By Lauren M. Graham, Ph.D.
On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). FDA states the purpose of the public meetings is “to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” This initiative, which Congress appropriated $3 million to fund, calls upon FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. More information on the initiative and information on how to register for the meetings is available on FDA’s website. Comments on questions listed in the Federal Register notice, scheduled to be published tomorrow, are also being requested and can be filed in Docket FDA-2017-N-5991 on www.regulations.gov. Comments are due by November 17, 2017.
By Kathleen M. Roberts
On August 25, 2017, the National Farmers’ Union (NFU) announced that the European Commission confirmed the extension of the Red Tractor voluntary scheme for biofuels for an initial three months. Red Tractor is a certification body used to prove that crops meet European Union (EU) sustainability requirements. To receive public support or count towards mandatory national renewable energy targets, biofuels used in the EU must comply with the EU's sustainability criteria. One way for a company to demonstrate compliance is to participate in voluntary schemes recognized by the European Commission.
As with the other voluntary schemes, Red Tractor was approved for a period of five years, which expired on August 1, 2017. On August 24, 2017, NFU called on the Commission to urgently address concerns that Red Tractor-approved crops will no longer be able to enter the European biofuels market. The Commission responded by confirming that the Red Tractor scheme continues to be considered compliant with the EU Renewable Energy Directive (RED) sustainability criteria until November 5, 2017, pending another five-year approval.
By Kathleen M. Roberts
On July 26, 2017, the European Commission announced the launch of the Bioeconomy Knowledge Centre, which was created by the Joint Research Centre (JRC) and the Directorate General for Research and Innovation (DG RTD) to better support policy makers with science-based evidence in the bioeconomy field. Rather than generate information, the objective is to build on JRC’s expertise in knowledge management. The online platform will collect, structure, and provide access to knowledge from a wide range of scientific sources on the bioeconomy, the sustainable production of renewable biological resources, and their conversion into valuable products. The platform will also support the European Commission in the review of the 2012 Bioeconomy Strategy, taking into account new political and policy developments, such as the Paris agreement, the United Nations' Sustainable Development Goals, and the Circular Economy Package.
By Lauren M. Graham, Ph.D.
On July 20, 2017, the U.S. Department of Agriculture's (USDA) National Institute of Food and Agriculture (NIFA) awarded 34 grants totaling $15.1 million for research on renewable energy, biobased products, and agroecosystems. The grants, which are funded through the agency’s Agriculture and Food Research Initiative (AFRI), are expected to help develop the next generation of renewable energy, bioproducts, and biomaterials; protect the ecosystems that support agriculture; and improve the agricultural systems and processes that help feed the nation.
The following institutions were awarded grants for projects focused on cover crop systems for biofuel production:
- USDA Agricultural Research Service (ARS) received $494,000 for the development of lupin, cereal rye, and carinata winter cover crops for biomass in the southern coastal plain;
- Purdue University received $498,000 for the development of cover cropping for the development of sustainable co-production of bioenergy, food, feed (BFF) and ecosystem services (ES);
- Iowa State University of Science and Technology received $498,378 for the development of perennial cover crop systems for maize grain and biomass production;
- Louisiana State University Agricultural Center received $387,000 to study the feedstock production potential of energy cane-sweet sorghum rotation with a winter cover crop system; and
- University of Nebraska received $500,000 to assess innovative strategies to maximize cover crop yields for biofuel across a precipitation gradient.
The following institutions were awarded grants for projects focused on the socioeconomic implications and public policy challenges of bioenergy and bioproducts market development and expansion:
- Auburn University received $499,886 to identify the economic barriers to biomass production, to evaluate the effectiveness of the Biomass Crop Assistance Program (BCAP) in stimulating biomass market expansion, and to explore the economic and ecosystem service implications of biomass production;
- Colorado State University received $499,000 to produce a unified atlas of marginal lands in the U.S., and provide insight on the costs, potential environmental benefits, and overall practical likelihood of using those lands for biomass feedstock production;
- Purdue University received $492,099 to develop a dynamic theoretical model on rejuvenating coal-power plants with biomass;
- Iowa State University of Science and Technology received $499,622 to provide an integrated model-based assessment of the socioeconomic, policy, and market implications of sustainable bioenergy derived from cellulosic biomass; and
- University of Missouri received $498,441 to evaluate impacts on forest resources surrounding power plants using woody biomass, assess economic impacts of wood biopower systems, and quantify tradeoffs between cost, carbon reductions, and renewable energy generation obtained by the increased use of wood biopower.
More information on the grants is available at the NIFA website
By Kathleen M. Roberts
On July 20, 2017, USDA released its technology transfer report for fiscal year 2016. The report outlines the public release of information, tools, and solutions and the adoption and enhancement of research outcomes by collaborative partners and formal Cooperative Research and Development Agreements (CRADA) that occurred in 2016.
