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David J. Glass, Ph.D.
D. Glass Associates, Inc.
 International Biotechnology Regulation
◦ Risk Assessment Issues
◦ Regulatory Frameworks
 Case Studies
◦ United States
◦ Europe
◦ Brazil
 Discussion (time permitting)
◦ Is there a need for a common regulatory approach?
◦ Is there a need for a common risk assessment
framework?
D. Glass Associates, Inc.
Risk assessment of industrial uses of microorganisms
have been based on familiar principles.
 Does the organism have harmful or deleterious
properties, e.g. toxicity, pathogenicity, enhanced
competitiveness?
 Have these properties been altered by the genetic
manipulations?
 If released to the environment, will the organism
survive, multiply, compete and disseminate in the
environment?
 Horizontal gene transfer: can genetic material be
transferred to indigenous organisms?
 Will any of the above cause adverse ecological effects?
D. Glass Associates, Inc.
 Many national laws are based on the principles of
the Cartagena Protocol on Biosafety, part of the
Convention on Biological Diversity, which was
adopted in January 2000.
 Under such laws, government approvals are
generally needed for importation of Living Modified
Organisms (LMOs) into countries, and for many
industrial activities including “contained uses” or
“environmental uses”.
 Such approvals may often require a risk
assessment of the LMO and its proposed use.
D. Glass Associates, Inc.
 Transboundary shipment usually requires “Advanced
Informed Agreements” (AIAs) with competent
national authority.
 Article 3 defines “contained use”.
"Contained use" means any operation, undertaken within a facility,
installation or other physical structure, which involves living
modified organisms that are controlled by specific measures that
effectively limit their contact with, and their impact on, the
external environment.
 Transboundary shipments of LMOs for contained
use don’t require AIA if undertaken in compliance
with applicable national law; labeling requirements
may apply.
D. Glass Associates, Inc.
 Ascertain “competent authority” in destination country.
 Shipment into country and subsequent contained use may
require permits from competent authority.
 If country has no applicable biotech laws or regulations,
ensure that competent authority is aware of shipment of
LMO into country.
 May also need to provide a risk assessment (e.g.
conducted by an agency of another government) and
proof that the manufacturing process is “contained”.
 Risk assessment and other required information should
be provided in accordance with Annexes I and III of the
Protocol.
D. Glass Associates, Inc.
D. Glass Associates, Inc.
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, animal feed, feed additives.
 Pharmaceuticals.
D. Glass Associates, Inc.
 Regulations adopted in 1997 under the Toxic Substances
Control Act (TSCA) cover commercial uses of new
(“intergeneric”) microorganisms not regulated by other
agencies: primary rules covering industrial biotechnology.
 R&D: No oversight for contained activities; advance EPA
approval needed for outdoor research (TSCA Experimental
Release Application; TERA).
 Commercial Uses: Advance EPA review needed for most
commercial applications through filing of Microbial Commercial
Activity Notice (MCAN). Exemptions for well-understood
industrial host species, e.g. E. coli, S. cerevisiae require strict
adherence to containment provisions.
D. Glass Associates, Inc.
 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. Most MCANs reviewed and cleared
within 90 day review period.
D. Glass Associates, Inc.
 At least 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.
 Four filed MCANs for cyanobacteria; 4 filed MCANs
for modified microalgae.
 Complete list available at
www.epa.gov/biotech_rule/pubs/submiss.htm.
D. Glass Associates, Inc.
D. Glass Associates, Inc.
Case Study
Joule Unlimited MCAN for Ethanol-Producing
Cyanobacteria
D. Glass Associates, Inc.
 Joule’s modified biocatalysts for ethanol production are
considered “new microorganisms” under EPA’s TSCA
biotechnology regulations (40 CFR Part 725):
◦ The modified organisms include coding sequences from outside
the Synechococcus genus and are considered “intergeneric”.
◦ The intended commercial use is for a purpose not regulated by
any other federal agency.
 First biocatalyst: modified strain of the cyanobacterium
Synechococcus for ethanol production.
 Laboratory, pilot and some demo plant activities qualify for
the “contained structure” (R&D) exemption.
 Commercial use requires filing a Microbial Commercial
Activity Notice (MCAN) at least 90 days before commercial
use.
D. Glass Associates, Inc. 14
 Plan was to file first MCAN well in advance of
anticipated start of commercial use.
 Early presubmission meeting with EPA staff (2011).
 First MCAN for commercial ethanol production
strain (MCAN Number J12-0006) filed July 2012.
 Short-term goal was to gain approval to use this
strain commercially at Joule’s Demonstration Plant
in Hobbs, New Mexico.
 EPA completed its review Fall 2012, began drafting
Consent Order that would allow use of strain at
Hobbs under specified conditions.
