ANSI ASTM F1356-2016 Standard Guide for Irradiation of Fresh Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms.pdf

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1、Designation: F1356 16Standard Guide forIrradiation of Fresh, Frozen or Processed Meat and Poultryto Control Pathogens and Other Microorganisms1This standard is issued under the fixed designation F1356; the number immediately following the designation indicates the year oforiginal adoption or, in the

2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe purpose of this guide is to present information on the use of ionizing radiation in

3、 treating fresh,frozen, or processed 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 spoilage microorganisms.This guide is intended to serve as a

4、set of recommendations to be followed when using irradiationtechnology where approved by an appropriate regulatory authority. It is not to be construed as settingforth rigid requirements for the use of irradiation. While the use of irradiation involves certainessential requirements to attain the obj

5、ective 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) developed under the auspices of theFood and Agriculture Organization (FAO

6、), the World Health Organization (WHO), and theInternational Atomic Energy Agency (IAEA) (1).21. Scope1.1 This guide outlines procedures for the irradiation offresh, frozen, or processed meat and poultry.NOTE 1The Codex Alimentarius Commission defines meat as “theedible part of any mammal” and poult

7、ry 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 meat andpoultry as listed in 9 CFR Section 301.2 and 381.1, respectively. (2, 3).1.2 This guide covers the use of ionizing radiation toe

8、liminate or reduce the numbers of vegetative, pathogenicmicroorganisms and parasites, and to extend the refrigeratedshelf-life of those products by reducing the numbers ofspoilage microorganisms in fresh, frozen, or processed meatand poultry. The absorbed dose for this application is typicallyless t

9、han 10 kGy.1.3 This guide addresses irradiation of pre-packaged prod-uct for retail sale or for use as an ingredient in other products.It also addresses the in-line irradiation of unpackaged product.Other specific ISO and ASTM standards exist for the irradia-tion of food. In those areas covered by I

10、SO 14470, thatstandard takes precedence.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-priate safety and health practices and determine the applica-bility of regulatory

11、limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E170 Terminology Relating to Radiation Measurements andDosimetryF1416 Guide for Selection of Time-Temperature IndicatorsF1640 Guide for Selection and Use of Packaging Materialsfor Foods to Be Irradiated2.2 ISO/ASTM Standards:351261

12、Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51539 Guide for Use of Radiation-Sensitive Indicators51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)1This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibi

13、lity of Subcommittee E61.05 on FoodIrradiation.Current edition approved Feb. 1, 2016. Published March 2016. Originallyapproved in 1991. Last previous edition approved in 2008 as F1356 08. DOI:10.1520/F1356-16.2The boldface numbers in parentheses refer to the list of references at the end ofthis stan

14、dard.3For referenced ASTM and ISO/ASTM standards, visit the ASTM website,www.astm.org, or contact ASTM Customer Service at serviceastm.org. ForAnnual Book of ASTM Standards volume information, refer to the standardsDocument Summary page on the ASTM website.Copyright ASTM International, 100 Barr Harb

15、or Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1Facility for Radiation Processing at Energies between 50keV and 7.5 MeV51649 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 300 keVand 25 MeV51702 Practice for Dosimetry in a Gamma

16、 Facility forRadiation Processing51818 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80 and 300keV52303 Guide for Absorbed-Dose Mapping in Radiation Pro-cessing Facilities52628 Practice for Dosimetry in Radiation Processing52701 Guide for Performance

17、 Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.3 Codex Alimentarius Commission Recommended Inter-national Codes and Standards:4CAC/RCP 1-1969, Rev. 4-2003, Recommended Interna-tional Code of PracticeGeneral Principles of FoodHygiene including Annex on Hazard

18、 Analysis and CriticalControl Point (HACCP) System and Guidelines for itsApplicationCAC/RCP 19-1979, Rev. 2003, Recommended InternationalCode of Practice for the Radiation Processing of FoodCX STAN 1-1985, Rev. 2010, General Standard for theLabeling of Prepackaged FoodsCX STAN 106, Rev. 2003, Genera

19、l Standard for IrradiatedFoodCAC/MISC 5-1993, Amd. 2003, Glossary of Terms andDefinitions (Veterinary Drug Residues in Food)CAC/GL21-1997, Rev. 2013, Principles and Guidelines forthe Establishment and Application of MicrobiologicalCriteria Related to Food2.4 ISO Standard5ISO 14470-2011 Food irradiat

20、ion-requirements for thedevelopment, validation and routine control of the processof irradiation using ionizing radiation for the treatment offood3. Terminology3.1 Definitions:3.1.1 Other terms used in this guide may be defined inTerminology E170.3.1.2 absorbed dosequotient of dbydm, where d is them

21、ean energy imparted by ionizing radiation to matter of massdm, thusD 5 ddm (1)3.1.2.1 DiscussionThe SI unit of absorbed dose is the gray(Gy), where 1 gray is equivalent to the absorption of 1 joule perkilogram of the specified material (1 Gy = 1 J/kg).3.1.3 D10valueabsorbed dose required to reduce t

22、he mi-crobial population in a given food by 90 %.3.1.4 dose distributionvariation in absorbed dose within aprocess load exposed to ionizing radiation.3.1.5 process loadvolume of material with a specifiedloading configuration irradiated as a single entity.3.1.6 transport systemconveyor or other mecha

23、nical sys-tem used to move the process load through the irradiator.4. Significance and Use4.1 The principal purpose of irradiation is to help ensure thesafety of these foods for human consumption. Irradiationsignificantly reduces the numbers of pathogenic bacteria suchas Campylobacter, Shiga toxin-P

