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 Richard E. Engler, Ph.D.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production, and use of new chemicals.

In the United States, all new chemicals must be reviewed by the U.S. Environmental Protection Agency (EPA) before they can enter commerce. The Agency looks at new chemicals to determine whether their manufacturing, processing, and use would adversely affect people or the environment. If EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through EPA for review and have been allowed into U.S. commerce.

In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).


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

EPA announced that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule to give stakeholders more time to review and comment. The current comment period was set to close on February 25, 2021. Comments are now due on March 27, 2021. Information on the proposed updates is available in the Bergeson & Campbell, P.C. (B&C®) December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”

On February 18, 2021, EPA held a virtual public meeting on the TSCA Fees Rule, allowing stakeholders to provide input on the proposed rulemaking. One of the main concerns by industry stakeholders was related to fees collection under TSCA Section 4. Stakeholders reported that EPA should not collect such fees under Section 4 because the same fees are collected under Section 5. The Alliance for Automotive Innovation proposed instead a tiered fees structure, given that the rule as proposed includes downstream user fees, which would double fees within the supply chain.

On the other hand, representatives from the Environmental Defense Fund (EDF) expressed opposition to the exemptions outlined in the proposed rule and criticized EPA for relying on voluntary information requests.

Tags: TSCA, Fees

 
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By Lynn L. Bergeson 

The United Kingdom (UK) completed its withdrawal from the EU on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective. Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes: the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR); the GB Classification, Labeling, and Packaging Regulation (GB CLP); the GB Prior Informed Consent (PIC) Regulation (GB PIC); Regulation (EC) 1107/2009 concerning plant protection products (PPP); and the UK REACH Regulation. On February 5, 2021, the UK Health and Safety Executive (HSE) provided a brief overview of the new chemical regulatory regimes and links to resources available online. Further information is available in The Acta Group’s, B&C’s affiliate, February 9, 2021, memorandum.

Tags: UK, UK REACH

 
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By Lynn L. Bergeson 

EPA published on February 8, 2021, a periodic update of the TSCA confidential business information (CBI) review statistics. TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim:

  • Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and
     
  • Review and make determinations on a representative subset of at least 25 percent of other CBI claims that are not exempt from substantiation and review.

The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020. In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.

EPA states that making this information publicly available continues to demonstrate its commitment to transparency while fulfilling its responsibilities under TSCA. EPA notes that it has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.

Tags: TSCA, CBI

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

On February 22, 2021, the U.S. Department of Energy’s (DOE) National Renewable Energy Laboratory (NREL) announced its comprehensive strategy to decarbonize transportation by 30-85 percent by 2050. A strategy based on research and engineering, it aims to enable industry stakeholders, government bodies, communities, and early adopters to meet their climate goals. In a nutshell, the strategy takes a whole-system approach to pair the best technology with the right application. Chris Gearhart, NREL’s Center for Integrated Mobility Sciences Director, stated that NREL envisions “a mobility system fueled with clean, renewable energy, delivered directly by vehicle electrification, or indirectly by low-carbon, energy dense fuels and renewable hydrogen for those sectors, like marine and aviation, that are harder to electrify.” Johney Green, Associate Laboratory Director for NREL’s Mechanical and Thermal Engineering Sciences, expanded: “The spectrum of technological, social, and environmental shifts happening today requires a novel research agenda.” Keeping long-term trends in mind, NREL’s vision entails a multi-pronged strategy that provides scientific building blocks for advancing research and development (R&D) priorities such as:

  • Accelerating vehicle technology innovations;
     
  • Increasing transport efficiency;
     
  • Maximizing the use of renewable electrons through time; and
     
  • Integrating transportation with building, the grid, and renewables to realize system-wide benefits.
     

