Food Irradiation

1
Food Irradiation

• The Law and the Science of Food Irradiation

2
Outline

• 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

3
Food Safety

• New Paradigm for Y2K
• Emerging Pathogens
• Foodborne Illness Outbreaks
• Food Safety Regulation
• Presidents Food Safety Initiatives
• National Academy of Sciences Report

4
Food Irradiation

• 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.

5
History 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
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History 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 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 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
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Food 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)

10
Classification of Irradiation as a Food Additive
11
Legal Basis

• Deposition of radiolytic byproducts considered
  components of food product.
• Radiolytic byproduct affect the
  characteristics of the food

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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

13
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 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 Classification

• Prior Sanctioned substances
• Approved substances (FAP)
• Substances generally recognized as safe (GRAS

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Generally 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 Criteria

• 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 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 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 Status

• 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

• 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

22
Irradiation 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

23
Irradiation 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

24
Some Examples
25
Nutra-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

26
Olestra

• 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 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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Benecol

• 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 Irradiation

• Recent outbreaks of foodborne illness
• FDA Modernization Act of 1997
• Presidents Food Safety Initiatives
• (Food Safety From Farm to Table)
• NASA Petitions
• Isomedix Petition

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Approval 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.
31
Labeling 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 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)
33
Consumer 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
34
Food Irradiation

• The Science

35
Food 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.

36
Ionizing 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

37
Ionizing 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

38
X- 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 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 (?)

• 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