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.
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.
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
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.
By Lynn L. Bergeson
The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states 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 addressing unreasonable risks to human health or the environment. President Biden’s proposed budget would provide $124 million and 449 full-time equivalents (FTE) to implement TSCA, an increase of more than $60 million. According to Regan, these resources will support EPA-initiated chemical risk evaluations, issue protective regulations in accordance with statutory timelines, and establish a pipeline of priority chemicals for risk evaluation. EPA “also has significant responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to screen new pesticides before they reach the market and ensure pesticides already in commerce are safe.” Regan notes that in addition, EPA is responsible for complying with the Endangered Species Act (ESA) and ensuring that federally endangered and threatened species are not harmed when EPA registers pesticides. The FY 2023 budget includes an additional $4.9 million to enable EPA’s pesticide program to integrate ESA requirements in conducting risk assessments and making risk management decisions that protect federally threatened and endangered species from exposure to new active ingredients.
After Regan gave his opening statement, the Committee asked questions. Committee Chair Tom Carper (D-DE) stated that President Biden requested $124 million and hiring of about 450 FTEs to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). According to Carper, despite the previous Administration’s failure to request funds to support implementation of the Lautenberg Act, EPA professionals have worked hard to meet the aspirations and mandates of the Act. Carper asked Regan to describe the resource challenges that the TSCA program is currently facing and how EPA plans to fulfill its obligations under the Lautenberg Act if Congress appropriates the increase in resources requested by the Biden Administration. Regan stated that the previous Administration missed nine of ten deadlines for chemical risk review evaluations. Meanwhile, the workload for the Biden EPA has doubled, with 20 high-priority risk evaluations to do and ten risk management rules to write, but EPA is still working with the same budget that it had before the Lautenberg Act. As a result, EPA has only about 50 percent of the resources that it thinks it needs to review the safety of new chemicals quickly and in the way that the law requires. The proposed FY 2023 budget reflects what EPA thinks it will actually take to implement the Lautenberg Act in the way that Congress and stakeholders expect and deserve. According to Regan, EPA would put those resources to good use. EPA wants to keep pace with what Congress requested.
According to Senator Kevin Cramer (R-ND), the North Dakota Agricultural Commissioner sent a letter to EPA’s Office of Pesticide Programs (OPP) (still waiting for a response) about unused stocks of chlorpyrifos. In August 2021, EPA issued a final rule revoking all tolerances for chlorpyrifos. Cramer stated that under the final rule, farmers and retailers have six months to dispose of it. To date, there has been very little to no guidance on how to dispose of it, and without guidance from EPA, there is worry about improper disposal or illegal use. Cramer asked Regan if he could provide some assurance that EPA is not going to seek to punish growers that currently have product in their possession. Regan responded that in this case, like others, EPA found itself in a situation where, because of inaction over decades, the court put it on a timeline to take action. Regan stated that he can commit that the EPA regional office is working with North Dakota now to think about how to address the situation.
As Regan noted in his testimony before the Committee, the Lautenberg Act includes statutory deadlines that EPA must meet as it evaluates existing chemicals. In addition to these mandates, after reviewing the risk evaluations completed by the previous Administration, the Biden EPA announced June 30, 2021, its plans to review and address certain issues. The Biden EPA is working to complete its revisions to the final risk evaluations and move to the risk management rulemaking stage. Under the previous Administration, EPA, in 2020 and 2021, directed significant energy to developing risk evaluations for the “Next 20” chemicals designated as high priority for risk evaluations through the TSCA prioritization process, completing scoping documents in September 2020. In light of the Biden Administration’s revised approach to risk evaluations, however, those scoping documents will need to be revisited and revised as appropriate, and work is expected to continue through 2022 and probably much of 2023. EPA also now has received four manufacturer-requested risk evaluations, three of which have been granted as of mid-December 2021, and one of which is pending. Without significant resources, the Biden EPA will struggle to meet the ambitious goals of the Lautenberg Act.
By Lynn L. Bergeson
The Office of Science and Technology Policy (OSTP) published on April 4, 2022, a request for information (RFI) from interested parties on federal programs and activities in support of sustainable chemistry. 87 Fed. Reg. 19539. OSTP notes that “[t]he term “sustainable chemistry” does not have a consensus definition and most uses of the term indicate that it is synonymous with “green chemistry.”” OSTP requests information on the preferred definition for sustainable chemistry. OSTP also seeks comments on how the definition of sustainable chemistry could impact the role of technology, federal policies that may aid or hinder sustainable chemistry initiatives, future research to advance sustainable chemistry, financial and economic considerations, and federal agency efforts. OSTP states that it will use comments provided in response to the RFI to address Subtitle E of Title II of the National Defense Authorization Act (NDAA) (Subtitle E), which includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E directs OSTP “to identify research questions and priorities to promote transformational progress in improving the sustainability of the chemical sciences.” Comments are due by 5:00 p.m. (EDT) on June 3, 2022. Additional Information is available in the B&C’s April 6, 2022, memorandum.
Register now to join B&C for “FIFRA Hot Topics,” a complimentary webinar covering key priorities of Office of Pesticide Programs (OPP) and what companies should know to avoid market delays. With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts. EPA’s OPP is focusing on long-standing challenges, especially a renewed effort to meet Endangered Species Act (ESA) consultation requirements and determining how best to meet core pesticide registration review obligations in 2022. These program priorities must reflect special considerations for environmental justice and climate change, advance critical science and policy issues, develop a fifth Pesticide Registration Improvement Act (PRIA) implementation framework, and display a renewed commitment to working collaboratively with state partners and other stakeholders to implement the program.
By Lynn L. Bergeson
On February 24, 2022, EPA announced the selection of 11 organizations to receive a total of approximately $2 million in funding to divert food waste from landfills by expanding anaerobic digester capacity nationwide. Anaerobic digestion (AD) produces biogas that can be captured and used for energy production and digestate (a fertilizer product) by using microorganisms to break down organic materials, such as food scraps and manure, in the absence of oxygen. By reducing the amount of wasted food in landfills and consequently methane emissions, AD may reduce significantly the impacts of climate change. EPA’s food recovery hierarchy includes AD as a strategy that is preferable to landfilling and incineration, because it contributes to building a circular economy. Each of the selected organizations will receive between $150,000 and $200,000 over two years. A list of the selected projects is available here.
By Lynn L. Bergeson and Carla N. Hutton
On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received more than 30 biofuel PMNs “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the [Renewable Fuel Standard (RFS)] program and help support the goals of energy security through increasing domestic production” within the United States. Future webinars will cover the TSCA Inventory, nomenclature, and Bona Fide process; new chemicals risk assessments, including applications of the tools, models, and databases; and new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).
More information on webinar is available in our March 1, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.
According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:
- Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
- Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
- Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
- Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
- Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.
EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.
Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.