The report highlights several research initiatives by ARS scientists focused on supporting the bioeconomy, including:
- Development of a new yeast strain with a unique cellulolytic enzyme that efficiently breaks down biofeedstock, shows resistance to inhibitory compounds, and eliminates the need to add other enzymes to the production process;
- Engineering a yeast strain from a Brazilian ethanol plant to convert plant xylose to ethanol and then identifying a strain with excellent performance;
- dentification of a strain of yeast capable of converting inulin, a major polysaccharide derived from coffee processing waste, into cellulosic ethanol;
- Development of genetic methods to control the conversion of agricultural sugars to compounds called liamocins using yeast; and
- Studying the use of lytic enzymes as an alternative to antibiotics for preventing and controlling bacterial contamination of fuel ethanol fermentations during biorefining.
The full report, titled “Fiscal Year 2016 Annual Report on Technology Transfer” is available on USDA’s website
Scientists, executives, and investors gathered in Montreal, Canada on Tuesday evening for a fascinating and wide-ranging discussion on current issues facing bioeconomy leaders and innovators. The reception, hosted by Bergeson & Campbell, P.C. (B&C®) and Sterne, Kessler, Goldstein & Fox P.L.L.C., included a brief question and answer (Q&A) session with Christine Lhulier, Corporate Counsel for DuPont Industrial Biosciences, Richard E. Engler, Ph.D., Senior Chemist with B&C, and Jeremiah B. Frueauf, Director in the Biotechnology/Chemical Group at Stern Kessler. The panel discussed the variety of the incentives and challenges related to growing the bioeconomy, and fielded questions from many of the attendees.
When asked what industries might be affected by the bioeconomy in 2040, Ms. Lhulier stated that she could not name an industry that would not be impacted by renewable resources in the future. In response to the question “what should be the key driver in growing the bioeconomy?,” the panelists highlighted the need for clear regulatory policies that ensure parity for the commercialization of biobased and petroleum-based products, while recognizing the role that industry and academic institutions play in driving innovation. It was also noted that global alignment on biobased policies and procedures, and the development of feedstock-agnostic technologies, would help to accelerate the growth of the bioeconomy.
After a guest commented on the impact the negative public perception of biotechnology has on innovation, Dr. Engler pointed out the public’s poor understanding of biotechnology, its safety, and the extent to which it is utilized in the marketplace already. Another attendee suggested that the biobased industry consider playing a role in informing the public of the benefits of biobased processes. At the conclusion of the Q&A portion of the evening, many guests stayed to continue the conversation with the panelists and attendees.
By Lauren M. Graham, Ph.D.
Renewable Industries Canada (RICanada), a principal stakeholder representing Canadian producers of clean-burning renewable fuels, announced that the Quebec Government’s 2017-2020 Action Plan under the 2030 Energy Policy included, for the first time, renewable fuel volume requirements for fuels such as ethanol and biodiesel. The renewable fuel blending requirement was set at 5% for gasoline and 2% diesel and is expected to increase after 2020. RICanada stated that the “announcement on renewable transportation fuels further entrenches Quebec’s position as a leader in the production of renewable energy and in the broader battle against climate change” and that its “members look forward to helping the Government of Quebec ensure that the province’s GHG targets in the transportation sector are achieved.” More information on the Action Plan for Energy Policy 2030 is available on the Minister of Energy and Natural Resources website.
By Lauren M. Graham, Ph.D.
On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS. The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming.” The committee reached consensus on its conclusions and recommendations regarding actions that can be taken to enhance the capabilities of the biotechnology regulatory system to prepare for the anticipated future of biotechnology products, which are also presented in the report.
More information on the NAS report is available in the Biobased and Renewable Product Advocacy Group (BRAG®) blog post “NAS Releases Final Report on Preparing for Future Products of Biotechnology.”
By Lynn L. Bergeson and Margaret R. Graham
On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.
The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.
More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.
By Lauren M. Graham, Ph.D.
On June 6, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced the winners of its Imagine Chemistry challenge. The following winners have been awarded joint development agreements with AkzoNobel’s Specialty Chemicals business to help bring their ideas to market:
- Ecovia Renewables was awarded for its fermentation technology to make polyglutamic acid, which can be used to make thickeners for personal care products and other uses;
- Industrial Microbes was awarded for its solution to use genetically modified microorganisms to turn CO2 and natural gas into key chemical building blocks, such as ethylene oxide; and
- Renmatix was awarded for its technology to use pressurized water to break down plant biomass into cellulosic products with a range of end-use applications.
The awardees were selected from a group of 20 finalists that participated in a three-day event at AkzoNobel’s Deventer Open Innovation Center. In addition to the winners, seven other finalists were awarded prizes, such as a research agreement with AkzoNobel, chemical research support from AkzoNobel, a rent voucher for the Deventer Open Innovation Center, partner support by Icos Capital and KPMG, and partner support by Icos Capital and KPMG. More information on the Imagine Chemistry Challenge is available in the BRAG blog post “AkzoNobel Launches Global Chemicals Start-Up Challenge