Supreme Court to Debate Overturning Chevron Doctrine

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.

New Tech Being Developed to Remove PFAS from Drinking Water

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.

EPA Issues SNUR for Inactive PFAS

On January 26, 2023, EPA proposed a significant new use rule (SNUR) for PFAS substances that are currently classified as “inactive” on the TSCA Inventory. A substance is considered inactive on the TSCA Inventory when it has not been manufactured, imported, or processed in the U.S. since 2006. When the rule is finalized, anyone who wants to begin any manufacturing, importing, or processing activity involving any of these PFAS substances would be subject to the SNUR and would be required to obtain permission from EPA via a Significant New Use Notification (SNUN) at least 90 days before commencing the said activity. EPA would then review and make an affirmative determination as to whether the activity detailed in the SNUN presents an unreasonable risk to human health or the environment. EPA proposes some exceptions from the SNUR requirement, including when one of these PFAS are present as an impurity or byproduct and when the substances are imported or processed as part of an article.  Comments on the proposed rule are being accepted until March 27, 2023.

Verdant Law’s Irene Hantman Gives Presentation to Chemical Society of Washington on Chemical Commercialization

Verdant Law is pleased to announce that Irene Hantman gave a presentation, Chemical Commercialization: What to Know about EPA Regulations, before the Chemical Society of Washington. The presentation provided a comprehensive overview of chemical commercialization under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The overview of TSCA detailed the definitions of chemical substances and substances in commerce, background on the TSCA Inventory and the premanufacture notification (PMN) process, and the EPA platforms for reporting and submitting data related to PMNs and active Inventory substances. The overview of FIFRA outlined the definition of pesticides under the law, the pesticide registration process, data requirements, review timelines and fees, and potential tolerance limitations EPA may set on chemicals with food uses. For questions about this presentation, contact Irene Hantman.

Biden-Harris Administration Expands Cybersecurity Partnership in Chemical Sector

On October 26, 2022, the Biden-Harris Administration announced it is expanding its Industrial Control Systems (ICS) Cybersecurity Initiative to the chemical sector. The ISC Cyber Security Initiative was launched in April 2021 to strengthen the cybersecurity of critical infrastructure across the country through private sector and government collaborations. The focus of the collaboration is to facilitate the deployment of technologies and systems that provide threat visibility, indications, detections and warnings, and facilitate responses. The Initiative is currently underway in other industrial sectors including water and wastewater, and energy.

The U.S. Cybersecurity and Infrastructure Agency (CISA) and the nation’s leading chemical companies are jointly developing the Chemical Action Plan over the next 100 days. The Plan will detail the chemical industry self-assessment of current cybersecurity practices, lessons learned and best practices. The plan will include the following:

  • Focus on high-risk chemical facilities that present significant chemical release hazards, with the ultimate goal of supporting enhanced ICS cybersecurity across the entire chemical sector.
  • Drive information sharing and analytical coordination between the Federal Government and the chemical sector.
  • Foster collaboration with sector owners and operators to facilitate and encourage the deployment of appropriate technologies, based on each chemical facility’s own risk assessment and cybersecurity posture (the Federal Government will not select, endorse, or recommend any specific technology or provider).
  • Support the continuity of chemical production critical to the national and economic security of the country.

For more information on CISA’s role in securing critical infrastructure and the Securing Industrial Control Systems initiative, visit the Agency’s website.

Verdant Law Gives Presentation on EPA’s New PMN Review Process at Annual Product Stewardship Conference

Verdant Law is pleased to announce that Phil Moffat gave a presentation on EPA’s new PMN review process at this year’s Product Stewardship Conference. Moffat highlighted EPA’s proposed rule (expected to be released in February 2023) updating date procedural regulation to conform with the Lautenberg amendment, which requires EPA to make affirmative determinations on whether new chemical substances present an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. The proposed rule, if implemented, would increase the quality of information initially submitted in a PMN and reduce Agency rework in the risk assessment process, and reduce the Agency’s review time for each PMN.

Additionally, in June 2020, EPA launched a series of webinars working towards its goal of increasing transparency and reducing reworks. The webinars highlight common issues that require EPA to reconduct new chemical assessments (reworks), which substantially delay the Agency in completing PMN reviews.

Moffat also discussed EPA’s recently announced effort to implement a streamlined and efficient process for risk evaluations on chemicals used in electric vehicles, semiconductor, and clean energy sectors with the goal of increasing the nation’s energy security. The effort will focus specifically on mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs).

