E-Beam Processing. Irradiation in The United States of Fresh Produce and Perishables Sadex Corporation September 2, 2009
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1 E-Beam Processing Irradiation in The United States of Fresh Produce and Perishables Sadex Corporation September 2, 2009
2 Objectives Introduce Sadex and the E-beam Irradiation Process Establish Purpose and Goals for Irradiation: Product Safety, Reduce or Eliminate Pathogens and Harmful Pests, and Extended Shelf-life Answer Questions
3 Patented Electron Beam System
4 How does Electron Beam Pasteurization Technology Work? Injector Accelerating Waveguide Input RF Power Magnetic Scanning System Electrons disrupt the DNA chains either destroying or preventing reproduction by the organism Product Container
5 Electron Deposition Electrons strike electrons in the product (inelastic scattering) imparting a fraction of their energy into kinetic energy of the secondary electrons. All the electrons (primary and secondary) then suffer additional collisions until all their energy is dissipated by ionization. 1 o electrons 2 o electrons ionization
6 Depth Dose Distribution 10 MeV Electrons in Water
7 Dose Distribution (Max / Min) Max Min
8 Max:Min Ratio What is it? The ratio of the maximum dose absorbed by the product divided by the minimum dose Why is it important? To achieve the necessary pathogen reduction, a minimum dose is required. If the max/min is too high you may exceed the FDA limits, or you may impact the organoleptic qualities of the product
9 Patented Electron Beam System Reduces or Eliminates dangerous bacteria and harmful pests Does not compromise food quality Extends shelf-life Refrigerated Facility Maintains Cold Chain Consumer friendly Uses commercial electricity Environmentally safe
10 Quality Control Refrigerated Facility: Cold Chain Management Throughout Process: Unloading, Handling, Treatment, and Re-loading Unit Count, Delivery Temperature, and External Damage Verified Processing Documentation/COA Available Upon Shipping Regulatory Compliance For Food Facility Customer s Determined Dose Delivery Guaranteed
11 Regulatory Compliance Facility is Fully Licensed and Regulated by On-Site USDA/FSIS Inspector Hazard Analysis Critical Control Point Plan (HACCP) USDA/FSIS required for processing meat/food products FDA/USDA Approvals In Place for Meat, Poultry, Fresh Produce, Spices, Shell Eggs, Animal Feeds, Feed Ingredients, Pet Treats, and Cosmetics Ag Marketing Service AMS Inspectors Available for School Lunch Program Products Homeland Security Center for Veterinary Biologics CVB FDA/USDA Dose Limits and Label Rules Apply FDA Approval is Pending for Other Products APHIS Approval and Inspection for Import/Export Products Pending Department of Public Health State Ag Dept. NIST, ASTM, RISO CODEX GMP s, SOP s, and SSOP s
12 Labeling and Packaging Update Irradiation Labeling Under Review by FDA if Irradiation should be Required on Label All Contact Surface Packaging Material Polymers Approved for Irradiation by FDA either by CFR or Threshold of Regulation (TOR) up to 3 kgy or higher Produce Packaging Material Availability for Irradiation Limited Since Additives in Polymers Currently Not Approved
13 Iceberg Lettuce and Spinach Approved for Irradiation August 22, 2008 FDA Approved Irradiation up to 4.0 kgy for Pathogen Reduction and Extended Shelf-life of Fresh Iceberg Lettuce and Spinach, Stating Irradiation Safe 21 CFR Part 179 GAO 2000 Report on Irradiation reduces Pathogens up to 99.9% FPA has RTE Petition Before FDA to Approve RTEs for Irradiation Petition Filed in 1999 but Held Up for Further Testing Produce from Foreign Countries and Hawaii is being Irradiated for Disinfestation and Consumer Acceptance is Good
14 Scientific Conclusions Process cannot make the product radioactive no matter how much dose is absorbed Compounds formed by irradiating food are the same as those produced by other processes Irradiation causes no toxic problems that adversely affect human health Only intervention to destroy internalized pathogens with the exception of cooking No Chemical Residue as from Fumigants and Chemical Interventions No evidence exists that pathogenic bacteria become stronger when irradiated there is no other means to kill bacterium such as E. coli O157:H7 in raw ground beef -USDA
15 Questions??? Should you have questions, please feel free to contact me at: Sadex Corporation Harlan E. Clemmons, President and COO 2650 Murray St. Sioux City, IA (O) (F)
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