GAO-10-309R Federal Oversight of Food Irradiation 

United States Government Accountability Office

Washington, DC 20548 

February 16, 2010 

Congressional Committees 

Subject: Food Irradiation: FDA Could Improve Its Documentation and 

Communication of Key Decisions on Food Irradiation Petitions 

According to the Centers for Disease Control and Prevention (CDC), pathogens such 

as Salmonella, E. coli, and Listeria cause an estimated 14 million cases of foodborne 

illnesses each year, resulting in about 60,000 hospitalizations and 1,800 deaths. 

Foodborne illness symptoms can range from mild gastroenteritis to life-threatening 

renal syndromes. The populations most susceptible to the more serious symptoms 

include very young children, individuals 60 years and older, pregnant women, and 

people who have a weakened immune system. In 2007, about 20 to 25 percent of the 

U.S. population was in this high-risk category. Moreover, consumers’ vulnerability to 

foodborne illness is increasing as a result of changes in demographics, among other 

things. For example, older Americans will make up an estimated 20 percent of the 

U.S. population by 2015. 

The pathogens that account for much of the most severe foodborne illness can be 

greatly reduced by subjecting food to ionizing radiation, also known as food 

irradiation. For example, irradiation can eliminate as much as 99.999 percent of E. 

coli 0157, Listeria, and Campylobacter. On the basis of extensive scientific studies 

and the opinions of experts, we reported in 2000 that the benefits of food irradiation 

outweigh the risks.1 Moreover, many experts believe that irradiation can be 

effectively incorporated into an establishment’s food safety program to further 

ensure the safety of the food against pathogens. Irradiation can also be used as a 

phytosanitary treatment where it is applied at low doses to safeguard natural 

resources by replacing fumigation or other chemical treatments to eliminate 

particular plant pests from fruits and vegetables imported into the United States. 

Three federal agencies have primary responsibility for the oversight of food 

irradiation.2

 The Department of Agriculture’s (USDA) Food Safety and Inspection 

Service (FSIS), which is responsible for ensuring that U.S. meat, poultry, and 

 

1

GAO, Food Irradiation: Available Research Indicates That Benefits Outweigh Risks, GAO/RCED-00-

217 (Washington, D.C.: Aug. 24, 2000). 

2

Food irradiation facilities that use nuclear materials, such as cobalt-60, must meet the Nuclear 

Regulatory Commission’s design, operating, management, training, and other requirements and are 

inspected yearly for compliance. 
processed egg products are safe, wholesome, and properly labeled,3

 reviews petitions 

to use irradiation on meat and poultry, as well as labels for use on irradiated 

products. USDA’s Animal and Plant Health Inspection Service (APHIS), which is 

responsible for protecting the health and value of American agriculture and natural 

resources, ensures that products are properly irradiated to neutralize plant pests 

(render insects incapable of maturation or reproduction) and are appropriately 

labeled for entry and distribution in the United States.4

 Finally, the Department of 

Health and Human Services’ Food and Drug Administration (FDA) is responsible for 

ensuring that the nation’s food supply—excluding meat, poultry, and processed egg 

products—is safe, wholesome, and properly labeled. FDA is authorized to review and 

approve petitions submitted by anyone for irradiation of a food product.5

 The burden 

is generally on the individual or group that submits the petition to demonstrate that 

radiation can be used safely on the food product named in the petition under the 

proposed conditions of use. Since October 2000, FDA has approved two petitions and 

issued a partial response to a third that permits the use of irradiation on two food 

items; six petitions are still pending and under review.6

 FDA is also responsible for 

administering federal food labeling requirements that prohibit labels that, among 

other things, are false or misleading. 

Irradiation has been approved for several food products—for example, it was 

approved for meat and poultry more than 10 years ago. However, according to several 

industry estimates, the amount of food irradiated has been relatively steady or slowly 

increasing since 2000. Some industry officials believe that the labeling requirements 

for irradiated food products suggest to consumers that these foods are less than safe 

and thus deter the purchase of such products. In addition, Congress, in the 2002 Farm 

Bill, directed the Secretary of Health and Human Services, delegated to FDA, to 

reconsider its labeling requirements for irradiated foods. In April 2007 FDA proposed 

revising its labeling requirements for irradiated foods. 

In this context, this report responds to your request for information on food 

irradiation. Our objectives were to determine (1) how FDA’s current labeling 

requirements for irradiated food products compare with USDA’s labeling 

requirements and how FDA’s proposed changes to its requirements might impact the 

amount of food that is irradiated and (2) the extent to which FDA has effectively 

managed the petition review process for irradiated food. To determine how FDA’s 

current labeling requirements for irradiated food products compare with USDA’s 

 

3

In addition, the 2008 Farm Bill made catfish subject to mandatory inspection by USDA. 

