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Tuesday, May 11, 2010

FDA/CFSAN: Food Irradiation

Presented by: Dr. Lane Highbarger

Food IrradiationFood Irradiation

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

May 11, 2010May 11, 2010

Poll QuestionPoll Question

Have you ever knowingly purchased an irradiated food?Have you ever knowingly purchased an irradiated food?

A)A) YesYes

B)B) NoNo

C)C) How would I know?How would I know?

EnergyEnergy

Radiation SpectrumRadiation Spectrum

Sources of RadiationSources of Radiation

Cobalt 60 - 1.33 MeVCobalt 60 - 1.33 MeV

Cesium 137 - 662 keVCesium 137 - 662 keV

Electron accelerators operated atElectron accelerators operated at

10 MeV or less10 MeV or less

X-ray generators operated atX-ray generators operated at

7.5 MeV or less7.5 MeV or less

Dose – What it MeansDose – What it Means

Irradiation doses are measured in gray (Gy)Irradiation doses are measured in gray (Gy)– Gy is measured in joule/kg absorbed energyGy is measured in joule/kg absorbed energy– 1 Gy = 1 = 1 m1 Gy = 1 = 1 m22 s s-2-2

– For X-rays and gamma rays == SievertFor X-rays and gamma rays == Sievert

Energy sources are constantEnergy sources are constant

Applied dose = energy sourceApplied dose = energy source ✕✕ time exposedtime exposed

Absorbed dose depends on other factors Absorbed dose depends on other factors

JKg

Food Irradiation FacilitiesFood Irradiation Facilities

Gamma Electron beam

Let’s Pause for Questions?Let’s Pause for Questions?

Food Irradiation OverviewFood Irradiation Overview

A Brief History of Food IrradiationA Brief History of Food Irradiation

1905 1905 Begins the era of food irradiation.Begins the era of food irradiation.1958 1958 Congress defines a source of radiation as a food Congress defines a source of radiation as a food additive.additive.1980 1980 Foods irradiated up to 10 kGy considered to be safe and Foods irradiated up to 10 kGy considered to be safe and wholesome.wholesome.1997 1997 Foods irradiated at any dose should be considered as Foods irradiated at any dose should be considered as safe and as wholesome as foods treated by any other safe and as wholesome as foods treated by any other conventional process.conventional process.2001 2001 Irradiation is used to eliminate possible traces of Anthrax.Irradiation is used to eliminate possible traces of Anthrax.1984-2009 1984-2009 FDA approves the use of irradiation in a variety of FDA approves the use of irradiation in a variety of foods.foods.

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

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

High Dose (> 30 kGy)High Dose (> 30 kGy)– Sterilize - analogous to canningSterilize - analogous to canning– Decontaminate certain food additives, e.g., spicesDecontaminate certain food additives, e.g., spices

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 byproducts Microbial Control 4 kGy/7 kGyMolluscan shellfishMolluscan shellfish Microbial Control 5.5 kGy maxFresh lettuce and spinach Microbial Control 4 kGy maxNASA Sterilization 44 kGy min

Other Irradiated SubstancesOther Irradiated Substances

Medical equipment Microbial Control

Laboratory animal Microbial Control diets 50 kGy max

Poultry feed Salmonella spp. 25 kGy max

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

Best return on irradiationBest return on irradiation

Which foods do you think would benefit most from being Which foods do you think would benefit most from being irradiated? Either from a food safety point of view or a irradiated? Either from a food safety point of view or a commercial point of view.commercial point of view.

A)A) Ground beef Ground beef

B)B) Lettuce Lettuce

C)C) Shell eggs Shell eggs

D) FruitsD) Fruits

E)E) NASA beefsteak NASA beefsteak

Let’s Pause for Questions?Let’s Pause for Questions?

Irradiation ActionIrradiation Action

E-beam – shallow penetrationE-beam – shallow penetration– Converted to x-ray for more penetrationConverted to x-ray for more penetration

Gamma – ‘deeper’ penetrationGamma – ‘deeper’ penetration

All act All act via via similar mechanismssimilar mechanisms

Mammals > Insects > Single Celled Organisms > Viruses; (Prions Likely Resistant)

D10 – The radiation dose needed to inactivate 90% of the microbial load in the food medium

All bacteria have different susceptibilities All bacteria have different susceptibilities to radiation (values in kGy)to radiation (values in kGy)– Salmonella spp. – 0.36 - 0.77Salmonella spp. – 0.36 - 0.77– Listeria monocytogenes – 0.35 - 0.7Listeria monocytogenes – 0.35 - 0.7– E. coli E. coli O157:H7 – 0.25 - 0.39O157:H7 – 0.25 - 0.39

A 99.999% reduction = 5 x DA 99.999% reduction = 5 x D1010 value value

Which number Which number soundssounds better as a descriptor better as a descriptor for the reduction of a bacterial population? for the reduction of a bacterial population? And which one is the And which one is the greatest greatest kill? kill?