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

On March 1, 2021, U.S. Senators Joe Manchin (D-WV) and Debbie Stabenow (D-MI) announced the American Jobs in Energy Manufacturing Act of 2021 (Act), which would incentivize domestic manufacturing of energy technologies by providing tax credits for domestic manufacturers in rural areas. The Act encourages the transition to cleaner energy by driving reinvestment into communities that have been most impacted by economic downturn. “This bill will help revitalize these areas by making smart changes to the 48C Advanced Energy Manufacturing Tax Credit to drive investment in these communities, strengthen domestic supply chains, create additional clean energy manufacturing jobs, and aid the nation’s recovery,” stated Senator Manchin. Senator Stabenow urged the Senate to pass the Act, stating that the transition to a clean energy economy would significantly contribute to the fight against climate change. The Act has been endorsed by several non-profit organizations and industry stakeholders.

Significant measures would be taken under the Act, including:

  • Investment of $8 billion in American manufacturing and industry to serve as a tool to expand or build new facilities that make or recycle energy-related products; and
     
  • Provision of assistance to applicants through new guidelines and technical assistance that promote reinvestment and job creation.

The full bill can be accessed here.


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

On March 3, 2021, the co-chairs of the House Biofuels Caucus, U.S. Representatives Cindy Axne (D-IA) and Rodney Davis (R-IL), introduced the Renewable Fuels Infrastructure Investment and Market Expansion Act, which would expand access to higher biofuel blends. Building off the U.S. Department of Agriculture’s (USDA) Higher Blends Infrastructure Inventive Program, this bill intends to provide consistent federal investment ($500 million over five years) on biofuels infrastructure, while also removing barriers to 15 percent ethanol and 85 percent gasoline (E15) fuel blends and allowing Underground Storage Tanks (UST) to store higher blends of ethanol.

On the same day, with the support of Representatives Axne and Davis, among others, U.S. Representative Dusty Johnson (R-SD) introduced the Adopt GREET Act. The Adopt GREET Act would require that EPA update its greenhouse gas (GHG) models for ethanol and biodiesel to reflect better the environmental benefits of agriculture and biofuels. Specifically, EPA would be obligated, under this Act, to adopt the Argonne National Laboratory’s Greenhouse Gases, Regulated Emissions, and Energy Use in Transportation (GREET) Model for both biodiesel and ethanol fuels and update its model as needed every five years.

Both pieces of legislation are being supported by several industry stakeholders, including the National Corn Growers Association, the Renewable Fuels Association, and Growth Energy.


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

On March 2, 2021, the University of Southern California (USC) Wrigley Institute for Environmental Studies on Santa Catalina Island announced a new aquaculture technique that increases dramatically kelp growth and, consequently, yields four times more biomass than other natural processes. Using a “kelp elevator,” this new technique optimizes growth for bronze-colored floating algae by raising and lowering it to different depths. These findings suggest that the use of open ocean to grow kelp biomass for biofuel production can serve as a solution to the generation of biofuels from feedstocks such as corn and soybeans, which often increase water pollution. Corresponding author of the study, Diane Y. Kim, Ph.D., stated that “[f]orging new pathways to make biofuel requires proving that new methods and feedstocks work. This experiment on the Southern California coast is an important step because it demonstrates kelp can be managed to maximize growth.”


 
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By Lynn L. Bergeson 

On February 1, 2021, the U.S. District Court for the District of Montana granted the U.S. Environmental Protection Agency’s (EPA) January 31, 2021, unopposed motion to vacate and remand its January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” (86 Fed. Reg. 469). EDF v. EPA, No. 4:21-cv-03-BMM. On January 11, 2021, the Environmental Defense Fund (EDF), Montana Environmental Information Center (MEIC), and Citizens for Clean Energy (CCE) filed suit against EPA, claiming that the January 6, 2021, final rule was unlawful and that EPA’s decision to make the final rule effective on publication was unlawful. On January 27, 2021, the court granted summary judgment to the plaintiffs, finding that EPA did not provide good cause to exempt the final rule from the Administrative Procedure Act’s (APA) 30-day notice requirement. The court stated that “EPA’s decision to make the Final Rule immediately effective on publication was ‘arbitrary, capricious’ and ‘otherwise not in accordance with law.’” In its January 31, 2021, motion, EPA states based on the court’s conclusion that the final rule constitutes a substantive rule and that EPA “lacked authorization to promulgate the rule pursuant to its housekeeping authority.” According to EPA, where EPA lacked the authority to promulgate the final rule, “remand without vacatur would serve no useful purpose because EPA would not be able to cure that defect on remand.” EPA notes that because the final rule was in effect for less than a month, and it had not applied the rule in any circumstance while the rule was in effect, “there would be no disruptive consequences in remanding and vacating the rule.”

