ASTM F1356-22

Standard Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms

SIGNIFICANCE AND USE
4.1 The principal purpose of irradiation is to help ensure the safety of these foods for human consumption. Irradiation significantly reduces the numbers of pathogenic bacteria such as Campylobacter, Shiga toxin-Producing E coli, Listeria monocytogenes, Salmonella, Staphylococcus aureus, and Yersinia enterocolitica.
Note 3: Ionizing radiation doses below 10 kGy will reduce but may not eliminate spores of pathogenic bacteria including those of Clostridium botulinum, Clostridium perfringens, and Bacillus cereus.  
4.2 The process also inactivates parasites such as Trichinella spiralis and Toxoplasma gondii.  
4.3 The process may extend the shelf life of fresh meat and poultry by reducing the numbers of viable, spoilage bacteria, such as Pseudomonas species and lactic acid bacilli.  
4.4 Radiation processing of fresh, frozen, or processed meat and poultry is a critical control point (CCP) of a Hazard Analysis of Critical Control Points (HACCP) program. It serves as an important measure to control any residual risk from pathogenic microorganisms before the product reaches the consumer (4).  
4.5 The “Recommended International Code of Practice for Radiation Processing of Food” (CAC/RCP 19-1979) of the Codex Alimentarius identifies the essential practices to be implemented to achieve effective radiation processing of food, in general, in a manner that maintains quality and yields food products that are safe and suitable for consumption.
SCOPE
1.1 This guide outlines procedures for the irradiation of fresh, frozen, or processed meat and poultry.
Note 1: The Codex Alimentarius Commission defines meat as “the edible part of any mammal” and poultry as “any domesticated bird, including chicken, turkeys, ducks, geese, guinea-fowls, or pigeons” (CAC/MISC 5).
Note 2: Current U.S. regulations limit the definition of meat and poultry as listed in 9 CFR Section 301.2 and 381.1, respectively. (2, 3).  
1.2 This guide covers the use of ionizing radiation to eliminate or reduce the numbers of vegetative, pathogenic microorganisms and parasites, and to extend the refrigerated shelf-life of those products by reducing the numbers of spoilage microorganisms in fresh, frozen, or processed meat and poultry. The absorbed dose for this application is typically less than 10 kGy.  
1.2.1 This guide covers gamma, electron beam, and X-radiation treatment.  
1.3 This guide addresses irradiation of pre-packaged product for retail sale or for use as an ingredient in other products. It also addresses the in-line irradiation of unpackaged product. Other specific ISO and ASTM standards exist for the irradiation of food. In those areas covered by ISO 14470, that standard takes precedence.  
1.4 This document is one of a set of standards that provides recommendations for properly implementing and utilizing radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 14-Jan-2022
• ICS: 07.100.30 - Food microbiology
• ICS: 67.120.01 - Animal produce in general
• Technical Committee: E61 - Radiation Processing
• Drafting Committee: E61.05 - Food Irradiation

Relations

• Replaces: ASTM E2449-05(2013) - Standard Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms (Withdrawn 2016)
• Effective Date: 18-Jul-2016
• Refers: ASTM F1416-96(2019) - Standard Guide for Selection of Time-Temperature Indicators
• Effective Date: 01-Mar-2019
• Refers: ASTM E3083-17 - Standard Terminology Relating to Radiation Processing: Dosimetry and Applications
• Effective Date: 01-Oct-2017
• Refers: ASTM F1416-96(2014) - Standard Guide for Selection of Time-Temperature Indicators
• Effective Date: 01-Apr-2014
• Refers: ASTM F1640-09 - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 01-Feb-2009
• Refers: ASTM F1416-96(2008) - Standard Guide for Selection of Time-Temperature Indicators
• Effective Date: 01-Oct-2008
• Refers: ASTM F1640-03 - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 01-Oct-2003
• Refers: ASTM F1416-96(2003) - Standard Guide for Selection of Time-Temperature Indicators
• Effective Date: 10-Feb-1996
• Refers: ASTM F1416-96 - Standard Guide for Selection of Time-Temperature Indicators
• Effective Date: 01-Jan-1996
• Refers: ASTM F1640-95(2001) - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 10-Sep-1995

Overview

ASTM F1356-22 – Standard Guide for Irradiation of Fresh, Frozen, or Processed Meat and Poultry to Control Pathogens and Other Microorganisms provides comprehensive recommendations for applying ionizing radiation to meat and poultry products. Developed by ASTM, this international guide ensures food safety by reducing or eliminating pathogenic microorganisms and parasites, while offering a means to extend shelf-life. The guide applies to a wide range of meat and poultry, including fresh, frozen, and processed products, and addresses both pre-packaged and unpackaged items for retail or further processing. The standard is compatible with global regulations and is intended as a critical resource for radiation processors, food producers, and regulatory authorities.

Key Topics

• Purpose of Irradiation:

  • Enhances safety of meat and poultry for human consumption
  • Targets pathogenic bacteria (e.g., Campylobacter, Salmonella, Listeria monocytogenes, Shiga toxin-producing E. coli, Staphylococcus aureus, Yersinia enterocolitica)
  • Inactivates parasites such as Trichinella spiralis and Toxoplasma gondii
  • Extends shelf life by reducing spoilage bacteria (e.g., Pseudomonas species and lactic acid bacilli)

• Scope of Application:

  • Covers procedures for irradiating fresh, frozen, and processed meat and poultry
  • Applicable to both pre-packaged products for retail and in-line irradiation of unpackaged product
  • Absorbed dose typically less than 10 kGy
  • Uses gamma, electron beam, and X-radiation techniques

• Integration with Safety Management Systems:

