Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On May 27, 2022, EPA announced that it is seeking nominations for technical experts to serve as Special Government Employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity. The deadline to submit nominations is June 30, 2022, and submissions should be made via the BOSC website. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum.

Tags: SGE, Science, EPA

 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On June 2, 2022, TSCA NCC submitted comments in response to the Office of Science and Technology Policy’s (OSTP) Request for Information (RFI) related to Subtitle E of the 2021 National Defense Authorization Act (NDAA), also called the Sustainable Chemistry Research and Development Act. TSCA NCC’s comments addressed specifically:

  • The definition of green chemistry and sustainable chemistry;
  • Policy considerations;
  • New chemicals bias;
  • The meaning of reasonably foreseen; and
  • Reduced risk considerations.

Additional information on the RFI is available here.


 
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By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On May 12, 2022, EPA published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under TSCA. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022. Additional information is available here.

Tags: TSCA, CBI

 
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By  Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:

  • Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
     
  • Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
     
  • Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
     
  • Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances; and
     
  • Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.

More information on EPA’s draft document is available in our March 14, 2022, memorandum.


 
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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.


 
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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

Tags: TSCA

 
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The American Chemical Society’s Green Chemistry Institute® (ACS GCI) will host its 26th Annual Green Chemistry & Engineering (GC&E) Conference in Reston, VA, from June 6 to June 8, 2022. The theme for the 2022 GC&E Conference is “Thinking in Systems: Designing for Sustainable Use.” This theme will explore how green and sustainable chemistry and engineering contribute to the development and commercialization of products for sustainable use.

On June 6, 2022,B&C will moderate a session organized by B&C’s Director of Chemistry, Richard E. Engler, Ph.D., and Ligia Duarte Botelho, Regulatory Assistant, titled “The Role of Sustainable Thinking in New Chemical Reviews.” B&C’s symposium will explore the “new chemical bias” and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Organized as a panel discussion, company representatives, EPA scientists, and invited speakers from non-governmental organizations will explore the “new chemicals bias,” as it is called, and how it continues to pose a barrier to market acceptance of novel chemistry and sustainable thinking. Attendees will gain an understanding of the regulatory landscape of TSCA implementation and how EPA might change its approach to reduce barriers to circular economy innovations. Ms. Botelho, the moderator, will introduce the topic, and following brief introductory remarks, the panelists will engage in 20 minutes of practical discussion, including a question and answer session to engage with the audience. Registration information is available here.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On June 1, 2022, the U.S. Department of Energy (DOE) issued a funding opportunity announcement (FOA) titled “Scale-Up of Integrated Biorefineries.” The FOA states that $59 million is available to expand the production of biofuels and bioproducts. In alignment with a broader DOE strategy to support biorefinery projects for the transportation sector, the FOA aims to reduce emissions in hard-to-decarbonize sectors and create jobs in rural areas of the United States. DOE is focused on applied research, development, and deployment of such products to improve the performance and cost of biofuel production technologies and scale-up production systems in partnership with industry.

U.S. Secretary of Energy, Jennifer M. Granholm, stated, “[e]nergy harnessed from plants and waste presents a huge opportunity to reduce emissions from hard-to-decarbonize sectors such as aviation, rail, and shipping, while supporting high-quality jobs across rural America. DOE’s investment in biofuels is a key component of the Biden Administration’s effort to support clean energy technologies that increase our energy independence and move us closer to a net-zero carbon economy.”

To be eligible for funding, applicants must submit a concept paper to DOE by 5:00 p.m. (EDT), July 8, 2022. Concept papers and applications must be submitted through DOE’s online application portal.


