Biosafety refers to policies and procedures to ensure safe applications of biotechnology. Biosafety levels classify microorganisms by risk, with level 1 posing the lowest risk and level 4 the highest. Several international organizations and Indian government bodies oversee biosafety regulation through various acts and rules. Risk assessment of genetically modified organisms considers potential health risks to humans, environmental risks, and risks to agriculture and biodiversity.

2. Biosafety
“It may be defined as the policies and procedures invariably
adopted to ensure the environmentally safe applications of
biotechnology”
Biosafety levels (BSL)
It usually refers to a classification system used to indicate
the safety precautions required for those investigating
microorganisms ,especially viruses known to be dangerous or
lethal to those exposed to them.

3. The European Community (EC)
Organization for Economic Cooperation and Development (OECD)
WHO/FAO Working Group on Biosafety
United Nations Conference on the Environment and Development (UNCED)
Codex Alimentarius Commission
Nodal agencies
Ministry of Environment and Forestry (MoEf)
Dept of Biotechnology- Ministry of Science and Technology
Competent authorities
RDAC- Recombinant DNA Advisory Committee
IBSC-Institutional biosafety committee
RCGM-Review Committee on Genetic Manipulation
GEAC- Genetic Engineering Appraisal Committee
SBCC-State Biotechnology Coordination Committee
DLC- district level committee

4. Rules for Manufacture, Use, Import, Export and Storage of Hazardous
Microorganisms (Genetically Engineered Organisms or Cells, 1989 under
the EPA (1986) known as ‘ Rules 1989’ by MoEF
The Biological Diversity Act, 2002 by MoEF
Plant Quarantine Order, 2004 by NBPGR under MoA
Seed Policy, 2002 by MoA
DGFT Notification Relating to Inclusion of GM Policy in Foreign Trade
Policy (2006-09) by MoC&I
Food Standards and Safety Act, 2006 by MoH&FW
Drugs and Cosmetics Amendment Act, 1972 by MoH&FW
Acts/Rules - Biosafety Regulation

5. The Protocol is an international legally binding treaty which sets
procedures and mechanisms to be applied in the transboundary movements of
Living Modified Organisms (LMOs)- living organisms that possesses a novel
combination of genetic material obtained through the use of modern
biotechnology (genetic modification).
The Protocol does not apply to other products of biotechnology.
Cartagena Protocol
Major elements of the protocol:
Advance informed Agreement procedure
Simplified system for agricultural commodities
Risk assessments
Risk management and emergency procedures
Export documentation
Bio-safety clearing House
Capacity-building and finance
Public awareness and participation
Issue of non-parties.

6. Human health
• Toxicity Vs food quality/safety
• Allergies
• Pathogen’s drug resistance that is antibiotic resistance
Risks for environment
• Persistence of gene/transgene/transgene products
• Resistance of target organisms or susceptibility of non-target organisms.
• Increased usage of chemical in agriculture
• Transgene instability
• Unpredictable gene expression
Risks for agriculture
• Weeds or superweeds
• Change in nutritional value
• Reduction of cultivars and loss of biodiversity
Risks for interaction with non-target organisms
• Genetic pollution via pollen or seed dispersal
• Horizontal gene transfer
• DNA uptake that is transfer of foreign gene to microorganisms
• Generation of new line viruses by recombinent DNA technology
General concerns
• Higher cost of agriculture production
• Loss of familiarity
• Ethical issues

7. Biosafety Issues
Following are some of the biosafety issues, which have been widely
discussed at the national and international levels and continue to receive
attention of scientists and the society at large:
Pollen flow and horizontal gene transfer of transgene to wild relatives and
bacteria
Allergenicity and toxicity
Invasiveness
Development of resistance in insects
Development of resistance in weeds against herbicides giving rise to
superweeds
Adverse effects on non-target organisms
Loss of biodiversity
Selectable and scorable markers involving antibiotic resistance
Disruption of ecosystem
Social, ethical and economic issues
These issues have been discussed in some detail in a recent document entitled “Agricultural Biotechnology-A Lot More
than Just GM Crops” brought out by International Service for the Acquisition of Agri-Biotech Applications (ISAAA)

8. Some important studies suggesting possible risks include
the following:
(i) adverse effect of Bt-corn on monarch butterfly
(ii) contamination of land races due to Bt-corn;
(iii) adverse effect of lectin in GM potato on rats
(iv) Aventis’s Star-Link corn with Bt gene Cry9C, which had to be
withdrawn from the market, although there was no evidence of any
harmful effect
(v) Adverse effect of herbicide resistant transgenic soybeans on the
fertility of rats, as reported by Irina Ermakova from Moscow

9. Research on transgenics must be continued with the aim of developing safer,
more productive and nutritious food crops
This concept of ‘Cisgenic’ technology, which has negligible food safety risk, and
therefore may face less opposition/criticism
GM crop events must be actually evaluated by the experts before their
commercial release to the farmers
The bio-safety is to be evaluated on a case-by-case basis
The process of in situ conservation of biodiversity of crop varieties.
The consequences of gene transfer via pollen should be evaluated on a case-
to-case basis and due precaution must be ensured
Reorganisation of resistance developed in the insects against insecticides and that
in the weeds against herbicides.
Contd.,