Also detailed was EPA’s recent decision to discontinue the use of exposure modeling thresholds in the new chemical review process. The change would require completing modeling for all potential exposures that may result from air releases and releases to groundwater from landfills, as opposed to only those above an established threshold under the current policy. EPA believes that the adoption of this new policy will allow for a more comprehensive accounting of all potential air and water releases to ensure any needed protections are in place before a new chemical comes to market.

Lastly, Moffat discussed EPA’s efforts to bring innovative science to the chemical review process detailed in an Agency document TSCA New Chemicals Collaborative Research Effort. The effort includes a multiyear research plan in collaboration with federal agencies such as NIH’s National Toxicology Program. The focus areas of the research include:

  • Updating and refining chemical categories.
  • Developing and expanding databases containing TSCA chemical information.
  • Developing and refining QSAR and predictive models for physical-chemical properties, environmental fate/transport, hazard exposure, and toxicokinetics.
  • Exploring was to integrate and apply New Approach Methodologies (NAMS) in new chemical assessments.
  • Developing a TSCA new chemicals decision support tool.

If you have questions about the topics of this presentation, please contact Phil Moffat.

Proposed Rule Changes to TSCA CBI

On May 12, 2022, EPA proposed a rule (87 FR 29078) that would update requirements for making confidential business information (CBI) claims under TSCA. According to the proposal, the focus of the rule is to enhance transparency and modernize reporting and review procedures for CBI claims.  In addition, the rule will impose some additional requirements for making CBI claims to better comport with the Lautenberg amendments. These new requirements include changes to the following areas detailed below.

Substantiation and Exemptions

Two changes are proposed for the substantiation requirements. First, proposed section 703.5 provides further clarification and reiterates that where a TSCA submission identifies a chemical substance listed on the confidential portion of the TSCA Inventory but does not assert a confidentiality claim, the specific chemical identity would no longer be eligible for confidential treatment on the TSCA Inventory. Second, proposed rule section 703.5(b)(1) would require claimants to assert their CBI claims at the time of submission.  It would also require that such claims are accompanied by the requisite substantiation.  Here-to-fore, substantiation at the time of submission has been required for some but not all TSCA submissions. The proposed rule, sections 703.5(b)(3) and (4), also specifies the standard set of substantiation questions that will apply to TSCA CBI claims. These questions include:

Proposed Section 703.5(b)(3) Substantiation Questions for all Claims:

  • What harm to the competitive position of your business would be likely to result from the release of the information claimed as confidential? How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable?
  • Has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures.
  • Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
  • Does any of the information claimed as confidential otherwise appear in any public documents? If yes, please explain why the information should be treated as confidential.
  • Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.

 

Proposed Section 703.5(b)(4) – Additional Substantiation Questions for Chemical Identity-Related Claims

  • Is this chemical substance publicly known to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status.
  • Does this specific chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent, emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.
  • Would disclosure of the specific chemical identity release confidential process information? If yes, please explain.

The substantiation requirements will not apply to information exempt under TSCA section 14(c)(2)(G), including specific information describing the processes used to manufacture or process a chemical; and marketing and sales information.

Public Copies of Submissions

EPA proposes changes to section 703.5(c), requiring the submitter to prepare a separate public copy of a submission where the reporting form or application contains CBI. These changes explicitly state that a public copy of a submission that redacts all or substantially all content within the original submission would most likely not meet the requirements of the rule because it is unlikely that all the information in a form or attachment can appropriately claimed as CBI.

Reporting

Pursuant to proposed section 703.5(f), nearly all TSCA confidentiality claims must be asserted electronically using the reporting tools within the Chemical Information Submission System (CISS).

Generic Name Criteria

The proposed rule addresses generic names for chemicals not on the TSCA inventory. It outlines the criteria for the masking of portions of the chemical name.  In addition, the proposed rule would require an accompanying explanation request for extensive masking. The proposed changes would be included in sections 703.5(d)(2)-(4).

Reporting Health and Safety Data Using Harmonized Templates

The proposed rule also addresses confidentiality claims and health and safety studies. Under TSCA section 14(b)(2), confidentiality claims cannot be asserted in health and safety studies. However, TSCA section 14(b)(2) does permit withholding specified information contained in these studies that do not apply to human or environmental health. Previously, the treatment of this information lacked uniformity. Accordingly, proposed section 703.5(g) mandates that health and safety information be reported using harmonized templates. Additionally, under section 703.3 of the proposed rule, EPA has identified the types of information within health and safety studies for which confidentiality claims may be asserted.

