ASTM F1736-09(2016)
(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 Clostridia 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 molluscs, crustacea, echinoderms, etc.
1.1.1.1 Molluscs 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
1.3 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 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 and health practices and determine the applicability of regulatory requirements prior to use.
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Designation:F1736 −09 (Reapproved 2016)
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.
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 1.3 The use of reduced-oxygen packaging (vacuum or
modified atmosphere, and including products packed in oil)
1.1 This guide outlines procedures and operations for the
with irradiated, raw product is not covered by this guide. The
irradiation of raw, untreated, fresh (chilled), or frozen finfish
anaerobic environment created by reduced-oxygen packaging
and aquatic invertebrates, while ensuring that the irradiated
provides the potential for outgrowth of, and toxin production
product is safe and wholesome.
from, Clostridium botulinum spores.
1.1.1 Aquatic invertebrates include molluscs, crustacea,
echinoderms, etc. 1.4 This guide does not cover the irradiation of smoked or
1.1.1.1 Molluscs include bivalve shellfish, such as clams, dried fish to reduce microbial load or to control insect
mussels, and oysters; snails; and cephalopods, such as squid infestation.
and octopus.
1.5 The values stated in SI units are to be regarded as
1.1.1.2 Crustacea include shellfish such as shrimp, lobster,
standard. No other units of measurement are included in this
crabs, prawns and crayfish.
standard.
1.1.1.3 Echinoderms include sea urchins and sea cucum-
1.6 This standard does not purport to address all of the
bers.
safety concerns, if any, associated with its use. It is the
1.2 This guide covers absorbed doses used to reduce the
responsibility of the user of this standard to establish appro-
microbial and parasite populations in aquatic invertebrates and
priate safety and health practices and determine the applica-
finfish. Such doses typically are below 10 kGy (1).
bility of regulatory requirements prior to use.
2. Referenced Documents
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
2.1 ASTM Standards:
Processing and is the direct responsibility of Subcommittee E61.05 on Food
Irradiation.
CurrenteditionapprovedJune1,2016.PublishedJuly2016.Originallyapproved
in 1996. Last previous edition approved in 2009 as F1736–09. DOI: 10.1520/ For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F1736-09R16. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1736−09 (2016)
E170Terminology Relating to Radiation Measurements and 3.1.3 dose distribution—variation in absorbed dose within a
Dosimetry process load exposed to ionizing radiation.
F1416Guide for Selection of Time-Temperature Indicators
3.1.4 process load—volume of material with a specified
F1640Guide for Selection and Use of Packaging Materials
product loading configuration irradiated as a single entity.
for Foods to Be Irradiated
3.1.5 transport system—conveyor or other mechanical sys-
2.2 ISO/ASTM Standards:
tem used to move the product to be irradiated through the
51204Practice for Dosimetry in Gamma Irradiation Facili-
irradiator.
ties for Food Processing
51261GuidefortheSelectionandApplicationofDosimetry
4. Significance and Use
Systems for Radiation Processing
4.1 Absorbed doses of or below 1 kGy can inactivate some
51431Practice for Dosimetry in Electron Beam and X-Ray
parasites, such as the broad fish tapeworm (Dibothrocephalus
(Bremsstrahlung) Irradiation Facilities for Food Process-
latus) (2).
ing
4.2 Absorbed doses below 10 kGy can reduce or eliminate
51539Guide for Use of Radiation-Sensitive Indicators
vegetative cells of pathogenic sporeforming and non-
2.3 Codex Alimentarius Commission Recommended Inter-
sporeforming microorganisms, such as Clostridia spp., Vibrio
national Codes and Standards:
spp., Salmonellae, Listeria monocytogenes,or Staphylococcus
Codex Stan 1 General Standards for the Labelling of
aureus, that may be present in fresh or frozen product.
Prepackaged Foods
4.2.1 Absorbeddosesbelow10kGycanreducethenumbers
Codex Stan 19 Recommended International Code of Prac-
of some spores, but are not adequate to reduce the potential
tice for the Operation of Irradiation Facilities for the
health risk from microbial spores or toxins (3).
Treatment of Food
Codex Stan 106Codex General Standard for Irradiated 4.3 Absorbed doses below 10 kGy can reduce or eliminate
Foods
the vegetative cells of sporeforming and non-sporeforming
CAC/RCP 9 Recommended International Code of Practice microorganisms,suchasBacillusorPseudomonasspecies,that
for Fresh Fish
cause spoilage of fresh product, thus extending refrigerated
CAC/RCP 16Recommended International Code of Practice shelf life in many cases (4).
