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'The ICMR Overlooked an Extensive Scientific Knowledge Base'

Prof. Nirmal Kumar Ganguly
Director General, Indian Council of Medical Research
V. Ramalingaswami Bhawan, Ansari Nagar,
New Delhi - 110029, India

Dear Prof. Ganguly:

Sub: The Importance of Evidence-Based Risk Assessments with GM Crops

By C.S. Prakash [and ten other co-authors listed at the bottom of the document]
August 10, 2004

After reviewing the April, 2004, report by the Indian Council of Medical Research (ICMR) entitled Regulatory Regimen for Genetically Modified Foods, The Way Ahead, we were disappointed that the ICMR overlooked the extensive scientific knowledge base supporting the food, feed and environmental safety of biotechnology-derived crops and foods, and economic and environmental and benefits to farmers and consumers.

The ICMR acknowledged that biotech crops are important for improving Indian agricultural productivity, through improvements in stress tolerance, soil nutrient utilization, nutritional enhancement, pest resistance and herbicide tolerance, and that biotech crops have the potential to improve food quality, nutrition and health. However, they ignored the extensive safety assessments and expert analyses that have accompanied the approval of the current biotech crops.

Instead, ICMR stated "there is limited scientific evidence regarding their toxicity or health risks, the methodology used for assessing the risks is not robust enough or sensitive enough, and the molecular and genetic effects of the technology are unpredictable in nature." Respectfully, these views are not shared by the dozens of scientific and regulatory authorities all over the world that have reviewed and accepted the extensive and growing base of published scientific information that established or confirmed the safety and benefits of biotech crops and foods.

We invite the ICMR to engage the expert community of scientists that have examined and researched the potential risks referenced in their report. Information is readily available through the scientific literature and via consultation with local and international experts. We recognize that certain opponents of biotechnology-derived crops remain skeptical and continue to focus on potential risks - even though these crops have been rigorously examined according to internationally accepted methods and standards. These potential risks represent perceptions, not realities.

An important first step toward improving the dialogue and eventual understanding of the issues surrounding biotech crops is to carefully evaluate the extensive scientific knowledge base that exists to address the potential risks. The ICMR should do this on behalf of those concerned about biotech crop safety, so that this critically important information is widely communicated and readily available to all. Failure to do this reinforces perceptions and fears that are not supported by the facts -- it is critical that ICMR conduct an evidence-based risk assessment, based on the breath of publicly available evidence.

The ICMR acknowledged that biotech food, feed and environmental safety assessment has been addressed by international organizations, including the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organization (FAO), World Health Organization (WHO) and Codex Alimentarius Commission (CAC). Unfortunately, they did not report the findings of these authorities, or the conclusions of other international regulatory bodies that have examined and approved biotech crops.

Here are some recent statements that relate directly to the questions raised by ICMR:

"Current internationally agreed approaches to the safety assessment of GM food crops offer a high level of safety assurance for the consumer." - ENTRANSFOOD, 2004

"GM foods share the same types of health risks as conventional foods. There is no plausible hypothesis suggesting long-term harm from GM foodsŠ and that the best defense against long-term health risks from GM foods is an effective pre-market safety assessment process. Experts view the regimen of safety tests as adequate" - U. S. GAO, 2002

" To date, no adverse health effects attributed to genetic engineering have been documented in the human population." - U.S. NAS, 2004

"Thus far, in those countries where transgenic crops have been grown, there have been no verifiable reports of them causing any significant health or environmental harm" -FAO, 2004

"The BMA shares the view of the Royal Society that there is no robust evidence to prove that GM foods are unsafe. However, we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit." - BMA, 2003

"The responsible genetic modification of plants is neither new nor dangerous. The addition of new or different genes into an organism by recombinant DNA techniques does not inherently pose new or heightened risks relative to the modification of organisms by more traditional methods, and the relative safety of marketed products is further ensured by current regulations intended to safeguard the food supply." - Statement by 25 Nobel Prize Winners and over 3,400 International Scientists, 2004 http://www.agbioworld.org

"With regard to health issues, tests on toxicity and allergenicity have been and are being conducted. So far none has shown significant toxic or allergenic harm. No peer-reviewed article on clinical trials or epidemiological study reporting adverse effects on human health has yet appeared. Where there have been indications of potential unacceptable effect, the present mechanisms have enabled us to identify them and prevent such products coming to the market." - OECD, 2000

Biotechnology offers opportunities to increase the availability and variety of food, increasing overall agricultural productivity while reducing seasonal variations in food supplies. Through the introduction of pest-resistant and stress-tolerant crops, biotechnology could lower the risk of crop failure under difficult biological and climatic conditions. Furthermore, biotechnology could help reduce environmental damage caused by toxic agricultural chemicals." - FAO, 2004

