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On 20 April the US EPA announced a proposed rule under section 6(a) of the Toxic Substances Control Act (TSCA) that would prohibit most uses of methylene chloride and require a workplace chemical protection program (WCPP) for non-prohibited uses. This article will outline the key elements of the EPA’s proposal and discuss the likely impact on industry. This article also looks at what this portends for the agency's future rulemaking activities on chemical substances undergoing...

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,...

July 11, 202310:00 a.m. - 11:00 a.m. (EDT)4:00 p.m. - 5:00 p.m. (CEST)REGISTER NOW Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of these global legal developments and take steps now to minimize legal, regulatory, and commercial risk.In the United States and globally, the number...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that Managing Partner Lynn L. Bergeson has been awarded the highest rank attainable, Band 1, in Chambers USA Guide 2023. This is Ms. Bergeson’s 19th year earning top marks from Chambers USA as one of the best lawyers in America. Chambers quotes clients as saying Ms. Bergeson is “extremely well regarded,” “top-notch for her TSCA work,” “The best nationwide practitioner on product-related environmental regulations; a...

8:00 a.m. - 5:30 p.m. EDTJune 29, 2023 REGISTER NOW The full program, including session details and confirmed speakers for the 7th annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform -- Seven Years Later,” is detailed below. This timely and essential day-long virtual conference will provide updates on risk evaluation, risk management, new chemical review, per- and polyfluoroalkyl substances (PFAS), and more.Bergeson & Campbell, P.C. (B&C®), the Environmental Law...

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 claims....

Each year about this time, companies are focused on the deadline to submit Toxics Release Inventory (TRI) data to the U.S. Environmental Protection Agency (EPA). Companies well acquainted with this reporting ritual have established protocols to collect the data to enable timely reporting. With the July 1, 2023, deadline rapidly approaching, there are a few new reporting features of which to be aware. This column briefly summarizes important new elements.

Download transcript This week I had the pleasure of speaking with Shanisha Smith, Health, Safety, and Environmental (HSE) Counsel for LyondellBasell, about her role as counsel and the rewards and challenges of advising a major chemical producer on HSE legal and product stewardship issues. In our conversation, we learn about Shanisha’s beginnings not far from here on Maryland’s Eastern Shore to now living in Houston and counseling LyondellBasell’s, one of the world’s largest chemical...

On June 5, 2023, Chemical Watch quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding a push from NGO's for the U.S. Environmental Protection Agency's (EPA) to use for the first time its authority under the Toxic Substances Control Act (TSCA) section 5 to block a Texas-based company from using a plastic fluorination process that generates several types of long-chain per- and polyfluoroalkyl substances (PFAS).  If the EPA were to make a 5(f)...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Director of Chemistry Richard E. Engler, Ph.D. will present “Circular Routes and Chemical Nomenclature” during the American Chemical Society’s (ACS) 27th Annual Green Chemistry & Engineering Conference. The theme of this year’s conference, occurring June 13-15, 2023, in Long Beach, CA, is “Closing the Loop: Chemistry for a Sustainable Future.” During his...

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) issued a final rule that exempts a class of plant-incorporated protectants (PIP) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the final rule includes exemptions as described in its October...

On May 30, 2023, the U.S. Environmental Protection Agency (EPA) announced it has taken additional steps in addressing concerns that per- and polyfluoroalkyl substances (PFAS) have been found in pesticide products. As part of its ongoing efforts, EPA has completed its verification analysis of a study published in September 2022 in the Journal of Hazardous Materials entitled “Targeted analysis and Total Oxidizable Precursor assay of several insecticides for PFAS.” This...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that additional FIFRA Tutor® regulatory training courses are now available at www.FIFRAtutor.com. The one-hour F105 -- Due Diligence and Transferring FIFRA Registrations and/or Data module and two-hour F208 -- Data Citation, Data Compensation, and Data Sharing module join six existing FIFRA Tutor courses providing expert, essential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) training....

Tuesday, June 6, and Thursday, June 8, 2023, via webinarBergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Director of Chemistry, Richard E. Engler, Ph.D., and Director of Product Stewardship and Regulatory Affairs, Catherine M. Croke, DBA, will join Chemical Watch to present TSCA Fundamentals. This two-day course will offer in-depth training on the very latest Toxic Substances Control Act (TSCA) regulatory and policy developments, their...

