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Sent: 09 May 2003 10:56
Subject: 36: Re: Experience of regulating GMOs in developing countries - India
This is from Ramesh V. Bhat, in response to Debasmita Patra's (Message 20, May 6) request: "I just wanted to know about the Genetic Engineering Approval Committee's (GEAC) recent stance about granting permission to the GMOs in India".
The Government of India's Genetic Engineers Approval Committee (GEAC), in its 36th meeting on 25 April 2003, rejected the proposal of commercial cultivation of a Bt cotton variety, Mech 915, in North India mainly because it is highly sensitive to leaf curl virus disease.
It called for more field trial data for GM mustard seeds to assess the agronomic superiority, effects of crossability and pollen transfer and resistance to herbicides, under the supervision of the Indian Council of Agriculture Research. The panel was also of the view that, as mustard seeds and leaves were used in food, there was a need to assess the possible health hazards.
RAMESH V. BHAT
Deputy Director (Sr.Gr.)
Food & Drug Toxicology Research Centre
National Institute of Nutrition
Indian Council of Medical Research
Telephone: 91-40-27008921 to 27 Extn.281
Email: rameshvbhat (at) yahoo.com
Sent: 09 May 2003 11:09
Subject: 37: Financial/time costs of GE crops
This is from Professor C Kameswara Rao, Bangalore, India.
Financial and time costs of commercialising transgenic crops and the need to reduce trial phase duration for repeated transgenic events.
It takes about 11-13 years for a specific transgenic variety to get into commercial cultivation. Five years to develop the transgenic event, such as pest resistance or herbicide resistance, 2 or 3 years of controlled greenhouse trials on approval by a regulatory agency, and 3 or more years of controlled field trials. This would cost US$ 5-7 million in the United States and 8-12 million in Europe. It takes some 5 years of commercial cultivation before it is de-regulated.
The regulatory authorities should have a rational and science based approach to giving or denying approval for a transgenic crop. For a number of crops there is only one annual growing season. If for any reason the trial phase is extended, as has just been done in India for 2 years each for GE mustard and Mech 915 Bt cotton meant for the north Indian States, the time lost would increase costs in terms of expense on the extended trials or maintenance, and interest on investment to date. This burden would fall on the cultivator/consumer.
Mahyco's Mech 915 variety has gone into a second deferment, after three other varieties containing the same gene for Cry 1Ac were approved last year, and this on the basis of a factor unrelated to Bt technology. Bt technology in cotton is meant to protect the cotton crop from the American bollworm and has nothing to do with the leaf curl virus. If susceptibility to the leaf curl virus makes Mech 915 unsuitable for cultivation now, one more year of field trial is not going to remedy that. GE or non-GE, no cotton variety in India is resistant to leaf curl virus and so none should be grown at all.
Transgenic technology for pest resistance and herbicide resistance have proved their merits and are being under increased acreage year by year, in increasing number of countries. Both their stability in the recipient genomes and their biosecurity have been proven beyond a reasonable doubt. The incidents related to Starlink or Prodigene were issues of human management errors and not technology lacunae.
If a particular transgenic event, like Cry 1Ac in cotton in India, is approved for commercial cultivation, the same event put into another cotton variety in India should not be required to pass through the entire 5-7 year trial phases. For example, Mahyco used Monsanto's Bt technology with Cry 1 Ac and the same is being used by Rasi Seeds. Under this scenario, the trial phase before commercialisation can be reduced for the gene construct with Cry 1 Ac, inserted into whatever variety of cotton in India. When a product developer introduces the same genetic event, as was used earlier, into a better variety, one year of controlled greenhouse trials and one year of controlled field trials should be adequate. It would be a different matter if the gene construct involves Cry 1 Ab or stacking of Cry 1 Ab and Cry 1 Ac.
Extended trial periods create another problem. The variety into which an event is introduced may be overtaken by other non-transgenic varieties, which results in an endless race and disadvantage to the transgenic varieties, benefiting no one. Mahyco's cotton varieties were among the best in the country when chosen for developing Bt varieties five or six years ago, but by the time they were allowed for commercial cultivation, they were overtaken in field performance by other non-Bt varieties.
Reduced time schedules will break monopolies in transgenic trade and provide the farmers with a wider choice of varieties of the same crop with a particular genetic event, from different developers.
Professor C Kameswara Rao,
Foundation for Biotechnology Awareness and Education,
e-mail: krao (at) vsnl.com
Sent: 09 May 2003 11:13
Subject: 38: Re: A dynamic interdependent network
This is from Dr Aisha, A. Badr, Tropical fruit division, Sabahia Horticultural Research Station, Alexandria, Egypt.
In response to Message 21 (May 6) of Dr Gert Willemse: "In summary then, the global GMO regulatory scenario is evolving into a dynamic interdependent network that could only benefit from cross-fertilization of all experiences and lessons learnt".
It is evident that network is important to help in regulating GMO in agriculture and related industries and other areas. This lead to my opinion, in the previous FAO conference [entitled "What should be the role and focus of biotechnology in the agricultural research agendas of developing countries?", held 13 November to 11 December 2002...Moderator] to regulating team work of all specializations for doing research and here to encourage developing counties to build its own base of GMOs in all areas of studies, including the most worried field of health and safety. Each developing country has its priorities in the way of development; its own culture, which is one of the factors needed to accept new technological techniques; its own customs, citizens who play great part in acceptance of GMOs. Even inside the same country we will find differences.
In my opinion, regulation of GMOs needs to be in regulated steps in both developed and developing countries including: certificated GMOs (I mentioned it in the previous FAO conference), similar to ISO, to be given for safe GMOs, because trust is the first effective factor. [International Organization for Standardization (ISO) Standards are voluntary and are used in a wide range of fields, such as agriculture and construction or information technology...Moderator]. This can be followed by guiding people to the importance of the certified GMOs. The developed countries can support by funding, according to priorities of each country. I agree with Dr Gert Willemse about the benefits from cross-fertilization of all experiences and lessons learnt.
Dr Aisha, A. Badr,
Tropical fruit division,
Sabahia Horticultural Research Station,
momidic (at) hotmail.com