Post on 25-Apr-2018
Environmental Risk Assessment and Biosafety
of
Genetically Modified Algae and Cyanobacteria
Tomal Dattaroy
Lead – Regulatory Affairs, Biology
Reliance Industries Limited
Navi Mumbai, India
Co-Authors: Ajit Sapre, Santanu Dasgupta, Pranesh Badami, Kannadasan Kaliyamoorthy
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DISCLAIMER
Any statement, opinion, prediction, comment, or observation made in this
presentation/publication are those of the presenter/author only and in no condition
should be construed necessarily representing the policy and intent of Reliance
Industries Ltd. (RIL).
The information presented herein are of the presenter/author’s own and in no way
RIL attracts any liability for any inconsistency or irregularity in terms of the accuracy
completeness, veracity, or truth of the content of the presentation/publication. In
addition, RIL shall not be liable for any copyright infringement and
misrepresentation for the presented content as the content is presumed in good
faith to be a creation of presenter’s/author’s own mind.
The scope of this presentation/publication is strictly for knowledge sharing
purposes and not necessarily to provide any advice or recommendation to the
audience/readers. Any endorsement, recommendation, suggestion, or advice made
by the presenter/author shall be in his personal capacity and not in professional
capacity as an employee of RIL. Any person acting on such endorsement,
recommendation, suggestion, or advice will himself/herself be responsible for any
injury/damage.
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Dhirubhai H. AmbaniFounder Chairman Reliance Group
• 1966- Establishes Textile mill in Naroda
• 1977- Public share offering Raised money from public
offerings oversubscribed 7X
• 1982- Builds fiber/filament plant in Patalganga
• 1995- Builds Polyolefin plants at Hazira
• 1997- Builds multi-feed cracker at Hazira
• 1999- Builds Jamnagar refinery
• 2002- Acquired IPCL a state run company
• 2008- Builds JERP refinery at Jamnagar
• 2009- Begins KG D6 gas production
• 2013- Builds PBR/SBR plants at Hazira
• 2014- Builds PTA plant at Dahej
• 2014- Builds PET plant at Dahej
• 2015- Commissioning of PTA plant at Dahej
• 2017- Jio, 4G Network launched revolutionizing India’s
telecom system
Reliance Industries Limited - brief introduction
© Reliance Industries Ltd., 2017
4RIL: A significant commitment to renewables R&D, major focus on advanced biotechnology
Large number of scientists and engineers working in India, trained in the best institutions globally
International collaborations with top notch institutions, leveraging talent of additional Two hundred scientists and engineers
Solutions for the entire spectrum of landmass
Barren land: Algae (use sea-water and desert land at coastline)
Marginal land: Jatropha (develop high yield varieties in low rainfall areas)
Fertile land: Surplus agri-residue (at least 100 MM MTpa biomass resulting in 25 MM MTpa biofuel)
Adopt Indian Prime Minister’s triple S Philosophy: Skill, Scale and Speed for these challenging problems
Algae oil
RIL committed to largest cutting-edge R&D program by any private enterprise to help India
leap-frog
Agri-residue to kerosene Jatropha to bio-diesel Algae to bio-crude
© Reliance Industries Ltd., 2017
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Three Pillars for Algal Biology
COLLECTION
Strategically collect strains
to create a unique
germplasm collection
DOMESTICATION
Using precision culture and
growth method, create optimum
growth and produce in laboratory
and outdoor
MODIFICATION
Supplement
domestication
advancements by adding
special beneficial genes
to the algae or mutation
ALL THREE ARE CRITICAL IN DELIVERING THE IDEAL STRAIN
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Renewed Focus on Algae and Cyanobacteria as well as
New Tools Open Up Newer Vistas
Absence of a defined regulatory framework worldwide for genetically modified algae makes
it even more pertinent today to brainstorm for developing the tools required for the same
Harnessing sunlight for photosynthesis
places this broad class of microorganisms
among the best options for renewable
sources for these industries
Renewed Explorations for
benefits to food, feed and