4

APHIS also regulates phytosanitary irradiation of approved articles (e.g., fruits, vegetables, cut 

flowers, and foliage) either prior to or upon arrival into the United States. The articles may originate 

from foreign countries, Hawaii, Puerto Rico, or the U.S. Virgin Islands. 

5

Congress defined a food additive to include sources of radiation. Thus, irradiation is considered an 

adulterant unless carried out in the manner FDA has approved as safe. As such, petitions seeking new 

uses of irradiation are reviewed through FDA’s food additive petition process. 

6

FDA approved a petition to irradiate seeds for sprouting on October 30, 2000, and molluscan shellfish on 

August 16, 2005. FDA also provided approval to irradiate fresh iceberg lettuce and fresh spinach on August 22, 

2008, which was a partial response to a petition that covered a much larger scope.

Page 2 GAO-10-309R Federal Oversight of Food Irradiation
labeling requirements and how FDA’s proposed changes to its requirements might 

impact the amount of food that is irradiated, we reviewed FDA’s and USDA’s current 

labeling requirements and FDA’s proposed revisions to its requirements. We also 

interviewed knowledgeable officials from FDA and USDA as well as representatives 

from the major industry and consumer advocacy groups. To determine the extent to 

which FDA has effectively managed the petition review process for irradiated food, 

we reviewed statutory and regulatory requirements for the petition review process, 

analyzed information on the six pending petitions, and interviewed officials from 

FDA and representatives from all of the organizations that filed the pending petitions. 

Enclosure I provides additional information on our scope and methodology. 

We conducted this performance audit from April 2009 to February 2010 in 

accordance with generally accepted government auditing standards. Those standards 

require that we plan and perform the audit to obtain sufficient, appropriate evidence 

to provide a reasonable basis for our findings and conclusions based on our audit 

objectives. We believe that the evidence obtained provides a reasonable basis for our 

findings and conclusions based on our audit objectives. 

Background 

Food irradiation is the process of exposing food products to ionizing radiation in 

order to, among other things, control foodborne pathogens. According to the 

International Atomic Energy Agency, 56 countries currently allow the irradiation of 

food products. The safety of irradiated foods has been extensively studied and has 

been endorsed by the World Health Organization, CDC, USDA, and FDA. Food is 

irradiated in facilities using gamma rays, X-rays, or electron beams as their source of 

ionizing radiation. Although the three work differently, the three types of ionizing 

radiation have the same effects on food. A more detailed explanation of the three 

types of irradiators is included in enclosure II. 

Although no comprehensive information exists on the amount of food that is 

currently irradiated in the United States, several industry experts estimate that the 

amount of food irradiated has been relatively steady or slowly increasing since 2000. 

Since our 2000 report, use of irradiation has expanded to include ground beef and 

imported fruits.7

 However, since 2000, poultry is no longer being irradiated and the 

amount of irradiated ground beef has likely declined, according to industry experts. 

The 2002 Farm Bill prohibited the Secretary of Agriculture from barring the use of 

safety technologies, which would include irradiation, in the National School Lunch 

Program.8

 However, according to USDA officials, generally because of cost factors, 

no schools ever received any irradiated beef. Currently about 15 to 18 million pounds 

of ground beef are irradiated annually, most of which is sold through mail-order 

services, according to beef industry representatives. Experts believe that the lack of 

an increase in irradiated ground beef can be attributed to the low acceptance by the 

 

7

GAO/RCED-00-217. 

8

The National School Lunch Program, administered by USDA’s Food and Nutrition Service, is a federally 

assisted meal program operating in public and nonprofit private schools and residential care institutions 

throughout the United States. Schools that choose to take part in the lunch program get cash subsidies and 

donated commodities from USDA for each meal they serve.

Page 3 GAO-10-309R Federal Oversight of Food Irradiation
general public and the high cost associated with irradiation. In contrast, use of 

irradiation for fruits and spices has increased. According to an industry source, the 

quantity of irradiated spices has increased recently because many spice processors 

have transitioned from ethylene oxide—a gas identified by the Environmental 

Protection Agency as a probable human carcinogen—to irradiation as an alternative 

treatment. However, according to a spice industry representative, the spice industry 

does not track information on the exact quantity of spices being irradiated. According 

to two companies that irradiate spices, however, they irradiated almost 88 million 

pounds of spices in 2008. According to APHIS officials, from 2007 through April 2009, 

about 9.5 million pounds of imported fruit—including guavas from Mexico, 

mangosteens from Thailand, and mangoes from India—were irradiated for 

phytosanitary purposes. In addition, according to an industry source, about 7 to 8 

million pounds of purple sweet potatoes and other fruits grown in Hawaii are also 

irradiated annually to eliminate pests. A list of the food products that FDA has 

approved for irradiation is included in enclosure III. 

