..-“l.“.“. l”“. ““. ““.. GAO May I !NO FOOD IRRADIATION Federal Requirements and Monitoring united states GAO General Accounting Of’fice Wahington, D.C. 20548 Human Resources Division B-239069 May 3,199O The Honorable Douglas H. Bosco House of Representatives Dear Mr. Bosco: Because of your concern about the safety of food that has been exposed to radiation for preservation purposes, you asked that we provide the following information: . federal agencies that are responsible for monitoring food irradiation activities, including inspecting firms that irradiate food; . food products approved for irradiation; l companies that are licensed and operating food irradiation facilities in the United States; and . state actions to restrict food irradiation. In performing our work, we contacted several federal and state agencies and private organizations to obtain data on food irradiation. Appendix I lists the organizations we contacted. On February 2,1990, we briefed your staff on the results of our work, and as requested, this report summarizes the information we provided. In short, we found that the Food and Drug Administration (FDA) andthe U.S. Department of Agriculture (USDA)have primary responsibility for regulating food irradiation. F’DAhas approved several food products to be irradiated, including fresh fruit and vegetables, pork, and spices. However, neither FDAnor USDAhas reliable information on what food products are irradiated or who is irradiating food. FDAbelieves that irra- diated foods pose a low health risk. However, because of consumer con- cerns, several states have enacted or proposed legislation restricting food irradiation. Neither F’DAnor USDAhas a specific program to inspect food irradiation facilities. FDA,as a part of its routine inspections of food processing establishments between 1986 and 1989, identified four firms that irradi- ated food and inspected their irradiation processes. These inspections did not identify any problems. No USDA-inspectedfood firms are irradi- ating meat, poultry, or egg products. The National Coalition to Stop Food Page 1 GAO/H&D90-118 Food Irradiation .- Y B-229069 Irradiation has identified 16 facilities that irradiate food; this was the most comprehensive list of such facilities that we found.’ Irradiation is used to sterilize and preserve foods. Foods are briefly Background exposed to a radiation source (typically cobalt-60) that penetrates the interior of the food and disrupts the organisms or-processes responsible for degradation or disease. Research on food irradiation has been going on for many years. Regula- tors throughout the world have been cautious in approving this process. However, with advances in radiation chemistry and increased research information, regulators are becoming increasingly satisfied that foods irradiated at low radiation doses are safe to eat. Federal Agencies includes approving irradiation of specific foods. The Nuclear Regulatory Reswnsible for Commission (NRC) is responsible for licensing firms to use nuclear mater- Monitoring Food ials to irradiate products, including foods. Irradiation Companies Under the Federal Food, Drug, and Cosmetic Act, FDA is responsible for and Products assuring that food products and food additives are safe to eat2 By stat- ute, food irradiation is defined as a food additive, and as such, FDA must first determine its safety before any food may be treated with radiation. FL)Aissues regulations prescribing the conditions under which a food may be treated with radiation and inspects domestic firms irradiating food and imported food products, As of May 1990, FDA had approved irradiation of several food products, including spices, pork, and fresh fruits and vegetables. Appendix II lists the foods that FDA has deter- mined can be irradiated safely, the maximum radiation dosages permit- ted, and the purpose for irradiating the foods. USDA is responsible for administering the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. These laws prohibit the marketing of adulterated meat, poultry, ‘The coalition, a nonprofit organization, was established in 1984 to protest the irradiation of food, educate the public, and provide assistance to concerned groups and individuals on food irradiation. 