Summary
- Provides articles written by members of the Pesticides and Chemicals committee in one location.
- Explores recent updates and cases in Pesticides and Chemicals law.
January Updates from the PCRRTK Committee
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January Featured Article
TSCA Enforcement Action Taken over Failure to Comply with PFAS SNUR
Ariel Neumann
In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain per- and polyfluoroalkyl substances (PFAS) in violation of the Toxic Substance Control Act (TSCA). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.
The first lawsuit was filed by the U.S. Department of Justice Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (EPA). The second case is a citizen suit, filed by the nonprofit organizations Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.
Defendant Inhance Technologies USA (Inhance) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.
According to the complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) Significant New Use Rule (SNUR) that requires manufacturers to file a Significant New Use Notice (SNUN) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 C.F.R. § 721.10536. This includes substances that are typically exempt by-products under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements. The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.
Inhance received warning of its violation of the LCPFAC Rule by the plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are by-products of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the by-products exemption in 40 C.F.R. § 721.45(e). The agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the agency’s warnings.
In March 2022, EPA issued a notice of violation (NOV), requesting that Inhance provide the agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.
In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.
EPA’s lawsuit was filed on December 19, 2022, with the nonprofit lawsuit following about a week behind. The complaints allege a variety of TSCA violations, namely the following:
- Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless 1. that person submits a SNUN to EPA; 2. EPA reviews that notice; and 3. EPA makes a determination on that use under section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
- Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
- Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
- Under 40 C.F.R. § 721.35, it is a violation of section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.
Plaintiffs in both cases are seeking declaratory and injunctive relief under section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.
January Updates
Forecast for U.S. Federal and International Chemical Regulatory Policy 2023—published January 5, 2023, by Lynn L. Bergeson
Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2023, our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. We have worked hard to offer our best-informed judgment on the trends and key developments we expect to see in 2023.
Nonprofit Organizations File Suit Claiming That Plastic Containers Treated with Fluorine Gas Leach PFAS in Violation of EPA Regulations––published January 6, 2023, by Lynn L. Bergeson, Christopher R. Blunck, and Carla N. Hutton
On December 27, 2022, Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed a lawsuit in the U.S. District Court for the District of Columbia to prevent Inhance Technologies USA from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. According to CEH and PEER’s joint press release, testing conducted by the U.S. Environmental Protection Agency (EPA), Notre Dame researchers, and other organizations “has found PFAS chemicals on the inner and outer surfaces of fluorinated containers and in the contents of the containers. The PFAS in the containers are likely formed as a result of chemical reactions that occur during the fluorination process conducted by Inhance.” According to the press release, Inhance “conducts fluorination operations at several facilities in the U.S. and is the leading supplier of post-mold fluorination services” in the United States. The press release notes that in 2020, EPA issued a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) barring firms from producing perfluorooctanoic acid (PFOA) and certain other PFAS until EPA had been notified and determined whether the proposed uses of these PFAS might present an unreasonable risk to health. The press release states that “[i]n this event, the law required EPA to ban or restrict the PFAS for these uses.” According to the lawsuit, Inhance did not notify EPA in 2020 and has been subsequently manufacturing PFOA and other PFAS in violation of TSCA.
EPA Announces Release of New PFAS Analytic Tools, Will Hold Webinar on January 10––published January 9, 2023, by Lynn L. Bergeson and Carla N. Hutton
EPA announced on January 5, 2023, the release of a new interactive web page on the “PFAS Analytic Tools” that provides information about PFAS across the country. EPA states that this information will help the public, researchers, and other stakeholders better understand potential PFAS sources in their communities. According to EPA, the PFAS Analytic Tools draw from multiple national databases and reports to consolidate information on one web page. The PFAS Analytic Tools include information on Clean Water Act PFAS discharges from permitted sources; reported spills containing PFAS constituents; facilities historically manufacturing or importing PFAS; federally owned locations where PFAS are being investigated; transfers of PFAS-containing waste; PFAS detection in natural resources, such as fish or surface water; and drinking water testing results.
EPA Adds Nine Chemicals and Removes One PFAS from Safer Chemical Ingredients List—published January 12, 2023, by Lynn L. Bergeson and Carla N. Hutton
EPA announced on January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
ECHA Receives “One of the Broadest” Proposals to Restrict PFAS under REACH—published January 17, 2023, by Lynn L. Bergeson and Carla N. Hutton
The European Chemicals Agency (ECHA) announced on January 13, 2023, that the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden have submitted a proposal to restrict PFAS under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. ECHA will publish the detailed proposal, “one of the broadest in the [European Union’s (EU)] history,” on February 7, 2023. According to ECHA, the national authorities found risks in the manufacture, placement on the market, and use of PFAS that are not adequately controlled and need to be addressed throughout the EU and the European Economic Area (EEA). ECHA states that it will run the required administrative checks before the proposed restriction and supporting documents are made available on February 7, 2023.
EPA’s Fall 2022 Unified Agenda Includes Proposed and Final TSCA and TRI Rules—published January 17, 2023, by Lynn L. Bergeson and Carla N. Hutton
The EPA fall 2022 Unified Agenda, published on January 4, 2023, includes the following rulemakings under TSCA or the Toxics Release Inventory (TRI).
