ASTM F1736-21
(Guide)Standard Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms
Standard Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms
SIGNIFICANCE AND USE
4.1 Absorbed doses of or below 1 kGy can inactivate some parasites, such as the broad fish tapeworm (Dibothrocephalus latus) (2).
4.2 Absorbed doses below 10 kGy can reduce or eliminate vegetative cells of pathogenic sporeforming and non-sporeforming microorganisms, such as Clostridium spp., Vibrio spp., Salmonellae, Listeria monocytogenes, or Staphylococcus aureus, that may be present in fresh or frozen product.
4.2.1 Absorbed doses below 10 kGy can reduce the numbers of some spores, but are not adequate to reduce the potential health risk from microbial spores or toxins (3).
4.3 Absorbed doses below 10 kGy can reduce or eliminate the vegetative cells of sporeforming and non-sporeforming microorganisms, such as Bacillus or Pseudomonas species, that cause spoilage of fresh product, thus extending refrigerated shelf life in many cases (4).
SCOPE
1.1 This guide outlines procedures and operations for the irradiation of raw, untreated, fresh (chilled), or frozen finfish and aquatic invertebrates, while ensuring that the irradiated product is safe and wholesome.
1.1.1 Aquatic invertebrates include mollusks, crustacea, echinoderms, etc.
1.1.1.1 Mollusks include bivalve shellfish, such as clams, mussels, and oysters; snails; and cephalopods, such as squid and 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 cucumbers.
1.2 This guide covers absorbed doses used to reduce the microbial and parasite populations in aquatic invertebrates and finfish. Such doses typically are below 10 kGy (1).2
1.2.1 This guide covers gamma, electron beam, and X-radiation treatment.
1.3 The use of reduced-oxygen packaging (vacuum or modified atmosphere, and including products packed in oil) with irradiated, raw product is not covered by this guide. The anaerobic environment created by reduced-oxygen packaging provides the potential for outgrowth of, and toxin production from, Clostridium botulinum spores.
1.4 This guide does not cover the irradiation of smoked or dried fish to reduce microbial load or to control insect infestation.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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 Practice 52628.
1.7 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.
1.8 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
- 30-Jun-2021
- Technical Committee
- E61 - Radiation Processing
- Drafting Committee
- E61.05 - Food Irradiation
Relations
- Effective Date
- 01-Mar-2019
- Refers
ASTM E3083-17 - Standard Terminology Relating to Radiation Processing: Dosimetry and Applications - Effective Date
- 01-Oct-2017
- Effective Date
- 01-Apr-2014
- Effective Date
- 01-Feb-2009
- Effective Date
- 01-Oct-2008
- Effective Date
- 01-Oct-2003
- Effective Date
- 10-Feb-1996
- Effective Date
- 01-Jan-1996
- Effective Date
- 10-Sep-1995
Overview
ASTM F1736-21 is the Standard Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms, published by ASTM International. This standard outlines best practices, procedures, and operational guidelines for the irradiation of raw, untreated, fresh (chilled), or frozen finfish and aquatic invertebrates-including mollusks, crustaceans, and echinoderms. The purpose of irradiation under this standard is to enhance food safety and quality by reducing or eliminating pathogenic microorganisms and parasites, as well as spoilage organisms, while ensuring the product remains wholesome and safe for consumption.
The guide is intended for use where food irradiation is authorized by regulatory bodies. It is not a prescriptive document but sets out recommended procedures for achieving effective microbial control while preserving sensory and nutritional qualities of seafood.
Key Topics
Scope of Application
- Covers irradiation of fresh or frozen finfish (both wild-caught and farm-raised) and aquatic invertebrates
- Includes mollusks (clams, mussels, oysters, squid), crustacea (shrimp, lobster, crabs, prawns), and echinoderms (sea urchins, sea cucumbers)
- Addresses absorbed radiation doses typically below 10 kGy for microbial and parasite reduction
Irradiation Process
- Utilizes gamma rays, electron beams, or X-radiation as ionizing sources
- Aims to inactivate pathogens like Clostridium spp., Vibrio spp., Salmonellae, Listeria monocytogenes, and parasites such as the broad fish tapeworm
- Focuses on maintaining product temperature and minimizing pre- and post-irradiation contamination
Operational Guidelines
- Emphasizes Good Manufacturing Practices (GMPs) throughout harvesting, storage, packaging, irradiation, and distribution
- Highlights traceability and comprehensive documentation, including lot tracking, dosimetry records, and labeling requirements
- Recommends regular auditing and corrective action procedures to ensure compliance and food safety
Limitations
- Does not cover the use of reduced-oxygen packaging with irradiated raw product due to potential risks of Clostridium botulinum growth
- Excludes irradiation for smoked or dried fish targeting insect infestation or microbial load
- Stresses the necessity to consider chemical spoilage in addition to microbial safety
Applications
Implementing ASTM F1736-21 provides practical value for:
- Seafood Processors seeking to reduce foodborne pathogen risks and extend refrigerated shelf life through validated irradiation treatments.
- Irradiation Facilities requiring standardized operational procedures for the safe irradiation of finfish and aquatic invertebrates.