  • Irradiation serves as a critical control point within Hazard Analysis and Critical Control Points (HACCP) frameworks
  • Emphasizes the role of Good Manufacturing Practices (GMP), standard operating procedures (SOPs), and proper documentation
  • Outlines best practices for process validation, product segregation, packaging, and temperature controls before and after irradiation

• Dosimetry and Quality Assurance:

  • Stresses the necessity for accurate dosimetry and process validation
  • Points to absorbed-dose mapping and verification to ensure effective microbial control
  • Aligns with international codes and practices (e.g., Codex Alimentarius, ISO/ASTM standards)

• Regulatory and Labeling Requirements:

  • Recognizes varying national and international labeling protocols
  • Encourages proper identification and documentation of irradiated products in compliance with food safety authorities

Applications

ASTM F1356-22 is highly relevant to several sectors within the food industry:

• Food Processing Facilities: Implement irradiation as a validated intervention to control harmful pathogens and increase product shelf-life under strict quality management conditions.

• Meat and Poultry Producers: Apply ionizing radiation to enhance product safety and reduce reliance on chemical preservatives or heat treatments.

• Retailers and Distributors: Source standardized irradiated products that meet stringent microbiological safety standards, supporting consumer confidence.

• Regulatory Compliance and Inspections: Use as a reference for meeting local, national, and international food safety requirements for meat and poultry irradiation.

• HACCP Program Development: Integrate irradiation as a critical control point to mitigate biological risks in the food processing chain.

By providing clear procedures, critical control measures, and documentation guidelines, this standard helps stakeholders ensure the consistent production of safe, high-quality meat and poultry.

Related Standards

• ISO 14470 – Food Irradiation – Requirements for development, validation, and routine control of the irradiation process using ionizing radiation
• ISO/ASTM 52628 – Practice for Dosimetry in Radiation Processing
• ISO/ASTM 51261/51539/51608/51649/51702/51818/52303/52701 – Suites covering radiation measurement, dosimetry, absorbed-dose mapping, and performance of dosimeters
• CAC/RCP 19-1979 – Recommended International Code of Practice for the Radiation Processing of Food (Codex Alimentarius)
• 9 CFR Section 301.2 and 381.1 – Definitions and scope for meat and poultry under US regulations

These standards collectively ensure that irradiation practices are aligned with international best practices, deliver food safety, and facilitate regulatory compliance across global markets.

