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Academic Credentials
  • Ph.D., Molecular Genetics and Cell Biology, University of Chicago, 1987
  • M.S., Biology, University of Chicago, 1983
  • B.S., Biology, Saint John's University, 1979
Professional Honors
  • FDA Outstanding Service Award For superior communication surrounding FDA’s draft guidance to the food industry for the voluntary reduction of sodium in processed and commercially prepared foods. (2017)
  • FDA Leveraging and Collaboration Award for successful implementation of a comprehensive, proactive stakeholder engagement strategy that leverages coalitions to achieve food safety and nutrition goals. (2017)
  • FDA Group Recognition Award for superior communication surrounding the FDA’s final determination that partially hydrogenated oils are not “generally recognized as safe” for use in human food. (2016)
  • FAO/WHO Certificate of Appreciation for significant contributions while serving as Chair of the GSFA Working Group of the Codex Committee on Food Additives. (2013)
  • CFSAN Exceptional Achievement Award as a member of the Melamine Infant Formula and Dairy Product Investigation Team for high quality performance to ensure the safety of infant formula and dairy containing foods and responding to consumer concerns. (2009)
  • CFSAN Exceptional Achievement Award as a member of the OFAS Enforcement Activities Team for superior performance in providing support to the Center’s enforcement actions related to food ingredients and food contact substances. (2008)
  • FDA Award of Merit for sustained superior performance and achievement as CFSAN's senior representative to Codex Alimentarius on food additive issues. (2007)
  • USDA’s International Honor Award for exemplary commitment to reduce trade barriers for U.S. food exports in the area of food additives. (2003)

Dr. Keefe has 30+ years working in FDA on food additive regulatory issues and 15+ years working on the development of international standards for food additives in the Codex Alimentarius. From 2011-2022 he was the Director of the FDA's Office of Food Additive Safety (OFAS). OFAS is responsible for the premarket review of food additives, color additives, and food contact substances. It also manages FDA's voluntary programs for Generally Recognized as Safe (GRAS) substances and Foods Derived from New Plant Varieties (Biotechnology Notifications — BNFs), the use of Recycled Plastics in Food Packaging and foods derived from cultured animal cells. Dr. Keefe was integral to the significant accomplishments of the Office during this period. These accomplishments include, folic acid fortification of corn masa flour, removal of partially hydrogenated oils (PHOs) from foods, sodium reduction guidance, negotiation of the voluntary removal of certain PFAS from use in food packaging, revoking previous approvals of the use of phthalates based on abandonment, approval of the use of soy leghemoglobin, and delisting of lead acetate's use in hair coloring. From the mid-1990's until 2011, Dr. Keefe led the Codex Alimentarius effort to develop the Codex General Standard for Food Additives.