Food Irradiation: Available Research Indicates That Benefits Outweigh
Risks (Letter Report, 08/24/2000, GAO/RCED-00-217).

Pursuant to a congressional request, GAO reviewed the benefits and risks
of food irradiation, focusing on the: (1) extent and the purposes for
which food irradiation is being used in the United States; and (2)
scientifically supported benefits and risks of food irradiation.

GAO noted that: (1) to date, only limited amounts of irradiated foods
have been sold in the United States; (2) irradiated spices, herbs, and
dry vegetable seasonings constitute the largest category of irradiated
food--in 1999, about 95 million pounds of these products were
irradiated, accounting for about 10 percent of their total consumption;
(3) in addition, small amounts of irradiated fresh fruits, vegetables,
and poultry have been available in wholesale and retail markets,
primarily in Florida and several midwestern states; (4) irradiated
frozen ground beef has recently begun to be marketed in several
midwestern states and Florida; (5) the major purchasers of irradiated
foods are health care and food service establishments, which purchase
them primarily to minimize the threat of foodborne illness; (6) concerns
on the part of food processors, retailers, and others about consumer
acceptance of irradiated foods have limited their availability to date;
(7) scientific studies conducted by public and private researchers
worldwide over the past 50 years strongly support the benefits of food
irradiation while indicating minimal potential risks; (8) for example,
an expert committee convened by the World Health Organization reviewed
the findings of over 500 studies and concluded that food irradiation
creates no toxicological, microbiological, or nutritional problems; (9)
cited benefits of food irradiation include: (a) reducing foodborne
pathogens; (b) extending the shelf life of some fruits and vegetables by
preventing sprouting, deactivating mold, and killing bacteria; and (c)
controlling insect pests--thus reducing the need for environmentally
harmful fumigants; (10) these studies have not borne out concerns about
the safety of consuming irradiated foods; (11) as for nutritional
quality, the main components of food--carbohydrates, protein, and
fats--undergo minimal change during irradiation, and vitamin loss
corresponds to that in foods that are cooked, canned, or held in cold
storage; (12) finally, regarding worker safety and the environment,
commercial irradiation plants are strictly regulated; (13) worldwide,
over the past 30 years, while several accidents have resulted in injury
or death to workers because of radiation exposure, all of the accidents
occurred because safety systems and control procedures had been
bypassed; and (14) in North America, in over 40 years of transporting
the types of radioactive isotopes used for irradiation, there has never
been an accident resulting in the escape of these materials into the
environment.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-00-217
     TITLE:  Food Irradiation: Available Research Indicates That
	     Benefits Outweigh Risks
      DATE:  08/24/2000
   SUBJECT:  Food industry
	     Food inspection
	     Contaminated foods
	     Radiation safety
	     Radiation monitoring
	     Consumer protection
	     Product safety
	     Occupational safety
	     Radiation exposure hazards
IDENTIFIER:  Florida
	     FSIS Hazard Analysis and Critical Control Point System

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GAO/RCED-00-217

Report to Congressional Requesters

August 2000 FOOD IRRADIATION Available Research Indicates That Benefits
Outweigh Risks

GAO/ RCED- 00- 217

Letter 3 Appendixes Appendix I: Scope and Methodology 24

Appendix II: Chronology of Food Irradiation Events 27 Appendix III: Food
Products Approved for Irradiation in the

United States 28 Appendix IV: Commonly Asked Questions and Answers About

Food Irradiation 29 Appendix V: GAO Contacts and Staff Acknowledgments 31

Tables Table 1: Estimated Annual Quantities and Percentage of Consumption
for Irradiated Food in the United States,

as of January 2000 11 Figures Figure 1: The International Food Irradiation
Symbol- the Radura 9

Abbreviations

FAO Food and Agriculture Organization FDA Food and Drug Administration FSIS
Food Safety and Inspection Service HACCP Hazard Analysis and Critical
Control Points IAEA International Atomic Energy Agency kGy kiloGray NRC
Nuclear Regulatory Commission USDA U. S. Department of Agriculture WHO World
Health Organization

Resources, Community, and Economic Development Division

Lett er

B- 215168 August 24, 2000 The Honorable Tom Bliley Chairman, Committee on
Commerce The Honorable Fred Upton Chairman, Subcommittee on Oversight and
Investigations Committee on Commerce House of Representatives

While the U. S. food supply is generally considered to be one of the safest
in the world, foodborne illness continues to be a source of concern for
consumers. Each year, millions of Americans become ill from foodborne
infections and up to 5, 000 people die. The economic costs are also large-
the U. S. Department of Agriculture (USDA) estimates that diseases caused by
seven major foodborne pathogens could result in medical costs and
productivity losses of between $6.6 billion and $37.1 billion annually.
Furthermore, recalls of contaminated food- such as the massive recalls of
thousands of pounds of ground beef contaminated with Escherichia coli (E.
coli) O157: H7- have resulted in severe economic losses to the affected
industry.

There is no silver bullet on the horizon to eliminate foodborne illness.
However, many food safety experts believe that irradiation can be an
effective tool in helping to control foodborne pathogens and should be
incorporated as part of a comprehensive program to enhance food safety.
Irradiation, which involves exposing food briefly to radiant energy (such as
gamma rays 1 or high- energy electrons), can reduce or eliminate
microorganisms that contaminate food or cause food spoilage and
deterioration. Nearly 40 countries worldwide have approved the use of
irradiation for various types of food.

In the United States, the Food and Drug Administration (FDA) has primary
regulatory responsibility for ensuring the safe use of irradiation on all
foods. At the same time, USDA's Food Safety and Inspection Service is
responsible for the lawful processing of meat, poultry, and some egg

1 Cobalt- 60, a radioactive isotope, is one of two approved gamma ray
sources for food irradiation. Cesium- 137 is the other approved source;
however, it is not currently being used commercially for irradiating food.

products, including the irradiation of such products. Hence the two agencies
have overlapping responsibilities for ensuring the safety of certain
irradiated foods. To date, irradiation has been approved by FDA (and USDA
where applicable) for use on uncooked meat and poultry and fresh shell eggs,
as well as a variety of other foods, including spices and fresh fruits and
vegetables. Final approval for the irradiation of meat (including ground
beef) took effect in February 2000. This action has heightened interest in
using irradiation to reduce foodborne pathogens. Ground beef poses
particular food safety concerns because the grinding process can spread
pathogens present on the meat's surface throughout the product.

While federal food safety agencies have approved irradiation as safe for a
variety of foods, concerns about the safety of these foods (such as toxicity
and reduced nutritional quality), the impact of the irradiation process on
worker safety and the environment, and consumers' willingness to purchase
irradiated foods have limited their availability in the United States. In
response to these concerns, you asked that we determine (1) the extent and
the purposes for which food irradiation is being used in the United States
and (2) the scientifically supported benefits and risks of food irradiation.

