1、Designation: F1356 08F1356 16Standard PracticeGuide forIrradiation of Fresh and Frozen Red Fresh, Frozen orProcessed Meat and Poultry to Control Pathogens andOther Microorganisms1This standard is issued under the fixed designation F1356; the number immediately following the designation indicates the
2、 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 practiceguide is to present inf
3、ormation on the use of ionizing radiation intreating fresh or frozen red fresh, frozen, or processed meat and poultry products to eliminate or reducethe numbers of vegetative, pathogenic microorganisms and parasites, and to extend the refrigeratedshelf-life of those products by reducing the numbers
4、of vegetative spoilage microorganisms.This practiceguide is intended to serve as a set of recommendations to be followed when usingirradiation technology where approved by an appropriate regulatory control authority. It is not to beconstrued as setting forth rigid requirements for the use of irradia
5、tion. While the use of irradiationinvolves certain essential requirements to attain the objective of the treatment, some parameters canbe varied in optimizing the process.This practiceguide has been prepared from a Code of Good Irradiation Practice published by theInternational Consultative Group on
6、 Food Irradiation (ICGFI) developed under the auspices of theFood and Agriculture Organization (FAO), the World Health Organization (WHO), and theInternational Atomic Energy Agency (IAEA) (1).21. Scope1.1 This practice outlines procedures for the irradiation of fresh or frozen meat and poultry.NOTE
7、1The Codex Alimentarius Commission defines meat as “the edible part of any mammal” and poultry as “any domesticated bird, includingchicken, turkeys, ducks, geese, guinea-fowls, or pigeons” (CAC/MISC 5).NOTE 2Current U.S. regulations limit the definition of livestock species to cattle, sheep, swine,
8、goat, horse, mule, or other equine and poultry speciesto chicken, turkey, duck, goose, and guinea (2, 3).1.2 This practice covers absorbed doses used for inactivation of parasites and reduction of bacterial load in fresh and frozen redmeat and poultry. Such doses are typically less than 10 kGy.1.3 T
9、his practice addresses irradiation of pre-packaged product for retail sale or for use as an ingredient in other products. Italso addresses the in-line irradiation of unpackaged product.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is th
10、e responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E170 Terminology Relating to Radiation Measurements and DosimetryE2303 Guide for Absorbed
11、-Dose Mapping in Radiation Processing Facilities1 This practiceguide is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.05 on FoodIrradiation.Current edition approved Jan. 1, 2008Feb. 1, 2016. Published February 2008March 2016
12、. Originally approved in 1991. Last previous edition approved in 19992008 asF1356 99.F1356 08. DOI: 10.1520/F1356-08.10.1520/F1356-16.2 The boldface numbers in parentheses refer to the list of references at the end of this standard.3 For referenced ASTM and ISO/ASTM standards, visit the ASTM website
13、, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Bookof ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication
14、of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be consider
15、ed the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F1416 Guide for Selection of Time-Temperature IndicatorsF1640 Guide for Selection and Use of Packaging Materials for Foods to Be Irradiated2.2 ISO/ASTM Standards
16、:351204 Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing51261 Guide for the Selection and Calibration of Dosimetry Systems for Radiation Processing51431 Practice for Dosimetry in Electron and X-ray (Bremsstrahlung) Irradiation Facilities for Food Processing51539 Guide for t
17、he Use of Radiation-Sensitive Indicators2.3 Codex Alimentarius Commission Recommended International Codes and Standards:4CAC/RCP 1-1969, Rev. 4-2003, A Recommended International Code of PracticeGeneral Principles of Food Hygiene(Including Annex): Hazard Analysis and Critical Control Point (HACCP) Sy
18、stem and Guidelines for ApplicationCAC/RCP 19-1979, Rev-2003, Recommended International Code of Practice for the Radiation Processing of FoodCX STAN 1-1985, Rev. 1991, Amd. 2001, General Standard for the Labeling of Prepackaged FoodsCX STAN 106, Rev. 2003, General Standard for Irradiated FoodCAC/MIS
19、C 5-1993, Amd. 2003, Glossary of Terms and Definitions (Veterinary Drug Residues in Food)3. Terminology3.1 Definitions:3.1.1 Other terms used in this practice may be defined in Terminology E170.3.1.2 absorbed dosequantity of ionizing radiation energy imparted per unit mass of a specified material. T