- Food Safety Authorities evaluating compliance with international food irradiation practices for export, import, or domestic markets.
- Quality Assurance Managers responsible for integrating dosimetry, traceability, and GMPs to ensure consistent food safety outcomes.
- Logistics and Supply Chain professionals involved in the storage, handling, and documentation of seafood before and after irradiation treatments.
By following the guidance of ASTM F1736-21, stakeholders in the seafood industry can achieve crucial objectives such as reducing public health risks, complying with international food safety standards, and preserving product quality throughout the distribution chain.
Related Standards
Several key standards and codes complement ASTM F1736-21, providing technical and regulatory context:
- ISO/ASTM 52628 – Practice for Dosimetry in Radiation Processing
- Codex Stan 106 – Codex General Standard for Irradiated Foods
- Codex Codes of Practice – Including standards for fresh fish, frozen fish, shellfish, shrimps and prawns, product labeling, and hygienic practices
- ISO 12749-4 – Nuclear Energy Vocabulary: Dosimetry for Radiation Processing
- ASTM F1640 – Guide for Contact Materials for Foods to Be Irradiated
- ISO/ASTM 51702, 51608, 51649 – Practices for dosimetry and operations in gamma, X-ray, and electron beam irradiation facilities
Utilizing ASTM F1736-21 in conjunction with these related standards promotes harmonized, science-based food irradiation practices that align with international trade and regulatory requirements.
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Frequently Asked Questions
ASTM F1736-21 is a guide published by ASTM International. Its full title is "Standard Guide for Irradiation of Finfish and Aquatic Invertebrates Used as Food to Control Pathogens and Spoilage Microorganisms". This standard covers: SIGNIFICANCE AND USE 4.1 Absorbed doses of or below 1 kGy can inactivate some parasites, such as the broad fish tapeworm (Dibothrocephalus latus) (2). 4.2 Absorbed doses below 10 kGy can reduce or eliminate vegetative cells of pathogenic sporeforming and non-sporeforming microorganisms, such as Clostridium spp., Vibrio spp., Salmonellae, Listeria monocytogenes, or Staphylococcus aureus, that may be present in fresh or frozen product. 4.2.1 Absorbed doses below 10 kGy can reduce the numbers of some spores, but are not adequate to reduce the potential health risk from microbial spores or toxins (3). 4.3 Absorbed doses below 10 kGy can reduce or eliminate the vegetative cells of sporeforming and non-sporeforming microorganisms, such as Bacillus or Pseudomonas species, that cause spoilage of fresh product, thus extending refrigerated shelf life in many cases (4). SCOPE 1.1 This guide outlines procedures and operations for the irradiation of raw, untreated, fresh (chilled), or frozen finfish and aquatic invertebrates, while ensuring that the irradiated product is safe and wholesome. 1.1.1 Aquatic invertebrates include mollusks, crustacea, echinoderms, etc. 1.1.1.1 Mollusks include bivalve shellfish, such as clams, mussels, and oysters; snails; and cephalopods, such as squid and 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 cucumbers. 1.2 This guide covers absorbed doses used to reduce the microbial and parasite populations in aquatic invertebrates and finfish. Such doses typically are below 10 kGy (1).2 1.2.1 This guide covers gamma, electron beam, and X-radiation treatment. 1.3 The use of reduced-oxygen packaging (vacuum or modified atmosphere, and including products packed in oil) with irradiated, raw product is not covered by this guide. The anaerobic environment created by reduced-oxygen packaging provides the potential for outgrowth of, and toxin production from, Clostridium botulinum spores. 1.4 This guide does not cover the irradiation of smoked or dried fish to reduce microbial load or to control insect infestation. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 Practice 52628. 1.7 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. 1.8 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.
SIGNIFICANCE AND USE 4.1 Absorbed doses of or below 1 kGy can inactivate some parasites, such as the broad fish tapeworm (Dibothrocephalus latus) (2). 4.2 Absorbed doses below 10 kGy can reduce or eliminate vegetative cells of pathogenic sporeforming and non-sporeforming microorganisms, such as Clostridium spp., Vibrio spp., Salmonellae, Listeria monocytogenes, or Staphylococcus aureus, that may be present in fresh or frozen product. 4.2.1 Absorbed doses below 10 kGy can reduce the numbers of some spores, but are not adequate to reduce the potential health risk from microbial spores or toxins (3). 4.3 Absorbed doses below 10 kGy can reduce or eliminate the vegetative cells of sporeforming and non-sporeforming microorganisms, such as Bacillus or Pseudomonas species, that cause spoilage of fresh product, thus extending refrigerated shelf life in many cases (4). SCOPE 1.1 This guide outlines procedures and operations for the irradiation of raw, untreated, fresh (chilled), or frozen finfish and aquatic invertebrates, while ensuring that the irradiated product is safe and wholesome. 1.1.1 Aquatic invertebrates include mollusks, crustacea, echinoderms, etc. 1.1.1.1 Mollusks include bivalve shellfish, such as clams, mussels, and oysters; snails; and cephalopods, such as squid and 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 cucumbers. 1.2 This guide covers absorbed doses used to reduce the microbial and parasite populations in aquatic invertebrates and finfish. Such doses typically are below 10 kGy (1).2 1.2.1 This guide covers gamma, electron beam, and X-radiation treatment. 1.3 The use of reduced-oxygen packaging (vacuum or modified atmosphere, and including products packed in oil) with irradiated, raw product is not covered by this guide. The anaerobic environment created by reduced-oxygen packaging provides the potential for outgrowth of, and toxin production from, Clostridium botulinum spores. 1.4 This guide does not cover the irradiation of smoked or dried fish to reduce microbial load or to control insect infestation. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 Practice 52628. 1.7 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. 1.8 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.