FDA’s and USDA’s Current Labeling Requirements for Irradiated Foods 

Differ in Two Important Ways, and FDA’s Proposed Changes Could 

Potentially Increase the Amount of Food Irradiated 

Although FDA’s and USDA’s labeling requirements for irradiated foods have some 

commonalities, they differ in important ways. The requirements are similar in that 

both agencies generally require that labels on irradiated foods packaged for retail sale 

include the international food irradiation symbol—the radura (see fig. 1)—and a 

statement disclosing that the food has been exposed to ionizing radiation.9

 FDA and 

USDA also allow processors to add additional language to the labels to identify the 

source of the radiation and purpose of the treatment. However, FDA’s and USDA’s 

labeling requirements for irradiated foods differ in two important ways. First, labels 

on food products subject to FDA jurisdiction do not have to be reviewed and 

preapproved by FDA before marketing.10 Rather, the processor is responsible for 

properly labeling its products. In fact, FDA officials told us that they do not collect 

information on how irradiated foods are labeled and marketed. In contrast, USDA 

reviews and preapproves all labels before use on meat and poultry products and has 

denied label submissions that do not meet its requirements.11 Second, FDA and USDA 

have different requirements when an irradiated ingredient is used in a multiingredient product. Specifically, FDA does not require the product’s ingredient list to 

disclose that a particular ingredient has been irradiated, while USDA generally does. 

 

9

Similar to the United States, select countries (such as Australia and member states of the European 

Union) also require a statement to disclose that the food product has been exposed to radiation on 

packages of irradiated foods sold at retail, but generally do not require the use of the radura symbol. 

10However, FDA inspectors review labels on at least three products during each food safety inspection. 

For more information on FDA’s oversight of food labels, see GAO, Food Labeling: FDA Needs to Better 

Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers 

Select Healthy Foods, GAO-08-597 (Washington, D.C.: Sept. 9, 2008). 

11USDA has denied several label submissions that sought to state that electricity (instead of an electron 

beam) was used to irradiate the food. USDA also denied submissions that used the term “pasteurized.” 

Page 4 GAO-10-309R Federal Oversight of Food Irradiation
Figure 1: The International Food Irradiation Symbol—the Radura

Regarding FDA’s proposed changes to its labeling requirements, FDA, industry, and 

USDA officials we spoke with generally agree that changes to FDA’s current labeling 

requirements could increase the amount of food that is irradiated. As of December 

2009, FDA officials stated they had completed a summary of the more than 32,000 

public comments on its proposed changes. Furthermore, FDA officials said FDA is 

actively working to develop a final rule, but given FDA’s competing priorities and 

limited resources, officials do not know when it will be completed. 

Specifically, FDA is proposing to eliminate the labeling requirements for irradiated 

foods in cases when the irradiation does not cause a material change in the food—

that is, when irradiation does not alter the characteristics, such as nutritional 

property, ordinarily found in the food—or a material change in the consequences that 

may result from use of the food. FDA officials stated that manufacturers will be 

responsible for determining if a material change has occurred and whether the 

labeling is required. Ultimately, according to FDA officials, FDA may have to decide 

whether manufacturers have identified relevant material changes and appropriately 

applied the labeling requirements. However, FDA cannot provide a blanket statement 

on when to require labeling for irradiation or establish a set of criteria for defining a 

material change because these changes can vary depending on the type of food and 

the irradiation process. According to FDA’s proposal, several benefits could come out 

of the proposed rule. First, if consumers look more favorably on irradiated foods as a 

result of the proposed rule, the supply of such food may increase. Second, if retailers 

become more willing to carry relabeled irradiated products, consumers benefit from 

the added opportunity to buy these products. Third, if manufacturers believe that 

choosing the no-label option will lead to increased profits they may start using 

irradiation to enhance the safety of their products. Finally, the price of irradiated 

food could decline if more people buy the unlabeled products. 

