1、Designation: F1885 04 (Reapproved 2010)An American National StandardStandard Guide forIrradiation of Dried Spices, Herbs, and VegetableSeasonings to Control Pathogens and OtherMicroorganisms1This standard is issued under the fixed designation F1885; the number immediately following the designation i
2、ndicates the year 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 () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe purpose of this guide is to present
3、 information on 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 irradiati
4、on technology where 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 parame
5、ters can be varied 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 Divisio
6、n of Nuclear Techniques 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 availa
7、ble in whole, ground, 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
8、of 30 kGy. (See21CFR 179.26 Irradiation in the Production, Processing and Handling ofFood.)1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any, asso
9、ciated 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 limitations prior to use.2. Referenced Documents2.1 ISO/ASTM Standards3E170 Terminology Relating to Radiation Measurements an
10、dDosimetryISO/ASTM 51204 Practice for Dosimetry in Gamma Irra-diation Facilities for Food ProcessingE1261 Guide for the Selection and Calibration of DosimetrySystems for Radiation ProcessingISO/ASTM 51431 Practice for Dosimetry in Electron andX-ray (Bremsstrahlung) Irradiation Facilities for FoodPro
11、cessingE1539 Guide for Use of Radiation Sensitive IndicatorsF1640 Guide for Packaging Materials for Foods to beIrradiated2.2 Codex Alimentarius Commission (CAC) RecommendedInternational Codes and Standards:STAN 1-1985 General Standard for the Labeling of Pre-packaged Foods4STAN 106-1983 General Stan
12、dard for Irradiated Food41This 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 Dec. 1, 2010. Published January 2011. Origina
13、llyapproved in 1998. Last previous edition approved in 2004 as F188504. DOI:10.1520/F1885-04R10.2The boldface 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 a
14、stm.org. For Annual Book of ASTMStandardsvolume information, refer to the standards Document Summary page onthe 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,
15、PO Box C700, West Conshohocken, PA 19428-2959, United States.CAC/RCP19-1979 (Rev. 1) Recommended InternationalCode of Practice for the Operation of Irradiation Facilitiesfor the Treatment of Food42.3 U.S. Food and Drug Administration, Code of FederalRegulations:5CFR Title 21, Part 110 Current Good M
16、anufacturing Prac-tices in Manufacturing, Packaging, or Handling HumanFoodCFR Title 21, Section 179.25 General Provisions for FoodIrradiationCFR Title 21, Section 179.26 Irradiation in the Production,Processing and Handling of Food3. Terminology3.1 DefinitionsOther terms used in this guide may bedef
17、ined in Terminology .3.1.1 absorbed dosequantity of ionizing radiation im-parted per unit mass of a specified material. The SI unit ofabsorbed dose is 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 co
18、mmonly used definition of ab-sorbed dose appears in Terminology .3.1.2 absorbed dose mappingmeasurement of absorbeddose within a process load using dosimeters placed at specifiedlocations to produce a one, two, or three-dimensional distribu-tion of absorbed dose, thus rendering a map of absorbed dos
19、evalues.3.1.3 dose distributionthe variation in absorbed dosewithin a process load exposed to ionizing radiation.3.1.4 dosimetry systema system used for determiningabsorbed dose, consisting of dosimeters, measurement instru-ments and their associated reference standards, and proceduresfro the system
20、s use.3.1.5 Good manufacturing practice (GMP)procedure es-tablished and exercised throughout the production, manufac-turing processing, packing, and distribution of foods, encom-passing maintenance of sanitation system, quality control andassurance, qualification of personnel and other relevant acti
21、vi-ties, to ensure the delivery of commercially acceptable and safeproduct.3.1.6 process loadone or more containers of productcollectively transported through the irradiator as a whole, forexample, a box, tote, pallet, or carrier.3.1.7 spicesincludes dried spices, herbs, and vegetableseasonings.3.1.
