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Food IrradiationFood Irradiation

The Law and the Science of The Law and the Science of Food IrradiationFood Irradiation

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OutlineOutline

• Introduction

• Classification of Irradiation as a Food Additive

• The Regulation of Irradiated Foods

• The Labeling of Irradiated Products

• Consumer Acceptance of Irradiated Products

• Irradiation as GRAS

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Food SafetyFood Safety

•New Paradigm for Y2K

• Emerging Pathogens

• Foodborne Illness Outbreaks

• Food Safety Regulation

• President’s Food Safety Initiatives

• National Academy of Sciences Report

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Food IrradiationFood Irradiation““The Law”The Law”

• Exposure of foods to ionizing radiation in form of gamma radiation, X-rays and electron beams to destroy pathogenic microorganisms

• In use for over 50 years in European Union

• US consumers perceptions of effects of radiation prevented widespread acceptance of food irradiation

• Limited use allowed since 1963 on specific food products for specific purposes.

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History of IrradiationHistory of Irradiation

First documented use of ionizing radiation was to “bring about an improvement in the condition of foodstuffs” and in “their general keeping quality”.

British patent issued to J. Appleby and A.J. Miller, analytical chemists

British Patent No. 1609 (Jan 26, 1905).

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History of IrradiationHistory of Irradiation

• US Army investigates use of irradiation to improve safety and quality of troop diets in 1930

• MIT hamburger sterilization study in 1943

• Approved by Soviet Union to increase potato consumption in 1958

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History of IrradiationHistory of Irradiation

•Approved for potatoes by Canada in 1960

• 1963 First FDA approval for insect control in wheat flour

• 1964 - dehydrated vegetable seasoning

• 1986 - fruit and vegetable ripening

• 1990 - fresh and frozen poultry to control salmonella and other pathogens

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Food AdditivesFood Additives

The term “food additive” means any substance the intended use of which results or may reasonably be expected to result , directly or indirectly, in its becoming a component of or otherwise affecting the characteristics of any food...(and including any source of radiation intended for such use), if such substance is not generally recognized.....to be safe under the conditions of its intended use;”

21 U.S.C. Section 321 (s)

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Food Additive AmendmentFood Additive Amendment

• Enacted in 1958 to control use of chemicals in food products

• First legislation to address irradiation directly

• Defined all sources of ionizing radiation as food additives (blanket prohibition)

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Classification of Irradiation as Classification of Irradiation as a Food Additivea Food Additive

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Legal BasisLegal Basis::

• Deposition of radiolytic byproducts considered “components” of food product.

• Radiolytic byproduct “affect the characteristics” of the food

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Scientific Basis:Scientific Basis:

• Ionizing radiation produces byproducts (radiolytic byproduct) which interact with and thereby become a component of foods

• The interaction of ionizing radiation with foods affects the characteristics of foods

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Factual Basis:Factual Basis:

• Perceived need to inform consumer of all “material facts” about the foods they consume

• Little understanding of the nature and effects of ionizing radiation in biological systems

• Inability to identify irradiated products

• Public reaction “Irradiation = Radioactive”

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Impact of ClassificationImpact of Classification

• Requirement for pre-market approval

• Costly and protracted review process

• Limited utilization of effective food safety tool

• Labeling requirement (Radura)

• Limited opportunity for consumer education and acceptance of irradiated products

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Statutory Exemptions to Statutory Exemptions to Classification Classification

•Prior Sanctioned substances

• Approved substances (FAP)

• Substances generally recognized as safe (GRAS

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Generally Recognized as SafeGenerally Recognized as Safe

• General recognition of safety among experts qualified by scientific training and experience to evaluate its safety

• No FDA approval required

• Can petition FDA for affirmation

• Congressional recognition of “safety” criteria

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GRAS CriteriaGRAS CriteriaWhat do you need for GRAS status?What do you need for GRAS status?

•General recognition of safety through scientific procedures based on published literature

• GRAS status must be based on same quality and quantity of scientific evidence as would be required for “food additive” petition (FAP)

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GRAS CriteriaGRAS Criteria

•Substantial history of consumption by significant number of consumers in the US (”common use”)

• GRAS status based on “common use” requires lesser quantity of scientific evidence than FAP

• GRAS affirmation should consider manufacturing process

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GRAS ExamplesGRAS Examples

•U.S. v. Articles of food.....Buffalo jerky 456 F. Supp 207 Nebraska, 1978. Affirmed by the 8th circuit in 1979. Buffalo patties adulterated because ingredient (nitrite) not GRAS.

• Caffeine, GRAS since 1960

• Simplesse, GRAS in 1990

• Menhaden fish oil, GRAS in1989

• Chymosin from recombinant DNA, GRAS in 1990.

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Self Determination of GRAS Self Determination of GRAS StatusStatus

•No requirement for Food Additive Petition

• Places burden on FDA to prove additive unsafe

• Avoids costly and protracted FDA approval process

• Can market product immediately

• Can seek FDA affirmation of GRAS status by petition

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Self Determination Criteria:Self Determination Criteria:

• Safety Determination by proponent

• Common use over a period of time (the “nothing happened” test)

• Lesser degree of scientific evidence if based upon “common use”

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Irradiation as GRASIrradiation as GRAS

•Common useage for over 50 years in US and European Union (nothing happened!)