Keywords: meat irradiation, poultry irradiation, pathogen control, shelf-life extension, HACCP, food safety, dosimetry, radiation processing, ionizing radiation, food labeling, ASTM F1356-22.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1356 − 22
Standard Guide for
Irradiation of Fresh, Frozen or Processed Meat and Poultry
to Control Pathogens and Other Microorganisms
This standard is issued under the fixed designation F1356; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The purpose of this guide is to present information on the use of ionizing radiation in treating fresh,
frozen, or processed meat and poultry products to eliminate or reduce the numbers of vegetative,
pathogenicmicroorganismsandparasites,andtoextendtherefrigeratedshelf-lifeofthoseproductsby
reducing the numbers of spoilage microorganisms.
This guide is intended to serve as a set of recommendations to be followed when using irradiation
technology where approved by an appropriate regulatory authority. It is not to be construed as setting
forth rigid requirements for the use of irradiation. While the use of irradiation involves certain
essential requirements to attain the objective of the treatment, some parameters can be varied in
optimizing the process.
This guide has been prepared from a Code of Good Irradiation Practice published by the
International Consultative Group on Food Irradiation (ICGFI) developed under the auspices of the
Food and Agriculture Organization (FAO), the World Health Organization (WHO), and the
International Atomic Energy Agency (IAEA) (1).
1. Scope 1.3 This guide addresses irradiation of pre-packaged prod-
uct for retail sale or for use as an ingredient in other products.
1.1 This guide outlines procedures for the irradiation of
It also addresses the in-line irradiation of unpackaged product.
fresh, frozen, or processed meat and poultry.
Other specific ISO and ASTM standards exist for the irradia-
NOTE 1—The Codex Alimentarius Commission defines meat as “the
tion of food. In those areas covered by ISO 14470, that
edible part of any mammal” and poultry as “any domesticated bird,
including chicken, turkeys, ducks, geese, guinea-fowls, or pigeons” standard takes precedence.
(CAC/MISC 5).
1.4 This document is one of a set of standards that provides
NOTE 2—Current U.S. regulations limit the definition of meat and
poultry as listed in 9 CFR Section 301.2 and 381.1, respectively. (2, 3). recommendations for properly implementing and utilizing
radiation processing. It is intended to be read in conjunction
1.2 This guide covers the use of ionizing radiation to
with ISO/ASTM 52628.
eliminate or reduce the numbers of vegetative, pathogenic
microorganisms and parasites, and to extend the refrigerated
1.5 The values stated in inch-pound units are to be regarded
shelf-life of those products by reducing the numbers of
as standard. The values given in parentheses are mathematical
spoilage microorganisms in fresh, frozen, or processed meat
conversions to SI units that are provided for information only
and poultry. The absorbed dose for this application is typically
and are not considered standard.
less than 10 kGy.
1.6 This standard does not purport to address all of the
1.2.1 This guide covers gamma, electron beam, and
safety concerns, if any, associated with its use. It is the
X-radiation treatment.
responsibility 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.
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
1.7 This international standard was developed in accor-
Processing and is the direct responsibility of Subcommittee E61.05 on Food
dance with internationally recognized principles on standard-
Irradiation.
Current edition approved Jan. 15, 2022. Published February 2022. Originally
ization established in the Decision on Principles for the
approved in 1991. Last previous edition approved in 2016 as F1356 – 16. DOI:
Development of International Standards, Guides and Recom-
10.1520/F1356-22.
mendations issued by the World Trade Organization Technical
The boldface numbers in parentheses refer to the list of references at the end of
this standard. Barriers to Trade (TBT) Committee.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1356 − 22
2. Referenced Documents ISO 14470-2011 Food irradiation-requirements for the
3 development, validation and routine control of the process
2.1 ASTM Standards:
of irradiation using ionizing radiation for the treatment of
E3083 Terminology Relating to Radiation Processing: Do-
food
simetry and Applications
2.5 International Commission on Radiation Units and Mea-
F1416 Guide for Selection of Time-Temperature Indicators
surements (ICRU) Reports:
F1640 Guide for Selection and Use of Contact Materials for
ICRU Report 80 Dosimetry Systems for Use in Radiation
Foods to Be Irradiated
Processing
2.2 ISO/ASTM Standards:
ICRU Report 85a Fundamental Quantities and Units for
51261 Practice for Calibration of Routine Dosimetry Sys-
Ionizing Radiation
tems for Radiation Processing
2.6 Joint Committee for Guides in Metrology (JCGM)
51539 Guide for Use of Radiation-Sensitive Indicators
Reports:
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
JCGM 100:2008, GUM 1995 with minor corrections,
Facility for Radiation Processing at Energies between 50
Evaluationofmeasurementdata-GuidetotheExpression
keV and 7.5 MeV
of Uncertainty in Measurement
51649 Practice for Dosimetry in an Electron Beam Facility
JCGM 200:2012 VIM International Vocabulary of
for Radiation Processing at Energies Between 300 keV
Metrology—Basic and General Concepts and Associated
and 25 MeV
Terms
51702 Practice for Dosimetry in a Gamma Facility for
Radiation Processing
3. Terminology
51818 Practice for Dosimetry in an Electron Beam Facility
3.1 Definitions:
for Radiation Processing at Energies Between 80 and 300
3.1.1 absorbed dose—quotient of dɛ¯bydm, where dɛ¯ is the
keV
mean energy imparted by ionizing radiation to matter of mass
52303 Guide forAbsorbed-Dose Mapping in Radiation Pro-
dm, thus
cessing Facilities
¯
52628 Practice for Dosimetry in Radiation Processing
D 5 dϵ⁄dm (1)
52701 Guide for Performance Characterization of Dosim-
3.1.1.1 Discussion—TheSIunitofabsorbeddoseisthegray
eters and Dosimetry Systems for Use in Radiation Pro-
(Gy),where1grayisequivalenttotheabsorptionof1jouleper
cessing
kilogram of the specified material (1 Gy = 1 J/kg).
2.3 Codex Alimentarius Commission Recommended Inter-
3.1.2 D value—absorbed dose required to reduce the mi-
national Codes and Standards:
crobial population in a given food by 90 %.
CAC/RCP 1-1969, Rev. 4-2003, Recommended Interna-
3.1.3 dose distribution—variation in absorbed dose within a
tional Code of Practice—General Principles of Food
process load exposed to ionizing radiation.
Hygiene includingAnnex on HazardAnalysis and Critical
3.1.4 process load—volume of material with a specified
Control Point (HACCP) System and Guidelines for its
loading configuration irradiated as a single entity.
Application
CAC/RCP19-1979, Rev. 2003, Recommended International 3.1.5 transport system—conveyor or other mechanical sys-
tem used to move the process load through the irradiator.
Code of Practice for the Radiation Processing of Food
CX STAN 1-1985, Rev. 2010, General Standard for the
3.2 Definitions of other terms used in this standard that
Labeling of Prepackaged Foods
