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GMO2009 - Biotechnology,GMOs2009 What is Biotechnology The...

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Biotechnology, GMOs 2009
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What is Biotechnology ? The application of technology to improve a biological organism. Modification of the biological function of an organism by adding genes (from another organism?) or
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But is there all of the diversity we need (want?) A rich source of variation already exists in nature. Is biotechnology necessary?
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World Food Supply: World Food Supply: We will have to double it by 2050 We will have to double it by 2050 75% of future growth must come from lands already in use Most of the production growth must occur in countries where it is consumed, including in marginal areas where many of the poor reside Limited potential for land expansions, except in the Americas and Sub- Saharan Africa Irrigation expansion crucial to meeting food demand
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What Happened to Early GE Crops and Why
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Who’s In Charge (1989-1990)? NIH – only agency with policies specific to biotechnology. FDA, USDA, EPA & OSHA competing for jurisdiction. Discovered: no agency w/clear jurisdiction over transgenic crops.
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With its first submittal in November 1990 for approval of the nptII selectable marker, Calgene did not want the confidentiality usually maintained by the FDA. Instead, the company requested that all findings and issues be made public.
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Result: Interagency group management of transgenic crops USDA given primary responsibility for regulation of specific research, product development and commercial applications. FDA given principal jurisdiction over products for human and animal food (CFSAN enforces policy). CFSAN – Center for Food Safety and Applied Nutrition. Calgene formally requested FDA advisory opinion on “marker gene” – even before CFSAN had developed appropriate regulatory path. Petitions to consider it an “additive.” EPA given jurisdiction for products that potentially contain pesticide residues.
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In May 1991, the FDA published its findings and called for comments on the marker gene (note that the first filing was for the marker, not the whole product, sort of a "straw man" for things to come). Only 43 public comments were received. In August 1991, Calgene submitted a second filing for the whole tomato.
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In May 1992, the FDA published a policy on genetically engineered foods and concluded that the technology did not make a difference. However, rather than coming directly from the FDA, this policy came via Dan Quayle's Council on Competitiveness, possibly not the most appropriate medium for such an important message.
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May 1992 FDA states that it will regulate biotechnology-derived food products in the same manner as conventional food products. Will not require special testing or labeling unless major modifications (e.g., GRAS) or foreign genes had been inserted. (GRAS = Generally Regarded As Safe, i.e. no detectable significant differences of major components from a the non-transformed parent.)
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Public Reaction Jeremy Rifkin (Foundation on Economic Trends) Argues FDA’s standards are too lax Primarily concerned with marker gene Rifkin actions
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