Food IrradiationFood Irradiation

Lane A. Highbarger, Ph.D.Lane A. Highbarger, Ph.D.Division of Biotech and GRAS Notice ReviewDivision of Biotech and GRAS Notice Review

Office of Food Additive SafetyOffice of Food Additive SafetyCenter for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

February 10, 2006February 10, 2006

Radiation SpectrumRadiation Spectrum

History of Food IrradiationHistory of Food Irradiation1905 1905 Scientists receive patents.Scientists receive patents.1921 1921 A U.S. Patent is granted for a process to kill A U.S. Patent is granted for a process to kill TrichinellaTrichinella spiralisspiralis..1943 1943 Scientists show that xScientists show that x--rays can be used to preserve ground beef.rays can be used to preserve ground beef.1950’s 1950’s Beginning of era of food irradiation.Beginning of era of food irradiation.1953 1953 Formation of the U.S. National Food Irradiation Program.Formation of the U.S. National Food Irradiation Program.19551955--1965 1965 Army Medical Department program.Army Medical Department program.1958 1958 Congress defines a source of radiation as a food additive.Congress defines a source of radiation as a food additive.1976 F1976 Food irradiation should be classified as a process.ood irradiation should be classified as a process.1980 F1980 Foods irradiated up to 10 kGy considered to be safe and oods irradiated up to 10 kGy considered to be safe and wholesome.wholesome.1997 F1997 Foods irradiated at any dose should be considered as safe and as oods irradiated at any dose should be considered as safe and as wholesome as foods treated by any other conventional process.wholesome as foods treated by any other conventional process.2001 2001 Irradiation is used to eliminate possible traces of Anthrax.Irradiation is used to eliminate possible traces of Anthrax.

Irradiation FacilityIrradiation Facility

Federal Food, Drug,Federal Food, Drug,and Cosmetic Actand Cosmetic Act

Sec. 201(s): Food Additive Definition

Any substance the intended use of which results or Any substance the intended use of which results or may reasonably be expected to result, directly or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise indirectly, in its becoming a component or otherwise affecting the characteristics of any foodaffecting the characteristics of any food (including (including any substance intended for use in producing, any substance intended for use in producing, manufacturing, packing, processing, preparing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; treating, packaging, transporting, or holding food; including any source of radiation intended for any including any source of radiation intended for any such use)***such use)***

Federal Food, Drug,Federal Food, Drug,and Cosmetic Actand Cosmetic Act

Sec. 201(s): Food Additive Definition

Any substance the intended use of which results or Any substance the intended use of which results or may reasonably be expected to result, directly or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise indirectly, in its becoming a component or otherwise affecting the characteristics of any foodaffecting the characteristics of any food (including (including any substance intended for use in producing, any substance intended for use in producing, manufacturing, packing, processing, preparing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; treating, packaging, transporting, or holding food; including any source of radiation intended for any including any source of radiation intended for any such use)***such use)***

Federal Food, Drug,Federal Food, Drug,and Cosmetic Actand Cosmetic Act

Sec. 201(s): Food Additive Definition

Any substance the intended use of which results or Any substance the intended use of which results or may reasonably be expected to result, directly or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise indirectly, in its becoming a component or otherwise affecting the characteristics of any foodaffecting the characteristics of any food (including (including any substance intended for use in producing, any substance intended for use in producing, manufacturing, packing, processing, preparing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food;treating, packaging, transporting, or holding food;including any source of radiation intended for any including any source of radiation intended for any such use)***such use)***

Federal Food, Drug andFederal Food, Drug andCosmetic ActCosmetic Act

Food additives are deemed unsafe until FDA writes a regulation

Regulations stipulate an identity,specifications and conditions of safe use

Regulations do not provide specific productapprovals

Sources of RadiationSources of Radiation

Cobalt 60Cobalt 60Cesium 137Cesium 137Electron Accelerators Operated atElectron Accelerators Operated at

10 10 MeVMeV or Lessor LessXX--ray Generators Operated atray Generators Operated at

7.5 7.5 MeVMeV or Lessor Less

Why Irradiate?Why Irradiate?Low Dose (<1 kGy)Low Dose (<1 kGy)–– Control insectsControl insects–– Inhibit maturationInhibit maturation–– Inhibit sproutingInhibit sprouting

Medium Dose (1Medium Dose (1--10 kGy)10 kGy)–– Extend shelf lifeExtend shelf life–– Reduce microorganism levelReduce microorganism level

High Dose (> 30 kGy)High Dose (> 30 kGy)–– Sterilize Sterilize -- analogous to canninganalogous to canning–– Decontamination of certain food additives, e.g., spicesDecontamination of certain food additives, e.g., spices

Safety ConsiderationsSafety Considerations

Radiological SafetyRadiological Safety

Chemical Change and Potential ToxicityChemical Change and Potential Toxicity

Nutritional AdequacyNutritional Adequacy

Potential Microbiological HazardPotential Microbiological Hazard

Chemical ChangeChemical Change

Energy Stimulates ChemistryEnergy Stimulates ChemistryIncreases When Liquid PresentIncreases When Liquid PresentInitiates Reaction With AirInitiates Reaction With AirGenerally Little Generally Little -- But Not Necessarily But Not Necessarily