Industry representatives we spoke with agree that the quantity of irradiated foods 

could increase if the labeling requirements are eliminated. They noted that although 

irradiation is a potential preventive solution to food safety problems, no one will 

invest in the use of the technology if there is no demand for the products. They 

further said that a significant deterrent to the use of irradiation would cease to exist if 

Page 5 GAO-10-309R Federal Oversight of Food Irradiation
the labeling requirement is eliminated, which could result in the irradiation of more 

foods and enhanced food safety. Industry representatives also told us that, currently, 

industry will avoid using irradiation if another option is available to achieve similar 

results. For example, a spice industry representative stated that even though 

irradiation is the most effective technology to eliminate bacterial contamination in 

spices, a company will choose an alternative technology, such as steam sterilization, 

to treat spices packaged for retail sale in order to avoid the labeling requirements 

required for irradiated foods. According to an industry representative, if the labeling 

requirement for certain irradiated foods is eliminated, then spices sold at the retail 

level will likely experience the biggest immediate change because spice producers 

have indicated that they would like to move away from the use of gas technologies. 

For example, ethylene oxide is routinely used to sterilize spices. In addition, 

according to industry representatives, the change could reduce the logistical 

complexity for retailers that sell both irradiated and nonirradiated foods because 

separate product numbers and labels would no longer be required. 

USDA officials also concurred that the proposal could change the amount of food 

irradiated and noted that the current labeling requirements are a deterrent to 

increasing the marketability and sale of these products. USDA officials told us that 

USDA follows FDA’s lead with issues concerning the safety of irradiated foods. They 

also said any change in FDA’s labeling requirements would impact USDA because 

there is a goal for federal agencies to have consistent regulations. Consequently, 

USDA would consider modifying its own labeling requirements for irradiated foods 

after FDA finalizes its proposed rule. However, USDA would have to go through its 

own rulemaking process before making any changes. 

Consumer groups we spoke with are not embracing FDA’s proposed rule and 

continue to support labeling requirements for irradiated foods. Since 1986, public 

comments have consistently supported labeling as a means to prevent consumer 

deception by informing consumers that the food has been exposed to radiation. In 

addition, consumer groups continue to believe consumers have a right to know if 

their food has been exposed to radiation so they can decide whether or not to 

purchase the food. 

FDA Has Not Effectively Managed Its Review of Six Pending Petitions to Use 

Irradiation on Food 

For the six currently pending food irradiation petitions, FDA has not met key 

statutory and regulatory time frames for the review of food additive petitions—which 

include petitions for new uses of irradiation on food—and has failed to consistently 

document its decisions about these petitions. Moreover, FDA has not communicated 

key information to the affected petitioners. As a result, FDA’s petition review process 

lacks transparency and leads to misunderstandings and confusion among petitioners. 

FDA is required to notify petitioners, within specified time frames, about certain 

decisions it has made regarding the petitions. For example, FDA regulations require 

that within 15 days of receiving a petition submission, FDA must notify the petitioner 

as to whether FDA will accept the petition and file it in the federal docket. However, 

Page 6 GAO-10-309R Federal Oversight of Food Irradiation
FDA did not do so for five of the six pending petitions.12 In one instance, FDA notified 

a petitioner almost 3 months after receiving a petition submission that it could not be 

filed until the petitioner made certain changes. A requirement in statute provides that 

within 90 days of filing the petition, FDA is to notify petitioners if the study and 

investigation of the petition will take longer than 90 days.13 For five of the six 

petitions, FDA did not notify the petitioners. In fact, FDA notified only one petitioner 

that it needed an additional 90 days to complete the scientific review. Finally, FDA is 

required by statute to complete its petition review and issue an order within 180 days 

after filing the petition. Furthermore, FDA regulations require that FDA notify 

petitioners whether their petition has been approved or denied. We found that FDA 

did not complete its review within this time frame, or notify petitioners, in any of the 

six cases. In fact, the six petitions have been active and pending, on average, about 

8.5 years—and some of them for about 10 years. FDA officials told us they believe 

the 180 day requirement is unrealistic for resolving petitions for the new uses of 

ionizing radiation on food, although FDA has never sought a change in the law. There 

are no reporting requirements once FDA surpasses the 180 day requirement for 

resolving such petitions. Enclosure IV provides additional information on the six 

pending petitions. 

 

Although FDA regulations require, among other things, that recommendations and 

decisions of FDA officials be documented and that those recommendations and 

decisions reveal any significant controversies or differences of opinion and reveal 

their resolution, FDA’s petition files contain little or no documentation of its decisionmaking on the six pending petitions, and in some cases fail to reveal the process FDA 

used to make decisions. As a result, FDA’s reasons for some of its decisions are 

unclear, and the process it used to arrive at these decisions is not transparent. For 

example, FDA did not document a decision that negatively affected the timely review 

of two pending petitions to irradiate meat and poultry products. FDA officials told us 

that FDA made an administrative decision to review these two petitions at the same 

time that it reviewed a third petition for multi-ingredient food products to minimize 

