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1.Comment from Kavitha Kuruganti
2.GEAC Surrenders India's health before GM food companies
3.Evidence of Reactions in Animals and Humans Due to Genetically Engineered Foods

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1.Comment from Kavitha Kuruganti

Dear friends

Please find a press release below from Coalition for GM-Free India on the exemption that GEAC has accorded to GM food products' imports through a notification issued on September 11th 2007.

The Genetic Engineering Approval Committee (GEAC) has notified that its role with respect to import of processed foods is restricted to ensure that no adverse environmental impacts occur. With this, it has washed its hands off the responsibility for ensuring safety of human and animal health. That the GEAC is unwilling to perform an unbiased role as a regulator is not only shocking but also makes a mockery of GM regulations in the country as laid down by the law.

The 1989 Rules under the Environment Protection Act clearly spell out that the GEAC is supposed to take care of all aspects of GM crops and foods, including health implications of GM foods which may be imported into the country, whether raw or in a processed form. GEAC suddenly re-defining its role to that of "environmental safety" alone is surprising and unacceptable.

It is obvious that the changed interpretation of regulations is meant to offer an opportunity to biotech food manufacturers to import untested and unreliable GM foods into the country. While there is a growing resistance worldwide against the proliferation of these products, the GEAC is turning the country into a dumping ground for GM foods.

The Ministry of Health and Family Welfare had announced draft amendments to the Prevention of Food Adulteration (PFA) Act in March 2006 and sought to introduce a mandatory labeling requirement for all GM foods that are either produced or imported into the country. Now, with this latest notification, the GEAC has subverted the labeling regulation and established that commercial interests weigh higher than health concerns of Indian citizens. It has also built a case to take apart the Indian Council for Medical Research's attempts to develop facilities for testing GM presence.

The main implications from this would be:

- unknown health impacts on Indian consumers from such GM products since the floodgates of imports would be opened up now. GM soy products (roundup ready soy mostly) have shown adverse impacts in several studies the more recent ones being from Russia, Italy etc. The attachment has references of some important studies in this respect.

- such exemption from regulation subverts the proposed labelling regime in the country before it has even begun!

- this exemption could have impacts on the non-GM soy advantage that India enjoyed so far.

Finally, GEAC making major regulatory changes when the Supreme Court PIL on GMOs is being heard is very surprising. By these latest moves, the GEAC has once again proven itself to be a controversial regulator, on the side of the GM industry and not with Indian citizens.

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2. GEAC Surrenders India's health before GM food companies: Coalition for GM-Free India
PRESS RELEASE

September 26, 2007: By issuing a notification that grants exemption from regulatory approval to GM food products (as opposed to GMOs which could propagate and/or reproduce), the Genetic Engineering Approval Committee (GEAC) is grossly abdicating its legally-mandated role that of being the apex regulatory body for "protecting the environment, nature and health, in connection with the application of gene technology and micro-organisms". The 1989 Rules under the Environment Protection Act clearly spell out that the Rules are applicable to the manufacture, import and storage of micro-organisms and gene technological products (2.1). Section (2) unambiguously spells out the application jurisdiction of the Rules.

1. GEAC suddenly re-defining its role to that of "environmental safety" is surprising and unacceptable. The mandate of the Committee is that related to "bio-safety" and the 1989 Rules clearly spell out protection of the environment, nature and health as the objective. Rule 11 of the EPA 1989 Rules had the following so far:

11. Permission and approval for food stuffs

Food stuffs, ingredients in food stuffs and additives including processing and containing or consisting of genetically engineered organisms or cells, shall not be produced, sold, imported or used except with the approval of the Genetic Engineering Approval Committee.

Many GM food importers had openly defied the GEAC's authority for years and had imported GM foodstuffs without GEAC's approval. The response of GEAC is quite shocking instead of fixing liability for such blatant violations of regulation (the GEAC has authority for punitive actions), it first sought to legitimize the imports through a one-time permission to the soybean importers' association for RoundupReady soy imports (crude de-gummed soybean oil as well as refined soybean oil) and by the September 11 th notification, has washed its hands off an important role it is expected to perform. The GEAC did this, knowing fully well that it is the only apex regulatory body which can and should perform the functions envisaged protecting environment, nature and health.

2. Further, GEAC also knows that while India is a signatory to the Cartagena Biosafety Protocol which means that it abides by the principles of the Protocol, it is ready to deal with a country like the USA which does not respect the Protocol. This exemption that GEAC is allowing for GM food products from regulatory processes is also a violation of the Cartagena Protocol's principles. Rule 11 of the 1989 Rules incidentally deal with production and use too within the country and not just imports. To not regulate GM food stuffs, as defined in Section 11 (given above in italics) is a clear violation of the Protocol.

3. GEAC also clearly knows that in countries like the USA from whom we import GM soy products, there is no regulatory regime worth speaking about. It is unacceptable that the Indian regulators should depend on other countries' (so-called) regulation for protecting the Indian consumers, while there is a clear trade lobby involved in promoting lax regulation in the exporting company in this case.

4. The decision to allow import of only Roundup Ready Soy is also a short-sighted one, in blatant support of Monsanto. Monsanto's court cases against importers in Europe on the issue of Argentinian GM soy consignments which Monsanto says is its patented product (roundup ready soy), does not seem to have taught any lessons to Indian importers either. While this part of the story is one related to IPRs being used to strengthen the monopolistic rights of large MNCs like Monsanto, the central issue related to health concerns from GM soy products remains.

5. It should be remembered that India 's labelling regime is still not in place pertaining to GMOs and products thereof. Further, exempting such products from regulatory approvals will make labelling laws impossible to enforce even if the Health Ministry finalises the regime and notifies it soon.