pertain to radiation measurement and dosimetry may be found
CX STAN 106, Rev. 2003, General Standard for Irradiated
in ISO/ASTM Practice 52628. Other terms that pertain to
Food
radiation measurement and dosimetry may be found in ASTM
CAC/MISC 5-1993, Amd. 2003, Glossary of Terms and
Terminology E3083 and ISO Terminology ISO 12749-4.
Definitions (Veterinary Drug Residues in Food)
Where appropriate, definitions used in these standards have
CAC/GL21-1997, Rev. 2013, Principles and Guidelines for
beenderivedfrom,andareconsistentwith,definitionsinICRU
the Establishment and Application of Microbiological
Report 85a and general metrological definitions given in the
Criteria Related to Food
VIM.
2.4 ISO Standard
4. Significance and Use
ISO 12749-4 Nuclear energy — Vocabulary — Part 4:
Dosimetry for radiation processing
4.1 The principal purpose of irradiation is to help ensure the
safety of these foods for human consumption. Irradiation
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
www.astm.org, or contact ASTM Customer Service at [e-mail]. For Available from International Commission on Radiation Units and
Annual Book of ASTM Standards volume information, refer to the standard’s Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
Document Summary page on the ASTM website. Document produced by Working Group 1 of the Joint Committee for Guides in
Available from the Joint FAO/WHO Food Standards Programme, Joint Office, Metrology (JCGM WG1). Available free of charge at the BIPM website (http://
FAO, Via delle Terme di Caracalla, 00100 Rome, Italy. www.bipm.org).
5 8
Available from International Organization for Standardization (ISO), ISO Document produced by Working Group 2 of the Joint Committee for Guides in
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Metrology (JCGM WG2). Available free of charge at the BIPM website (http://
Geneva, Switzerland, http://www.iso.org. www.bipm.org).
F1356 − 22
significantly reduces the numbers of pathogenic bacteria such Determining whether a specified irradiation treatment will
as Campylobacter, Shiga toxin-Producing E coli, Listeria reduce the likelihood of illness can only be based on a formal
monocytogenes, Salmonella, Staphylococcus aureus, and Yers- quantitative microbial risk assessment (QMRA) approach (6,
inia enterocolitica. 7). The numbers of pathogenic bacteria that can result in an
NOTE 3—Ionizing radiation doses below 10 kGy will reduce but may infectious product vary with the specific bacterium.
not eliminate spores of pathogenic bacteria including those of Clostridium
botulinum, Clostridium perfringens, and Bacillus cereus. NOTE 4—Susceptibility of a person to pathogenic bacteria varies and is
based on the health of the individual and the virulence of the particular
4.2 The process also inactivates parasites such as
strain of the pathogen (8, 9).
Trichinella spiralis and Toxoplasma gondii.
5.2.2 Irradiation for Inactivation of Parasites—The crite-
4.3 The process may extend the shelf life of fresh meat and
rion should be that the parasites in uncooked, irradiated
poultry by reducing the numbers of viable, spoilage bacteria,
product are noninfectious or noninvasive, as appropriate.
such as Pseudomonas species and lactic acid bacilli.
5.2.3 Irradiation for Shelf-Life Extension—The criterion
4.4 Radiation processing of fresh, frozen, or processed meat
should be the bacterial plate count using appropriate time,
and poultry is a critical control point (CCP) of a Hazard
temperature, and media parameters. Reduction in bacterial
Analysis of Critical Control Points (HACCP) program. It
counts as final criteria cannot be specified unless local
serves as an important measure to control any residual risk
regulations, customer specifications, or both, are known.
from pathogenic microorganisms before the product reaches
Therefore, the final product specification regarding bacterial
the consumer (4).
plate count should be established by the food producer or food
processor.
4.5 The “Recommended International Code of Practice for
Radiation Processing of Food” (CAC/RCP 19-1979) of the
6. Pre-Irradiation Product Handling
Codex Alimentarius identifies the essential practices to be
implemented to achieve effective radiation processing of food,
6.1 Producthandlingshouldbeunderconditionsthatprotect
in general, in a manner that maintains quality and yields food
the product against physical, chemical, or biological hazards.
products that are safe and suitable for consumption.
Microbial contamination and growth should be minimized by
following relevant standards of GMPs; see for example U.S.
5. Criteria for Assessing Process Control and Irradiation
Food and Drug Administration (FDA) GMPs (10), U.S. Food
Efficacy
Safety and Inspection Service (FSIS) Standard Sanitary Oper-
5.1 Process Control System—The criterion should be that ating Procedures (SSOPs) (11), CAC Recommended Interna-
tional Codes of Practice, (CAC/RCP 1 (see 2.3) and HACCP)
hazard analysis and critical control point (HACCP) system or
another similar process control system is applied to the entire (4, 5, 12).
processing and distribution chain. With this system, any point
6.2 Unpackaged Product—In facilities handling unpack-
in the chain where a hazardous or critical situation could result
aged product, the irradiation environment and equipment
is monitored and controlled to prevent unsafe and unwhole-
shouldbedesignedandconstructedtobecleanableanddurable
some product from reaching the consumer. See CAC/RCP 1
to maintain a sanitary condition and, thereby, not increase the
and (4, 5). Failure to meet these criteria should be investigated,
risk of contamination.
toassesstheefficacyofstandardoperatingprocedures(see8.1)
NOTE 5—An operating environment with high moisture or airflow may
and the re-establishment, if necessary, of Good Manufacturing
contribute to the risk of bacterial contamination. Moisture provides a
Practice (GMPs).
growth medium for bacteria and airflow provides a means of transport for
5.1.1 Implementation of a process control system (see 4.4) bacteria. Food contact surfaces may contribute chemical or physical
contaminants to products unless such surfaces are fabricated from
to assess radiation-processing efficacy should include bacterio-
appropriate materials and properly maintained and cleaned. Also, em-
logical examination of the product before and after irradiation,
ployee hygiene and pest control should be closely monitored.
use of time/temperature indicators throughout the processing
6.3 Pre-Packaged Product—For pre-packaged product, the
chain (see Guide F1416), and testing of package integrity.
package itself provides a barrier that helps to reduce the risk of
Irradiation efficacy has to be validated to ensure that the
recontamination. Thus, many of the requirements for the
minimum absorbed dose delivered (see 8.3–8.4) to the product
irradiation environment and equipment necessary for handling
is able to achieve the minimum reduction in target microbial
unpackaged product may not be applicable for facilities han-
organisms that is expected. The target organism(s) have to be
dling only pre-packaged product. Information on applicable
identified prior to this validation. Bacteriological testing after
requirements should be obtained from the appropriate regula-
specific irradiation doses should yield a predicted decline in
