International Treaties

on Biosafety
Genetically Modified Organism
Cultivation
Countries that allow import of GM
food but not it’s cultivation

• Russia
• Norway
• Israel
Countries that allow import of GM
food as well as its cultivation

• Japan
• South Korea
Countries that do not allow import
or cultivation of GM crops but allow
research

E.g. India
History of regulation of
genetic engineering
 1975-1976
• Regulatory framework development began in 1975.
• Recommendations were done in Asilomar, California.
• Voluntary guidelines were set-up regarding rDNA research
• Followed by USDA, EPA, FDA, and NIH of USA.

USDA- United States Department of Agriculture

EPA- Environmental Protection Agency
FDA- Food and Drug Administration
1982-1986
• OECD released a report on hazards of GMO
• OSTP was established, regulates the developing tech.
• OSTP gave regulatory approval of GM plants to USDA, FDA, EPA.
1997
• European Union was the first to introduce laws stating that GMO have
to be labelled if it comes to the market
1990-2003
• Strategies for Assessing Safety of Foods produced by Biotechnology
published by WHO and FAO
• OECD, WHO, FAO continuously make standards for safety testing by
‘Substantial Equivalence’
• Cartagena Protocol on Biosafety was adopted on 2000 and came into
force on 11 Sept, 2003.

OECD – Organisation for Economic Cooperation and Development

FAO – Food and Agricultural Organisation
In Laboratory and Release
Laboratory
• For research permission has to be taken for governmental authorities
• All staff must be trained in use of GMO
• A biological Control Safety Officer has to be appointed
• All experiments with GMO has to be documented
• Usually research in categorized into risk categories and done in
containment certified laboratories .
• Different countries have different nomenclature to describe risk
categories.
Release
• Vary greatly from country to country.
• European Union has the most stringent laws
• All ‘new food’ is subject to extensive case-by-case, evaluations
• Done by EFSA
• In USA evaluations are done by FDA, and EPA
• The tests are relaxed and are based on Substantial Equivalence
• Severity of tests in other countries lie between EU and USA.

EFSA – European Food Safety Authority

• India and China are the two largest producers of GM foods
in Asia

• Brazil and Argentina are the next largest producers of GM

foods
 Region Regulators
USA USDA, FDA, EPA
Continental Europe European Food Safety Authority
England Department for Environmental Food and
Rural Affairs
Canada Health Canada and the Canadian Food
Inspection Agency
Regulation Africa Common Market for Eastern and
Agencies by China
Southern Africa
Office of Agricultural Genetic Engineering
Geographical Biosafety Administration
India Institutional Biosafety Committee, Review
Regions Committee on Genetic Manipulation and
Genetic Engineering Approval Committee
Argentina National Agricultural Biotechnology
Advisory Committee, NSHAQ
Brazil National Biosafety Technical Commission
Australia Office of Gene technology regulator
Cartagena Protocol on Biosafety
What does the protocol cover?
“transboundary movement, transit, handling and use of all living
modified organisms that may have adverse effects on the conservation
and sustainable use of biological diversity, taking into account risks to
human health”.
Key Features
• Advanced Informed Agreement (AIA)
• Biosafety Clearing-House (BCH)
• Risk Assessment
• Capacity Building
• Public Awareness
What does the protocol not cover?
• Products derived from LMOs (e.g. paper from GM trees)

• LMOs, which are pharmaceuticals for humans that are addressed by

other relevant international agreements or organizations
rDNA regulations in India
• Ministry of Environment, Forest, and Climate Change (MoEFFC)

• MoEFFC introduced Environmental Protection Act (EPA)

• Rules for the proper handling of rDNA technology

• Six Competent Authorities made by Department of Biotechnology and

MoEFFC
The Six competent Authorities
• rDNA Advisory Committee (RDAC)
• Institutional Biosafety Committee (IBSC)
• Review Committee on Genetic Manipulation (RCGM)
• Genetic Engineering Appraisal Committee (GEAC)
• State Biotechnology Coordination committee (SBCC)
• District Level Committee (DLC)
Approvals and Prohibitions
• No import, export, transport, manufacture, process, use or sell any
GMOs, substances or cells without approval of the GEAC.

• Use of pathogenic organisms or GMOs or cells for research only in

labs notified under EPA

• Use of GMOs for scale up or pilot operations requires the permission

of GEAC
• Experiments for the purpose of education involving GMOs done under
oversight of IBSCs.

• Deliberate or unintentional release of GMOs not allowed.

• Production in which GMOs are made or used shall not start without the
approval of GEAC

• Approvals are for a period of 4 years at first instance, renewable for

2 years at a time.
• GEAC shall have powers to revoke approvals in case of:

i. Any new information on harmful effects of GMOs.

ii. GMOs cause such damage to the environment as could not be

envisaged when approval was given.

iii. Non-compliance of any conditions stipulated by GEAC.