1、Designation: E 2449 05Standard Guide forIrradiation of Pre-packaged Processed Meat and PoultryProducts to Control Pathogens and Other Microorganisms1This standard is issued under the fixed designation E 2449; the number immediately following the designation indicates the year oforiginal adoption or,
2、 in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe purpose of this guide is to present information on the use of ionizing radi
3、ation for eliminatingor reducing the number of pathogenic microorganisms and parasites and for reducing the number ofspoilage microorganisms on Processed Meat and Poultry. Information on the handling of processedmeat and poultry prior to and after irradiation is also provided.This guide is intended
4、to serve as a set of recommendations to be followed when using irradiationtechnology where approved by an appropriate regulatory control authority. It is not to be construed assetting forth rigid requirements for the use of irradiation. While the use of irradiation involves certainessential requirem
5、ents to attain the objective of the treatment, some parameters can be varied inoptimizing the process.This guide has been prepared from a Code of Good Irradiation Practice published by theInternational Consultative Group on Food Irradiation (ICGFI) under the auspices of the Food andAgriculture Organ
6、ization (FAO), the World Health Organization (WHO), and the InternationalAtomicEnergy Agency (IAEA). (1)21. Scope1.1 This guide outlines procedures for the irradiation ofpre-packaged refrigerated and frozen processed meat andpoultry products.NOTE 1The CodexAlimentarius Commission defines “meat” (inc
7、lud-ing poultry and game) as “the edible part of any mammal slaughtered inan abattoir,” and “poultry meat” as “the edible part of slaughtereddomesticated birds, including chicken, turkeys, ducks, geese, guinea-fowls, or pigeons.” (CAC/RCP 13-1976)NOTE 2Current U.S. regulations limit the definition o
8、f livestockspecies to cattle, sheep, swine, goat, horse, mule, or other equine andpoultry species to chicken, turkey, duck, goose, and guinea (2, 3).1.2 This guide addresses all refrigerated and frozen meatand poultry products NOT covered by Guide F 1356.1.3 This guide provides information regarding
9、 absorbeddoses used for inactivation of parasites and reduction ofbacterial load. Such doses are typically less than 10 kilogray(kGy).2. Referenced Documents2.1 ASTM Standards:3E 170 Terminology Relating to Radiation Measurementsand DosimetryF 1356 Guide for Irradiation of Refrigerated and FrozenRed
10、 Meat and Poultry to Control Pathogens and OtherMicroorganismsF 1640 Guide for Packaging Materials for Foods to BeIrradiatedE 2232 Guide for Selection and Use of Mathematical Meth-ods for CalculatingAbsorbed Dose in Radiation ProcessingApplicationsE 2303 Guide for Absorbed-Dose Mapping in RadiationP
11、rocessing Facilities2.2 ISO/ASTM Standards:351204 Practice for Dosimetry in Gamma Irradiation Facili-ties for Food Processing51261 Guide for the Selection and Calibration of DosimetrySystems for Radiation Processing1This guide is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and
12、Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved June 1, 2005 Published July 2005.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3For referenced ASTM standar
13、ds, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA
14、19428-2959, United States.51431 Practice for Dosimetry in Electron and X-ray(Bremsstrahlung) Irradiation Facilities for Food Process-ing51539 Guide for the Use of Radiation Sensitive Indicators2.3 Codex Alimentarius Commission Recommended Inter-national Codes of Practice and Standards:4CAC/RCP 13-19
15、76, Rev. 1985 - Recommended Interna-tional Code of Hygienic Practice for Processed Meat andPoultry ProductsCAC/RCP 1-1969, Rev. 3-1997, Amd. 1999, A Recom-mended International Code of Practice, General Principlesof Food HygieneCAC/RCP 19-1979, Rev. 2003 Recommended InternationalCode of Practice for
16、Radiation-processing of FoodCX STAN 1-1985, Rev. 1991, Amd. 2001 - General Stan-dard for the Labelling of Prepackaged FoodsCX STAN 106 1983, Rev. 2003 - General Standard forIrradiated FoodCAC/GL21-1997 Principles for the establishment and ap-plication of microbiological criteria for Food3. Terminolo
17、gy3.1 DefinitionsOther terms used in this guide may bedefined in Terminology E 170.3.1.1 absorbed doseQuantity of ionizing radiation energyimparted per unit mass of a specified material. The SI unit ofabsorbed dose is the gray (Gy), where 1 gray is equivalent tothe absorption of 1 joule per kilogram
18、 of the specified material(1 Gy = 1 J/kg).3.1.1.1 DiscussionA standard definition of absorbed doseappears in Terminology E 170 .3.1.2 D10-valueabsorbed dose required to reduce the mi-crobial population in a given food by 90 % (1 log10).3.1.3 dose distributionvariation in absorbed dose within aproces
