All Knowledge & Insights By Date

On December 6, 2023, comments by Lynn L. Bergeson and Richard E. Engler, Ph.D. were featured in Chemical Watch's article on the U.S. Environmental Protection Agency’s (EPA) recent proposal to overhaul its 2017 risk evaluation ‘framework’ rule. Lynn Bergeson and Rich Engler of Bergeson & Campbell said their primary concern centres around the proposal to remove scientific definitions like ‘best available science’ and ‘weight of the scientific evidence’ from the...

On December 4, 2023, comments by Lynn L. Bergeson and Christopher Blunck were featured in Chemical Watch's article regarding a TSCA section 5(f) orders prohibiting Texas-based Inhance Technologies from producing certain PFAS when fluorinating plastic containers, a move the company said will threaten its "very existence" and affect thousands of downstream businesses. According to Bergeson & Campbell managing partner Lynn Bergeson, the severity of the remedy (cessation of...

On December 6, 2023, comments by Lynn L. Bergeson and Richard E. Engler, Ph.D. were featured in Chemical Watch's article on the U.S. Environmental Protection Agency's (EPA) plan to conduct its TSCA risk evaluation of formaldehyde following procedures in its existing risk evaluation ‘framework’ rule, rather than those set out in a recent regulatory proposal. Lynn Bergeson and Richard Engler of law firm Bergeson & Campbell said they were surprised to hear the agency would rely...

On November 24, 2023, the U.S. Environmental Protection Agency (EPA) published a proposed rule that will amend the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of the five persistent, bioaccumulative, and toxic (PBT) chemicals addressed in final rules issued under the Toxic Substances Control Act (TSCA) in January 2021. 88 Fed. Reg. 82287. In the proposed rule, EPA states that after receiving additional comments following the...

Unsurprisingly, the U.S. Environmental Protection Agency (EPA) proposed on Oct. 31, to ban all uses of trichloroethylene (TCE) after determining it presents an unreasonable risk of injury to human health under conditions of use pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used in cleaning and furniture-care products, degreasers, brake cleaners and tire repair sealants. Alternatives are available for many uses. The proposed rule would ban TCE’s manufacture, processing...

The U.S. Environmental Protection Agency (EPA) proposed on October 31, 2023, to ban all uses of  trichloroethylene (TCE) after determining that it presents an unreasonable risk of injury to human health under its conditions of use as documented in EPA’s November 2020 risk evaluation (2020 TCE RE) and January 2023 revised risk determination (2023 Revised RD) pursuant to the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 74712. According to EPA’s October 23, 2023, press release, TCE is...

The U.S. Environmental Protection Agency (EPA) announced on October 19, 2023, a proposed rule that would amend the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). Published in the Federal Register on October 30, 2023, the proposed rule states that the purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without considering costs or...

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The rule requires reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed in this article, the final rule is not what many of us expected nor wanted....

On October 10, 2023, comments by Lynn L. Bergeson were featured in Bloomberg Law's article on the U.S. Environmental Protection Agency's (EPA) decision to require companies to report extensive information about per- and polyfluoroalkyl substances (PFAS) in their merchandise. Not every attorney thinks the rule could be legally vulnerable.The regulatory burden, especially on small business entities, is high, and the scope of the reporting obligation is “insanely broad,” said...

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released a long-overdue final rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) regarding reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). As discussed below, the final rule is not what many of us expected, nor wanted. EPA states that the reporting rule is a statutory requirement under the fiscal year (FY) 2020 National Defense Authorization Act (NDAA) that requires...

The U.S. Environmental Protection Agency (EPA) announced on September 27, 2023, that the U.S. Department of Justice (DOJ), on behalf of EPA, filed a complaint against eBay Inc. (eBay) “for unlawfully selling, offering for sale, causing the sale of, and distributing hundreds of thousands of products” in violation of the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). According to EPA, the complaint seeks a...

The U.S. Environmental Protection Agency (EPA) announced on August 15, 2023, that it issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy. EPA has ordered the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), “a substance used as...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 6, 2023, on its new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS under the Toxic Substances Control Act (TSCA). According to EPA, the Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of existing PFAS to ensure that, if allowed to enter into commerce, they will not be...

On August 2, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) released a report entitled The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions. According to OIG, EPA’s New Chemicals Division (NCD) “lacks assurance that the new chemicals review process operates as intended and achieves its objective to protect human health and the environment.” OIG made four recommendations,...

On July 10, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft supplement to the risk evaluation for 1,4-dioxane for public comment and peer review. 88 Fed. Reg. 43562. EPA states in its July 7, 2023, press release that the draft supplement to the 2020 risk evaluation considers air and water exposure pathways that were excluded from the earlier risk evaluation and exposure to 1,4-dioxane generated as a byproduct. The draft...

On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will propose to ban uses of carbon tetrachloride (CTC) that have been phased out and establish a workplace chemical protection program (WCPP) for uses not prohibited to address the unreasonable risk to human health. EPA states in the prepublication version of the proposed rule that it determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and...

The U.S. Environmental Protection Agency (EPA) announced on June 29, 2023, a new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS. The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment....