Results in Brief To date, only limited amounts of irradiated foods have been
sold in the United States. Irradiated spices, herbs, and dry vegetable
seasonings

constitute the largest category of irradiated food; in 1999, about 95
million pounds of these products were irradiated, accounting for about 10
percent of their total consumption. In addition, small amounts of irradiated
fresh fruits, vegetables, and poultry have been available in wholesale and
retail markets, primarily in Florida and several midwestern states.
Irradiated frozen ground beef has recently begun to be marketed in several
midwestern states and Florida. The major purchasers of irradiated foods are
health care and food service establishments, which purchase them primarily
to minimize the threat of foodborne illness. For example, nursing homes and
hospitals serve irradiated poultry to patients with weakened immune systems
to reduce the risk of contracting a foodborne illness that would further
jeopardize their condition. Concerns on the part of food processors,
retailers, and others about consumer acceptance of irradiated foods have
limited their availability to date.

Scientific studies conducted by public and private researchers worldwide
over the past 50 years support the benefits of food irradiation while
indicating minimal potential risks. For example, an expert committee

convened by the World Health Organization reviewed the findings of over 500
studies and concluded that food irradiation creates no toxicological,
microbiological, or nutritional problems. Cited benefits of food irradiation
include (1) reducing foodborne pathogens; (2) extending the shelf life of
some fruits and vegetables by preventing sprouting, deactivating mold, and
killing bacteria; and (3) controlling insect pests- thus reducing the need
for environmentally harmful fumigants. These studies have not borne out
concerns about the safety of consuming irradiated foods. For example, the
studies indicated that chemical compounds in irradiated food are generally
the same as those in cooked foods, and any differences do not put consumers
at risk. As for nutritional quality, the main components of food-
carbohydrates, protein, and fats- undergo minimal change during irradiation,
and vitamin loss corresponds to that in foods that are cooked, canned, or
held in cold storage. Finally, regarding worker safety and the environment,
commercial irradiation plants are strictly regulated. Worldwide, over the
past 30 years, while several accidents have resulted in injury or death to
workers because of radiation exposure, all of the accidents occurred because
safety systems and control procedures had been bypassed. Furthermore, in
North America, in over 40 years of transporting the types of radioactive
isotopes used for irradiation, there has never been an accident resulting in
the escape of these materials into the environment.

We provided a draft of this report to FDA for its review and comment. FDA
officials, including the Director of the Division of Product Policy, Center
for Food Safety and Applied Nutrition, generally agreed with the information
presented in the report and provided technical clarifications, which were
incorporated as appropriate.

Background Several Processes Are Used

Food irradiation is the process of exposing food, either prepackaged or in
to Irradiate Food

bulk, to controlled levels of ionizing radiation. Ionizing radiation is a
type of energy similar to radio and television waves, microwaves, and
infrared radiation. However, the high energy produced by ionizing radiation
allows it to penetrate deeply into food, killing microorganisms without
significantly raising the food's temperature.

In the United States, three types of ionizing radiation have been approved
for irradiating food- gamma rays, high- energy electrons (sometimes referred
to as electron beams), and X- rays. Until recently, gamma rays-
specifically, those produced by cobalt- 60- have been the exclusive source
of food irradiation in the United States. While the three types of ionizing
radiation have the same effects on food, there are some differences in how
they work. For example, electron beams and X- ray radiators are operated by
electricity and do not use radioactive isotopes (e. g., cobalt- 60).
However, electron beams cannot penetrate as far into food as gamma rays or
X- rays; 2 thus, they are used primarily for treating thin packages of food
or a thin stream of grains or powders.

Only two gamma ray facilities in the United States are used primarily for
irradiating food. However, many such facilities are used for other purposes,
such as sterilizing medical, pharmaceutical, and consumer products (e. g.,
syringes, bandages, dairy and juice containers, and baby bottle nipples). 3
The one electron beam facility that irradiates food commercially began
supplying irradiated ground beef to grocery stores in Minnesota in May of
this year. Additional electron beam facilities are expected to begin
irradiating beef and poultry for commercial sale later this year and early
next year. However, as with gamma ray facilities, other electron beam
plants- primarily used for sterilizing medical supplies- have been
operational for years. X- ray technology is still being tested for use in
food irradiation, and a plant is being constructed in Hawaii to disinfest
tropical fruit. However, at this point, X- ray technology is not as
economical as gamma rays or electron beam technology.

Depending on the dose of radiation used, rapidly growing cells (such as
those in foodborne pathogens, spoilage microorganisms, 4 insects, parasites,
and plant tissues) are deactivated or killed. As a result, irradiation is
used for a variety of purposes, such as reducing or eliminating foodborne
pathogens, disinfesting food, and extending product shelf life. However, not
all foods are suitable for irradiation. For example, some fruits

2 Electron beams have a maximum one- sided treatment penetration capability
of about 1-ï¿½ inches in food items at the approved dose ranges; with double-
sided electron beam treatment, these items can be no more than about 3-ï¿½
inches thick.

3 Some of these facilities also treat food products. 4 Spoilage
microorganisms, such as certain bacteria, yeast, and mold, cause strong
odors and shorten shelf life but are not generally associated with human
illness.

are very sensitive to radiation and their skins are damaged, and other foods
(such as cucumbers, grapes, and some tomatoes) turn mushy.

In the United States, FDA first approved irradiation for use on a food
product (i. e., wheat and wheat flour) in 1963. (See app. II for a
chronology of food irradiation events.) Since then, it has been approved for
use on such products as vegetables, spices, fruits, poultry, and, most
recently, refrigerated and frozen uncooked meat and fresh shell eggs.
Worldwide, almost 40 countries permit the use of irradiation on over 50
different foods, and an estimated 500,000 tons of food are irradiated
annually. However, national laws are divergent. For example, the European
Union has not yet agreed on guidelines for regulating food irradiation,
primarily because of resistance from Germany. On the other hand, the
Netherlands, Belgium, and France irradiate many types of food, including
considerable amounts of frozen seafood and frog legs and dry food
ingredients. Spices are irradiated in many countries, including Argentina,
Israel, Norway, France, South Africa, and Mexico.

Many Federal Agencies Many federal agencies have regulatory responsibilities
related to food

Regulate Food Irradiation irradiation, including FDA, USDA, the Nuclear
Regulatory Commission

(NRC), the Occupational Safety and Health Administration, and the Department
of Transportation- with FDA having primary regulatory responsibility for
ensuring the safety of irradiated foods. These agencies regulate a range of
issues, including the types of food that can be irradiated, the process by
which food can be irradiated, the safe use of radiation, the safety of the
workers in irradiation facilities, and the safe transportation of
radioactive material.

