David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproducts Confeence
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David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproducts Confeence

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These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed ...

These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed the U.S. regulatory framework for the industrial uses of genetically modified algae and the scientific issues involved in the risk assessments that determine decision-making under such regulations. I argued that these regulations, particularly the US EPA "TERA" regulations, are not difficult to navigate and are well designed to allow careful, stepwise testing of modified algae strains both in contained reactors and in open ponds. I also discussed the roles that academic, industry and government researchers can play in developing the research database to support regulatory decision-making.

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David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproducts Confeence David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproducts Confeence Presentation Transcript

  • David J. Glass, Ph.D. D. Glass Associates, Inc. June 18, 2014
  • Overview, Key Points  History and overview of U.S. biotechnology regulation affecting industrial uses of GM algae.  Although the U.S. biotechnology framework singles out modified organisms for additional scrutiny, approvals for commercial uses of GM algae can be obtained with proper planning.  Scientific issues relating to regulation and risk assessment of uses of GM algae.  Legitimate scientific issues should be addressed in a risk assessments for industrial uses of GM algae.  Industry, government and academia can collaborate to create research database to support risk assessments. D. Glass Associates, Inc.
  • Advanced Biotechnology can Improve Usefulness of Algae  Enhance algal growth rate.  Enhance or alter lipid biosynthesis.  Enhance photosynthesis.  Enable use of alternate food sources.  Create new biosynthetic pathways; enable production of new products.  Enable secretion of lipids to aid oil/water separation. Rosenberg et al. 2008, Li et al. 2008; Angermayr et al. 2009, Radakovits et al 2010. D. Glass Associates, Inc.
  • U.S. Biotechnology Regulation: Historical Perspective  Biotechnology framework arose in the mid-1980s amid considerable public interest and debate.  The Reagan Administration decided against a biotechnology-specific law, in favor of relying on existing laws and regulations.  Although meant to be “product-based” rather than “process-based”, inevitably some regulations single out uses of engineered organisms for greater scrutiny than uses of unmodified organisms.  Although broad enough to cover all commercial uses, the greatest focus was on “deliberate releases” to the environment. D. Glass Associates, Inc.
  • Overview of U.S. Biotechnology Regulation Environmental Protection Agency  Microbial pesticides, plant pesticides.  Engineered microorganisms used for other industrial purposes. U.S. Department of Agriculture  Transgenic plants, potential plant pests.  Plant-produced industrial products. Food and Drug Administration  Foods, food additives, pharmaceuticals. TSCA biotech rule USDA biotech rule Product –specific regulation Possible applicability to algae D. Glass Associates, Inc.
  • Regulatory Jurisdiction for Engineered Algae  Proposed use of engineered algae by Mera Pharmaceuticals in pharmaceutical production in Hawaii in 2005: no federal agency claimed jurisdiction, state law and state courts ultimately determined outcome.  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.  Can USDA, EPA work together on GM algae regulation, with one agency designated as the lead? D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Regulations (1)  Regulations adopted in 1997 under the Toxic Substances Control Act (TSCA) cover commercial uses of “new microorganisms”.  Regulations cover only those industrial uses not regulated by other agencies as foods, drugs, cosmetics, pesticides.  Among covered activities: industrial enzyme production, bioremediation, biotreatment, manufacture of fuels, chemicals.  New microorganisms are defined as “intergeneric”: containing deliberate combinations of coding nucleic acids from more than one taxonomic genus. D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Regulations (2) EPA considers scope of coverage to include algae. From the biotechnology rule: “Microorganism” means an organism classified, using the 5-kingdom classification system of Whittacker, in the kingdoms Monera (or Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of the Plantae, and a virus or virus-like particle. From the rule’s preamble: Therefore, this definition includes, but is not limited to, bacteria, protozoa, fungi, mycoplasmas, mycoplasma-like organisms, spiroplasmas, microphytoplanktons, green and red algae, viruses, and virus-like particles (e.g., viroids, satellites, and virusoids). D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Regulations (3)  Commercial use or importation of intergeneric organism requires 90 day advance notification to EPA, through submission of a Microbial Commercial Activity Notice (MCAN).  