On July 6, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) that will require reporting and recordkeeping requirements for asbestos. The pre-publication version of the final rule states that EPA will require certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of...

On June 29, 2023, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and where...

On June 20, 2023, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals that were the subject of premanufacture notices (PMN) and are also subject to an order issued by EPA pursuant to TSCA. 88 Fed. Reg. 39804. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a...

The U.S. Environmental Protection Agency (EPA) proposed on June 16, 2023, to ban most uses of perchloroethylene (PCE). 88 Fed. Reg. 39652. According to EPA’s June 8, 2023, press release, the proposed rule “would protect people from these risks by banning all consumer uses while allowing for many industrial/commercial uses to continue only where strict workplace controls could be implemented, including uses related to national security, aviation and other critical infrastructure,...

The U.S. Environmental Protection Agency (EPA) published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 37155. The final rule notes that amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and treatment of confidentiality...

The U.S. Environmental Protection Agency (EPA) announced on May 16, 2023, that it will propose amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to the pre-publication version of the proposed rule, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act...

On May 3, 2023, the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing on “A Review of the President’s Fiscal Year 2024 Budget Request for the Environmental Protection Agency.” On May 10, 2023, the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials held a hearing on “The Fiscal Year 2024 Environmental Protection Agency Budget.” For each Subcommittee, Michael S. Regan, Administrator of the U.S....

On April 24, 2023, the U.S. Environmental Protection Agency (EPA) held a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment (CRA) under the Toxic Substances Control Act...

On March 30, 2023, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program (NCP) held the second of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to...

On March 28, 2023, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). EPA Administrator Michael Regan was the Committee’s only witness. As reported in our March 14, 2023, blog item, according to EPA’s March 9, 2023, press release, President Biden’s budget requests over $12 billion in discretionary budget...

The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on the U.S. Environmental Protection Agency’s (EPA) fiscal year (FY) 2024 budget proposal. EPA Administrator Michael Regan was the Committee’s only witness. In his written testimony, Regan notes that EPA has “significant responsibilities” under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and to...

On March 17, 2023, the U.S. Environmental Protection Agency (EPA) released additional data related to the proposed risk management rule for chrysotile asbestos for public comment. 88 Fed. Reg. 16389. According to EPA’s March 16, 2023, press release, these data concern chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA states that it may use the data in the development of the final rule,...

On March 14, 2023, the U.S. Environmental Protection Agency (EPA) held the first of two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA’s March 2, 2023, press release, EPA will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the...

On February 28, 2023, the U.S. Environmental Protection Agency (EPA) New Chemicals Program held the third and final webinar in its series on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar covered commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter...

On February 27, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on two draft documents that are being submitted to the Science Advisory Committee on Chemicals (SACC) for peer review: “Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act” (draft proposed principles) and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested...

The U.S. Government Accountability Office (GAO) released a report on February 23, 2023, entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines.” GAO evaluated the extent to which the U.S. Environmental Protection Agency (EPA) met selected Toxic Substances Control Act (TSCA) deadlines for reviewing existing and new chemicals since June 2016, and to which EPA engaged in workforce planning for implementing its chemical review responsibilities. GAO identified...

The U.S. Environmental Protection Agency (EPA) announced on January 4, 2023, that it issued the next Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (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...

The U.S. Environmental Protection Agency (EPA) announced on January 9, 2023, the availability of the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (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...

The U.S. Environmental Protection Agency (EPA) announced on December 14, 2022, the availability of the final revision to the risk determination for the perchloroethylene (PCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 76481. EPA determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). On December 19, 2022, EPA announced the availability of the final...

The U.S. Environmental Protection Agency (EPA) proposed on December 5, 2022, to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). 87 Fed. Reg. 74379. EPA notes that these PFAS already have a...

On November 25, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis following the completion of a Small Business Advocacy Review (SBAR) Panel for the Toxic Substances Control Act (TSCA) proposed rule for reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 72439. EPA states that it seeks...

On November 17, 2022, the U.S. Environmental Protection Agency (EPA) held the first of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment....

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) published a much-anticipated supplemental notice of proposed rulemaking (SNPRM) to modify and supplement its 2021 proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 87 Fed. Reg. 68647. EPA states that “[w]ith over five years of experience administering the TSCA amendments of 2016, EPA is publishing this document to ensure that the fees charged accurately reflect the level of effort and...

The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). TSCA Section 26(m) requires EPA to submit an initial report to Congress within...

On October 18, 2022, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and...

The U.S. Environmental Protection Agency (EPA) announced on October 5, 2022, a new effort under the Toxic Substances Control Act (TSCA) to implement a streamlined and more efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors, and renewable energy generation. The new process is for mixed metal oxides (MMO), including new and modified...

On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g.,...

On September 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final revision to the risk determination for the Colour Index Pigment Violet 29 (PV29) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 54491. EPA states that the revision to the PV29 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...

On August 29, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the carbon tetrachloride risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 52766. EPA states that the draft revision to the carbon tetrachloride risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way...

The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA....