Generally Recognized As Safe . . .
20482 Jacklight Lane 541-678-5522
Bend, OR 97702-3074 mcquate@gras-associates.com
www.gras-associates.com
Biography
Dr. George Pauli retired from the Food and Drug Administration in March 2006 after nearly 29 years of service in the food and color additive program. During his tenure with FDA, he held several leadership and management positions that addressed food ingredient safety, considering GRAS ingredients, direct and indirect food additives, and color additives. His influence has been noted in first implementing FDA’s carcinogenic constituents policy in the early 1980s, and he was instrumental in advancing the agency position on food irradiation and oversaw many FDA decisions on genetically engineered foods.
Dr. Pauli guided the safety evaluations of a number of unique or high profile topics that included the food uses of olestra and the use of methylene chloride as a decaffeinating agent. While serving as Director of the Division of Product Policy, he headed efforts at replacing FDA’s GRAS petition and regulation process with the notification process that is in effect today. Included among the various posts held by Dr. Pauli was that of Acting Director of the Office of Food Additive Safety. He has also served on expert panels for the World Health Organization in addressing food irradiation safety topics.
Dr. Pauli has received numerous awards during his career, including FDA’s highest honor, the Award of Merit.
FDA/ Center for Food Safety & Applied Nutrition (1977-2006)
Associate Director for Science and Policy, Office of Food Additive Safety
2001 -- 2006
- Oversaw cross-cutting issues within the Office; Ensured consistency among Divisions; Evaluated and recommended policy as needed; Provided rapid response analysis for Center issues.
- Served as major spokesman to press on food additive issues
- Served as Acting Director, Office of Food Additive Safety, February 2004-June 2004
Director, Division of Product Policy, Office of Premarket Approval
1992 -- 2001
- Directed multidisciplinary (Regulatory Affairs; Chemistry; Toxicology; Environmental Science) unit that evaluated safety and regulatory status of bioengineered foods; irradiated foods; food contact substances; and food ingredients.
- Led development of science and regulatory policy, including reform of policy for implementing GRAS provisions of law, for novel food ingredients and technologies.
- Communicated basis for FDA safety and regulatory decisions via Federal Register and other means.
- Led development of regulatory and safety decisions for novel ingredients and bioengineered foods such as: olestra; sucralose; aspartame; acesulfame potassium; genetically engineered plants and bacteria.
Chief, Novel Ingredients and Biotechnology Branch, Division of Food and Color Additives
1990 -- 1992
- Recruited, trained and directed scientists in a regulatory role concerning novel ingredients, biotechnology, and food irradiation.
Deputy Program Manager, Food and Color Additives Program
Supervisor, Food Additive Policy Staff, Division of Food and Color Additives
1985 -- 1990
- Led small staff to develop regulatory positions for novel or controversial issues such as irradiation, chlorinated dioxins in paper, methylene chloride in coffee.
Supervisor, Petitions Control Branch, Division of Food and Color Additives: 1981-1985
- Led petition review and regulation development for several color additives.
- Supervised development and implementation of carcinogenic constituents policy.
- Supervised development and implementation of food irradiation policy.
Consumer Safety Officer, Petitions Control Branch, Division of Food and Color Additives
1977 -- 1981
- Managed petition review of indirect food additives.
- Served as Bureau of Foods project manager for immunotoxicity research.
- Served on small working group to develop Bureau of Foods Research Plan
Resume
Private Sector & Academic Experience
- Research Associate, Emulsion Polymer Research Institute, Lehigh University: 1976-1977
- Assistant Professor, Chemistry Department, Lafayette College: 1967-1976
Education
- Bachelor of Science in Chemistry, University of Michigan, 1961
- Doctor of Philosophy (Physical Chemistry), Indiana University, 1968.
Awards
- FDA Distinguished Career Service Award 2006
- CFSAN Distinguished Career Service Award 2006
- CFSAN Exceptional Achievement Award 2006 (Allergen Labeling Notifications Workgrouo)
- FDA Award of Merit 2005
- CFSAN Legacy Award 2004
- CFSAN 2001 Team Award (Omega-3 Health Claim Support)
- National Partnership for Reinventing Government 2000 (Spice Reconditioning Group)
- CFSAN 1999 Special Recognition Award (GRAS Notification Group)
- FDA 1996 Award of Merit (Olestra Group)
- FDA 1993 Group Recognition Award (CFSAN Reorganization)
- FDA 1992 Commissioner's Special Citation
- FDA 1985 Commendable Service Award (Food Irradiation)
Publications
- G.H. Pauli and L.M. Tarantino, FDA Regulatory Aspects of Food Irradiation, Journal of Food Protection, 58: 209-212 (1995).
- George H. Pauli, Evaluating the Safety of Irradiated Foods, in Radiation and Public Perception, Jack P. Young and Rosalyn Yalow, ed., Advances in Chemistry Series 243, American Chemical Society, Washington DC, 1995.
- George H. Pauli, Food Ingredient Safety Evaluation, in Food Safety Assessment, John W. Finley, Susan F. Robinson, and David J. Armstrong, ed., ACS Symposium Series 484, American Chemical Society, Washington DC, 1992.
- Edward J. Machuga, George H. Pauli and Alan M. Rulis, A threshold of regulation policy for food-contact articles, Food Control 3:180 (1992).
- A.M. Rulis, P.J. McLaughlin, P.A. Salsbury, and G.H. Pauli, Carcinogenic Impurities in Food and Color Additives - An Analysis of Presumptive Risk Levels, in The Analysis, Communication and Perception of Risk, B.J. Garrick and W.C. Geckler, ed., Plenum Press, New York, 1991.
- G.H. Pauli., Food irradiation in the United States, in Food Irradiation, S. Thorne, ed., Elsevier, London, 1991.
- G.H. Pauli and C.A. Takeguchi, Irradiation of foods: an FDA perspective, Food Reviews International, 2: 79 (1986).
- F. Leo Kauffman, Clyde A. Takeguchi, and George H. Pauli, The Food Irradiation Regulatory Picture in the United States, Radiat. Phys. Chem., 22: 715 (1985).
- George H. Pauli, Chemistry of Food Additives - Direct and Indirect Effects, Journal of Chemical Education, 61: 332 (1984).
- S.M. Ahmed, M.S. El Asser, G.H. Pauli, G.W. Poehlein, and J.W. Vanderhoff, Cleaning Latexes for Surface Characterization by Serum Replacement, J. Colloid Interface Science, 73: 388 (1980).
- M. Askari, G. H. Pauli, W. Schubert and Lothar Schafer, Combined ab initio, Electron Diffraction, Molecular Mechanics and Vibrational Investigations of 1,1-Dimethyl-trans- 2-Decalone, J. Molec. Structure, 37: 275 (1977).
- George H. Pauli, Massoud Askari, Wolfgang Schubert and Lothar Schafer, Combined Vibrational, Conformational and Electron Diffraction Studies of 10-Methyl-trans-2-Decalone, J. Molec. Structure, 32, 145 (1976).
- Wolfgang Schubert, Lothar Schafer and George H. Pauli, Combined Vibrational, Conformational Energy and Electron Diffraction Studies of trans-2-Decalone, J. Molec. Structure, 21, 53 (1974).
- Wolfgang Schubert, Lothar Schafer and G H. Pauli, Conformational Analyses of some trans-2-Decalones, J.C.S. Chem. Comm. 1973, 949.
- George H. Pauli, A Special Topic Approach to the Non-science Major Course, J. Chem. Ed., 50, 210 (1973).
- George H. Pauli, The Molecular Structure of trans-2-Decalone as Determined by Gas Phase Electron Diffraction, J. Am. Chem. Soc., 90, 6432 (1968).
- George H. Pauli, Problems in a Least Squares Analysis of Electron Diffraction Data, Trans. Am. Cryst. Assoc., 2, 126 (1966).
- G.H. Pauli, F.A. Momany and R.A. Bonham, The Structure and Conformational Analysis of Isobutyl Chloride, J. Am. Chem. Soc., 86, 1286 (1964).
Presentations Delivered Since 2000
- George H. Pauli, Update on Regulatory Activities on Food Irradiation, Intertech 2000 Conference, April 2000
- George H. Pauli, Antimicrobials and Preservatives: FDA Perspective, Institute of Food Technologists, June 10, 2000
- George H. Pauli, New Packaging Materials for Irradiation; Regulatory Issues, Institute of Food Technologists, June 11, 2000
- George H. Pauli, Regulatory Considerations for Novel Food Ingredients That Are Intended to Have an Effect on Human Health, Institute of Food Technologists, June 12, 2000
- George H. Pauli, Regulatory Developments with Irradiation and New Biotechnology, U.S. Marine Corps Food Service, December 2000
- George H. Pauli, Ensuring Safety In Food Products: U.S. Regulatory Structure and Functions, Parma, Italy, February 2001
- George H. Pauli, Regulatory Update on Food Irradiation From FDA, Intertech 2001 Conference, February 2001
- George H. Pauli,Regulatory History of Food Irradiation, U. of Illinois-Chicago, June 2001
- George H. Pauli,FDA’s Regulatory Approach to Food Irradiation, Toxicology Forum, Aspen, CO, July 2001
- George H. Pauli,Associate Directorate for Science and Policy Role, Toxicology Forum, Aspen, CO, July 2001
- George H. Pauli,Update on Food Irradiation at the FDA, NIST, October 2001
- George H. Pauli,Triggers for Safety Reassessment on Food Additives, Toxicology Forum, Washington, DC, February 2002
- George H. Pauli, U. S. Requirements for Effective Use of Irradiation As a Sanitary Treatment for Food; IAEA Thematic Planning Meeting on Irradiation as a Sanitary and Phytosanitary Treatment for Food in the New Millennium, Vienna, Austria May 6, 2002
- George Pauli, Regulation of Irradiated Foods and Packaging Used For Irradiation; July 2004 IFT Meeting, Las Vegas, NV