the costs and time associated with rulemaking. However, FDA officials did not 

document the decision or the reason in the three petition files—all of which have 

now been pending for about 10 years. In 2001 FDA identified that furan—a colorless 

and volatile liquid—can form during the irradiation process.14 This discovery 

impacted FDA’s food irradiation petition reviews because furan is considered 

possibly carcinogenic to humans through long-term exposure. However, FDA officials 

told us that they determined in 2003 that furan formation was not a safety concern 

with irradiated meat and poultry products. Nevertheless, FDA has not moved forward 

in reviewing the two petitions for meat and poultry products because they continue 

to be “linked” to the multi-ingredient petition, upon which FDA continues to have 

concerns regarding furan formation because different levels of furan are formed in 

different types of foods. FDA officials acknowledged that FDA’s failure to revisit this 

administrative decision represented an oversight by FDA. They further noted that it is 

possible for FDA to move forward with its review of the petitions on the meat and 

 

12For two petitions, FDA did not notify the petitioners that their petitions were filed. For the remaining 

three petitions, FDA notified the petitioners 20 to 37 days after receiving the petitions. 

1321 U.S.C. § 348. 

14Furan is also formed during traditional heat processing techniques, such as canning and cooking. 

Page 7 GAO-10-309R Federal Oversight of Food Irradiation
poultry products, but that FDA has not established a time frame to revisit its 

administrative decision and proceed with its review of these two petitions. 

Finally, although FDA has acknowledged the need to provide clear, adequate, and 

timely information on its review process, FDA has not effectively communicated 

pertinent information to the six petitioners. As a result, FDA’s petition review process 

is not transparent and creates confusion and misunderstandings. In addition, 

petitioners are not provided valuable information to help them better understand the 

status of their petition reviews and better respond to FDA changes in its review 

process. According to the six petitioners we spoke with, all believe they have fulfilled 

the technical requirements for a successful petition and that FDA does not have any 

outstanding data requirements. However, this is inconsistent with what FDA told us, 

which was that the identification of furan in 2001 completely changed the course of 

the irradiation petition review process. According to FDA, its research on furan is 

ongoing and likely will not conclude until sometime after 2013.15 This research 

includes FDA’s overall Furan Action Plan as well as studies on total dietary intake of 

foods with potential for furan exposure.16 Consequently, FDA has halted approving 

food irradiation petitions where furan has been identified as a result of the irradiation 

process until the research on furan is complete. In addition, FDA has not 

systematically informed petitioners about key information, and officials are unable to 

provide a reason for this omission. 

• When a petitioner requested an update on a petition that it had submitted in 

2000, FDA officials orally advised the petitioner to modify the scope of the 

petition to irradiate crustaceans to exclude breaded and battered products 

because furan formation has been documented when these types of products 

are irradiated. Having complied by sending a letter to FDA requesting a scope 

change, the petitioner told us it believes FDA is proceeding with its review of 

the petition. However, officials at FDA told us FDA will not make a final 

decision until they have responded to relevant objections received in response 

to the final rule for irradiation of molluscan shellfish. FDA officials could not 

provide a time frame as to when it would be able to move forward with the 

crustacean petition and FDA has not communicated these issues to the 

petitioner. 

 

• A second petitioner believes that a petition it submitted in 2002 to irradiate 

dietary supplements is actively under review because it has met FDA’s 

requirements for providing all of the pertinent information and FDA has never 

requested any additional data. According to FDA officials, FDA is moving 

slower with the review of this petition, in part due to concerns about the broad 

scope of the petition and a lack of clarity regarding what specific dietary 

supplements could be included in this category. FDA said that they do not 

have data regarding how dietary supplements are used, and therefore cannot 

 

15FDA told us it made a decision to move forward with its own research into furan because of the 

importance of the research to the public health and did not choose to place the responsibility on the 

petitioners to demonstrate the safety of furan. 

16Canada and the European Union are also conducting research on the occurrence and formation of 

furan in foods and have not made any conclusions with respect to the human health risks related to 

consuming foods that contain furan. 

Page 8 GAO-10-309R Federal Oversight of Food Irradiation
begin to evaluate the possibilities with respect to the generation of furan in 

dietary supplement ingredients, or the possibilities for dietary exposure of 

different dietary supplements. However, FDA officials communicated none of 

these issues to the petitioner. 

Most of the six petitioners have expressed concern or frustration with the length of 

time their petitions have been under review with little or no feedback from FDA. 