Most research and pilot projects would not require EPA review if conducted in suitably “contained” facilities, with procedures for controlled access, inactivation of wastes, emission controls, worker notification.  R&D with intergeneric organisms under non-contained conditions, such as open-pond algae reactors, would require EPA review through submission of a TSCA Experimental Release Application (TERA) 60 days in advance of proposed activity. D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Rule: TSCA Experimental Release Applications  TERAs submitted to EPA 60 days in advance, describing the organism, the proposed research, and the proposed controls and monitoring procedures.  EPA can approve or deny TERAs, or approve testing with limitations or required monitoring.  To date, 30 TERAs submitted, most for agricultural or bioremediation microorganisms. All but three of these have been approved.  The 5 TERAs most recently filed and approved were from Sapphire Energy, Inc., for open-pond research at UCSD using different modified strains of the photosynthetic green algae Scenedesmus dimorphus. D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Rule: Microbial Commercial Activity Notifications (MCANs)  MCAN reporting required at least 90 days before commencing commercialization or importing a “new microorganism” for a TSCA purpose.  MCAN requires submission of data to EPA.  Microorganism identity, construction and its properties  Potential health and environmental impacts.  Information about the industrial process, control/containment measures, worker exposure, possible environmental release.  EPA review, clearance of MCAN authorizes commercial use for any purpose. D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Rule: Biofuel, Bio-Based Chemical MCANs  Approx. 65 MCANs filed since 1997. Number and frequency have increased in last 3 years.  Most early MCANs covered GMOs for production of industrial enzymes.  14 MCANs for S. cerevisiae, 3 for Zymomonas mobilis, all for ethanol production.  Joule, Algenol have filed MCANs for cyanobacteria; Solazyme has filed 2 MCANs for modified microalgae.  Complete list available at www.epa.gov/biotech_rule/pubs/submiss.htm. D. Glass Associates, Inc.
  • 0 2 4 6 8 10 12 14 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 (to date) MCANs Submitted to EPA by Fiscal Year D. Glass Associates, Inc.
  • ©2013 Joule. Rights Reserved. Proprietary & Confidential. www.jouleunlimited.com Joule SunSpringsTM Hobbs: Where the vision becomes reality Production Unit Central Plant  Commissioned in September 2012 to test and demonstrate the platform at increasingly larger scale  Core production unit and infrastructure in place to advance to full process demonstration  Achieving progress on numerous variables, e.g. productivity, process efficiency  Sustained Sunflow®-E ethanol production, with other products to follow  Facility and processes will become the blueprint for future commercial plants Biocatalyst Prep ©2013 Joule. Rights Reserved.
  • Joule Unlimited: MCAN for Modified Synechococcus  First MCAN for commercial ethanol production strain filed July 2012. The MCAN included all available information to enable a risk assessment for the strain.  EPA completed its review Fall 2012, concluded that the use of the strain at Hobbs facility is unlikely to present unreasonable risk.  Consent Order signed July 2013, allows use of the strain at Hobbs under specified conditions, with certain additional testing, monitoring and reporting required.  Additional MCANs will be needed for improvements to the strain. ©2013 Joule. Rights Reserved.D. Glass Associates, Inc.
  • EPA TSCA Biotechnology Rule: Summary  Algae and cyanobacteria covered under the rule; EPA has recent experience with MCANs and TERAs for algae and cyanobacteria.  MCAN reviews for contained manufacturing have been straightforward; EPA has recent track record reviewing microorganisms for use in biofuels, bio- based chemical production.  The TERA process provides a stepwise approach to regulation and risk assessment of outdoor uses. D. Glass Associates, Inc.
  • USDA Biotechnology Regulations (1)  Regulations issued in 1987, administered by USDA Animal and Plant Health Inspection Service (APHIS).  Regulations cover environmental uses or interstate movement of organisms considered to be “potential plant pests”.  Potential plant pest status is based on presence of DNA sequences from listed potential plant pests. Inclusion of Agrobacterium on the list has captured most transgenic plants.  Most submissions have been for transgenic plants, some for modified agricultural microorganisms. D. Glass Associates, Inc.