19、s load exposed to ionizing radiation.3.1.4 process loada volume of material with a specifiedloading configuration irradiated as a single entity.3.1.5 transport systemconveyor or other mechanical sys-tem used to move the process load through the irradiator.4. Significance and Use4.1 The principal pur
20、pose of irradiation is to reduce thenumber of pathogenic bacteria, such as Campylobacter, Es-cherichia coli 0157:H7, Listeria monocytogenes, Staphylococ-cus aureus or Salmonella spp., in processed meats and poultryto make these foods safer for human consumption.NOTE 3Ionizing radiation doses below 1
21、0 kGy will reduce but noteliminate spores of pathogenic bacteria including those of Clostridiumbotulinum, Clostridium perfringens and Bacillus cereus.4.2 Irradiation treatment can extend the shelf life of pro-cessed meats and poultry by reducing the numbers of vegeta-tive spoilage bacteria, such as
22、Pseudomonas species and lacticacid bacilli.4.3 Irradiation treatment also inactivates parasites such asTrichinella spiralis and Toxoplasma gondii.4.4 Radiation processing of the final product in its packag-ing is a critical control point (CCP) of a Hazard Analysis ofCritical Control Points (HACCP) c
23、oncept for the production ofProcessed Meat and Poultry. It serves as an important measureto control any residual risk from pathogen microorganisms justbefore the product reaches the consumer.4.5 The “Recommended International Code of Practice forRadiation-processing of Food” (CAC/RCP 19-1979) of the
24、Codex Alimentarius identifies the essential practices to beimplemented to achieve effective radiation processing of food,in general, in a manner that maintains quality and yields foodproducts that are safe and suitable for consumption.5. Pre-Irradiation Product Handling5.1 Product should be handled
25、in an environment that doesnot increase the risk of contamination from physical, chemical,or biological hazards. Minimize microbial contamination andgrowth by following relevant standards of Good Manufactur-ing Practice (GMPs); see for example U.S. Food and DrugAdministration (FDA) GMPs (4), U.S. Fo
26、od Safety and In-spection Service (FSIS) Standard Sanitary Operating Proce-dures (SSOPs) (5), CAC Recommended International Codes ofPractice, (CAC/RCP 13-1976 and CAC/RCP 1-1969)(see 2.3)and HACCP (6, 7).5.2 Pre-Irradiation InspectionInspect packages and con-tainers of processed meat and poultry upo
27、n receipt at theirradiation facility to ensure that the product is suitable forirradiation (see 5.2.1, 5.2.2, and 5.2.3). Written acceptancecriteria for product temperature, package integrity and inspec-tion frequency, as applicable, should be established by theproduct owner and agreed to by managem
28、ent of the irradiationfacility prior to accepting product from the owner.Also, criteriafor handling product unsuitable for irradiation should beestablished.5.2.1 Product TemperatureUpon receipt, using a cali-brated temperature-sensing device, measure the temperature ofthe product at a pre-determined
29、 location and frequency asspecified by HACCP and GMPs. Temperature should bebetween 2 and +4C for refrigerated processed meat andpoultry or 18C or lower for frozen processed meat andpoultry.5.2.2 Package IntegrityPerform a visual inspection of theproduct packaging to ensure there is no evidence of c
30、ompro-mised or damaged product.5.2.3 Product InventoryCount the number of containersand verify the description/identification of the product to beirradiated and compare with the documentation from theproduct owner.Acomparison of this pre-irradiation count witha count performed after irradiation prov
31、ides a check that allproducts received have been irradiated.5.2.4 Product IdentificationA unique identification num-ber for tracking the product throughout the irradiation processshould be issued and documented for the incoming product.5.3 Pre-Irradiation Storage:4Available from the Joint FAO/WHO Fo
32、od Standards Programme, Joint Office,FAO, Via delle Terme di Caracalla, 00100 Rome, Italy.E24490525.3.1 Refrigerated Processed Meats and Poultrythe prin-cipal requirement for pre-irradiation storage is maintenance ofthe product temperature between 2 and +4C without freez-ing. Pre-irradiation storage
33、 at the irradiation facility should beminimized to approximately one day or less, whenever pos-sible.NOTE 4Holding product under refrigeration for an unduly long timewould violate principles of GMPs because such treatment may result inexcessive growth of psychrotrophic bacteria and undesirable chang
34、es inproducts.5.3.2 Frozen Processed Meats and Poultrymaintain theproduct temperature at or below 18C at all times. Therelatively short duration of frozen storage prior to irradiation isnot particularly critical under normal commercial conditions.However, freezing does not provide an unlimited produ
