ASTM F1355-19

Standard Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment

SIGNIFICANCE AND USE
4.1 The purpose of radiation treatment, as discussed in this guide, is to minimize the pest risk and to maximize the safety associated with the movement and use of fresh agricultural produce.  
4.2 Irradiation as a phytosanitary treatment can prevent development or emergence of the adult stage where adults are not present in the agricultural produce (for example, fruit flies) or sterilize the adult where that stage is present (for example, weevils). (4)
SCOPE
1.1 This guide provides procedures for the radiation processing of fresh agricultural produce, for example, fruits, vegetables, and cut flowers, as a phytosanitary treatment. This guide is directed primarily toward the treatment needed to control regulated pests commonly associated with fresh agricultural produce.  
1.2 This guide covers gamma, electron beam and X-radiation treatment.  
1.3 The typical absorbed dose range used for phytosanitary treatments is between 60 gray (Gy) and 600 gray (Gy). The practical minimum or maximum dose of a treatment may be higher or lower than this range, depending on the type of pest to be controlled and the radiation tolerance of a particular type of produce. If the minimum effective dose necessary to achieve the desired phytosanitary effect is greater than the radiation tolerance of the produce, then irradiation is not an appropriate treatment (see 5.2).  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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: 30-Nov-2019
• ICS: 65.020.20 - Plant growing
• Technical Committee: E61 - Radiation Processing
• Drafting Committee: E61.05 - Food Irradiation

Relations

• Replaces: ASTM F1355-06(2014) - Standard Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment
• Effective Date: 01-Dec-2019
• Refers: ASTM E3083-17 - Standard Terminology Relating to Radiation Processing: Dosimetry and Applications
• Effective Date: 01-Oct-2017
• Refers: ASTM F1640-09 - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 01-Feb-2009
• Refers: ASTM F1640-03 - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 01-Oct-2003
• Refers: ASTM F1640-95(2001) - Standard Guide for Packaging Materials for Foods to Be Irradiated
• Effective Date: 10-Sep-1995
• Referred By: ASTM ISO/ASTM51818-20 - Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV
• Effective Date: 01-Dec-2019
• Referred By: ASTM ISO/ASTM51649-15 - Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 300 keV and 25 MeV
• Effective Date: 01-Dec-2019
• Referred By: ASTM F1640-21 - Standard Guide for Selection and Use of Contact Materials for Foods to Be Irradiated
• Effective Date: 01-Dec-2019
• Referred By: ASTM ISO/ASTM52628-20 - Standard Practice for Dosimetry in Radiation Processing
• Effective Date: 01-Dec-2019

Overview

ASTM F1355-19: Standard Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment is a vital guideline for the radiation processing of fruits, vegetables, and cut flowers to control pests. Developed by ASTM International, this standard ensures the safe movement and use of fresh produce by minimizing pest risks through irradiation. The guide provides a framework for implementing phytosanitary treatments using ionizing radiation, helping producers and regulatory authorities comply with international trade and food safety requirements.

Key Topics

• Purpose of Irradiation: The primary goal of irradiation as outlined in ASTM F1355-19 is to reduce the risk of introducing regulated pests during the transportation and commercial use of fresh produce.

• Scope of Application: The standard covers a variety of produce, including fruits, vegetables, and cut flowers, and is primarily aimed at treatments necessary to control quarantine pests, such as fruit flies and weevils.

• Irradiation Methods: Accepted methods include gamma radiation, electron beam, and X-ray treatments. The guide specifies typical absorbed dose ranges between 60 and 600 Gray (Gy), though actual doses may vary based on pest type and produce tolerance.

• Dose Measurement and Control: Detailed procedures for dosimetry-accurate measurement and mapping of absorbed doses-are critical for ensuring efficacy and safety. The standard emphasizes the use of proper dosimetry systems that are traceable to national or international standards.

• Good Manufacturing Practices (GMPs): The guide integrates GMPs for pre-irradiation inspection, proper packaging, and post-irradiation handling to maintain produce quality and safety.

• Labeling and Documentation: It requires proper labeling of irradiated products (often using the Radura symbol) and comprehensive record-keeping to assure traceability and regulatory compliance.