tory authorities before starting operations.
viable counts of the target pathogen(s). Temperature monitor-
ing should provide an alert of any product abuse that could
6.4 Pre-Irradiation Inspection—Packages and containers of
result in increases in bacterial counts after irradiation.
fresh, frozen, or processed meat and poultry should be in-
5.2 Criteria for Irradiation Treatment: spected upon receipt at the irradiation facility to ensure that the
5.2.1 Irradiation for Control of Pathogenic Bacteria—The product is suitable for irradiation. Written acceptance criteria
criterion should be that the irradiation treatment is able to for product temperature, package integrity and inspection
reduce the number of pathogenic bacteria in the meat or frequency, as applicable, should be established by the product
poultry, such that they are no longer able to cause illness. owner and agreed to by management of the irradiation facility
F1356 − 22
prior to accepting product from the owner. Also, criteria for 7. Packaging and Product Loading Configuration
handling of product unsuitable for irradiation should be estab-
7.1 Packaging Materials:
lished.
7.1.1 Use packaging materials suitable to the product, that
6.4.1 Product Temperature—Upon receipt of product, its
take into account planned processing (including irradiation)
temperature should be measured using a calibrated sanitized
and is consistent with regulatory requirements (see Guide
temperature-sensing device, at a predetermined location and
F1640).
frequency as specified by HACCP and GMPs. Temperature
7.1.2 Packaging materials should provide appropriate gas
should be between –2 °C and +4 °C for refrigerated fresh or
and moisture permeability to maintain product quality.
processed meat and poultry or –18 °C or lower for frozen meat
NOTE 9—There are mechanisms other than bacterial action that cause
and poultry. For unpackaged product, insert the device directly meat spoilage. These are largely chemical in nature and generally involve
oxidation of the product, resulting in discoloration and rancidity. Other
into the product and sanitize the device between each measure-
measures in addition to irradiation may be necessary to obtain a
ment.Forprepackagedproduct,useadevicethatcanbeplaced
satisfactory product. Where applicable, a package providing a reduced
between individual packages without puncturing them.
oxygen environment (for example, vacuum packaging) minimizes such
effects.
6.4.2 Package Integrity—Avisual inspection of the product
NOTE 10—Fresh meats, especially the more highly pigmented ones
packaging should be performed to ensure there is no evidence
such as beef, ordinarily require the presence of oxygen in order to
of compromised or damaged product. Also, a sensory inspec-
maintain their normal red color. The use of vacuum packaging and
tion should be performed. No leakage of fluids or odor
oxygen-impermeablefilmscausesmeattodarkeninthepackage,although
indicative of product spoilage should be evident upon inspec- the normal red color will return when the package is opened. For the less
pigmented meat and for poultry, the color change resulting from vacuum
tion.
packaging is less significant.
6.4.3 Product Inventory—The number of containers should
7.2 Product Loading Configuration:
be counted and the description/identification of the product to
7.2.1 Thesize,shape,densityandloadingconfigurationofa
be irradiated should be verified and compared with the docu-
processloadtobeirradiatedshouldbedeterminedprimarilyby
mentation from the product owner. A comparison of this
considering design parameters of the irradiation facility. Criti-
pre-irradiation count with a count performed after irradiation
cal design parameters include the characteristics of product
provides a check that all products received have been irradi-
transport systems and of the radiation source as they relate to
ated.
the dose distribution determined within the process load.
6.4.4 Product Identification—A unique identification num-
7.2.2 Thedosedistributionwithintheprocessloadcanoften
ber for tracking the product throughout the irradiation process
be optimized by using product packages that are geometrically
should be issued and documented for the incoming product.
well defined and uniformly loaded. With certain irradiation
6.5 Pre-Irradiation Storage:
facilities, it may be necessary to limit the use of particular
package shapes and sizes depending on the density of the
6.5.1 Refrigerated Fresh or Processed Meats and Poultry—
The principal requirement for pre-irradiation storage is to product and facility operational qualification (OQ) data (see
ISO/ASTM 51608, 51649, 51702, and 51818).
maintain product temperature between –2 °C and +4 °C with-
7.2.3 Prescribedproductdosespecificationsshouldbetaken
out freezing. Whenever possible, the pre-irradiation storage at
intoaccountwhendeterminingtheappropriateproduct-loading
the irradiation facility should be minimized to one day or less.
configuration (see 8.4).
NOTE 6—U.S.A. poultry regulations presently require that the tempera-
ture of fresh poultry be maintained at or below 4.4 °C (12).
8. Irradiation
NOTE 7—Holding product under refrigeration for an unduly long time
would violate principles of GMPs because such treatment may result in 8.1 Standard Operating Procedures (SOPs)—A standard
excessive growth of psychrotrophic bacteria and undesirable changes in
operating procedure for food irradiation is a documented
products.
procedure that is used to ensure that the technologically
established dose range and irradiation conditions selected by
6.5.2 Frozen Meats and Poultry—The product temperature
the radiation processor are achievable in a specific facility.The
should be maintained at or below –18 °C at all times.
procedures should be established and validated by qualified
6.6 Product Segregation—Distinguishing irradiated from
persons having knowledge in irradiation requirements specific
un-irradiated product by visual inspection might not be pos-
to the food and the irradiation facility (13). The procedures
sible. Therefore, it is important that appropriate means integral
should meet the requirements of CX STAN 106 and should
to the facility design, such as physical barriers or clearly
follow the recommendations of CAC/RCP 19.
definedstagingareas,beusedtomaintainun-irradiatedproduct
8.1.1 Installation qualification, operational qualification,
separate from irradiated product.
performance qualification, and process control should be per-
NOTE 8—Radiation-sensitive indicators undergo a color change when
formed following the requirements of ISO/ASTM Practice
exposed to radiation in the pertinent dose range. These indicators may be
51702, ISO/ASTM Practice 51608, ISO/ASTM Practice
useful within the irradiation facility to provide a visual check for
51649, or ISO/ASTM Practice 51818.
determining whether or not product has been exposed to the radiation
source.Theyarenotdosimetersintendedformeasuringabsorbeddoseand
8.2 Radiation Sources—The sources of ionizing radiation
must not be used as a substitute for proper dosimetry. Information about
that should be employed for irradiating fresh, frozen, or
dosimetry systems and the proper use of radiation-sensitive indicators is
processed meat and poultry products are limited to the follow-
pro
...