Petitioners also noted that FDA officials would not provide specific details when 

asked about the status of a petition. One petitioner said that FDA did not provide 

sufficient guidance on what it required to approve or deny a petition and that it 

seemed to use a “we’ll know it when we see it” approach. FDA officials 

acknowledged FDA has a responsibility to proactively communicate with the 

petitioners about the status of their petition, problems, and the need for additional 

data. However, the officials also noted that FDA staff are “not consultants” and that 

the petitioners, not FDA, are primarily responsible for making contact. FDA’s 

management of the petition review process appears to conflict with the objective of 

“maximizing the availability and clarity of information about the process for review of 

applications and submissions (including petitions, notifications, and any other similar 

forms of requests) made under [the Food and Drug Administration Modernization Act 

of 1997]” as articulated in that act and restated in FDA’s Plan for Statutory 

Compliance issued in November 1998.17

 

Conclusions 

Pathogens such as Salmonella and E. coli continue to cause severe foodborne illness 

outbreaks, with the populations most susceptible to these illnesses growing in 

number. Subjecting food to ionizing radiation has been shown to not only be safe but 

to reduce pathogens in food by as much 99.999 percent. Despite the effectiveness of 

food irradiation, consumers are still unsure about its safety. In addition, according to 

several industry experts, the amount of food irradiated has been relatively steady or 

slowly increasing since 2000. While FDA is proposing changes to its labeling 

requirements for irradiated food that may increase the amount of food that is 

irradiated, it has not effectively managed its petition review process, which is the 

vehicle to potentially allow more food products to be irradiated. In addition, despite 

regulatory requirements, FDA has not documented pertinent decisions about its 

petition review process and has not communicated this information to the affected 

petitioners. These deficiencies limit the ability of petitioners to understand the 

actions FDA takes, the ability of petitioners to respond appropriately when FDA 

changes the requirements of the review process, and the transparency of the petition 

review process. 

Recommendations for Executive Action 

To more effectively manage its food irradiation petitions, we recommend that the 

Commissioner of the Food and Drug Administration direct the Office of Food 

Additive Safety to take the following two actions to be consistent with FDA 

regulations: 

 

17FDA, Regulatory Information: FDA Plan for Statutory Compliance, (November 1998). 

Page 9 GAO-10-309R Federal Oversight of Food Irradiation
• document its key decisions in its administrative files; and 

• communicate its key decisions to its petitioners and, for new petitions, the 

status of its decisionmaking, consistent with regulatory time frames. 

Agency Comments 

We provided the Departments of Agriculture and Health and Human Services with a 

draft of this report for their review and comment. USDA said that we accurately 

described the department’s role within the context of the report and provided us with 

a technical comment that we incorporated. The Department of Health and Human 

Services, representing FDA, provided written comments and said that the draft raised 

legitimate issues regarding its management of the food irradiation petition process. 

FDA agreed with our recommendations and said that it had already begun to 

implement them. FDA’s specific comments are presented in enclosure V. 

- - - - - - - - - - 

As agreed with your offices, unless you publicly announce the contents of this report 

earlier, we plan no further distribution until 30 days from the report date. At that 

time, we will send copies of this report to the Commissioner of the Food and Drug 

Administration, the Secretary of Agriculture, appropriate congressional committees, 

and other interested parties. This report is also available at no charge on GAO’s Web 

site at http://www.gao.gov. 

If you or your staffs have any questions about this report, please contact me at (202) 

512-3841 or shamesl@gao.gov. Contact points for our Offices of Congressional 

Relations and Public Affairs may be found on the last page of this correspondence. 

Key contributors to this report are listed in enclosure VI. 

Lisa Shames 

Director, Natural Resources and Environment 

Enclosures (6) 

Page 10 GAO-10-309R Federal Oversight of Food Irradiation
List of Congressional Committees 

The Honorable Henry A. Waxman 

Chairman 

The Honorable John D. Dingell 

Chairman Emeritus 

The Honorable Joe Barton 

Ranking Member 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Bart Stupak 

Chairman 

The Honorable Greg Walden 

Ranking Member 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Page 11 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure I 

Scope and Methodology 

The three federal agencies that have primary responsibility for the oversight of food 

irradiation are (1) the Department of Agriculture’s (USDA) Food Safety and 

Inspection Service (FSIS), (2) USDA’s Animal and Plant Health Inspection Service 

(APHIS), and (3) the Department of Health and Human Services’ Food and Drug 

Administration (FDA). To determine how FDA’s current labeling requirements for 

irradiated foods compare with USDA’s labeling requirements and how FDA’s 

proposed changes to these requirements might impact the amount of food that is 

irradiated, we reviewed FDA and FSIS labeling regulations, relevant Federal Register 

notices, FDA’s proposed changes to the labeling requirements, and obtained food 

irradiation labels submitted to USDA for review and approval. We also spoke with 

officials from FDA, FSIS, and APHIS and representatives from 

 

