Dr. Kristina E. Paquette
Senior Scientist Food Contact Legal Matters
E-mail: paquette@efg-law.com
Education
Ph. D. University of Maryland 1994, Analytical/Environmental Chemistry
B.A. University of Kansas 1983, Chemistry
B.A. University of Kansas 1983, Russian
Professional Experience
8/96 Chemist U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition(CFSAN), Office of Food Additive Safety Division of Food Contact
Notifications, Washington DC.
12/94 Environmental Chemist (GS-12 through GS-13), FDA CFSAN Environmental Impact Staff, Washington DC.
9/85 Intelligence Officer (GS-8 through GS-12), Central Intelligence Agency, Washington DC.
Selected Professional Activities
At FDA, evaluated the chemical data and supporting analytical methodology contained in food contact notifications (FCN) submitted by companies requesting approval of new food-contact substances in order to determine quantitatively the chemicals that will be in food due to use of the substances. This involved determining the migration potential of these chemicals from packaging materials into food as exhibited by food-simulating solvents or migration modeling based on Fick's law of diffusion. Wrote detailed reports on my conclusions regarding the estimated human exposure to these chemicals and the adequacy of the chemistry data, which, when coupled with the safety and environmental reviews, determined whether FCNs would be approved. Assisted companies in developing and augmenting their chemistry data submissions via memoranda, guidance document development, and meeting presentations. Provided expert advice to officials and scientists in FDA, other federal agencies, the European Union, private industry, and consumer groups on matters pertaining to the use of recycled plastics and paper in food packaging and to the testing needed to determine exposure to radiolysis products formed in polymeric packaging materials during the irradiation of prepackaged food. Agency expert on evaluating consumer exposure to perfluorooctanoic acid (PFOA) migrating from perfluoropolymer food-contact substances. (1996-2007).
At FDA, reviewed petitions submitted by companies requesting approval of new food additives (including food-packaging materials) in order to determine the environmental impact of such approvals as part of FDA's responsibilities under the National Environmental Policy Act (NEPA). Wrote findings of no significant impact (FONSI) based on analysis of the environmental assessment (EA) portion of petitions. EAs and FONSIs became part of the public record. Assisted companies in preparing and revising EAs via memoranda, guidance document development, and meeting presentations. Extensive experience in conducting life cycle assessments (LCA) of new food-packaging materials (primarily polymers) and in developing methods for calculating and comparing the environmental introductions (to water, air, and soil) and energy use resulting from the production, use, and disposal of these materials to those of currently used materials. Detailed knowledge about the recycling of food-packaging materials (primarily plastics) and the effects of new additives on current recycling processes and on solid waste management in general. (1994-1996).
At CIA, wrote articles and research papers and gave briefings that supported, described, and evaluated intelligence collection programs and Soviet military research, development, testing, and evaluation (RDT&E) activity. In the Office of Soviet Analysis, was in charge of generating an estimate of Soviet expenditures on RDT&E and maintaining its supporting database. At the Foreign Broadcast Information Service, read all chemistry journals published in the Soviet Union (in Russian) and selected items of interest to analysts and policymakers for translation; wrote articles analyzing trends and developments in Soviet chemical research and industry. (1985-1990).
Academia
Graduate Research Assistant, Laboratory of Aqueous Geochemistry, Department of Chemistry and Biochemistry, University of Maryland, College Park, MD. Conducted dissertation research with Prof. George Helz to determine experimentally the solubility of mercuric sulfide (HgS) and the speciation of mercury-sulfide complexes in anoxic conditions to understand better the fate of mercury in estuarine environments such as the Chesapeake Bay. Research included laboratory solubility experiments, computer modeling, and building a homemade cold vapor Hg atomic absorption apparatus to detect ppb levels of mercury. Extensive experience in amperometric, potentiometric, and iodimetric titration of total sulfide, ion chromatography of total sulfur measured as SO42- in the presence of interfering anions, and preparing and analyzing samples in a nitrogen-filled glove box. (1991-1994).