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it 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 version
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Designation: F1356 − 16 F1356 − 22
Standard Guide for
Irradiation of Fresh, Frozen or Processed Meat and Poultry
to Control Pathogens and Other Microorganisms
This standard is issued under the fixed designation F1356; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The purpose of this guide is to present information on the use of ionizing radiation in treating fresh,
frozen, or processed meat and poultry products to eliminate or reduce the numbers of vegetative,
pathogenic microorganisms and parasites, and to extend the refrigerated shelf-life of those products by
reducing the numbers of spoilage microorganisms.
This guide is intended to serve as a set of recommendations to be followed when using irradiation
technology where approved by an appropriate regulatory authority. It is not to be construed as setting
forth rigid requirements for the use of irradiation. While the use of irradiation involves certain
essential requirements to attain the objective of the treatment, some parameters can be varied in
optimizing the process.
This guide has been prepared from a Code of Good Irradiation Practice published by the
International Consultative Group on Food Irradiation (ICGFI) developed under the auspices of the
Food and Agriculture Organization (FAO), the World Health Organization (WHO), and the
International Atomic Energy Agency (IAEA) (1).
1. Scope
1.1 This guide outlines procedures for the irradiation of fresh, frozen, or processed meat and poultry.
NOTE 1—The Codex Alimentarius Commission defines meat as “the edible part of any mammal” and poultry as “any domesticated bird, including chicken,
turkeys, ducks, geese, guinea-fowls, or pigeons” (CAC/MISC 5).
NOTE 2—Current U.S. regulations limit the definition of meat and poultry as listed in 9 CFR Section 301.2 and 381.1, respectively. (2, 3).
1.2 This guide covers the use of ionizing radiation to eliminate or reduce the numbers of vegetative, pathogenic microorganisms
and parasites, and to extend the refrigerated shelf-life of those products by reducing the numbers of spoilage microorganisms in
fresh, frozen, or processed meat and poultry. The absorbed dose for this application is typically less than 10 kGy.10 kGy.
1.2.1 This guide covers gamma, electron beam, and X-radiation treatment.
1.3 This guide addresses irradiation of pre-packaged product for retail sale or for use as an ingredient in other products. It also
addresses the in-line irradiation of unpackaged product. Other specific ISO and ASTM standards exist for the irradiation of food.
In those areas covered by ISO 14470, that standard takes precedence.
This guide is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.05 on Food Irradiation.
Current edition approved Feb. 1, 2016Jan. 15, 2022. Published March 2016February 2022. Originally approved in 1991. Last previous edition approved in 20082016 as
F1356 – 08.F1356 – 16. DOI: 10.1520/F1356-16.10.1520/F1356-22.
The boldface numbers in parentheses refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1356 − 22
1.4 This document is one of a set of standards that provides recommendations for properly implementing and utilizing radiation
processing. It is intended to be read in conjunction with ISO/ASTM 52628.
1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
E170E3083 Terminology Relating to Radiation Measurements Processing: Dosimetry and DosimetryApplications
F1416 Guide for Selection of Time-Temperature Indicators
F1640 Guide for Selection and Use of Contact Materials for Foods to Be Irradiated
2.2 ISO/ASTM Standards:
51261 Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
51539 Guide for Use of Radiation-Sensitive Indicators
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and
7.5 MeV
51649 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 keV and 25 MeV
51702 Practice for Dosimetry in a Gamma Facility for Radiation Processing
51818 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV
52303 Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
52628 Practice for Dosimetry in Radiation Processing
52701 Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing
2.3 Codex Alimentarius Commission Recommended International Codes and Standards:
CAC/RCP 1-1969, Rev. 4-2003, Recommended International Code of Practice—General Principles of Food Hygiene including
Annex on Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application
CAC/RCP 19-1979, Rev. 2003, Recommended International Code of Practice for the Radiation Processing of Food
CX STAN 1-1985, Rev. 2010, General Standard for the Labeling of Prepackaged Foods
CX STAN 106, Rev. 2003, General Standard for Irradiated Food
CAC/MISC 5-1993, Amd. 2003, Glossary of Terms and Definitions (Veterinary Drug Residues in Food)
CAC/GL21-1997, Rev. 2013, Principles and Guidelines for the Establishment and Application of Microbiological Criteria
Related to Food
2.4 ISO Standard
ISO 12749-4 Nuclear energy — Vocabulary — Part 4: Dosimetry for radiation processing
ISO 14470-2011 Food irradiation-requirements for the development, validation and routine control of the process of irradiation
using ionizing radiation for the treatment of food
2.5 International Commission on Radiation Units and Measurements (ICRU) Reports:
ICRU Report 80 Dosimetry Systems for Use in Radiation Processing
ICRU Report 85a Fundamental Quantities and Units for Ionizing Radiation
2.6 Joint Committee for Guides in Metrology (JCGM) Reports:
JCGM 100:2008, GUM 1995 with minor corrections, Evaluation of measurement data - Guide to the Expression of Uncertainty
in Measurement
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book
of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from the Joint FAO/WHO Food Standards Programme, Joint Office, FAO, Via delle Terme di Caracalla, 00100 Rome, Italy.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Available from International Commission on Radiation Units and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
Document produced by Working Group 1 of the Joint Committee for Guides in Metrology (JCGM WG1). Available free of charge at the BIPM website
(http://www.bipm.org).
F1356 − 22
JCGM 200:2012 VIM International Vocabulary of Metrology—Basic and General Concepts and Associated Terms
3. Terminology
3.1 Definitions:
3.1.1 Other terms used in this guide may be defined in Terminology E170.
3.1.1 absorbed dose—quotient of dɛ¯ by dm, where dɛ¯ is the mean energy imparted by ionizing radiation to matter of mass dm,
thus
¯
D 5 dϵ⁄dm (1)
3.1.1.1 Discussion—
The SI unit of absorbed dose is the gray (Gy), where 1 gray is equivalent to the absorption of 1 joule per kilogram of the specified
material (1 Gy = 1 J/kg).
3.1.2 D value—absorbed dose required to reduce the microbial population in a given food by 90 %.
