1、Designation: F 1885 04An American National StandardStandard Guide forIrradiation of Dried Spices, Herbs, and VegetableSeasonings to Control Pathogens and OtherMicroorganisms1This standard is issued under the fixed designation F 1885; the number immediately following the designation indicates the yea
2、r oforiginal 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
3、 the use of ionizing energy (radiation) intreating dried spices, herbs, and vegetable seasonings to reduce pathogens and spoilage microorgan-isms. Information on handling these commodities before and after irradiation is also provided.This guide should be followed when using irradiation technology w
4、here approved by an appropriateregulatory control authority. It is not to be construed as a requirement for the use of irradiation, or asa rigid code of practice. While the use of irradiation involves certain essential requirements to attainthe objectives of the treatment, some parameters can be var
5、ied in optimizing 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 Joint Food andAgriculture Organization/International Atomic Energy Agency Division of Nuclear Te
6、chniques inFood and Agriculture, which serves as the Secretariat to ICGFI (1).21. Scope1.1 This guide covers procedures for irradiation of driedspices, herbs, and vegetable seasonings for microbiologicalcontrol. Generally, these items have moisture content of 4.5 to12 % and are available in whole, g
7、round, chopped, or otherfinely divided forms, or as blends. The blends may containsodium chloride and minor amounts of dry food materialsordinarily used in such blends.1.2 This guide covers absorbed doses ranging from 3 to 30kiloGray (kGy).NOTE 1U.S. regulations permit a maximum dose of 30 kGy. (See
8、21CFR 179.26 Irradiation in the Production, Processing and Handling ofFood.)1.3 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 determi
9、ne the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ISO/ASTM Standards3E 170 Terminology Relating to Radiation Measurementsand DosimetryISO/ASTM 51204 Practice for Dosimetry in Gamma Irra-diation Facilities for Food ProcessingE 1261 Guide for the Selection and Cal
10、ibration of Dosim-etry Systems for Radiation ProcessingISO/ASTM 51431 Practice for Dosimetry in Electron andX-ray (Bremsstrahlung) Irradiation Facilities for FoodProcessingE 1539 Guide for Use of Radiation Sensitive IndicatorsF 1640 Guide for Packaging Materials for Foods to beIrradiated2.2 Codex Al
11、imentarius Commission (CAC) RecommendedInternational Codes and Standards:STAN 1-1985 General Standard for the Labeling of Pre-packaged Foods4STAN 106-1983 General Standard for Irradiated Food4CAC/RCP19-1979 (Rev. 1) Recommended International1This guide is under the jurisdiction of ASTM Committee E10
12、 on NuclearTechnology and Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved Jan. 1, 2004. Published February 2004. Originallyapproved in 1998. Last previous edition approved in 1998 as F 188598.2The boldfa
13、ce numbers given in parentheses refer to a list of references at theend of the text.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact Customer Service at service astm.org. For Annual Book of ASTMStandardsvolume information, refer to the standards Document Summary page o
14、nthe ASTM website.4Available from Joint FAO/WHO Food Standards Program, 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.Code of Practice for the Operation of Irradiat
15、ion Facilitiesfor the Treatment of Food42.3 U.S. Food and Drug Administration, Code of FederalRegulations:5CFR Title 21, Part 110 Current Good Manufacturing Prac-tices in Manufacturing, Packaging, or Handling HumanFoodCFR Title 21, Section 179.25 General Provisions for FoodIrradiationCFR Title 21, S
16、ection 179.26 Irradiation in the Production,Processing and Handling of Food3. Terminology3.1 DefinitionsOther terms used in this guide may bedefined in Terminology E 170.3.1.1 absorbed dosequantity of ionizing radiation im-parted per unit mass of a specified material. The SI unit ofabsorbed dose is
17、the gray (Gy), where one Gray is equivalentto the absorption of one joule per kilogram of the specifiedmaterial (iGy = I J/kg).3.1.1.1 DiscussionA commonly used definition of ab-sorbed dose appears in Terminology E 170.3.1.2 absorbed dose mappingmeasurement of absorbeddose within a process load usin
18、g dosimeters placed at specifiedlocations to produce a one, two, or three-dimensional distribu-tion of absorbed dose, thus rendering a map of absorbed dosevalues.3.1.3 dose distributionthe variation in absorbed dosewithin a process load exposed to ionizing radiation.3.1.4 dosimetry systema system us
