Environmental and Biosafety issues in modern Biotechnology


Oct 23, 2013 (4 years and 8 months ago)


Environmental and Biosafety issues

in modern Biotechnology

Dr Veena Chhotray, IAS

Senior Fellow, TERI


February, 2006

‘Biosafety’ means the need to
protect human and animal health
and environment from the possible
adverse effects of the products of
modern biotechnology


Environmentalism emerged as a distinct
development in the last forty years.

Emergence of “pressure groups” in the sixties

First Earth Day (1970)

The United Nations Conference on the Human
Environment and Development (1972)

The Brundtland Report: our Common Future

The Rio Earth Summit (1992)

Convention on Biodiversity (CBD) [1992]

Cartagena Protocol on Biosafety (CPB) [1993]

International Evolution

Convention of Biodiversity (CBD) [1992]

Focus: conservation and sustainable use of

Recognized the potential of modern biotechnology
for human well being

Took cognizance that
modern biotechnology
could have serious effects on
environment and

Article 8(g) emphasized the need to regulate the
risks associated with the use of LMOS.

Article 19(3) set the stage for a legally binding
international instrument about biosafety.

The Cartagena Protocol on Biosafety (CPB)

Entered into force on 29

December 1993

Focus on
transboundary movement of the

Seeks to lay down an internationally acceptable
framework to provide for an adequate level of
protection against the possible adverse affects of
LMOS on biodiversity and human health.

Basic Premises of CPB

“Advance Informed Agreement” between Parties

Decision on the basis of scientific risk

Precautionary Principle

How is
Genetic Engineering (GE)

from conventional breeding (CB)?

Combining DNA in new combinations and
introducing it into a new organism are the GE

Main differences between CB and GE

Ability to move
across sexual barriers

Amount of change: a specific gene embodying a
particular trait or thousands of genes embodying
desirable and undesirable traits

Occurrence of change in one or several generations.

Genetic engineering:Recombinant DNA technology

Two diametrically opposite trends of thought


No new risks associated with GM crops

New regulations not considered necessary

Safety assessments

‘Product’ rather than ‘process’ based

In comparison and contrast to their ‘familiarity’ and

substantial’ equivalence

to conventional crops

Is GE inherently unsafe?


GE crops considered new and special

Existing legislation not considered sufficient

Safety assessment

Process based

Principle of ‘substantial equivalence’ beginning rather than
the end

Adoption of ‘Precautionary Principle’ as guide

…Is GE inherently unsafe?

GE technology carries certain inherent unpredictability

Some facts

Isolation of a gene from its natural environment and
integration into entirely different organism

Possible transgenic instability due to triggering of the
inbuilt defense mechanisms of the host organism
leading to inactivation or silencing of foreign genes.

….Is GE inherently unsafe?

Possibilities of integration of foreign gene at a site
predisposed to silencing of genes (position effect).

Variance in the levels of expression of the
transgene in different environmental conditions
(heat, humidity, light…..)

Possibilities of silencing of genes arising in
subsequent generations

….Is GE inherently unsafe?

Case by case sound scientific

assessment is of utmost significance

Relate to environmental, human and animal health

Both can have short and long term implications

Biosafety risks involve the entire spectrum of biodiversity

A universal ‘true for all’ approach may not be applicable

Biosafety issues in transgenic crops

Known Probability

Unknown Probability


Rigorous Scientific Assessment

Risk Mitigation

Precautionary Principle

Biosafety concerns arise from:

Horizontal gene transfer

Genetic contamination

Transfer of allergens and toxins from one
life form to another and creation of new
toxins and allergenic compounds

..Biosafety issues in transgenic crops


Main Concerns

Development of
aggressive weeds
/ wild relatives by
transfer of transgenic traits

Erosion of land races
/wild relatives by genetic
pollution in centres of origin/ diversity

Harm to the
target organisms

Development of
pest resistance
by prolonged use


and limitations to farmers’ choice in
crop management

Hazard to human and animal health by transfer of
toxins and allergens

and by creation of new toxins
and allergenic compounds

..Biosafety issues in transgenic crops



GE venturing into an unknown biological

ASILOMAR Conference (1975): No research till
safety guidelines in place

Initially, focus on laboratory safety procedures

Wider definition of biosafety with possibilities of
commercialization of GM products

The broad format of biosafety parametres
essentially the same in all regulations

..Biosafety issues in transgenic crops

Two main stages:

Laboratory/green house stage

Confined Trial Stage


Prevention of the spread of genetically

engineered material outside lab/field

..Biosafety issues in transgenic crops

Laboratory/green house stage

Different biosafety levels as per the
degree of risk involved

Two methods of containment



A confined trial is a small scale release of a
transgenic plant species for research purposes
conducted under conditions that prevent spread
of the organism and mitigate its impact on the
surrounding environment

Objective is to collect data to evaluate the
crops’ performance

Confined Trial Stage

Risk mitigation

the terms and conditions that are
necessary to conduct the trial safely.

Prevent Gene Flow

Prevent entry of GMOs into food chain

Prevent Persistence of GMOs in the field

Focus on Risk Mitigation

pharmaceutical therapeutics

Biosafety risk

Survival, multiplication and dissemination of
GMOs in contained/ open environment

Interaction of GMOs with biological systems

Routes of dissemination: physical; biological

Risk depends upon

Nature of organism invovled

Extent of use of LMOs

End product LMO or not?

pharmaceutical therapeutics

Risk categorization of micro organisms:

determining factors

Capability to cause disease

Hazard to laboratory workers

Risk of spread to community

Availability of effective treatment

Health risks




Antibiotic resistance

pharmaceutical therapeutics

Environmental risks

Outcrossing between GMOs and pathogens

Negative effects on populations of non target

Risk assessment




Risk management and communication



Expressed proteins generally not a part of regular
food supply

Food complex mixtures e.g. nutrients, anti
nutrients and natural toxins

Directly enter human system

Assume different forms

Involve storage, processing, transportation

GM foods: need for safety assessment

Guidelines by Codex Alimentarius Commission

Assessment of possible allergenicity

Assessment of possible toxicity

Compositional analysis of key components

Food processing

Nutritional modification

.. Safety assessment of GM foods comprise

….GM foods: Allergenicity; Toxicity


It is a hypersensitive reaction initiated by immunologic
mechanisms caused by specific substances called


Is the gene source allergenic?

Expression level of introduced gene

Unintended effect

Digestibility and heat stability


New proteins as a result of intended modification

Unintended new proteins as a result of the modification

Natural constituents beyond their level of normal

….GM foods: nutritional aspects;
unintended effects

Intended and unintended changes in nutrient levels

Bioavailability of nutrients, stability and processing

Presence and effect of anti

Impact of individual changes on overall nutritional profile

Unintended effects

Random integration of transgenes

Insertional mutagenesis

Disruption of gene functions

Production of new proteins

Changes in






Concluding Note……

Biosafety is integral to modern biotechnology

The adoption of modern biotech products
needs to be balanced with adequate biosafety

Case by case scientific risk assessment and
cost benefit analysis

Greater acceptance of health care applications

Need based adoption in GM crops and foods

Participation of various stakeholders

Dissemination of knowledge and information

Thank you