ASTM F1736-21 is classified under the following ICS (International Classification for Standards) categories: 67.120.30 - Fish and fishery products. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F1736-21 has the following relationships with other standards: It is inter standard links to ASTM F1416-96(2019), ASTM E3083-17, ASTM F1416-96(2014), ASTM F1640-09, ASTM F1416-96(2008), ASTM F1640-03, ASTM F1416-96(2003), ASTM F1416-96, ASTM F1640-95(2001). Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F1736-21 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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: F1736 −21
Standard Guide for
Irradiation of Finfish and Aquatic Invertebrates Used as
Food to Control Pathogens and Spoilage Microorganisms
This standard is issued under the fixed designation F1736; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber 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 for eliminating
or reducing the number of pathogenic microorganisms and parasites and for reducing the number of
spoilage microorganisms on finfish and aquatic invertebrates. Information on the handling of finfish
and aquatic invertebrates before receipt by the irradiation facility and after shipment from the facility
is also provided.
The food commodities covered by this standard can include, but are not limited to: molluscan
shellfish,crustaceanshellfish,finfish,andflatfish,includingthosethataresaltwater,freshwater,wild
caught and farm-raised.
This guide is intended to serve as a set of recommendations to be followed when using irradiation
technology where approved by an appropriate regulatory control 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 is based on a guideline published by the International Consultative Group on Food
Irradiation (ICGFI) at the initiation of the Joint Food and Agriculture Organization/International
Atomic EnergyAgency Division of NuclearTechniques in Food andAgriculture, which serves as the
Secretariat to the ICGFI.
1. Scope 1.2 This guide covers absorbed doses used to reduce the
microbial and parasite populations in aquatic invertebrates and
1.1 This guide outlines procedures and operations for the 2
finfish. Such doses typically are below 10 kGy (1).
irradiation of raw, untreated, fresh (chilled), or frozen finfish
1.2.1 This guide covers gamma, electron beam, and
and aquatic invertebrates, while ensuring that the irradiated
X-radiation treatment.
product is safe and wholesome.
1.3 The use of reduced-oxygen packaging (vacuum or
1.1.1 Aquatic invertebrates include mollusks, crustacea,
modified atmosphere, and including products packed in oil)
echinoderms, etc.
with irradiated, raw product is not covered by this guide. The
1.1.1.1 Mollusks include bivalve shellfish, such as clams,
anaerobic environment created by reduced-oxygen packaging
mussels, and oysters; snails; and cephalopods, such as squid
provides the potential for outgrowth of, and toxin production
and octopus.
from, Clostridium botulinum spores.
1.1.1.2 Crustacea include shellfish such as shrimp, lobster,
1.4 This guide does not cover the irradiation of smoked or
crabs, prawns and crayfish.
dried fish to reduce microbial load or to control insect
infestation.
1.1.1.3 Echinoderms include sea urchins and sea cucum-
bers.
1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
standard.
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
1.6 This document is one of a set of standards that provides
Processing and is the direct responsibility of Subcommittee E61.05 on Food
recommendations for properly implementing and utilizing
Irradiation.
Current edition approved July 1, 2021. Published August 2021. Originally
approved in 1996. Last previous edition approved in 2016 as F1736–09 (2016). Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
DOI: 10.1520/F1736-21. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1736 − 21
radiation processing. It is intended to be read in conjunction CAC/RCP 16Recommended International Code of Practice
with ISO/ASTM Practice 52628. for Frozen Fish
CAC/RCP17 RecommendedInternationalCodeofPractice
1.7 This standard does not purport to address all of the
for Shrimps and Prawns
safety concerns, if any, associated with its use. It is the
CAC/RCP 18Recommended International Code of Hy-
responsibility of the user of this standard to establish appro-
gienic Practice for Molluscan Shellfish
priate safety, health, and environmental practices and deter-
CAC/RCP 24Recommended International Code of Practice
mine the applicability of regulatory limitations prior to use.
for Lobsters
1.8 This international standard was developed in accor-
CAC/RCP27 RecommendedInternationalCodeofPractice
dance with internationally recognized principles on standard-
for Minced Fish Prepared by Mechanical Separation
ization established in the Decision on Principles for the
CAC/RCP 28Recommended International Code of Practice
Development of International Standards, Guides and Recom-
for Crabs
mendations issued by the World Trade Organization Technical
CAC/RCP37 RecommendedInternationalCodeofPractice
Barriers to Trade (TBT) Committee.
