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)

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May I !NO
                                   FOOD IRRADIATION
                                   Federal Requirements
                                   and Monitoring
          united states
GAO       General Accounting Of’fice
          Wahington, D.C. 20548

          Human Resources Division


          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


                        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

                        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


                                labeling requirements for irradiated pork are similar to FDA'S

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

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.
                                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

                       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

                       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

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


            P a g e7   G A O ,‘IfJID-W - 1 1F8o o dIrradhtion

Appendix I                                                                                    10
Organizations GAO
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


                        FDA       Food and Drug Administration
                        NRC       Nuclear Regulatory Commission
                        USDA      U.S. Department of Agriculture

                        Fa$e 8                                     GAO/lXRJMO-118Food Irradiation

    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
                    ---                                              rwrmitted                  irradiation
                   Pork                                              i 00,000 RADB              Control Trichinella
                   Fresh and frozen poultry products                 300,000 RAD                Control Salmonella
                                                                                                and other bacteria
                   Fresh fruit and vegetables                         100,000 RAD               Inhibit growth and
                   Wheat. rice. barlev. fruit, veaetables, nuts,      100,000 RAD               Disinfestation of
                   and other fdods ihere infesiation occurs                                     arthropod pests
                                                                                                (insects, spiders,
                   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.


                   Page 11                                                           GAO/HBD4MM18Food Irradiation
Appendix III                                                                                                 a

CompaniesWith Licenses to Operate
Commercid Radiation Facilities
(As of August 1989)
               State and firm                                                                  foods?
               Process Technoloav. Inc., West Memphis                                          Yes
               Radiation Sterilizers, Tustin                                                   Yes
               Cobe Laboratories, Lakewood                                                     No
               lotech, Inc., Englewood                                                         No
               Becton Dickenson and Companv. North Canaan                                      No
               Sherwood Medical, Deland                                                        No
               Radiation Sterilizers, Decatur                                                  Yes
               Isomedix, Morton Grove                                                          Yes
               Isomedix, Liberty                                                               Yes
               Radiation Sterilizers, Shamberg                                                 Yes
               Neutron Products, Dickerson (2 facilities)                                      No
               Terumo Medical Corporation, Elkton                                              No
               Isomedix, Northborouah                                                          Yes
               Minnesota Mining and Manufacturing     Company, St. Paul                        No
               Isomedix, Columbus                                                              Yes
               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
               Isomedix, Groveport                                                              No
               Radiation Sterilizers, Westerville                                               No

               Page 12                                                    GAO/HUD-fIO-1
                                                                                      18 Food Irradiation

    Appendix III
    C!+mpanieo With Ldcenaes to Operate
    Canmercial Radiation Facilities
    (Aa of August 1989)

    State and firm                                                                               foods?
    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
    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
    Isomedix. Sandv                                                                              Yes
    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
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