Prior to EPA’s motion to vacate and remand the final rule, on January 20, 2021, President Biden signed an Executive Order (EO) on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. According to the EO, it is the policy of the Biden Administration “to listen to the science; to improve public health and protect our environment; to ensure access to clean air and water; to limit exposure to dangerous chemicals and pesticides; to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to the impacts of climate change; to restore and expand our national treasures and monuments; and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals.” The EO directs all executive departments and agencies to review immediately and, as appropriate and consistent with applicable law, take action to address the promulgation of federal regulations and other actions during the Trump Administration that conflict with the Biden Administration’s national objectives, and to commence work immediately to confront the climate crisis. The EO calls for the heads of all agencies to review immediately “all existing regulations, orders, guidance documents, policies, and any other similar agency actions (agency actions) promulgated, issued, or adopted between January 20, 2017, and January 20, 2021, that are or may be inconsistent with, or present obstacles to,” the Biden Administration’s policy. For any identified actions, the EO directs the heads of agencies to “consider suspending, revising, or rescinding the agency actions.” In addition, for certain specified agency actions, the EO states that the head of the relevant agency “shall consider publishing for notice and comment a proposed rule suspending, revising, or rescinding the agency action within the time frame specified.” The specified agency actions include EPA’s January 6, 2021, final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.”

As reported in our January 11, 2021, memorandum, the origin of EPA’s January 6, 2021, final rule is rooted in legislative proposals more clearly intended to challenge important regulatory requirements, particularly related to EPA’s air program. We predicted that the final rule would likely be among the first items subject to reversal or “clarifying” guidance making it consistent with previously established science policies (see Bergeson & Campbell, P.C.’s (B&C®) Forecast 2021 memo). With Democratic control of both houses of Congress, there might also be attempts to repeal the rule via action under the Congressional Review Act (CRA) of recently promulgated regulations.


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

On January 19, 2021, the U.S. Department of Energy (DOE) released its Plastics Innovation Challenge Draft Roadmap (Draft Roadmap) alongside a Request for Information (RFI) seeking stakeholder input on the draft document. The Plastics Innovation Challenge is a DOE program focused on accelerating innovations in energy-efficient plastic recycling technologies. The aim of the Plastics Innovation Challenge is to make domestic processing of plastic waste energy efficient and economically viable, develop new and improved plastic materials lacking the same end-of-life concerns as incumbent materials, and to reduce plastic waste accumulation. Based on these aims, the Plastics Innovation Challenge has outlined four strategic goals within its scope:

  • Deconstruction: Develop biological and chemical methods for deconstructing plastic wastes into useful chemicals;
     
  • Upcycling: Develop technologies to upcycle waste chemical streams into higher value products;
     
  • Recycle by Design: Design new, renewable plastics and bioplastics that are easily upcycled and can be manufactured domestically at scale; and
     
  • Scale and Deployment: Support an energy and material-efficient domestic plastics supply chain.

The Draft Roadmap, therefore, identifies key research needs and opportunities for DOE-sponsored research and development (R&D). It also identifies challenges and opportunities across thermal, chemical, biological, and physical recycling and upcycling methods, as well as material design strategies for recyclability. According to DOE, the Draft Roadmap additionally:

  • Provides an overview of the plastic waste problem;
     
  • Identifies the initiative’s 2030 vision, mission, strategic goals, and objectives;
     
  • Details challenges and opportunities identified by previous DOE activities;
     
  • Lays out key research directions;
     
  • Delivers an outline of current DOE activities, capabilities and coordination; and
     
  • Describes targets for each research area.