Under the Federal Food, Drug, and Cosmetic Act, FDA has overall
responsibility for regulating the safety of all foods, except for meat,
poultry, and some egg products that are USDA's responsibility. FDA's
specific responsibilities for food irradiation derive from the Food
Additives Amendment of 1958, which gave the agency responsibility for
ensuring the safety of food additives. While most food additives are
substances that are added to foods, the act specifically defined the source
of radiation to be a food additive. 5 Radiation sources (i. e., cobalt- 60,
electron beams, and X- ray generators) are considered to be food additives
because their use could affect the characteristics of food. FDA's
responsibilities for food irradiation include (1) determining the safety of
the radiation sources used in food processing; (2) issuing regulations that
prescribe the conditions under which foods can be irradiated and the maximum
permitted radiation dose, which is measured in units called kiloGray (kGy);
6 and (3) inspecting the facilities that irradiate food products.

Food additive regulations governing the use of food irradiation are
initiated either by a petition submitted to the agency or, less often, by
FDA itself. In both instances, FDA must determine whether the additive is
safe under all conditions of permitted use. Once FDA issues a final
regulation, the additive can be used by anyone who adheres to the specified
conditions of use. Since 1963, FDA has approved the use of irradiation for
several foods to (1) reduce illness- causing microorganisms, (2) retard
product maturation, and/ or (3) meet quarantine requirements for certain
insect pests. Petitions to irradiate shellfish, seeds for sprouts,
nonrefrigerated meat products, and processed foods are pending. (See app.
III for a list of foods and uses approved by FDA.)

USDA's Food Safety and Inspection Service (FSIS) is also responsible for
ensuring the safety of certain irradiated foods. Under the Federal Meat
Inspection Act, the Poultry Products Inspection Act, and the Egg Products
Inspection Act, 7 FSIS is responsible for prohibiting the marketing of

5 Under 21 U. S. C. 321( s), “a food additive is any substance the
intended use of which results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any source of radiation. .
.).”

6 The kiloGray is the unit of measurement for the amount of energy absorbed
by food during the irradiation process. For example, FDA has approved a dose
of up to 7 kiloGray for frozen meat to control pathogens and extend shelf
life.

7 21 U. S. C. 601 et. seq., 21 U. S. C. 451 et. seq., and 21 U. S. C. 1031
et. seq., respectively.

adulterated meat, poultry, and egg products. When irradiated, these products
are considered adulterated and, thus, cannot be sold unless they have been
irradiated in conformity with FDA's and USDA's regulations. Both FDA and
USDA require that irradiated food products be labeled; in general, their
labeling regulations are similar. For example, both agencies require
irradiated foods to be labeled with the international food irradiation
symbol- the radura. (See fig. 1)

Figure 1: The International Food Irradiation Symbol- the Radura

Source: USDA.

In addition, the label must state that the product has been intentionally
subjected to radiation. However, FDA's and FSIS' labeling requirements
differ in at least one respect. FSIS' regulations require that irradiated
meat and poultry ingredients in multi- ingredient meat and poultry products
be identified on the list of ingredients. FDA does not have a similar
requirement for multi- ingredient products.

In November 1997, the Congress directed FDA to reconsider its overall
labeling requirement and seek public comment on possible changes. In
February 1999, FDA issued a notice discussing labeling issues and invited
public comments on whether changes were needed. As of June 2000, FDA had not
completed analyzing the approximately 4,500 public comments it had received.

USDA's Animal and Plant Health Inspection Service regulates the use of
irradiation as a pest control treatment on quarantined fruits and
vegetables. Many countries (including the United States) require treatment
of certain fresh produce, such as citrus, mangoes, and papayas, that often
harbor nonnative insects or plant pathogenic pests that would have a
negative economic, health, or environmental impact, if introduced.
Currently, the Animal and Plant Health Inspection Service permits the use of
irradiation to destroy these pests in certain fresh produce imported from
Hawaii before their interstate distribution on the U. S. mainland.

NRC, the Department of Transportation, and the Occupational Safety and
Health Administration have primary responsibilities for environmental and
worker safety issues relating to radioactive materials.

NRC is responsible for ensuring that nuclear materials are used safely
within irradiation facilities. Food irradiation facilities must meet NRC's
design, operating, management, training, and other requirements and are
inspected yearly for compliance. In some instances, NRC relinquishes
regulatory authority to state governments, which must require at least as
much protection as NRC. Food irradiation facilities that use electron beams
and X- ray technology are regulated by state governments. NRC and the
Department of Transportation share primary responsibility

for regulating the transport of radioactive materials. (The U. S. Postal
Service, the Department of Energy, and the states are also involved in
regulating the transportation of these materials.) The Occupational Safety
and Health Administration regulates worker

safety in food irradiation facilities. The agency requires that all
radiation facilities operate under a worker safety program that, among other
things, establishes procedures to protect workers from accidental exposure
to radiation. This includes prominently displaying caution signs, labels,
and signals and providing each employee with a personal device to measure
radiation absorption. NRC, FSIS, and the Animal and Plant Health Inspection
Service regulate aspects of worker protection in facilities that use nuclear
materials, irradiate meat and poultry, and irradiate plant products,
respectively.

Quantities and Uses of Despite extensive research on the safety of
irradiated food and the

Irradiated Food in the approval of irradiation for several food products,
only limited amounts of

irradiated food are available in the United States. The food industry cites
United States are

concerns about consumer acceptance as a major reason for the limited Limited

availability of irradiated food. While still limited, with the recent
approvals of meat and fresh shell egg irradiation, the availability of
irradiated food is increasing; additional increases are anticipated as a
result of the expected approval of irradiation for other foods along with
increased consumer education about food irradiation. Health care and food
service establishments have been the primary users of irradiated food; 8
they purchase these foods primarily to minimize the threat of foodborne
illnesses.

Volume of Irradiated Food In the United States, an estimated 97 million
pounds of food products are

Is Small but Increasing irradiated annually, representing a tiny fraction of
the total amount of food

consumed. Spices, herbs, and seasonings are the largest category of
irradiated food, accounting for about 95 million pounds annually. Fruits and
vegetables account for about 1. 5 million pounds annually, and poultry
accounts for approximately 500,000 pounds. Table 1 lists the estimated
quantities and percentage of annual consumption for the types of foods that
are irradiated in the United States.