• industry (Dairy Queen; Food Technology Service, Inc.; GrayStar, Inc.; Hawaii 

Pride; Omaha Steaks; RayFresh; Sadex Corporation; Sterigenics; STERIS 

Corporation; the Society of Plastics Industry; and Wegmans), 

• trade associations (the American Meat Institute, the American Spice Trade 

Association, the Food Irradiation Processing Alliance, the Grocery 

Manufacturers Association, the International Food Information Council, the 

Minnesota Beef Council, the National Chicken Council, the National Fisheries 

Institute, the National Grocers Association, the North American Meat 

Processors Association, and the United Fresh Produce Association), and 

• consumer advocacy groups (the Consumer Federation of America, the Center 

for Science in the Public Interest, and Food and Water Watch). 

In addition, we interviewed food irradiation experts at Michigan State University, the 

University of California at Davis, and the state of Florida. We visited four irradiation 

facilities of the four major companies that irradiate meat and spices in Florida, Iowa, 

and New Jersey using different types of irradiators. We also visited the ports of 

Philadelphia and Newark/New York, which are primary points of entry for fruits and 

vegetables on the East Coast. At these ports, we observed Customs and Border 

Protection examinations of incoming shipments of fruits and vegetables. Finally, we 

spoke with representatives from Australia, Belgium, Canada, the European Union, 

France, Germany, Mexico, and Thailand to learn about food irradiation practices in 

other countries. 

To determine the extent to which FDA has effectively managed the petition review 

process for food irradiation petitions, we reviewed FDA statutory and regulatory 

requirements for reviewing food additive petitions, which include irradiation 

petitions; analyzed data on the six pending food additive petitions to irradiate food 

products; and reviewed FDA files containing documentation on the management of 

those six pending irradiation petitions. We spoke with officials from FDA responsible 

for reviewing food additive petitions and the organizations that filed the six pending 

petitions to irradiate food products. We also spoke with one consumer advocacy 

Page 12 GAO-10-309R Federal Oversight of Food Irradiation
group that filed a citizen petition against a prior FDA decision to allow irradiation of 

meat. Although FDA receives numerous food additive petitions for such things as 

sweeteners and emulsifiers, the focus of our review was the six pending petitions 

dealing with ionizing radiation. 

We conducted this performance audit from April 2009 to February 2010 in 

accordance with generally accepted government auditing standards. Those standards 

require that we plan and perform the audit to obtain sufficient, appropriate evidence 

to provide a reasonable basis for our findings and conclusions based on our audit 

objectives. We believe that the evidence obtained provides a reasonable basis for our 

findings and conclusions based on our audit objectives.

Page 13 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure II

Ionizing Radiation Processes 

Food irradiation facilities use three types of ionizing irradiation: gamma rays, X-rays, 

and electron beams. These three types of ionizing radiation have the same effects, in 

that each process generally kills bacterial pathogens or neutralizes plant pests on 

food, but differ in how they work. Gamma irradiators use a radioactive source—

either cobolt-60, most commonly, or cesium-137—as their source of ionizing 

radiation, while X-ray and electron beam irradiators electronically generate ionizing 

radiation without the use of radioactive material. The extent to which the radiation 

penetrates into food products depends on the type of food and the energy of the 

photons emitted by a gamma ray or X-ray source or particles emitted by an electron 

beam source.18 The penetration of electron beam radiation is relatively shallow, 

generally a few centimeters, while gamma rays and X-rays can penetrate much more 

deeply—for example, a half meter or more. Depending on the nature of the food, 

among other things, gamma radiation can take from 15 to 45 minutes, while electron 

beam radiation can take from several seconds to several minutes. X-ray radiation 

involves a substantial energy loss—generally greater than 90 percent—as the 

electrons are converted into X-rays. When food is irradiated, it does not come in 

contact with radioactive materials and, therefore, it remains free of radioactive 

contamination. 

In total there are approximately 50 facilities in the United States that have irradiators. 

Of these only four facilities irradiate nonspice food products like meat and fruits. 

There are more than a dozen facilities that irradiate spices and these facilities 

generally also irradiate nonfood products like medical devices, such as surgical kits. 

In addition, the majority of the facilities that irradiate food are gamma irradiators and 

the vast majority of products that are irradiated are not food products. In addition, 

there appears to be no irradiators located at the same facility where the food 

products are processed. Irradiators can be expensive to purchase, with the total 

capital cost ranging from $2 million dollars to several times that. According to an 

industry group, the capital costs of irradiation equipment are often seen as 

prohibitive. 