for Cephalopods
CAC/RCP20CodeofEthicsforInternationalTradeinFood
2. Referenced Documents
CAC/RCP42Sampling Plans for Prepackaged Foods (AQL
2.1 ASTM Standards:
6.5)
E3083Terminology Relating to Radiation Processing: Do-
2.4 ISO Standards:
simetry and Applications
ISO 12749-4Nuclear energy – Vocabulary – Part 4: Dosim-
F1416Guide for Selection of Time-Temperature Indicators
etry for radiation processing
F1640Guide for Selection and Use of Contact Materials for
2.5 International Commission on Radiation Units and Mea-
Foods to Be Irradiated
surements (ICRU) Reports:
2.2 ISO/ASTM Standards:
ICRU Report 80Dosimetry Systems for Use in Radiation
51261Practice for Calibration of Routine Dosimetry Sys-
Processing
tems for Radiation Processing
ICRU Report 85aFundamental Quantities and Units for
51539Guide for Use of Radiation-Sensitive Indicators
Ionizing Radiation
51608PracticeforDosimetryinanX-Ray(Bremsstrahlung)
2.6 Joint Committee for Guides in Metrology (JCGM)
Facility for Radiation Processing at Energies between 50
Reports:
keV and 7.5 MeV
JCGM100:2008,GUM1995,withminorcorrectionsEvalu-
51649Practice for Dosimetry in an Electron Beam Facility
ation of measurement date – Guide to the Expression of
for Radiation Processing at Energies Between 300 keV
Uncertainty in Measurement
and 25 MeV
JCGM 200:2012,VIM International Vocabulary of Metrol-
51702Practice for Dosimetry in a Gamma Facility for
ogy – Basic and General Concepts andAssociatedTerms
Radiation Processing
52303Guide forAbsorbed-Dose Mapping in Radiation Pro-
3. Terminology
cessing Facilities
3.1 Definitions:
52628Practice for Dosimetry in Radiation Processing
3.1.1 absorbed dose—quotient of dɛ¯bydm, where dɛ¯ is the
52701Guide for Performance Characterization of Dosim-
mean energy imparted by ionizing radiation to matter of mass
eters and Dosimetry Systems for Use in Radiation Pro-
dm, thus
cessing
D 5dε¯ ⁄dm
2.3 Codex Alimentarius Commission Recommended Inter-
3.1.1.1 Discussion—TheSIunitofabsorbeddoseisthegray
national Codes and Standards:
(Gy),where1grayisequivalenttotheabsorptionof1jouleper
CAC/RCP 1-1985, Rev. 1991, and 2001General Standard
kilogram of the specified material (1 Gy=1J/ kg).
for the Labelling of Prepackaged Foods
CAC/RCP 19-1979, Rev. 2003Recommended International
3.1.2 absorbed dose mapping—measurement of absorbed
CodeofPracticefortheOperationofIrradiationFacilities
dose within an irradiated product to produce a one-, two-, or
for the Treatment of Foods
three-dimensionaldistributionofabsorbeddose,thusrendering
CAC/RCP 106-1983, Rev. 2003General Standard for Irra-
a map of absorbed dose values.
diated Foods
CAC/RCP 9Recommended International Code of Practice
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
for Fresh Fish
4th Floor, New York, NY 10036, http://www.ansi.org.
Available from International Commission on Radiation Units and Measure-
ments (ICRU), 7910 Woodmont Ave., Suite 400, Bethesda, MD 20841-3095,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or http://www.icru.org.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM DocumentproducedbyWorkingGroup1oftheJointCommitteeforGuidesin
Standards volume information, refer to the standard’s Document Summary page on Metrology (JCGM WG1). Available free of charge at the BIPM website (http://
the ASTM website. www.bipm.org).
4 8
Available from Joint FAO/WHO Food Standards Program, Joint Office, Food DocumentproducedbyWorkingGroup2oftheJointCommitteeforGuidesin
and Agriculture Organization of the United Nations, Via delle Terme di Caracalla, Metrology (JCGM WG2). Available free of charge at the BIPM website (http://
00100 Rome, Italy. www.bipm.org).
F1736 − 21
3.1.3 dose distribution—variation in absorbed dose within a 5.3 Deliver product to the irradiation facility without delay,
process load exposed to ionizing radiation. such that irradiation occurs as close to the time of harvest as
possible. Products approaching the end of their shelf life
3.1.4 good manufacturing practice (GMP)—procedure es-
should not be irradiated in an attempt to extend that shelf life.
tablished and exercised throughout the production, manufac-
NOTE 1—While irradiation can improve finfish and aquatic inverte-
turing processing, packing, and distribution of foods, encom-
brates from a public health aspect by reducing the microbial and parasite
passing maintenance of sanitation system, quality control and
populations within product, chemical reactions (for example, oxidative
assurance, qualification of personnel and other relevant
degradation) that cause product to spoil also need to be considered when
activities, to ensure the delivery of commercially acceptable assessing the appropriateness of radiation treatment (6).
and safe product.
6. Packaging and Product Loading Configuration
3.1.5 process load—volume of material with a specified
product loading configuration irradiated as a single entity.
