The document discusses risks associated with genetically modified foods, including allergic reactions, development of antibiotic resistance, and contamination of non-GM crops. It provides examples like the recall of StarLink corn, which was approved only for animal feed but contaminated the human food supply. Another example discussed is contamination of an organic corn field by pollen drift from a nearby GM corn field. The document also outlines various ministries and departments involved in regulating GM foods in India as well as key research institutions working on issues related to GM foods. It discusses India's support for mandatory labeling of GM foods as recommended by Codex Alimentarius.

1. Assignment
Subject : Breeding Designer Crops (GPB822)
Presented by: Mr. Indranil Bhattacharjee
Student I.D. No.: 17PHGPB102
Presented to : Prof. (Dr.) B.G.Suresh
Sam Higginbottom University of Agriculture, Technology &
Sciences
Allahabad-211007
BIOSAFETY AND REGULATION
Risks of Genetically-GM Food Labelling

2. Risks of Genetically Modified Foods
Some people argue that along with the benefits of genetically
modifying food come risks. Such risks may include: exposure to
possible allergens and toxins, harm to the environment, antibiotic
resistance, and the spread of introduced genes to non-target plants
by out-crossing and pollen drift. In November 2000 the Food and
Drug Administration recalled 300 supermarket and restaurant
products made with StarLink™ corn.
StarLink™, produced by Aventis, Research Triangle Park, N.C.,
contains the gene Cry9C, which protects the plants against insect
pests. The EPA had approved StarLink™ corn in 1998 with the
stipulation that it was not for human consumption. Studies had
shown that the Cry9C protein produced in the modified corn was
heat stable and resistant to stomach acids and enzymes, all
characteristics of human allergens, hence the restriction on human
use. Aventis failed to keep StarLink™ corn separate from approved
and nongenetically modified corn so the unapproved corn entered
the market, initiating the massive recall (USDA 2000).

3. Starlink corn, a GM corn expressing Bt delta
endotoxin, is approved for use as livestock feed
Source: www.amazon.com

4. A different problem arose for the Terra Prima
organic corn chip company in Hudson,
Wisconsin, in 1995. Despite strict practices by its
organic corn growers, it was discovered that
some of Terra Prima’s Apache Tortilla chips
showed traces of Bt corn. Genetic testing
revealed that pollen from a crop of Novartis Bt
corn planted more than a quarter-mile away had
contaminated an organic corn field of one of
Terra Prima’s suppliers. Because of the
contamination by pollen drift, Terra Prima
recalled and destroyed 90,000 bags of chips, a
significant monetary loss to the small company.

5. Risk factors
Bt insect-resistant genes in crops put stress on the insect
pests → mutations → emergence of Bt-resistant insects
It is recommended that refuge crop is grown along with Bt
crops, so that insects may multiply on this refuge crop
GM crops can cause allergenic reaction in human beings
GM soybean carrying the Brazil nut gene
GM potatoes containing a transgene for a toxic lectin caused
suppression of immune systems and damage to internal organs
of rats when fed on these potatoes
Are antibiotic resistance marker genes safe?
Used marker genes are normal components of bacteria that
live on many of our foods or in our intestines
Development of novel viruses through viral recombination

6. Arguments
Various arguments against herbicide-tolerant
transgenics in crop plants have come up:
- use of herbicide-tolerant transgenic crops can lead
to transfer of herbicide tolerance genes to sexually
compatible wild relatives or weeds, which can be major
potential threat to environment → ″superweeds″,
problems with weed control
- it would actually increase the dependence on a few
herbicide rather than reducing herbicide usage
However, according to a 10-year study on oilseed rape,
potato, maize and sugar beet, genetically improved
crops show no signs of turning into superweeds →
conventional crops actually outlived the biotech ones

7. GM labeling

8. According to Regulation (EC) No. 1829/2003 (EC,
2003a), all foods and feeds containing or
derived from approved GM products in amounts
greater than a 0.9% threshold are subject to
labeling rules. In addition, a 0.5% labeling
threshold has been mandated for GM crops that
have been given a favorable risk assessment but
are not yet approved within the EU. Unapproved
varieties are managed with zero tolerance. This
differs from previous legislation by which foods
only had to be labeled if GM plant material,
namely recombinant DNA or proteins, could be
detected above the threshold (EC, 2000).

