ASTM F1885-2018 Standard Guide for Irradiation of Dried Spices Herbs and Vegetable Seasonings to Control Pathogens and Other Microorganisms.pdf

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1、Designation: F1885 18Standard 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 adoption or, in th

2、e 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 i

3、n treating driedspices, herbs, and vegetable seasonings to control pathogens and spoilage microorganisms. Informa-tion on handling these commodities before and after irradiation is also provided.This guide should be followed when using irradiation technology where approved by an appropriateregulator

4、y authority. It is not to be construed as a requirement for the use of irradiation, or as a rigidcode of practice. While the use of irradiation involves certain essential requirements to attain theobjectives of the treatment, some parameters can be varied in optimizing the process.This guide has bee

5、n 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 inFood and Agriculture, which serves as

6、 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, or otherfinely divided forms, or

7、 as blends. The blends may containsodium chloride and minor amounts of dry food materialsordinarily used in such blends.1.2 This guide covers gamma, electron beam, andX-radiation treatment. This guide also covers low energyelectron beam treatment where only part of the product isirradiated (that is,

8、 surface treatment).1.3 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.) EU regulations permit a maximum dose of 10 kGy. (SeeDirective 1999/3/EC.)1.4 The values stated in SI units are to be regarded asstand

9、ard. No other units of measurement are included in thisstandard.1.5 This document is one of a set of standards that providesrecommendations for properly implementing and utilizingradiation processing. It is intended to be read in conjunctionwith Practice ISO/ASTM 52628.1.6 This standard does not pur

10、port 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, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.7 This international standa

11、rd was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Ref

12、erenced Documents2.1 ASTM Standards:3E170 Terminology Relating to Radiation Measurements andDosimetry1This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.05 on FoodIrradiation.Current edition approved Nov. 1, 2018. Pu

13、blished December 2018. Originallyapproved in 1998. Last previous edition approved in 2010 as F1885 04 (2010).DOI: 10.1520/F1885-18.2The 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, orco

14、ntact Customer Service at service astm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standar

15、d was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1E3083 Te

16、rminology Relating to Radiation Processing: Do-simetry and ApplicationsF1640 Guide for Selection and Use of Contact Materials forFoods to Be Irradiated2.2 ISO/ASTM Standards:3ISO/ASTM 51261 Practice for Calibration of Routine Do-simetry Systems for Radiation ProcessingISO/ASTM 51539 Guide for Use of

17、 Radiation SensitiveIndicatorsISO/ASTM 51608 Practice for Dosimetry in an X-Ray(Bremsstrahlung) Facility for Radiation Processing atEnergies between 50 keV and 7.5 MeVISO/ASTM 51649 Practice for Dosimetry in an ElectronBeam Facility for Radiation Processing at Energies Be-tween 300 keV and 25 MeVISO

18、/ASTM 51702 Practice for Dosimetry in a GammaFacility for Radiation ProcessingISO/ASTM 51818 Practice for Dosimetry in an ElectronBeam Facility for Radiation Processing at Energies Be-tween 80 and 300 keVISO/ASTM 52303 Guide for Absorbed-Dose Mapping inRadiation Processing FacilitiesISO/ASTM 52628 P

19、ractice for Dosimetry in Radiation Pro-cessingISO/ASTM 52701 Guide for Performance Characterizationof Dosimeters and Dosimetry Systems for Use in Radia-tion Processing2.3 Codex Alimentarius Commission (CAC) RecommendedInternational Codes and Standards:4CAC/GL21-1997 Rev. 2013, Principles and Guideli

20、nes forthe Establishment and Application of MicrobiologicalCriteria related to FoodCAC/MISC 5-1993 Amd. 2003, Glossary of Terms andDefinitions (Veterinary Drug Residues in Food)CAC/RCP 1-1969 Rev. 2003, Recommended InternationalCode of PracticeGeneral Principles of Food HygieneCAC/RCP 19-1979 Rev. 2