6.1 Packaging:
6.1.1 Guide F1640 provides guidance on packaging mate-
3.1.6 transport system—the conveyor or other mechanical
rials in contact with food during irradiation.
means used to move the process load through the irradiator.
3.2 Definitions of other terms used in this standard that 6.2 Appropriate packaging materials should be used for
pertain to radiation measurement and dosimetry may be found safeguarding the product as part of the effort to ensure product
in ISO/ASTM Practice 52628. Other terms that pertain to integrity (for example, see Ref (5)).
radiation measurement and dosimetry may be found in Termi-
6.3 Product Loading Configuration:
nology E3083 and ISO Terminology 12749-4. Where
6.3.1 Thesize,shape,andloadingconfigurationofaprocess
appropriate, definitions used in these standards have been
loadforthecommoditiestobeirradiatedshouldbedetermined
derived from, and are consistent with definitions in ICRU
primarily by considering design parameters of the irradiation
Report 85a, and general metrological definitions given in the
facility (see ISO/ASTM 51608, 51649, and 51702). Critical
VIM.
irradiation parameters include the characteristics of product
transport systems and of the radiation source as they relate to
4. Significance and Use
the dose distribution obtained within the process load. These
4.1 Absorbed doses of or below 1 kGy can inactivate some
parameters and product dose specifications should be taken
parasites, such as the broad fish tapeworm (Dibothrocephalus
into account in determining the size, shape and loading
latus) (2).
configuration of a process load (8.1).
4.2 Absorbed doses below 10 kGy can reduce or eliminate
7. Pre-Irradiation Product Handling
vegetative cells of pathogenic sporeforming and non-
sporeformingmicroorganisms,suchasClostridiumspp.,Vibrio
7.1 Inspect product as soon as it arrives at the radiation
spp., Salmonellae, Listeria monocytogenes,or Staphylococcus
processing facility to determine that it has been properly
aureus, that may be present in fresh or frozen product.
handled prior to arrival.
4.2.1 Absorbeddosesbelow10kGycanreducethenumbers
7.2 Temperature Control of Product:
of some spores, but are not adequate to reduce the potential
7.2.1 The temperature of fresh product, excluding
health risk from microbial spores or toxins (3).
unshucked, live molluscan shellfish, received in the chilled
4.3 Absorbed doses below 10 kGy can reduce or eliminate
state should be maintained as close to 0 °C (32 °F) as possible
the vegetative cells of sporeforming and non-sporeforming
in accordance with good manufacturing practices (GMPs).
microorganisms,suchas Bacillusor Pseudomonasspecies,that
Care should be taken to prevent freezing of the product.
cause spoilage of fresh product, thus extending refrigerated
Pre-irradiation storage at the irradiation facility should be
shelf life in many cases (4).
short; less than one day is recommended.
NOTE2—Freshproductisusuallystoredandtransportedundercrushed,
5. Harvest/Raw Material
melting ice. When refrigeration is used, the risk of freezing exists.
5.1 Follow relevant Recommended International Codes of
7.2.2 The temperature of unshucked, live molluscan shell-
Practice(RCP)andStandardsofGoodManufacturingPractice
fish received in the chilled state should be maintained between
oftheCodexAlimentariusCommission(CAC)formaintaining
4 °C (39 °F) and 7 °C (45 °F) in accordance with GMPs.
theinitialqualityofthefreshorfrozenproductduringhandling
Pre-irradiation storage at the irradiation facility should be
from the time of harvest through the time of sale to the
short; less than one day is recommended.
consumer (5). See CAC/RCP 9, CAC/RCP 16, CAC/RCP 17,
CAC/RCP 18, CAC/RCP 24, CAC/RCP 27, CAC/RCP 28,
NOTE 3—To maintain unshucked molluscan shellfish in the live state,
CAC/RCP 37, and CAC/RCP 20.
the storage temperature should be above 4 °C (39 °F).
5.2 In handling, preparing, freezing, storing, and thawing 7.2.3 The surface temperature of product received in the
finfish and aquatic invertebrates intended for irradiation, take frozen state should be maintained below −18 °C (0 °F).
precautions at all times to minimize microbial contamination
NOTE 4—Freezing does not provide an unlimited shelf life without loss
and outgrowth. Use standards of hygiene as high as those
of quality, and the pre-irradiation storage period should therefore be
applied in the processing or preparation of product for the
minimized. The effect of frozen storage on product quality will be a
frozen or fresh markets. function of time, temperature, and degree of temperature fluctuation.
F1736 − 21
7.2.4 Handlingandstorageproceduresthatdifferfromthose tions to achieve the intended effect on a specific product in a
described in Sections 5 and 6, especially holding under specific facility. These procedures should be established and
refrigeration for an unduly long time, do not constitute GMP. validated by qualified persons having knowledge in irradiation
Such treatment may result in excessive bacterial growth and requirements specific for the food and the irradiation facility
undesirable changes in the products. (see CAC/RCP 19).
8.2.1 Installation qualification, operational qualification,
7.3 Inspect all shipping documents arriving with the ship-
performance qualification and process control should be per-
ment to verify that they are complete and accurate.
formed following the requirements of ISO/ASTM Practice
7.3.1 The documents should include a lot number or other
51702, ISO/ASTM Practice 51608, or ISO/ASTM Practice
means of traceability (see 12.1).
