David Glass Presentation at 2010 Algae Biomass Summit

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Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.

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    Thanks for posting a very informative presentation with applicability beyond algae.
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David Glass Presentation at 2010 Algae Biomass Summit

  1. 1. Impact of Government Biotechnology Regulations on Use of Genetically Modified or Synthetic Algae in Biofuel Production<br />David J. Glass, Ph.D.<br />D. Glass Associates, Inc.<br />Algae Biomass Summit<br />September 28, 2010<br />
  2. 2. Biotechnologies Applicable to Biofuels<br />Classical mutation and selection<br />Plant breeding<br />Recombinant DNA<br />Directed evolution<br />DNA shuffling<br />Metabolic engineering<br />Synthetic biology<br />
  3. 3. Applications of Biotechnology to Clean Fuel Production<br />Enhanced or engineered microorganisms for fermentation of ethanol, butanol, other fuels.<br />Enzymes for fuel production manufactured using engineered microorganisms or plants.<br />Selected or engineered plant species for use as improved biofuel feedstocks.<br />Improved algal strains for production of biodiesel, jet fuel, ethanol, other fuels.<br />
  4. 4. Genetic Engineering Strategies: Algae<br />Enhance algal growth rate.<br />Enhance or alter lipid biosynthesis.<br />Enhance photosynthesis.<br />Enable use of alternate food sources.<br />Create new biosynthetic pathways.<br />Enable secretion of lipids to aid oil/water separation.<br />
  5. 5. Scientific Issues in the Regulation of Modified Algae<br />Legitimate scientific issues need to be addressed for many projects involving modified algal strains. <br />Stability of vector and introduced genes.<br />Possible deleterious functions encoded by transgene(s).<br />Potential for horizontal gene transfer, crossing to wild algae species.<br />Potential for engineered strain to be transported outside facility, survive and compete in environment.<br />
  6. 6. Overview of U.S. Biotechnology Regulation <br />Environmental Protection Agency<br />Microbial pesticides, plant pesticides.<br />Engineered microorganisms used for other industrial purposes. <br />U.S. Department of Agriculture<br />Transgenic plants, potential plant pests.<br />Plant-produced industrial products. <br />Food and Drug Administration<br />Foods, food additives, pharmaceuticals <br />Possible applicability to algae<br />TSCA biotech rule<br />USDA biotech rule<br />Product –specific regulation<br />
  7. 7. Overview: EPA TSCA Biotechnology Regulations<br />Regulations under the Toxic Substances Control Act (TSCA).<br />Regulations cover industrial uses of “intergeneric” microorganisms not regulated by other agencies; e.g. industrial enzyme production, bioprocessing.<br />Scope of coverage could include algae.<br />Most research and pilot projects are not regulated if suitably “contained”.<br />Commercial use or importation requires 90 day advance notification to EPA.<br />
  8. 8. Overview: USDA Biotechnology Regulations<br />Regulations issued in 1987 cover environmental uses, interstate movement of “potential plant pests”.<br />Applicability to algae under current definitions not clear.<br />Rules have generally not covered “contained” use of organisms in manufacturing.<br />USDA has been considering revisions to the rule since 2007.<br />Regulatory program being challenged in the courts over NEPA compliance.<br />
  9. 9. Overview: FDA Biotechnology Regulations<br />Engineered algae used for food, food additive, pharmaceutical production would be subject to FDA product-specific regulations.<br />These regulations focus more on safety, efficacy of end product, and less on risks of production organism.<br />Algae used for an FDA-regulated purpose would likely be exempt from EPA oversight under TSCA.<br />
  10. 10. Regulatory Jurisdiction for Engineered Algae<br />Proposed use of engineered algae by Mera Pharmaceuticals in pharmaceutical production in Hawaii in 2005 generated controversy, no federal agency claimed jurisdiction: state law and state courts ultimately determined outcome.<br />2008 USDA opinion letter to Coastal BioMarine stated no USDA oversight over engineered algal strain if no “plant pest” sequences, and no oversight for smaller-scale use in contained reactors.<br />It is important to avoid jurisdictional disputes as the industry moves forward.<br />
  11. 11. EPA TSCA Biotechnology Rule:“New Organism” Definition <br />TSCA covers only “new chemicals”, so Biotech Rule covers only “new microorganisms”.<br />“New microorganisms” defined as “intergeneric”: i.e., containing deliberate combinations of coding nucleic acids from more than one taxonomic genus.<br />Many recombinant microorganisms will not meet this definition, and not be covered by these rules.<br />
  12. 12. EPA TSCA Biotechnology Rule:R&D (“Small Quantities”) Exemption<br />R&D uses of “new microorganisms” may qualify for exemption, if used “solely for R&D” in a suitably “contained structure”.<br />Applicant must adopt procedures at the facility for controlled access, inactivation of wastes, emission controls, worker notification. <br />Exemption could apply to R&D by for-profit entities, including pilot plants.<br />Open-pond algae reactors may not be judged to be “contained structures”.<br />Non-contained uses may require EPA notification, review prior to commencement.<br />