Graduate Research Assistant, Laboratory for Surface Spectroscopy, Department of Chemistry and Biochemistry, University of Maryland, College Park, MD. Conducted research with Assoc. Prof. Janice Reutt-Robey on the sorption of simple molecules onto the surface of nickel monocrystals in ultra-high vacuum. Operated ultra-high vacuum equipment, Ar+ sputtering equipment, a quadrupole mass spectrometer with Faraday cup detector, low-energy electron diffraction (LEED) and Auger spectrometers, and a fast-scanning Fourier transform IR interferometer. Wrote a Basic program for computer control of and data acquisition from the mass spectrometer. Designed (using Claris CAD software) and installed a nozzle holder and gas and electrical connections for a pulsed molecular beam source. (1990-1991).
Translating
FDA, CFSAN, Office of Nutritional Products, Labeling, and Dietary Supplements, College Park, MD. Translated an article on clinical studies of an antibiotic from Russian into English. (2003).
Joint Publications Research Service (JPRS), Reston, VA. Abstracted and translated chemistry, biochemistry, and materials-related articles from Russian scientific and technical journals for publication in the JPRS serials USSR: Chemistry Report and USSR: Life Sciences Report. (1989-1994).
Delphic Associates, Inc., Falls Church, VA. Translated articles and monographs on varied topics, including torpedo development, seismology, econometric modeling, and industrial quality control, from Russian into English. (1988-1989).
Leo Kanner Associates, Redwood City, CA. Translated articles on pharmacology, physics, radio engineering, and computer hardware from Russian into English. (1987-1988).
U.S. Department of Commerce, Washington, DC. Translated a book and five patents on polybutadiene rubber development in the USSR. (1988).
Awards
FDA's Outstanding Service Award as a member of the Fluorochemical Review Group for exceptional efforts in working with regulated industry to resolve critical and extremely complex post-market safety issues concerning perfluorochemicals, (2007).
CFSAN OFAS Division of Food Contact Notifications Cash Award for successfully performing under severe time constraints and with exemplary efforts to resolve complex scientific review issues related to irradiation processing of prepackaged food, (2006).
CFSAN OFAS Division of Food Contact Notifications Certificate of Achievement for extraordinary efforts in resolving issues associated with consumer exposure to perfluorooctanoic acid in food, (2004).
CFSAN Team Award for outstanding and timely work to formulate FDA's position on perfluorooctanoic acid in food, (2004).
CFSAN Teamwork/Collegiality Award for outstanding efforts in the management of food contact notification reviews during the first 3 quarters of FY03 in reducing the average review time for FCNs from the previous low of 113 days to 89 days, a reduction of over 21%, (2003).
CFSAN Special Accomplishment Award for outstanding presentation at a graduate-level course on food packaging which included a discussion of the unique and complex issues regarding FDA's policies on food-contact uses of recycled plastics and paper, (2003).
CFSAN Special Accomplishment Award for substantial and thorough revision of the guidance document discussing chemistry considerations for the use of recycled plastics in food packaging, (2002).
CFSAN Leadership Award for outstanding leadership as Acting Group Leader in the Division of Food Contact Substance Notification Review, (2002).
FDA Group Recognition Award for exceptional performance in the preparation and execution of a series of mission-oriented training workshops based on the Grand Rounds Format, (2002).
CFSAN's Quality Performance Award for providing exemplary guidance to industry concerning recycled plastics for use in contact with food, (2001).
CFSAN Team Award for outstanding work in the conversion of more than 50 food additive petitions to notifications in the initial implementation of the food contact substance notification program, (2001).
CFSAN's Teamwork/Collegiality Award for teamwork and collegiality in support of the mission of the Office of Premarket Approval/CFSAN by the Division of Product Manufacture and Use personnel, (2000).
CFSAN's Quality Performance Award for exceptional performance in reviewing a precedent-setting submission concerning the use of recycled non-food-contact PET for food-contact applications, (1999).
Special Accomplishment Award for outstanding performance in ensuring the successful implementation and completion of a contract awarded to assess resource needs for petition review, (1998).
Quality Performance Award for outstanding contributions to improving the efficiency of FDA's environmental guidance and regulations that will result in enormous savings of FDA's and industry's resources, FDA, (1998).
Certificate awarded in recognition of Ten Years of Service in the Government of the United States, (1998).
Special cash award for work done on the environmental review of new plastic food-packaging materials that could contaminate the current polyethylene terephthalate (PET) recycling stream, FDA, (1997).
Publications
Guidance for Industry. Use of Recycled Plastics in Food Packaging: Chemistry Considerations. FDA CFSAN OFAS. August 2006. Available at http://www.cfsan.fda.gov/~dms/opa2cg3b.html.
