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 Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) recently announced the selection of five external collaborations totaling over $3.7 million to conduct research and development (R&D) needed to accelerate the U.S. biomanufacturing sector. Working with scientists at the Agile BioFoundry (ABF) consortium, these industry and academic groups will leverage national laboratory capabilities to address challenges in biomanufacturing. The projects include:

  • University of California, Berkeley will address the pressing need for a scalable method for double-stranded ribonucleic acid (RNA) production for agricultural pesticide applications, employing microbial strain engineering and fermentation scale-up;
  • Birch Biosciences will develop improved technologies that enable engineering of high-performance enzymes for economical and sustainable plastic recycling;
  • Kiverdi will develop a platform for sequestering carbon dioxide to produce secreted recombinant proteins;
  • University of Nebraska-Lincoln will expand the synthetic biology biosensor toolkit for Methanosarcina, a promising archaeal host organism that can be used to create fuels and renewable chemicals; and
  • Azolla will leverage ABF’s capabilities to engineer a bacterium capable of using sunlight and carbon dioxide to produce nanocellulosic fiber to replace current unsustainable production practices in the textile industry.

The selected projects all directly contribute to producing renewable biofuels and biobased chemicals and materials. They also help ABF build foundational technologies critical for the decarbonization of the industrial and transportation sectors. Funded by BETO, ABF aims to advance biomanufacturing by uniting and expanding the capabilities of the national laboratories.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our January 4, 2023, blog item, on January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled “Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft)” for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. The draft report focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane.
 
ERG, an EPA contractor, is organizing an independent external peer review of the draft report. The peer review meetings are open to anyone who would like to attend as an observer and will include a brief public comment period on the first day (February 24, 2023). Registration is required. Panel peer review meetings will be held:

  • February 24, 2023, 11:00 a.m.-6:45 p.m. (EST);
     
  • February 27, 2023, 11:00 a.m.-6:30 p.m. (EST); and
     
  • February 28, 2023, 1:00 p.m.-3:40 p.m. (EST).

Comments on the draft report are due March 6, 2023.

Tags: Biofuels, DOE, USDA

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) will hold a webinar on February 22, 2023, entitled “DOE’s Progress Toward Meeting the Goals of the Sustainable Aviation Fuel Grand Challenge.” The Sustainable Aviation Fuels (SAF) Grand Challenge is a government-wide commitment to scale up production of SAF to 35 billion gallons per year by 2050 and reduce lifecycle aviation greenhouse gas (GHG) emissions by 50 percent compared to conventional fuel. According to BETO, the upcoming webinar is an effort to increase SAF awareness and communicate the progress and impact of the SAF Grand Challenge. Attendees will learn about DOE’s focus on:

  • SAF priorities and program alignment with the SAF Grand Challenge Roadmap;
  • Implementation planning; and
  • Stakeholder engagement and outreach.

The webinar will feature speakers from BETO, including Director Dr. Valerie Reed, who will share information about the six action areas outlined in the Roadmap that support the Grand Challenge goals. Scheduled BETO speakers include:

  • Dr. Valerie Reed: Director -- Program Overview;
  • Zia Haq: Senior Analyst -- SAF Overview and Enabling End Use;
  • Dr. Art Wiselogel: Oak Ridge Institute for Science and Education (ORISE) Fellow -- Feedstock Innovation;
  • Dr. Ian Rowe: Technology Manager, Conversion Research and Development (R&D) -- Conversion Innovation;
  • Dr. Mark Shmorhun: Technology Manager, Systems, Development, and Integration -- Building Regional SAF Supply Chains;
  • Andrea Bailey: Technology Manager, Data, Modeling, and Analysis -- Policy and Valuation Analysis; and
  • Sheila Dillard: Communications Lead -- Communicating Progress and Building Support.

Attendees can submit questions prior to the event, no later than February 17, 2023, by sending an email to .(JavaScript must be enabled to view this email address).


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced outreach to describe how it evaluates engineering (i.e., environmental release and worker exposure) data for new chemical submissions and common causes of EPA having to reconduct risk assessments (i.e., “rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
The February 28, 2023, webinar is the third and final webinar in a series to increase the efficiency and transparency of EPA’s new chemical determinations. The first two webinars, held in July and October 2022, focused on common issues that cause EPA to rework risk assessments, clarifications of common misconceptions in EPA’s new chemical assessments, and other information related to TSCA Section 5 submissions. More information on these webinars is available on EPA’s website and in our July 28, 2022, and October 25, 2022, memoranda.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On February 8, 2023, the U.S. Department of Energy (DOE) announced $25.5 million in funding to enable the sustainable use of domestic biomass and waste resources, such as agricultural residues and algae, to produce low-carbon biofuels and bioproducts. DOE notes that this funding will advance the Biden Administration’s goals of delivering an equitable, clean energy future, and will put the United States on a path to achieve net-zero emissions, economy-wide, by 2050. According to DOE, the “Reducing Agricultural Carbon Intensity and Protecting Algal Crops” funding opportunity will improve the production of environmentally sustainable feedstocks for bioenergy through two topic areas:

  • Climate-Smart Agricultural Practices for Low-Carbon Intensity Feedstocks; and
  • Algae Crop Protection.