"GM crops have demonstrated the potential to reduce environmental degradation and to address specific health, ecological and agricultural problems which have proved less responsive to the standard tools of plant breeding and organic or conventional agricultural practices. Thus, we affirm the conclusion of our 1999 Report that there is an ethical obligation to explore these potential benefits responsibly, in order to contribute to the reduction of poverty, and to improve food security and profitable agriculture in developing countries." - Nuffield Council on Bioethics, 2003

These conclusions represent a broad consensus of international scientific and regulatory experts, and are just a few examples from a comprehensive database of published work focused on assessing and assuring food, feed and environmental safety of biotech crops.

We encourage ICMR to further explore this database of information and to provide a more thorough and thoughtful analysis to the authorities and public. We recommend the following reports and scientific reviews:

National Academy of Sciences Report on the Safety of Biotech Foods A new report from the National Academy of Sciences' Institute of Medicine entitled "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects" focuses on identifying and assessing potential unintended effects of novel foods on human health. The report discusses unintended effects resulting from genetic modification, including traditional breeding, genetic engineering, chemical mutagenesis and irradiation, all processes that can introduce unintended compositional changes in a food crop. The full report is available at: http://www.nap.edu/catalog/10977.html.

ILSI Taskforce Paper on Nutritional Assessments of Biotech Foods A publication prepared by the International Life Sciences Institute's (ILSI) Food Biotechnology Committee Task Force entitled "Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology" contains chapter reviews in the following topic areas: Introduction of Modern Agricultural Biotechnology; Improved Nutrition through Modern Biotechnology; Safety Assessment of Nutritionally Improved Foods and Feeds Developed through the Application of Modern Biotechnology; Nutritional Assessment Process for Nutritionally Improved Food Crops; Nutritional Assessment of Animal Feeds Developed through the Application of Modern Biotechnology; The Role of Analytical Techniques in Identifying Unintended Effects in Crops Developed through the Application of Modern Biotechnology; and Postmarket Monitoring of Foods Derived through Modern Biotechnology. The paper is available at: http://www.ift.org/pdfs/crfsfs/crfsfsv3n2p0035-0104ms20040106.pdf.

ISNAR / IFPRI Report on Biotech Research Programs A report "To Reach the Poor - Results from the ISNAR/IFPRI Next Harvest Study on Genetically Modified Crops, Public Research, and Policy Implications" from the International Food Policy Research Institute (IFPRI) in collaboration with the International Service for National Agricultural Research (ISNAR) reviews the public research pipelines for biotech crop development in 16 developing countries including China, South Africa, Indonesia, Argentina, India, Philippines, Egypt, Brazil, Bulgaria, Thailand, Zimbabwe, Pakistan, Costa Rica, Malaysia, Kenya and Mexico. Regulations, GM crop approvals, choice of transgene and policy implications are discussed as they affect the research. Recommendations are also presented that would help sustain and increase efficiency of publicly supported research while meeting the biosafety requirements. The 63-page report (EPTD Discussion Paper No. 116) is available at: http://www.ifpri.org/divs/eptd/dp/papers/eptdp116.pdf.

IFPRI Brief on Food Safety The International Food Policy Research Institute (IFPRI) has released a brief entitled "Food Safety and GM Crops: Implications for Developing Country Research." The report focuses on essential components of capacity building for biotechnology and biosafety, including agreement on reasonable standards for safety in developing countries and competency to assure food safety for biotech. The brief by Joel I. Cohen, Hector Quemada, and Robert Frederick is available at: http://www.ifpri.org/2020/focus/focus10/focus10_16.pdf.

Report on the Impact of Biotech Crops on Biodiversity Professor Klaus Ammann, Head of the Botanical Garden in Berne, Switzerland has issued a report "Biodiversity and Agricultural Biotechnology - A Review of the Impact of Biotechnology on Biodiversity." The study is a comprehensive review of the relevant literature on the impact of agricultural biotechnology on biodiversity in comparison with other commonly used agricultural practices. The complete report is available at: http://www.botanischergarten.ch/Biotech-Biodiv/Report-Biodiv-Biotech3.doc.

International Council for Science Report on Biotech Crops The International Council for Science (ICSU) has published a report "Food and Agriculture: Scientific Discoveries - Societal Dilemmas." The report represents an analysis of a selection of approximately 50 science-based reviews published by national academies of science, governments, international organizations, and private agencies in years 2000-2003 covering modern genetics and its applications in food, agriculture and the environment. The report addresses five key questions about genetically modified food and living modified organisms: Who needs them? Are they safe to eat? Will there be any effects on the environment? Are the regulations adequate? Will they affect trade? ICSU represents more than 100 science academies including the U. S. National Academy of Science and the UK's Royal Society. The full report along with additional background research from the study is available at: http://www.icsu.org.