• FDA approval is government admission of the safety of irradiation

• Irradiation does not fit definition of a food additive

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Irradiation as GRASIrradiation as GRAS

•Original classification erroneous

•Radiolytic byproducts products by irradiation are the same as those produced by traditional processing methods whose status as GRAS or as a food additive has never been asserted or challenged. (Heat treatment, freezing)

• Advances in analytical capabilities have determined nature, quantity and effects of radiolytic byproducts in biological systems

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Some ExamplesSome Examples

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Nutra-SweetNutra-Sweet

•Aspartyl-phenylalanine-methyl ester

• Heavily criticized because of delayed submission of negative data

• Agency insiders retained by industry

• Caused FDA to adopt “strict scrutiny” of all data submission in support of FAPs

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OlestraOlestra

•Originally submitted for approval as a DRUG for cholesterol reduction in 1974.

• Withdrew drug application in 1988

• Filed as “fat replacer” in 1988

• Not approved until 1996

• 200,000 pages of data submitted

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High Fructose Corn SyrupHigh Fructose Corn Syrup

•Developed at time as Olestra

• Marketed as GRAS in mid-60's

• “Self Determination” of GRAS status

• Marketed and sold continuously for over 30 years without resort to FDA approval process

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BenecolBenecol

•New Approach

• Cholesterol absorption inhibitor

• FDA alleged Benecol margarine “plant stanol ester” is un-approved food additive

• Manufacturer alleges Benecol is Dietary Supplement in food form

• Sold in Finland since 1995

• FDA can seize or sue (refer to Dept of Justice)

• Why not assert “GRAS” status?

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Approval of IrradiationApproval of Irradiation

•Recent outbreaks of foodborne illness

• FDA Modernization Act of 1997

• President’s Food Safety Initiatives

• (Food Safety From Farm to Table)

• NASA Petitions

• Isomedix Petition

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Approval of IrradiationApproval of Irradiation

Isomedix petition filed 1994 seeking approval to use ionizing radiation for treatment of beef products.

December 1997 FDA approved use of ionizing radiation for the treatment of refrigerated or frozen uncooked meat, meat byproducts and certain meat food products to control foodborne pathogens and extend shelf life.

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Labeling of Irradiated FoodsLabeling of Irradiated Foods

FDA has required labeling of irradiated food products since 1966

Radura logo required since 1986

Irradiated ingredients excluded

Only “First Generation” foods must be labeled

Reduces acceptability of irradiated food products because of consumer association with radioactivity and lack of consumer education regarding safety and efficacy of irradiation

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Labeling ConsiderationsLabeling Considerations

Effect of Irradiation Declaration on acceptance of irradiated foods and food safety generally

Does labeling at the retail level ensure the safety of the food product

Inconsistent application of labeling requirement (potatoes, wheat flour)

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Consumer AcceptanceConsumer Acceptance

Affected by Irradiation label declaration

Tested by consumer surveys, limited market testing and retail sales

Affected by perception that irradiation equals radioactive

72% of consumers have heard of irradiation but 30% of those think irradiated foods are radioactive (1996 survey)

Survey found that education increases acceptanc

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Food Food IrradiationIrradiation

““The Science”The Science”

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Food IrradiationFood Irradiation

• Exposure of foods to ionizing radiation in form of gamma radiation, X-rays and electron beams to destroy pathogenic microorganisms

• In use for over 50 years in European Union

• US consumers perceptions of effects of radiation prevented widespread acceptance of food irradiation

• Limited use allowed since 1963 on specific food products for specific purposes.

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Ionizing RadiationIonizing Radiation

•Causes disruption of internal metabolism of cells by destruction of chemical bonds

• DNA cleavage results in loss of cells ability to reproduce

• “Free radicals” formed upon contact with water containing foods

• Free radicals react with cellular DNA causing radiation damage

• DNA considered “radiation sensitive” portion of cells

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Ionizing RadiationIonizing Radiation

•Exists in form of waves

• Shorter wavelength = greater energy

• Light, radio, microwave, television = long wavelength, low energy cannot alter structure of an atom

• Shorter wavelengths have enough energy to “knock off” an electron to form a “free radical” but not high enough to “split” an atom and cause target to become “radioactive”

• Interaction between free radicals and DNA responsible for “killing effect” of IR

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X- RaysX- Rays

•Produced during high energy collisions of gamma rays and heavy elements (i.e. Tungsten)

• Little practical application because of low conversion efficiency of gamma to X-rays

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Electron BeamsElectron Beams

•Produced by linear accelerators

• Coherent, directional beam of high energy electrons

• Low dose

• Portable (no reactor required)

• Not inherently radioactive

• Requires less shielding than gamma radiation

• Flip of the switch technology

• Lack penetration depth of gamma

• Advantage is shorter exposure time

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Gamma Radiation (Gamma Radiation ())

•Most widely used type of ionizing radiation

• All penetrating, emitted in all directions continuously

• Produced at MURR by exposure of natural Cobalt-59 to neutrons in a reactor where reaction between the two species produces Cobalt-60

• Cobalt-60 specifically manufactured, for radiotherapy, medical device sterilization and food irradiation, not a waste product of nuclear reactors