Paquette, K.E. Irradiation of Prepackaged Food: Evolution of the Food and Drug Administration's Regulation of the Packaging Materials. Chapter 12 in Irradiation of Food and Packaging. Recent Developments. American Chemical Society Symposium Series No. 875, 2004, 182-202. Available at http://www.cfsan.fda.gov/~dms/irrapac3.html.
Song, Y.S., T. Begley, K. Paquette, and V. Komolprasert. Effectiveness of polypropylene film as a barrier to migration from recycled paperboard packaging to fatty and high-moisture food. Food Additives and Contaminants. September 2003, 20(9), 875-883.
Begley, T.H., T.P. McNeal, J.E. Biles, and K.E. Paquette. Evaluating the Potential for Recycling All PET Bottles into New Food Packaging. Food Additives and Contaminants. January 2002, 19(1), Supp. 1, 135-143.
Paquette, K. FDA Regulation of Paper Products for Food Contact. Food, Cosmetics and Drug Packaging. PJ Barnes & Associates, Bridgwater, UK. February 1998, 35-39.
Paquette, K.E. and G.R. Helz. Inorganic Speciation of Mercury in Sulfidic Waters: The Importance of Zero-Valent Sulfur. Environmental Science and Technology. 1997, 31(7), 2148-2153.
Amey, E., F. Consoli, W. Haaf, L. Laibson, K. Paquette, and J.A. Todd. Impact Assessment Applications in Updating the SETAC [Society of Environmental Toxicology and Chemistry] LCA [Life-Cycle Assessment] Impact Assessment Framework, a white paper by the SETAC Life-Cycle Impact Assessment Work Group. Spring 1996.
Paquette, K.E. and G.R. Helz. Solubility of Cinnabar (Red HgS) and Implications for Mercury Speciation in Sulfidic Waters. Water, Air, and Soil Pollution. 1995, 80, 1053-1056.
Presentations
Testing Protocol for Determining Exposure to Radiolysis Products from Packaging Materials Irradiated in Contact with Food. Ciba Expert Services seminar "Global Regulatory Requirements for Food and Medical Packaging," Washington, DC, May 25, 2004.
Testing Protocol for Determining Exposure to Radiolysis Products from Packaging Materials Irradiated in Contact with Food. Flexible Packaging Conference 2004, sponsored by the Institute of Packaging Professionals and the Society of Plastics Engineers, Atlanta, GA, March 26, 2004.
Testing Protocol for Determining Exposure to Radiolysis Products from Packaging Materials Irradiated in Contact with Food. Symposium on Recent Developments in the Regulation of Irradiated Packaged Food, American Chemical Society National Meeting, New York, NY, September 9, 2003.
Irradiation of Prepackaged Food: Evolution of FDA's Regulation of the Packaging Materials. Symposium on Food Irradiation and Packaging for Irradiated Food, American Chemical Society National Meeting, Boston, MA, August 20, 2002.
Instructor for "FDA Regulation of Food-Contact Substances" segment of "Food Packing 541," a graduate-level course offered by the Illinois Institute of Technology at the National Center for Food Safety and Technology, Summit-Argo, IL, April 2000 - 2003.
Recycled Plastics in Contact with Food: FDA's Policy. Society of the Plastics Industry Symposium on Global Packaging Regulatory Issues, Baltimore, MD, June 20, 2001.
Recycled Paper in Contact with Food: Purity Issues. European Union Project FAIR "Recyclability" consortium meeting, Central Science Laboratory of the Ministry of Agriculture, Fisheries, and Food, York, UK, June 5, 2000.
Recycled Plastics in Contact with Food: FDA's Policy. "California's Rigid Plastic Packaging Container Law: How Does It Impact You?" Conference sponsored by the California Integrated Waste Management Board, San Diego, CA, May 16, 2000.
Instructor for the "FDA Regulation of Indirect Food Additives" and "Recycled Plastics in Contact with Food: FDA's Policy" segments of "Product/Package Interaction and Compatibility," a short course offered by the Michigan State University School of Packaging, East Lansing, MI, November 10, 1999.
FDA Regulation of Paper Products for Food Contact. "Specialty & Technical Papers '97" Conference, Toronto, Canada, June 5, 1997.