for Frozen Fish
5. Harvest/Raw Material
CAC/RCP17 RecommendedInternationalCodeofPractice
for Shrimps and Prawns
5.1 Follow relevant Recommended International Codes of
CAC/RCP 18Recommended International Code of Hy-
Practice(RCP)andStandardsofGoodManufacturingPractice
gienic Practice for Molluscan Shellfish
oftheCodexAlimentariusCommission(CAC)formaintaining
CAC/RCP 24Recommended International Code of Practice
theinitialqualityofthefreshorfrozenproductduringhandling
for Lobsters
from the time of harvest through the time of sale to the
CAC/RCP27 RecommendedInternationalCodeofPractice
consumer (5). See CAC/RCP 9, CAC/RCP 16, CAC/RCP 17,
for Minced Fish Prepared by Mechanical Separation
CAC/RCP 18, CAC/RCP 24, CAC/RCP 27, CAC/RCP 28,
CAC/RCP 28Recommended International Code of Practice
CAC/RCP 37, and CAC/RCP 20.
for Crabs
5.2 In handling, preparing, freezing, storing, and thawing
CAC/RCP37 RecommendedInternationalCodeofPractice
finfish and aquatic invertebrates intended for irradiation, take
for Cephalopods
precautions at all times to minimize microbial contamination
CAC/RCP20CodeofEthicsforInternationalTradeinFood
and outgrowth. Use standards of hygiene as high as those
CAC/RCP42 SamplingPlansforPrepackagedFoods(AQL
applied in the processing or preparation of product for the
6.5)
frozen or fresh markets.
3. Terminology
5.3 Deliver product to the irradiation facility without delay,
such that irradiation occurs as close to the time of harvest as
3.1 Definitions:
possible. Products approaching the end of their shelf life
3.1.1 Other terms used in this guide may be defined in
should not be irradiated in an attempt to extend that shelf life.
Terminology E170.
NOTE 1—While irradiation can improve finfish and aquatic inverte-
3.1.2 absorbed dose—quantity of ionizing radiation energy
brates from a public health aspect by reducing the microbial and parasite
imparted per unit mass of specified material. The SI unit for
populations within product, chemical reactions (for example, oxidative
absorbeddoseisthegray(Gy),whereonegrayisequivalentto
degradation) that cause product to spoil also need to be considered when
assessing the appropriateness of radiation treatment (6).
the absorption of 1 joule per kilogram of the specified material
(1Gy = 1 J/kg).
6. Packaging
3.1.2.1 Discussion—Astandard definition of absorbed dose
appears in Terminology E170. 6.1 Packaging product prior to irradiation is one means of
preventing post-irradiation contamination.
6.2 Use packaging materials suitable to the product consid-
Available from Joint FAO/WHO Food Standards Program, Joint Office, Food
ering any planned processing (including irradiation) and con-
and Agriculture Organization of the United Nations, Via delle Terme di Caracalla,
00100 Rome, Italy. sistent with any regulatory requirements (see Guide F1640).
F1736−09 (2016)
6.3 Withcertainirradiationfacilities,itmaybenecessaryto 7.5 Plan preparatory operations for irradiation, such as, but
limit use to particular package shapes and sizes. See ISO/ not limited to, dosimeter placement and reconfiguration of
ASTM Practices 51204 and 51431. Irradiation can be opti- product in the product unit, to permit expeditious handling of
mized if the product packages are geometrically well defined consecutivebatches.Thesepreparatorysteps,inadditiontothe
and uniform. placement of the product on the transport system and the time
required for the irradiation treatment contribute to the cumu-
lative time and temperature exposure that will influence the
7. Pre-Irradiation Product Handling
extent of deterioration by chemical or biological mechanisms
7.1 Inspect product as soon as it arrives at the radiation
or the development of microorganisms of public health signifi-
processing facility to determine that it has been properly
cance (see Practices 51204 and 51431, and Guide 51261).
handled prior to arrival.
7.5.1 The size, shape, and product-loading configuration of
7.2 Temperature Control of Product:
a product unit used to hold product for irradiation are deter-
mined largely by certain design parameters of the irradiation
7.2.1 The temperature of fresh product, excluding
facility. Critical parameters include the characteristics of prod-
unshucked, live molluscan shellfish, received in the chilled
uct transport systems and of the radiation source as they relate
stateshouldbemaintainedascloseto0°C(32°F)aspossiblein
to the dose distribution obtained within the product unit.
accordance with good manufacturing practices (GMPs). Care
Pre-determined minimum and maximum dose limits may also
should be taken to prevent freezing of the product. Pre-
influence the choice of size, shape, and product-loading con-
irradiation storage at the irradiation facility should be short;
figuration of the product unit.
less than one day is recommended.
NOTE2—Freshproductisusuallystoredandtransportedundercrushed,
8. Irradiation
melting ice. When refrigeration is used, the risk of freezing exists.
8.1 Scheduled Process—Irradiation of food should conform
7.2.2 The temperature of unshucked, live molluscan shell-
to a scheduled process. A scheduled process for food irradia-
fish received in the chilled state should be maintained between
tion is a written procedure that is used to ensure that the
4°C (39°F) and 7°C (45°F) in accordance with GMPs. Pre-
absorbed-dose range and irradiation conditions selected by the
irradiation storage at the irradiation facility should be short;
radiation processor are adequate under commercial processing
less than one day is recommended.
conditions to achieve the intended effect on a specific product
in a specific facility. The scheduled process should be estab-
NOTE 3—To maintain unshucked molluscan shellfish in the live state,
lished by qualified persons having expert knowledge of the
the storage temperature should be above 4°C (39°F).
irradiation requirements specific for the food and the proces-
7.2.3 The surface temperature of product received in the
sor’s irradiation facility (7).
frozen state should be maintained below −18°C (0°F).