Applications

ASTM F1355-19 serves multiple stakeholders across the agricultural, food processing, and regulatory sectors:

• Food Exporters and Importers: Ensures compliance with international phytosanitary requirements, facilitating global trade by preventing the spread of invasive species.
• Irradiation Facilities: Offers process control guidelines for implementing safe and effective irradiation procedures, including equipment qualification, absorbed-dose mapping, and record management.
• Regulatory Authorities: Provides a reference for plant protection organizations and inspectors responsible for enforcing quarantine and food safety measures.
• Food Retailers and Distributors: Helps deliver pest-free, safe, and high-quality fresh produce to consumers.

Typical produce that can benefit from irradiation under this guide include apples, citrus fruits, grapes, mangoes, peaches, and strawberries, among others. The treatment helps prevent post-harvest losses and extends shelf life without compromising quality when applied at appropriate doses.

Related Standards

ASTM F1355-19 references and aligns with several key standards and regulatory documents to ensure global harmonization and technical accuracy:

• ISO/ASTM Practice 52628: Dosimetry in radiation processing
• ASTM E170, E3083, F1640: Terminology and guidance for radiation measurements and food contact materials
• ISO Standards (e.g. ISO 873, 931, 1134, 1212, 1838, 2168, 3631): Guides on storage and transport of fresh produce
• Codex Alimentarius Standards (CX STAN 106-1983, CAC/RCP 19-1979): International codes for labeling, processing, and practice for irradiated foods
• U.S. FDA 21 CFR Sections 110, 179.25, 179.26: Regulations on food irradiation and manufacturing practices

These related standards ensure that irradiation as a phytosanitary treatment is implemented consistently, safely, and in accordance with both national and international policy frameworks.

---

Keywords: phytosanitary treatment, irradiation, agricultural produce, food irradiation, pest control, quarantine, dosimetry, fresh produce safety, international trade standards, ASTM F1355-19.

