1、Designation: F 1736 03An American National StandardStandard Guide forIrradiation of Finfish and Aquatic Invertebrates Used asFood to Control Pathogens and Spoilage Microorganisms1This standard is issued under the fixed designation F 1736; the number immediately following the designation indicates th
2、e 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 (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe purpose of this guide is to present informati
3、on on the use of ionizing radiation for eliminatingor reducing the number of pathogenic microorganisms and parasites and for reducing the number ofspoilage microorganisms on finfish and aquatic invertebrates. Information on the handling of finfishand aquatic invertebrates before receipt by the irrad
4、iation facility and after shipment from the facilityis also provided.This guide is intended to serve as a set of recommendations to be followed when using irradiationtechnology where approved by an appropriate regulatory control authority. It is not to be construed assetting forth rigid requirements
5、 for the use of irradiation. While the use of irradiation involves certainessential requirements to attain the objective of the treatment, some parameters can be varied inoptimizing the process.This guide is based on a guideline published by the International Consultative Group on FoodIrradiation (I
6、CGFI) at the initiation of the Joint Food and Agriculture Organization/InternationalAtomic Energy Agency Division of Nuclear Techniques in Food and Agriculture, which serves as theSecretariat to the ICGFI.1. Scope1.1 This guide outlines procedures and operations for theirradiation of raw, untreated,
7、 fresh (chilled), or frozen finfishand aquatic invertebrates, while ensuring that the irradiatedproduct is safe and wholesome.1.1.1 Aquatic Invertebrates include molluscs, crustacea,echinoderms, etc.1.1.1.1 Molluscs include bivalve shellfish, such as clams,mussels, and oysters; snails; and cephalopo
8、ds, such as squidand octopus.1.1.1.2 Crustacea include shellfish such as shrimp, lobster,crabs, prawns and crayfish.1.1.1.3 Echinoderms include sea urchins and sea cucum-bers.1.2 This guide covers absorbed doses used to reduce themicrobial and parasite populations in aquatic invertebrates andfinfish
9、. Such doses typically are below 10 kGy (1).21.3 The use of reduced-oxygen packaging (vacuum ormodified atmosphere, and including products packed in oil)with irradiated, raw product is not covered by this guide. Theanaerobic environment created by reduced-oxygen packagingprovides the potential for o
10、utgrowth of, and toxin productionfrom, Clostridium botulinum spores.1.4 This guide does not cover the irradiation of smoked ordried fish to reduce microbial load or to control insectinfestation.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use.
11、It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2. Referenced Documents2.1 ASTM Standards:3E 170 Terminologies Relating to Radiation Measurementsand DosimetryF 1416 Gui
12、de for the Selection of Time-Temperature Indi-catorsF 1640 Guide for Selection and Use of Packaging Materialsfor Foods to be Irradiated1This guide is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation
13、 Processing: Dosimetry and Applications.Current edition approved July 10, 2003. Published November 2003. Originallyapproved in 1996. Last previous edition approved in 1996 as F 1736 96.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced AST
14、M standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshoho
15、cken, PA 19428-2959, United States.2.2 ISO/ASTM Standards:351204 Practice for Dosimetry in Gamma Irradiation Facili-ties for Food Processing51261 Guide for the Selection and Application of Dosim-etry Systems for Radiation Processing51431 Practice for Dosimetry in Electron and Bremsstrahl-ung Irradia
16、tion Facilities for Food Processing51539 Guide for Use of Radiation-Sensitive Indicators2.3 Codex Alimentarius Commission Recommended Inter-national Codes and Standards:4Codex Stan 1 General Standards for the Labelling ofPrepackaged FoodsCodex Stan 19 Recommended International Code of Prac-tice for