9. In compliance with Regulation (EC) No.
1830/2003 (EC, 2003b) and in order to help
implement the labeling legislation of Regulation
(EC) No. 1829/2003, any feed product containing
more than the allowable thresholds of GM plant
content must be accompanied by proper
documentation stating that it consists of GM
constituents within the EU. The thresholds
account for the adventitious or technically
unavoidable presence of GM organisms in
foods/feeds. Labeling of feeds containing GM
ingredients informs farmers and gives them the
choice of using such feed for their livestock.

14. OVERVIEW OF MINISTRIES AND DEPARTMENTS INVOLVED IN
REGULATION OF GM FOOD
Several central ministries and departments are involved in India’s program of food
quality and safety and hence each one of them has a role to play in the activities
related to GM foods in India. These include:
1. Ministry of Environment and Forest: Th is ministry holds the Secretariat of the
Genetic Engineering Approval Committee, the apex body that gives approval for
manufacture, sale, import and export of all GMOs and products thereof
including foodstuff , ingredients in foodstuff and additives using genetically
modifi ed (GM) organisms or cells.
2. Department of Biotechnology: Th is department holds the Secretariat of the
Review Committee on Genetically Modifi cation that gives approval for research
and small scale fi eld trials involving GMOs and products thereof. It also
interacts with the Institutional Biosafety Committees (IBSCs) set up in all
organizations undertaking activities involves GMOs.
3. Department of Health in the Ministry of Health and Family Welfare:
Department of Health is responsible for implementation of the PFA Act under
which the quality and safety of food is regulated. The Directorate General of
Health Services has also been designed as the nodal Ministry with the Codex
Alimentarious Commission.

15. 4. The Indian Council of Medical Research (ICMR) is the apex body in India for the
formulation, coordination and promotion of biomedical research under the
Ministry of Health and Family Welfare. ICMR acts as an advisory body for
MoHFW on various issues including GM foods.
5. Ministry of Agriculture: Ministry of Agriculture is the nodal ministry for
agriculture growth in the country. It comprises of three Departments viz.
Department of Agriculture and Cooperation, Department of Agricultural
Research & Education/ Indian Council of Agricultural Research (ICAR) and
Department of Animal Husbandry & Dairying. The officials from ICAR and
Ministry of Agriculture have an important role to play in the approval of GM
crops as per Seed Policy, 2002.
6. Ministry of Commerce and Industry: This ministry is responsible for the
formulation of the Export and Import (EXIM) Policy in the country. It implements
a legislation prescribing a system of quality control and inspection for both
export/import.
7. Ministry of Food Processing Industries: This ministry is responsible for the
formulation of policy for the healthy growth of the food processing industries
and provides developmental support to these industries. It encourages research
and developmental activities and assists the industries in active participation in
the laying down of food standards as well as their harmonization with
international standards. This ministry is also the licensing authority for
processed fruits and vegetable industries.

16. Research Institutions:
1. National Institute of Nutrition (NIN), Hyderabad is India’s premier nutrition research
institute working under the aegis of Indian Council of Medical Research (ICMR), Ministry of
Health and Family Welfare, Government of India. ICMR proposes to set up a GM Food Safety
Cell in NIN.
2. Central Food Technological Research Institute (CFTRI), Mysore is a premier institute working
under Council of Scientific and Industrial Research. Its multi-disciplinary spread (across 16
R&D departments) covers almost every field of scientific investigation connected with foods
and their relationship to humans, including the cutting edge area of food biotechnology.
3. The Defence Food Research Laboratory (DFRL), Mysore under the aegis of Defence
Research Development Organization (DRDO) caters to the varied food challenges for military
and paramilitary forces. This laboratory is engaged in research & development of traditional
indigenous foods and their preservation
4. Industrial Toxicology Research Center (ITRC), Lucknow a constituent laboratory of Council of
Scientific & Industrial Research (CSIR) is dedicated to provide health safeguards to industrial
and agricultural workers through its rich knowledgebase, created painstakingly over the
years.
5. National Bureau of Plant Genetic Resources (NBPGR), New Delhi is the nodal organisation
in India for collecting, introducing, evaluating and conserving plant genetic resources.
NBPGR is also responsible for plant quarantine activities relating to exotic samples.
6. Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad is an autonomous
institution supported by the DBT and is engaged in providing services for DNA fi ngerprinting
and diagnostics in addition to basic research in related areas. DNA fi ngerprinting services
are also being provided to various government and law enforcement agencies.