Download transcript This week I had the pleasure of speaking with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), about the regulation of PFAS under REACH. Many of our listeners know the European Chemicals Agency (ECHA) released on February 7 its long-awaited restriction proposal for the regulation of per- and polyfluoroalkyl substances in the European Union (EU) under the Registration,...

On May 20, 2023, Canada published a Canada Gazette notice announcing the availability of its Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Draft Report). Canada proposes to conclude that the class of PFAS meets one or more criteria set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the notice, the Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of...

Bergeson & Campbell, P.C.’s (B&C®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed...

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...

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the preparation of a regulatory management options analysis (RMOA) that examines exposure of the general public to formaldehyde from formaldehyde releasers in articles. HSE states that it is “interested in all aspects of the manufacture, import and use of articles that...

Each year about this time, companies are focused on the deadline to submit Toxics Release Inventory (TRI) data to the U.S. Environmental Protection Agency (EPA). This year is no different as the July 1, 2023, deadline is rapidly approaching. By this date, entities subject to the reporting requirement must submit data for activities that occurred during 2022. Companies are required to report if they meet chemical activity thresholds and: Are either in a covered industry sector and exceed the...

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 7, 2023, the Office of Management and Budget (OMB) requested comments on proposed Circular A-4, “Regulatory Analysis.” 88 Fed. Reg. 20915. According to OMB, since 2003, OMB Circular A-4, Regulatory Analysis, has provided guidance to federal agencies on the development of regulatory analysis as required under Section 6(a)(3)(C) of Executive Order (EO) 12866 (Regulatory Planning and Review), the Regulatory Right-to-Know Act, and a variety of related authorities. OMB...

On May 10, 2023, the Northeast Waste Management Officials’ Association, Inc. (NEWMOA) held a webinar to provide an overview and discuss the provisions of its PFAS Draft Model Legislation (draft model) that is intended to reduce the use of per- and polyfluoroalkyl substances (PFAS) in consumer products. Viewers had the opportunity to ask questions and provide comments regarding the draft. NEWMOA invites the submission of public comments until June 29, 2023,...

Download transcript. This week, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, returned to the studio to discuss a recently filed lawsuit challenging the U.S. Environmental Protection Agency’s (EPA) issuance of a Consent Order under Section 5(e) of the Toxic Substances Control Act (TSCA). Judicial challenges to TSCA Section 5(e) orders are rare, and this one is even more unusual because the petitioner is a non-governmental...

On May 3, 2023, the U.S. Environmental Protection Agency (EPA) proposed under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit most uses of methylene chloride. This column summarizes this important initiative.

On April 20, 2023, the European Commission (EC) announced the implementation dates for the introduction of new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labelling, and Packaging of Substances and Mixtures (CLP). The new hazard classes and criteria rules will be phased in over several years. New substances must comply by May 1, 2025, and new mixtures by May 1, 2026. Substances placed on the market before May 1, 2025,...

The implementation of the game-changing 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act (TSCA), is now a hotbed of legal dispute. Lawsuits challenging key aspects of the law’s implementation are piling up. While all are legally noteworthy, one citizen enforcement case in particular merits attention. As discussed below, two recent cases have raised novel issues pertinent to the scope of the U.S. Environmental Protection Agency’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 (TSCA). As reported in our...

Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to announce the seventh annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform -- Seven Years Later,” to occur Thursday, June 29, 2023. This complimentary virtual conference featuring speakers from the U.S. Environmental Protection Agency (EPA) and non-governmental and industry stakeholders will provide...

A major task we face in achieving circularity is ensuring that policies remain nimble in addressing environmental and public health challenges. Our suite of laws and their regulatory implementation sometimes reflect an unhelpful resistance to circularity, expressed in policies that are indifferent or antithetical to an efficient transition to true resource economy.

On May 2, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of the Draft National Strategy to Prevent Plastic Pollution (Draft Strategy) for public comment. 88 Fed. Reg. 27502. EPA states in its April 21, 2023, press release that the Draft Strategy includes “ambitious actions to eliminate the release of plastic and other waste from land-based sources into the environment by 2040.” EPA released the Draft Strategy alongside a new White...

During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment...

On April 27, 2023, Chemical Watch quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding the proposed TSCA risk management rule that would ban all consumer uses and most commercial applications of methylene chloride. For ten continuing uses, the agency outlined a new workplace chemical protection programme (WCCP) requiring adherence to exposure limits well below those set by the U.S. Occupational Safety and Health Administration (OSHA)...