3.1.3 dose distribution—variation in absorbed dose within a process load exposed to ionizing radiation.
3.1.4 process load—volume of material with a specified loading configuration irradiated as a single entity.
3.1.5 transport system—conveyor or other mechanical system used to move the process load through the irradiator.
3.2 Definitions of other terms used in this standard that pertain to radiation measurement and dosimetry may be found in
ISO/ASTM Practice 52628. Other terms that pertain to radiation measurement and dosimetry may be found in ASTM Terminology
E3083 and ISO Terminology ISO 12749-4. Where appropriate, definitions used in these standards have been derived from, and are
consistent with, definitions in ICRU Report 85a and general metrological definitions given in the VIM.
4. Significance and Use
4.1 The principal purpose of irradiation is to help ensure the safety of these foods for human consumption. Irradiation significantly
reduces the numbers of pathogenic bacteria such as Campylobacter,Shiga toxin-Producing E coli,Listeria monocytogenes,
Salmonella,Staphylococcus aureus, and Yersinia enterocolitica.
NOTE 3—Ionizing radiation doses below 10 kGy will reduce but may not eliminate spores of pathogenic bacteria uncludingincluding those of Clostridium
botulinum,Clostridium perfringens, and Bacillus cereus.
4.2 The process also inactivates parasites such as Trichinella spiralis and Toxoplasma gondii.
4.3 The process may extend the shelf life of fresh meat and poultry by reducing the numbers of viable, spoilage bacteria, such
as Pseudomonas species and lactic acid bacilli.
4.4 Radiation processing of fresh, frozen, or processed meat and poultry is a critical control point (CCP) of a Hazard Analysis of
Critical Control Points (HACCP) program. It serves as an important measure to control any residual risk from pathogenic
microorganisms before the product reaches the consumer (4).
4.5 The “Recommended International Code of Practice for Radiation Processing of Food” (CAC/RCP 19-1979) of the Codex
Alimentarius identifies the essential practices to be implemented to achieve effective radiation processing of food, in general, in
a manner that maintains quality and yields food products that are safe and suitable for consumption.
5. Criteria for Assessing Process Control and Irradiation Efficacy
5.1 Process Control System—The criterion should be that hazard analysis and critical control point (HACCP) system or another
Document produced by Working Group 2 of the Joint Committee for Guides in Metrology (JCGM WG2). Available free of charge at the BIPM website
(http://www.bipm.org).
F1356 − 22
similar process control system is applied to the entire processing and distribution chain. With this system, any point in the chain
where a hazardous or critical situation could result is monitored and controlled to prevent unsafe and unwholesome product from
reaching the consumer. See CAC/RCP 1 and (4, 5). Failure to meet these criteria should be investigated, to assess the efficacy of
standard operating procedures (see 8.1) and the re-establishment, if necessary, of Good Manufacturing Practice (GMPs).
5.1.1 Implementation of a process control system (see 4.4) to assess radiation-processing efficacy should include bacteriological
examination of the product before and after irradiation, use of time/temperature indicators throughout the processing chain (see
Guide F1416), and testing of package integrity. Irradiation efficacy has to be validated to ensure that the minimum absorbed dose
delivered (see 8.3–8.4) to the product is able to achieve the minimum reduction in target microbial organisms that is expected. The
target organism(s) have to be identified prior to this validation. Bacteriological testing after specific irradiation doses should yield
a predicted decline in viable counts of the target pathogen(s). Temperature monitoring should provide an alert of any product abuse
that could result in increases in bacterial counts after irradiation.
5.2 Criteria for Irradiation Treatment:
5.2.1 Irradiation for Control of Pathogenic Bacteria—The criterion should be that the irradiation treatment is able to reduce the
number of pathogenic bacteria in the meat or poultry, such that they are no longer able to cause illness. Determining whether a
specified irradiation treatment will reduce the likelihood of illness can only be based on a formal quantitative microbial risk
assessment (QMRA) approach (6, 7). The numbers of pathogenic bacteria that can result in an infectious product vary with the
specific bacterium.
NOTE 4—Susceptibility of a person to pathogenic bacteria varies and is based on the health of the individual and the virulence of the particular strain of
the pathogen (8, 9).
5.2.2 Irradiation for Inactivation of Parasites—The criterion should be that the parasites in uncooked, irradiated product are
noninfectious or noninvasive, as appropriate.
5.2.3 Irradiation for Shelf-Life Extension—The 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, customer
specifications, or both, are known. Therefore, the final product specification regarding bacterial plate count should be established
by the food producer or food processor.
6. Pre-Irradiation Product Handling
6.1 Product handling should be under conditions that protect the product against physical, chemical, or biological hazards.
Microbial contamination and growth should be minimized by following relevant standards of GMPs; see for example U.S. Food
and Drug Administration (FDA) GMPs (10), U.S. Food Safety and Inspection Service (FSIS) Standard Sanitary Operating
Procedures (SSOPs) (11), CAC Recommended International Codes of Practice, (CAC/RCP 1 (see 2.3) and HACCP) (4, 5, 12).
6.2 Unpackaged Product—In facilities handling unpackaged product, the irradiation environment and equipment should be
designed and constructed to be cleanable and durable to maintain a sanitary condition and, thereby, not increase the risk of
contamination.
NOTE 5—An operating environment with high moisture or airflow may contribute to the risk of bacterial contamination. Moisture provides a growth
medium for bacteria and airflow provides a means of transport for bacteria. Food contact surfaces may contribute chemical or physical contaminants to
products unless such surfaces are fabricated from appropriate materials and properly maintained and cleaned. Also, employee hygiene and pest control
should be closely monitored.
6.3 Pre-Packaged Product—For pre-packaged product, the package itself provides a barrier that helps to reduce the risk of
recontamination. Thus, many of the requirements for the irradiation environment and equipment necessary for handling
unpackaged product may not be applicable for facilities handling only pre-packaged product. Information on applicable
requirements should be obtained from the appropriate regulatory authorities before starting operations.
6.4 Pre-Irradiation Inspection—Packages and containers of fresh, frozen, or processed meat and poultry should be inspected upon
