1、Designation: F 1356 99An American National StandardStandard Guide 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 ofori
2、ginal 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 guide is to present information on the us
3、e of ionizing energy (radiation) intreating fresh or frozen red meat and poultry products to eliminate or reduce the numbers ofvegetative, pathogenic microorganisms and parasites, and to extend the refrigerated shelf-life of thoseproducts by reducing the numbers of vegetative spoilage microorganisms
4、.This guide is intended to serve as a recommendation when using irradiation technology whereapproved by an appropriate regulatory authority. It is not to be construed as a requirement for the useof irradiation, nor as a rigid code of practice. While the use of irradiation involves certain essentialr
5、equirements to attain the objective of the treatment, some parameters can be varied in optimizing theprocess.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 andAgricultur
6、e Organization (FAO), the World Health Organization (WHO), and the InternationalAtomicEnergy Agency (IAEA).(1)21. Scope1.1 This guide outlines procedures for the irradiation offresh or frozen meat and poultry as defined by the CodexAlimentarius Commission (CAC), (CAC/RCP 11-1976 andCAC/RCP 14-1976).
7、 Codex defines meat as “the edible part ofany mammal slaughtered in an abattoir,” and poultry as“ theedible part of slaughtered domesticated birds, includingchicken, turkeys, ducks, geese, guinea-fowls, or pigeons.”NOTE 1Current U.S. regulations limit the definition of livestockspecies to cattle, sh
8、eep, swine, goat, horse, mule, or other equine andpoultry species to chicken, turkey, duck, goose, and guinea (2, 3).1.2 This guide covers absorbed doses used for inactivationof parasites and reduction of bacterial load. Such doses aretypically less than 10 kiloGray (kGy).1.3 This guide addresses ir
9、radiation 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.2. Referenced Documents2.1 ASTM Standards:E 170 Terminology Relating to Radiation Measurementsand Dosimetry3E 1204 Practice for Dosimetry i
10、n Gamma Irradiation Facili-ties for Food Processing3E 1261 Guide for the Selection and Calibration of Dosim-etry Systems for Radiation Processing3E 1431 Practice for Dosimetry in Electron and Bremsstrahl-ung Irradiation Facilities for Food Processing3E 1539 Guide for the Use of Radiation Sensitive I
11、ndicators3F 1416 Guide for the Selection of Time-Temperature Indi-cators4F 1640 Guide for Packaging Materials for Foods to BeIrradiated42.2 Codex Alimentarius Commission Recommended Inter-national Codes and Standards:5CAC/RCP 1-1969, Rev. 3, (Annex) Hazard Analysis andCritical Control Point (HACCP)
12、System and Guidelinesfor Its Application1This guide is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved May 10, 1999. Published July 1
13、999. Originallypublished F 1356 91. Last previous edition F 1356 93.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3Annual Book of ASTM Standards, Vol 12.02.4Annual Book of ASTM Standards, Vol 15.09.5Available from the Joint FAO/WHO Food Standards Progr
14、amme, Joint Office,FAO, Via delle Terme di Caracalla, 00100 Rome, Italy.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.CAC/RCP 11-1976 Recommended International Code ofHygienic Practice for Fresh MeatCAC/RCP 14-1976 Recommended Code
15、 of Hygienic Prac-tice for Poultry ProcessingCAC/Vol A Recommended International Code of Practice,General Principles of Food Hygiene, Edition 2STAN 1-1985 General Standard for the Labelling of Pre-packaged FoodsSTAN 106-1983 General Standard for Irradiated Food3. Terminology3.1 DefinitionsOther term
16、s used in this guide may bedefined in Terminology E 170.3.1.1 absorbed dose, nthe quantity of energy from ioniz-ing radiation imparted to a unit mass of a specified material(food). The special name for the unit of absorbed dose is theGray (Gy). One Gy is equal to one joule of absorbed energy perkilo
17、gram. Formerly, the unit of absorbed dose was the rad (1rad = 0.01 Gy).3.1.1.1 DiscussionA standard definition of absorbed doseappears in Terminology E 170.3.1.2 D10-value, nabsorbed dose required to reduce themicrobial population in a given food by 90 % (1 log10).3.1.3 dose distribution, nthe varia
18、tion in absorbed dosewithin a process load exposed to ionizing radiation.3.1.4 process load, na volume of material with a specifiedloading configuration irradiated as a single entity.3.1.5 transport system, nthe conveyor or other mechani-cal system used to move the process load through the irradiato
19、r.4. Significance and Use4.1 The principal purpose of irradiation is to control (reducethe number of) pathogenic bacteria in fresh or frozen red meatsand poultry to make these foods safer for human consumption.Irradiation significantly reduces the numbers of viable, vegeta-tive bacteria such as Camp
20、ylobacter, Escherichia coli, Listeria,or Salmonella.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 meatsand poultry by reducing the numbers of viable, vegetativespoilage bacteria, such as Pseudomon
21、as species.5. Pre-Irradiation Product Handling5.1 Product should be handled in an environment that doesnot increase the risk of contamination from physical, chemical,or biological hazards. Take measures at all times to minimizemicrobial contamination and growth by following relevantstandards of Good
22、 Manufacturing Practice (GMP); see forexample U.S. Food and Drug Administration (FDA) GMP (4),U.S. Food Safety and Inspection Service (FSIS) StandardSanitary Operating Procedures (SSOP) (5), and CAC Recom-mended International Codes of Practice, (CAC/RCP 11-1976,CAC/RCP 14-1976, and CAC/Vol A)(see 2.