Administrative Changes

Proposed section 703.5(e) addresses deficient claims (e.g., submissions that include a generic name that does not meet the requirements of proposed section 703.5(d) or rely on inappropriate substantiation exemption assertions).  When EPA identifies a claim as deficient, the Agency will provide notice of the deficiency to the submitter.  Confidentiality claims identified as deficient will be held for ten business days after the claimant has been notified. If the deficiency is not remedied during the suspension, EPA may proceed with reviewing the submission as is and may subsequently deny the claim. Proposed section 703.5(i) refers to the procedures for withdrawing confidentiality claims.

* * *

These proposed changes are intended to narrow the scope of CBI claims. EPA contends that these changes will provide the public with greater access to up-to-date information regarding the status of CBI claims and the data supporting said claims. EPA also anticipates the guidance provided by the new rule will enhance the clarity and uniformity of CBI claim submissions. This is expected to expedite the CBI claim review process and help EPA meet the statutory review deadlines.

 

Lawsuit over Coloring Agent in Skittles Dismissed

Mars Inc. was sued in July 2022 regarding claims related to the titanium dioxide content of its skittles candy.  The complaint alleged that the titanium dioxide – a coloring ingredient– was toxic and that its presence made the candy unfit for human consumption.  This suit was filed as a proposed class action in the U.S. district court, northern district of California.  The lawsuit also claimed titanium dioxide causes DNA damage, chromosomal damage, inflammation, and other adverse health effects.

EPA’s assessment of titanium dioxide in 2005 states that inhalation of the chemical in high concentrations can cause pulmonary effects in rats, however the Agency noted that the possibility that the negative effects might not occur in humans.  EPA’s assessment also found that there is no carcinogenic effect associated with exposure to titanium dioxide dust – concentrations up to five percent of the rat’s diet of titanium dioxide did not result in adverse effects.

The lawsuit claimed Mars Inc. failed to inform consumers of the dangers of consuming titanium dioxide and that reasonable consumers did not know that Skittles contained the substance dioxide.  Additionally, the suit asserted that Mars Inc. knew about the risks posed by titanium dioxide when it announced a plan to phase out the substance in 2016.

Mars Inc. responded to the complaint with a series of motions to dismiss.  The company argued that it was in compliance with FDA regulations that approved titanium dioxide as a safe color additive, and that the complaint failed to identify any harm to the plaintiff.  Ultimately the plaintiff agreed to a voluntary dismissal.

PCRRTK Friday Forum with Tala Henry and Jeff Dawson on PFAS

Join the ABA/SEER’s Pesticide, Chemical Regulation, Right-to-Know Committee for a remote Friday Forum with EPA’s Tala Henry, Deputy Director, Office of Pollution Prevention & Toxics, and Jeff Dawson, Deputy Director, Health Effects Division, Office of Pesticide Programs for an overview of EPA’s PFAS Roadmap with emphasis on OCSPP key activities. The program will be held on Friday, December 17th 11-12 pm ET. There is no charge for participation. RSVP to ihantman@verdantlaw.com if you would like to attend.

False Claims Suit Against Danimer Scientific

Danimer Scientific is facing a federal securities class action after an investor, Darryl Keith Rosencrants, filed a suit against the manufacturer in May, 2021.  The suit is a result of severe stock price drops after the publication of articles alleging the manufacturer made false claims on their products.  Danimer maintains that their claims are accurate.

Danimer sells polyhydroxyalkanoates (PHAs) under their brand name Nodax.  These PHAs are used in the creation of various plastic items, such as water bottles, straws, and food containers.  Danimer claims on their website that their Nodax products are 100 percent renewable and biodegradable in marine, freshwater, and soil environments.  They further state that the biodegradability due to certain microorganisms means the Nodax products have the possibility to biodegrade in landfills.

The plaintiff alleges Danimer overstated and exaggerated claims on the biodegradability of Nodax in oceans and landfills.  The plaintiff further claims that these statements led to an inflated value of the company and resulted in the severe drop in stock price once publication reported on the issue.  An article published in the Wall Street Journal on March 20, 2021 states Danimer made misleading claims and cites at least one expert calling Nodax’s biodegradability “not accurate” and “greenwashing”.  When stock trading opened again, Danimer’s value dropped 12.87 percent.

Spruce Point Capital Management, an investment firm, published a report critical of Danimer on several issues, including degradability, on April 22, 2021.  Throughout the trading day, the stock dropped 8.04 percent.  From March 20, 2021 to April 22, 2021, the total drop in value was 54 percent.  The Plaintiff and other Class members are claiming losses and damages due to the precipitous decline of Danimer’s market value securities.