The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
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By Lynn L. Bergeson

On December 19, 2019, the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, signed the final rule on the Renewable Fuel Standard (RFS) program, setting the renewable fuel percentages for 2020. Titled Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021 and Other Changes, the final rule establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in 2020. The rule also establishes the applicable volume of biomass-based diesel for 2021. The final volume requirements can be accessed here. Thus far, industry stakeholders seem displeased with the standard calculations to account for volumes of fuels projected to be exempted from the renewable volume obligations (RVOs). The waiver limits biofuel producers were hoping for are not reflected in the final rule. While the final rule has not yet been published in the Federal Register (FR), it will become effective 60 days after the FR publication. Bergeson & Campbell, P.C. will continue to monitor and provide further details once the final rule is published.

Tags: RFS, Biofuel

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

The implementation date of the United States (U.S.) National Bioengineered Food Disclosure Standard (NBFDS) is January 1, 2020. Adopted in February 2019 by the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Services (AMS), the NBFDS regulations (7 C.F.R. Part 66) directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered (BE). NBFDS requires food manufacturers, importers, and certain retailers to disclose information about whether food offered for sale is BE or uses BE food ingredients. Designed to inform consumers about the food they are purchasing, AMS developed a list of BE foods to identify crops or foods that are available in BE form. In this case, USDA defines BE foods “as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.” The list includes any BE crops or foods that are in legal production somewhere in the world and is to be updated by AMS annually. Because new BE crops and foods continue to be developed, even if a food is not listed, regulated entities whose records show that a food they are selling is BE must make the appropriate food disclosure. The NBFDS timeline is as follows:

  • Implementation Date: January 1, 2020, for large food manufacturers; January 1, 2021, for small food manufacturers;
  • Voluntary Compliance Date: ends on December 31, 2021; and
     
  • Mandatory Compliance Date: January 1, 2022.

A decision tool has been made available by USDA to guide regulated entities subject to NBFDS in determining whether compliance with the law is necessary. The tool is to be used for each individual ingredient that may be used in a food. Frequently asked questions (FAQ) are also available.

Tags: USDA

 
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By Lynn L. Bergeson

On December 13, 2019, EPA announced that it has contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “integrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.” EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method. NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020. EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process. EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”


 
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By Lynn L. Bergeson

On December 9, 2019, the Sustainable Chemistry Research and Development Act of 2019 (H.R. 2051) was passed by the House of Representatives. H.R. 2051 establishes an interagency working group (IWG) led by the Office of Science and Technology Policy to coordinate Federal programs and activities in support of sustainable chemistry. The IWG will develop a roadmap for sustainable chemistry with a framework of attributes characterizing sustainable chemistry, assess the state of sustainable chemistry in the United States, and identify methods by which federal agencies can incentivize sustainable chemistry activities, challenges to sustainable chemistry progress, and opportunities for expanding federal sustainable chemistry efforts. On December 10, 2019, the bill was received in the Senate, read twice, and referred to the Committee on Commerce, Science, and Transportation.


 
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By Lynn L. Bergeson

On December 9, 2019, 22 Senate Democrats released a letter supporting the expansion of green energy tax credits. This letter was drafted in response to the Growing Renewable Energy and Efficiency Now (GREEN) Act discussion draft that was circulated in the U.S. House of Representatives on November 19, 2019. The Senators agree with the priorities of the GREEN Act and pledge to similarly prioritize and include:

  • Offshore Wind Investment Tax Credit,
     
  • Storage Investment Tax Credit,
     
  • Solar and Clean Energy Investment Tax Credit Extension,
     
  • Energy Efficiency Tax Credit,
     
  • Clean Vehicles, and
     
  • Onshore Wind.
     

 
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By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include:

The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g). The table contains information from CBI reviews including:

  • Case Number;
     
  • Submission Type;
     
  • CBI Review Category (specific chemical identity, other information, or both);
     
  • Final Determination;
     
  • Determination Rationale Summary;
     
  • For CBI Claims for Specific Chemical Identity:
     
    • EPA Unique Identifier (UID);
       
    • Accession Number;
       
    • Generic Name; and
  • Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.

EPA states that it plans to update this information on a quarterly basis.