 Consent Order signed July 2013.
D. Glass Associates, Inc. 15
 Minimal concerns for adverse human health effects, and
minimal concerns for ecological effects from use in ethanol
production.
 Introduced genes unlikely to pose potential hazards.
 Potential for horizontal gene transfer is expected to be low.
 Survival of the MCAN strain in Hobbs soil is expected to be
low in the event of breach of containment.
 EPA was unwilling to extend approval to locations other than
Hobbs, pending additional data on MCAN strain survival in
other environments; so EPA required Joule to enter into a
Consent Order limiting approved uses to Hobbs.
 Certain testing and data are required to allow an assessment
of commercial use at sites other than Hobbs.
D. Glass Associates, Inc. 16
D. Glass Associates, Inc.
 Oversight under national laws adopted by EU
member states based on binding EU Directives.
 Contained manufacturing: Contained uses of LMO
microorganisms require national government
notification under EU “Contained Use” Directive
2009/41/EC.
 Open Ponds and Transgenic Plants: Uses of LMOs
in the open environment would be covered by EU
Directive 2001/18/EC on “Environmental Release”.
D. Glass Associates, Inc.
 “Contained Use” defined:
“contained use” means any activity in which microorganisms are
genetically modified or in which such GMMs are cultured, stored,
transported, destroyed, disposed of or used in any other way,
and for which specific containment measures are used to limit
their contact with, and to provide a high level of safety for, the
general population and the environment
 User has obligation to carry out risk assessment and
choose a level of containment appropriate for the risks
of the organism.
 User must notify competent national authority, and
provide data and information specified in directive and
under the applicable national law.
D. Glass Associates, Inc.
 Approval for contained uses of GMOs would
come from applicable EU member state.
 The national laws and regulations of
individual EU member states may have
stricter requirements; permits or approvals
may be needed for industrial uses.
 Applicants should identify national authority
in countries of interest, obtain copies of laws
and regulations.
 Early consultation with regulatory agencies in
individual countries is recommended.
D. Glass Associates, Inc.
Case Study
ThyssenKrupp Industrial Solutions AG
Process Technologies, Germany
Applying Myriant`s E.coli KJ122 for Succinic
Acid Production
D. Glass Associates, Inc.
 Signatory to Cartagena Protocol.
 National Biosafety Law adopted in 2005;
regulations under the law also adopted in 2005.
 Created national framework administered by two
interagency committees: CTNBio and CNBS.
 Applications would need to be submitted to
government for approval for importation of GMO,
use in a laboratory or facility, and use in
manufacturing.
 There are now 6 approvals for contained
industrial manufacturing using GMOs.
D. Glass Associates, Inc.
The following commercial approvals of GM microorganisms
are listed on the CTNBio website
 Amyris, Saccharomyces cerevisiae CEPA Y1979, February
2010; S. cerevisiae CEPA Y5056, May 2012, both
expressing Artemisia annua farnesene synthase for
production of farnesene.
 Solazyme, Prototheca moriformis for production of
triglycerides, October 2013; September 2014.
 Bio Celere Agroindustrial Ltda., Saccharomyces cerevisiae
RN 1016 (Royal Nedalco strain, Piromyces xylA xylose
isomerase) for production of ethanol, December 2013;
November 2014.
D. Glass Associates, Inc.
Case Study
Comments on Amyris Experience in Brazil
D. Glass Associates, Inc.
D. Glass Associates, Inc.
Risk assessment of industrial uses of microorganisms
have been based on familiar principles.
 Does the organism have harmful or deleterious
properties, e.g. toxicity, pathogenicity, enhanced
competitiveness?
 Have these properties been altered by the genetic
manipulations?
 If released to the environment, will the organism
survive, multiply, compete and disseminate in the
environment?
 Horizontal gene transfer: can genetic material be
transferred to indigenous organisms?
 Will any of the above cause adverse ecological effects?
D. Glass Associates, Inc.
(a) Recipient organism or parental organisms. The biological
characteristics of the recipient organism or parental organisms.
(b) Donor organism or organisms. Taxonomic status and relevant
biological characteristics of the donor organisms.
(c) Vector. Characteristics of the vector, including its source or origin,
and its host range.
(d) Inserts and/or characteristics of modification. Genetic characteristics
of the inserted nucleic acid and the function it specifies.
(e) Living modified organism. Identity of the LMO, and the differences
from the recipient organism or parental organisms.
(f) Detection and identification of the living modified organism.
Suggested detection and identification methods.
(g) Information relating to the intended use.
(h) Receiving environment. location, geographical, climatic and ecological
characteristics of the likely potential receiving environment.
D. Glass Associates, Inc.
Containment principles for industrial manufacturing with
modified microorganisms are well known.