6. Most importantly, such imports should not have been allowed in the first place since there is ample evidence to point out to serious health concerns with GM soy.

For instance, recent studies from Russia (in 2006 and 2007) show that Monsanto's Roundup Ready GM-soy used during tests on rats and mice caused serious mutilations of their internal organs (liver, kidneys, testicles) and in histological and cellular construction. Besides, it influences the number of babies in a litter, caused increased death rates among descendants, and results in increased aggressiveness and loss of maternal instinct, it was found.

7. India should remember that the soybean producers here have the advantage of being non-GM and thus enjoy a trade advantage. It is not clear, in the absence of segregation mechanisms, how India's non-GM soy products can be maintained as such at the processing stage, with GM crude de-gummed soy oil now coming in with no barriers at all. This advantage for Indian non-GM soy could very well be lost by GEAC's decisions.

8. It is also surprising that GEAC is making major changes in the regulatory regime while the Supreme Court of India is hearing public interest petitions on the matter of GM technology, GMOs' and their impacts and the regulatory regime in the country.

The Coalition for GM-Free India demands that GEAC stop abdicating its role as per the 1989 Rules of the EPA and take responsibility to safeguard the interests of Indians in all its decisions and take responsibility for ensuring that no GM food products enter the Indian food chain, without proper assessment and regulatory procedures.

For more information, contact:

1. Usha of Thanal at 094-470-22775
2. Kavitha of Centre for Sustainable Agriculture at 093-930-01550
3. Bhaskar Goswami of Forum for Biotechnology & Food Security at 098-111-91335

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3.Evidence of Reactions in Animals and Humans Due to Genetically Engineered Foods

Adapted from: Genetic Roulette: A documented health risks of genetically engineered foods / Jeffrey M. Smith.

1. Rats fed on genetically modified potato developed precancerous cell growth in the digestive tract, inhibited development of their brains, livers, and testicles, partial atrophy of the liver, enlarged pancreases and intestines, and immune system damage.

Source: Arpad Pusztai, Can science give us the tools for recognizing possible health risks of GM food, Nutrition and Health, 2002, Vol 16 pp73-84

2. Monsanto's own experiment with feeding rats with Bt corn for 90 days caused significant changes in their blood cells, livers, and kidneys.

Source: John M. Burns, 13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002, December 17, 2002

3. In 1997, twelve dairy cows died on a farm in Hesse, Germany after being fed a diet with Bt corn.

Source: Henning Strodthoff and Christoph Then, Is GM maize responsible for deaths of cows in Hesse?, Greenpeace Report, Greenpeace e.V.22745 Hamburg. December 2003.

4. Liver cells of mice fed Roundup Ready soybeans developed irregularly shaped nuclei and nucleoli, an increased number of nuclear pores and other changes.

Source: M. Malatesta, C. Caporaloni, S. Gavaudan, M.B. Rocchi, S. Serafini, C. Tiberi, G. Gazzanelli, Ultrastructural Morphometrical and Immunocytochemical Analyses of Hepatocyte Nuclei from Mice Fed on Genetically Modified Soybean, Cell Struct Funct. 27 (2002): 173-180

5. Mice fed GM soy showed changes in the synthesis and processing of digestive enzymes. The production of alpha-amylase, a major digestive enzyme, dropped by as much as 77%.

Source: Malatesta et al, Ultrastructural Analysis of Pancreatic Acinar Cells from Mice Fed on Genetically Modified Soybean," 409

6. The structure and gene expression of testicle cells of mice fed Roundup Ready soybeans changed significantly.

Source: L. Vecchio et al, Ultrastructural Analysis of Testes from Mice Fed on Genetically Modified Soybean, European Journal of Histochemistry 48, no. 4 (Oct-Dec 2004): 449-454

7. Rabbits fed GM soy for about 40 days showed significant differences in the amounts of certain enzymes in their kidneys, heart and livers.

Source: Tudisco et al, Genetically Modified Soybean in Rabbit Feeding: detection of DNA Fragments and Evaluation of Metabolic Effects by Enzymatic Analysis, 193-199.

8. In a single year, 1999, soy allergies in the United Kingdom jumped from 10 percent to 15 percent of the sampled population. GM soy was imported into the country shortly before 1999.

Source: Mark Townsend, Why soya is a hidden destroyer, Daily Express, March 12, 1999.

9. The livers of rats fed GM canola were 12-16 percent heavier than those fed non-GM varieties. Heavier livers may indicate liver disease or inflammation.

Source: Comments on ANZFA about Applications A346, A362 and A363 from the Food Legislation and Regulation Advisory Group (FLARG) of the Public Health Association of Australia (PHAA) on behalf of the PHAA, Food produced from glyphosate-tolerant canola line GT73.

10. The death rate for chickens fed Chardon LL GM corn for 42 days was twice of that among controls. GM-fed chicken also had more erratic body weight and food intake, and less weight gain overall/

Source: S. Leeson, The Effect of Glufosinate Resistant Corn on Growth of Male Broiler Chickens, Department of Animal and Poultry Sciences, University of Guelph, Report No. A56379, July 12, 1996.

11. Protein produced by GM peas generated a dangerous immune response in mice. The response in mice suggested that the GM peas could provoke inflammatory or allergic reactions in humans.

Source: V.E. Prescott, et al, Transgenic Expression of Bean r-Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity, Journal of Agricultural Food Chemistry (2005): 53.

12. One brand of food supplement L-tryptophan created a deadly US epidemic in the 1980s. About 100 people died while 5,000-10,000 fell sick.

Source: William E. Crist, The Toxic L-Tryptophan Epidemic"