Table 1: Estimated Annual Quantities and Percentage of Consumption for
Irradiated Food in the United States, as of January 2000

Amount irradiated Percentage of annual Food product (millions of pounds)
consumption

Spices and dry or dehydrated 95.0 9. 5

aromatic vegetable substances a Fruits and vegetables 1.5 0. 002 Fresh and
frozen uncooked

0.5 0. 002 poultry Total 97.0

Notes: Refrigerated and frozen uncooked beef, pork, lamb, and goat have been
approved for irradiation; however, as of January 2000, these products were
not available commercially.

8 This does not include spices, herbs, and dry vegetable substances that are
used as ingredients in other food products.

a Refers to substances used for flavoring or aroma (e. g., culinary herbs,
seeds, spices, and vegetable seasonings).

Source: GAO's presentation of information from 21 C. F. R. 179.26 (Apr. 1,
1999, ed.) and estimates provided by the International Atomic Energy Agency
and officials from the food irradiation industry.

Concerns about consumer acceptance of irradiated food are often cited by
food industry officials as a major reason for the limited use of this
technology. While several retail establishments, including a Chicago- area
supermarket and Florida- area restaurant chain, sell irradiated chicken and
some irradiated fruit, the nationwide availability of irradiated food has
been extremely limited. Officials from a supplier of irradiated poultry said
that, on several occasions, they tried to establish partnerships with
poultry producers and retailers to expand the scope of their business but
were unsuccessful. They said that retailers were reluctant to be the first
to sell irradiated food in their areas.

Attitudes might be changing, however. Government and food industry officials
believe that the market for irradiated food will increase following the
recent approval to irradiate meat and fresh shell eggs and the anticipated
approval for ready- to- eat products, such as precooked beef patties,
luncheon meats, and sprouts. According to an irradiation company official,
retailers and others might have more of an incentive to purchase irradiated
beef, and particularly ground beef, because nonirradiated ground beef and
beef are significant sources of E. coli O157: H7- a deadly foodborne
pathogen. USDA considers raw beef products containing this pathogen to be
adulterated, and the product must be destroyed. Although poultry is a source
of dangerous foodborne pathogens, such as Salmonella (several species) and
Campylobacter jejuni, these pathogens have not been declared adulterants,
and products found to contain them are not required to be destroyed. 9

In addition, consumers might be more inclined to purchase irradiated food as
a result of the concerted public education effort that food irradiation
companies have undertaken. These companies are using pamphlets, videos, and
other educational tools to inform retailers and the public about the
benefits of irradiation. The results of several consumer surveys indicate
that as consumers become more educated about food irradiation, they are more
likely to purchase these foods.

9 In addition, poultry is more likely than beef to be thoroughly cooked
prior to consumption; proper cooking kills most pathogens, thus making the
product safer to eat.

Earlier this year, two food irradiation companies collaborated with several
large food producers to test irradiated foods for consumer acceptance and
marketability. One of the companies aligned with a beef processor to
introduce irradiated beef patties into Minnesota supermarkets in May 2000.
According to a company official, the patties were introduced into 84 stores
on the first day, and over 250 supermarkets in five states were receiving
irradiated beef patties by June 2000. The second company has established a
partnership with a beef processor in Florida. As of June 2000, a few small
food retailers have purchased irradiated beef products from this company.

Irradiated Foods Are According to consumer surveys, 10 irradiated food is
purchased primarily

Purchased Primarily for for food safety benefits. These benefits are
particularly important to health

Their Food Safety Benefits care and food service establishments- the primary
purchasers of

irradiated foods. For example, nursing homes and hospitals serve irradiated
poultry to patients with weakened immune systems to reduce the risk of
contracting a foodborne illness that would further jeopardize their health.
In addition, a restaurant chain in Florida serves irradiated chicken to
reduce its risk of having an outbreak of a foodborne illness. With the
recent outbreaks of Listeria monocytogenes (a foodborne pathogen most
commonly found in processed meats and soft cheeses), food processors are
expected to become major users of food irradiation if the petition to allow
irradiating ready- to- eat, processed food is approved.

Scientific Evidence Irradiation has been studied extensively, and the
consensus emerging from

Supports the Benefits these studies is that food irradiation is a safe,
effective tool for reducing

foodborne pathogens. Other benefits of food irradiation include extending of
Food Irradiation and

the shelf life of certain foods, decontaminating spices and other Indicates
that Risks are

seasonings, and controlling insect infestation in grain products, fruits,
and Minimal

vegetables. Moreover, the risks that have sometimes been attributed to
irradiated food- such as the creation of potentially harmful chemical by-
products and the loss of nutrients- have been shown to be minimal. Worker
and environmental safety issues, particularly with respect to the use of
cobalt10

Consumer Expectations Regarding Irradiated Foods, Christine Bruhn, Director,
Center for Consumer Research, University of California- Davis, Apr. 2000;
Consumer Perceptions of Meat Irradiation, Marjorie Troxel, Research
Specialists, Sosland Research Services, Apr.

2000.

60 (a source of gamma rays) in food irradiation, have also raised concerns.
However, irradiation facilities are subject to strict federal and state
regulations. Worldwide, over the past 30 years, while several accidents have
injured or killed workers because of radiation exposure, all of these
accidents occurred because safety systems and control procedures had been
bypassed. Furthermore, in North America, in over four decades of
transporting the types of radioactive isotopes used for irradiation, there
has never been an accident resulting in the escape of radioactive materials
into the environment. (See app. IV for commonly asked questions and answers
on the benefits, the risks, and other issues relating to food irradiation.)

Numerous national and international health and scientific organizations-
including the American Medical Association, FDA, the World Health
Organization, and the Food and Agriculture Organization- have endorsed food
irradiation. Most major U. S. food- related consumer groups cautiously
support or are neutral on the use of food irradiation, particularly for
vulnerable populations. However, several groups- such as Public Citizen and
Food and Water, Inc.- oppose its use because they believe that FDA has not
sufficiently proven that irradiation can safely be used on food and that
more long- term research on the effects of consuming irradiated food is
needed.

Irradiation Reduces A major benefit of food irradiation is its effectiveness
as a tool in reducing

Foodborne Pathogens, foodborne pathogens, according to numerous studies
conducted

Extends Shelf Life, worldwide for over 50 years. Irradiation, within
approved dosages, has

Decontaminates Spices, and been shown to destroy at least 99.9 percent of
common foodborne

pathogens, such as Salmonella (various species), Campylobacter jejuni, E.
Controls Insect Infestation

coli O157: H7, and Listeria monocytogenes, which are associated with meat
and poultry. 11 However, irradiation at the approved doses does not
sterilize food nor make it shelf- stable (i. e., capable of being stored
without refrigeration); FDA officials and others emphasize that irradiation
does not replace proper food handling- irradiated food must still be
properly refrigerated and cooked prior to consumption.

