ANSI ASTM F1885-2004 Standard Guide for Irradiation of Dried Spices Herbs and Vegetable Seasonings to Control Pathogens and Other Microorganisms.pdf

1、Designation: F1885 04 (Reapproved 2010)Standard 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 indicates the year oforiginal

2、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 information on the use of io

3、nizing 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 where approved

4、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 varied in optimiz

5、ing 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 Techniques inFoo

6、d 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, ground, chopped

7、, 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. (See21CFR 179.26 I

8、rradiation 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, associated with its use. It is th

9、eresponsibility 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 ASTM Standards3E170 Terminology Relating to Radiation Measurements andDosimetryF1640 Guide for Selecti

10、on and Use of Packaging Materialsfor Foods to Be Irradiated2.2 ISO/ASTM Standards:3ISO/ASTM 51204 Practice for Dosimetry in Gamma Irra-diation Facilities for Food ProcessingISO/ASTM 51261 Guide for the Selection and Calibrationof Dosimetry Systems for Radiation ProcessingISO/ASTM 51431 Practice for

11、Dosimetry in Electron andX-ray (Bremsstrahlung) Irradiation Facilities for FoodProcessingISO/ASTM 51539 Guide for Use of Radiation SensitiveIndicators1This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.05 on FoodIrra

12、diation.Current edition approved Dec. 1, 2010. Published January 2011. Originallyapproved 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,

13、 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 onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-295

14、9. United States12.3 Codex Alimentarius Commission (CAC) RecommendedInternational Codes and Standards:STAN 1-1985 General Standard for the Labeling of Prepack-aged Foods4STAN 106-1983 General Standard for Irradiated Food4CAC/RCP19-1979 (Rev. 1) Recommended InternationalCode of Practice for the Opera

15、tion of Irradiation Facilitiesfor the Treatment of Food42.4 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 FoodIrradiatio

16、nCFR Title 21, Section 179.26 Irradiation in the Production,Processing and Handling of Food3. Terminology3.1 Definitions:3.1.1 Other terms used in this guide may be defined inTerminology E170.3.1.2 absorbed dosequantity of ionizing radiation im-parted per unit mass of a specified material. The SI un

17、it 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).3.1.2.1 DiscussionA commonly used definition of ab-sorbed dose appears in Terminology E170.3.1.3 absorbed dose mappingmeasurement of absorbeddose withi

18、n 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 dosevalues.3.1.4 dose distributionthe variation in absorbed dosewithin a process load exposed to ionizing radiation.3.1.5 dosime

19、try systema system used for determiningabsorbed dose, consisting of dosimeters, measurement instru-ments and their associated reference standards, and proceduresfro the systems use.3.1.6 Good manufacturing practice (GMP)procedure es-tablished and exercised throughout the production, manufac-turing p

20、rocessing, packing, and distribution of foods, encom-passing maintenance of sanitation system, quality control andassurance, qualification of personnel and other relevantactivities, to ensure the delivery of commercially acceptableand safe product.3.1.7 process loadone or more containers of productc

21、ollectively transported through the irradiator as a whole, forexample, a box, tote, pallet, or carrier.3.1.8 spicesincludes dried spices, herbs, and vegetableseasonings.3.1.9 transport systemthe conveyor or other mechanicalsystem used to move the process load through the irradiator.4. Significance a

22、nd 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 in theproducts (2,3,4,5,6, 7).4.2 The process will also kill any insects present, at allstages of development.5. Pre-Irradiati

23、on Product Handling5.1 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

24、 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. There are nospecial requirements for handling of spices prior to irradiationexcept for providing control measures to prevent pos

25、t-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 distin-guish irradiated from non-irradiated product by inspection. It istherefore important that appropriate means, such as phy

26、sicalbarriers, or clearly 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

27、 Use packaging materials suitable to the product con-sidering any planned processing (including irradiation) andconsistent with any regulatory requirements (see GuideF1640).6.2 Product Loading Configuration.6.2.1 Irradiation will be facilitated if the product packagesare geometrically well defined a

28、nd 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 at known product densities in theirradiation facility (see ISO/ASTM 51204 and ISO/ASTM51431).6.2.2 The size, shape, and loa

29、ding 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 characteristics of prod-uct transport systems and of the radiation source as they relateto the dose distri

30、bution 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 of a process load (7.3).4Available from Joint FAO/WHO Food Standards Program, Joint Office, FA

31、O,Via delle Terme di Caracalla, 00100, Rome, Italy.5Available from the U.S. Government Printing Office, Superintendent ofDocuments, Washington, DC 204029328.F1885 04 (2010)27. Irradiation7.1 Scheduled ProcessIrradiation of food should conformto a scheduled process. A scheduled process for food irrad

32、ia-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. The scheduled process should

33、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 limited to thefollowing: (see Co

34、dex STAN 106)7.2.1 Isotopic Sourcesgamma rays from radionuclides60Co (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 a

35、nd 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 maximumabsorbed dose limits (see 7.3.3): a minimum necessary toensure the intended effect and a maximum to prevent productdegradation. One or both

36、 of these limits may be prescribed 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 va

37、lues during routine processing. (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 re

38、quired (see ISO/ASTM 51261).7.3.2 Absorbed-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 a

39、bsorbed dose. If thoselocations are not accessible, place dosimeters at referencelocations that have been previously related to the maximumand minimum absorbed dose locations (see ISO/ASTM 51204and ISO/ASTM 51431.)NOTE 3Radiation sensitive indicators (RSIs), such as labels, papers,or inks that under

40、go a color change or become colored when exposed toirradiation 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 indicator

41、s are not dosimeters and must notbe used as a substitute for proper dosimetry (see Guide ISO/ASTM51539.)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 diffe

42、r 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 acceptable quality level. Historical information onpreviously processed lots may be useful for determining theappropriate dose (see T

43、able 1.) The irradiation facility isresponsible for delivering the specified dose range. (SeePractices ISO/ASTM 51204 and ISO/ASTM 51431.) Theabsorbed dose range for a given spice depends on the the typeand number of microorganisms in the unprocessed spice, theradiation sensitivity of the microorgan

44、isms present, and thenumber of non-pathogenic microorganisms considered accept-able by the customer. See 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 microo

45、rganisms, mostcommonly bacteria, yeasts, and molds, vary with the particular material,its geographic origin, climatic conditions, harvesting, processing (forexample, cleaning, drying), storage, transportation, and packaging. Themost common bacteria in spices are the spore-formers such as the Bacillu

46、sSpecies 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 and some of the Aspergillusgroup. While it is theoretically possible to have only yeasts and moldspresent in a

47、 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, portions of the load will receive higher doses. The highestdose must be kept below the specified maximum absorbe

48、d 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 kGy, and spore forming bacteria are reduced toacceptable levels at a minimum 8 to 15 kGy dose range. Table1 l

49、ists suggested minimum dose ranges for selected spices andherbs. Microbiological analysis of untreated 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 asTABLE 1 Suggested Minimum DosesAof Irradiation for SelectedSpices, Herbs and Vege