Negligible Negligible -- ChangeChangeCan Be Controlled By Controlling ConditionsCan Be Controlled By Controlling Conditions

Heated Lipid (180 ºC/1Hr) vs Irrad (120 kGy)

Nutrition IssuesNutrition Issues

Vitamins Can Be Labile to Heat and Vitamins Can Be Labile to Heat and IrradiationIrradiationEffects Most Significant at Medium DosesEffects Most Significant at Medium DosesMust Distinguish Safety of Food From Safety Must Distinguish Safety of Food From Safety of Dietof DietNo Issues Unique to IrradiationNo Issues Unique to IrradiationGenerally Accepted that Irradiation Losses Generally Accepted that Irradiation Losses Should be Handled Like Heating LossesShould be Handled Like Heating Losses

MicrobiologicalMicrobiologicalComplex Organism More Sensitive Than Simple Complex Organism More Sensitive Than Simple OrganismOrganism–– Mammals > Fresh Fruits or Insects > Single Celled Mammals > Fresh Fruits or Insects > Single Celled

Organisms > Viruses; (Organisms > Viruses; (PrionsPrions Likely Resistant)Likely Resistant)Radiation Sensitivity Varies With SpeciesRadiation Sensitivity Varies With SpeciesSensitivity Varies With EnvironmentSensitivity Varies With Environment–– Temperature; Water Activity; pH; Salt; etcTemperature; Water Activity; pH; Salt; etc

Same Issues as Heat ProcessingSame Issues as Heat Processing

Foods Permitted to Be Irradiated Foods Permitted to Be Irradiated Under FDA’s RegulationsUnder FDA’s Regulations

All foods Arthropod Control 1 kGy maxDry Enzyme Preps. Microbial Control 10 kGy maxFresh Foods Maturation Inhibition 1 kGy maxSpices/Seasonings Microbial Control 30 kGy maxPoultry Microbial Control 3 kGy maxSeeds for sprouting Microbial Control 8 kGy maxShell eggs Microbial Control 3 kGy maxMeat and meat bypoducts Microbial Control 4 kGy/7 kGyMolluscan shellfishMolluscan shellfish Microbial Control 5.5 kGy maxNASA Sterilization 44 kGy min

Other Irradiated SubstancesOther Irradiated SubstancesMedical equipment Microbial Control

Laboratory animal Microbial Controldiets 50 kGy max

Poultry feed Salmonella sp. 25 kGy Max

Pet foods, treats and Salmonella sp.chews 50 kGy max

Active Ionizing Radiation PetitionsActive Ionizing Radiation Petitions

Control of pathogens in crustaceansControl of pathogens in crustaceans–– National Fisheries InstituteNational Fisheries Institute

To control pathogens in a variety of multipleTo control pathogens in a variety of multiple--ingredient products ingredient products –– Food Irradiation CoalitionFood Irradiation Coalition

Active Petitions (Continued)Active Petitions (Continued)

To control microorganisms on To control microorganisms on nonrefrigeratednonrefrigeratedmeat food productsmeat food products–– USDA/FSISUSDA/FSIS

Amend poultry regulation to raise maximum Amend poultry regulation to raise maximum dose and remove packaging limitationdose and remove packaging limitation–– USDA/FSISUSDA/FSIS

Active Petitions (Continued)Active Petitions (Continued)

To control microbial contamination on dietary To control microbial contamination on dietary supplements, and ingredients used in the supplements, and ingredients used in the manufacture of dietary supplementsmanufacture of dietary supplements–– SterisSteris Corp.Corp.

MultiMulti--ingredient shelf stable foodsingredient shelf stable foods–– IBAIBA

Labeling CriteriaLabeling Criteria

Misleading if it fails to reveal facts that are Misleading if it fails to reveal facts that are material in light of: material in light of: –– Representations made,Representations made,–– Consequences of useConsequences of use

No statutory requirement specific to irradiationNo statutory requirement specific to irradiation

“Treated with radiation” or “Treated by “Treated with radiation” or “Treated by irradiation”irradiation”

LabelingLabeling

Congress Directed Reconsideration Congress Directed Reconsideration -- 19971997Advance Notice of Proposed Rulemaking Advance Notice of Proposed Rulemaking Published February 1999Published February 1999–– Cited Various PositionsCited Various Positions–– Requested Comment on 15 QuestionsRequested Comment on 15 Questions

Labeling StatusLabeling Status

Lead Is With Lead Is With CFSAN’sCFSAN’s Labeling GroupLabeling Group

Comments Did Not Provide Clear Consensus or Comments Did Not Provide Clear Consensus or RationaleRationale

2002 Farm Bill 2002 Farm Bill

Controversy and QueriesControversy and Queries

ObjectionsObjections–– ConsumerConsumer–– Public Citizen / Center for Food SafetyPublic Citizen / Center for Food Safety

Formal CorrespondenceFormal Correspondence