17、the Operation of Irradiation Facilities for theTreatment of FoodCodex Stan 106 Codex General Standard for IrradiatedFoodsCAC/RCP 9 Recommended International Code of Practicefor Fresh FishCAC/RCP 16 Recommended International Code of Practicefor Frozen FishCAC/RCP 17 Recommended International Code of
18、Prac-tice for Shrimps and PrawnsCAC/RCP 18 Recommended International Code of Hy-gienic Practice for Molluscan ShellfishCAC/RCP 24 Recommended International Code of Practicefor LobstersCAC/RCP 27 Recommended International Code of Prac-tice for Minced Fish Prepared by Mechanical SeparationCAC/RCP 28 R
19、ecommended International Code of Practicefor CrabsCAC/RCP 37 Recommended International Code of Prac-tice for CephalopodsCAC/RCP 20 Code of Ethics for International Trade inFoodCAC/RCP 42 Sampling Plans for Prepackaged Foods(AQL 6.5)3. Terminology3.1 DefinitionsOther terms used in this guide may bede
20、fined in Terminology E 170.3.1.1 absorbed dosethe quantity of energy from ionizingradiation absorbed per unit mass of specified material. The SIunit for absorbed dose is the gray (Gy). One gray is equal toone joule of absorbed energy per kilogram of specified mate-rial. Formerly, the unit of absorbe
21、d dose was the rad (1 rad =0.01 Gy).3.1.1.1 DiscussionA standard definition of absorbed doseappears in Terminology E 170.3.1.2 dose distributionthe variation in absorbed dosewithin a product unit exposed to ionizing radiation.3.1.3 product unitone or more containers of productcollectively transporte
22、d through the irradiator as a whole, forexample, a box, tote, pallet, or carrier.3.1.4 transport systemthe conveyor or other mechanicalsystem used to move the product to be irradiated through theirradiator.4. Significance and Use4.1 Absorbed doses of or below 1 kGy can inactivate someparasites, such
23、 as the broad fish tapeworm (Dibothrocephaluslatus) (2).4.2 Absorbed doses below 10 kGy can reduce or eliminatevegetative cells of pathogenic sporeforming and non-sporeforming microorganisms, such as Clostridia spp., Vibriospp., Salmonellae, Listeria monocytogenes,orStaphylococcusaureus, that may be
24、 present in fresh or frozen product.4.2.1 Absorbed doses below 10 kGy can reduce the numbersof some spores, but are not adequate to reduce the potentialhealth risk from microbial spores or toxins (3).4.3 Absorbed doses below 10 kGy can reduce or eliminatethe vegetative cells of sporeforming and non-
25、sporeformingmicroorganisms, such as Bacillus or Pseudomonas species, thatcause spoilage of fresh product, thus extending refrigeratedshelf life in many cases (4).5. Harvest/Raw Material5.1 Follow relevant Recommended International Codes ofPractice (RCP) and Standards of Good Manufacturing Practiceof
26、 the CodexAlimentarius Commission (CAC) for maintainingthe initial quality of the fresh or frozen product during handlingfrom the time of harvest through the time of sale to theconsumer (5). See CAC/RCP 9, CAC/RCP 16, CAC/RCP 17,CAC/RCP 18, CAC/RCP 24, CAC/RCP 27, CAC/RCP 28,CAC/RCP 37, and CAC/RCP
27、20.5.2 In handling, preparing, freezing, storing, and thawingfinfish and aquatic invertebrates intended for irradiation, takeprecautions at all times to minimize microbial contaminationand outgrowth. Use standards of hygiene as high as thoseapplied in the processing or preparation of product for the
28、frozen or fresh markets.5.3 Deliver product to the irradiation facility without delay,such that irradiation occurs as close to the time of harvest aspossible. Products approaching the end of their shelf lifeshould not be irradiated in an attempt to extend that shelf life.NOTE 1While irradiation can
29、improve finfish and aquatic inverte-brates from a public health aspect by reducing the microbial and parasitepopulations within product, chemical reactions (for example, oxidativedegradation) that cause product to spoil also need to be considered whenassessing the appropriateness of radiation treatm
30、ent (6).6. Packaging6.1 Packaging product prior to irradiation is one means ofpreventing post-irradiation contamination.6.2 Use packaging materials suitable to the product consid-ering any planned processing (including irradiation) and con-sistent with any regulatory requirements (see Guide F 1640).