8.2 Radiation Sources—The sources of ionizing radiation
NOTE 4—Freezing does not provide an unlimited shelf life without loss
that may be employed in irradiating food are limited to the
of quality, and the pre-irradiation storage period should therefore be
following (see Codex Stan 106):
minimized. The effect of frozen storage on product quality will be a
8.2.1 Isotopic Sources—Gamma rays from the radionu-
function of time, temperature, and degree of temperature fluctuation.
60 137
clides Co (1.17 and 1.33 MeV) or Cs (0.66 MeV), and
7.2.4 Handlingandstorageproceduresthatdifferfromthose
8.2.2 Machine Sources—X-rays and accelerated electrons.
described in Sections 5 and 6, especially holding under
NOTE6—TheCodexAlimentariusCommissionaswellasregulationsin
refrigeration for an unduly long time, do not constitute GMP.
some countries currently limit the maximum electron energy and nominal
Such treatment may result in excessive bacterial growth and
X-ray energy for the purpose of food irradiation (Codex Stan 106).
undesirable changes in the products.
8.3 Absorbed Dose—Food irradiation specifications may
7.3 Inspect all shipping documents arriving with the ship-
include minimum and maximum absorbed dose limits. A
ment to verify that they are complete and accurate.
minimum absorbed dose may be specified to ensure that the
7.3.1 The documents should include a lot number or other
intended effect is achieved, and a maximum absorbed dose
means of traceability (see 12.1).
may be based on government regulations resulting from a
safety assessment or be stipulated to prevent product degrada-
7.4 Use appropriate means, such as physical barriers, to
tion.Foragivenapplication,oneorbothoftheselimitsmaybe
keep non-irradiated and irradiated product separated at all
prescribed by regulation. It is therefore necessary, prior to the
timeswhileattheirradiationfacility.Thisisnecessarybecause
irradiation of product, to establish an irradiation protocol that
it may not be possible to distinguish non-irradiated from
will ensure that the absorbed dose requirements can be
irradiated product by inspection.
satisfied.Thisisaccomplishedthroughabsorbed-dosemapping
NOTE 5—Radiation-sensitive indicators (RSIs), such as labels, papers,
todeterminethemagnitudesandlocationsoftheminimumand
or inks
...
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 F1736 − 09 (Reapproved 2016)
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.
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, crustacea, echinoderms, etc.
1.1.1.1 Molluscs 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).
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 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 and health practices and determine the applicability of regulatory
requirements prior to use.
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, 2009June 1, 2016. Published March 2009July 2016. Originally approved in 1996. Last previous edition approved in 20032009 as
F1736 – 03.F1736 – 09. DOI: 10.1520/F1736-09.10.1520/F1736-09R16.
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
F1736 − 09 (2016)
2. Referenced Documents
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
F1416 Guide for Selection of Time-Temperature Indicators
F1640 Guide for Selection and Use of Packaging 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 Dosimetry Systems for Radiation Processing
51431 Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Processing
51539 Guide for Use of Radiation-Sensitive Indicators
2.3 Codex Alimentarius Commission Recommended International Codes and Standards:
Codex Stan 1 General Standards for the Labelling of Prepackaged Foods
Codex Stan 19 Recommended International Code of Practice for the Operation of Irradiation Facilities for the Treatment of
Food
Codex Stan 106 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
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)
3. Terminology
3.1 Definitions:
3.1.1 Other terms used in this guide may be defined in Terminology E170.
3.1.2 absorbed dose—quantity of ionizing radiation energy imparted per unit mass of specified material. The SI 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).
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.
3.1.2.1 Discussion—
A standard definition of absorbed dose appears in Terminology E170.
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 product loading configuration irradiated as a single entity.
3.1.5 transport system—conveyor or other mechanical system used to move the product to be irradiated through the irradiator.
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 Clostridia 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).
F1736 − 09 (2016)
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
6.1 Packaging product prior to irradiation is one means of preventing post-irradiation contamination.
6.2 Use packaging materials suitable to the product considering any planned processing (including irradiation) and consistent
with any regulatory requirements (see Guide F1640).
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.
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) 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) 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).
7.2.3 The surface temperature of product received in the frozen state should be maintained below −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 Use 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.
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 51261 and 51539, 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).
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
F1736 − 09 (2016)
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.
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 facility. The
scheduled process should be established by qualified persons having expert knowledge of the irradiation requirements specific for
the food and the processor’s irradiation facility (7).
8.2 Radiation Sources—The sources of ionizing radiation that may be employed in irradiating food are limited to the followin
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