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, 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, including one presented by Lynn L. Bergeson; 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.
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”:
- 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.
- 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.
- 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.
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 February 21, 2017, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the launch of its Chemical Catalysis for Bioenergy Consortium (ChemCatBio), a research and development consortium focused on overcoming catalysis challenges for biomass conversion processes
. The consortium, which consists of the National Renewable Energy Laboratory, the Pacific Northwest National Laboratory, and five other DOE national laboratories, aims to accelerate the development of catalysts and related technologies to bring new catalytic materials to commercial bioenergy applications at least two times faster and at half the cost. The unique properties of biomass, such as high oxygen content, high moisture content, and high acidity, make developing catalysts for bioenergy applications a challenge. Through computational modeling, and materials synthesis and characterization capabilities, researchers involved with the consortium have already designed new multi-functional catalysts that enable carbon-efficient conversion and reduce costs by more than $0.5/gallon.
On February 22, 2017, the DOE’s Office of Fossil Energy announced seven recipients of $5.9 million in funding to develop novel ways to use carbon dioxide (CO2) captured from coal-fired power plants. The projects will focus on converting captured CO2 to useable products. Recipients of the funding include:
||The University of Kentucky Research Foundation will receive nearly $1 million to convert CO2 to bioplastics using microalgae. In addition to developing a strategy to maximize value from the algae biomass, researchers will aim to decrease the cost of algae cultivation;
||Researchers at the University of Delaware will receive $800,000 to develop a two-stage electrolyzer process for the conversion of CO2 to alcohols, such as ethanol and propanol;
||The Gas Technology Institute will receive nearly $799,997 to develop a Direct E-Beam Synthesis process to produce chemicals, such as acetic acid, methanol, and CO, from CO2, and an additional $799,807 to develop a novel catalytic reactor process to convert CO2 into methane for syngas production;
||TDA Research, Inc. will receive nearly $799,985 to develop a sorbent-based, thermo-catalytic process to convert CO2 into syngas; and
||Southern Research will receive $799,442 to develop a process to produce light olefins, such as ethylene and propylene, from coal-fired flue gas using novel nano-engineered catalysts.
On February 4, 2017, the Canadian Department of the Environment and the Department of Health published in the Canada Gazette the draft screening assessment of the commercially relevant fungus, Trichoderma reesei, stating that the organism is nontoxic and does not require regulatory action under Section 77 of the Canadian Environmental Protection Act (CEPA). Following a screening assessment, Trichoderma reesei , which is used to convert biomass to biofuels and sugars and to produce food and health products, was found to not meet the criteria set out in CEPA Section 64 since the amount entering the environment does not pose a risk to human health. Options are being considered, however, for follow-up activities to track changes in the commercial use of and exposure to Trichoderma reesei . Comments on the draft assessment and the related scientific considerations are due by April 5, 2017.