20、he SI unit ofabsorbed dose is the gray (Gy), where 1 gray is equivalent to the absorption of 1 joule per kilogram of the specified material (1Gy = 1 J/kg).3.1.2.1 DiscussionA standard definition of absorbed dose appears in Terminology E170.3.1.3 D10-valueabsorbed dose required to reduce the microbia
21、l population in a given food by 90 % (1 log10).3.1.4 dose distributionvariation in absorbed dose within a process load exposed to ionizing radiation.3.1.5 process loadvolume of material with a specified loading configuration irradiated as a single entity.3.1.6 transport systemconveyor or other mecha
22、nical system used to move the process load through the irradiator.4. Significance and Use4.1 The principal purpose of irradiation is to control (reduce the number of) pathogenic bacteria in fresh or frozen red meat andpoultry to ensure the safety of these foods for human consumption. Irradiation sig
23、nificantly reduces the numbers of vegetativepathogenic bacteria such as Campylobacter,Escherichia coli,Listeria,Salmonella,Staphylococcus aureus, or Yersinia enteroco-litica.4.2 The process also inactivates parasites such as Trichinella spiralis and Toxoplasma gondii.4.3 The process may extend the s
24、helf life of fresh red meat and poultry by reducing the numbers of viable, vegetative spoilagebacteria, such as Pseudomonas species.4.4 Radiation processing of fresh and frozen red meat and poultry is a critical control point (CCP) of a Hazard Analysis ofCritical Control Points (HACCP) program. It s
25、erves as an important measure to control any residual risk from pathogenicmicroorganisms before the product reaches the consumer.5. Criteria for Assessing Irradiation Efficacy5.1 Irradiation for Control of Pathogenic BacteriaThe numbers of pathogenic bacteria that can result in an infectious product
26、vary with the specific bacterium and the susceptibility of the consumers involved. The adoption of criteria, such as those used inthe U.S. for the pasteurization of milk or in scheduled processes for low-acid canned food, is the most reasonable in the absenceof microbiological end product criteria f
27、or expected pathogenic bacteria (4, 5).5.2 Irradiation for Inactivation of ParasitesThe criterion should be that the parasites in uncooked, irradiated product arenoninfectious or noninvasive, as appropriate. (This does not necessarily require the parasite to be killed by the irradiation process.)5.3
28、 Irradiation for Shelf-Life ExtensionThe criterion should be the bacterial plate count using appropriate time, temperature,and media parameters. Reduction in bacterial counts as final criteria cannot be specified unless local regulations, customerspecifications, or both, are known. Therefore, the fi
29、nal product specification regarding bacterial plate count should be establishedby the customer.4 Available from the Joint FAO/WHO Food Standards Programme, Joint Office, FAO, Via delle Terme di Caracalla, 00100 Rome, Italy.F1356 1625.4 Failure to meet these criteria should direct attention to the sc
30、heduled process (see 8.1) and the reestablishment, if necessary,of Good Manufacturing Practice (GMPs). The hazard analysis and critical control point (HACCP) system or another similarprocess control system should be applied to the entire processing and distribution chain. With this system, any point
31、 in the chainwhere a hazardous or critical situation could result is monitored and controlled to prevent unsafe and unwholesome product fromreaching the consumer. See CAC/RCP 1 and (6, 7).5.4.1 Implementation of a process control system to assess radiation-processing efficacy should include bacterio
32、logicalexamination of the product before and immediately after irradiation, use of time/temperature indicators throughout the processingchain (see Guide F1416), and testing of package integrity. Bacteriological testing should reveal a significant reduction in relevantbacterial counts compared to tho
33、se of the non-irradiated product. Temperature monitoring should alert observers of any productabuse that could result in increases in bacterial counts after irradiation.6. Pre-Irradiation Product Handling6.1 Product should be handled in an environment that does not increase the risk of contamination
34、 from physical, chemical, orbiological hazards. Minimize microbial contamination and growth by following relevant standards of GMPs; see for example U.S.Food and Drug Administration (FDA) GMPs (8), U.S. Food Safety and Inspection Service (FSIS) Standard Sanitary OperatingProcedures (SSOPs) (9), CAC