21、003, Recommended InternationalCode of Practice for the Radiation Processing of FoodCX/STAN 1-1985 Rev. 2010, General Standard for theLabeling of Prepackaged FoodsCX/STAN 106-1983 Rev. 2003, General Standard for Irra-diated Food2.4 U.S. Food and Drug Administration, Code of FederalRegulations:5CFR Ti

22、tle 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, Section 179.26 Irradiation in the Production,Processing and Handling of Food2.5 ISO Standard:6ISO 14470-2011 Food

23、Irradiation Requirements for theDevelopment, Validation and Routine Control of theProcess of Irradiation using Ionizing Radiation for theTreatment of Food2.6 The European Parliament and the Council of the Euro-pean Union:7Directive 1999/3/EC Implementing EU List of IrradiatedFood and Food Ingredient

24、s3. Terminology3.1 Definitions:3.1.1 Other terms used in this guide may be defined inTerminology E170 and Terminology E3083.3.1.2 absorbed dose, nquotient of d by dm, where d isthe mean energy imparted by ionizing radiation to matter ofmass dm, thusD 5 ddm3.1.2.1 DiscussionThe SI unit of absorbed do

25、se is the gray(Gy), where one gray is equivalent to the absorption of onejoule per kilogram of the specified material (1 Gy=1J/kg).3.1.3 absorbed dose mapping, nmeasurement of absorbeddose within an irradiated product to produce a one-, two-, orthree-dimensional distribution of absorbed dose, thus r

26、enderinga map of absorbed dose values.3.1.4 dose distribution, nvariation in absorbed dosewithin a process load exposed to ionizing radiation.3.1.5 dosimetry system, ninterrelated elements used formeasuring absorbed dose, consisting of dosimeters, measure-ment instruments and their associated refere

27、nce standards, andprocedures for the systems use.3.1.6 Good Manufacturing Practice, GMP, nprocedureestablished and exercised throughout the production, manufac-turing processing, packing, and distribution of foods, encom-passing maintenance of sanitation system, quality control andassurance, qualifi

28、cation of personnel and other relevantactivities, to ensure the delivery of commercially acceptableand safe product.3.1.7 process load, nvolume of material with a specifiedproduct loading configuration irradiated as a single entity.3.1.8 spices, ndried spices, herbs, and vegetable season-ings.3.1.9

29、transport system, nconveyor or other mechanicalsystem used to move the process load through the irradiator.4. Significance and Use4.1 The purpose of irradiation of dried spices, herbs, andvegetable seasonings is to control pathogenic bacteria, molds,and yeasts present in these commodities (2-7).4Ava

30、ilable from the Joint FAO/WHO Food Standards Programme, Joint Office,FAO, Via delle Terme di Caracalla, 00100, Rome, Italy.5Available from the U.S. Government Printing Office, Superintendent ofDocuments, Washington, DC 204029328.6Available from International Organization for Standardization (ISO), I

31、SOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.7Available from the Publications Office of the European Union, 2, rue Mercier,2985 Luxembourg, Luxembourg, https:/publications.europa.eu/en/home.F1885 1824.2 The process will also kill

32、 any insects present, at allstages of development.NOTE 2CAC/RCP 19-1979 of the Codex Alimentarius identifies theessential practices to be implemented to achieve effective radiationprocessing of food, in general, in a manner that maintains quality andyields food commodities that are safe and suitable

33、 for consumption.5. Pre-Irradiation Product Handling5.1 Upon receipt at the irradiation facility, inspect packagesand containers of the commodities according to relevant GoodManufacturing Practices (GMPs) to ensure that their integrityhas not been compromised. See for example 21 CFR 110.5.2 Radiatio

34、n can be applied to these commodities in bulk,in-line prior to packaging, or in commercial packages.5.3 Handling of the commodities in an irradiation facilityshould be in accordance with relevant and current GMPs.There are no special requirements for handling of the com-modities prior to irradiation

35、 except for providing controlmeasures to prevent post-irradiation re-contamination in stor-age facilities and for assuring separation of irradiated andnon-irradiated product.5.3.1 Product SeparationIt may not be possible to distin-guish irradiated from non-irradiated product by inspection. It isther