receipt at the irradiation facility to ensure that the product is suitable for irradiation. Written acceptance criteria for product
temperature, package integrity and inspection frequency, as applicable, should be established by the product owner and agreed to
by management of the irradiation facility prior to accepting product from the owner. Also, criteria for handling of product
unsuitable for irradiation should be established.
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6.4.1 Product Temperature—Upon receipt of product, its temperature should be measured using a calibrated sanitized
temperature-sensing device, at a predetermined location and frequency as specified by HACCP and GMPs. Temperature should be
between –2–2 °C and +4°C+4 °C for refrigerated fresh or processed meat and poultry or –18°C–18 °C or lower for frozen meat
and poultry. For unpackaged product, insert the device directly into the product and sanitize the device between each measurement.
For prepackaged product, use a device that can be placed between individual packages without puncturing them.
6.4.2 Package Integrity—A visual inspection of the product packaging should be performed to ensure there is no evidence of
compromised or damaged product. Also, a sensory inspection should be performed. No leakage of fluids or odor indicative of
product spoilage should be evident upon inspection.
6.4.3 Product Inventory—The number of containers should be counted and the description/identification of the product to be
irradiated should be verified and compared with the documentation from the product owner. A comparison of this pre-irradiation
count with a count performed after irradiation provides a check that all products received have been irradiated.
6.4.4 Product Identification—A unique identification number for tracking the product throughout the irradiation process should be
issued and documented for the incoming product.
6.5 Pre-Irradiation Storage:
6.5.1 Refrigerated Fresh or Processed Meats and Poultry—The principal requirement for pre-irradiation storage is to maintain
product temperature between –2–2 °C and +4°C+4 °C without freezing. Whenever possible, the pre-irradiation storage at the
irradiation facility should be minimized to one day or less.
NOTE 6—U.S.A. poultry regulations presently require that the temperature of fresh poultry be maintained at or below 4.4°C4.4 °C (12).
NOTE 7—Holding product under refrigeration for an unduly long time would violate principles of GMPs because such treatment may result in excessive
growth of psychrotrophic bacteria and undesirable changes in products.
6.5.2 Frozen Meats and Poultry—The product temperature should be maintained at or below –18°C–18 °C at all times.
6.6 Product Segregation—Distinguishing irradiated from un-irradiated product by visual inspection might not be possible.
Therefore, it is important that appropriate means integral to the facility design, such as physical barriers or clearly defined staging
areas, be used to maintain un-irradiated product separate from irradiated product.
NOTE 8—Radiation-sensitive indicators undergo a color change when exposed to radiation in the pertinent dose range. These indicators may be useful
within the irradiation facility to provide a visual check for determining whether or not product has been exposed to the radiation source. They are not
dosimeters intended for measuring absorbed dose and must not be used as a substitute for proper dosimetry. Information about dosimetry systems and
the proper use of radiation-sensitive indicators is provided in ISO/ASTM Practice 52628 and ISO/ASTM GuideGuides 51539 and 52701, respectively.
7. Packaging and Product Loading Configuration
7.1 Packaging Materials:
7.1.1 Use packaging materials suitable to the product, that take into account planned processing (including irradiation) and is
consistent with regulatory requirements (see Guide F1640).
7.1.2 Packaging materials should provide appropriate gas and moisture permeability to maintain product quality.
NOTE 9—There are mechanisms other than bacterial action that cause meat spoilage. These are largely chemical in nature and generally involve oxidation
of the product, resulting in discoloration and rancidity. Other measures in addition to irradiation may be necessary to obtain a satisfactory product. Where
applicable, a package providing a reduced oxygen environment (for example, vacuum packaging) minimizes such effects.
NOTE 10—Fresh meats, especially the more highly pigmented ones such as beef, ordinarily require the presence of oxygen in order to maintain their
normal red color. The use of vacuum packaging and oxygen-impermeable films causes meat to darken in the package, although the normal red color will
return when the package is opened. For the less pigmented meat and for poultry, the color change resulting from vacuum packaging is less significant.
7.2 Product Loading Configuration:
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7.2.1 The size, shape, density and loading configuration of a process load to be irradiated should be determined primarily by
considering design parameters of the irradiation facility. Critical design parameters include the characteristics of product transport
systems and of the radiation source as they relate to the dose distribution determined within the process load.
7.2.2 The dose distribution within the process load can often be optimized by using product packages that are geometrically well
defined and uniformly loaded. With certain irradiation facilities, it may be necessary to limit the use of particular package shapes
and sizes depending on the density of the product and facility operational qualification (OQ) data (see ISO/ASTM 51608, 51649,
51702, and 51818).
7.2.3 Prescribed product dose specifications should be taken into account when determining the appropriate product-loading
configuration (see 8.4).
8. Irradiation
8.1 Standard Operating Procedures (SOPs)—A standard operating procedure for food irradiation is a documented procedure that
is used to ensure that the technologically established dose range and irradiation conditions selected by the radiation processor are
achievable in a specific facility. The procedures should be established and validated by qualified persons having knowledge in
irradiation requirements specific to the food and the irradiation facility (13). The procedures should meet the requirements of CX
STAN 106 and should follow the recommendations of CAC/RCP 19, including installation qualification (IQ), operational
qualification (OQ), and performance qualification (PQ).19.
8.1.1 Installation qualification, operational qualification, performance qualification, and process control should be performed
following the requirements of ISO/ASTM Practice 51702, ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, or ISO/ASTM
Practice 51818.
8.2 Ra
...