A) 5000 timesA) 5000 timesB) 99.99%B) 99.99%C) Reduced by 10C) Reduced by 10-5-5

D) A 4 DD) A 4 D1010 reduction reduction

E) I have a headache now E) I have a headache now

Let’s Pause for Questions?Let’s Pause for Questions?

Safety ConsiderationsSafety Considerations

Safety ConsiderationsSafety Considerations

Radiological Safety

Chemical Change and Potential Toxicity

Nutritional Adequacy

Potential Microbiological Hazard

Chemical ChangeChemical Change

Energy stimulates chemistry

Increases when liquid is present

Initiates reaction with air

Generally little – but not necessarily negligible change

Can be controlled by controlling conditions

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

Nutrition IssuesNutrition Issues

Vitamins can be labile to heat and irradiation

MicrobiologicalMicrobiological

Radiation sensitivity varies with speciesSensitivity varies with environment– Temperature; water Activity; pH; Salt;

etc

Poll QuestionPoll Question

Has an explanation about Has an explanation about food irradiation made you food irradiation made you feel more or less feel more or less comfortable about comfortable about purchasing irradiated purchasing irradiated foods?foods?

Do you want more Do you want more information?information?

More Yes

Les No

Let’s Pause for Questions?Let’s Pause for Questions?

Foods Currently Under ReviewFoods Currently Under Review

CrustaceansCrustaceans

Multiple-ingredient productsMultiple-ingredient products

Non-refrigerated meat food productsNon-refrigerated meat food products

PoultryPoultry

Dietary supplementsDietary supplements

Labeling CriteriaLabeling Criteria

The FDA requires that irradiated foods bear The FDA requires that irradiated foods bear the radura label and state on the label the radura label and state on the label “Treated with radiation” or “Treated by irradiation”“Treated with radiation” or “Treated by irradiation”

There is no statutory requirement specific to There is no statutory requirement specific to irradiationirradiation

Poll QuesitonPoll Quesiton

Would you prefer to have food labeled if it Would you prefer to have food labeled if it were irradiated?were irradiated?

√ YesYes X X NoNo

Controversy and QueriesControversy and Queries

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

Formal CorrespondenceFormal Correspondence

Let’s Pause for Questions?Let’s Pause for Questions?

Other non-Thermal Other non-Thermal Mitigation TechnologiesMitigation Technologies

High Pressure ProcessingHigh Pressure Processing

80k – 130k lb/in80k – 130k lb/in22

Effective at elimination of microbial Effective at elimination of microbial contaminationcontamination

Spores are resistantSpores are resistant

ExpensiveExpensive

Pulsed FieldPulsed Field

Short bursts of electricity used for microbial Short bursts of electricity used for microbial control.control.

Liquids, e.g., juice, milk, liquid eggs.Liquids, e.g., juice, milk, liquid eggs.

Low cost.Low cost.

UV RadiationUV Radiation

Effective at microbial decontamination in Effective at microbial decontamination in liquids.liquids.

Approved for use in surface decontamination.Approved for use in surface decontamination.

Approved for use in juices.Approved for use in juices.

Web Based Information ResourcesWeb Based Information ResourcesFood Safety and IrradiationFood Safety and Irradiation

Food Irradiation Processors Alliance – http://www.fipa.us/Food Irradiation Processors Alliance – http://www.fipa.us/

Kansas State University – http://www.foodsafety.ksu.edu/en/Kansas State University – http://www.foodsafety.ksu.edu/en/

USDA Fact sheet – USDA Fact sheet –

http://www.fsis.usda.gov/Fact_Sheets/Irradiation_and_Food_Safety/index.asphttp://www.fsis.usda.gov/Fact_Sheets/Irradiation_and_Food_Safety/index.asp

FSIS on labeling – http://www.fsis.usda.gov/OPPDE/larc/Policies/IrradiationQA.htmFSIS on labeling – http://www.fsis.usda.gov/OPPDE/larc/Policies/IrradiationQA.htm

Food Safety dot gov – http://www.foodsafety.gov/Food Safety dot gov – http://www.foodsafety.gov/

Printable informationPrintable information: Irradiated Lettuce and Spinach – : Irradiated Lettuce and Spinach –

http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143389.pdfhttp://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143389.pdf

Recent NewsRecent News: : E. coliE. coli O145 in romaine lettuce – O145 in romaine lettuce –

http://www.cdc.gov/ecoli/2010/ecoli_o145/index.htmhttp://www.cdc.gov/ecoli/2010/ecoli_o145/index.htm

WSJ Blog on WSJ Blog on E. Coli E. Coli – –

http://blogs.wsj.com/health/2010/05/07/health-blog-qa-what-to-do-about-e-coli/http://blogs.wsj.com/health/2010/05/07/health-blog-qa-what-to-do-about-e-coli/

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