Use well-established principles of Good Laboratory
Practice, Good Large-Scale Practice, commensurate with
Risk Group of the host organism. Practices to include:
 Controlled access to facility.
 Inactivation of liquid and solid wastes.
 Minimize release from air vents (e.g. HEPA filters), other
potential release points.
 Institute spill control procedures and other emergency
protocols.
 Worker training in proper microbiological techniques and
emergency procedures.
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)
D. Glass Associates, Inc.
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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Challenges and Opportunities in Industrial Biotech Regulation

  • 1. David J. Glass, Ph.D. D. Glass Associates, Inc.
  • 2.  International Biotechnology Regulation ◦ Risk Assessment Issues ◦ Regulatory Frameworks  Case Studies ◦ United States ◦ Europe ◦ Brazil  Discussion (time permitting) ◦ Is there a need for a common regulatory approach? ◦ Is there a need for a common risk assessment framework? D. Glass Associates, Inc.
  • 3. Risk assessment of industrial uses of microorganisms have been based on familiar principles.  Does the organism have harmful or deleterious properties, e.g. toxicity, pathogenicity, enhanced competitiveness?  Have these properties been altered by the genetic manipulations?  If released to the environment, will the organism survive, multiply, compete and disseminate in the environment?  Horizontal gene transfer: can genetic material be transferred to indigenous organisms?  Will any of the above cause adverse ecological effects? D. Glass Associates, Inc.
  • 4.  Many national laws are based on the principles of the Cartagena Protocol on Biosafety, part of the Convention on Biological Diversity, which was adopted in January 2000.  Under such laws, government approvals are generally needed for importation of Living Modified Organisms (LMOs) into countries, and for many industrial activities including “contained uses” or “environmental uses”.  Such approvals may often require a risk assessment of the LMO and its proposed use. D. Glass Associates, Inc.
  • 5.  Transboundary shipment usually requires “Advanced Informed Agreements” (AIAs) with competent national authority.  Article 3 defines “contained use”. "Contained use" means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.  Transboundary shipments of LMOs for contained use don’t require AIA if undertaken in compliance with applicable national law; labeling requirements may apply. D. Glass Associates, Inc.
  • 6.  Ascertain “competent authority” in destination country.  Shipment into country and subsequent contained use may require permits from competent authority.  If country has no applicable biotech laws or regulations, ensure that competent authority is aware of shipment of LMO into country.  May also need to provide a risk assessment (e.g. conducted by an agency of another government) and proof that the manufacturing process is “contained”.  Risk assessment and other required information should be provided in accordance with Annexes I and III of the Protocol. D. Glass Associates, Inc.
  • 8. 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, animal feed, feed additives.  Pharmaceuticals. D. Glass Associates, Inc.
  • 9.  Regulations adopted in 1997 under the Toxic Substances Control Act (TSCA) cover commercial uses of new (“intergeneric”) microorganisms not regulated by other agencies: primary rules covering industrial biotechnology.  R&D: No oversight for contained activities; advance EPA approval needed for outdoor research (TSCA Experimental Release Application; TERA).  Commercial Uses: Advance EPA review needed for most commercial applications through filing of Microbial Commercial Activity Notice (MCAN). Exemptions for well-understood industrial host species, e.g. E. coli, S. cerevisiae require strict adherence to containment provisions. D. Glass Associates, Inc.
  • 10.  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. Most MCANs reviewed and cleared within 90 day review period. D. Glass Associates, Inc.
  • 11.  At least 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.  Four filed MCANs for cyanobacteria; 4 filed MCANs for modified microalgae.  Complete list available at www.epa.gov/biotech_rule/pubs/submiss.htm. D. Glass Associates, Inc.
  • 13. Case Study Joule Unlimited MCAN for Ethanol-Producing Cyanobacteria D. Glass Associates, Inc.
