Comments on Irradiation Phytosanitary Treatment of Imported Fruits and Vegetables

Regulatory Development and Analysis, PPD
APHIS, Suite 3C03
4700 River Road, Unit 118
Riverdale, MD 20737-1238

Re: [Docket Number: 98-030-1]
Irradiation Phytosanitary Treatment of Imported Fruits and Vegetables
65 Federal Register 34113 (May 26, 2000)

Dear Sir or Madam:

The National Food Processors Association (NFPA) submits the following comments on the docket referenced above.

NFPA is the voice of the $460 billion food processing industry on scientific and public policy issues involving food safety, nutrition, technical and regulatory matters and consumer affairs. NFPA’s three scientific centers, its scientists and professional staff represent food industry interests on government and regulatory affairs and provide research, technical services, education, communications and crisis management support for the association’s U.S. and international members. NFPA’s members produce processed and packaged fruits and vegetables, meat and poultry, seafoods, drinks, and juices or provide supplies and services to food manufacturers.

The National Food Processors Association (NFPA) supports food irradiation as a proven and safe technology that will provide direct benefits to consumers. It is a useful mechanism in the management of food wholesomeness in the production chain and gives the food industry a tool for further improving food safety, maintaining food quality and for enhancing the keeping properties of foods. NFPA is commenting on behalf of its member companies who will be purchasing and processing irradiated fruits and vegetables from foreign countries. These may be sold directly to the consumer or used as ingredients in formulated food products.

NFPA commends the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) for proposing regulations for the irradiation disinfestation of imported fresh fruits and vegetables. The use of low-levels of irradiation provides a needed addition to the methods currently used to disinfest
fruit and vegetables, a number of which have recognized limitations. It also represents another step toward harmonization between the U.S. and countries that have already approved irradiation for this purpose, thus opening trading opportunities.

Irradiation is a Valuable Tool for Sanitary and Phytosanitary Food Applications

NFPA agrees that it is appropriate for APHIS to outline regulatory procedures regarding the use of irradiation for food disinfestation. When properly used, along with good sanitation practices, irradiation is a valuable tool to aid in the production and manufacture of safe and wholesome foods by:

A broad spectrum of international studies have concluded that food irradiation can be used safely to accomplish these tasks. In most cases, irradiation has its dramatic effect on pathogens and/or pests without affecting a food’s quality or other properties.

NFPA believes that irradiation is a much needed addition to existing phytosanitary treatments for imported fruits and vegetables. Most importantly, irradiation is needed for disinfestation purposes as fumigation with methyl bromide has current and future limitations. The Environmental Protection Agency is placing restrictions on methyl bromide under the terms of the Montreal Protocol and the Clean Air Act. APHIS is to be commended for stepping forward with tools to ensure phytosanitary needs are not compromised.

As mentioned above, in addition to effectively disinfesting imported fruits and vegetables, irradiation enhances the food safety profile of treated fruits and vegetables. Although a radiation dose of 1 kiloGray (kGy) is not sufficient to kill viruses or spore-forming bacteria, this level of treatment is effective against protozoa and to a degree, most vegetative bacteria.

Irradiation is Not a Substitute for Good Sanitation Practices

The food industry strives to produce safe and wholesome foods. NFPA supports the use of irradiation as a food safety and quality enhancement tool. We emphasize that irradiation is not a substitute for good sanitation practices or hygienic food handling procedures. New uses and additional applications of irradiation do not lessen the food industry’s commitment to Current Good Manufacturing Practice (GMPs), good sanitation and hygienic practices and other food safety practices. The use of irradiation as a phytosanitary measure for imported fruits and vegetables is a strong companion practice to be used with existing good sanitation programs.

The Scope of Applications Should Not Be Limited

The proposed rule provides a list of pests which may be prevented from introduction into the U.S. by treating food with ionizing radiation. This list includes 11 species of fruit flies and the mango seed weevil.

NFPA would encourage APHIS to consider future applications of irradiation disinfestation use on foods from many locations around the world. We suggest APHIS consider developing regulations that will provide for treatment of fruits and vegetables which may contain pests beyond those identified in this Federal Register notice. We recommend that a more general regulatory scope be incorporated in the proposed rule which will allow use of irradiation for disinfestation purposes on all imported fruits and vegetables at levels of treatments up to 1kGy. This approach will cover those identified pests and provide for future applications when new pests are identified without having to modify the regulatory oversight structure on a case-by-case basis in the future. The expanded use to control newly identified pests would be allowed through verification of efficacy of treatment.