DOE states that “[r]ecognizing that decarbonizing transportation and agriculture are inherently linked when it comes to the thoughtful production and deployment of biofuels, this funding opportunity focuses on improving climate-smart agricultural practices that reduce the carbon intensity of biomass feedstocks used for biofuel production, and cultivating and protecting algae crops, an abundant and renewable biofuel source.” Both topic areas support DOE’s Sustainable Aviation Fuel (SAF) Grand Challenge goal of furthering the production of 35 billion gallons of SAF annually by 2050.
 
Concept papers are due by 5:00 p.m. (EDT) March 20, 2023, and full applications are due by 5:00 p.m. (EDT) on May 16, 2023.

Tags: DOE, Algae, Biofuel

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) announced on January 26, 2023, $118 million in funding for 17 projects to accelerate the production of sustainable biofuels for America’s transportation and manufacturing needs. According to DOE, the selected projects, located at universities and private companies, “will drive the domestic production of biofuels and bioproducts by advancing biorefinery development, from pre-pilot to demonstration, to create sustainable fuels that reduce emissions associated with fossil fuels.” Projects selected will contribute to meeting DOE’s goal to achieve cost-competitive biofuels and at least a 70 percent reduction in greenhouse gas (GHG) emissions by 2030.
 
According to DOE, “[m]ade from widely available domestic feedstocks and advanced refining technologies, energy-dense biofuels provide a pathway for low-carbon fuels that can lower greenhouse gas emissions throughout the transportation sector and accelerate the bioeconomy.” DOE notes that financing for novel biorefinery process systems can be a barrier to commercializing advanced biofuels, and states that its funding will reduce technological uncertainties and enable industry deployment. The selected projects include pre-pilot, pilot, and demonstration projects that will scale-up existing biomass to fuel technologies that will eventually create millions of gallons of low-carbon fuel annually.

Tags: DOE, Biofuel, GHG

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The Federal Trade Commission (FTC) announced on January 31, 2023, that it has extended the deadline for public comment on its Guides for the Use of Environmental Marketing Claims (Green Guides) to April 24, 2023. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” FTC expects “many public comments” on the following specific issues:

  • Carbon Offsets and Climate Change: The current Green Guides provide guidance on carbon offset and renewable energy claims. FTC invites comments on whether the revised Green Guides should provide additional information on related claims and issues;
     
  • The Term “Recyclable”: Among other things, FTC seeks comments on whether it should change the current threshold that guides marketers on when they can make unqualified recyclable claims, as well as whether the Green Guides should address in more detail claims for products that are collected (picked up curbside) by recycling programs but not ultimately recycled;
     
  • The Term “Recycled Content”: FTC requests comments on whether unqualified claims about recycled content -- particularly claims related to “pre-consumer” and “post industrial” content -- are widely understood by consumers, as well as whether alternative methods of substantiating recycled content claims may be appropriate; and
     
  • The Need for Additional Guidance: FTC also seeks comment on the need for additional guidance regarding claims such as “compostable,” “degradable,” “ozone-friendly,” “organic,” and “sustainable,” as well as those regarding energy use and energy efficiency.

More information and an insightful commentary are available in our December 16, 2022, memorandum.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
     
  • Application-oriented use case demonstrations; and
     
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) recently published its new Strategy for Plastics Innovation (SPI), which will guide DOE’s collaborative research and development (R&D) on plastic waste reduction. Four strategic goals focus the scope of the SPI:

  • Deconstruction: Create new chemical, thermal, and biological/hybrid pathways to deconstruct plastics efficiently into useful chemical intermediates;
     
  • Upcycling: Advance the scientific and technological foundations that will underpin new technologies for upcycling chemical intermediates from plastic waste into high-value products;
     
  • Recyclable by Design: Design new and renewable plastics and bioplastics that have the properties of today’s plastics, are easily upcycled, and can be manufactured at scale domestically; and
     
  • Scale and Deploy: Support an energy- and material-efficient domestic plastics supply chain by helping companies scale and deploy new technologies in domestic and global markets, while improving existing recycling technologies such as collection, sorting, and mechanical recycling.

