1. Food Safety and Technology: The Case of Food Irradiation Drew L. Kershen Earl Sneed Centennial Prof. Emer. University of Oklahoma AALA-Madison, Nov. 1, 2013 4A-3-3-1

2. Food Irradiation— Purposes for Use Reduction of Foodborne Pathogens – Five of most interest: E-coli 0157; campylobacter jejuni; salmonella, listeria monocytogenes; toxoplasma gondii – CDC Est. 2011 for the top five (not identical to the five above): illnesses(8,541,422); hospitalizations (49.028); deaths(1185) Extended food life – shelf life and delay of spoilage, sprouting, maturing – Reduction in post-harvest and post-purchase loss Pest infestations – phytosanitary regulations for interstate and international movement -- disinfection – Improves trade in agricultural product, especially for developing nations Three purposes together means improved food security for wholesome foods 4A-3-3-2

3. Food Irradiation: Basic Factual Information Food irradiation is a food preservation, food processing technique – Like salting, refrigerating, heating, cooking, canning, drying Food preserved by wave energy – irradiation is not radioactive – Radio, television, microwave, electricity Food properly preserved is unchanged in nutrition, not made toxic – can have minor effects on texture and feel depending on the food, like microwave ovens Combinational technique with best management practices and good manufacturing practices 4A-3-3-3

4. Legal Landscape: Food additive 21 U.S.C. § 342 – adulterated food unless FDA issues a food additive regulation (FAR) under § 348 21 U.S.C. § 348 – two paths to a FAR – FDA initiated through rule-making Has not been used for food irradiation – Petition process by those seeking a FAR Lengthy, exhausting process USDA-Food Safety Inspection Service (FSIS) – Meat and poultry WHO and EU 4A-3-3-4

5. Legal Landscape Food labels 21 C.F.R. § 179.26(c) – Labeling – Radura symbol – “Treated with radiation” – “Treated by irradiation” 9 C.F.R. § 317.4 – FSIS Similar labels required in EU and elsewhere Added explanation permissible “… for the purpose of reducing foodborne pathogens.” 4A-3-3-5

6. Legal Landscape Food safety impact Food irradiation is the “exception” rather than the “ordinary” Food companies see little benefit from seeking a FAR Consumer acceptance is misinformed Consumers go unprotected and suffer Society bears the costs in terms of – Poor scientific knowledge – Medical expenses – Health consequences 4A-3-3-6

7. Legal Landscape Possible Ways Forward 21 U.S.C. § 343(h)(3) – – FDA, Proposed Rule, 72 F.R. 16291 (April 2007) Only label if a “material change” For “material change” labels a new terminology – Proposal for a Proposed Rule Not a material change Lack of Label is not a food safety issue Voluntary label – E.g. “wave-energy pasteurized to protect wholesomeness” USDA-FSIS says will follow FDA 4A-3-3-7

8. Legal Landscape Possible Ways Forward FDA adopts a general FAR – Codex Alimentarius standards; IPPC standards WTO implications to protect American food trade – Allow food irradiation for all foods as manufacturers see fit FDA adopts “food preservation” approach – Probably requires Congressional change of statute – Gets the science correct about 50 years 4A-3-3-8

9. Legal Landscape Other possible implications Products Liability Lawsuits – Design defect – not possible at present because adulterated food without a FAR – Punitive damages for failure to use once allowed Organic Production – Irradiation-- not permissible food processing – Duty to warn consumers of greater risk – Informed consumer choice Organic peanut butter; organic leafy greens Raw Milk 4A-3-3-9

10. Selected References International Consultative Group on Food Irradiation, Facts about Food Irradiation (1999), 48 pp. D. Parke et al., Review: Meat Irradiation (2005), Professional Animal Scientist, 21:75-80 C. Sommers & X. Fan, Food Irradiation Research and Technology (Institute of Food Technologies Press, 2006) 289 pp. R. Tauxe, Food Safety and Irradiation: Protecting the Public from Foodborne Infections, (2001) Emerging Infectious Diseases, 7(3 Supp.):516-521 4A-3-3-10

11. Thank you. dkershen@ou.edu 4A-3-3-11