23、2).5.2 Unpackaged ProductIn facilities handling unpack-aged product, the irradiation environment and equipmentshould be designed and constructed to be cleanable and durableto maintain a sanitary condition and, thereby, not increase therisk of contamination.NOTE 2An operating environment with high mo
24、isture or air flow maycontribute to the risk of bacterial contamination. Moisture provides agrowth medium for bacteria and air flow provides a means of transport forbacteria. Food contact surfaces may contribute chemical or physicalcontaminants to products unless such surfaces are fabricated fromapp
25、ropriate materials and properly maintained and cleaned. Also, em-ployee hygiene and pest control should be closely monitored.5.3 Pre-Packaged ProductFor pre-packaged product, thepackage itself provides a barrier that helps to reduce the risk ofrecontamination. Thus, many of the requirements for thei
26、rradiation environment and equipment may not be applicablefor facilities handling only pre-packaged product. Obtaininformation on applicable requirements from the appropriateregulatory authorities before starting operations.5.4 Pre-Irradiation InspectionInspect packages and con-tainers of red meat a
27、nd poultry upon receipt at the irradiationfacility to ensure that the product is suitable for irradiation. (see5.4.1, 5.4.2, and 5.4.3). Written acceptance criteria for inspec-tion frequency, product temperature and package integrity, asapplicable, should be established by the product owner andagree
28、d to by management of the irradiation facility prior toaccepting product from an owner. Also, disposition of productunsuitable for irradiation should be among the criteria estab-lished.5.4.1 Product TemperatureUsing a calibratedtemperature-sensing device, measure the temperature of theproduct upon r
29、eceipt. Temperature should be between 2 and+4C for fresh red meat or poultry or 18C or lower for frozenred meat or poultry. For unpackaged product, insert the devicedirectly into the product and sanitize the device between eachmeasurement. For prepackaged product, use a device that canbe placed betw
30、een individual packages without puncturingpackaging materials in direct contact with the product.5.4.2 Package IntegrityPerform a sensory inspection ofthe product. No leakage of fluids or odor indicative of productspoilage should be evident upon inspection.5.4.3 Count the number of containers to be
31、irradiated andcompare that count with documentation from the productowner. A comparison of this pre-irradiation count with a countperformed after irradiation provides a check that all productreceived has been irradiated.5.5 Pre-Irradiation Storage:5.5.1 For fresh meats and poultry, the principal req
32、uirementfor pre-irradiation storage is maintenance of the producttemperature between 2 and +4C without freezing.NOTE 3U.S. poultry regulations presently require a maximum tem-perature of 40F (4.4C) for fresh poultry.(6)5.5.2 A second requirement is that the pre-irradiation stor-age period at the irr
33、adiation facility be minimized, approxi-mately one day or less, whenever possible.5.5.3 For frozen meats and poultry, maintain the producttemperature at or below 18C at all times. The relatively shortduration of frozen storage prior to irradiation is not particularlycritical under normal commercial
34、conditions. However, freez-ing does not provide an unlimited product life without loss ofquality, and the pre-irradiation storage period should thereforebe minimized.5.6 Handling of red meats and poultry differently from theprocedures described in 5.5 violates the principles of GMP,F1356992which con
35、stitute the total of all measures taken to produce meatand poultry products containing as low a level of contaminantsas possible. Holding product under refrigeration for an undulylong time would violate these principles because such treat-ment may result in excessive bacterial growth and undesirable
36、changes in products. Radiation processing can neither reversethese undesirable changes nor replace GMP.5.7 Product SeparationIt may not be possible to distin-guish irradiated from unirradiated product by inspection. It istherefore important that appropriate means integral to thefacility design, such