According to the SPI, a lack of robust chemical and biological mechanisms limits the deconstruction of existing plastics. This is further complicated by the need for more robust processes that can convert diverse and contaminated plastic waste streams into useful chemical intermediates that can be upcycled into high-value products. The SPI states that “even when robust processes are developed to deconstruct existing plastics, the demand for plastics remains, leading to a critical need for new plastic materials that have the same advantages as current plastics but can be economically recycled or biodegraded safely in the environment.” The SPI notes that underscoring these goals “is the need to approach this problem in a manner informed by life cycle and techno-economic assessment, ensuring solutions are cost-competitive and environmentally benign.” The SPI identifies key research needs and opportunities for DOE-sponsored R&D and catalogs challenges and opportunities facing SPI efforts. DOE intends the SPI to transform its approach to plastic waste and develop new classes of plastic that are recyclable and upgradable by design.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) announced on January 23, 2023, that researchers at the National Renewable Energy Laboratory (NREL) examined the benefits and trade-offs of current and emerging technologies for recycling certain types of plastics to determine the optimal options. According to BETO, the researchers provided a comparison of various closed-loop recycling technologies, which allow for the reuse of plastic through mechanical and chemical reprocessing, eliminating the need for fossil-fuel-derived virgin materials. They considered technical metrics, such as the quality and retention of recycled plastics, as well as environmental metrics, including energy use and greenhouse gas (GHG) emissions. BETO and the Advanced Materials and Manufacturing Technologies Office provided funding for the research as part of the BOTTLE™ Consortium (Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment). The Consortium is a collaborative effort among industry, academia, national labs, and the government to change the way we recycle. More information is available in the January 2023 article “Technical, Economic, and Environmental Comparison of Closed-Loop Recycling Technologies for Common Plastics,” published in ACS Sustainable Chemistry & Engineering.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) announced on January 20, 2023, that a collaborative team of BETO-funded scientists from Argonne National Laboratory (ANL) and National Renewable Energy Laboratory (NREL) are searching for carbon utilization technologies that can make better use of the carbon dioxide generated by industry, transportation, and agriculture by transforming it into sustainable aviation fuel and other useful products. According to BETO, the goal is to identify catalysts that can make beneficial products, such as sustainable aviation fuel, efficiently and selectively. BETO states that methanol has “rich potential for uses that contribute to lower greenhouse gas emissions and help in the fight against climate change.” It can generate electricity when used for fuel cells, serve as a heating fuel for boilers, or be used as a sustainable or blended fuel for road, marine, or (potentially) aviation. Additionally, methanol is used as a chemical industry feedstock for the synthesis of formaldehyde, acetic acid, and other health and life sciences products. BETO notes that the long-term challenge of the research will be scaling up scientific findings into commercial applications. With atmospheric carbon dioxide levels on the rise, “innovative research that finds ways to transform CO2 in the atmosphere into something positive is more important than ever.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

  • A consistent definition of scientific integrity for all federal agencies;
  • A model scientific integrity policy to guide agencies as they build and update their policies; and
  • A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

  • Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
  • Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
  • Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
  • Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
  • Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
  • For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

 
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 By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA changed the status for one chemical (1-octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-) that has recently been identified on the SCIL as a per- or polyfluoroalkyl substance (PFAS). According to EPA, the chemical is not used in any Safer Choice-certified products. It was added to the SCIL in 2012 based on the data available and the state of EPA’s knowledge at the time. EPA has now updated the SCIL listing for this chemical to a grey square because of a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances. A grey square notation means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list this chemical on the SCIL. EPA will determine the data required on a case-by-case basis. According to EPA, in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA will remove the chemical from the SCIL 12 months after the grey square designation.
 
EPA states that after this update, there are 1,064 chemicals listed on the SCIL. The SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use this list to promote the safer chemicals they manufacture;
  • Retailers use the list to help shape their sustainability programs; and
  • Environmental and health advocates use the list to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on December 15, 2022, that it intends to issue two funding opportunity announcements (FOA) in early 2023. According to BETO, these potential FOAs, “Reducing Agricultural Carbon Intensity and Protecting Algal Crops” (RACIPAC) and the “2023 Conversion R&D,” will enable the sustainable use of domestic biomass and waste resources to produce biofuels and bioproducts, and to advance the Biden Administration’s goal of delivering an equitable, clean energy future that puts the United States on a path to achieve net-zero emissions, economy-wide, no later than 2050. The prospective RACIPAC FOA would support high-impact research and development (R&D), focusing on reducing the carbon intensity of agricultural feedstocks, improving soil carbon levels, and protecting cultivated algae from pests under two areas of interest:

  • Climate-smart agricultural practices for low carbon intensity feedstocks; and
  • Algae crop protection.

The prospective 2023 Conversion R&D FOA would support the development of technologies that convert domestic lignocellulosic biomass and waste resources, including industrial syngas, into affordable biofuels and bioproducts that significantly reduce carbon emissions under two main areas of interest:

  • Overcoming barriers to syngas conversion; and
  • Strategic opportunities for decarbonization of the chemicals industry through biocatalysts.

According to BETO, both potential FOAs will help to meet the goals of the Sustainable Aviation Fuel Grand Challenge, which are to reduce aviation emissions by 20 percent by 2030 and produce sufficient sustainable aviation fuel to meet 100 percent of domestic aviation demand by 2050.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not previously reviewed. Developers may submit a request for an RSR when they believe a modified plant is not subject to regulation. APHIS will review the modified plant and consider whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS will post the request, its response letter, the plant, trait, and a general description of the Mechanism of Action (MOA) on its website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if APHIS is unable to make such a finding, the modified plant is subject to regulation.

Tags: APHIS, GE, USDA

 
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