24、roducing E coli, Listeriamonocytogenes, Salmonella, Staphylococcus aureus, and Yers-inia enterocolitica.NOTE 3Ionizing radiation doses below 10 kGy will reduce but maynot eliminate spores of pathogenic bacteria uncluding those of Clostridiumbotulinum, Clostridium perfringens, and Bacillus cereus.4.2

25、 The process also inactivates parasites such asTrichinella spiralis and Toxoplasma gondii.4.3 The process may extend the shelf life of fresh meat andpoultry by reducing the numbers of viable, spoilage bacteria,such as Pseudomonas species and lactic acid bacilli.4.4 Radiation processing of fresh, fro

26、zen, or processed meatand poultry is a critical control point (CCP) of a HazardAnalysis of Critical Control Points (HACCP) program. Itserves as an important measure to control any residual riskfrom pathogenic microorganisms before the product reachesthe consumer (4).4.5 The “Recommended Internationa

27、l Code of Practice forRadiation Processing of Food” (CAC/RCP 19-1979) of theCodex 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 c

28、onsumption.5. Criteria for Assessing Process Control and IrradiationEfficacy5.1 Process Control SystemThe criterion should be thathazard analysis and critical control point (HACCP) system oranother similar process control system is applied to the entireprocessing and distribution chain. With this sy

29、stem, any pointin the chain where a hazardous or critical situation could resultis monitored and controlled to prevent unsafe and unwhole-some product from reaching the consumer. See CAC/RCP 1and (4, 5). Failure to meet these criteria should be investigated,to assess the efficacy of standard operati

30、ng procedures (see 8.1)and the re-establishment, if necessary, of Good ManufacturingPractice (GMPs).5.1.1 Implementation of a process control system (see 4.4)to assess radiation-processing efficacy should include bacterio-logical examination of the product before and after irradiation,use of time/te

31、mperature indicators throughout the processingchain (see Guide F1416), and testing of package integrity.Irradiation efficacy has to be validated to ensure that theminimum absorbed dose delivered (see 8.38.4) to the product4Available from the Joint FAO/WHO Food Standards Programme, Joint Office,FAO,

32、Via delle Terme di Caracalla, 00100 Rome, Italy.5Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.F1356 162is able to achieve the minimum reduction in target micro

33、bialorganisms that is expected. The target organism(s) have to beidentified prior to this validation. Bacteriological testing afterspecific irradiation doses should yield a predicted decline inviable counts of the target pathogen(s). Temperature monitor-ing should provide an alert of any product abu

34、se that couldresult in increases in bacterial counts after irradiation.5.2 Criteria for Irradiation Treatment:5.2.1 Irradiation for Control of Pathogenic BacteriaThecriterion should be that the irradiation treatment is able toreduce the number of pathogenic bacteria in the meat orpoultry, such that

35、they are no longer able to cause illness.Determining whether a specified irradiation treatment willreduce the likelihood of illness can only be based on a formalquantitative microbial risk assessment (QMRA) approach (6,7). The numbers of pathogenic bacteria that can result in aninfectious product va

36、ry with the specific bacterium.NOTE 4Susceptibility of a person to pathogenic bacteria varies and isbased on the health of the individual and the virulence of the particularstrain of the pathogen (8, 9).5.2.2 Irradiation for Inactivation of ParasitesThe crite-rion should be that the parasites in unc

37、ooked, irradiatedproduct are noninfectious or noninvasive, as appropriate.5.2.3 Irradiation for Shelf-Life ExtensionThe criterionshould be the bacterial plate count using appropriate time,temperature, and media parameters. Reduction in bacterialcounts as final criteria cannot be specified unless loc

38、alregulations, customer specifications, or both, are known.Therefore, the final product specification regarding bacterialplate count should be established by the food producer or foodprocessor.6. Pre-Irradiation Product Handling6.1 Product handling should be under conditions that protectthe product

39、against physical, chemical, or biological hazards.Microbial contamination and growth should be minimized byfollowing relevant standards of GMPs; see for example U.S.Food and Drug Administration (FDA) GMPs (10), U.S. FoodSafety and Inspection Service (FSIS) Standard Sanitary Oper-ating Procedures (SS

40、OPs) (11), CAC Recommended Interna-tional Codes of Practice, (CAC/RCP 1 (see 2.3) and HACCP)(4, 5, 12).6.2 Unpackaged ProductIn facilities handling unpack-aged product, the irradiation environment and equipmentshould be designed and constructed to be cleanable and durableto maintain a sanitary condi

41、tion and, thereby, not increase therisk of contamination.NOTE 5An operating environment with high moisture or airflow maycontribute to the risk of bacterial contamination. Moisture provides agrowth medium for bacteria and airflow provides a means of transport forbacteria. Food contact surfaces may c

42、ontribute 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-packaged product, thepackage itself provides

43、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. Information on applicablerequirements should be ob

44、tained from the appropriate regula-tory authorities before starting operations.6.4 Pre-Irradiation InspectionPackages and containers offresh, frozen, or processed meat and poultry should be in-spected upon receipt at the irradiation facility to ensure that theproduct is suitable for irradiation. Wri

45、tten acceptance criteriafor product temperature, package integrity and inspectionfrequency, as applicable, should be established by the productowner and agreed to by management of the irradiation facilityprior to accepting product from the owner. Also, criteria forhandling of product unsuitable for

46、irradiation should be estab-lished.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 be between 2 and +4C for refrigera

47、ted fresh orprocessed meat and poultry or 18C or lower for frozen meatand poultry. For unpackaged product, insert the device directlyinto the product and sanitize the device between each measure-ment. For prepackaged product, use a device that can be placedbetween individual packages without punctur

48、ing 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 should be evident upon inspec-t

49、ion.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 performed 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-Irradi