fuel sectors
Depleting fossil fuel and
agricultural land
resources as well as a
burgeoning population,
these organisms offer a
very unique advantage
Synthetic biology and
gene editing processes
such as CrispR-Cas9 and
TALENs open up exciting
prospects for deriving
these benefits optimally
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Exploiting Biotechnology and Chemical
engineering for the production of Algal Biofuels
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Regulatory
approval to
work with
natural living
resources
RIL validated &
optimized strains
Developing pioneering algae biotechnology to
overcome nature’s constraints
Improved
biomass
productivity
Application of cutting edge advanced biotechnology shows enormous potential to meet
commercial targets
Regulatory
approval to
work with GM
organism
Enhanced
Photosynthesis
Cell
regulations
Improved
Stress
tolerance
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Increased Biomass productivity is the key
Synthetic biology to improve strain
Cultivation optimization
Optimized light Management
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Increasing biomass productivity in algae: Complex and diverse scientific challenge
Light
• Intensity
• Penetration
• Absorption
• Wavelength
Photosynthetic
machinery
• Spectral Expansion
• Spectral quality
• Antennae reduction
• Photosystem repair
• Redox modulation
• Electron flow
modulation
CO2
• Concentration
• Transport
• Assimilation
• Fixation
Energy
• Conversion
Efficiency
• Biomass
productivity
Cell Division
• Biological clock
Manipulation
• Cell Cycle
analysisBiotic
Stresses
High
Light
Salinity
Hot
Cold
pH
Low
Light
© Reliance Industries Ltd., 2017
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One of the Must-Win Battles in Any Algal Biotechnology Research
Centres Around Regulatory Matters
Complex governmental procedures for import and export of live algae
Regulatory Challenges for Algal Biotechnology
Challenges Are:
Collecting germplasm with appropriate permits issued timely
Evolving a simple, easy-to-follow set of guidelines and regulations for
environmental release of algae modified through genetic manipulation
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India Regulatory Framework for GMO:Key players- Current
Ministry of Environment, Forests & Climate Change (MoEFCC)
– Responsible for the manufacture, import, use, research, and commercialization of GMO’s under ‘Rules 1989’ (EPA Act, 1986)
– GEAC: Genetic Engineering Appraisal Committee (31+ members)
Large Scale trial approvals and Environmental release recommendation
Ministry of Science Technology- Department of Biotechnology (DBT)
– Responsible for guidelines for the safety evaluation of GMO
– RCGM: Review Committee on Genetic Manipulation (28+ members)
• Transgenic import for research, Research trial approvals, safety studies
Ministry of Agriculture- Indian Council of Agricultural Research (ICAR)
© Reliance Industries Ltd., 2017
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Collection of Bioresources and Exchange with Overseas Collaborators
India – A Party to the Convention on Biological Diversity (CBD) (1992).
Recognizing the sovereign rights of States to use their own biological
resources, CBD expects the Parties to facilitate access to genetic
resources by other Parties subject to national legislation and on
mutually agreed upon terms (Article 3 and 15 of CBD).
The Biological Diversity Act, 2002 (Biological Diversity Rules, 2004) is
as per CBD Guidelines
Collection of germplasm from Indian coastline, export of strains to
overseas collaborators and filing of IP using the germplasm need
clearances required from the National Biodiversity Authority (NBA),
Ministry of Environment, Forests & Climate Change (MoEFCC)
The NBA needs to redefine bioresources as
“non-renewable” for endangered species
and
“renewable” for microorganisms like algae and cyanobacteria
© Reliance Industries Ltd., 2017
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Regulatory Challenges for Algal Biotechnology
In India, import of wild type strains needs a clearance from the Directorate of Plant
Protection, Quarantine & Storage (PPQS), Ministry of Agriculture
Classifies all algae as agricultural pests/pathogens!