Tags: TSCA, CBI

 
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By Lynn L. Bergeson

On December 10, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) Bioenergy Technologies Office (BETO) published a notice of intent to issue a joint Funding Opportunity Announcement (FOA) with the Advanced Manufacturing Office (AMO), titled “BOTTLE: Bio-Optimized Technologies to Keep Thermoplastics out of Landfills and the Environment.” This FOA supports the Department’s Plastics Innovation Challenge, a comprehensive program to accelerate innovations in energy-efficient plastics recycling technologies by supporting high-impact research and development for plastics. The primary goal of the FOA is to develop new bio-based plastics that are capable of efficient recyclability and developing improved recycling strategies that can break down existing plastics into chemical building blocks that can be used to make higher value products.


 
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By Lynn L. Bergeson

On December 6, 2019, DOE announced that the applications currently being accepted for free assistance preparing Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) FY 2020 Phase I Release 2 applications. There are a variety of eligibility criteria, and because space is limited, DOE Phase 0 applicants are admitted on a first-come, first-served basis. Each small business, however, is evaluated for selection to receive administrative and technical assistance based on the following selection criteria:

  • The small business offers technology innovations relevant to the current and open DOE SBIR/STTR research topics and subtopics (topics can be accessed at science.osti.gov/sbir);
     
  • The small business is or will be prior to award an eligible small business per 13 CFR Section 121.702;
     
  • The small business has not previously applied for an SBIR or STTR award from the DOE; and
     
  • Small business and/or owner has not received any Phase 0 technical assistance from DOE.

Qualified small businesses can submit an application at www.dawnbreaker.com/doephase0/apply.php.

Tags: DOE, SBIR, STTR

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

First published last week, on November 25, 2019, the article titled “Consolidated Production of Coniferol and Other High-Value Aromatic Alcohols Directly from Lignocellulosic Biomass” has gained media attention across the globe. Given the finite geological oil reserves, the competition to identify alternative biobased and biorefinery processes continues to grow. According to the article, the aim in identifying such products is not only to find alternatives, but most importantly to “overcome significant costs and productivity barriers.” In the aforementioned article, published in the Green Chemistry Journal, scientists write about a novel technique using the biocatalytic production of coniferol (a versatile chemical block) directly from lignocellulosic biomass. The process to do so involves a biocatalytic treatment of lignocellulose, which releases and converts ferulic acid with feruloyl esterase (XynZ), carboxylic acid reductase (CAR), and aldo-keto reductase (AKR). This catalytic reaction achieves the equivalent release of ferulic acid from lignocellulose compared to alkaline hydrolysis, also displaying efficient conversion of ferulic acid to coniferol. Consolidating a biodegradation-biotransformation strategy for the production of high value fine chemicals from waste plant biomass, this novel process offers a potential to minimize environmental waste and add value to agro-industrial residues. A number of grants, including from the São Paulo Research Foundation and David Phillips Fellowship, supported the study outlined in the journal article. Grants of these types continue to arise as the need to address resource efficiency and, therefore, biobased chemical production has become the focus of various government agencies in many countries. The U.S. Department of Energy (DOE) for example, often provides scientist from all backgrounds similar opportunities.


 
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By Lynn L. Bergeson

On December 3, 2019, Governor of Iowa, Kim Reynolds, signed an Executive Order that requires all new contracts for the purchase of state vehicles with diesel engines to have written support from the manufacturer to use B20 biodiesel (a mix of 20 percent biodiesel and 80 percent petroleum-based diesel) or more. The Iowa Department of Transportation (DOT) started using biodiesel blends in 1994. B20 is used for most of the year already, in most equipment with a diesel engine, including motor graders and snowplows, among others. Largely contributing to Iowa’s job market and accounting for $568 million of the state’s gross domestic product (GDP), Iowa’s biodiesel plants increased their biodiesel production by 20 percent by the end of 2018. Governor Reynolds stated: “Ethanol and biodiesel remain essential to the health of the agricultural economy, sustainable environmental commitments and employ thousands of Iowans. I am proud to stand alongside Iowa Farm Bureau and key stakeholders in the renewable fuels industry to secure the continued demand for biofuels.”

Tags: Iowa, Biofuel, B20, DOT

 
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By Lynn L. Bergeson

From December 11 through 12, 2019, DOE’s Office of Bioenergy Technologies Office will host a workshop titled “Plastics for a Circular Economy” in Denver, Colorado. The workshop will include discussions on technology solutions to address plastic waste and focus on the development of new recycling and degradation strategies. The objective of the workshop will be to identify early-stage applied research problems in the aforementioned area that need to be addressed both in the long- and near-term. Representatives from waste management facilities, circular economy experts, commercial plastic producers, and biobased plastic innovators will be some of the participants.


