1、Designation: F 1356 08An American National StandardStandard Practice forIrradiation of Fresh and Frozen Red Meat and Poultry toControl Pathogens and Other Microorganisms1This standard is issued under the fixed designation F 1356; the number immediately following the designation indicates the year of
2、original adoption or, 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 practice is to present information on
3、the use of ionizing radiation in treatingfresh or frozen red meat and poultry products to eliminate or reduce the numbers of vegetative,pathogenic microorganisms and parasites, and to extend the refrigerated shelf-life of those products byreducing the numbers of vegetative spoilage microorganisms.Th
4、is practice is intended 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 c
5、ertainessential requirements to attain the objective of the treatment, some parameters can be varied inoptimizing the process.This practice has been prepared from a Code of Good Irradiation Practice published by theInternational Consultative Group on Food Irradiation (ICGFI) under the auspices of th
6、e Food andAgriculture Organization (FAO), the World Health Organization (WHO), and the InternationalAtomicEnergy Agency (IAEA) (1).21. Scope1.1 This practice outlines procedures for the irradiation offresh or frozen meat and poultry.NOTE 1The Codex Alimentarius Commission defines meat as “theedible
7、part of any mammal” and poultry as “any domesticated bird,including chicken, turkeys, ducks, geese, guinea-fowls, or pigeons”(CAC/MISC 5).NOTE 2Current U.S. regulations limit the definition of livestockspecies to cattle, sheep, swine, goat, horse, mule, or other equine andpoultry species to chicken,
8、 turkey, duck, goose, and guinea (2, 3).1.2 This practice covers absorbed doses used for inactiva-tion of parasites and reduction of bacterial load in fresh andfrozen red meat and poultry. Such doses are typically less than10 kGy.1.3 This practice addresses irradiation of pre-packagedproduct for ret
9、ail sale or for use as an ingredient in otherproducts. It also addresses the in-line irradiation of unpackagedproduct.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-pria
10、te safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E 170 Terminology Relating to Radiation Measurementsand DosimetryE 2303 Guide for Absorbed-Dose Mapping in RadiationProcessing FacilitiesF 1416 Guide for
11、Selection of Time-Temperature IndicatorsF 1640 Guide for Selection and Use of Packaging Materialsfor Foods to Be Irradiated2.2 ISO/ASTM Standards:351204 Practice for Dosimetry in Gamma Irradiation Facili-ties for Food Processing51261 Guide for the Selection and Calibration of DosimetrySystems for Ra
12、diation Processing51431 Practice for Dosimetry in Electron and X-ray(Bremsstrahlung) Irradiation Facilities for Food Process-ing51539 Guide for the Use of Radiation-Sensitive Indicators1This practice is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and Applications and is the dir
13、ect responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved Jan. 1, 2008. Published February 2008. Originallyapproved in 1991. Last previous edition approved in 1999 as F 1356 99.2The boldface numbers in parentheses refer to the list of refer
14、ences at the end ofthis standard.3For referenced ASTM standards, 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 Internationa
15、l, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Copyright by ASTM Intl (all rights reserved); Thu Feb 19 02:09:22 EST 2009Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.2.3 Codex Alimentarius Commission
16、Recommended Inter-national Codes and Standards:4CAC/RCP 1-1969, Rev. 4-2003, A Recommended Interna-tional Code of PracticeGeneral Principles of FoodHygiene (Including Annex): Hazard Analysis and CriticalControl Point (HACCP) System and Guidelines for Ap-plicationCAC/RCP19-1979, Rev-2003, Recommended
17、 InternationalCode of Practice for the Radiation Processing of FoodCX STAN 1-1985, Rev. 1991,Amd. 2001, General Standardfor the Labeling of Prepackaged FoodsCX STAN 106, Rev. 2003, General Standard for IrradiatedFoodCAC/MISC 5-1993, Amd. 2003, Glossary of Terms andDefinitions (Veterinary Drug Residu
18、es in Food)3. Terminology3.1 DefinitionsOther terms used in this practice 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 absorpti
19、on of 1 joule per kilogram 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 abs