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: F1355 − 19
Standard Guide for
Irradiation of Fresh Agricultural Produce as a Phytosanitary
Treatment
This standard is issued under the fixed designation F1355; 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 energy (radiation) in
treating fresh agricultural produce to control insects and other arthropod pests, in order to meet
phytosanitary requirements.
This guide is intended to serve as a recommendation to be followed when using irradiation
technology where approved by an appropriate regulatory authority. It is not to be construed as a
requirement for the use of irradiation nor as a required code of practice. 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), under the auspices of the Food and
AgricultureOrganization(FAO),theWorldHealthOrganization(WHO),andtheInternationalAtomic
Energy Agency (IAEA). (1)
1. Scope 1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This guide provides procedures for the radiation pro-
standard.
cessing of fresh agricultural produce, for example, fruits,
vegetables, and cut flowers, as a phytosanitary treatment. This 1.5 This document is one of a set of standards that provides
recommendations for properly implementing and utilizing
guide is directed primarily toward the treatment needed to
control regulated pests commonly associated with fresh agri- radiation processing. It is intended to be read in conjunction
with ISO/ASTM Practice 52628.
cultural produce.
1.6 This standard does not purport to address all of the
1.2 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-
1.3 The typical absorbed dose range used for phytosanitary
priate safety, health, and environmental practices and deter-
treatments is between 60 gray (Gy) and 600 gray (Gy). The
mine the applicability of regulatory limitations prior to use.
practical minimum or maximum dose of a treatment may be
1.7 This international standard was developed in accor-
higher or lower than this range, depending on the type of pest
dance with internationally recognized principles on standard-
to be controlled and the radiation tolerance of a particular type
ization established in the Decision on Principles for the
ofproduce.Iftheminimumeffectivedosenecessarytoachieve
Development of International Standards, Guides and Recom-
the desired phytosanitary effect is greater than the radiation
mendations issued by the World Trade Organization Technical
tolerance of the produce, then irradiation is not an appropriate
Barriers to Trade (TBT) Committee.
treatment (see 5.2).
2. Referenced Documents
2.1 ASTM Standards:
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
F1640 Guide for Selection and Use of Contact Materials for
Processing and is the direct responsibility of Subcommittee E61.05 on Food
Irradiation.
Current edition approved Dec. 1, 2019. Published December 2019. Originally
approved in 1991. Last previous edition approved in 2014 as F1355 – 06(2014). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F1355-19. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
The boldface numbers in parentheses refer to a list of references at the end of 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
F1355 − 19
Foods to Be Irradiated 2.5 U.S. Food and Drug Administration, Code of Federal
E3083 Terminology Relating to Radiation Processing: Do- Regulations:
simetry and Applications CFR Title 21, Part 110 Current Good Manufacturing Prac-
tices in Manufacturing, Packaging, or Handling Human
2.2 ISO/ASTM Standards:
Food
51261 Practice for Calibration of Routine Dosimetry Sys-
CFR Title 21, Section 179.25 General Provisions for Food
tems for Radiation Processing
Irradiation
51539 Guide for Use of Radiation-Sensitive Indicators
CFR Title 21, Section 179.26 Irradiation in the Production,
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
Processing and Handling of Food
Facility for Radiation Processing at Energies between 50
CFR Title 7, Part 305.31 Irradiation treatment of imported
keV and 7.5 MeV
regulated articles for certain plant pests
51649 Practice for Dosimetry in an Electron Beam Facility
forRadiationProcessingatEnergiesbetween300keVand
2.6 International Commission on Radiation Units and Mea-
25 MeV
surements (ICRU) Report:
51702 Practice for Dosimetry in a Gamma Facility for
ICRU 85a Fundamental Qualities and Units for Ionizing
Radiation Processing
Radiation
52303 Guide forAbsorbed-Dose Mapping in Radiation Pro-
2.7 Joint Committee for Guides in Metrology (JCGM)
cessing Facilities
Reports:
52628 Practice for Dosimetry in Radiation Processing
JCGM 200:2012, (JCGM 200:2008 with minor revi-
52701 Guide for Performance Characterization of Dosim-
sions) VIM, International vocabulary of metrology – Ba-
eters and Dosimetry Systems for Use in Radiation Pro-
sis and general concepts and associated terms
cessing
2.3 Codex Alimentarius Commission Recommended Inter-
3. Terminology
national Codes of Practice and Standards:
3.1 Definitions:
CX STAN 1-1985, Rev. 1991, and 2001 General Standard
for the Labeling of Prepackaged Foods 3.1.1 absorbed dose—quotient of dɛ¯by dm, where dɛ¯ is the
mean energy imparted by ionizing radiation to matter of mass
CX STAN 106-1983, Rev. 2003 General Standard for Irra-
diated Food dm, thus
CAC/RCP 19-1979, Rev. 2003 Recommended International
D 5 dε¯⁄dm
Code of Practice for the Radiation Processing of Food
3.1.1.1 Discussion—the SI unit of absorbed dose is the gray