Regulated by Plant Quarantine (Regulation of Import into India) Order, 2003 (revised
guidelines 2015) issued under the Destructive Insects & Pests Act, 1914
Absence of a defined regulatory framework for algal biotechnology is a challenge
Requirements of elaborate studies result in increasing the project costs and time; these
requirements prescribed are not consistent and uniform due to the absence of a defined
set of guidelines
Consequently, there are inordinate delays in receiving strains from overseas
collaborators and start of projects
© Reliance Industries Ltd., 2017
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Algal movement is inevitable and
unavoidable (both from open pond
cultivations as well as, to a
relatively much lesser extent, from
contained photobioreactors)
Algae are always in a state of flux
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Spread from Open Ponds
AEROSOLIZATION
PADDLE WHEEL WIND
LOCAL FAUNA
NATURAL DISASTERS
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Spread from Contained PBRs
Spillage
Human Error
Entrapment in channels and O-rings
Natural Disasters
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Paradox of the Plankton
Large numbers of species with varying degrees of
fitness co-exist in natural ecosystems in an
unpredictable, fluctuating species balance
Hutchinson, G. E. (1961) The American Naturalist, 95 (882):137-145
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Conceptual Flow Chart for Environmental Risk
Problem Formulation for Escaping GM Algae
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Algae modified through genetic manipulation need to go through complex regulations for
environmental release
Recombinant DNA Safety Guidelines
Greenhouse and PBR facility design for
compliance with the biosafety guidelines
Proof-of-concept experiments using wild type
strains to test their ability to spread and persist
in environment
Data from these experiments will help
formulating guidelines for biosafety
experiments using recombinant algae
GEAC (MoEFCC) Approval
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Driving regulatory framework for algae
The Regulatory Framework for Algal Biofuels is Nascent and Evolving
A Focused and Engaged Dialogue Among All Stakeholders in Industry, Academia
and Government Regulatory Bodies is Needed
US EPA initiated deliberations on risk assessment of GM algae
OECD has published guidelines highlighting GM algae need & risk assessment
In India, a core special interest group is working on opinion building
RIL has taken a major initiative in these opinion building exercises
Recommendations submitted to different government regulatory agencies
RCGM, DBT is working on draft guidelines on biosafety of GM microorganisms which will cover
algae and cyanobacteria
Steering through regulatory challenges
National Biodiversity Authority: Received approval for FTO
PPQS: Strain import, process modified based on RIL input
IBSC/RCGM: All recombinant research at RIL approved
RIL has initiated proof-of-concept experiments on dispersal, invasiveness and persistence of
algal strains in the environment for future field trials
Inputs to frame Regulatory guidelines as an opportunity to pioneer the cause of developing a
regulatory framework for algae
The key to the success of any biofuels effort is a conducive regulatory climate
© Reliance Industries Ltd., 2017
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In 2013, EPA approved an open pond trial of a genetically modified Scenedesmus
conducted by Sapphire Energy within the UCSD campus
[Szyjka, et al (2017) Evaluation of phenotype stability and ecological risk of a genetically
engineered alga in open pond production. Algal Research,
http://dx.doi.org/10.1016/j.algal.2017.04.006]
Precedence of Open Pond Trial of GM Algae
and
Associated Challenges
Trials need to be dealt with caution
Misinformed activism assisted by electronic social media as well
as the press can be detrimental to progress of a worthy cause
© Reliance Industries Ltd., 2017
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Algal research and associated Regulatory framework – a comparatively new field
Major learnings from plant research can be taken to formulate one
Bottlenecks anticipated due to the worldwide absence of regulatory framework for algae
More regulatory science based experiments to be carried out for GM algae to anticipate
and mitigate environmental hazard associated with it
Genetically modified algae currently can be grown in closed bioreactors or green houses
till the time adequate information available regarding their spread or effect on the native
ecosystem if cultivated outdoors.
Algae and Cyanobacteria either need to be classified as a “crop” (as done with legislations
in Ohio, Arizona and Iowa) OR as an economically useful microbe (e.g., yeast for brewing)
Summarized Recommendations of Different Panels
Opinion Building Among Key Stakeholders in India
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Regulatory implications are much more complex for
R&D with living organisms
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Thank You
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