By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2022, the Senate Committee on Environment and Public Works will hold a hearing on “Toxic Substances Control Act Amendments Implementation.” This coincides with the sixth anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) that amended the Toxic Substances Control Act (TSCA). The only witness scheduled is Michal Freedhoff, Ph.D., Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).
B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health will present “TSCA Reform – Six Years Later” on June 29, 2022. This complimentary virtual conference marks the sixth TSCA Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers will dive into a host of topics, including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. Register here.
Full Agenda (subject to change):
|9:15 a.m. - 9:30 a.m.
||Welcome and Overview of Virtual Forum
|9:30 a.m. - 10:00 a.m.
||Morning Keynote Discussion
Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)
|10:15 a.m. - 11:45 a.m.
||Panel 1: The Interface of Science and Policy under TSCA
This panel will examine key issues at the interface of science and policy under TSCA, including the continuing role of animal studies in supporting risk evaluations, the potential use of New Approach Methodologies (NAM) to inform safety determinations for new and existing chemicals, scientific integrity and the TSCA program, methodologies for systematic review, and more.
Moderated by James J. Jones, President, J. Jones Environmental
|12:00 p.m. - 1:30 p.m.
||Panel 2: New Chemical Review
The TSCA New Chemicals Program was strengthened in the 2016 Lautenberg Amendments and what the law requires has been vigorously debated. This panel will discuss opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, use of Significant New Use Rules (SNUR) and Section 5(e) orders, and more.
Moderated by Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
|1:45 p.m. - 3:15 p.m.
||Panel 3: Risk Evaluation and Management
With the “first 10” evaluations completed, this panel will look back at the lessons learned and areas for improvement; discuss EPA efforts to enhance these evaluations through risk determinations for fenceline communities, revised worker protection assumptions, and the “whole chemical approach”; examine the asbestos risk management proposal and other emerging risk management approaches; evaluate the impact of resource constraints on meeting statutory deadlines; discuss the role of environmental justice considerations; and more.
Moderated by Robert M. Sussman, Principal, Sussman & Associates
|3:30 p.m. - 5:00 p.m.
||Panel 4: TSCA Regulation of Articles
TSCA requirements can apply to “articles,” a manufactured good or finished product. This panel will discuss the potential role of articles as contributors to health and environmental concerns, EPA’s push to remove traditional exemptions of articles and resulting compliance and implementation challenges, potential new rules for per- and polyfluoroalkyl substances (PFAS) and asbestos requiring reporting on articles, and the application of SNURs and risk management rules to articles, and more.
Moderated by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C.
|5:00 p.m. – 5:10 p.m.
||Concluding Remarks and Adjournment
Join B&C, ELI, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers for a robust exploration of the issues and regulations surrounding TSCA. Full program and registration available online.
Materials from the 2021 conference are available at https://www.lawbc.com/news/recording-of-tsca-reform-five-years-later-conference-and-other-resources-av
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:
- Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
- Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
- Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
- Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
- Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.
EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA Section 15(3)(B). EPA notes that TSCA Section 12(b), and the regulations set forth at 40 C.F.R. Section 707.60, require any person who exports or intends to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA Sections 5 or 6 to notify EPA of such exportation to a particular country. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. The complaint states that Vorbeck has claimed the identity of the carbon nanomaterial as TSCA confidential business information (CBI). Vorbeck has subsequently submitted a TSCA Section 12(b) export notification for the carbon nanomaterial.
Based upon the facts alleged in the complaint, and upon the nature, circumstances, extent, and gravity of the violations alleged, as well as Vorbeck’s ability to pay, effect on ability to continue to do business, any history of prior such violations of TSCA, the degree of culpability, and such other matters as justice may require, EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved.
Bergeson & Campbell, P.C.’s (B&C®) May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. During the webinar, Ms. Sellers outlined barriers and enablers to the circular economy, including practical challenges like supply chain limitations and industry frameworks; Dr. Engler highlighted how the Toxic Substances Control Act (TSCA) regulates discarded substances used as feedstocks by others and articles that may contain contaminants that could affect how an article is classified by the U.S. Environmental Protection Agency (EPA) under TSCA; and Mr. Stanislaus reviewed policy issues, including waste management hierarchy, circular economy hierarchy, and other mechanisms that incentivize sustainability.
We encourage you to view the webinar, listen to the All Things Chemical® episodes “Trends in Product Sustainability and Circularity — A Conversation with Kate Sellers” and “How Can Battery Production Be Greener? — A Conversation with Mathy Stanislaus,” read ERM’s report Circularity: From Theory to Practice, and subscribe to B&C’s informative blogs and newsletters.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 19, 2022, the availability of the meeting minutes and final report for the March 15-17, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0 under the Toxic Substances Control Act (TSCA). According to the meeting minutes and final report, SACC “agreed that the methodological document was well organized and generally well written.” SACC states that it “had difficulty reproducing results that were relevant to understanding and reviewing the document and indicated multiple limitations and uncertainties,” however. SACC suggested the methodology could only be used as part of a tiered approach to evaluate risk to fenceline communities and should not be used to evaluate risks in isolation. The screening level approach may be protective for the specific exposure pathways included, but it may not be protective overall because potential key exposure pathways are excluded and because it does not consider cumulative exposures, multiple source exposures, aggregate exposures, and double/aggregate and occupational exposures from workers living near and working at the facilities. Some SACC members also suggested that additional risk factors, such as stress, poverty, cultural practices, and diet, should be considered for a comprehensive assessment.