11 Viruses, bacterial spores, some mold and yeasts, mycotoxins produced by
certain types of bacteria and mold, and prion particles (the agent thought
to be responsible for bovine spongiform encephalopathy, or “mad
cow” disease) are highly resistant to irradiation.

Because of irradiation's effectiveness in controlling common foodborne
pathogens and in treating packaged food (thereby minimizing the possibility
of cross- contamination prior to consumer use), federal food safety
officials and others view irradiation as an effective critical control point
in a Hazard Analysis and Critical Control Points (HACCP) system. 12
According to a food scientist who is currently the director of the Food
Chemicals Codex at the National Academies Institute of Medicine, irradiation
fulfills several conditions necessary for a critical control point. In
addition to its pathogen- reducing abilities, appropriate radiation doses
are well- known, and compliance can be monitored by accurately measuring the
absorbed radiation dosage.

A second important benefit of irradiation is that it can prolong the shelf
life of many fruits and vegetables. It does this by reducing spoilage
bacteria and mold and inhibiting sprouting and maturation. As a result,
products can be harvested when fully ripened and can be transported and
displayed for longer periods while maintaining desirable sensory qualities
longer than nonirradiated products. For example, according to the Council
for Agricultural Science and Technology, 13 irradiating strawberries extends
their refrigerated shelf life to 3 weeks without decay or shrinkage.
Irradiation can also be used as an alternative to chemical sprout inhibitors
for tubers, bulbs, and root crops. These inhibitors are considered by some
to be harmful, and many countries have prohibited their use. The softening
and browning associated with the ripening of certain fruits and vegetables,
such as bananas, mangoes, and mushrooms, can be delayed with irradiation.

Irradiation is also an effective means to decontaminate certain food
products, thereby eliminating or reducing the use of toxic or
environmentally harmful fumigants. Spices, herbs, and dry vegetable
seasonings are the most commonly irradiated food products in the United
States. These products are frequently dried in the open air and become

12 A HACCP system is a science- based process intended to identify potential
sources of pathogen contamination and establish procedures to prevent
contamination. All state and federally inspected meat and poultry slaughter
and processing plants are required to have HACCP plans. A critical control
point is a point, step, or procedure at which control can be applied and a
food safety hazard can be prevented or reduced to an acceptable level.

13 The Council is a nonprofit organization composed of 38 scientific
societies and other members (e. g., individuals, companies, and nonprofits).
Its mission is to identify food and fiber, environmental, and other
agricultural issues and interpret related scientific research information
for public policy decisionmakers.

severely contaminated by air- and soil- borne microorganisms and insects.
Food processors often fumigate spices, herbs, and dry vegetable seasonings
with ethylene oxide to reduce or eliminate pathogens and with methyl bromide
to reduce insects. However, both of these products are extremely toxic and/
or damaging to the environment- ethylene oxide has been banned in many
countries and methyl bromide is being phased out globally for environmental
reasons.

Finally, irradiation can be used as a pest control treatment on quarantined
fruits and vegetables to prevent the importation of harmful pests- such as
the Mediterranean fruit fly. To minimize this risk, USDA's Animal and Plant
Health Inspection Service's quarantine procedures require the use of
fumigation or heat (hot water or hot air) or cold treatment of fruit that is
not ripe. Irradiation treatment is an effective alternative for many types
of fresh produce because it can be used on riper fruit and on fruit that
cannot tolerate heat treatment. Moreover, a number of past quarantine
treatments have recently been prohibited- an example being fumigation with
ethylene dibromide. In 1997, the Inspection Service issued a final rule
allowing the use of irradiation as a quarantine treatment for papayas,
carambola, and litchi coming from Hawaii to the U. S. mainland. In May 2000,
the Inspection Service proposed a rule to allow irradiation for use in
killing fruit flies and mango seed weevils on fruits and vegetables imported
into the United States. If approved, this rule will further expand the use
of irradiation in pest control.

Scientific Studies Indicate Despite the benefits of irradiation, the
widespread use of irradiated food

Minimal Risks Are hinges largely on consumer confidence in the safety and
the

Associated With Food wholesomeness of these products. The cumulative
evidence from over four

Irradiation decades of research- carried out in laboratories in the United
States,

Europe, and other countries worldwide- indicates that irradiated food is
safe to eat. The food is not radioactive; there is no evidence of toxic
substances resulting from irradiation; and there is no evidence or reason to
expect that irradiation produces more virulent pathogens among those that
survive irradiation treatment. In addition, nutritional losses from food
irradiation are similar to other forms of food processing and would not
adversely affect a food's nutritional value. In particular:

Radioactivity in irradiated foods is not seen as a concern because the
energy in the currently approved radiation sources (cobalt- 60, cesium137,
electron beams, and X- rays) is too low to induce radioactivity. According
to the International Consultative Group on Food Irradiation, 14 irradiation
cannot increase the normal trace amounts of background radioactivity of food
at approved energy levels- no matter how long the food is exposed to the
radiation source or how much of the energy dose is absorbed. With regard to
toxicity, the evidence from numerous studies conducted

worldwide over the past 50 years indicates that the compounds formed in
irradiated food are generally the same as those produced during cooking,
canning, pasteurization, and other forms of food preparation and that any
differences do not put consumers at risk. 15 Three United Nations agencies-
the Food and Agriculture Organization (FAO), the World Health Organization
(WHO), and the International Atomic Energy Agency (IAEA)- convened Joint
Expert Committees on the Wholesomeness of Irradiated Foods in 1964, 1969,
1976, and 1980 to evaluate studies on the safety of irradiated foods and
other irradiationrelated issues. These committees' evaluations, along with
independent evaluations by experts in Denmark, France, the Netherlands,
Japan, the United Kingdom, and the United States, found no toxic effects as
a result of consuming irradiated food. In 1992, WHO had an expert committee
evaluate all the literature and data available since 1980- over 500 studies-
on the safety of irradiated food. This committee reiterated earlier findings
that food irradiation causes no toxicological, microbiological, or
nutritional problems that adversely effect human health. Finally, FDA has
found no evidence that food irradiation results in

pathogenic bacteria that are more virulent or more resistant to heat (e. g.,
less likely to be destroyed in cooking). In fact, pathogenic bacteria that
survive irradiation are destroyed at lower cooking temperatures than those
that have not been irradiated.

14 The International Consultative Group on Food Irradiation, established
under the aegis of the Food and Agriculture Organization (FAO), the World
Health Organization (WHO), and the International Atomic Energy Agency (IAEA)
provides information to these three United Nations agencies and their member
nations on the safe and proper use of food irradiation technology.

15 The standard procedure in these studies is to feed laboratory animals the
irradiated food product and look for health indicators, such as impacts on
longevity, reproductive capacity, and tumor incidence.