19、ed for determiningabsorbed dose, consisting of dosimeters, measurement instru-ments and their associated reference standards, and proceduresfro the systems use.3.1.5 Good manufacturing practice (GMP)procedure es-tablished and exercised throughout the production, manufac-turing processing, packing, a
20、nd distribution of foods, encom-passing maintenance of sanitation system, quality control andassurance, qualification of personnel and other relevant activi-ties, to ensure the delivery of commercially acceptable and safeproduct.3.1.6 process loadone or more containers of productcollectively transpo
21、rted through the irradiator as a whole, forexample, a box, tote, pallet, or carrier.3.1.7 spicesincludes dried spices, herbs, and vegetableseasonings.3.1.8 transport systemthe conveyor or other mechanicalsystem used to move the process load through the irradiator.4. Significance and Use4.1 The purpo
22、se of irradiation to decontaminate spices, asreferred to in this guide, is to reduce the population ofpathogens, other bacteria, molds, and yeasts present in theproducts (2,3,4,5,6, 7).4.2 The process will also kill any insects present, at allstages of development.5. Pre-Irradiation Product Handling
23、5.1 Upon receipt at the irradiation facility, inspect packagesand containers of spices according to relevant Good Manufac-turing Practices (GMPs) to ensure that their integrity has notbeen compromised. See for example 21 CFR 110.5.2 Irradiation can be applied to spices as they are preparedfor proces
24、sing in-line, in bulk or in commercial packages.5.3 Handling of spices in an irradiation facility should be inaccordance with relevant and current GMPs. There are nospecial requirements for handling of spices prior to irradiationexcept for providing control measures to prevent post-irradiation re-co
25、ntamination in storage facilities and for assur-ing separation of irradiated and non-irradiated product.5.3.1 Product SeparationIt may not be possible to distin-guish irradiated from non-irradiated product by inspection. It istherefore important that appropriate means, such as physicalbarriers, or c
26、learly defined staging areas, be used to maintainnon-irradiated product separate from irradiated product.6. Packaging and Product Loading Configuration6.1 Packaging Materials.6.1.1 Packaging spices prior to irradiation is one means ofpreventing post-irradiation contamination.6.1.2 Use packaging mate
27、rials suitable to the product con-sidering any planned processing (including irradiation) andconsistent with any regulatory requirements (see GuideF 1640).6.2 Product Loading Configuration.6.2.1 Irradiation will be facilitated if the product packagesare geometrically well defined and uniform. With c
28、ertainirradiation facilities, it may be necessary 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 ISO/ASTM 51204 and 51431).6.2.2 The size, shape, and loading configuration of a pr
29、ocessload for spices to be irradiated should be determined primarilyby considering design parameters of the irradiation facility.Critical design parameters include the characteristics of prod-uct transport systems and of the radiation source as they relateto the dose distribution obtained within the
30、 process load. Thedesign parameters of the irradiation facility and product dosespecifications should be taken into account in determining thesize, shape and loading configuration of a process load (7.3).7. Irradiation7.1 Scheduled ProcessIrradiation of food should conformto a scheduled process. A s
31、cheduled process for food irradia-tion is a written procedure that is used to ensure that theabsorbed dose range and irradiation conditions selected by theradiation processor are adequate under commercial processingconditions to achieve the intended effect on a specific productin a specific facility
32、. The scheduled process should be estab-lished by qualified persons having expert knowledge in irra-diation requirements specific for the food and the processorsirradiation facility (21 CFR 179.25).7.2 Radiation SourcesThe sources of ionizing radiationthat may be employed in irradiating spices are l
33、imited to thefollowing: (see Codex STAN 106)5Available from the U.S. Government Printing Office, Superintendent ofDocuments, Washington, DC 204029328.F18850427.2.1 Isotopic Sourcesgamma rays fromradionuclides60Co (1.17 and 1.33 MeV) or137Cs (0.66 MeV);7.2.2 Machine SourcesX-rays and accelerated elec
34、trons,NOTE 2The USA, other governments, and the Codex AlimentriusCommission currently limit the use of x-rays with energies not to exceed5 MeV and the energies of electrons not to exceed 10 MeV.7.3 Absorbed Dose Food irradiation specifications fromthe owner of the spice should include minimum and ma