2.4 ISO Standards:
(Gy), where one gray is equivalent to the absorption of 1 joule
ISO 873 Peaches — Guide to Cold Storage
per kilogram of the specified material (1 Gy = 1 J/kg).
ISO 931 Green Bananas — Guide to Storage and Transport
3.1.2 absorbed dose mapping—measurement of absorbed
ISO 1134 Pears — Guide to Cold Storage
dose within an irradiated product to produce a one-, two-, or
ISO 1212 Apples — Guide to Cold Storage
three-dimensionaldistributionofabsorbeddose,thusrendering
ISO 1838 Fresh Pineapples — Guide to Storage and Trans-
a map of absorbed dose values.
port
ISO 2168 Table Grapes — Guide to Cold Storage 3.1.3 dose distribution—variation in absorbed dose within a
ISO 2826 Apricots — Guide to Cold Storage process load exposed to ionizing radiation.
ISO 3631 Citrus Fruits — Guide to Cold Storage
3.1.4 good manufacturing practice (GMP)—procedure es-
ISO 3659 Fruits and Vegetables — Ripening After Cold
tablished and exercised throughout the production, manufac-
Storage
turing processing, packing, and distribution of foods, encom-
ISO 6660 Mangoes — Guide to Storage
passing maintenance of sanitation system, quality control and
ISO 6661 Fresh Fruits and Vegetables — Arrangement of
assurance, qualification of personnel and other relevant
Parallelpipedic Packages in Land Transport Vehicles
activities, to ensure the delivery of commercially acceptable
ISO 6664 Bilberries and Blueberries — Guide To Cold
and safe product.
Storage
3.1.5 pest—anyspecies,strainorbiotypeofplant,animalor
ISO 6665 Strawberries — Guide to Cold Storage
pathogenic agent injurious to plant or plant products (2).
ISO 6949 Fruits and Vegetables — Principles and Tech-
niques of the Controlled Atmosphere Method of Storage
3.1.6 process load—volume of material with a specified
ISO 7558 Guide to the Prepacking of Fruits and Vegetables
product loading configuration irradiated as a single entity.
ISO 12749-4 Nuclear energy, nuclear technologies, and
radiological protection — Vocabulary — Part 4: Dosim-
etry for radiation processing
Available from the U.S. Government Printing Office, Superintendent of
Documents, Washington, DC 20402-9328.
Available from the International Commission on Radiation Units and
AvailablefromJointFAO/WHOFoodStandardsProgrammeJointOffice,FAO, Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 USA.
Viale delle Terme di Caracalla 00100 Rome, Italy. Document produced by Working Group 2 of the Joint Committee for Guides in
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Metrology (JCGM/WG 2). Available free of charge from at the BIPM website
4th Floor, New York, NY 10036. (http://www.bipm.org).
F1355 − 19
3.1.7 quarantine pest—a pest of potential economic impor- evaluating the suitability of treating product at the minimum
tance to an endangered area and not yet present there, or dose necessary to inactivate pests, tolerance of the product to
present but not widely distributed and being officially con- the expected maximum dose should be evaluated.
trolled (3).
6. Packaging and Product Loading Configuration
3.1.8 quarantine treatment—pertaining to the killing,
6.1 Packaging
removal, or rendering infertile of regulated plant pests on host
6.1.1 Guide F1640 provides guidance on packaging mate-
material that has been placed in quarantine (or seized and
rials in contact with food during irradiation.
detained) by regulatory authorities because of the potential or
actual presence of a quarantine pest (4).
6.2 Appropriate packaging materials should be used for
3.1.9 regulated non-quarantine pest—non-quarantine pest safeguarding the produce as part of the effort to ensure
whose presence in plants for planting affects the intended use phytosanitary integrity (for example, see 7 CFR 305.31).
of those plants with an economically unacceptable impact and
6.3 Product Loading Configuration
which is therefore regulated within the territory of the import-
6.3.1 Thesize,shape,andloadingconfigurationofaprocess
ing contracting party (3).
load for the commodities to be irradiated should be determined
3.1.10 regulated pest—quarantine pest or a regulated non-
primarily by considering design parameters of the irradiation
quarantine pest (3).
facility (see ISO/ASTM Practices 51608, 51649, and 51702).
Critical irradiation parameters include the characteristics of
3.1.11 transport system—the conveyor or other mechanical
product transport systems and of the radiation source as they
means used to move the process load through the irradiator.
relate to the dose distribution obtained within the process load.
3.2 Definitions of other terms used in this standard that
These parameters and product dose specifications should be
pertain to radiation measurement and dosimetry may be found
taken into account in determining the size, shape and loading
in ISO/ASTM 52628, Terminology E3083, and ISO Terminol-
configuration of a process load (8.3).
ogy 12749-4. Definitions in these documents are compatible
with ICRU Report 85a, and therefore, may be used as
7. Pre-Irradiation Product Handling and Treatment
alternative references. Where appropriate, definitions used in
7.1 Fresh agricultural produce intended to be irradiated
this standard have been derived from, and are consistent with,
shouldbeofgoodoverallqualityandreflecttheresultsofgood
general metrological definitions given in the VIM.
agronomic practices.
7.1.1 Upon receipt at the irradiation facility, inspect pack-