  • USDA Biotechnology Regulations (2)  Rules have generally not covered “contained” use of organisms in manufacturing, but could cover open- pond uses.  Applicability to algae under current definitions not clear; most algae strains would not be covered unless engineered to contain DNA from potential plant pest. D. Glass Associates, Inc.
  • USDA Biotechnology Regulation: Oversight over R&D  R&D use covered only if in open environment.  Notifications: 30 day advance notice.  Permits: submit application 120 days in advance.  Permits generally required for industrial uses.  Submissions require:  Description of host organism and genetic modifications.  Description of field test; proposed procedures and controls.  Assess environmental impact of field use. D. Glass Associates, Inc.
  • USDA Biotechnology Regulation: Approvals for Commercial Use  Approval for commercial use and sale through “petitions for nonregulated status”.  Since early 1990s, USDA has approved over 100 petitions to allow commercial sale of engineered crop plants.  Commercial approvals can take 1-4 years, and require USDA to prepare Environmental Impact Statements. D. Glass Associates, Inc.
  • USDA Biotechnology Regulation: Summary  Tens of thousands of transgenic plant field tests approved under these regulations, over 100 modified crop varieties approved for commercial sale – no approvals for algae?  Limited experience with R&D permits for novel biofuel feedstocks, no commercial approvals.  USDA likely to have scientific expertise to review biology of photosynthetic algae, but applicability under existing definitions unclear. D. Glass Associates, Inc.
  • International Biotechnology Regulation  Most countries around the world have biotechnology regulations, in most cases based on principles of the Cartagena Protocol on Biosafety.  These countries differ from the U.S. in having unified laws and regulations that cover all genetically modified organisms.  However, principles of risk assessments for algae and microorganisms should be similar throughout the world. D. Glass Associates, Inc.
  • Scientific Issues in the Regulation of GM Algae (1) Legitimate scientific issues need to be addressed for many projects involving modified algal strains.  Stability of vector and introduced genes.  Possible deleterious functions encoded by transgene(s) such as algal toxins.  Potential for horizontal gene transfer, crossing to wild algae species. D. Glass Associates, Inc.
  • Scientific Issues in the Regulation of GM Algae (2)  Potential for engineered strain to be transported outside facility, survive and compete in environment.  Potential persistence in the environment: soil or water in vicinity of site of use.  Potential disruption of natural ecosystems or native algae populations.  Creation or enhancement of harmful algal blooms or ecologically disruptive algal blooms. D. Glass Associates, Inc.
  • Research Needs for GM Algae Risk Assessment (contained research)  Basic research into biology, ecology, natural history of commercially-relevant wild type algae strains.  Basic research addressing key regulatory concerns: gene transmissibility, survival, persistence in environment, genetics of algal toxin production.  Laboratory, microcosm and macrocosm studies to model behavior of modified species in the environment. D. Glass Associates, Inc.
  • Research Needs for GM Algae Risk Assessment (controlled field tests)  Stepwise field studies with GM strains, carried out under regulatory auspices, e.g. EPA TERA process.  Conduct and monitor small-scale field tests of modified algae in open ponds: develop database addressing dispersal, environmental persistence, etc.  Create a role for USDA and academic investigators in EPA review of commercial uses of GM algae.  Government support for field research: utilize DOE national labs, other government facilities as field test sites? D. Glass Associates, Inc.
  • Impact of Biotechnology Regulations  Efforts to promote interagency cooperation and the participation of the research community, are important to ensure a science-based regulatory framework.  The existing biotech regulatory framework provides a straightforward path to commercial approval, with many prior successes in agricultural, industrial biotechnology.  The regulatory process can be successfully managed with proper advance planning. D. Glass Associates, Inc.
  • Thank you very much David J. Glass, Ph.D. D. Glass Associates, Inc. 124 Bird Street Needham, MA 02492 Phone 617-653-9945 dglass@dglassassociates.com www.dglassassociates.com D. Glass Associates, Inc.