20、orbed dose within aprocess load exposed to ionizing radiation.3.1.4 process loadvolume 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 U
21、se4.1 The principal purpose of irradiation is to control (reducethe number of) pathogenic bacteria in fresh or frozen red meatand poultry to ensure the safety of these foods for humanconsumption. Irradiation significantly reduces the numbers ofvegetative pathogenic bacteria such as Campylobacter, Es
22、-cherichia coli, Listeria, Salmonella, Staphylococcus aureus,orYersinia enterocolitica.4.2 The process also inactivates parasites such as Tri-chinella spiralis and Toxoplasma gondii.4.3 The process may extend the shelf life of fresh red meatand poultry by reducing the numbers of viable, vegetativesp
23、oilage bacteria, such as Pseudomonas species.4.4 Radiation processing of fresh and frozen red meat andpoultry is a critical control point (CCP) of a HazardAnalysis ofCritical Control Points (HACCP) program. It serves as animportant measure to control any residual risk from pathogenicmicroorganisms b
24、efore the product reaches the consumer.5. Criteria for Assessing Irradiation Efficacy5.1 Irradiation for Control of Pathogenic BacteriaThenumbers of pathogenic bacteria that can result in an infectiousproduct vary with the specific bacterium and the susceptibilityof the consumers involved. The adopt
25、ion of criteria, such asthose used in the U.S. for the pasteurization of milk or inscheduled processes for low-acid canned food, is the mostreasonable in the absence of microbiological end productcriteria for expected pathogenic bacteria (4, 5).5.2 Irradiation for Inactivation of ParasitesThe criter
26、ionshould be that the parasites in uncooked, irradiated product arenoninfectious or noninvasive, as appropriate. (This does notnecessarily require the parasite to be killed by the irradiationprocess.)5.3 Irradiation for Shelf-Life ExtensionThe criterionshould be the bacterial plate count using appro
27、priate time,temperature, and media parameters. Reduction in bacterialcounts as final criteria cannot be specified unless local regula-tions, customer specifications, or both, are known. Therefore,the final product specification regarding bacterial plate countshould be established by the customer.5.4
28、 Failure to meet these criteria should direct attention tothe scheduled process (see 8.1) and the reestablishment, ifnecessary, of Good Manufacturing Practice (GMPs). Thehazard analysis and critical control point (HACCP) system oranother similar process control system should be applied to theentire
29、processing and distribution chain. With this system, anypoint in the chain where a hazardous or critical situation couldresult is monitored and controlled to prevent unsafe andunwholesome product from reaching the consumer. See CAC/RCP 1 and (6, 7).5.4.1 Implementation of a process control system to
30、 assessradiation-processing efficacy should include bacteriologicalexamination of the product before and immediately afterirradiation, use of time/temperature indicators throughout theprocessing chain (see Guide F 1416), and testing of packageintegrity. Bacteriological testing should reveal a signif
31、icantreduction in relevant bacterial counts compared to those of thenon-irradiated product. Temperature monitoring should alertobservers of any product abuse that could result in increases inbacterial counts after irradiation.6. Pre-Irradiation Product Handling6.1 Product should be handled in an env
32、ironment that doesnot increase the risk of contamination from physical, chemical,or biological hazards. Minimize microbial contamination andgrowth by following relevant standards of GMPs; see forexample U.S. Food and DrugAdministration (FDA) GMPs (8),U.S. Food Safety and Inspection Service (FSIS) St
33、andardSanitary Operating Procedures (SSOPs) (9), CAC Recom-mended International Codes of Practice, (CAC/RCP1 (see 2.3)and HACCP) (10).6.2 Unpackaged ProductIn facilities handling unpack-aged product, the irradiation environment and equipmentshould be designed and constructed to be cleanable and dura
34、bleto maintain a sanitary condition and, thereby, not increase therisk of contamination.NOTE 3An operating environment with high moisture or airflow may4Available from the Joint FAO/WHO Food Standards Programme, Joint Office,FAO, Via delle Terme di Caracalla, 00100 Rome, Italy.F1356082Copyright by A
35、STM Intl (all rights reserved); Thu Feb 19 02:09:22 EST 2009Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.contribute to the risk of bacterial contamination. Moisture provides agrowth medium for bacteria and airflow provides a means of transp