In addition to safety issues, nutritional loss has been a concern. While
some nutrient losses are associated with irradiation, they are less than
those associated with cooking or many other food- processing methods,
according to the Institute of Food Technologists' Expert Panel on Food
Safety and Nutrition. Furthermore, carbohydrates, proteins, and fats- the
main components of food- are not significantly affected by irradiation doses
even greater than those currently approved by FDA. Food processors minimize
nutrient loss by irradiating food in a cold or frozen state and under
reduced levels of oxygen.

There is also some vitamin loss associated with irradiation- with certain
vitamins, such as thiamin (B1), ascorbic acid (C), and alpha- tocopherol
(E)- more affected by irradiation than others. However, according to the
Institute of Food Technologists, it is highly doubtful that there would ever
be any vitamin deficiency resulting from eating irradiated food. For
example, thiamin is the most radiation- sensitive, water- soluble vitamin.
With regard to this vitamin, the American Dietetic Association's position
statement on food irradiation notes that FDA evaluated an extreme case in
which all meat, poultry, and fish were irradiated at the maximum permissible
dose under conditions resulting in the maximum destruction of thiamin. Even
in these circumstances, the average thiamin intake was above the Recommended
Dietary Allowance, leading FDA to conclude that there was no deleterious
effect on the total dietary intake of thiamin as a result of irradiating
foods. In its 1980 evaluation of food irradiation, the Joint Expert
Committee convened by FAO, WHO, and IAEA concluded that irradiation caused
no special nutritional problems in food. Another meeting of experts in 1997-
organized by the same three international organizations- concluded that even
high doses of irradiation (i. e., over 10 kGy) would not result in nutrient
losses that could adversely affect a food's nutritional value.

Worker and Environmental Worldwide, there are about 170 industrial gamma
irradiation facilities,

Safety Is a Concern, but the about 40 of which are in the United States.
While some of these facilities

Record Has Been Good process food, most are used to sterilize medical
equipment and consumer

goods. However, the technology and equipment used in these facilities are
similar, regardless of the product that is being irradiated. While all
industrial activities typically pose certain risks to human beings and the
environment, reports by the Council for Agricultural Science and Technology
and the International Consultative Group on Food Irradiation state that the
radiation processing industry is considered to have a strong

safety record. 16 According to the International Consultative Group on Food
Irradiation, over the past 30 years worldwide, several accidents have
resulted in injury or death to workers because of radiation exposure;
however, all of these accidents occurred because safety systems had been
bypassed and proper control procedures had not been followed. Furthermore,
none of the accidents endangered public health or environmental safety.

To decrease the risk of accidental exposure to ionizing radiation,
irradiation facilities are built with several layers of redundant protection
to detect equipment malfunctions and protect employees from accidental
exposure. Potentially hazardous areas are monitored; a system of interlocks
prevents unauthorized entry while products are being irradiated; and a maze
constructed of thick concrete walls protects workers from radiation.
Furthermore, all irradiation facilities must be licensed and are subject to
regular inspections, audits, and other reviews to ensure that they are
safely and properly operated. 17 In the United States, NRC has exempted
facilities that use radioisotopes (such as cobalt- 60 and cesium- 137) from
having to prepare an environmental impact statement (which is required for
nuclear facilities) because it found that these facilities do “not
individually or cumulatively have a significant effect on the human
environment.”

All radioactive materials required for irradiation facilities are
transported in lead- shielded steel casks. The containers meet stringent
national and international government standards designed to withstand the
most severe accidents, including collisions, punctures, and exposure to fire
and water. In North America, in over 40 years of transporting the types of
radioactive isotopes used for irradiation, there has never been an accident
resulting in the escape of radioactive materials into the environment.
According to the International Consultative Group on Food Irradiation, this
excellent safety record exceeds that of other industries shipping hazardous
materials, such as toxic chemicals, crude oil, or gasoline.

16 Issue Paper: Radiation Pasteurization of Food, Council for Agricultural
Science and Technology, No. 7, Apr. 1996; Facts About Food Irradiation, the
International Consultative Group on Food Irradiation, 1999.

17 As discussed, U. S. facilities using gamma ray sources must be licensed
by NRC; those using electron beams and X- rays are licensed by the states.

While Major Health and Many prominent health and scientific organizations
have agreed that food

Scientific Organizations irradiation is an effective tool for enhancing food
safety. Trade groups, such

Endorse Food Irradiation, as the American Meat Institute, the Grocery
Manufacturers of America, and

Some U. S. Consumer the National Food Processors Association, also support
irradiation. In

addition, nearly 40 countries, including the United States, Canada, the
Groups Have Reservations

United Kingdom, France, Germany, the Netherlands, South Africa, About, or
Oppose, the

Argentina, Brazil, China, India, and Russia, have approved food irradiation
Practice

for certain types of food. Following are some of the major scientific and
health- related organizations that consider food irradiation to be safe:

U. S. government agencies

Food and Drug Administration Department of Agriculture Public Health Service
Centers for Disease Control and Prevention U. S. scientific and health-
related organizations

American Dietetic Association American Medical Association American
Veterinary Medical Association Council for Agricultural Science and
Technology Institute of Food Technologists National Association of State
Departments of Agriculture International scientific and health- related
organizations

Food and Agriculture Organization International Atomic Energy Agency World
Health Organization Codex Alimentarius Commission Scientific Committee of
the European Union

At the same time, however, FDA officials and others caution that irradiation
should not be seen as a panacea but as an intervention strategy that can be
used as part of a comprehensive food safety program. When irradiation is
used to control bacteria, it should be part of a well- designed HACCP
system.

Major U. S. consumer food groups, including the Center for Science in the
Public Interest, Safe Tables Our Priority, the National Consumer League, and
the Consumer Federation of America, for the most part, cautiously support or
are neutral regarding the limited use of food irradiation. In

general, the groups acknowledge that irradiation can be an effective tool to
eliminate pathogens in food, particularly for consumers with compromised or
vulnerable immune systems, but they are concerned that the process could be
used at the “end of the line to mask inadequate sanitation practices
in processing plants.” They generally believe there is a continuing
need for strong government food safety inspection programs and clear
labeling of irradiated foods, and some groups advocate stronger labeling
requirements. However, several consumer groups, such as Food and Water, Inc.
and Public Citizen, strongly oppose food irradiation. Among other things,
they believe that FDA has not sufficiently proven that irradiation can
safely be used on food and that more long- term research on the effects of
consuming irradiated food is needed.