4. Significance and Use
ages and containers of the commodities according to relevant
4.1 The purpose of radiation treatment, as discussed in this
Good Manufacturing Practices (GMPs) to ensure that their
guide, is to minimize the pest risk and to maximize the safety
integrity has not been compromised. See for example 21 CFR
associated with the movement and use of fresh agricultural
110.
produce.
7.2 Radiation can be applied to these commodities in bulk,
4.2 Irradiation as a phytosanitary treatment can prevent
in-line prior to packaging, or in commercial packages.
development or emergence of the adult stage where adults are
However, some countries may require that pest-proof packag-
not present in the agricultural produce (for example, fruit flies)
ing be in place prior to irradiation.
or sterilize the adult where that stage is present (for example,
7.3 Fresh agricultural produce should be appropriately seg-
weevils). (4)
regated or otherwise safeguarded prior to irradiation as part of
5. Selection of Fresh Agricultural Produce for Irradiation the effort to ensure phytosanitary integrity.
5.1 Most fresh agricultural produce is not adversely affected 7.4 Normal storage procedures should be used prior to
at the minimum doses indicated in 8.5.2. In particular, the radiation treatment. Pre-irradiation storage should include
following fruits have been found to be tolerant of those appropriate temperature and atmospheric conditions. Informa-
minimum doses: apple, cantaloupe, carambola, cherry, citrus, tion on storage conditions is provided in ISO Standards (see
currant, date, fig, grape, guava, honeydew melon, kiwi, lychee, 2.4).
mango, muskmelon, nectarine, papaya, peach, prune,
7.5 Handling of the commodities in an irradiation facility
raspberry, strawberry, and tomato.
should be in accordance with relevant and current GMPs.
5.2 Some fresh agricultural produce may be damaged or There are no special requirements for handling of the com-
exhibit unacceptable changes in shelf-life, color, taste, or other modities prior to irradiation except for providing control
properties at the minimum doses indicated in 8.5.2, making it measures to prevent post-irradiation re-contamination in stor-
necessarytoevaluatetheeffectsofirradiationonthefruitatthe age facilities and for ensuring separation of irradiated and
required dose level. Differences among varieties, origins, non-irradiated product.
growing and harvest conditions, and elapsed time between
7.6 Product Separation—It may not be possible to distin-
harvest and processing should be considered.
guishirradiatedfromnon-irradiatedproductbyinspection.Itis
5.3 Irradiation of product will result in a distribution of therefore important that appropriate means, such as physical
absorbed dose in a process load, which is characterized by a barriers, or clearly defined areas, be used to maintain non-
maximum and minimum absorbed dose. Thus, in addition to irradiated product separate from irradiated product.
F1355 − 19
NOTE 1—Radiation-sensitive indicators undergo a color change when female lays eggs in the agricultural produce. Later, these eggs hatch and
exposed to radiation in the pertinent dose range. These indicators may be larvae emerge. These larvae feed and develop in the fruit and in this
useful within the irradiation facility as a visual check for determining manner damage it.The larvae leave the fruit upon maturation and undergo
whether or not a product has been exposed to the radiation source. They pupation in the ground. In packaged agricultural produce, pupation may
are not dosimeters intended for measuring absorbed dose and must not be occur in the container. Seed weevils can infest fresh agricultural produce
used as a substitute for proper dosimetry. Information about dosimetry at an early stage and upon emergence as adults, damage the seed and the
systems and the proper use of radiation-sensitive indicators is provided in fruit. One should concentrate on developing a treatment against the most
ISO/ASTM Guides 51261 and 51539, respectively. radiation-tolerant stage, that can be reasonably expected to be in, on, or
with the fresh agricultural produce. The most tolerant stage is usually the
one closest to the adult if the adult itself is not present in the agricultural
8. Irradiation
produce.
8.1 Standard Operating Procedures (SOPs)—Standard op-
8.3.3 Dosimetry—Dosimetry is a major component of a
erating procedures for food irradiation are documented proce-
total quality assurance program for adherence to Good Manu-
dures that are used to ensure that the technologically estab-
facturing Practices used in radiation processing of food. CX
lished dose range and irradiation conditions selected by the
STAN 106 and CAC/RCP 19 strongly emphasize the role of
radiation processor are achievable on a specific product in a
dosimetry for ensuring that irradiation is properly performed,
specific facility. These procedures should be established and
sincedosimetryispartofaverificationprocessforestablishing
validated by qualified persons having knowledge in irradiation
that the irradiation process is under control.
requirements specific for the food and the irradiation facility
8.3.4 Dosimetry System—Dosimetry used in the
(see CAC/RCP 19).
development, validation and routine control of the irradiation
8.1.1 Installation qualification, operational qualification,
...