51649.
7.4 Product Separation—It may not be possible to distin-
8.3 Radiation Sources—The sources of ionizing radiation
guishirradiatedfromnon-irradiatedproductbyinspection.Itis
that may be employed in irradiating food are limited to the
therefore important that appropriate means, such as physical
following (see Codex Stan 106):
barriers, or clearly defined areas, be used to maintain non-
8.3.1 Isotopic Sources—Gamma rays from the radionu-
irradiated product separate from irradiated product.
60 137
clides Co (1.17 and 1.33 MeV) or Cs (0.66 MeV), and
NOTE 5—Radiation-sensitive indicators (RSIs), such as labels, papers,
8.3.2 Machine Sources—X-rays and accelerated electrons.
or inks that undergo a color change when exposed to radiation in the
pertinent dose range are commercially available.These indicators may be
NOTE 6—The Codex Alimentarius Commission, as well as regulations
useful within the irradiation facility as a visual check for determining
in some countries, currently limit the maximum electron energy and
whether or not a product has been exposed to the radiation source. They
nominal X-ray energy for the purpose of food irradiation (Codex Stan
are not dosimeters intended for measuring absorbed dose and must not be
106).
used as a substitute for proper dosimetry. Information about dosimetry
systems and the proper use of RSIs is provided in Guides 51261 and
8.4 Absorbed Dose—Food irradiation specifications may
51539, 52628 and 52701 respectively.
include minimum and maximum absorbed dose limits. A
7.5 Plan preparatory operations for irradiation, such as, but minimum absorbed dose may be specified to ensure that the
intended effect is achieved, and a maximum absorbed dose
not limited to, dosimeter placement and reconfiguration of
product in the product unit, to permit expeditious handling of may be based on government regulations resulting from a
safety assessment or be stipulated to prevent product degrada-
consecutivebatches.Thesepreparatorysteps,inadditiontothe
tion.Foragivenapplication,oneorbothoftheselimitsmaybe
placement of the product on the transport system and the time
prescribed by regulation. It is therefore n
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
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
of the standard as published by ASTM is to be considered the official document.
Designation: F1736 − 09 (Reapproved 2016) F1736 − 21
Standard Guide for
Irradiation of Finfish and Aquatic Invertebrates Used as
Food to Control Pathogens and Spoilage Microorganisms
This standard is issued under the fixed designation F1736; 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 for eliminating
or reducing the number of pathogenic microorganisms and parasites and for reducing the number of
spoilage microorganisms on finfish and aquatic invertebrates. Information on the handling of finfish
and aquatic invertebrates before receipt by the irradiation facility and after shipment from the facility
is also provided.
The food commodities covered by this standard can include, but are not limited to: molluscan
shellfish, crustacean shellfish, fin fish, and flat fish, including those that are saltwater, fresh water, wild
caught and farm-raised.
This guide is intended to serve as a set of recommendations to be followed when using irradiation
technology where approved by an appropriate regulatory control 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 is based on a guideline published by the International Consultative Group on Food
Irradiation (ICGFI) at the initiation of the Joint Food and Agriculture Organization/International
Atomic Energy Agency Division of Nuclear Techniques in Food and Agriculture, which serves as the
Secretariat to the ICGFI.
1. Scope
1.1 This guide outlines procedures and operations for the irradiation of raw, untreated, fresh (chilled), or frozen finfish and aquatic
invertebrates, while ensuring that the irradiated product is safe and wholesome.
1.1.1 Aquatic invertebrates include molluscs,mollusks, crustacea, echinoderms, etc.
1.1.1.1 MolluscsMollusks include bivalve shellfish, such as clams, mussels, and oysters; snails; and cephalopods, such as squid
and 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 cucumbers.
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 June 1, 2016July 1, 2021. Published July 2016August 2021. Originally approved in 1996. Last previous edition approved in 20092016 as
F1736 – 09.F1736 – 09 (2016). DOI: 10.1520/F1736-09R16.10.1520/F1736-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1736 − 21
1.2 This guide covers absorbed doses used to reduce the microbial and parasite populations in aquatic invertebrates and finfish.
Such doses typically are below 10 kGy (1).
1.2.1 This guide covers gamma, electron beam, and X-radiation treatment.
1.3 The use of reduced-oxygen packaging (vacuum or modified atmosphere, and including products packed in oil) with irradiated,
raw product is not covered by this guide. The anaerobic environment created by reduced-oxygen packaging provides the potential
for outgrowth of, and toxin production from, Clostridium botulinum spores.
1.4 This guide does not cover the irradiation of smoked or dried fish to reduce microbial load or to control insect infestation.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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 Practice 52628.
1.7 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 requirementslimitations prior to use.