2FDA shares responsibility with the Department of Commerce for the regulation of fish products. Commerce does not routinely inspect fish for irradiation, but upon request will certify that fish for export has not been irradiated. Page 2 GAO/IiIRD~llS Food Irradiation B239069 and egg products. Irradiated meat, poultry, or egg products are consid- ered adulterated and not allowed to be marketed in the United States or exported unless they are irradiated in conformity with the Federal Food, Drug, and Cosmetic Act and related regulations. Therefore, for these products, FDA makes the initial determination on safety and the conditions under which such foods may be treated with radiation and promulgates regulations. USDAthen issues its own regulations, which are based on the requirements contained in FDA’S regulations. Both FDA and USDAhave approved the irradiation of pork. Firms that want to irradiate pork or other products under the regulatory authority of USDAmust have their quality control programs approved by USDA. As of May 1, 1990, no firm had received USDAapproval to irradiate pork. On May 1, FDAapproved the irradiation of fresh and frozen poultry prod- ucts. However, USDA will need to issue regulations before these products can be irradiated. NRC, under the Atomic Energy Act of 1964, is responsible for granting licenses to companies operating nuclear facilities that irradiate commer- cial products, including foods. These facilities are required to meet NRC design, operating, management, training, and other requirements. NRC and states inspect these facilities for compliance with NRC requirements according to a priority systeme3The facilities fall into seven priority groups, with Priority 1 facilities requiring the most frequent inspections because of the nature of the operations and the kinds of material that they handle. Facilities that irradiate commercial products are in Priority 1, and these facilities are inspected every year. These inspections focus on assuring that employees of the facility using nuclear materials and the public communities surrounding the facility are adequately pro- tected from radiation exposure. As of January 1990, NRC and the states had granted licenses for the operation of 40 facilities to irradiate com- mercial products. Labeling Requirements Since 1966, FDA has required that irradiated whole foods carry a label stating that they have been irradiated. Since 1986, the labels of these products have had to also include a designated logo indicating that they have been irradiated. However, no statement or logo is required for processed products containing multiple ingredients, such as herbs, spices, or seasonings, some of which may have been irradiated. USDA 3NRChas formal agreements with 29 states to regulate certain licensees under programs comparable to NRC’s Page 3 GAO/EJlUWO-118 Food Irradiation I Q B-222060 labeling requirements for irradiated pork are similar to FDA'S regulations. Federal Monitoring of fore, do not know the extent to which food is irradiated. Neither agency Food Irradiation has a formal procedure to collect information on food products that are irradiated, irradiated ingredients used in foods, or companies that irradiate food. The most comprehensive information we identified was contained in a 1989 survey by the National Coalition to Stop Food Irradiation. The survey showed that, as of August 1989, NRC had granted licenses for 40 facilities to use nuclear materials in the manufac- turing or processing of commercial products, including foods, baby pow- der, and medical supplies. Of these 40 facilities, 16 reported that they were involved in irradiating food at the time of the survey. Appendix III lists the 40 facilities and notes those that reported they were irradiating foods. Food Irradiation Firm s Not To date, federal inspections have not targeted companies irradiating Targeted for Special food. FDA and USI~Ainspect companies irradiating food as part of their regular inspection programs of domestic and foreign firms. Inspection If, during a regular inspection of a food firm , FDA finds that the firm is irradiating food, it will inspect the firm ’s irradiation process. During fiscal years 1986 through 1989, FDA made over 42,000 inspections of domestic food establishments. These inspections included four firms that were irradiating foods. FDA found no violations. In the past 12 years, FDA has sent letters of violation to two firms that were irradiating food or using irradiated food ingredients that m had not approved. One letter resulted from a 1978 FDA inspection that found a New Jersey firm had violated the Federal Food, Drug, and Cosmetic Act and FDA regulations because it irradiated several food products for which FDA had not approved irradiation. In 1988, FDA sent a letter to a California firm , after being advised that the firm had used, as a food ingredient, mushrooms that had been irradiated at a level exceeding FRA’Sapproved dosage. Both firms discontinued the violative practices. USI~Ahas inspectors permanently stationed in domestic slaughterhouses and meat, poultry, and egg processing plants and periodically inspects foreign establishments. USDA'S regular inspections have not found any of these products being irradiated. Nevertheless, a USDA official told us