22、8 transport systemthe conveyor or other mechanicalsystem used to move the process load through the irradiator.4. Significance and Use4.1 The purpose of irradiation to decontaminate spices, asreferred to in this guide, is to reduce the population ofpathogens, other bacteria, molds, and yeasts present
23、 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 Handling5.1 Upon receipt at the irradiation facility, inspect packagesand containers of spices according to relevant Good Manufac-turing Practices (GMPs) to ensur
24、e that their integrity has notbeen compromised. See for example 21 CFR 110.5.2 Irradiation can be applied to spices as they are preparedfor processing 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. T
25、here are nospecial requirements for handling of spices prior to irradiationexcept for providing control measures to prevent post-irradiation re-contamination in storage facilities and for assur-ing separation of irradiated and non-irradiated product.5.3.1 Product SeparationIt may not be possible to
26、distin-guish irradiated from non-irradiated product by inspection. It istherefore important that appropriate means, such as physicalbarriers, or clearly defined staging areas, be used to maintainnon-irradiated product separate from irradiated product.6. Packaging and Product Loading Configuration6.1
27、 Packaging Materials.6.1.1 Packaging spices prior to irradiation is one means ofpreventing post-irradiation contamination.6.1.2 Use packaging materials suitable to the product con-sidering any planned processing (including irradiation) andconsistent with any regulatory requirements (see Guide ).6.2
28、Product Loading Configuration.6.2.1 Irradiation will be facilitated if the product packagesare geometrically well defined and uniform. With certainirradiation facilities, it may be necessary to limit use toparticular package shapes and sizes based on the density of theproduct and validation testing
29、at known product densities in theirradiation facility (see and ).6.2.2 The size, shape, and loading configuration of a processload for spices to be irradiated should be determined primarilyby considering design parameters of the irradiation facility.Critical design parameters include the characteris
30、tics of prod-uct transport systems and of the radiation source as they relateto the dose distribution obtained within the process load. Thedesign parameters of the irradiation facility and product dosespecifications should be taken into account in determining thesize, shape and loading configuration
31、 of a process load (7.3).7. Irradiation7.1 Scheduled ProcessIrradiation of food should conformto a scheduled process. A scheduled 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
32、adequate under commercial processingconditions to achieve the intended effect on a specific productin a specific facility. The scheduled process should be estab-lished by qualified persons having expert knowledge in irra-diation requirements specific for the food and the processorsirradiation facili
33、ty (21 CFR 179.25).5Available from the U.S. Government Printing Office, Superintendent ofDocuments, Washington, DC 204029328.F1885 04 (2010)27.2 Radiation SourcesThe sources of ionizing radiationthat may be employed in irradiating spices are limited to thefollowing: (see Codex STAN 106)7.2.1 Isotopi
34、c Sourcesgamma rays fromradionuclides60Co (1.17 and 1.33 MeV) or137Cs (0.66 MeV);7.2.2 Machine SourcesX-rays and accelerated electrons,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 electron
35、s not to exceed 10 MeV.7.3 Absorbed Dose Food irradiation specifications fromthe owner of the spice should include minimum and maximumabsorbed 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 pre
36、scribed byregulation for a given application. See for example 21 CFR179.26. It is necessary to configure irradiation parameters toensure processing is carried out within these limits. Once thiscapability is established, it is necessary to monitor and recordabsorbed dose values during routine process
37、ing. (See 11.1.3.)7.3.1 Dosimetry SystemRoutine dosimetry is part of averification process for establishing that the irradiation processis under control. Select and calibrate a dosimetry systemappropriate for the radiaion source being used and the range ofabsorbed doses required (see Guide ).7.3.2 A
38、bsorbed-dose MappingVerify that the product re-ceives the required absorbed dose by using proper dosimetermeasurement procedures, with appropriate statistical controlsand documentation. Place dosimeters in or on the process loadat locations of maximum and minimum absorbed dose. If thoselocations are
39、 not accessible, place dosimeters at referencelocations that have been previously related to the maximumand minimum absorbed dose locations (see and .)NOTE 3Radiation sensitive indicators (RSIs), such as labels, papers,or inks that undergo a color change or become colored when exposed toirradiation
40、in the pertinent dose range are commercially available. Thepurpose of these indicators is to determine visually 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 pr
41、oper dosimetry (see Guide .)7.3.3 Absorbed Dose Required to Accomplish SpecificEffectThe minimum absorbed 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 responsibl
42、e for specifying foreach lot the absorbed dose required to reduce the microbialload to the acceptable 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
43、 dose range. (SeePractices and .) The absorbed dose range for a given spicedepends on the the type and number of microorganisms in theunprocessed spice, the radiation sensitivity of the microorgan-isms present, and the number of non-pathogenic microorgan-isms considered acceptable by the customer. S
44、ee Section 9.NOTE 4Spices contain microorganisms indigenous to the soil and tothe environment 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 o
45、rigin, climatic conditions, harvesting, processing (forexample, cleaning, drying), storage, 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 b
46、acteria can also be present. The most commonmolds are the Penicillium species, Rhizopus 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 ye
47、asts and molds.NOTE 5To achieve the minimum absorbed dose throughout theprocess load, portions 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
48、6 kGy. Vegetativebacteria are reduced or eliminated at a minimum dose rangingfrom 4 to 7 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
49、 product should beperformed to determine the effective minimum absorbed dose.The maximum 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 m
