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 December 8, 2021, President Joseph Biden signed an Executive Order (EO) on Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability. The EO calls for the federal government to achieve a carbon pollution-free electricity sector by 2035 and net-zero emissions economy-wide by no later than 2050. Using a whole-of-government approach, the federal government “will demonstrate how innovation and environmental stewardship can protect our planet, safeguard Federal investments against the effects of climate change, respond to the needs of all of America’s communities, and expand American technologies, industries, and jobs.” The EO directs agencies to “incentivize markets for sustainable products and services by prioritizing products that can be reused, refurbished, or recycled; maximizing environmental benefits and cost savings through use of full lifecycle cost methodologies; purchasing products that contain recycled content, are biobased, or are energy and water efficient, in accordance with relevant statutory requirements; and, to the maximum extent practicable, purchasing sustainable products and services identified or recommended by” the U.S. Environmental Protection Agency (EPA). According to the fact sheet, sustainable products include “products without added perfluoroalkyl or polyfluoroalkyl substances (PFAS).”
By Lynn L. Bergeson and Carla N. Hutton
On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019. It is co-sponsored by Representative John Moolenaar (R-MI). The bill is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems by establishing a coordinating entity under the National Science and Technology Council within the Office of Science and Technology Policy. The legislation would allow the agencies involved in this entity to work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the United States and encourage the validation of tools for assessment of sustainable chemistry processes or products. The agencies would include the U.S. Environmental Protection Agency, the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, the Department of Agriculture, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and other related federal agencies, as appropriate. The bill also supports improved education and training in sustainable chemistry.
By Lynn L. Bergeson and Carla N. Hutton
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design: Innovations in Sustainable Chemistry” on July 25, 2019. Witnesses will include:
- Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
- Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry;
- Dr. Julie Zimmerman, Professor and Senior Associate Dean, School of Forestry and Environmental Studiesa and Deputy Director, Center for Green Chemistry and Green Engineering, Yale University;
- Ms. Anne Kolton, Executive Vice President, Communications, Sustainability, and Market Outreach, American Chemistry Council; and
- Mr. Mitchell Toomey, Director of Sustainability, BASF in North America.
By Lynn L. Bergeson
On June 11-13, 2019, the American Chemical Society (ACS) Green Chemistry Institute® will host the 23rd Annual Green Chemistry and Engineering Conference and the 9th International Conference on Green and Sustainable Chemistry. The Conference will be held right outside of Washington D.C. in Reston, Virginia, and will focus on the theme of “Closing the Loop” in the chemical life cycle. With over three days of programming, the Conference offers more than 40 technical sessions in seven concurrent tracks and multiple opportunities to network with hundreds of attendees from around the world. This year’s featured keynote speakers are:
- Udit Batra, Ph.D., Chief Executive Officer, MilliporeSigma;
- Lee Cronin, Ph.D., Regis Professor of Chemistry, University of Glasgow; and
- Dana Kralisch, Ph.D., Professor of Pharmaceutical Technology and Biopharmacy, Institute of Pharmacy, Faculty of Biological Sciences, Friedrich Schiller University of Jena, and Chief Technical Officer, JeNACell GmbH.
Richard E. Engler, Ph.D., Director of Chemistry for Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), will be presenting Regulatory Barriers to a Circular Economy on June 13, 2019, and Ligia Duarte Botelho, M.A., a Regulatory Associate with B&C and Acta and Manager with B&C® Consortia Management, L.L.C. (BCCM), will be presenting Role of Regulations in Circular Economy: Challenge of New Chemical Bias on June 13, 2019.
Reduced rates for advanced registration are available until May 31, 2019. Registration is available online.
By Richard E. Engler, Ph.D., Lynn L. Bergeson, Kathleen M. Roberts, and Lauren M. Graham, Ph.D.
On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA). EPA offered brief prepared remarks and previously solicited questions from stakeholders. Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues. For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.” Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).
Conditions of Use, SNURs, and PMNs: EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding. EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible. Several commenters requested clarification and examples on the information that will support such identifications. This is plainly an area of intense interest and on which EPA pledged to clarify.
EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns. In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews. Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.
NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot. Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency. Several NGOs also voiced concern with the delay of EPA getting PMN information posted online. Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).
Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs. Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs. The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final. Industry representatives also suggested that EPA seek to scale its information needs appropriately. For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical. Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.
Chemical Categories: EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews. These are:
- Lung Effects Categories: Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
- Photo-Acid Generators (PAG) Category;
- Tracer Chemical; and
- Perfluorinated Chemicals.
EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).
OSHA Focus: On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language. Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits. In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.
Sustainable Futures Program: EPA asked for input as to whether it should continue the Sustainable Futures Program. Some commenters supported the Sustainable Futures Program; no commenters spoke against it.
The presentations from the meeting are listed below and available online:
- New Chemical Review under Amended TSCA -- Jeff Morris, Ph.D., Director, OPPT
- Points to Consider (PtC) When Preparing TSCA New Chemical Notifications -- David A. Tobias, Ph.D., Risk Assessment Division, OPPT
- New Chemicals Decision Guidelines Manual Detailed Outline
- Chemical Categories -- Tala R. Henry, Ph.D., Director, Risk Assessment Division, OPPT
- Other Advance Questions -- Tanya Hodge Mottley, Acting Deputy Director of Programs, OPPT
EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017. More information on this upcoming meeting is available on our blog under key phrase public meeting.