36、ort forbacteria. Food contact surfaces may contribute chemical or physicalcontaminants to products unless such surfaces are fabricated fromappropriate materials and properly maintained and cleaned. Also, em-ployee hygiene and pest control should be closely monitored.6.3 Pre-Packaged ProductFor pre-p
37、ackaged product, thepackage itself provides a barrier that helps to reduce the risk ofrecontamination. Thus, many of the requirements for theirradiation environment and equipment necessary for handlingunpackaged product may not be applicable for facilities han-dling only pre-packaged product. Inform
38、ation on applicablerequirements should be obtained from the appropriate regula-tory authorities before starting operations.6.4 Pre-Irradiation InspectionPackages and containers offresh and frozen red meat and poultry should be inspected uponreceipt at the irradiation facility to ensure that the prod
39、uct issuitable for irradiation. Written acceptance criteria for producttemperature, package integrity and inspection frequency, asapplicable, should be established by the product owner andagreed to by management of the irradiation facility prior toaccepting product from the owner.Also, criteria for
40、handling ofproduct unsuitable for irradiation should be established.6.4.1 Product TemperatureUpon receipt of product, itstemperature should be measured using a calibrated sanitizedtemperature-sensing device, at a predetermined location andfrequency as specified by HACCP and GMPs. Temperatureshould b
41、e between 2 and +4C for refrigerated fresh red meatand poultry or 18C or lower for frozen red meat and poultry.For unpackaged product, insert the device directly into theproduct and sanitize the device between each measurement.For prepackaged product, use a device that can be placedbetween individua
42、l packages without puncturing them.6.4.2 Package IntegrityA visual inspection of the productpackaging should be performed to ensure there is no evidenceof compromised or damaged product. Also, a sensory inspec-tion should be performed. No leakage of fluids or odorindicative of product spoilage shoul
43、d be evident upon inspec-tion.6.4.3 Product InventoryThe number of containers shouldbe counted and the description/identification of the product tobe irradiated should be verified and compared with the docu-mentation from the product owner. A comparison of thispre-irradiation count with a count perf
44、ormed after irradiationprovides a check that all products received have been irradi-ated.6.4.4 Product IdentificationA unique identification num-ber for tracking the product throughout the irradiation processshould be issued and documented for the incoming product.6.5 Pre-Irradiation Storage:6.5.1 F
45、or fresh red meat and poultry, the principal require-ment for pre-irradiation storage is maintenance of the producttemperature between 2 and +4C without freezing.NOTE 4U.S. poultry regulations presently require that the temperatureof fresh poultry be maintained at or below 4.4C (10).NOTE 5Holding pr
46、oduct under refrigeration for an unduly long timewould violate principles of GMPs because such treatment may result inexcessive growth of psychrotrophic bacteria and undesirable changes inproducts.6.5.2 A second requirement is that the pre-irradiation stor-age period at the irradiation facility be m
47、inimized, approxi-mately one day or less, whenever possible.6.5.3 For frozen red meat and poultry, the product tempera-ture should be maintained at or below 18C at all times. Therelatively short duration of frozen storage prior to irradiation isnot particularly critical under normal commercial condi
48、tions.However, freezing does not provide an unlimited product lifewithout loss of quality, and the pre-irradiation storage periodshould therefore be minimized.6.6 Product SegregationDistinguishing irradiated fromnon-irradiated product by inspection might not be possible.Therefore, the use of appropr
49、iate means integral to the facilitydesign, such as physical barriers or special segregation inclearly defined staging areas, to maintain non-irradiated prod-uct separate from irradiated product is important.NOTE 6Radiation-sensitive indicators undergo a color change whenexposed to radiation in the pertinent dose range. These indicators may beuseful within the irradiation 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
