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FDA’S FOOD BIOTECHNOLOGY POLICY

FDA’S FOOD BIOTECHNOLOGY POLICY. 2001 and Beyond. New Inititatives for Bioengineeered Foods. Proposed Notification to FDA - 120 days prior to marketing Draft Guidance - Voluntary Labeling Biotechnology Advisory Subcommittee Research. Proposed Pre-Market Notification.

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FDA’S FOOD BIOTECHNOLOGY POLICY

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  1. FDA’S FOOD BIOTECHNOLOGY POLICY 2001 and Beyond

  2. New Inititatives for Bioengineeered Foods • Proposed Notification to FDA - 120 days prior to marketing • Draft Guidance - Voluntary Labeling • Biotechnology Advisory Subcommittee • Research

  3. Proposed Pre-Market Notification • Scope -Bioengineered Plant Derived Foods • Proposed 120 Day Notification • FDA Letter

  4. Proposed Improved Transparency • Industry Notification -FDA Electronic Reading Room • Expanded Web Site Information • Web Links to FDA Evaluation Memos and Letters

  5. FDA Food Labeling Policy • Food Drug and Cosmetic Act • Truthful and not misleading • Common or usual name • Material facts • representations made or implied • consequences of use • Bioengineering - Not Material Fact

  6. Draft Guidance -Voluntary Labeling • Where Firms Disclose Process-Based Information…. • Must be Truthful & Not Misleading • OK - Food Produced/ Not Produced Using Modern Biotechnology • Problem - “GMO” “Free” “Modified”

  7. RESEARCH • Sequence database for assessing allergenicity • Comparison-digestion/acid stability of food allergenic/non-allergenic proteins • Evaluate/develop immunochemical tests methods for food allergens • Detection of human Ab to recombinant food protein Cry9C

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