environmental risk assessment and biosafety of genetically modified algae...

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

2

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.

3

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


5

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


6

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


7

Exploiting Biotechnology and Chemical

engineering for the production of Algal Biofuels


8

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


http://www.google.co.in/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCIWJucH8m8gCFZAZjgod1LsERw&url=http://algae.illinois.edu/projects/Hydrothermal.html&psig=AFQjCNHIAoekD1BD6hNz3rDFAd3hWYY3og&ust=1443606697657919

http://www.google.co.in/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCIWJucH8m8gCFZAZjgod1LsERw&url=http://algae.illinois.edu/projects/Hydrothermal.html&psig=AFQjCNHIAoekD1BD6hNz3rDFAd3hWYY3og&ust=1443606697657919

9

Increased Biomass productivity is the key

Synthetic biology to improve strain

Cultivation optimization

Optimized light Management


10

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


11

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


12

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)


13

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


14

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


15

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


16

Spread from Open Ponds

AEROSOLIZATION

PADDLE WHEEL WIND

LOCAL FAUNA

NATURAL DISASTERS


17

Spread from Contained PBRs

Spillage

Human Error

Entrapment in channels and O-rings

Natural Disasters


18

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


19

Conceptual Flow Chart for Environmental Risk

Problem Formulation for Escaping GM Algae


20

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


21

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


22

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


23

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


24

Regulatory implications are much more complex for

R&D with living organisms


25

Thank You


environmental risk assessment and biosafety of genetically modified algae...

Documents