 

18X-ray and gamma radiation sources generate photons, which are pure energy and contain no mass or 

weight. Electron beam radiation sources generate small particles of matter moving at high velocity; 

they carry energy due to the motion of these particles. 

Page 14 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure III 

Table 1: Food Products Approved for Irradiation in the United States 

Food product Agency and approval 

date 

Purpose of irradiation Maximum permitted 

dosage (kiloGray) 

Dry or dehydrated enzyme 

preparations 

Food and Drug 

Administration (FDA), 

June 10, 1985 

Control of insects and 

micro-organisms 

10.0 

Pork carcasses or fresh 

nonheated processed cuts 

FDA, July 22, 1985 

United States Department 

of Agriculture (USDA), 

January 15, 1986 

Control Trichinella spiralis 0.30 to 1.00 

Fresh foods FDA, April 18, 1986 Delay maturation 1.0 

Food FDA, April 18, 1986 Arthropod disinfestation 1.0 

Dry or dehydrated 

aromatic vegetable 

substances 

FDA, April 18, 1986 Microbial disinfection 30.0 

Fresh, frozen uncooked 

poultry 

FDA, May 2, 1990 

USDA, September 21, 

1992 

Control foodborne 

pathogens 

3.0 

Refrigerated and frozen 

uncooked sheep, cattle, 

swine, and goat 

FDA, December 3, 1997 

USDA, December 23, 

1999 

Control foodborne 

pathogens and extend 

shelf-life 

4.5 (refrigerated) 

7.0 (frozen) 

Fresh shell eggs FDA, July 21, 2000 Reduction of Salmonella 3.0 

Seeds for sprouting FDA, October 30, 2000 Control microbial 

pathogens 

8.0 

Fresh or frozen molluscan 

shellfish 

FDA, August 16, 2005 Control Vibrio bacteria and 

other foodborne 

pathogens 

5.5 

Fresh iceberg lettuce and 

fresh spinach 

FDA, August 22, 2008 Control foodborne 

pathogens and extend 

shelf-life 

4.0 

Source: GAO presentation of information from 21 C.F.R. 179.26 and Federal Register notices. 

Page 15 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure IV 

Table 2: The Six Food Irradiation Petitions Pending Review With FDA 

Petitioner Federal 

Register date 

Years in 

FDA review 

Purpose for petition 

United States 

Department of 

Agriculture’s 

(USDA)–Food 

Safety and 

Inspection Service 

(FSIS) 

December 21, 1999 10.0 Use of Ionizing Radiation on Unrefrigerated, 

Refrigerated, and Frozen Poultry Products (FAP 

9M4696) 

USDA–FSIS December 22, 1999 10.0 Use of Ionizing Radiation on Unrefrigerated Meat 

Food Products (FAP 9M4695) 

Grocery 

Manufacturers 

Association 

(formerly National 

Food Producers 

Association) 

January 5, 2000 10.0 Use of Ionizing Radiation on Certain Refrigerated, 

Frozen or Dried Meat, Poultry, Fruit or Vegetable 

Products (FAP 9M4697) 

National Fisheries 

Institute 

February 6, 2001 8.9 Use of Approved Sources of Ionizing Radiation as a 

Physical Process to Reduce the Food Safety Risk in 

Consuming Crustaceans (FAP 1M4727) 

STERIS 

Corporation 

May 9, 2003 6.6 Use of Gamma Rays to Reduce Micro-organisms 

on Dietary Supplements (FAP 2M4741) 

Sterigenics November 30, 2004 5.0 Request Approval for Shelf Stable Foods Processed 

with Irradiation in Combination with Other Methods 

(FAP 3M4744) 

Source: GAO analysis of Food and Drug Administration information. 

Page 16 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 17 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 18 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 19 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 20 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 21 GAO-10-309R Federal Oversight of Food Irradiation
Enclosure V 

Comments from the Department of Health and Human Services 

Page 22 GAO-10-309R Federal Oversight of Food Irradiation
Page 23 GAO-10-309R Federal Oversight of Food Irradiation

Enclosure VI 

GAO Contact and Staff Acknowledgments

GAO Contact

Lisa Shames, (202) 512-3841 or shamesl@gao.gov

Staff Acknowledgments

In addition to the contact named above, Jose Alfredo Gomez (Assistant Director), 

David Moreno (Analyst-in-Charge), Nancy Crothers, Diana Goody, Jessica Lotz, Alise 

Nacson, and Alex Winograd made key contributions to this report. Important 

contributions were also made by Kevin Bray, Cindy Gilbert, and Maria Stattel. 

(361064)