to be proven in real-world settings at scale, and the team is currently conducting pilot trials in British Columbia.

Experts agree that removing PFAS from water and breaking them down is only part of the solution to the PFAS problem. National and state regulations on PFAS are also necessary to reduce PFAS’s impact. However, the potential impact of this new technology is significant, and it could be part of a collective toolbox for addressing PFAS contamination of our water supplies.

European Commission Sets Implementation Dates for New Hazard Classes

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The European Commission has released implementation dates for new hazard classes introduced by an amendment to the Classification, Labelling, and Packaging of Substances and Mixtures Regulation.  The new hazard classes are as follows:

  • Endocrine disruption for human health (ED HH) in category 1 and category 2
  • Endocrine disruption for the environment (ED ENV) in category 1 and category 2
  • Persistent, bioaccumulative, toxic (PBT) / very persistent, very bioaccumulative (vPvB)
  • Persistent, mobile, toxic (PMT) / very persistent, very mobile (vPvM)

The delegated regulation is in force as of April 20, 2023.  New substances must come into compliance by May 1, 2025, while existing substances will have until November 1, 2026, to comply.  There is a separate transition timeline for mixtures: new mixtures must be compliant on May 1, 2026, and existing mixtures have until May 1, 2028, to update classifications and labeling.

The regulation covers all chemicals substances and mixtures in the EU market under REACH, as well as active substances in biocidal products and plant protection products.  The regulation applies to manufacturers, importers, downstream users, and distributors in the EU market.

EPA Hosts CERCLA PFAS Enforcement Listening Sessions

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In March, EPA hosted two public listening sessions requesting individual feedback regarding concerns about PFAS liability under CERCLA. The listening sessions follow the Agency’s August 2022 proposed rule, which would designate two of the most widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). EPA  has stated that the information gathered during these sessions and any written comments submitted on the topic will be reviewed and considered in drafting its enforcement and discretion policy.

The webinars each began with presentations summarizing CERCLA, detailing the potential harms of PFAS substances, and describing EPA’s plan to issue an enforcement discretion and settlement policy. In addition to comments voiced during the webinars, EPA is reviewing written comments received on the proposed rule. The Agency stated it intends to focus enforcement efforts on manufacturers, federal facilities, and other industrial parties whose actions result in the release of significant amounts of PFAS. EPA clarified that parties that resolve their liability with EPA through settlement would not be liable for third-party claims. Therefore, settlements may provide CERCLA contribution protection to some parties. The Agency’s enforcement discretion policy will be contingent on a party’s cooperation, and it retains the ability to address any situations which present imminent and substantial endangerment.

The Agency also commented on parties against which it does not intend to pursue CERCLA enforcement for PFAS contamination, including:

  • Water utilities and publicly owned treatment works;
  • Publicly owned and/or operated municipal solid waste landfills;
  • Farms that apply biosolids; and
  • Certain airports and fire departments.

EPA further commented that enforcement discretion under this policy would be limited to CERCLA and not impact EPA enforcement actions under any other applicable statute.

EPA has posted the recordings of the sessions, which can be viewed here.