1.8 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:
51204 Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing
51261 Guide for the Selection and Application of Practice for Calibration of Routine Dosimetry Systems for Radiation
Processing
51539 Guide for Use of Radiation-Sensitive Indicators
5143151608 Practice for Dosimetry in Electron Beam and an X-Ray (Bremsstrahlung) Irradiation Facilities Facility for Food
Processing 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
52303 Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
52628 Practice for Dosimetry in Radiation Processing
5153952701 Guide for Use of Radiation-Sensitive IndicatorsPerformance Characterization of Dosimeters and Dosimetry
Systems for Use in Radiation Processing
2.3 Codex Alimentarius Commission Recommended International Codes and Standards:
Codex Stan 1CAC/RCP 1-1985, Rev. 1991, and 2001 General StandardsStandard for the Labelling of Prepackaged Foods
Codex Stan 19CAC/RCP 19-1979, Rev. 2003 Recommended International Code of Practice for the Operation of Irradiation
Facilities for the Treatment of FoodFoods
Codex Stan 106CAC/RCP 106-1983, Rev. 2003 Codex General Standard for Irradiated Foods
CAC/RCP 9 Recommended International Code of Practice for Fresh Fish
CAC/RCP 16 Recommended International Code of Practice for Frozen Fish
CAC/RCP 17 Recommended International Code of Practice for Shrimps and Prawns
CAC/RCP 18 Recommended International Code of Hygienic Practice for Molluscan Shellfish
The boldface numbers in parentheses refer to the list of references at the end of this standard.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from Joint FAO/WHO Food Standards Program, Joint Office, Food and Agriculture Organization of the United Nations, Via delle Terme di Caracalla, 00100
Rome, Italy.
F1736 − 21
CAC/RCP 24 Recommended International Code of Practice for Lobsters
CAC/RCP 27 Recommended International Code of Practice for Minced Fish Prepared by Mechanical Separation
CAC/RCP 28 Recommended International Code of Practice for Crabs
CAC/RCP 37 Recommended International Code of Practice for Cephalopods
CAC/RCP 20 Code of Ethics for International Trade in Food
CAC/RCP 42 Sampling Plans for Prepackaged Foods (AQL 6.5)
2.4 ISO Standards:
ISO 12749-4 Nuclear energy – Vocabulary – Part 4: Dosimetry for radiation processing
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 date – Guide to the Expression of Uncertainty
in Measurement
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—quantityquotient of ionizingdɛ¯ radiation by dm, where dɛ¯energy imparted per unit mass of specified
material. is the mean energy imparted by ionizing radiation to matter of mass dm, The SIthus
D 5 dε¯ ⁄dm
unit for absorbed dose is the gray (Gy), where one gray is equivalent to the absorption of 1 joule per kilogram of the specified
material (1Gy = 1 J/kg).
3.1.1.1 Discussion—
A standard definitionThe SI unit of absorbed dose appears in Terminologyis the gray E170.(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 absorbed dose mapping—measurement of absorbed dose within an irradiated product to produce a one-, two-, or
three-dimensional distribution of absorbed dose, thus rendering a map of absorbed dose values.
3.1.3 dose distribution—variation in absorbed dose within a process load exposed to ionizing radiation.
3.1.4 good manufacturing practice (GMP)—procedure established and exercised throughout the production, manufacturing
processing, packing, and distribution of foods, encompassing maintenance of sanitation system, quality control and assurance,
qualification of personnel and other relevant activities, to ensure the delivery of commercially acceptable and safe product.
3.1.5 process load—volume of material with a specified product loading configuration irradiated as a single entity.
3.1.6 transport system—the conveyor or other mechanical systemmeans used to move the product to be irradiated 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 Terminology E3083
and ISO Terminology 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.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from International Commission on Radiation Units and Measurements (ICRU), 7910 Woodmont Ave., Suite 400, Bethesda, MD 20841-3095, http://
www.icru.org.
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).
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).
F1736 − 21
4. Significance and Use
4.1 Absorbed doses of or below 1 kGy can inactivate some parasites, such as the broad fish tapeworm (Dibothrocephalus latus)
(2).
4.2 Absorbed doses below 10 kGy can reduce or eliminate vegetative cells of pathogenic sporeforming and non-sporeforming
microorganisms, such as ClostridiaClostridium spp., Vibrio spp., Salmonellae,Listeria monocytogenes, or Staphylococcus aureus,
that may be present in fresh or frozen product.
4.2.1 Absorbed doses below 10 kGy can reduce the numbers of some spores, but are not adequate to reduce the potential health
risk from microbial spores or toxins (3).
4.3 Absorbed doses below 10 kGy can reduce or eliminate the vegetative cells of sporeforming and non-sporeforming
microorganisms, such as Bacillus or Pseudomonas species, that cause spoilage of fresh product, thus extending refrigerated shelf
life in many cases (4).
5. Harvest/Raw Material
5.1 Follow relevant Recommended International Codes of Practice (RCP) and Standards of Good Manufacturing Practice of the
Codex Alimentarius Commission (CAC) for maintaining the initial quality of the fresh or frozen product during handling from the
time of harvest through the time of sale to the consumer (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 20.
5.2 In handling, preparing, freezing, storing, and thawing finfish and aquatic invertebrates intended for irradiation, take
precautions at all times to minimize microbial contamination and outgrowth. Use standards of hygiene as high as those applied
in the processing or preparation of product for the 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 as possible.
Products approaching the end of their shelf life should not be irradiated in an attempt to extend that shelf life.
