Biotechnology

Announcements	Presentations & Testimony	Information for Consumers
Regulations & Guidance	Products: Completed Consultations	Compliance
Food Labeling		International
Center for Veterinary Medicine	Other Government Agencies	Non-Government Information

Announcements

2002

• FDA Action on Corn Bioengineered to Produce Pharmaceutical Material November 19, 2002
• Notice of Meeting. Food Advisory Committee: Food Biotechnology Subcommittee Meeting, August 13-14, 2002. July 25, 2002
• Genetically Modified Foods: Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced GAO-02-566, May 23, 2002

2001

• FDA and CDC Reports to EPA on Cry9C in StarLink^TM Corn
  • CDC: Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn
  • FDA Documents:
    • Food and Drug Administration cover letter regarding their findings concerning StarLink^TM (available in PDF) June 12, 2001
    • FDA Evaluation of Consumer Complaints Linked to Foods Allegedly Containing Containing StarLink^TM Corn (available in PDF) June 13, 2001
    • Development and Use of a Method for Detection of IgE Antibodies to Cry9C (available in PDF, 6.26 Mb) June 13, 2001
  • Additional FDA letters to EPA regarding StarLink^TM Corn
• FIFRA Scientific Advisory Panel Meeting on July 17-19, 2001 on StarLink^TM
• How to Facilitate a Traceback Investigation: Overall Program Evaluation May 2001
• FDA 2002 Performance Plan: Biotechnology Strategies April 2001
• Second Joint Symposium on Food Safety and Nutrition, July 11-13, 2001: Current Issues in Food Biotechnology
• Letter About Updated Internet Site Regarding Completed Consultations Between FDA and Developers of Foods Derived Through Biotechnology March 14, 2001
• FDA Announces Proposal and Draft Guidance for Food Developed Through Biotechnology January 17, 2001

2000

• U.S. District Court Dismisses Genetically Engineered Food Law Suit Against FDA October 6, 2000
• FDA to Strengthen Pre-Market Review of Bioengineered Foods May 3, 2000
• Clinton Administration Agencies Announce Food and Agricultural Biotechnology Initiative: Strengthening Science-Based Regulation and Consumer Access to Information May 3, 2000

1999

• FDA Announces Meetings on Bioengineered Foods October 18, 1999
  • More information on Public Meetings
• Announcement Archives

FDA Presentations and Testimony about Bioengineered Foods

• Statement by CFSAN Director Joseph A. Levitt before the Senate Committee on Health, Education, Labor, and Pensions September 26, 2000
• Association for Food and Drug Officials (AFDO) Millenium Conference June 19, 2000 Presentation -- FDA's Policy on Genetically Modified Food
• Testimony Before the Senate Committee on Agriculture, Nutrition and Forestry October 7, 1999
• Presentation Archives

Information for Consumers

• Genetic Engineering: The Future of Foods? FDA Consumer, November-December 2003
• Cloning: Revolution or Evolution in Animal Production? FDA Consumer, May-June 2003
• Proposed Rules Issued for Bioengineered Foods FDA Consumer, March-April 2001
• Are Bioengineered Foods Safe? FDA Consumer, January-February 2000
• Bioengineered Foods: Will They Cause Allergic Reactions? from Food Allergy News, October-November 1997

Regulations and Guidance on Safety Assessments

• Statement of Policy: Foods Derived From New Plant Varieties (available in PDF, 2 MB) Federal Register, May 29, 1992
• Proposed Rule: Premarket Notice Concerning Bioengineered Foods January 18, 2001
• Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants - September 1998
• Consultation Procedures under FDA's 1992 Statement of Policy: Foods Derived from New Plant Varieties - October 1997
• Summary: Conference on Scientific Issues Related to Potential Allergenicity in Transgenic Food Crops April 18-19, 1994

Products

• List of Completed Consultations on Bioengineered Foods

Food Labeling

• Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering January 17, 2001
• Report on Consumer Focus Groups on Biotechnology and Labeling October 20, 2000

Compliance

• Guidance for Industry: FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues January 19, 2001

International

• Codex Ad Hoc Intergovernmental Task Force on Food Derived from Biotechnology
  • Elaboration of Standards, Guidelines or Other Principles for Foods Derived from Biotechnology December 27, 1999
• International Activities and Codex

Additional Information

• Information from FDA's Center for Veterinary Medicine
  • Biotechnology in Animals and Feeds
  • A New Kind of Fish Story: The Coming of Biotech Animals FDA Consumer Magazine - January/February 2001
     
• Information from Other Federal Government Agencies
  • United States Regulatory Agencies Unified Biotechnology Website
  • U.S. Department of Agriculture
    • Biotechnology Information Center
  • U.S. Environmental Protection Agency
    • Office of Pesticide Programs
       
• Information from Non-Government Sources
  • Food and Agricultural Organization of the United Nations
    • Food and Nutrition Division's Biotechnology Home Page