10. Access to seed of approved GM crops .,the government should make a policy for
procuring the seeds of useful GM food crops
A “National Institute of Bio-safety and Bio-Security” should be created with state of
the art infrastructure, human resource and research programs for conducting
frontier research, providing policy support and technical advice to the government.
The public needs to be educated properly about the facts regarding both food safety
and economic benefits of the GM food technology.
Need to establish PPP (Public-Private Partnership) for joint development and
ownership of the GM food crop products.
The monopolistic control of seed business by MNCs (multi-national companies)

11. In view of the long gestation period for the development of useful GM
crop events, and the high cost of research and development, there seems to be
a need to have a sound biosafety evaluation and regulatory infrastructure.
Following plan of action is suggested for this purpose:
Bio-safety Evaluation and Regulatory Mechanism
Pre- and Post-release Monitoring and Evaluation of GM Crops
Accessibility of Approved GM Seeds to the Farmers
Research and Development including PPP
Education and Public Awareness

12. Risk Assessment and Management
Risk is defined as the probability of harm.
Risk analysis consists of three steps
Risk assessment
• Evaluates and compares the scientific evidence regarding the risks
associated with alternative activities
Risk management
• Develops strategies to prevent and control risks within acceptable
limits and relies on risk assessment
Risk communication
• Involves an ongoing dialogue between regulators and the public
about risk and options to manage risk so that appropriate decision
can be made

13. Green peace
Navdanya
Friends of earth
GMO awareness
GMO free new jersey
GMO free Utah
Millions against Monsanto
Texas
Gene watch site
Organic consumer association
Gene Campaign

14. Substantial Equivalence
A functional part of the current risk assessment
The concept of substantial equivalence is that novel crops or foods, such as
those made using genetic engineering, can be compared with the same
kinds of conventional crops or foods to know the risk factors.
A number of properties of the novel and conventional products, including
the levels of nutrients, toxic substances, and potential allergens, may be
compared taking into account established patterns of processing and
consumption.
If the comparison reveals that there are no significant differences between
the two kinds of food, the novel food is presumed to be no less safe than
the conventional food.

15. Tests used for assessing GMO safety
Based on length of exposure Based on generations
Acute tests
Sub chronic tests
Chronic tests
Single generations studies
Multi generation studies

16. Adverse effects of a substance that
result either from a single exposure
Acute testing on mice
Helps in determining …
The nature and duration of any
acute toxic response.
Provide the maximum non-lethal
dose
Preliminary information relevant
to single exposure or over-dosage in
humans.
No observed effect concentration
Lowest observed effect concentration
Maximum allowable toxicant
concentration
Acute tests….
Alterations in metabolic pathways
due to GM.
Potential impacts on nutritional
status.
Minimum test to assess safety of
long-term consumption of GM foods.
Effects of repeated exposure over
prolonged period of time
Information on, immunological,
histological and neurological effects
Chronic tests
Sub chronic tests
Proliferative changes in tissues during
the 90-day study
Possible nervous, reproductive and
hormonal disorders

17. Risk Assessment of Laboratory research
(a)Initial risk assessment-

18. RiskGroup1Agents
•E.coli K-12
•Transgenic Plants
•Plasmids
•Fungi
•Mold
•Yeast
BSL-1 Practices
•Bench-top work allowed
•Daily Decontamination
•Manual pipetting
•Required Handwashing
•Red bag waste
•Bio cabinet not required
(unless creating aerosols)
•2˚ containment

19. RiskGroup2Agents
• Human or Primate Cells
• Herpes Simplex Virus
• Replication
Incompetent Attenuated
Human
Immunodeficiency
Virus
• Patient specimens
BSL-2 Practices
• Limited access to lab when
work in progress
• Daily decontamination
• Mechanical pipetting
• Labcoat, safety glasses
and gloves required
• Red bag & sharps
containers required

20. RiskGroup3Agents
• Human
Immunodeficiency
Virus
• Mycobacterium
tuberculosis
• Coxiella burnetii
Biosafety Level 3
• Public access NOT permitted
• Daily decontamination after spill
and upon completion of
experiment
• Autoclave required and waste is
disposed at the end of day
• Required foot activated hand
washing sink and controls
• No sharps unless absolutely
necessary

21. Biosafety Level 4
• Lassa Fever Virus
• Ebola Hemmorrhagic
Fever Virus
• Marburg Virus
• Herpes B Virus
Biosafety Level 4
• Builds on BSL-3 practices
• Maximum containment
facilities
• Pressurized Containment
Suite – BSL-3 + Class III
Biosafety Cabinet
• Chemical decontamination
showers
• Liquid effluent collection /
decontamination

22. (b)Comprehensive Risk Assessment-
• Organism Factors
• Type of Manipulation

23. “The controversy about the health safety of Transgenic
foods is complex and good science and its communication are
required in order to find solutions”
Biosafety regulations required to assess the safety of transgenic crops before its
release in to environment.
Conclusion

24. Queries
&
Discussions