Proposed Rule Stage
- Fees for the Administration of TSCA (2070-AK64);
- Updates to New Chemicals Regulations under TSCA (2070-AK65); and
- Procedures for Chemical Risk Evaluation under TSCA (2070-AK90).
Final Rule Stage
- TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for PFAS (2070-AK67);
- Confidential Business Information (CBI) Claims under TSCA (2070-AK68); and
- Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use under TSCA Section 6(a) (2070-AK86).
EPA Finds TCE, as a Whole Chemical Substance, Poses an Unreasonable Risk to Human Health—published January 19, 2023, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford
EPA announced on January 9, 2023, the availability of the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under TSCA. 88 Fed. Reg. 1222. EPA determined that TCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). EPA states that the revision to the risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law.
In its January 9, 2023, press release, EPA states that 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 Announces Next Test Order Issued under National Testing Strategy for PFAS Used in Plastics, Chemical Manufacturing—published January 23, 2023, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford
EPA announced on January 4, 2023, that it issued the next TSCA test order requiring testing on PFAS under its National PFAS Testing Strategy. The test order requires companies to conduct and submit testing on trifluoro(trifluoromethyl)oxirane (HFPO), a perfluoroalkyl substance used in making plastics. EPA states that this is “the second test order under the strategy and the latest action taken under EPA’s PFAS Strategic Roadmap to confront contamination from forever chemicals nationwide.” According to the press release, EPA will use the information received under the order to improve its understanding of human health effects of HFPO, as well as “the effects of dozens of PFAS that are structurally similar to HFPO and in the same Testing Strategy category of PFAS, improving the agency’s overall data on PFAS.”
EPA Finalizes its Long-Awaited IRIS Handbook Updating a Number of Key Elements—published January 24, 2023, by Nancy B. Beck, Javaneh S. Tarter, Paul T. Nyffeler, Gregory R. Wall, and Matthew Z. Leopold
On December 22, 2022, EPA’s Integrated Risk Information System (IRIS) program released its ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). EPA began working on the approaches in the IRIS Handbook after a 2011 National Research Council report recommended several improvements to the overall IRIS assessment process. In 2020, EPA released a draft IRIS Handbook for public comment and commissioned a peer review by the National Research Council.
Established in 1985 to ensure agency-wide consistent toxicity evaluations, IRIS assessments provide chemical toxicity values for noncancer and cancer human health effects resulting from chronic exposure to chemicals. These values are often utilized in EPA regulations under the Clean Air Act (CAA); the Safe Drinking Water Act (SDWA); and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). While chemical risk evaluations conducted under TSCA require more information and analysis than that provided by an IRIS assessment, IRIS assessments will likely continue to be used to inform TSCA risk evaluations. State agencies and international bodies also rely on IRIS assessments.
EPA Requests Comment on NAMs to Screen for Endocrine Effects—published January 25, 2023, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford
EPA announced on January 19, 2023, the availability of and solicited public comment on a draft white paper entitled “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” 88 Fed. Reg. 3406. EPA states that it developed the draft white paper pursuant to the Federal, Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a screening program to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. The draft white paper announces that certain NAMs have been validated and may now be accepted by EPA as alternatives for certain EDSP Tier 1 assays, while others are useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight of evidence (WoE) evaluations. Comments on the draft white paper are due March 20, 2023.
Hazard: A new danger—published January 27, 2023, by Ales Bartl and David B. Fischer
TSCA sets forth a risk-based approach to chemical evaluation and potential regulation. In 2022, however, EPA announced a “whole chemical” approach to chemical evaluation, which jettisons the prior, entirely risk-based approach.
EU REACH, meanwhile, has always been based on a whole chemical approach, combining hazard and risk. However, the upcoming revision of REACH, as well as of surrounding EU legislation, will further strengthen the hazard element.
EPA Proposes SNUR for PFAS Designated as Inactive on the TSCA Inventory—published January 27, 2023, by Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler
On January 26, 2023, EPA proposed a SNUR for those PFAS that are currently on the TSCA Inventory but that have not been actively manufactured (including imported) or processed in the United States since 2006 and are consequently designated as inactive on the TSCA Inventory. 88 Fed. Reg. 4937. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review will assess whether the use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the PFAS subject to this SNUR. Comments on the proposed SNUR are due March 27, 2023.
EPA Proposes to Bar Manufacturing and Processing of 300 PFAS Assumed to be Out of Commerce—published January 30, 2023, by Thomas C. Berger, Gregory A. Clark, Herbert Estreicher, James G. Votaw, David B. Fischer, and Elizabeth L. Nugent
EPA recently proposed a TSCA SNUR to block companies from manufacturing, importing, or processing over 300 PFAS listed on the TSCA Inventory but assumed not to be moving within U.S. commerce because the substances are designated on the Inventory as “inactive.” Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule 88 Fed. Reg. 4937 (proposed Jan. 26, 2023). Before manufacturing, importing, or processing any of these substances, a company would first be required to prepare and submit a SNUN and then await EPA’s review and risk determination. At that time, EPA may elect to impose any of a wide range of risk management measures, if the Agency allows the substance to return to commerce at all. EPA is accepting comments on the proposal until March 27, 2023 (60 days).
