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.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2022, a 15-day public comment period on two additional peer review candidates for the external peer review of the Biofuels and the Environment: Third Triennial Report to Congress (RtC3). 87 Fed. Reg. 46958. EPA previously requested comment on an initial pool of 20 candidates announced in a May 9, 2022, Federal Register notice. EPA states that after considering public comments and the balance and collective expertise of the reviewers, it asked ERG, the independent contractor organizing the peer review, to identify additional candidates to strengthen expertise gaps and allow a more balanced panel. EPA seeks public comment on additional peer review candidates to strengthen underrepresented areas of expertise, specifically economics, water quality, and ecology disciplines. According to EPA, ERG will ensure the peer reviewers’ combined expertise best spans the following disciplines: economics, engineering, agronomics, land use change, remote sensing, air quality, biogeochemistry, water quality, hydrology, conservation biology, limnology, and ecology. Comments are due August 16, 2022.
 
The first report to Congress (RtC1), completed in 2011, provided an assessment of the environmental and resource conservation impacts associated with increased biofuel production and use. The second report to Congress (RtC2) was completed in 2018 and reaffirmed the overarching conclusions of RtC1. RtC3 builds on the previous two reports and provides an update on the impacts to date of the RFS Program on the environment. It assesses air, water, and soil quality; ecosystem health and biodiversity; and other effects. RtC3 also includes new analyses not previously included in RtC1 and RtC2.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions caused by submitters supplementing incomplete initial new chemicals review submissions, contributing to delays in EPA’s review of these chemicals, and stretching already limited resources. EPA notes that it shares an interest with stakeholders in reducing process inefficiencies while also ensuring a protective review of new chemical risks. EPA states that it anticipates this outreach effort will be “particularly helpful” for Low Volume Exemptions (LVE), which constitute about 60 percent of Toxic Substances Control Act (TSCA) Section 5 submissions annually.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.


 

By  Lynn L. Bergeson

On June 6, 2022, 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 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

 

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.

Commentary

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.

Tags: Senate, Budget

 

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.


 
 1 2 3 >  Last ›