The Draft Roadmap aims to guide DOE efforts to meet the Plastics Innovation Challenge goals. The purpose of DOE’s RFI on the Draft Roadmap, therefore, is to solicit feedback from stakeholders to ensure the road toward the Plastics Innovation Challenge 2030 goals is clear and well positioned. Responses to the RFI are due to DOE by March 1, 2021.


 
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By Lynn L. Bergeson 

On January 13, 2021, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) announced the availability of $123.6 million in funding and $44.7 million of cost share available for 46 projects to stimulate technology innovation, improve energy productivity of American manufacturing, and enable the manufacturing of cutting-edge products in the United States. The 46 projects that will be selected under this funding opportunity announcement will focus in three areas to improve energy efficiency in energy-intensive processes:

  • Efficiency improvements in advanced manufacturing processes;
     
  • Efficiency improvements in chemical manufacturing; and
     
  • Connected, flexible, and efficient manufacturing facilities, products, and energy systems.

Additional information is available here.

Tags: DOE, EERE, Funding

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

On January 27, 2021, U.S. President Biden signed an “Executive Order on Tackling the Climate Crisis at Home and Abroad,” which established a National Climate Task Force (Task Force) and puts the climate crisis at the forefront of U.S. domestic and foreign policy. Highlighting the urgency in addressing the climate crisis, this EO requires short-term global reductions of greenhouse gas (GHG) emissions and net-zero emissions by 2050 or before. Under the EO, the United States has rejoined the Paris Agreement and will begin implementing its three overarching goals:

  1. A safe global temperature;
     
  2. Increased resilience; and
     
  3. Financial goals aligned with a pathway toward low GHG emissions and climate-resilient development.

The EO also includes a provision (Section 216(b)(i)) stating that the Secretary of Agriculture must initiate efforts in the first 60 days, to obtain input from Tribes, farmers, forest owners, conservation groups, and other stakeholders on how to maximize the use of different U.S. Department of Agriculture (USDA) programs and those of other authorities. Input on how to encourage the voluntary adoption of climate-smart agricultural and forestry practices will also be welcome. The aim of this provision is to achieve additional measurable and verifiable carbon reductions and sequestration that source sustainable bioproducts and biofuels. The input received must be submitted to the Task Force for review within 90 days of the date of the EO, including recommendations for an agricultural and forestry climate strategy. This EO may play a key role for the biobased products and biofuels industry.


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

EPA, on January 15, 2021, issued a proposed rule to modify certain compliance dates under the Renewable Fuel Standard (RFS). The proposed deadline extension for the 2019 compliance year and the associated deadline for submission of attest engagement reports for the 2019 compliance year for small refineries are as follows: November 30, 2021, and June 1, 2022, respectively. The second extension would be for the 2020 compliance year and the associated deadline for submission of attest engagement reports for obligated parties and Renewable Identification Number (RIN)-generating renewable fuel producers and importers, among other parties holding RINs. The new deadlines for these would be January 31, 2022, and June 1, 2022, respectively.

Comments on the proposed rule must be submitted by March 11, 2021. A virtual public hearing will take place on February 9, 2021, to discuss questions and concerns about the proposed rule.


 
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By  Lynn L. Bergeson 

On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected. TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary. The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined. The proposed updates include:

  • Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for R&D purposes, and companies that produce a chemical as a non-isolated intermediate;
     
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
     
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
     
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
     
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
     
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
     
  • Adding three new fee categories, two associated with new chemical activities and one associated with test orders.
     

Comments are due February 25, 2021. More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.

Tags: TSCA, Fees

 
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By   Lynn L. Bergeson 

EPA announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer. EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.” According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool. It features:

  • A streamlined interface that does not require expert knowledge to navigate;
     
  • A standardized reporting format that allows users to view and export results quickly; and
     
  • Increased transparency in the science behind the predictions provided by the model.

EPA notes that OncoLogic™ is one of many publicly available assessment methods, databases, and predictive tools it developed to estimate hazard to humans and the environment, particularly in the absence of test data. According to EPA, these tools and models support it in implementing programs and regulations, such as TSCA, and help external users assess and manage chemical risks. EPA states that version 8.0, which continues to include modules for fibers, metals, and polymers, will remain available to the public.


 
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