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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE 24 February 2005
RE: FDA DRAFT GUIDANCE FOR EARLY FOOD SAFETY EVALUATION OF EXPERIMENTAL GE CROPS The Open-Ended Technical Expert Group on Identification Requirements of Living Modified Organisms Intended for Direct Use as Food or Feed, or for Processing will meet in Montreal from 16-18 March 2005. This is a group set up under the Cartagena Protocol on Biosafety. Issues related to the unintentional presence of genetically engineered organisms will be pertinent to the discussions. In this respect, we wish to bring to your attention a draft "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use" that was issued by the Food and Drug Administration (FDA) of the United States in November 2004. Comments were invited on this draft Guidance by 24 January 2005. The stated purpose of the draft Guidance is to set up a voluntary mechanism for "early food safety evaluation" of new (non-pesticidal) proteins from experimental bioengineered or genetically engineered plants intended for food use, which are being field-tested. This is to address the likelihood that cross-pollination and commingling of seeds will occur, resulting in the presence of untested novel proteins in the food supply. While the FDA has recognized the need to address the unintentional presence of untested or insufficiently tested proteins in the food chain - a phenomenon commonly known as "contamination" - the proposed "early food safety evaluation" is inadequate for genuine food safety evaluation. The proposed process is non-mandatory, and fully reliant on companies and developers to voluntarily provide a synopsis of safety data and information about the new protein, focussed mainly on toxicity and allergenicity. The concern over toxicity and allergenicity is welcome, but the scope and substance of the proposed data and information that should be provided is limited. There is no specific mention of the need to assess changes in nutritional composition, nor for comprehensive animal feeding trials or tests for unintended effects caused by genetic engineering. The draft Guidance assumes that if a protein introduced in one plant species raises no safety concerns, this implies that the introduction of that same protein in another species is likewise "safe", thereby ignoring potential problems related to unintended insertion events (e.g., gene silencing). Unintended effects of genetic engineering are an acknowledged risk factor by the Codex Alimentarius Commission, the joint agency of the World Health Organization and the UN Food and Agriculture Organization, responsible for the international regulation of food safety. Instead of a voluntary process, strict rules and procedures to prevent contamination of the food supply with transgenic proteins are necessary, as is a mandatory, science-based and rigorous review process designed to ensure food safety. Such safety assessments should be long term, intergenerational and on the whole food, not just on the new substance that the genetically engineered plant produces. Given the concerns about the inadequacies of the early food safety evaluation as currently described in the FDA draft Guidance, confidence in the process is not justified. However, if the new proteins are deemed by the FDA to not raise food safety concerns, this effectively permits contamination of the US food supply with experimental and inadequately tested transgenic proteins. Countries that import food from the US could also be affected, and efforts to ensure zero tolerance for unapproved and experimental transgenic proteins in their food supply may be compromised. It is unclear how the FDA, with this draft Guidance, intends to comply with other countries' domestic regulations for unapproved or unauthorized genetically engineered organisms. As most developing countries lack the regulations, capacity and means to enforce biosafety legislation or bans, the reality remains that unapproved genetically engineered organisms may slip through. Short of FDA specifically notifying importing countries of the presence of unapproved novel proteins in US food exports and providing the necessary reference materials to facilitate detection and identification, the only way other countries can determine if there is presence of unapproved genetically engineered material is to randomly test for their presence. However, this shifts the burden and costs of testing on the recipient countries and does not provide a guarantee of detection and identification. The FDA reportedly intends to use this draft Guidance as an international model to address the presence of low levels of genetically engineered plant material in non-genetically engineered crop fields. However, many countries have already expressed their concern over the potential adverse impacts of genetically engineered plants and food, and view contamination seriously. Meanwhile, 113 countries have ratified the Cartagena Protocol on Biosafety. The Protocol specifically preserves the right of importing countries to reject or place conditions on the import of genetically engineered organisms intended for food or feed, and to formulate their own biosafety legislation, which can be crafted to keep them GE-free. The draft Guidance is available at http://www.cfsan.fda.gov/~dms/bioprgui.html With best wishes,
Third World Network
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