that Page4 GAO/HRDB&118Food Irradiation B-289069 in 1986 an informant reported that a North Carolina firm had irradiated pork products without usm approval. USIIA’Sinvestigation of the reported incident confirmed this to be the case, and the firm was fined for its action. Because many foreign governments permit various food products to be irradiated, FDA and USL~A review import documents at US. ports of entry to identify such products.4 FDA and usw have not found any irradiated foods that have been imported into the United States. However, officials of these agencies said that irradiated foods are difficult to identify and there is no practical method to test imported food products for irradia- tion. These officials said that unless the import documents note that a food product has been irradiated, irradiation is very difficult to detect. Eight states have taken or are considering action to restrict the use of Some States Restrict food irradiation. Maine, New Jersey, and New York have enacted legisla- Use of Food tion restricting the use of irradiation on foods or the sale or distribution Irradiation of irradiated foods, except for spices used as an ingredient in a product. Officials of these states told us that their states took the actions in response to public concern by citizen groups rather than as a result of scientific evidence questioning the safety of food irradiation. New Jersey and New York officials also said that their states’ actions to restrict the use of food irradiation were taken, in part, (1) because of perceived gaps in safety data related to food irradiation and (2) to allow more time to study the process and allow a consensus to emerge on its efficacy. Legislatures in Alaska, California, Massachusetts, New Hampshire, and Pennsylvania have introduced resolutions or legislation that would ban or restrict the irradiation of foods.6 FDAand usw officials agreed that irradiating foods with low-dose radia- Views of Agency tion is safe. An FDA official told us that food irradiation firms have not Officials been targeted for inspection because FI~Ahas no basis to suspect that the process poses a serious health risk. He said that if FDA was to increase its 4An April 1988 Food Irradiation Newsletter of the International Atomic Energy Agency listed 25 foreign governments that permit the irradiation of various food products, including chicken, fish products, shrimp, and coffee beans. / 6Actions by state legislatures on food irradiation were reported in the Preservation of Food by Irradi- ation by the Congressional Research Service, Aug. 18,1989. Page 5 GAO/HRD90-118 Food Irradiation J3-239om inspection effort of food irradiation firms, it would have to divert resources from issues that it believes pose a greater health concern. As requested by your office, we did not provide a copy of this report for comment to FDA, usm, or NRC. However, we discussed the information in this report with officials of these agencies and incorporated their com- ments where appropriate. These officials generally agreed with the report’s contents. Also, as agreed with your office, unless you publicly announce its con- tents earlier, we plan no further distribution of this report until 30 days after its issue date. At that time, we will send copies to cognizant con- gressional committees and other interested parties, and we will make copies available to others on request. Should you need additional information on the contents of this report, please call me on (202) 276-6196. Other major contributors to this report are listed in appendix IV. Sincerely yours, Mark V. Nadel Associate Director, National and Public Health Issues Page0 GAO/HRD-SO-118FoodIrmdiation t , I , P a g e7 G A O ,‘IfJID-W - 1 1F8o o dIrradhtion Contents Letter Appendix I 10 Organizations GAO Contacted Appendix II 11 Food Products Approved for Irradiation by Food and Drug Administration (As of May 1,199O) Appendix III 12 Companies With Licenses to Operate Commercial Radiation Facilities (As of August 1989) Appendix IV 14 Major Contributors to This Report Abbreviations Y FDA Food and Drug Administration NRC Nuclear Regulatory Commission USDA U.S. Department of Agriculture Fa$e 8 GAO/lXRJMO-118Food Irradiation Y P a g ea G A O / H R D - 9 0 - 1 F1 8o o d Irradiation Appendix I Organizations GAO Contacted Department of Health and Human Services: Federal Agencies Food and Drug Administration U.S. Department of Agriculture: Agricultural Marketing Service Agricultural Research Service Animal and Plant Health Inspection Service Economic Research Service Federal Grain Inspection Service Food Safety and Inspection Service Department of Commerce: . Chairman, Interagency Committee on Food Irradiation . National Marine Fisheries Service Department of Defense: . U.S. Army, Office of Food Inspection Nuclear Regulatory Commission Congressional Research Service Office of Technology Assessment Department of Agriculture and Food, Augusta, Maine State Agencies Department of Health, Trenton, New Jersey Department of Agriculture and Markets, Albany, New York Food Marketing Institute, Washington, DC. Private Organizations National Coalition to Stop Food Irradiation, San Francisco, California Page 10 GAO/IiRDBMlg Food Irradiation *Appendix II Food Products Approved for Irradiation by Food and Drug Administration (As of May 1,199O) Maximum dosage Purpose of Fad --- rwrmitted irradiation Pork i 00,000 RADB Control Trichinella Spiralis Fresh and frozen poultry products 300,000 RAD Control Salmonella and other bacteria Fresh fruit and vegetables 100,000 RAD Inhibit growth and maturation Wheat. rice. barlev. fruit, veaetables, nuts, 100,000 RAD Disinfestation of and other fdods ihere infesiation occurs arthropod pests (insects, spiders, mites) Dry and dehydrated enzyme preparationsb 1 million RAD Microbial disinfection Dry and dehydrated aromatic vegetable 3 million RAD Microbial disinfection substances-including herbs, seeds, spices, vegetable seasonings, blends of these substances, and turmeric and paprika when used as color additives T?AD is e unit of measurement used by FDA to express the mount of energy (radiation) absorbed by the subject exposed to the energy. bEnzymes are used to improve food processing and the quality of the finished food Source: 21 C.F.R. 179.26. Y Page 11 GAO/HBD4MM18Food Irradiation 7’ 9 Appendix III a CompaniesWith Licenses to Operate Commercid Radiation Facilities (As of August 1989) Irradiating State and firm foods? Arkansas Process Technoloav. Inc., West Memphis Yes California Radiation Sterilizers, Tustin Yes Colorado Cobe Laboratories, Lakewood No lotech, Inc., Englewood No Connecticut Becton Dickenson and Companv. North Canaan No Florida Sherwood Medical, Deland No Georala Radiation Sterilizers, Decatur Yes Illinois Isomedix, Morton Grove Yes Isomedix, Liberty Yes Radiation Sterilizers, Shamberg Yes Marvland Neutron Products, Dickerson (2 facilities) No Terumo Medical Corporation, Elkton No Massachusetts Isomedix, Northborouah Yes Minnesota Minnesota Mining and Manufacturing Company, St. Paul No Mlsslssiooi Isomedix, Columbus Yes Nebraska Becton. Dickenson and Companv. Broken Bow No Sherwood Medical, Norfolk No New Jersey Isomedix. Whipoanv Yes Isomedix, Dover Yes Ethicon (Johnson and Johnson), Sommerville No Radiation Technoloav. Rockawav Yes North Carolina Processed Technology, Inc., Haw River Yes Ohio Isomedix, Groveport No Radiation Sterilizers, Westerville No (continued) Page 12 GAO/HUD-fIO-1 18 Food Irradiation , Appendix III C!+mpanieo With Ldcenaes to Operate Canmercial Radiation Facilities (Aa of August 1989) Irradiating State and firm foods? Pennsylvania Permagrain Products, Inc., Karthaus No South Carolina Becton Dickenson and Companv, Sumter No Isomedix, Spartanburg Yes Bausch and Lomb. Greenville No South Dakota Minnesota Mining and Manufacturing Company, South Brookings No Texas Ethicon, Inc., San Angelo No Johnson and Johnson Products, Inc., South Sherman No Convertors (Baxter-Travenol Corp.), El Paso No - Suraikos, Inc., Arlinaton No Surcikos, El Paso No Sherwood Medical, Commerce No Radiation Sterilizers, Fort Worth Yes Ansell International, El Paso No Utah Isomedix. Sandv Yes Vlrginla Applied Radiant Energy Corporation, Lynchburg Yes Note: This survey identified 40 radiation facilities, of which 16 irradiated foods Source: National Coalition to Stop Food Irradiation survey, August 1989. Page 13 GAO/HUD-99-119 Food Irradiation Appendix IV Major Contributors to This Report Janet L. Shikles, Director, Health Financing and Policy Issues, Human Resources (202)276-5461 Division. Albert B. Jojokian, Assistant Director Rodney E. Ragan, Assignment Manager Washington, D.C. Benjamin F. Herr, Jr., Evaluator-in-Charge (loeoas) Page 14 GAO/HUD-90-118 Food Irradiation -- .--l..~_--l---ll -- K c q u tts ts fo r c o p i e so f G A 0 re p o rts s h o u l db e s e n t L o : 1 J .SG. tw v -a l A c c o u n ti n gO ffi c e P o s t.O ff-Ic e B o x 6 0 1 5 G a i th e rs b u rg M, a ry l a n d2 0 8 7 7 ‘I’c ~ l e p h o2n0t~2 -2 7 5 -6 2 4 1 T h e fi rs t fi v e c o p i e so f e a c hre p o rt a re fre e . A d d i ti o n a l c o p i e sa re $ 2 .0 0t1 a c h . O rd e rs m u s t b e p re p a i db y c a s ho r b y c h e c ko r m o n e yo rd e r m a d e o u t to th e S u p e ri u te n d e not f Ih c u m rn ts . First-Class Mail Postage & Fees Paid GAO Permit No. 6100
Food Irradiation: Federal Requirements and Monitoring
Published by the Government Accountability Office on 1990-05-03.
Below is a raw (and likely hideous) rendition of the original report. (PDF)