Download Food Irradiation

Food Irradiation
The Law and the Science of
Food Irradiation
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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
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Food 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 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.
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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
British Patent No. 1609 (Jan 26, 1905).
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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;”
21 U.S.C. Section 321 (s)
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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)
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Classification of Irradiation as
a Food Additive
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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
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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”
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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
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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
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Some Examples
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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
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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
• President’s 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.
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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)
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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
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Food
“The Science”
Irradiation
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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.
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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
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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
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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 Cobalt59 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
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