Agency Comments We provided the Food and Drug Administration with a draft of
this report for its review and comment. We met with the Director of the
Division of

Product Policy, Center for Food Safety and Applied Nutrition, and several
officials from the Center's Office of the Director as well as
representatives from the Office of Legislation and the Office of the Chief
Counsel. These officials generally agreed with the substance of the report
and provided technical and clarifying comments that we have incorporated as
appropriate.

We conducted our work from January through July 2000 in accordance with
generally accepted government auditing standards. Appendix I discusses our
scope and methodology.

As arranged with your offices, unless you publicly announce the contents
earlier, we plan no further distribution of this report until 30 days after
the date of this letter. At that time, we will provide copies to interested
congressional committees; the Honorable Dan Glickman, Secretary of
Agriculture; the Honorable Donna E. Shalala, Secretary of Health and Human
Services; and other interested parties. We will also make copies available
to others on request.

If you or your staffs have any questions about this report, please contact
me at (202) 512- 5138. Key contributors to this report are listed in
appendix V.

Robert E. Robertson Associate Director,

Food and Agriculture Issues

Appendi Appendi xes xI

Scope and Methodology To determine the extent and the purposes for which
food irradiation is being used, we interviewed representatives from the
federal government, the food irradiation and food processing industries, and
food industry organizations. Specifically, we interviewed and obtained
information from officials from the Food and Drug Administration's (FDA)
Center for Food Safety and Applied Nutrition and the U. S. Department of
Agriculture's (USDA) Food Safety and Inspection Service (FSIS), Animal and
Plant Health Inspection Service, Economic Research Service, and Agricultural
Research Service. We interviewed officials from five major North American
irradiation firms- Food Technology Service, Inc., Titan Corporation, IBA
Food Safety Division, STERIS Corporation- Isomedix Services, and MDS
Nordion- as well as the National Food Processors Association; the American
Spice Trade Association; and the American Meat Institute. We also obtained
data on the quantities of irradiated food from the five irradiation firms,
the American Spice Trade Association, the International Atomic Energy
Agency, the International Consultative Group on Food Irradiation, and USDA.

To determine the scientifically supportable benefits and risks of food
irradiation, we reviewed reports, journal articles, position papers, and
other documents prepared by public and private organizations in the United
States and other countries, international organizations, and individual
scientists. Many of these documents draw upon scientific studies conducted
in the United States and elsewhere over the past 50 years. These documents
were prepared by the following organizations:

1. Federal agencies, including USDA's Economic Research Service, FSIS, and
Agricultural Research Service; the Centers for Disease Control and
Prevention; and FDA's Center for Food Safety and Applied Nutrition;

2. U. S. food and health- related organizations, public policy
organizations, and universities, including the American Council on Science
and Health; the Council for Agricultural Science and Technology; the
Foundation for Food Irradiation Education; the Institute of Food
Technologists; the American Enterprise InstituteBrookings: Joint Center for
Regulatory Studies; the American Dietetic Association; the American Medical
Association; Iowa State University; Massachusetts Institute of Technology;
and the universities of California- Davis, Connecticut, Florida, Georgia,
and Michigan;

3. International food and health- related organizations, including the Joint
Expert Committee on the Wholesomeness of Irradiated Foods, sponsored by the
International Atomic Energy Agency, the Food and Agriculture Organization,
and the World Health Organization; the International Consultative Group on
Food Irradiation; and the International Food Information Council;

4. Consumer and public interest organizations, including Public Citizen;
Safe Tables Our Priority; Food and Water, Inc.; the Center for Science in
the Public Interest; and the International Organization of Consumers Unions;
and

5. Industry trade associations, including the National Food Processors
Association, the Grocery Manufacturers of America, the American Meat
Institute, and the American Spice Trade Association.

In addition, we reviewed texts by scientists and others including Safety of
Irradiated Foods, by J. F. Diehl, Marcel Dekker, Inc., second edition, 1995;
Biology of Food Irradiation, by David R. Murray, Research Studies Press, LTD
and John Wiley and Sons, Inc., 1990; and Food Irradiation: Who Wants It? by
Tony Webb, Tim Lang, and Kathleen Tucker, Thorsons Publishers, Inc., 1987.

Our examination of the benefits and the risks of food irradiation also
included a review of FDA's and FSIS' final rules relating to the irradiation
of fresh foods, spices, poultry, and refrigerated or frozen meat. We also
reviewed a petition to irradiate raw and preprocessed vegetables and fruits
and certain multi- ingredient food products for which a final rule has not
yet been issued. Among other things, these documents evaluate the safety of
irradiation and include assessments of the chemical reactions that occur as
a result of irradiation, toxicity studies of irradiated foods, studies of
the nutritional adequacy of irradiated products, and studies of the effects
of irradiation on microorganisms. We also reviewed FSIS' Review of Risk
Analysis Issuesfor information relating to environmental impact and worker
and transportation safety issues and reviewed comments proponents or
opponents of food irradiation have provided to FDA on its proposed rules.

Finally, for added perspective on the stated positions of some of these
organizations, we interviewed the Director, Division of Product Policy, FDA
Center for Food Safety and Applied Nutrition; the Director, Regulations
Development and Analysis Division, FSIS; executives from the five major

North American irradiation firms; officials from consumer and public
interest organizations, including the Center for Science in the Public
Interest, the Consumer Federation of America, Food and Water, Inc., Public
Citizen, and Safe Tables Our Priority; and representatives from two food
industry organizations, the American Meat Institute and the National Food
Processors Association. We also attended the international food irradiation
conference held in Arlington, Virginia, in April 2000.

We conducted our review from January through July 2000 in accordance with
generally accepted government auditing standards.

Appendi xII

Chronology of Food Irradiation Events Year Event

1905 Scientists receive patents for a food preservative process that uses
ionizing radiation to kill bacteria in food.

1921 U. S. patent is granted for a process to kill Trichinella spiralis in
meat by using X- ray technology.

1953- 1980 The U. S. government forms the National Food Irradiation Program.
Under this program, the U. S. Army and the Atomic Energy Commission sponsor
many research projects on food irradiation.

1958 The Food, Drug, and Cosmetic Act is amended and defines sources of
radiation intended for use in processing food as a new food additive. Act
administered by FDA.

1963 FDA approves irradiation to control insects in wheat and flour. 1964
FDA approves irradiation to inhibit sprouting in white potatoes. 1964- 1968
The U. S. Army and the Atomic Energy Commission petition FDA to approve the
irradiation

of several packaging materials. 1966 The U. S. Army and USDA petition FDA to
approve the irradiation of ham. 1971 FDA approves the irradiation of several
packaging materials based on the 1964- 68 petition

by the U. S. Army and the Atomic Energy Commission. 1976 The U. S. Army
contracts with commercial companies to study the wholesomeness of

irradiated ham, pork, and chicken. 1980 USDA inherits the U. S. Army's food
irradiation program. 1985 FDA approves irradiation at specific doses to
control Trichinella spiralisin pork. 1986 FDA approves irradiation at
specific doses to delay maturation, inhibit growth, and disinfect

foods, including vegetables and spices. The Federal Meat Inspection Act is
amended to permit gamma radiation to control Trichinella spiralisin fresh or
previously frozen pork. Law is administered by USDA.