Publications on Genetically Modified Food Safety Assessment

* "Assessment of the food safety issues related to genetically modified foods"describes an international consensus on the principles regarding evaluation of the food safety of genetically modified plants. Kuiper HA, Kleter GA, Noteborn HPJM, Kok EJ. 2001. Plant Journal 27 (6): 503-528.

* "Safety assessment of genetically modified foods" discusses the extensive and comprehensive safety assessment process widely employed for genetically modified crops with emphasis on food and feed uses. Taylor, SL. 2001. Journal Of Nematology 33 (4): 178-182.

* "Food safety evaluation of crops produced through biotechnology" examines the principal food safety issues associated with genetically modified crops, including 1) potential toxicity of the newly introduced protein(s), 2) potential changes in allergenicity, 3) changes in nutrient composition, 4) unintended effects giving rise to allergenicity or toxicity and 5) the safety of antibiotic proteins included with the transgene. Chassy, BN. 2002. Journal Of The American College Of Nutrition 21 (3): 166S-173S Suppl.

Publications on Environmental Safety Assessment and Impacts of Genetically Modified Crops

* "The release of genetically modified crops into the environment - Part I. Overview of current status and regulations" discusses environmental risk assessment of genetically modified crops and regulatory approaches in different world areas. Nap JP, Metz PLJ, Escaler M, Conner AJ. 2003. Plant Journal 33 (1): 1-18.

* "The release of genetically modified crops into the environment - Part II. Overview of ecological risk assessment" examines key issues in the environmental assessment of genetically modified crops, including the potential for invasiveness, vertical or horizontal gene flow, other ecological impacts, effects on biodiversity and the impact of presence of genetically modified material in other crops. Conner AJ, Glare TR, Nap JP. 2003. Plant Journal 33 (1): 19-46.

* "Comparative Environmental Impacts of Biotechnology-derived and Traditional Soybean, Corn, and Cotton Crops" is a comprehensive scientific literature review of the environmental impacts of biotechnology-derived crops in relation to the current agricultural practices for crop and pest management in conventionally bred crops. The impacts examined include: changes in pesticide use patterns, soil management and conservation tillage, crop weediness, gene flow and outcrossing, pest resistance, pest population shifts, nontarget and beneficial organisms, land use efficiency/productivity and human exposure. Carpenter J, Felsot A, Goode T, Hammig M, Onstad D, Sankula S. 2002. http://www.talksoy.com/ComparativeStudy/default.htm

* "Biodiversity: the impact of biotechnology" reviews the various aspects of biodiversity in relation to biotechnology and includes the combined contributions of scientists, industrialists, and governmental and public interest organisations across Europe. This 2001 briefing paper by the European Federation of Biotechnology is intended to provide balanced information and advance public debate. http://www.botanischergarten.ch/EFB/Biodiversity(EFB).pdf

The Indian public places a great deal of confidence in the assessments and perspectives provided by authorities, including the ICMR. We believe that the public is entitled to a thorough assessment of all available, scientific information. This is a substantial undertaking given the extensive amount of information available. We encourage the ICMR to undertake such an assessment and disseminate the information publicly. We are confident that ICMR will reach the same conclusion as other leading scientists and authorities around the world, namely that the currently approved biotech crops have been thoroughly assessed for food, feed and the environmental safety, according to well-established, internationally accepted, scientific standards and guidelines, and found to be wholesome, nutritious, and as safe as conventional crops and foods. These are the facts -- ICMR needs to base their assessment and recommendations on evidence-based risk assessments.

We thank you for this opportunity to provide you with this information. We look forward to hearing from you,

Signatories to the Letter:

Dr. Gurdev Khush, Scientist Emeritus, International Rice Research Institute
Prof. C Kameswara Rao, Foundation for Biotechnology Awareness and Education, Bangalore
Dr. Seetharam Annadana ASR BIOTEC &, Keygene Genetics, Bangalore
Dr. Gurumurti Natarajan, Emirates Agriculture Technologies, Sharjah, UAE
Prof. Klaus Ammann, Director, Botanical Garden, Berne, Switzerland
Prof. David Tribe, University of Melbourne, Australia
Dr. Sivramiah Shantharam, President, Biologistics International, USA
Prof. Richard Roush, Director, IPM Program, University of California, USA
Prof. K. V. Raman, Cornell University, USA
Prof. Bruce Chassy, Associate Dean, University of Illinois, USA
Prof. C. S. Prakash, President, AgBioWorld Foundation, Inc. USA