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 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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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

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

On March 9, 2022, U.S. Senators Joni Ernst (R-IA) and Amy Klobuchar (D-MN) introduced the Home Front Energy Independence Act that would ban Russian oil and replace it with the use of biofuels produced in the United States. This bill combines parts of past bills that would make ethanol 15 (E15) available year-round, establish an E15 and Biodiesel Tax Credit, direct the U.S. Environmental Protection Agency (EPA) to finalize the E15 labeling rule, and provide biofuel infrastructure and compatibility with retailers:

Several Senators co-sponsored the bill, including Tammy Baldwin (D-WI), Tammy Duckworth (D-IL), Deb Fischer (R-NE), Chuck Grassley (R-IA), and Roger Marshall (R-KS0. Senator Klobuchar stated that this bill will help to hold Vladmir Putin accountable for Russia’s invasion of Ukraine, while also investing in affordable, readily available biofuels produce in the United States.


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

On March 10, 2022, EPA issued a notice of disclosure to all obligated parties under the Renewable Fuel Standard (RFS) program that have petitioned for a small refinery exemption (SRE) or that have submitted certain RFS compliance reports. EPA will disclose information that is claimed to be, or has been determined to be confidential business information (CBI) from May 21, 2021, through December 31, 2023, to the Government Accountability Office (GAO). These records include:

  • All materials submitted by small refineries as part of petitions;
  • Any documentation that the Department of Energy (DOE) provided to EPA stating DOE’s petition findings and scores and any EPA responses thereto;
  • Any EPA record addressing the subject of the exemption petitions; and
  • EPA’s final exemption decisions sent to refineries.

GAO will destroy, delete, or return to EPA all CBI claimed documents at the conclusion of its review.

Tags: EPA, DOE, RFS, Biofuel

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

On March 22, 2022, DOE announced a $34.5 million funding opportunity to improve the science and infrastructure for converting waste streams into bioproducts and biofuels that can benefit the local energy economy. DOE Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy (EERE), Kelly Speakes-Backman, stated that “through this investment, we see an opportunity to support the bioeconomy and the equitable transition to a clean energy economy.” The FY22 Waste Feedstock and Conversion R&D Funding Opportunity Announcement (FOA) encourages the development of improved organisms and inorganic catalysts to support the next generation of low-carbon biofuels and bioproducts. This FOA has four topic areas:

  • Community Scale Resource and Energy Recovery from Organic Wastes;
  • Municipal Solid Waste Feedstock Technologies;
  • Robust Catalytic Processes; and
  • Robust Microbial Cells.

DOE will accept concept papers for this FOA until 5:00 p.m. (EDT) on April 18, 2022. Applications are due by 5:00 p.m. (EDT) on June 7, 2022. Additional information on this FOA is available here.


 
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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.


 
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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.

Speakers include:

Tags: Webinar, FIFRA

 
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By Lynn L. Bergeson and Carla N. Hutton

On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” 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. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:

  • Chemistry Assessment:
    • Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
    • Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
    • Complete characterization of the new chemical substance is often unavailable;
  • Environmental Fate and Transport Assessment:
    • Analysis of constituents may not represent the properties of the new chemical substance;
  • Engineering Assessment: Environmental Releases:
    • EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
    • Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
    • Release estimates have limitations -- examples:
      • Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
      • Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
  • Engineering Assessment: Occupational Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
    • Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
    • Exposure models do not account for some engineering controls (vapor capture/reduction);
  • Exposure Assessment: General Population and Consumer Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
    • The confidence of the exposure estimates are affected by:
      • Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
      • Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
  • Hazard Assessment:
    • Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
    • EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
    • There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.

For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).


 
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By Lynn L. Bergeson

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing was intended to help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Read more in Bergeson & Campbell, P.C.’s (B&C®) March 18, 2022, memorandum, “House Committee Holds Hearing on Bioenergy RD&D for the Fuels and Chemicals of Tomorrow."


 
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By Lynn L. Bergeson

As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA the 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. EPA will hold a virtual public meeting April 20-21, 2022, to seek individual input. Written comments on the draft document are due April 26, 2022. Read more in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum, “EPA Posts Draft Document on 'Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA'.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing will help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Witnesses will include:

  • Dr. Jonathan Male, Chief Scientist for Energy Processes and Materials, Pacific Northwest National Laboratory (PNNL);
     
  • Dr. Andrew Leakey, Director of the Center for Advanced Bioenergy and Bioproducts Innovation at the University of Illinois Urbana-Champaign;
     
  • Dr. Laurel Harmon, Vice President of Government Affairs, LanzaTech; and
     
  • Dr. Eric Hegg, Professor, Biochemistry and Molecular Biology, Michigan State University.

The hearing charter notes that in addition to fuels, biomass can be used to create valuable chemicals and materials, known as “bioproducts.” According to the hearing charter, approximately 16 percent of U.S. crude oil consumption is used to make petrochemicals and products, such as plastics for industrial and consumer goods, fertilizers, and lubricants. Common biobased products include household cleaners, paints and stains, personal care items, plastic bottles and containers, packaging materials, soaps and detergents, lubricants, clothing, and building materials. The hearing charter states that the production of bioproducts relies on much of the same feedstocks, infrastructure, feedstock commoditization, and technologies that are central to biofuels production. Therefore, according to DOE, once technologies are proven for bioproduct applications, they could be readily transferred and greatly improve biofuel production.


 
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By Lynn L. Bergeson 

On January 31, 2022, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) and 12 of their colleagues submitted a letter to EPA Administrator, Michael Regan, regarding EPA’s RFS Annual Rules and Proposed RFS Small Refinery Exemption Decision. In the bipartisan letter, Senators Klobuchar and Grassley and their colleagues urge EPA to prioritize the RFS in support of a “homegrown energy future” by:

  1. Maintaining the blending requirements for 2022, including the 250 million gallon remand;
  2. Denying all pending SRE;
  3. Eliminating the proposed retroactive cuts to the 2020 RVO; and
  4. Setting 2021 volumes at the statutory levels.

The letter commends EPA’s efforts to better the RFS program and highlights areas with room for improvement. Of particular concern to the letter signatories is EPA’s proposal to waive retroactively 2.96 billion gallons of renewable fuel from the 2020 RVOs. The letter states that adjusting these biofuel volumes more than two years after they were finalized would set a troubling precedent and impact negatively the entire agriculture and fuel supply chain. Therefore, Klobuchar and her colleagues urge EPA to eliminate the proposed retroactive cuts to the 2020 volumes and require obligated parties to comply with the 2020 standards that were issued in final in 2019. The signatories express similar concerns with the proposal to reset retroactively authority to establish 2021 RVOs and state that EPA cannot meet its ambitious climate goals without providing for growth and certainty in the RFS.

Senators Klobuchar and Grassley and their colleagues request that EPA finalize these actions as quickly as possible to restore integrity, stability, and growth to the RFS program and the U.S. biofuel sector.


 
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