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 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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By Lynn L. Bergeson

On November 12, 2019, DOE published a Funding Opportunity Announcement (FOA) for topics for its Fiscal Year (FY) 2020 Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Phase I Release 2 funding. Participating in this FOA are the following DOE program offices:

  • Office of Cyber Security, Energy Security, and Emergency Response (CESER);
     
  • Office of Defense Nuclear Nonproliferation (NNSA);
     
  • Office of Electricity (OE);
     
  • EERE;
     
  • Office of Environmental Management (EM);
     
  • Office of Fossil Energy (FE);
     
  • Office of Fusion Energy Sciences (FES);
     
  • Office of High Energy Physics (HEP); and
     
  • Office of Nuclear Energy (NE).
     

Interested applicants may register for one or more of DOE’s FY 2020 Phase I Release 2 SBIR/STTR Topics webinars. Presented by DOE Topic Managers, a series of three 90-minute webinars will be available:

For those unable to participate in the live webinars, they will be recorded and made available online.

In addition to the aforementioned webinars, a fourth one will be held to discuss the FOA and application process. This webinar will be held on December 19, 2019.

Tags: DOE, Funding, SBIR

 
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By Lynn L. Bergeson

On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) held a webinar on the Green Chemistry Challenge Awards Program.  Participants learned about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation covered award eligibility, the application process, and evaluation criteria.  There were also questions from the webinar participants.

As reported in Bergeson & Campbell’s (B&C®) September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment. EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health. Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019. EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020.


 
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By Lynn L. Bergeson

EPA announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:

EPA notes that it is required to publish information pertaining to new chemical submissions under TSCA Section 5. EPA states that historically, these data have been, and will continue to be, made available monthly in the Federal Register via www.regulations.gov. According to EPA, the new web pages “are a much easier way for the public to access information about new chemical submissions.” The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a confidential business information (CBI) claim. EPA states that it will update the web pages monthly.

Tags: PMN, SNUN, MCAN, NOC

 
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By Lynn L. Bergeson

On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The Committee will hear from the following witnesses:

Panel 1

  • Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor.
     

Panel 2

  • Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-2019;
     
  • Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard Medical School; Pulmonary and Critical Care Physician, Beth Israel Deaconess Medical Center;
     
  • Dr. David Allison, Dean, School of Public Health, Indiana University-Bloomington; Member, “Reproducibility and Replicability in Science” Committee, The National Academies of Sciences, Engineering, and Medicine; and
     
  • Dr. Todd Sherer, Chief Executive Officer (CEO), The Michael J. Fox Foundation for Parkinson’s Research.
     

 
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By Lynn L. Bergeson

On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision. EPA notes that the supplemental notice is limited in scope and that “it impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.


 
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By Lynn L. Bergeson

On November 4, 2019, 60 organizations unified in an effort to urge U.S. President Donald Trump to reconsider EPA’s proposed amendments to the Renewable Fuel Standard (RFS) program. Signed by organizations such as the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, the letter to the President indicates flaws within the aforementioned proposal released on October 15, 2019. Arguing that the proposed amendments would not accurately account for small refiner exemptions (SRE), the letter authors state that “[t]he flawed proposal swaps out a critical component of the SRE remedy sought by farmers and the biofuels industry,” failing to achieve its mission to incentivize farm economies. Given the proposal to recover gallons of biofuel exemptions based on the U.S. Department of Energy’s (DOE) recommendations, the proposed amendment would lead to a “bureaucratically uncertain path that recovers only one fraction of those gallons lost to SREs and could result in RFS backsliding in 2020.” Therefore, the letter concludes by urging President Trump to consider SRE accountability based on a rolling average of the actual volumes exempted by EPA during the three compliance years. Similar concerns and requests have been expressed by many industry stakeholders via docket comments as well as during last week’s public hearing held by EPA. The comment period ends on November 29, 2019, and doubts continue as industry expects EPA’s final rulemaking.

Tags: RFS, BIO, BRAG

 
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By Lynn L. Bergeson

On October 30, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. The first meeting is scheduled for November 19, 2019, from 8:00 a.m. to 5:00 p.m. (EST), and the second meeting will take place on November 20, 2019, from 8:00 a.m. to 1:30 p.m. (EST) in Washington, D.C. The purpose of the committee is to advise the Secretaries of Energy and Agriculture with respect to the Biomass Initiative. The committee also evaluates and makes recommendations in writing to the Biomass R&D Board. The meetings will address the advice and guidance the committee will promote for R&D leading to the production of biobased fuels and biobased products. The meetings’ tentative agenda includes updates on the U.S. Department of Agriculture (USDA) Biomass R&D activities, presentations from government and industry that provide insights on the intersection of forest health and bioenergy growth, and updates on DOE Biomass R&D activities. Written and oral statements will be accepted. The meeting summary will be available for public review here.

Tags: DOE, EERE, Biomass

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

USDA Deputy Under Secretary Donald LaVoy and DOE Under Secretary of Energy Mark W. Menezes announced on October 24, 2019, a Memorandum of Understanding (MOU) signed between the two departments to promote rural energy and the development of technologies to support and advance rural and agricultural communities and domestic manufacturing. Required under Section 6501 of the 2018 Farm Bill, the MOU is meant to improve collaboration and coordination between DOE and USDA. A number of areas are covered by the MOU, including:

  • Streamlining, leveraging, and optimizing program resources;
     
  • Strengthening energy-related infrastructure;
     
  • Facilitating energy-related investments in rural communities;
     
  • Ensuring affordable and reliable power;
     
  • Offering technical assistance to rural communities;
     
  • Encouraging innovation; and
     
  • Helping rural businesses export energy products and manufactured goods around the globe.
     
Tags: USDA, DOE

 
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