ASTM/ISO 51431-05

4.1 Food products may be treated with acceleratorgenerated radiation (electrons and X-rays) for numerous purposes, including control of parasites and pathogenic microorganisms, insect disinfestation, growth and maturation inhibition, and shelf-life extension. Food irradiation specifications almost always include a minimum or a maximum limit of absorbed dose, sometimes both: a minimum limit may be set to ensure that the intended beneficial effect is achieved and a maximum limit may be set for the purpose of avoiding product or packaging degradation. For a given application, one or both of these values may be prescribed by government regulations that have been established on the basis of scientific data. Therefore, prior to the irradiation of the food product, it is necessary to determine the capability of an irradiation facility to consistently deliver the absorbed dose within any prescribed limits. Also, it is necessary to monitor and document the absorbed dose during each production run to verify compliance with the process specifications at a predetermined level of confidence.

NOTE 3 - The Codex Alimentarius Commission has developed an international General Standard and a Code of Practice that address the application of ionizing radiation to the treatment of foods and that strongly emphasize the role of dosimetry for ensuring that irradiation will be properly performed (1).4

4.2 For more detailed discussions of radiation processing of various foods, see Guides F 1355, F 1356, F 1736, and F 1885 and Refs (2-15).

4.3 Accelerator-generated radiation can be in the form of electrons or X-rays produced by the electrons. Penetration of radiation into the product required to accomplish the intended effect is one of the factors affecting the decision to use electrons or X-rays.

4.4 To ensure that products are irradiated within a specified dose range, routine process control requires routine product dosimetry, documented product handling procedures (before, during and after the irradiation), consistent orientation of the products during irradiation, monitoring of critical operating parameters, and documentation of all relevant activities and functions

1.1 This practice outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification and routine processing in facilities that process food with high-energy electrons and X-rays (bremsstrahlung) to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory dose limits for food products, and appropriate energy limits for electron beams used directly or to generate X-rays is not within the scope of this practice (see ASTM Guides F 1355, F 1356, F 1736, and F 1885).

Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in the production of safe and wholesome food.

ISO/ASTM Practice 51204 describes dosimetric procedures for gamma irradiation facilities for food processing.

1.2 For guidance in the selection and calibration of dosimetry systems, and interpretation of measured absorbed dose in the product, see ISO/ASTM Guide 51261 and ASTM Practice E 666. For the use of specific dosimetry systems, see ASTM Practices E 1026 and E 2304, and ISO/ASTM Practices 51205, 51275, 51276, 51310, 51401, 51538, 51540, 51607, 51650 and 51956. For discussion of radiation dosimetry for electrons and X-rays also see ICRU Reports 35 and 14. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34.

1.3 While gamma radiation from radioactive nuclides has discrete energies, X-rays (bremsstrahlung) from machine sources cover a wide range of energies, from low values (about 35 keV) to the energy of the incident electron beam. For information concerning electron beam irradiation technology and dosimetry, see ISO/ASTM Practice 51649. For information concerning X-ray irradiation technology and dosimetry, see ISO/ASTM Practice 51608.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.