  • 14.  Joule’s modified biocatalysts for ethanol production are considered “new microorganisms” under EPA’s TSCA biotechnology regulations (40 CFR Part 725): ◦ The modified organisms include coding sequences from outside the Synechococcus genus and are considered “intergeneric”. ◦ The intended commercial use is for a purpose not regulated by any other federal agency.  First biocatalyst: modified strain of the cyanobacterium Synechococcus for ethanol production.  Laboratory, pilot and some demo plant activities qualify for the “contained structure” (R&D) exemption.  Commercial use requires filing a Microbial Commercial Activity Notice (MCAN) at least 90 days before commercial use. D. Glass Associates, Inc. 14
  • 15.  Plan was to file first MCAN well in advance of anticipated start of commercial use.  Early presubmission meeting with EPA staff (2011).  First MCAN for commercial ethanol production strain (MCAN Number J12-0006) filed July 2012.  Short-term goal was to gain approval to use this strain commercially at Joule’s Demonstration Plant in Hobbs, New Mexico.  EPA completed its review Fall 2012, began drafting Consent Order that would allow use of strain at Hobbs under specified conditions.  Consent Order signed July 2013. D. Glass Associates, Inc. 15
  • 16.  Minimal concerns for adverse human health effects, and minimal concerns for ecological effects from use in ethanol production.  Introduced genes unlikely to pose potential hazards.  Potential for horizontal gene transfer is expected to be low.  Survival of the MCAN strain in Hobbs soil is expected to be low in the event of breach of containment.  EPA was unwilling to extend approval to locations other than Hobbs, pending additional data on MCAN strain survival in other environments; so EPA required Joule to enter into a Consent Order limiting approved uses to Hobbs.  Certain testing and data are required to allow an assessment of commercial use at sites other than Hobbs. D. Glass Associates, Inc. 16
  • 18.  Oversight under national laws adopted by EU member states based on binding EU Directives.  Contained manufacturing: Contained uses of LMO microorganisms require national government notification under EU “Contained Use” Directive 2009/41/EC.  Open Ponds and Transgenic Plants: Uses of LMOs in the open environment would be covered by EU Directive 2001/18/EC on “Environmental Release”. D. Glass Associates, Inc.
  • 19.  “Contained Use” defined: “contained use” means any activity in which microorganisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment  User has obligation to carry out risk assessment and choose a level of containment appropriate for the risks of the organism.  User must notify competent national authority, and provide data and information specified in directive and under the applicable national law. D. Glass Associates, Inc.
  • 20.  Approval for contained uses of GMOs would come from applicable EU member state.  The national laws and regulations of individual EU member states may have stricter requirements; permits or approvals may be needed for industrial uses.  Applicants should identify national authority in countries of interest, obtain copies of laws and regulations.  Early consultation with regulatory agencies in individual countries is recommended. D. Glass Associates, Inc.
  • 21. Case Study ThyssenKrupp Industrial Solutions AG Process Technologies, Germany Applying Myriant`s E.coli KJ122 for Succinic Acid Production
  • 23.  Signatory to Cartagena Protocol.  National Biosafety Law adopted in 2005; regulations under the law also adopted in 2005.  Created national framework administered by two interagency committees: CTNBio and CNBS.  Applications would need to be submitted to government for approval for importation of GMO, use in a laboratory or facility, and use in manufacturing.  There are now 6 approvals for contained industrial manufacturing using GMOs. D. Glass Associates, Inc.
  • 24. The following commercial approvals of GM microorganisms are listed on the CTNBio website  Amyris, Saccharomyces cerevisiae CEPA Y1979, February 2010; S. cerevisiae CEPA Y5056, May 2012, both expressing Artemisia annua farnesene synthase for production of farnesene.  Solazyme, Prototheca moriformis for production of triglycerides, October 2013; September 2014.  Bio Celere Agroindustrial Ltda., Saccharomyces cerevisiae RN 1016 (Royal Nedalco strain, Piromyces xylA xylose isomerase) for production of ethanol, December 2013; November 2014. D. Glass Associates, Inc.
  • 25. Case Study Comments on Amyris Experience in Brazil D. Glass Associates, Inc.
  • 27. Risk assessment of industrial uses of microorganisms have been based on familiar principles.  Does the organism have harmful or deleterious properties, e.g. toxicity, pathogenicity, enhanced competitiveness?  Have these properties been altered by the genetic manipulations?  If released to the environment, will the organism survive, multiply, compete and disseminate in the environment?  Horizontal gene transfer: can genetic material be transferred to indigenous organisms?  Will any of the above cause adverse ecological effects? D. Glass Associates, Inc.
  • 28. (a) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms. (b) Donor organism or organisms. Taxonomic status and relevant biological characteristics of the donor organisms. (c) Vector. Characteristics of the vector, including its source or origin, and its host range. (d) Inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies. (e) Living modified organism. Identity of the LMO, and the differences from the recipient organism or parental organisms. (f) Detection and identification of the living modified organism. Suggested detection and identification methods. (g) Information relating to the intended use. (h) Receiving environment. location, geographical, climatic and ecological characteristics of the likely potential receiving environment. D. Glass Associates, Inc.
  • 29. Containment principles for industrial manufacturing with modified microorganisms are well known. Use well-established principles of Good Laboratory Practice, Good Large-Scale Practice, commensurate with Risk Group of the host organism. Practices to include:  Controlled access to facility.  Inactivation of liquid and solid wastes.  Minimize release from air vents (e.g. HEPA filters), other potential release points.  Institute spill control procedures and other emergency protocols.  Worker training in proper microbiological techniques and emergency procedures. D. Glass Associates, Inc.
  • 30. 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) D. Glass Associates, Inc.
  • 31. 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.