31、6.3 With certain irradiation facilities, it may be necessary tolimit use to particular package shapes and sizes. See ISO/ASTM Practices 51204 and 51431. Irradiation can be opti-mized if the product packages are geometrically well definedand uniform.4Available from Joint FAO/WHO Food Standards Progra
32、m, Joint Office, Foodand Agriculture Organization of the United Nations, Via delle Terme di Caracalla,00100 Rome, Italy.F17360327. Pre-Irradiation Product Handling7.1 Inspect product as soon as it arrives at the radiationprocessing facility to determine that it has been properlyhandled prior to arri
33、val.7.2 Temperature Control of Product:7.2.1 The temperature of fresh product, excluding un-shucked, live molluscan shellfish, received in the chilled stateshould be maintained as close to 0C (32F) as possible inaccordance with good manufacturing practices (GMPs). Careshould be taken to prevent free
34、zing of the product. Pre-irradiation storage at the irradiation facility should be short;less than one day is recommended.NOTE 2Fresh product is usually stored and transported under crushed,melting ice. When refrigeration is used, the risk of freezing exists.7.2.2 The temperature of unshucked, live
35、molluscan shell-fish received in the chilled state should be maintained between4C (39F) and 7C (45F) in accordance with GMPs. Pre-irradiation storage at the irradiation facility should be short;less than one day is recommended.NOTE 3To maintain unshucked molluscan shellfish in the live state,the sto
36、rage temperature should be above 4C (39F).7.2.3 The surface temperature of product received in thefrozen state should be maintained below 18C (0F).NOTE 4Freezing does not provide an unlimited shelf life without lossof quality, and the pre-irradiation storage period should therefore beminimized. The
37、effect of frozen storage on product quality will be afunction of time, temperature, and degree of temperature fluctuation.7.2.4 Handling and storage procedures that differ from thosedescribed in Sections 5 and 6, especially holding underrefrigeration for an unduly long time, do not constitute GMP.Su
38、ch treatment may result in excessive bacterial growth andundesirable changes in the products.7.3 Inspect all shipping documents arriving with the ship-ment to verify that they are complete and accurate.7.3.1 The documents should include a lot number or othermeans of traceability (see 12.1).7.4 Use a
39、ppropriate means, such as physical barriers, tokeep non-irradiated and irradiated product separated at alltimes while at the irradiation facility. This is necessary becauseit may not be possible to distinguish non-irradiated fromirradiated product by inspection.NOTE 5Radiation-sensitive indicators (
40、RSIs), such as labels, papers,or inks that undergo a color change when exposed to radiation in thepertinent dose range are commercially available. These indicators may beuseful within the irradiation facility as a visual check for determiningwhether or not a product has been exposed to the radiation
41、 source. Theyare not dosimeters intended for measuring absorbed dose and must not beused as a substitute for proper dosimetry. Information about dosimetrysystems and the proper use of RSIs is provided in Guides 51261 and51539, respectively.7.5 Plan preparatory operations for irradiation, such as, bu
42、tnot limited to, dosimeter placement, label placement, andreconfiguration of product in the product unit, to permitexpeditious handling of consecutive batches. These prepara-tory steps, in addition to the placement of the product on thetransport system and the time required for the irradiationtreatm
43、ent contribute to the cumulative time and temperatureexposure that will influence the extent of deterioration bychemical or biological mechanisms or the development ofmicroorganisms of public health significance (see Practices51204 and 51431, and Guide 51261).7.5.1 The size, shape, and product-loadi
44、ng configuration ofa product unit used to hold product for irradiation are deter-mined largely by certain design parameters of the irradiationfacility. Critical parameters include the characteristics of prod-uct transport systems and of the radiation source as they relateto the dose distribution obt
45、ained within the product unit.Pre-determined minimum and maximum dose limits may alsoinfluence the choice of size, shape, and product-loading con-figuration of the product unit.8. Irradiation8.1 Scheduled ProcessIrradiation of food should conformto a scheduled process. A scheduled process for food i
46、rradia-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 sho
47、uld be estab-lished by qualified persons having expert knowledge of theirradiation requirements specific for the food and the proces-sors irradiation facility (7).8.2 Radiation SourcesThe sources of ionizing radiationthat may be employed in irradiating food are limited to thefollowing (see Codex Sta
48、n 106):8.2.1 Istopic SourcesGamma rays from theradionuclides60Co (1.17 and 1.33 MeV) or137Cs (0.66 MeV),and8.2.2 Machine SourcesX-rays and accelerated electrons.NOTE 6The USA, other governments, and the Codex AlimentriusCommission currently limit the use of x-rays with energies not to exceed5 MeV an
49、d the energies of electrons not to exceed 10 MeV.8.3 Absorbed DoseFood irradiation specifications mayinclude minimum and maximum absorbed dose limits. Aminimum absorbed dose may be specified to ensure that theintended effect is achieved, and a maximum absorbed dosemay be based on government regulations resulting from asafety assessment or be stipulated to prevent product degrada-tion. For a given application, one or both of these limits may beprescribed by regulation. It is therefore necessary, prior to theirradiation of product, to establish an irradiatio