35、ct lifewithout loss of quality, and the pre-irradiation storage periodshould therefore be minimized.5.4 Product SeparationIt may not be possible to distin-guish irradiated from un-irradiated product by visual inspec-tion. It is therefore important that appropriate means integral tothe facility desig
36、n, such as physical barriers or clearly definedstaging areas, be used to maintain un-irradiated product sepa-rate from irradiated product.NOTE 5Radiation-sensitive indicators undergo a color change whenexposed to radiation in the pertinent dose range. These indicators may beuseful within the irradia
37、tion facility as a visual check for determiningwhether or not a product has been exposed to the radiation source. Theyare not dosimeters intended for measuring absorbed dose and must not beused as a substitute for proper dosimetry. Information about dosimetrysystems and the proper use of radiation-s
38、ensitive indicators is provided inISO/ASTM Guides 51261 and 51539, respectively.6. Packaging and Product Loading Configuration6.1 Packaging Materials:6.1.1 Use packaging materials suitable to the product con-sidering any planned processing (including irradiation) andconsistent with any regulatory re
39、quirements (see GuideF 1640). Packaging materials should provide appropriate gasand moisture permeability to maintain product quality.6.1.2 For frozen processed meats and poultry, the packageshould be as free as possible of voids or open spaces. Suchspaces can cause a form of desiccation known as “f
40、reezerburn.”6.2 Product Loading Configuration:6.2.1 The size, shape, density and loading configuration of aprocess load to be irradiated should be determined primarily byconsidering design parameters of the irradiation facility. Criti-cal design parameters include the characteristics of producttrans
41、port systems and of the radiation source as they relate tothe dose distribution obtained within the process load.6.2.2 The dose distribution within the process load can oftenbe optimized by using product packages that are geometricallywell defined and uniformly loaded. With certain irradiationfacili
42、ties, it may be necessary to limit use to particular packageshapes and sizes depending on the density of the product andvalidation testing at known product densities. (see ISO/ASTMPractices 51204 and 51431).6.2.3 Prescribed product dose specifications should be takeninto account when determining the
43、 appropriate product-loadingconfiguration (7.4).7. Irradiation7.1 Standard Operating Procedures (SOPs)A standardoperating procedure for food irradiation is a written procedurethat is used to ensure that the absorbed dose range andirradiation conditions selected by the radiation processor areadequate
44、 under commercial processing conditions to achievethe intended effect on a specific product in a specific facility.The procedures shall be established by qualified personshaving knowledge in irradiation requirements specific to thefood and the irradiation facility (21 CFR 179.25).7.2 Radiation Sourc
45、esThe sources of ionizing radiationthat may be employed in irradiating food products are limitedto the following: (see CX STAN 106-1983)7.2.1 Isotopic Sourcesgamma rays from the radionuclides60Co (1.17 and 1.33 MeV) or137Cs (0.66 MeV);7.2.2 Machine SourcesX-rays and accelerated electrons.NOTE 6The C
46、odex Alimentarius Commission as well as regulationsin some countries currently limit the maximum electron energy andnominal X-ray energy for the purpose of food irradiation (CX STAN106-1983).7.3 Dosimetry SystemSelect and calibrate a dosimetrysystem appropriate for the radiation source being used, t
47、herange of absorbed doses required, and the environmentalconditions (e.g., product temperature, irradiation cell tempera-ture) expected during irradiation (see ISO/ASTM 51204,51261 and 51431) (8).7.4 Absorbed Dose7.4.1 Absorbed Doses Required to Accomplish SpecificEffects:The owner of the processed
48、meat or poultry product shallprovide required minimum and maximum absorbed dose limits(9): the lowest dose necessary to ensure the intended effect(e.g., microbial load reduction, pathogen inactivation), and thehighest dose that does not negatively affect the product qualitythrough the formation of o
49、ff-flavors, aromas and color changes(8,9). One or both of these limits may be prescribed bygovernment authorities for a given application. The sensitivityto irradiation of processed meat and poultry product varies withthe type and product formulation, the packaging atmosphere,the product temperature during irradiation, and other factors.Experience indicates that a higher minimum dose may berequired for frozen product than that for product irradiated inthe refrigerated state to achieve the same intended objective.7.4.2 Absorbed Dose for the Control of