The meeting minutes and final report states that the accuracy and/or completeness of the data used to develop the screening analysis were not adequately supported in the document, and SACC decided it did not defensibly represent actual exposure of fenceline communities. Overall, SACC indicated the basis for several model inputs was insufficiently transparent and that, in particular, daily life activities of all communities disproportionately impacted by chemical exposures was missing in this current version. SACC recommended the term “fenceline” be refined to include the characteristics, behaviors, and realities of communities exposed through means that are not dependent on being within a limited radius from a chemical facility. SACC agreed that Version 1 of the screening tool for fenceline communities “is currently not adequate for evaluating potential exposures relevant to tribes, indigenous populations, subsistence lifestyles, cultural practices, or other unique circumstances. The pathways by which people in unique communities are exposed to chemicals of the contaminated areas are much broader than those represented in the current defining criteria of ‘Fenceline Communities.’” To make the tool applicable for any unique community, the meeting minutes and final report state that additional exposure scenarios and relevant data must be applied.
SACC recommended that knowledgeable community representatives “be intrinsically involved for perspective on how such information is applied in a screening endeavor, as well as the relevance and pedigree of values used to inform exposure algorithms, and relevance of default data and assumptions.” Complementary to this process is the need for enhanced and meaningful outreach to “fenceline communities” and all parties interested in these screens. SACC offered specific commentary and suggestions, along with a collection of references. A meeting transcript is available.
By Lynn L. Bergeson and Carla N. Hutton
On May 12, 2022, the White House Office of Science and Technology Policy’s (OSTP) National Science and Technology Council’s (NSTC) Strategy Team on Sustainable Chemistry will host the second webinar in a series regarding the team’s tasks of defining, assessing, and preparing a strategic plan in the area of sustainable chemistry in response to direction in the National Defense Authorization Act of 2020. The presenters in the webinar will discuss the science, technology, and innovation needs of the chemical industries, including carbon capture, sustainable process design, and chemical separation technologies. Speakers will include:
- Dionisios (Dion) G. Vlachos, University of Delaware;
- Joan F. Brennecke, University of Texas at Austin; and
- Jennifer Wilcox, Principal Deputy Assistant Secretary in the Office of Fossil Energy and Carbon Management at the U.S. Department of Energy.
Registration is now open.
Wednesday, May 18, 2022
12:00 p.m. - 1:00 p.m. (EDT)
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.”
- Achieving sustainability and the promise of the circular economy
- Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act
- Federal policy and Toxic Substances Control Act (TSCA) regulatory shifts intended to support sustainability and circularity
- Transitioning chemicals from research and development (R&D) platforms into the market
- Changes to TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that affect chemical innovation
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.
Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.
Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University
Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.
By Lynn L. Bergeson and Carla N. Hutton
On March 15-17, 2022, the U.S. Environmental Protection Agency (EPA) held a meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA presented its screening methodology, as well as the results of applying the screening methodology to 1-brompropane (air pathway), n-methylpyrrolidone (water pathway), and methylene chloride (air and water pathway). EPA will use the scientific advice, information, and recommendations from SACC, as well as public comments, to inform the final protocol. EPA has posted the following materials:
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include:
- Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon toxicity data generated from laboratory test species for the protection of wildlife in the environment. Typically, ecological risk assessments integrate safety factors to account for interspecies variability. According to EPA, the SeqAPASS tool is a more informed way to extrapolate knowledge from model species to other species that does not require the use of animals in toxicity testing and instead uses existing protein sequence knowledge. LaLone will describe EPA’s SeqAPASS tool and its applications for cross-species extrapolation relative to understanding conservation of biology and predicting chemical susceptibility.
- Michael Lowit, Ph.D., EPA Office of Pesticide Programs (OPP), on “Exploring Potential Reductions in Fish Testing in a Regulatory Context.” According to EPA, as part of its commitment to reducing animal testing, OPP is conducting retrospective analyses of existing data to evaluate critically which EPA guideline studies form the basis of regulatory decisions. EPA states that the results from these analyses can inform if reductions can be made to the number of animals used without reducing the quality of ecological risk assessments. EPA is currently conducting a retrospective analysis for fish acute toxicity tests, which are used by OPP to assess potential risk to fish species from pesticides. For each pesticide, EPA typically requires in vivo testing of three different fish species. Lowit will focus on the relative sensitivity among species subjected to in vivo fish acute toxicity studies. The results of this analysis will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions.
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers. Registration is now open.