35、ximumabsorbed dose limits (see 7.3.3): a minimum necessary toensure the intended effect and a maximum to prevent productdegradation. One or both of these limits may be prescribed byregulation for a given application. See for example 21 CFR179.26. It is necessary to configure irradiation parameters t
36、oensure processing is carried out within these limits. Once thiscapability is established, it is necessary to monitor and recordabsorbed dose values during routine processing. (See 11.1.3.)7.3.1 Dosimetry SystemRoutine dosimetry is part of averification process for establishing that the irradiation
37、processis under control. Select and calibrate a dosimetry systemappropriate for the radiaion source being used and the range ofabsorbed doses required (see Guide E 1261).7.3.2 Absorbed-dose MappingVerify that the product re-ceives the required absorbed dose by using proper dosimetermeasurement proce
38、dures, with appropriate statistical controlsand documentation. Place dosimeters in or on the process loadat locations of maximum and minimum absorbed dose. If thoselocations are not accessible, place dosimeters at referencelocations that have been previously related to the maximumand minimum absorbe
39、d dose locations (see ISO/ASTM 51204and 51431.)NOTE 3Radiation sensitive indicators (RSIs), such as labels, papers,or inks that undergo a color change or become colored when exposed toirradiation in the pertinent dose range are commercially available. Thepurpose of these indicators is to determine v
40、isually whether or not aproduct has been irradiated, rather than to measure the absorbed dosereceived by the product. These indicators are not dosimeters and must notbe used as a substitute for proper dosimetry (see Guide E 1539.)7.3.3 Absorbed Dose Required to Accomplish SpecificEffectThe minimum a
41、bsorbed dose that has been shown toachieve the intended objective of the treatment should be used.Each lot of spices may differ in microbial load from all otherlots. The owner of the spice is responsible for specifying foreach lot the absorbed dose required to reduce the microbialload to the accepta
42、ble quality level. Historical information onpreviously processed lots may be useful for determining theappropriate dose (see Table 1.) The irradiation facility isresponsible for delivering the specified dose range. (SeePractices E 1204 and E 1431.) The absorbed dose range for agiven spice depends on
43、 the the type and number of microor-ganisms in the unprocessed spice, the radiation sensitivity ofthe microorganisms present, and the number of non-pathogenicmicroorganisms considered acceptable by the customer. SeeSection 9.NOTE 4Spices contain microorganisms indigenous to the soil and tothe enviro
44、nment in which they are grown, and which survive the dryingprocess. Generally, the numbers and types of microorganisms, mostcommonly bacteria, yeasts, and molds, vary with the particular material,its geographic origin, climatic conditions, harvesting, processing (forexample, cleaning, drying), stora
45、ge, transportation, and packaging. Themost common bacteria in spices are the spore-formers such as the BacillusSpecies and Clostridia. Vegetative bacteria such as salmonellae, Escheri-chia coli, and lactic acid bacteria can also be present. The most commonmolds are the Penicillium species, Rhizopus
46、and some of the Aspergillusgroup. While it is theoretically possible to have only yeasts and moldspresent in a product, generally spices contain a broad spectrum ofmicroorganisms, including bacteria as well as yeasts and molds.NOTE 5To achieve the minimum absorbed dose throughout theprocess load, po
47、rtions of the load will receive higher doses. The highestdose must be kept below the specified maximum absorbed dose.7.3.3.1 Generally, yeasts and molds are controlled at aminimum absorbed dose ranging from 3 to 6 kGy. Vegetativebacteria are reduced or eliminated at a minimum dose rangingfrom 4 to 7
48、 kGy, and spore forming bacteria are reduced toacceptable levels at a minimum 8 to 15 kGy dose range. Table1 lists suggested minimum dose ranges for selected spices andherbs. Microbiological analysis of untreated product should beperformed to determine the effective minimum absorbed dose.The maximum
49、 absorbed dose permitted to be used to reducebacteria, yeasts, and molds may be specified by nationalregulatory authorities.7.3.3.2 In general, dehydrated products show few qualitychanges from maximum absorbed doses up to 30 kGy. Theremay be some discoloration in vegetable seasonings such asonion powder and minor losses of volatiles for some otherspices. These products are very stable under a wide range ofradiation doses.7.3.3.3 Absorbed doses effective for control of microorgan-isms are greater than those needed for insects. Therefore, theirradiation of spi
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