35、Recommended International Codes of Practice, (CAC/RCP1 (see 2.3) and HACCP) (10).6.2 Unpackaged ProductIn facilities handling unpackaged product, the irradiation environment and equipment should bedesigned and constructed to be cleanable and durable to maintain a sanitary condition and, thereby, not
36、 increase the risk ofcontamination.NOTE 3An operating environment with high moisture or airflow may contribute to the risk of bacterial contamination. Moisture provides a growthmedium for bacteria and airflow provides a means of transport for bacteria. Food contact surfaces may contribute chemical o
37、r physical contaminants toproducts unless such surfaces are fabricated from appropriate materials and properly maintained and cleaned. Also, employee hygiene and pest controlshould be closely monitored.6.3 Pre-Packaged ProductFor pre-packaged product, the package itself provides a barrier that helps
38、 to reduce the risk ofrecontamination. Thus, many of the requirements for the irradiation environment and equipment necessary for handlingunpackaged product may not be applicable for facilities handling only pre-packaged product. Information on applicablerequirements should be obtained from the appr
39、opriate regulatory authorities before starting operations.6.4 Pre-Irradiation InspectionPackages and containers of fresh and frozen red meat and poultry should be inspected uponreceipt at the irradiation facility to ensure that the product is suitable for irradiation. Written acceptance criteria for
40、 producttemperature, package integrity and inspection frequency, as applicable, should be established by the product owner and agreed toby management of the irradiation facility prior to accepting product from the owner. Also, criteria for handling of productunsuitable for irradiation should be esta
41、blished.6.4.1 Product TemperatureUpon receipt of product, its temperature should be measured using a calibrated sanitizedtemperature-sensing device, at a predetermined location and frequency as specified by HACCP and GMPs. Temperature should bebetween 2 and +4C for refrigerated fresh red meat and po
42、ultry or 18C or lower for frozen red meat and poultry. Forunpackaged product, insert the device directly into the product and sanitize the device between each measurement. Forprepackaged product, use a device that can be placed between individual packages without puncturing them.6.4.2 Package Integr
43、ityA visual inspection of the product packaging should be performed to ensure there is no evidence ofcompromised or damaged product. Also, a sensory inspection should be performed. No leakage of fluids or odor indicative ofproduct spoilage should be evident upon inspection.6.4.3 Product InventoryThe
44、 number of containers should be counted and the description/identification of the product to beirradiated should be verified and compared with the documentation from the product owner. A comparison of this pre-irradiationcount with a count performed after irradiation provides a check that all produc
45、ts received have been irradiated.6.4.4 Product IdentificationAunique identification number for tracking the product throughout the irradiation process shouldbe issued and documented for the incoming product.6.5 Pre-Irradiation Storage:6.5.1 For fresh red meat and poultry, the principal requirement f
46、or pre-irradiation storage is maintenance of the producttemperature between 2 and +4C without freezing.NOTE 4U.S. poultry regulations presently require that the temperature of fresh poultry be maintained at or below 4.4C (10).NOTE 5Holding product under refrigeration for an unduly long time would vi
47、olate principles of GMPs because such treatment may result in excessivegrowth of psychrotrophic bacteria and undesirable changes in products.6.5.2 Asecond requirement is that the pre-irradiation storage period at the irradiation facility be minimized, approximately oneday or less, whenever possible.
48、6.5.3 For frozen red meat and poultry, the product temperature should be maintained at or below 18C at all times. Therelatively short duration of frozen storage prior to irradiation is not particularly critical under normal commercial conditions.However, freezing does not provide an unlimited produc
49、t life without loss of quality, and the pre-irradiation storage period shouldtherefore be minimized.F1356 1636.6 Product SegregationDistinguishing irradiated from non-irradiated product by inspection might not be possible. Therefore,the use of appropriate means integral to the facility design, such as physical barriers or special segregation in clearly definedstaging areas, to maintain non-irradiated product separate from irradiated product is important.NOTE 6Radiation-sensitive indicators undergo a color change when exposed to radiation in the
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