37、 as physical barriers or clearly definedstaging areas, be used to maintain unirradiated product separatefrom irradiated product.6. Packaging6.1 Packaging meat or poultry products prior to irradiationreduces the risk of contaminating the product and the irradia-tion facility. Prepackaging may not be
38、necessary in the case ofirradiation for inactivation of parasites or if other controlprocedures (for example, aseptic processing) are in place tomaintain the intended effect of the treatment.6.2 If products are packaged, use materials suitable to theproduct considering any planned processing (includ
39、ing irradia-tion) and consistent with any regulatory requirements (seeGuide F 1640).6.2.1 Packaging materials should provide appropriate gasand moisture permeability to maintain product quality. (see7.6)6.2.2 For frozen red meats and poultry, the package shouldbe as free as possible of voids or open
40、 spaces. Such spaces cancause a form of desiccation known as “freezer burn.”6.3 To achieve a more uniform dose distribution within aprocess load, the product packages or containers should begeometrically well defined and uniform in shape and size. Withcertain irradiation facilities, it may be necess
41、ary to limit use toparticular package shapes and sizes based on the density of theproduct and validation testing at known product densities in theirradiation facility. See Practices E 1204 and E 1431.7. Irradiation7.1 Scheduled ProcessIrradiation of food should conformto a scheduled process. A sched
42、uled process for food irradia-tion is a written procedure that is used to ensure that theabsorbed dose range and irradiation conditions (for example,product temperature) are adequate under commercial process-ing conditions to achieve the intended effect on a specificproduct in a specific facility.Th
43、e procedure should also addressdisposition of improperly irradiated product and correctiveactions to be taken if the irradiation process is not adequatelycontrolled. The scheduled process should be established andvalidated by qualified persons having expert knowledge inirradiation requirements speci
44、fic for the food and the proces-sors irradiation facility. See, for example, FDAregulations (7).7.2 Radiation SourcesThe sources of ionizing radiationthat may be employed in irradiating meat and poultry productsare limited to the following (see CAC STAN 106-1983):7.2.1 Gamma rays from the radionucli
45、des60Co or137Cs,7.2.2 X-rays generated from machine sources operated at orbelow an energy level of 5 MeV, and7.2.3 Electrons generated from machine sources operated ator below an energy level of 10 MeV.NOTE 4The depth of penetration of electrons in a material isdependent on the energy of the electro
46、ns and the density of the material.7.3 Radiation Process Parameters:7.3.1 Absorbed DoseFood irradiation specifications fromthe owner of the product should include minimum and maxi-mum absorbed dose limits (see 7.4): a minimum necessary toensure the intended effect; and a maximum to prevent productde
47、gradation. One or both of these limits may be prescribed byregulation for a given application. See, for example, FDAregulations (8). It is necessary to configure irradiation param-eters to ensure that processing is carried out within these limits.Once this capability is established, it is necessary
48、to monitorand record absorbed dose values during routine processing (see11.2.2).7.3.1.1 Routine dosimetry is part of a verification processfor establishing that the irradiation process is under control.7.3.1.2 Select and calibrate a dosimetry system appropriateto the radiation source being used, the
49、 environmental condi-tions, and the range of absorbed doses required (see GuideE 1261).7.3.1.3 Verify that the product receives the required ab-sorbed dose by using proper dosimetric measurement proce-dures, along with appropriate statistical controls and documen-tation. Place dosimeters in or on the process load at locationsof maximum and minimum absorbed dose. If those locationsare not accessible, place dosimeters at reference locations thathave a known and quantifiable relationship to the maximumand minimum absorbed dose locations (see Practices E 120