 
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By Lynn L. Bergeson

On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the corn ethanol mandate and immediately reduce the amount of ethanol in fuel by as much as 1 billion gallons by capping the amount of ethanol that can be blended into conventional gasoline at 9.7 percent. The legislation also seeks to help farmers return cornfields to pasture and wildlife habitat through a 10 cents per renewable identification number (RIN) fee to fund a new Private Land Protection and Restoration Fund in the U.S. Treasury. The fund will help pay for Department of Interior (DOI) programs that pay for easements on private lands to keep them out of agricultural production; keep the lands in conservation uses like grass, forest, stream buffers, or pollinator habitat; and help farmers transition land currently in crop production into other uses. The GREENER Fuels Act also would extend the cellulosic and advanced next-generation biofuel mandate until 2 billion gallons of annual production is achieved or 2037, whichever is sooner, and alters the way the mandate is implemented to produce liquid transportation fuels that dramatically reduce greenhouse gas emissions.

Tags: RFS, Biofuel

 
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By Lynn L. Bergeson

On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include:

  • An overview of EPA’s updated “Working Approach” document that builds on EPA’s “New Chemicals Decision Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
     
  • A demonstration of how EPA uses key concepts in the Working Approach to reach certain conclusions and/or make determinations under TSCA Section 5(a)(3) using case examples;
     
  • An update on confidential business information (CBI) process improvements and clarifications; and
     
  • A discussion of EPA’s ongoing efforts and progress to increase transparency.

During the meeting, EPA will provide an opportunity for stakeholders to provide input on the topics mentioned above. Feedback can also be submitted via the docket on or prior to January 24, 2020.

By the end of 2019, EPA expects to make the “Working Approach” document available for written public comments


 
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By Lynn L. Bergeson

On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing the overall total of biosimilar approvals to 25, Dr. Yim states: “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.” Approved under FDA’s Biosimilar Product Development Program, the 25th biosimilar announced is one of 38 products that have been enrolled in the program. The program’s goal is to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.

Typically more complex than other drugs and developed through advanced science, biological products, commonly referred to as biologics, are generally made from natural or living sources, such as animal and plant cells, and microorganisms such as bacteria or yeast. Biologics and biosimilar products are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic products called reference products. As part of FDA’s efforts to support these products, Dr. Yim also highlighted FDA’s work under the Biosimilars Action Plan. The work under this plan includes efforts to develop and implement new biosimilar-specific review templates and progress toward the development and validation of pharmacodynamic biomarkers tailored to biosimilar development. Part of these efforts involves FDA’s provision of scientific and regulatory clarity for the biosimilar development community, combined with communication and outreach education. Dr. Yim concludes: “The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”


 
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By Lynn L. Bergeson

On November 8, 2019, the U.S. Department of Energy (DOE) announced that $12 million will be available in funds for new projects to support research and development (R&D) and education and workforce development to increase plastics recovery, recycling, reuse, and remanufacturing. Designed for U.S. manufacturers, 12 to 18 exploratory and full R&D projects and four to eight education and workforce development projects will be funded by DOE’s Reducing Embodied Energy and Decreasing Emissions (REMADE) Manufacturing Institute. REMADE was founded in 2017 in partnership with DOE’s Office of Energy Efficiency and Renewable Energy’s (EERE) Advanced Manufacturing Office. The REMADE Manufacturing Institute aims to enable early-stage applied R&D of technologies that could dramatically reduce embodied energy and carbon dioxide emissions resulting from industrial-scale materials production and processing. This particular opportunity will focus on projects that align with REMADE’s research focus areas:

  • Development of novel manufacturing and recycling technologies to increase secondary feedstock use by 20 percent without loss of properties or performance;
     
  • Design of alternatives to increase recovery, recycling, reuse, and remanufacturing of products at the end of their life cycles;
     
  • Development of technologies to separate and recover specific polymers and metal in e-waste materials;
     
  • Technological advancements to remove pigments from polymers; and
     
  • Provision of cutting-edge training in recycling for the American workforce and in support of the development of a new REMADE professional certificate program.
     

REMADE is currently accepting letters of intent, which are due today. Full proposals are due on December 18, 2019. Further submission information is available on REMADE’s website.

Tags: DOE, Plastics

 
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