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.

By Kathleen M. Roberts

On July 31, 2017, the U.S. Energy Information Administration (EIA) released its monthly biodiesel production report for May 2017.  According to the report, U.S. biodiesel production increased by nine million gallons between April and May of this year, and by 1 million gallons compared to May 2016.  The Midwest (Petroleum Administration for Defense District 2) accounted for 69 percent of the total U.S. biodiesel produced.  The report also states that 66 million gallons of 100 percent biodiesel (B100) were sold, and an additional 82 million gallons of B100 were sold in biodiesel blends.  Of the 1,054 million pounds of feedstocks used to produce biodiesel in May 2017, soybean oil remained the largest biodiesel feedstock with 546 million pounds consumed in May.


 

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.

 

By Lauren M. Graham, Ph.D.

On July 14, 2017, the Royal Academy of Engineering (Academy) published a report on the sustainability pros and cons of biofuels, which was commissioned by the Department of Transport and the Department for Business, Energy and Industrial Strategy.  The report aims to provide advice on the future strategy for the development of biofuels in the United Kingdom (UK).  In its statement announcing the report, the Academy stated that biofuels, particularly second generation biofuels from waste and byproducts, have a role to play in meeting the UK commitment to climate change mitigation.  While such biofuels have the potential to be sustainable and make a real impact, the Academy warned that action is needed to manage risks, improve traceability, and avoid fraudulent practice. 
 
The report calls on government to incentivize the development of second generation biofuels in the UK, specifically those derived from wastes and agricultural, forest, and sawmill residues, and to incentivize the use of marginal land, such as land unsuitable for food production or housing, for the production of biofuels.  The Academy also recommended that the government properly regulate the biofuels sector with clear and consistent categorization of wastes and residues to help avoid unintended market distortions within the UK and internationally, and that other sustainability issues, such as competitiveness of biofuels with fossil fuels; food, energy and water security; employment provision; rural development; and human health impacts, be evaluated.


 

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 April 3, 2017, the European Environment Agency (EEA) announced the publication of the report titled “Renewable Energy in Europe 2017:  Recent Growth and Knock-On Effects,” which demonstrates that renewables have been a major contributor to the energy transition in Europe.  An analysis of the compound annual growth rate demonstrated that the use of biofuels in transport grew fastest between 2005 and 2014 at 18 percent per year.  Renewables provided six percent of the energy used for the European Union’s (EU) transportation sector in 2014, with biofuels accounting for nearly 90 percent of renewable energy.  According to the report, a plateau in first-generation biofuel capacity and delays in overcoming technical and financial obstacles related to second-generation biofuel technologies resulted in fewer investments in biofuels in 2015, compared to 2005.  The report also stated that electricity from solid biomass increased seven percent from 2005 to 2014, but the implementation of sustainability criteria could influence future growth in solid biomass fuel.  The full report is available on the EEA website.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report:  Preparing for Future Products of Biotechnology.  Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” NAS was tasked with looking into the future and describing the possible future products of biotechnology that will arise over the next five to ten years, as well as providing some insights that can help shape the capabilities within the agencies as they move forward.  More information regarding the July 2015 memorandum is available on our website under the key phrase Biobased Products, Biotechnology.

Via an ad hoc committee, the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), NAS developed this report through several months of gathering and synthesizing information from several sources, including:  74 speakers over the course of three in-person meetings and eight webinars; responses to its request for information from a dozen federal agencies; statements solicited from members of the public at its in-person meetings; written comments through the duration of the study; and recent NAS studies related to future products of biotechnology.  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 presents conclusions concerning the future biotechnology products themselves, as well the challenges that federal agencies will face in regulating them, which include:

  • The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion;
  • The profusion of biotechnology products over the next five to ten years has the potential to overwhelm the U.S. regulatory system, which may be exacerbated by a disconnect between research in regulatory science and expected uses of future biotechnology products;
  • Regulators will face difficult challenges as they grapple with a broad array of new types of bio-technology products -- for example, cosmetics, toys, pets, and office supplies -- that go beyond contained industrial uses and traditional environmental release;
  • The safe use of new biotechnology products requires rigorous, predictable, and transparent risk-analysis processes whose comprehensiveness, depth, and throughput mirror the scope, scale, complexity, and tempo of future biotechnology applications.

The report provides three recommendations for federal agencies in responding to these challenges, which it states should be taken to “enhance the ability of the biotechnology regulatory system to oversee the consumer safety and environmental protection required for future biotechnology products”:

  1. The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and other agencies involved in regulation of future bio-technology products should increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences. 
  2. EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation. 
  3. The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund bio-technology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.  

Commentary

The report is well-written and contains an impressive amount of new, relevant, and important information.  The Committee participants are to be commended for an important new piece of scholarship in this area.

The report’s conclusions are also significant, but not entirely unexpected.  For those of us working in this space, we have recognized for years the lack of clarity regarding jurisdictional boundaries, the paucity of government resources, and the urgent need for regulatory clarity and significantly enhanced funding.  Unfortunately, given current Trump Administration efforts to diminish government funding for EPA, FDA, and elsewhere, the well-crafted and spot-on recommendations may tragically fall on deaf ears.  Shareholders should carefully review the report and work hard to ensure the recommendations are implemented.  The consequences of failing to “increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural regulatory, and social sciences” -- the number one recommendation in the report -- are too great to ignore.


 

On February 27, 2017, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the publication of the Biorefinery Optimization Workshop Summary Report.  The report provides an overview of the discussion on industry challenges and opportunities that took place during the October 2016 Biorefinery Optimization Workshop in Chicago, Illinois.  The workshop, which comprised a combination of presentations and breakout sessions, focused on feedstock and materials handling; process scale-up, intensification, and cost reduction; and co-product and waste stream monetization.  Discussions from the breakout sessions include key findings on best practices, lessons learned, challenges, potential solutions, and resources needed to overcome current challenges.


 

On September 7, 2016, the Biotechnology Innovation Organization (BIO) released the report "Advancing the Biobased Economy: Renewable Chemical Biorefinery Commercialization, Progress, and Market Opportunities, 2016 and Beyond." This report documents substantial growth in the renewable chemical industry, and covers domestic policies impacting renewable chemical commercialization. Policy drivers that are explored include the Renewable Fuel Standard (RFS), the 2014 Farm Bill, draft legislation, state and federal tax incentives, and the Master Limited Partnerships Parity Act (MLP). The report also reviews currently operating biorefineries to identify biotechnology solutions beyond biofuels currently undergoing commercial development.


 

On September 5, 2016, a group of non-profits, including Oxfam International, Fern, and Greenpeace, published a report outlining policy measures that should be taken by the European Commission (EC) to ensure that bioenergy is as low-carbon and resource efficient as possible. The report, "A New EU Sustainable Bioenergy Policy Report," was published after EC stated a willingness to listen to new proposals to improve sustainable bioenergy policies. EC is planning on proposing an updated bioenergy sustainability policy for the use of biomass in heating, electricity, and transport by the end of 2016, as part of the Climate and Energy Package for 2030. To ensure the sustainability of new bioenergy policies, the report discusses the need and practicality of implementing the following safeguards:

  • A limit to the use of biomass for energy production to levels that can be sustainably supplied;
     
  • An efficient and optimal use of biomass resources, in line with the principle of cascading use;
     
  • Robust and verifiable emission savings on the basis of correct carbon accounting for bioenergy emissions; and
     
  • A comprehensive, binding set of environmental and social sustainability criteria.

This report proposed sustainability criteria across all energy uses of biomass that has been grown on land, as well as residues, waste, and side-products, but not for biomass from aquaculture and marine areas.


 
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