Download transcript. This week, I sat down with the truly legendary Robert M. Sussman, of Sussman & Associates, to discuss Bob’s extraordinary career engaging in all things Toxic Substances Control Act (TSCA), new and old. Bob was a prominent private-practice attorney and frequent senior official at the U.S. Environmental Protection Agency (EPA) before TSCA was amended in 2016. Since the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Bob has been extraordinarily...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of Chemical Risk Governance, Volume XII of the Elgar Encyclopedia of Environmental Law. Lynn L. Bergeson, Managing Partner, B&C, and Bethami Auerbach, Of Counsel, B&C, edited the volume with Adam D.K. Abelkop, Associate Professor and Director of Legal Writing, University of San Francisco School of Law, and Lucas Bergkamp, Senior Policy Adviser, European Governance & Sustainability Center, The...

April 27, 2023, 1:00 pm - 2:00 p.m. (EDT) via webinarBergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Director of Chemistry Richard E. Engler, Ph.D. will present during the National Association of Chemical Distributors’ (NACD) “IRS Issues Proposed Superfund Chemical Excise Tax Regulations -- What Now, What is Next?” webinar. In late March, the Internal Revenue Service (IRS) issued long-awaited proposed Superfund (Comprehensive...

On April 20, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would prohibit most uses of methylene chloride. EPA states that its unreasonable risk determination for methylene chloride was driven by risks associated with workers, occupational non-users (ONU), consumers, and those in close proximity to a consumer use. EPA identified risks for adverse human health effects,...

May 17, 202311:00 a.m. - 12:00 p.m. EDTREGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing...

On April 14, 2023, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a request for feedback on its recycled plastics policy. 88 Fed. Reg. 23140. PHMSA states that it published the notice to solicit information pertaining to how the potential use of recycled plastic resins in the manufacturing of specification packagings may affect hazardous materials transportation safety; ensure transparency of its current policy pertaining...

On April 12, 2023, Chemical Watch quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding a federal lawsuite filed by a Mississippi community group against the U.S. Environmental Protection Agency (EPA), alleging the agency improperly approved the manufacture of a plastic-derived biofuel that "would result" in a high cancer risk to exposed residents.  Rich Engler, director of chemistry with Bergeson & Campbell, said the EPA frequently...

Download transcript. This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss the newly enacted Modernization of Cosmetics Regulation Act of 2022, better known as MoCRA. The U.S. Food and Drug Administration has been the subject of criticism for years over what some regard as inadequate regulation of cosmetics and the facilities where they are...

The U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) on April 13, 2023, seeking information to assist in the consideration of potential development of future regulations pertaining to per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 88 Fed. Reg. 22399. EPA states that it seeks input and data regarding potential future hazardous substance designation under...

In a somewhat unexpected move, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. MoCRA significantly strengthens the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products. Key provisions are summarized in this article.

On April 11, 2023, Chemical Processing quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) regarding the U.S. Environmental Protection Agency’s (EPA) proposed rule to cut toxic emissions by 6,000 tons per year. The EPA estimated that chemical producers would incur about $501 million in total capital costs and approximately $190 million in total annualized costs to comply with updates to National Emissions Standards for Hazardous Air Pollutants, which the...

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 April 4, 2023, Bloomberg Law quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding the U.S. Environmental Protection Agency's (EPA) process for reviewing new chemicals. Chemical manufacturers should anticipate the EPA’s reviews of new chemicals to take a year or more, not the 90-180 days mandated by the law, said Richard Engler, director of chemistry at Bergeson & Campbell, P.C. Yet “the agency is improving,” he said. TSCA...

On March 29, 2023, the Internal Revenue Service (IRS) published a notice of proposed rulemaking (NPRM) relating to the Superfund excise taxes imposed on certain chemicals and certain imported substances, effective July 1, 2022. 88 Fed. Reg. 18446. There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” The NPRM contains proposed regulations under Sections 4661, 4662, 4671,...

Download transcript. The train derailment in East Palestine, Ohio, has inspired a lot of conversation involving a wide range of topics, including emergency response measures, rail transport of chemicals, and most pertinent to this conversation, communicating chemical risk information to the public. Several of my colleagues here at Bergeson & Campbell have worked at the U.S. Environmental Protection Agency (EPA) in varying capacities and other federal agencies charged with regulating...

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 authority for EPA in...