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David J. Glass, Ph.D.
D. Glass Associates, Inc.
BIO World Congress on Industrial Biotechnology
July 20, 2015
Advanced Biotechnology can
Improve Usefulness of Algae
 Enhance algal growth rate.
 Enhance or alter lipid biosynthesis....
Overview of U.S. Biotechnology
Regulation
Environmental Protection Agency
 Microbial pesticides, plant pesticides.
 Engi...
Regulatory Jurisdiction for
Engineered Algae
 Proposed use of engineered algae by Mera
Pharmaceuticals in pharmaceutical ...
EPA TSCA Biotechnology
Regulations (1)
 Regulations adopted in 1997 under the Toxic Substances
Control Act (TSCA) cover c...
EPA TSCA Biotechnology
Regulations (2)
EPA considers scope of coverage to include algae.
From the biotechnology rule:
“Mic...
EPA TSCA Biotechnology
Regulations (3)
 Commercial use or importation of intergeneric organism
requires 90 day advance no...
EPA TSCA Biotechnology Rule:
TSCA Experimental Release Applications
 TERAs submitted to EPA 60 days in advance, describin...
EPA TSCA Biotechnology Rule:
TSCA Experimental Release Applications
 Sapphire TERAs covered open-pond research at UCSD us...
EPA TSCA Biotechnology Rule: Microbial
Commercial Activity Notifications (MCANs)
 MCAN reporting required at least 90 day...
EPA TSCA Biotechnology Rule:
Biofuel, Bio-Based Chemical MCANs
 Approx. 85 MCANs filed since 1997. Number and
frequency h...
D. Glass Associates, Inc.
0
5
10
15
20
25
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 ...
EPA TSCA Biotechnology Rule:
Summary
 Algae and cyanobacteria covered under the rule;
EPA has recent experience with MCAN...
USDA Biotechnology
Regulations (1)
 Regulations issued in 1987, administered by USDA
Animal and Plant Health Inspection S...
USDA Biotechnology
Regulations (2)
 Rules have generally not covered “contained” use of
organisms in manufacturing, but c...
USDA Biotechnology Regulation:
Oversight over R&D
 R&D use covered only if in open environment.
 Notifications: 30 day a...
USDA Biotechnology Regulation:
Approvals for Commercial Use
 Approval for commercial use and sale through
“petitions for ...
USDA Biotechnology Regulation:
Summary
 Tens of thousands of transgenic plant field tests
approved under these regulation...
International Biotechnology
Regulation
 Most countries around the world have biotechnology
regulations, in most cases bas...
Pathway for approval:
Contained Use of GM Algae
D. Glass Associates, Inc.
Pathway for approval:
Open-Pond Use of GM Algae
D. Glass Associates, Inc.
D. Glass Associates, Inc.
Industrial Biotechnology,
April 2015
Volume 11, Number 2
Pages 71-83
DOI: 10.1089/ind.2015.1503
...
Thank you very much
David J. Glass, Ph.D.
D. Glass Associates, Inc.
124 Bird Street
Needham, MA 02492
Phone 617-653-9945
d...
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David Glass BIO World Congress Algae Regulation July 2015

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Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.

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David Glass BIO World Congress Algae Regulation July 2015

  1. 1. David J. Glass, Ph.D. D. Glass Associates, Inc. BIO World Congress on Industrial Biotechnology July 20, 2015
  2. 2. 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, Radakovits et al 2010, Jones et al. 2012, Larkum et al. 2012, Work et al. 2013 (and others). D. Glass Associates, Inc.
  3. 3. 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.
  4. 4. 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.
  5. 5. 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.
  6. 6. 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.
  7. 7. 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.
  8. 8. 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 with modified algae. D. Glass Associates, Inc.
  9. 9. EPA TSCA Biotechnology Rule: TSCA Experimental Release Applications  Sapphire TERAs covered open-pond research at UCSD using different modified strains of the photosynthetic green algae Scenedesmus dimorphus.  Goals: assess ecological impact; test field efficacy of strains shown effective in laboratory.  Among findings (J. Shurin, personal communication):  Modified algae can disperse and spread up to 50 meters away from the test site, but rate of dispersal declines with distance.  Both modified and wild-type algae grew in water from nearby lakes.  GM algae had no apparent effects on biomass, diversity, or native algae species.  GM Scenedesmus is ecologically indistinguishable from the wild-type strains. D. Glass Associates, Inc.
  10. 10. 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.
  11. 11. EPA TSCA Biotechnology Rule: Biofuel, Bio-Based Chemical MCANs  Approx. 85 MCANs filed since 1997. Number and frequency have increased in last 4-5 years.  Most early MCANs covered GMOs for production of industrial enzymes.  18 MCANs for S. cerevisiae, 3 for Zymomonas mobilis, all for ethanol production.  Joule, Algenol have filed MCANs for cyanobacteria; Solazyme has filed 4 MCANs for modified microalgae.  Complete list available at www.epa.gov/biotech_rule/pubs/submiss.htm. D. Glass Associates, Inc.
  12. 12. D. Glass Associates, Inc. 0 5 10 15 20 25 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Number of MCANs Fiscal Year MCANs Submitted to EPA by Fiscal Year
  13. 13. 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.
  14. 14. 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.
  15. 15. 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.
  16. 16. 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.
  17. 17. 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.
  18. 18. 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.
  19. 19. International Biotechnology Regulation  Most countries around the world have biotechnology regulations, in most cases based on principles of the Cartagena Protocol on Biosafety.  Many countries differ from the U.S. in having unified laws and regulations that cover all genetically modified organisms: no jurisdictional issues for algae.  However, principles of risk assessments for algae and microorganisms should be similar throughout the world. D. Glass Associates, Inc.
  20. 20. Pathway for approval: Contained Use of GM Algae D. Glass Associates, Inc.
  21. 21. Pathway for approval: Open-Pond Use of GM Algae D. Glass Associates, Inc.
  22. 22. D. Glass Associates, Inc. Industrial Biotechnology, April 2015 Volume 11, Number 2 Pages 71-83 DOI: 10.1089/ind.2015.1503 Additional information available at our blog, Advanced Biotechnology for Biofuels (dglassassociates.wordpress.com)
  23. 23. 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.

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