17. LABELLING ISSUES
India, along with a number of other countries, has supported the
mandatory labeling of GM food by Codex. Out of the two options under
discussion by Codex i.e.
Option 1 requires labeling when the products obtained through
biotechnology differ significantly from the corresponding food as
regards the composition, nutritional value or intended use and
Option 2 require the declaration of the method of production for food
and ingredients composed of or containing genetically
modified/engineered organisms and food or food ingredients produced
from, but not containing, genetically modified/engineered organisms if
they contain protein or DNA resulting from gene technology or differ
significantly from the corresponding food.
The labeling of food derived from biotechnology is a major issue for
India as its delegation at the CCFL has been seeking to achieve
mandatory labeling as set out in Option 2. However, Option 2 has also
raised a number of issues of concern including the enforcement,
methodology, economic cost, consumer perception and difficulties likely
to be faced.

19. India’s food regulator intends to make it compulsory for
manufacturers to disclose details of GM ingredients in their foods.
• That’s according to Pawan Kumar Agarwal, chief executive of the Food Safety and
Standards Authority of India, which is finalising guidelines on rules governing the
labelling of genetically modified ingredients.
• “Genetically modified items are being used in a lot of processed foods. Consumers
have the right to know which products may have GM items,” he said.
• A scientific panel has already begun work on deciding how these will be labelled, he
added.
• The FSSAI is responsible for regulating GM foods, though another body, the Genetic
Engineering Appraisal Committee, has the final say in signing off on its decisions,
according to the Food safety and Standards Act, 2006. The Environment Ministry,
meanwhile, is able to sign off on domestic transgenic crops.
• Ministers had wanted the regulator to take overall responsibility for GM foods,
though it has declined for the time being. The authority insists that GMOs should only
come under its purview once both imports and local agricultural production are
permitted.
• “[At that point] all GM foods would be subject to the same standards that apply to
regular food,” Agarwal told DNA.
• Processed food businesses are not currently required to declare the presence of GM
ingredients, which are now imported into India in considerable quantities.
• In light of this, the GEAC expressed concern to ministers earlier this year over the
absence of regulations governing GMOs in processed foods.

20. • Domestically, a moratorium has been in place concerning the cultivation of GM food
crops, though transgenic mustard was given the go-ahead last month, pending
ministerial approval. Bt aubergine also received approval several years ago, though
its introduction remains unlikely following sweeping protests.
• Some farmer groups have been strongly opposing the introduction of GM
technology into Indian fields in the belief that such a move would lead to the
widespread industrialisation of food production and compromise food security.
• Though the FSSAI says it is close to completing regulatory guidelines for GM
labelling, it has acknowledged complexity of doing so.
• In a status report it provided to India’s Supreme Court earlier this year, it warned:
“Any labelling regime... will have practical implications on trade as it will necessitate
implementation of large-scale threshold testing regimes and traceability protocols
with back up documentation, which would cause significant escalation of costs.”
• Elsewhere, the regulator is on course to launch a food safety index for India, under
which each state will be judged on its enforcement of food laws and consumer
awareness of related issues.
• FSSAI chief executive Agarwal said it would help officials to gauge the resources
available and the progress being made across the country. The index will be
particularly useful in assessing “gaps” in inspection protocols, and in generating new
systems for inspectors.

21. Thank You