biosafety on gmc, rules guidelines, people concern

1. - Sheetal Vishwakarma
Genetically Engineered Crops
Biosafety

2. What are
GE crops ?
-Plants derived from organisms
-DNA of which has been modified
-Genetic Engineering methods
-Golden rice, Bt corn or Maize, Brinjal,
Soyabean and many
-Bt cotton was obtained from Cry
genes, production of endotoxin from
Bacillus thuringiensis bacteria

3. Applications of
GE crops
HERBICIDE TOLERANCE-
DISEASES RESISTANCE-
INSECT RESISTANCE-
PRODUCT QUALITY-

4. -Genetic engineering is itself an evolution of
traditional selective breeding
-Vegetarian, vegan people objection as organisms
gene (animals, bacteria) artificially inserted in
plants
-General public accepts the merits, moral and
legal status of the technology
-Playing with nature
Why concerns ?

5. Biosafety
● Principle, Procedures, Policies
to ensure environmental &
personal safety
● Fundamental objective is
containment of potentially
harmful biological agents or
toxin.
The 'Cartagena Protocol on
Biosafety India- 17th January 2003
11th September, 2003
1st international regulatory
framework for safe transfer
To control international transfers
of LMOs
It creates framework to protect
biodiversity
● The 'Cartagena Protocol on
Biosafety (under CBD)
● India- 17th January 2003
● 11th September, 2003
● 1st international regulatory
framework for safe transfer
● To control international transfers
of LMOs
● It creates framework to protect
biodiversity

6. i. Recombinant DNA Advisory Committee (RDAC)
(review the developments, appropriate safety regulations)
ii. Review Committee of Genetic Manipulation (RCGM)
(monitor the safety related aspects in respect of on-going research projects and activities)
iii. Genetic Engineering Approval Committee (GEAC)
(activities of large scale and recombinant products)
iv. Institutional Biosafety Committees (IBSC)
(activities of large scale and recombinant products)
v. State Biosafety Coordination Committees (SBCC)
(primarily monitoring responsibilities)
vi. District Level Committees (DLC)
(to monitor the safety regulations in the use of GMOs/hazardous microorganisms)
Six authorities for implementation of regulation &
guidelines in India
Advisory
Approval
Monitor

7. Biosafety regulation in India
Two main agencies
MoEF
(Ministry of Environment & Forest)
- Rules by MoEF
DBT
(Department of Biotechnology)
- Guidelines by DBT
Regulatory Farmework
RULES & POLICIES
(under EPA, 1986)
• Rule, 1989
• Seed Policy, 2002
GUIDELINES
• Recombinant DNA guidelines,
1990
• Guidelines research, 1998

8. Rules Guidelines
● No import, export, manufacture, use
or sell any GMOs without GEAC.
● For education, experiments - IBSC,
Government of India.
● Unintentional release not allowed.
● GEAC supervision - SBCC, DLC
● Any person operating GMOs must
obtain permission from GEAC.
● Experiments in lab must use defined
DNA fragments non-pathogenic to
human and animals for genetic
transformation of plants, both bacteria
species and crop species.
● Activities or Research - review and
approval of authority before
commencement any experiments as
per the guidelines.

9. Agencies for approval GE crops
● Authorize large-scale
trials.
● Approval for using
hazardous organisms
and recombinant
products.
● Monitoring institute
level research
● Manufacture, use &
storage of organisms and
to bring regulatory
process for research.
● Authorize small-scale
trials.
● Monitoring on-going
research and applications
with a view to ensure
environmental safety..
GEAC
(Genetic Engineering Approval Committee)
RCGM
(Review Committee of Genetic Manipulation)
IBSC
(Institutional Biosafety Committee)

10. Safety assessment for GE crops

11. Thank you
TYBSc Biotech
Sheetal Vishwakarma
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