NOTE 1—While irradiation can improve finfish and aquatic invertebrates from a public health aspect by reducing the microbial and parasite populations
within product, chemical reactions (for example, oxidative degradation) that cause product to spoil also need to be considered when assessing the
appropriateness of radiation treatment (6).
6. Packaging and Product Loading Configuration
6.1 Packaging product prior to irradiation is one means of preventing post-irradiation contamination.
6.1 Use packaging materials suitable to the product considering any planned processing (including irradiation) and consistent with
any regulatory requirements (see Guide F1640).Packaging:
6.1.1 Guide F1640 provides guidance on packaging materials in contact with food during irradiation.
6.2 Appropriate packaging materials should be used for safeguarding the product as part of the effort to ensure product integrity
(for example, see Ref (5)).
6.3 With certain irradiation facilities, it may be necessary to limit use to particular package shapes and sizes. See ISO/ASTM
Practices 51204 and 51431. Irradiation can be optimized if the product packages are geometrically well defined and
uniform.Product Loading Configuration:
6.3.1 The size, shape, and loading configuration of a process load for the commodities to be irradiated should be determined
primarily by considering design parameters of the irradiation facility (see ISO/ASTM 51608, 51649, and 51702). Critical
irradiation parameters include the characteristics of product transport systems and of the radiation source as they relate to the dose
distribution obtained within the process load. These parameters and product dose specifications should be taken into account in
determining the size, shape and loading configuration of a process load (8.1).
F1736 − 21
7. Pre-Irradiation Product Handling
7.1 Inspect product as soon as it arrives at the radiation processing facility to determine that it has been properly handled prior
to arrival.
7.2 Temperature Control of Product:
7.2.1 The temperature of fresh product, excluding unshucked, live molluscan shellfish, received in the chilled state should be
maintained as close to 0°C (32°F) 0 °C (32 °F) as possible in accordance with good manufacturing practices (GMPs). Care should
be taken to prevent freezing of the product. Pre-irradiation storage at the irradiation facility should be short; less than one day is
recommended.
NOTE 2—Fresh 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 molluscan shellfish received in the chilled state should be maintained between 4°C
(39°F) and 7°C (45°F) 4 °C (39 °F) and 7 °C (45 °F) in accordance with GMPs. Pre-irradiation storage at the irradiation facility
should be short; less than one day is recommended.
NOTE 3—To maintain unshucked molluscan shellfish in the live state, the storage temperature should be above 4°C (39°F).4 °C (39 °F).
7.2.3 The surface temperature of product received in the frozen state should be maintained below −18°C (0°F). −18 °C (0 °F).
NOTE 4—Freezing does not provide an unlimited shelf life without loss of quality, and the pre-irradiation storage period should therefore be minimized.
The effect of frozen storage on product quality will be a function of time, temperature, and degree of temperature fluctuation.
7.2.4 Handling and storage procedures that differ from those described in Sections 5 and 6, especially holding under refrigeration
for an unduly long time, do not constitute GMP. Such treatment may result in excessive bacterial growth and undesirable changes
in the products.
7.3 Inspect all shipping documents arriving with the shipment to verify that they are complete and accurate.
7.3.1 The documents should include a lot number or other means of traceability (see 12.1).
7.4 Product Separation—Use It may not be possible to distinguish irradiated from non-irradiated product by inspection. It is
therefore important that appropriate means, such as physical barriers, to keep non-irradiated and irradiated product separated at all
times while at the irradiation facility. This is necessary because it may not be possible to distinguish non-irradiated from irradiated
product by inspection.or clearly defined areas, be used to maintain non-irradiated product separate from irradiated product.
NOTE 5—Radiation-sensitive indicators (RSIs), such as labels, papers, or inks that undergo a color change when exposed to radiation in the pertinent dose
range are commercially available. These indicators may be useful within the irradiation facility as a visual check for determining whether or not a 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 RSIs is provided in Guides 5126151261 and 5153951539,, 52628 and 52701
respectively.
7.5 Plan preparatory operations for irradiation, such as, but not limited to, dosimeter placement and reconfiguration of product in
the product unit, to permit expeditious handling of consecutive batches. These preparatory steps, in addition to the placement of
the product on the transport system and the time required for the irradiation treatment contribute to the cumulative time and
temperature exposure that will influence the extent of deterioration by chemical or biological mechanisms or the development of
microorganisms of public health significance (see Practices 51204 and 51431, and Guide 51261).significance.
7.5.1 The size, shape, and product-loading configuration of a product unit used to hold product for irradiation are determined
largely by certain design parameters of the irradiation facility. Critical parameters include the characteristics of product transport
systems and of the radiation source as they relate to the dose distribution obtained within the product unit. Pre-determined
minimum and maximum dose limits may also influence the choice of size, shape, and product-loading configuration of the product
unit.
F1736 − 21
8. Irradiation
8.1 Scheduled Process—Irradiation of food should conform to a scheduled process. A scheduled process for food irradiation is a
written procedure that is used to ensure that the absorbed-dose range and irradiation conditions selected by the radiation processor
are adequate under commercial processing conditions to achieve the intended effect on a specific product in a specific facil
...
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