 
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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.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 9, 2022, researchers from the University of Groningen’s Stratingh Institute for Chemistry and the Department of Chemistry, Organic and Bioorganic Chemistry at the University of Graz, published a study in the journal Green Chemistry titled “A molecular motor from lignocellulose.” The study explores lignin’s use as the largest natural source of functionalized aromatics on the planet and its inherent structural features. The authors showcase the synthesis of a novel light-driven unidirectional motor from a specific aromatic platform chemical that can be obtained through a reductive catalytic fractionation strategy of lignocellulose. Taking into account the principles of green chemistry, the synthetic path used in the study aims to maintain the intrinsic functionality of the lignin-derived platform molecule. The molecular motor is synthesized for the first time from exclusively renewable building blocks sourced from renewable feedstock. According to the study, this concept can be applied as a general strategy that opens paths for future machines, motors, and nanoscience made from sustainable sources. This strategy would benefit the environment and decrease expenses related to hazardous waste management.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 18, 2022, EPA announced the opportunity for public comment on its proposed analysis of the lifecycle greenhouse gas (GHG) emissions associated with biofuels produced from canola/rapeseed oil. EPA’s assessment considers diesel, jet fuel, heating oil, naphtha, and liquefied petroleum gas (LPG) produced from canola/rapeseed oil through a hydrotreating process. EPA is proposing to find that these pathways would meet the lifecycle GHG emissions reduction threshold of 50 percent required for advanced biofuels and biomass-based diesel under the Renewable Fuel Standard (RFS) program. Based on its analyses, EPA is also proposing to approve these fuel pathways, making them eligible to generate Renewable Identification Numbers (RIN) if they meet the definitional and RIN generation criteria for renewable fuel specified in the RFS regulations.

Comments must be submitted by May 18, 2022.

Tags: EPA, GHG, Biofuel, RFS, RIN

 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 12, 2022, U.S. Department of Agriculture’s (USDA) Tom Vilsack, Agriculture Secretary, announced steps that USDA is taking to implement President Biden’s plan to enable energy independence by boosting homegrown biofuels. President Biden’s plan aims to reduce energy prices and tackle the rising consumer prices caused by “Putin’s Price Hike.” As part of USDA’s measures to help the Biden Administration to achieve its goals, USDA is making the following investments:

  • $5.6 million in funding for seven states to build infrastructure for renewable fuels through the Higher Blends Infrastructure Incentive Program;
     
  • $700 million for biofuels producers through USDA’s new Biofuel Producer Program;
     
  • $100 million for biofuels infrastructure grants; and
     
  • Billions of dollars to support a new market in sustainable aviation fuels by partnering with the federal government to advance the use of cleaner and more sustainable fuels in the United States.

According to USDA, these investments will assist in the development, transportation, and distribution of low-carbon fuels, more affordable and cleaner fuels for consumers, and better market access for producers.


 
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By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) Safer Choice Program announced on March 28, 2022, that it is accepting submissions for its 2022 Safer Choice Partner of the Year Awards. 87 Fed. Reg. 17287. EPA states that it developed the Partner of the Year Awards “to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection and use of products with safer chemicals, that further outstanding or innovative source reduction.” EPA “especially encourages submission of award applications that show how the applicant’s work in the design, manufacture, selection and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality.” According to EPA, all Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for the award should submit to EPA information about their accomplishments and contributions during 2021. EPA notes that there is no form associated with this year’s application. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2022. Submissions are due May 31, 2022.


 
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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. 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 B&C presents “Domestic Chemical Regulation and Achieving Circularity.” 

Topics Covered:

  • Achieving sustainability and the promise of the circular economy;
     
  • Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act;
     
  • Federal policy and TSCA regulatory shifts intended to support sustainability and circularity;
     
  • Transitioning chemicals from research and development (R&D) platforms into the market; and
     
  • Changes to TSCA and FIFRA that affect chemical innovation.

Speakers Include:

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.

Register Now


 
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By  Lynn L. Bergeson

On April 20-21, 2022, EPA held a virtual public meeting to provide an overview of the TSCA New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. Written comments on the draft document are due May 10, 2022. Additional information is available here.


 
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