36、efore important that appropriate means, such as physicalbarriers, or clearly defined areas, be used to maintain non-irradiated product separate from irradiated product.6. Packaging and Product Loading Configuration6.1 Packaging:6.1.1 Packaging commodities prior to irradiation is onemeans of preventi

37、ng 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 GuideF1640).6.2 Product Loading Configuration:6.2.1 The size, shape, and loading configuration of a

38、processload for the commodities to be irradiated should be determinedprimarily by considering design parameters of the irradiationfacility (see Practices ISO/ASTM 51608, ISO/ASTM 51649,ISO/ASTM 51702, and ISO/ASTM 51818). Critical irradiationparameters include the characteristics of product transpor

39、tsystems and of the radiation source as they relate to the dosedistribution obtained within the process load. These parametersand product dose specifications should be taken into account indetermining the size, shape, and loading configuration of aprocess load (7.3).7. Irradiation7.1 Standard Operat

40、ing Procedures (SOPs)Standard op-erating procedures for food irradiation are documented proce-dures that are used to ensure that the technologically estab-lished dose range and irradiation conditions selected by theradiation processor are achievable in a specific facility. Theprocedures should be es

41、tablished by qualified persons havingknowledge in irradiation requirements specific to the food andthe irradiation facility (21 CFR 179.25).7.1.1 Installation qualification, operational qualification,performance qualification and process control should be per-formed following the requirements of Pra

42、ctices ISO/ASTM51702, ISO/ASTM 51608, ISO/ASTM 51649,orISO/ASTM51818.7.2 Radiation SourcesThe sources of ionizing radiationthat may be employed in irradiating these commodities arelimited to the following (see CX/STAN 106-1983):7.2.1 Isotopic SourcesGamma rays from radionuclides60Co (1.17 and 1.33 M

43、eV) or137Cs (0.66 MeV) (see PracticeISO/ASTM 51702);7.2.2 Machine SourcesX-rays and accelerated electrons,(see Practices ISO/ASTM 51608, ISO/ASTM 51649, andISO/ASTM 51818).NOTE 3The Codex Alimentarius Commission, as well as regulationsin some countries, currently limits the maximum electron and X-ra

44、yenergies for the purpose of food irradiation (CX/STAN 106-1983).7.3 Absorbed DoseIrradiation specifications from the pro-cessor of the commodities should include minimum andmaximum absorbed dose limits and the volume of interestwhere these limits should be regarded (see 7.3.3): the lowestdose neces

45、sary to ensure the intended effect (for example,microbial load reduction, pathogen inactivation), and a highestdose that does not negatively affect the product quality toprevent product degradation. One or both of these limits maybe prescribed by government authorities for a given applica-tion. See

46、for example 21 CFR 179.26. It is necessary toconfigure irradiation parameters to ensure processing is carriedout within these limits in the volume of interest. Once thiscapability is established, it is necessary to monitor and recordabsorbed dose values during routine processing. (See 11.1.3.)NOTE 4

47、The minimum dose absorbed by a certain part of productvolume might be zero for some applications where a targeted location ofproduct needs to be treated. The volume of interest might be a thinexternal layer of the product if it has been demonstrated that microorgan-ism control is satisfactory.7.3.1

48、DosimetryDosimetry is a major component of atotal quality assurance program for adherence to good manu-facturing practices used in radiation processing of food. CX/STAN 106-1983 and CAC/RCP 1-1969 strongly emphasize therole of dosimetry for ensuring that irradiation is properlyperformed, since dosim

49、etry is part of a verification process forestablishing that the irradiation process is under control.7.3.2 Dosimetry SystemDosimetry used in thedevelopment, validation, and routine control of the irradiationprocess shall have measurement traceability to national orinternational standards and shall have a known level ofuncertainty. The selected dosimetry system should be appro-priate for the radiation source being used, the range ofabsorbed doses required, and the environmental conditions(e.g., product temperature, irradiation temperature) expected