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 March 6, 2017, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register that an information collection request (ICR) had been submitted to the Office of Management and Budget (OMB) regarding consultations on the Safer Choice logo redesign. Following the launch of the new Safer Choice logo, EPA plans to conduct consumer surveys to gauge consumer recognition of the new logo and to determine whether the new logo and educational activities are changing purchasing decisions. This ICR was previously published as part of a public review opportunity in the Federal Register on November 3, 2016, and did not receive any comments. With this Notice, there will be an additional 30 days of review as comments are due by April 5, 2017.
On March 2, 2017, Kathleen M. Roberts, Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), participated as a panelist alongside four other trade associations in the “Domestic Policy Forum” at the 2017 Advanced Bioeconomy Leadership Conference (ABLC2017). Ms. Roberts discussed the challenges facing the bioeconomy, including the implementation of the amendments to the Toxic Substances Control Act (TSCA), issues with the TSCA nomenclature system, and the potential for increased scrutiny of renewable products under the current Administration, as well as the work being done by BRAG to address these challenges and to level the playing field for biobased chemicals. If companies wish to ensure equitable regulations for biobased chemicals and products, they should consider joining BRAG to assist with future engagement with EPA.
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 17, 2017, the U.S. Department of Agriculture (USDA) announced it is accepting applications for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program. The Program provides guaranteed loans for projects developing, constructing, or retrofitting commercial scale biorefineries and biobased product manufacturing facilities. The developments must use eligible technology, including new commercial scale processing and manufacturing equipment. Applicants must submit a Letter of Intent by March 6, 2017, that identifies the Borrower, Lender, and Project sponsors, and describes the project, project location, proposed feedstock, primary technologies of the facility, primary products, loan amount, and total project cost estimate. Applications are due on April 3, 2017, at 4:30 pm (EDT).
On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended. The proposed rule aims to amend the Guidelines for Designating Biobased Products for Federal Procurement to add 12 product categories composed of intermediate ingredient and feedstock materials and to propose a minimum biobased content for each category. In addition to the product categories and biobased content, USDA is seeking comments on appropriate performance standards for each product category, the positive environmental and human health attributes of biobased products within the proposed categories, and how small businesses may be affected by the proposed rule. Comments are now due by April 13, 2017.
On February 9, 2017, Avantium announced a partnership with AkzoNobel (a member of the Biobased and Renewable Products Advocacy Group (BRAG®)), Chemport Europe, RWE Generation, and Staatsbosbeheer to develop a reference plant at the Chemie Park Delfzijl in the Netherlands. The plant will use a new technology, referred to as the Zambezi process, for the cost-effective production of high-purity glucose from non-food biomass, including forestry residue, pulp, and agricultural byproducts. Once the woody biomass is converted into sugars and lignin, it can be used to produce a wide range of biobased chemicals and materials. The design of the plant includes an expansion-ready footprint to enable a rapid increase in capacity following the demonstration phase.
Each partner will contribute a unique strength to the overall project. The infrastructure, utilities, and expertise of the reference plant will be based on the AkzoNobel site in Delfzijl. The forestry residue feedstock will be sourced by Staatsbosbeheer. RWE Generation will generate renewable energy from the bio-lignin residue of the Zambezi process, and Chemport Europe will provide strategic support to the project through a range of initiatives.