1 December 2008
To Whom It May Concern
I write on behalf of the Institute of Science in Society (I-SIS), a civil society organisation dedicated to providing critical scientific information to the public and to promoting social accountability and ecological sustainability in science. Our scientists have monitored and reviewed extensive scientific literature and empirical evidence on genetically modified organisms (GMOs) over the past ten years. I am on the Roster of Experts for the international Cartegena Protocol on Biosafety that seeks to protect biological diversity from the potential risks of GMOs and came into force on 11 September 2003.
We fully concur with Dr. Pushpa Bhargava’s recommendations to the Genetic Engineering Approval Committee (GEAC) on the biosafety assessment of GMOs, and take great exception to GEAC’s defamatory remarks on him and its unscientific and unprofessional response to his recommendations. We are referring to GEAC’s Counter Affidavit of September 2008, the Indian Government’s ‘Reply’ to the Application filed by Aruna Rodrigues and others in August 2008 (Reference Application I.A. No. 25 of 2008 in the matter of Writ Petition (Civil) No. 260 of 2005).
Dr. Bhargava, founder and director of India’s prestigious Centre for Cellular and Molecular Biology, is an acknowledged world-class authority on genetic engineering, biotechnology and molecular biology, and highly regarded in international scientific circles. GEAC’s defamatory remarks on him betray its possible lack of competence in the relevant scientific and technological disciplines on which the Committee is providing advice to the Indian Government, and/or its willingness to compromise science to serve vested interests in GMO approval.
All of Professor Bhargava recommendations are fully justified on the most rigorous scientific basis as key elements of biosafety assessment, and consistent with widely recognized standards of good, responsible science; as is also clear from both the text and ‘annexures’ to the Petitioner’s Rejoinder Affidavit of November 2008. Ample evidence has been presented in depositions by several leading biosafety experts appended to the Rejoinder Affidavit.
In the Rejoinder Affidavit of November 2008 the Petitioners have abstracted the essential elements of a biosafety assessment protocol from world-class biosafety experts in section 23, and noted that Dr Bhargava's guidelines are virtually the same. The testing procedures outlined in Section 23 of the Rejoinder, which are to be combined with standard crop testing procedures, to determine if a new GM product falls within the accepted norm of safety of current food crops, are:
1. The Ames test for mutagenicity
2. Metabolic Profiling for toxic and nutritional compounds; to detect unexpected changes in small-molecule metabolism
3. Molecular analysis of the gene insertion sites and transformation-induced mutations
4. Extended multigenerational animal feeding studies for carcinogenic, reproductive, and other adverse effects
5. Allergenicity testing,
6. Genomic profiling/DNA Finger Printing/Proteomics
7. Gene flow, testing on non-target organisms, soil micro-organisms
8. Post market surveillance, both health and the environment
The list is complete except for tests on genetic stability of the GM insert, which is required in EU Directive for environmental release, although it is seldom enforced (see Transgenic Lines Unstable hence Illegal and Ineligible for Protection (https://www.i-sis.org.uk/transgenicLinesUnstable2.php). Transgenic instability in the field essentially compromises all safety assessment performed before environmental release, a point that has been stressed by ISIS from the beginning.
The Austrian Government study published in November 2008 (GM Maize Reduces Fertility & Deregulates Genes in Mice https://www.i-sis.org.uk/GmMaizeReducesMiceFertility.php), followed by a peer-reviewed report from the Italian Government showing that GM Maize Disturbs Immune System of Young and Old Mice (https://www.i-sis.org.uk/MON810gmMaizeMiceImmuneSystem.php) confirm a string of previous findings on adverse health impacts from GM food and feed, which has served to convince scientists like us that GM is Dangerous and Futile (https://www.i-sis.org.uk/GMDangerousFutile.php), essentially because the technology is based on an obsolete view of genetics.
The recent studies find problems with fertility, immune response and gene regulation in different GM maize varieties by carrying out precisely the kind of tests recommended by Dr Bhargava and other scientists; i.e., long-term multi-generational feeding trials, coupled with DNA arrays, proteins and metabolic profiling. The GM crops in the feeding trials have been commercialized; they were approved by government regulators in United States and Europe that have ignored stern scientific warnings over safety, as documented in ISIS’ peer-reviewed publication (Ho MW, Cummins J and Saunders PT. GM food nightmare unfolding in the regulatory sham. Microbial Ecology in Health and Disease 2007, 19, 66-77, https://www.i-sis.org.uk/pdf/GM_Food_Nightmare_Unfolding.pdf). GEAC should not be allowed to repeat their mistake, which is overwhelmingly condemned by the European and American public.
For India to implement the series of assessments recommended by Dr. Bhargava and other scientists would not only be good science, but would also be extremely prudent government policy in view of India’s great genetic biodiversity, and her many farming communities whose health and livelihood depend on crops that are proven safe and productive through appropriate tests. At the very least, a five-year moratorium would allow the desired protocols for rigorous safety assessment to be put in place to ensure that any GMO introduced will not cause harm.
ISIS brought together an Independent Science Panel (ISP) of dozens of eminent scientists from nine countries to compile all the evidence on the health and environmental impacts of GM crops on the one hand, and the benefits and successes of non-GM sustainable agriculture on the other. The ISP produced a report in 2003, The Case for a GM-free Sustainable World (https://www.i-sis.org.uk/pdf/GM_Food_Nightmare_Unfolding.pdf), calling for a world-wide ban on further releases of GMOs and a comprehensive shift to non-GM sustainable agriculture. The report was translated into at least 5 languages and republished within a year. Our demands have proven all the more relevant and urgent since then, as evidence of harm from GMOs has accumulated further, while organic, localized agriculture is now widely acknowledged as the solution to the current food, fuel and financial crisis as well as the most important means for mitigating and adapting to climate change (see ISIS Report, Food Futures Now: *Organic *Sustainable *Fossil Fuel Free (https://www.i-sis.org.uk/foodFutures.php)
Dr. Mae-Wan Ho
Institute of Science in Society
Article first published 08/12/08
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