APHIS has specified certain “insect dependent” minimum treatments to ensure reaching the prescribed probit 9 level of inactivation. Minimum doses must meet or exceed an absorbed dose of 150, 210, 225 or 250 Gy. NFPA believes that the irradiation treatment providers are in the best position to establish the level of treatment required to accomplish the intended effect. Many variables will be considered in establishing the dose. The minimum doses as described should be presented only as guidelines with the actual dose being established by the provider in a range from a minimum to accomplish probit 9 level as a phytosanitary treatment to a maximum of 1kGy.

NFPA Encourages Mutual Recognition of Facility Certifications

NFPA recognizes that public health concerns exist regarding possible misuse of ionizing radiation and we agree that approved radiation units should be subject to official control. Certification, inspection and record keeping requirements are appropriate. In the U.S., facilities are licensed by the State under the authority of the Nuclear Regulatory Commission (NRC) and, where food products are involved, monitored by the Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS). Approved facilities would be recognized on a list maintained by the U.S. Department of Commerce (DOC).

This proposed regulation prohibits the importation of irradiated foodstuffs from a third country unless they have been treated at an irradiation facility certified by APHIS under part 305.2(c). NFPA encourages APHIS to recognize those facilities on the DOC list and urges that mutual recognition, whereby APHIS would recognize certification by foreign government regulatory agencies, be considered where appropriate. Currently the U.S./EU Transatlantic Economic Partnership (TEP) is striving to identify areas of cooperation that will reduce barriers to trade between the TEP partners. NFPA suggests that the TEP is an appropriate forum to discuss a mutual recognition agreement of parties that would provide the certification proposed under 305.2(c).

NFPA Suggests International Harmonization

NFPA respectfully requests APHIS to continue to promote international harmonization of these proposed regulations to ensure uniform standards with other countries. It is suggested that, where practical, these proposed regulations conform with those standards developed within the Codex Alimentarius Commission to the maximum extent possible and that U.S. agencies work with other nations for the establishment of comparable international standards. In some cases, other countries may have already established standards that would be useful for APHIS to consider.

Records and Documents

NFPA agrees that it is appropriate to retain records of the ionization of fruits and vegetables and that suppliers of this technology commonly provide information relative to the dosage, source and date of application as described in proposed 305.2(i).

NFPA encourages APHIS to consider the sample certificate prepared by the International Consultative Group on Food Irradiation (ICGFI) which was established under the aegis of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) in 1984 and which includes information similar to that suggested in proposed 305.2(i) (a copy of this certificate is attached). It was developed in an effort to harmonize international requirements and thus facilitate global trade in irradiated products.

Labeling Considerations

NFPA recognizes that mandatory “in commerce” labeling of irradiated fruits and vegetables is necessary as evidence that a given shipment has received phytosanitary treatment. However, we question the need for, and the wisdom of, labeling directed to retail consumers. Consumer labeling should be based upon the properties of the food itself and not on the method or process used to produce the food. In addition, labeling of imported fruits and vegetables that have been irradiated as a phytosanitary treatment may be misleading to consumers in two ways. First, the required label statement “treated by irradiation” or “treated with radiation” may frighten some consumers and discourage them from eating fruits and vegetables. It is widely recognized that the average American’s intake of fruits and vegetables already is inadequate, and any measures that might further reduce fruit and vegetable intake should be avoided. Second, irradiation is generally perceived as a food safety measure, and some consumers may mistakenly believe that irradiated fruits and vegetables are absolutely safe and may therefore not wash them or follow other safe handling practices. As previously noted, irradiation up to 1 kGy will improve the safety profile of imported fruits and vegetables, but it will not render them pathogen free.

While NFPA understands that the requirement to label irradiated fruits and vegetables at the retail level is a FDA requirement, we urge APHIS to raise this issue with FDA. NFPA believes that applying the labeling requirement to imported fruits and vegetables irradiated pursuant to this proposed rule is highly questionable. We would support voluntary disclosure of irradiation treatment to the consumer.


Irradiation is a valuable food safety tool which has an important role in maintaining food sanitation. APHIS has correctly recognized the need to provide a regulatory approach for the use of this technology for disinfestation of imported foods. NFPA is optimistic that providing this regulatory framework will help avoid barriers to international trade that are not science based while encouraging international acceptance of this important technology.

Thank you for the opportunity to comment on this important issue.


Jeffrey T. Barach, Ph.D.
Vice President Special Projects
Scientific and Regulatory Affairs