1990 FDA approves irradiation for poultry to control salmonella and other
foodborne bacteria. 1992 USDA approves irradiation for poultry to control
salmonella and other foodborne bacteria. 1997 FDA's regulations are amended
to permit ionized radiation as a source of radiation to treat

refrigerated or frozen uncooked meat, meat byproducts, and certain food
products to control foodborne pathogens and to extend shelf life.

2000 USDA's regulations are amended to allow the irradiation of refrigerated
and frozen uncooked meat, meat byproducts, and certain other meat food
products to reduce the levels of foodborne pathogens and to extend shelf
life. FDA's regulations are amended to permit the irradiation of fresh shell
eggs to control salmonella.

Food Products Approved for Irradiation in the

Appendi xI II

United States Maximum permitted dosage Food product Agency and approval date
Purpose for irradiation (kiloGray)

Wheat and wheat powder FDA - August 21,1963 Insect Deinfestation 0. 20 to 0.
50 White potatoes FDA - July 8, 1964 Inhibit sprout development 0. 05 to 0.
15 a Spices and dry vegetables FDA - July 5, 1983 Microbial disinfection and

10. 0 insect deinfestation b Dry or dehydrated enzyme

FDA - June 10, 1985 Microbial disinfection 10. 0 preparations Pork carcasses
or fresh

FDA - July 22, 1985 Control Trichinella spiralis 0. 30 to 1. 00 nonheated
processed cuts Fresh foods FDA - April 18, 1986 Delay maturation 1. 0

Dry or dehydrated aromatic FDA - April 18, 1986 Microbial disinfection 30. 0

vegetable substances c Fresh, frozen uncooked FDA - May 2, 1990

Control foodborne 3.0 poultry USDA - October 21, 1992 pathogens Refrigerated
and frozen

FDA - December 3, 1997 Control foodborne

4. 5 (refrigerated) uncooked beef, lamb, goat,

USDA - February 22, 2000 pathogens and extend shelf 7. 0 (frozen) and pork

life Fresh shell eggs FDA - July 21, 2000 Control salmonella 3. 0

a Maximum dose increased from 0. 10 to 0. 15 on November 9, 1965. b Insect
deinfestation approved June 1984. c Refers to substances used as ingredients
for flavoring or aroma (e. g., culinary herbs, seeds, spices, and vegetable
seasonings). Includes turmeric and paprika when used as color additives.

Source: 21 C. F. R. 179.26 (Apr. 1, 1999, ed.) and FDA and USDA/ FSIS
officials.

Commonly Asked Questions and Answers

Appendi xI V

About Food Irradiation How does food irradiation work to reduce or eliminate
foodborne microorganisms and insects?

Exposing food to radiation energy disrupts the organic processes essential
to life and the reproduction of organisms. During the irradiation process,
energy waves from gamma rays, electrons, or X- rays break molecular bonds
inside the genetic material of pathogens, spoilage organisms, and insects,
which causes them to die or prevents them from replicating.

Do microorganisms that survive irradiation treatment at low or medium doses
pose a more serious threat than if they had not been irradiated at all?

FDA has found no evidence that food irradiation results in pathogens that
are more virulent or more resistant to heat after treatment. To the
contrary, research shows that radiation is more likely to reduce the
virulence of any surviving pathogens. For example, bacteria that survive
irradiation are destroyed at a lower cooking temperature than bacteria that
have not been irradiated.

Does the dose of irradiation required for destroying microorganisms in food
differ for electron beam, gamma ray, and Xray processing?

The absorbed dose, measured in kiloGray, delivered by the three processes
has the same effects on microorganisms and food. The absorbed dose is
controlled by the intensity of radiation and the length of time the food is
exposed.

Does irradiated food need to be refrigerated?

At the approved doses, irradiation does not eliminate the need for
refrigeration or the need for careful handling, storage, and cooking of
perishable foods. For example, the levels of irradiation approved for
poultry can reduce the numbers of pathogenic and spoilage bacteria. However,
the product is not sterilized and still requires proper refrigeration and
handling by retailers and consumers.

Can irradiation make spoiled or dirty food marketable?

Irradiation cannot reverse the spoilage process- the bad appearance, taste,
and/ or smell will remain the same after irradiation. In addition, current

regulations do not allow food processors to use doses of irradiation on
meat, poultry, fruits, and vegetables that would be high enough to sterilize
extremely contaminated food. If a processor attempted to use a sterilization
dose on many of these products, the odor, flavor, taste, and texture would
be seriously impaired and the consumer would reject such products.

Will irradiated food be more expensive?

While there have been relatively few irradiated products marketed to date,
those that have been sold have been more expensive than their counterparts.
According to food irradiation industry officials, meat and poultry could be
3 to 8 cents a pound more; fruits and vegetables could cost 2 to 3 cents a
pound more. However, as a facility irradiates more food, the cost per pound
should decline over time.

Does USDA accept imported meat and poultry that have been irradiated in
other countries for distribution in the United States?

Yes, provided they are treated and labeled consistent with USDA's
regulations.

Can an accident at a gamma ray facility lead to the “meltdown”
of the irradiator and the release of radioactivity into the atmosphere?

It is impossible for a meltdown to occur in an irradiation facility or for
the radiation source to explode. The source of radiation used at irradiation
facilities cannot produce neutrons, which can make materials radioactive, so
no chain reaction can occur. Similarly, nothing inside the irradiation
facility- the food being processed, the machinery, or the walls- can become
radioactive.

Is food irradiated with nuclear waste materials?

None of the gamma irradiators in the United States use radioactive waste
materials. All U. S. gamma irradiation facilities use colbalt- 60 as the
irradiation source. This source does not produce radioactive waste material
because it can be returned to the supplier for reactivation or reuse in
another application.

Appendi xV

GAO Contacts and Staff Acknowledgments GAO Contacts Robert E. Robertson
(202) 512- 5138 Jerilynn Hoy (202) 512- 5138 Acknowledgments In addition to
those named above, Rebecca Johnson and John Smith made

key contributions to this report.

(150162) Lett er

GAO United States General Accounting Office

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Appendix I

Appendix I Scope and Methodology

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Appendix I Scope and Methodology

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Appendix II

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Appendix III

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Appendix IV

Appendix IV Commonly Asked Questions and Answers About Food Irradiation

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