  13. 13. EPA TSCA Biotechnology Rule: Microbial Commercial Activity Notifications (MCANs)<br />Commercial use or importation of “new microorganisms” requires MCAN reporting at least 90 days before commencing commercialization or importing microbe.<br />MCAN requires submission of data to EPA.<br />Microorganism identity, construction and its properties.<br />Information about the industrial process, control/containment measures, worker exposure, possible environmental release.<br />EPA review, clearance of MCAN authorizes commercial use.<br />
  14. 14. EPA TSCA Biotechnology Rule:Biofuel, Bio-Based Chemical MCANs <br />29 MCANs reviewed since 1997, including:<br />Numerous MCANs for industrial enzymes.<br />Modified E. coli and Klebsiella oxytoca for the conversion of lignocellulosic biomass sugars to ethanol (Verenium, 2008, 2010).<br />“Biopolymer producing organism” for the industrial manufacture of a biopolymer (Company Confidential, 2008).<br />Modified Zymomonas mobilis for cellulosic ethanol production (DuPont, 2009).<br />
  15. 15. EPA TSCA Biotechnology Rule:Summary<br />Most R&D would be exempt if “contained”.<br />Commercial uses require 90 day advance notice.<br />EPA has a track record in recent years reviewing microorganisms for use in biofuels, bio-based chemical production.<br />EPA review considers risks and benefits.<br />MCAN review clears the way for commercial use.<br />EPA review is generally considered to meet requirements under NEPA, so Environmental Impact Statement not needed.<br />
  16. 16. USDA Biotechnology Regulation:Scope of Coverage<br />USDA Biotech Regulations administered by Animal and Plant Health Inspection Service (APHIS).<br />Rules cover organisms that are potential plant pests, generally based on presence of DNA sequences from potential plant pests.<br />Rules cover environmental use or interstate movement of potential plant pest organisms.<br />Most submissions have been for transgenic plants, some for modified agricultural microorganisms.<br />
  17. 17. USDA Biotechnology Regulation:Oversight over R&D<br />R&D use covered only if in open environment.<br />Notifications: 30 day advance notice.<br />Permits: submit application 120 days in advance.<br />Permits generally required for industrial uses.<br />Submissions require:<br />Description of host organism and genetic modifications.<br />Description of field test; proposed procedures and controls.<br />Assess environmental impact of field use.<br />
  18. 18. USDA Biotechnology Regulation:Approvals for Commercial Use<br />Approval for commercial use and sale through “petitions for nonregulated status”. <br />Since early 1990s, USDA has approved 78 petitions to allow commercial sale of engineered crop plants.<br />Approvals can take 1-4 years.<br />Recent court cases have ruled that these approvals may require Environmental Impact Statements.<br />
  19. 19. USDA Biotechnology Regulation:Summary<br />Tens of thousands of field tests approved under these regulations – no approvals for algae?<br />Limited experience with R&D permits for novel biofuel feedstocks, no commercial approvals.<br />USDA likely to have scientific expertise to review biology of photosynthetic algae, but applicability under existing definitions unclear.<br />Uncertain future for these regulations, due to ongoing rulemaking and court decisions regarding NEPA compliance.<br />
  20. 20. Environmental Impact Statements?<br />National Environmental Policy Act (NEPA) requires Environmental Assessments, Environmental Impact Statements, for “major federal actions”.<br />Courts have ruled that product approvals under USDA biotech regulation require EIS’s.<br />EPA actions under most of its regulations considered to inherently comply with NEPA requirements.<br />Recent calls for DOE to conduct EIS for its program supporting algal biofuel research.<br />Question: are EIS’s needed, and if so, when?<br />
  21. 21. ABO Technical Standards Committee: Goals Published in Initial Draft<br />Set the terms of the debate; encourage responsible, science-based regulation.<br />Distinguish between different biotechnologies used to create organisms.<br />Develop standards for data submission, performance of production facilities, organism containment.<br />Develop a “road map” for regulatory approval of industrial uses of modified algae.<br />Influence public perception.<br />
  22. 22. ABO Technical Standards Committee: Challenges to Achieving Goals<br />Biotech regulations use longstanding definitions to define which organisms are covered; would be difficult to introduce new classification schemes.<br />Regulations differ in performance standards, data requirements and review procedures; standardization would be easier if one agency had sole jurisdiction.<br />Growth of GM algae in open ponds.<br />Public perception is critical. Although not as bad as the 1980s, there are still many vocal critics out there.<br />
  23. 23. Impact of Biotechnology Regulations<br />Efforts to promote standardization, interagency cooperation are important to ensure a science-based regulatory framework.<br />However, the existing biotech regulatory framework provides a straightforward path to commercial approval, with many prior successes in agricultural, industrial biotechnology.<br />The regulatory process can be successfully managed with proper advance planning.<br />
  24. 24. Thank you very much<br />David J. Glass, Ph.D.<br />D. Glass Associates, Inc.<br />124 Bird Street<br />Needham, MA 02492<br />Phone 617-653-9945<br />DGlassAssc@aol.com<br />www.dglassassociates.com<br />http://dglassassociates.wordpress.com<br />

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