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: F1355 − 06 (Reapproved 2014) F1355 − 19
Standard Guide for
Irradiation of Fresh Agricultural Produce as a Phytosanitary
Treatment
This standard is issued under the fixed designation F1355; 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 energy (radiation) in
treating fresh agricultural produce to control insects and other arthropod pests, in order to meet
phytosanitary requirements.
This guide is intended to serve as a recommendation to be followed when using irradiation
technology where approved by an appropriate regulatory authority. It is not to be construed as a
requirement for the use of irradiation nor as a required code of practice. 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), 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 provides procedures for the radiation processing of fresh agricultural produce, for example, fruits, vegetables,
and cut flowers, as a phytosanitary treatment. This guide is directed primarily toward the treatment needed to control regulated
pests commonly associated with fresh agricultural produce.
1.2 This guide covers gamma, electron beam and X-radiation treatment.
1.3 The typical absorbed dose range used for phytosanitary treatments is between 15060 gray (Gy) and 600 gray (Gy). The
practical minimum or maximum dose of a treatment may be higher or lower than this range, depending on the type of pest to be
controlled and the radiation tolerance of a particular type of fruit.produce. If the minimum effective dose necessary to achieve the
desired phytosanitary effect is greater than the radiation tolerance of the produce, then irradiation is not an appropriate treatment
(see 5.2).
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
1.6 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.
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, 2014Dec. 1, 2019. Published June 2014December 2019. Originally approved in 1991. Last previous edition approved in 20062014 as
F1355 – 06.F1355 – 06(2014). DOI: 10.1520/F1355-06R14.10.1520/F1355-19.
The boldface numbers in parentheses refer to a 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
F1355 − 19
2. Referenced Documents
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
F1640 Guide for Selection and Use of Contact Materials for Foods to Be Irradiated
E3083 Terminology Relating to Radiation Processing: Dosimetry and Applications
2.2 ISO/ASTM Standards:
51204 Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing
51261 GuidePractice 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 X-ray (Bremsstrahlung) Irradiation Facilities for Food Processingan
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
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 of Practice and Standards:
CX STAN 1-1985, Rev. 1991, Amdand 2001 General Standard for the Labeling of Prepackaged Foods
CX STAN 106-1983, Rev. 2003 General Standard for Irradiated Food
CAC/RCP 19-1979, Rev. 2003 Recommended International Code of Practice for the Radiation Processing of Food
2.4 ISO Standards:
ISO 873 Peaches—Guide Peaches — Guide to Cold Storage
ISO 931 Green Bananas—Guide Bananas — Guide to Storage and Transport
ISO 1134 Pears—Guide Pears — Guide to Cold Storage
ISO 1212 Apples—Guide Apples — Guide to Cold Storage
ISO 1838 Fresh Pineapples—Guide Pineapples — Guide to Storage and Transport
ISO 2168 Table Grapes—Guide Grapes — Guide to Cold Storage
ISO 2826 Apricots—Guide Apricots — Guide to Cold Storage
ISO 3631 Citrus Fruits—Guide Fruits — Guide to Cold Storage
ISO 3659 Fruits and Vegetables—Ripening Vegetables — Ripening After Cold Storage
ISO 6660 Mangoes—Guide Mangoes — Guide to Storage
ISO 6661 Fresh Fruits and Vegetables—Arrangement Vegetables — Arrangement of Parallelpipedic Packages in Land Transport
Vehicles
ISO 6664 Bilberries and Blueberries—Guide Blueberries — Guide To Cold Storage
ISO 6665 Strawberries—Guide Strawberries — Guide to Cold Storage
ISO 6949 Fruits and Vegetables—Principles Vegetables — Principles and Techniques of the Controlled Atmosphere Method of
Storage
ISO 7558 Guide to the Prepacking of Fruits and Vegetables
ISO 12749-4 Nuclear energy, nuclear technologies, and radiological protection — Vocabulary — Part 4: Dosimetry for radiation
processing
2.5 U.S. Food and Drug Administration, Code of Federal Regulations:
CFR Title 21, Part 110 Current Good Manufacturing Practices in Manufacturing, Packaging, or Handling Human Food
CFR Title 21, Section 179.25 General Provisions for Food Irradiation
CFR Title 21, Section 179.26 Irradiation in the Production, Processing and Handling of Food
CFR Title 7, Part 305.31 Irradiation treatment of imported regulated articles for certain plant pests
2.6 International Commission on Radiation Units and Measurements (ICRU) Report:
ICRU 85a Fundamental Qualities and Units for Ionizing Radiation
2.7 Joint Committee for Guides in Metrology (JCGM) Reports:
JCGM 200:2012, (JCGM 200:2008 with minor revisions) VIM, International vocabulary of metrology – Basis and general
concepts and associated terms
For referenced 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 Joint FAO/WHO Food Standards Programme Joint Office, FAO, Viale delle Terme di Caracalla 00100 Rome, Italy.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
Available from the U.S. Government Printing Office, Superintendent of Documents, Washington, DC 20402-9328.
Available from the International Commission on Radiation Units and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 USA.
Document produced by Working Group 2 of the Joint Committee for Guides in Metrology (JCGM/WG 2). Available free of charge from at the BIPM website
(http://www.bipm.org).
F1355 − 19
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 ionizing radiationdɛ¯ by dm,energy imparted per unit mass of a specified where dɛ¯
is the mean energy imparted by ionizing radiation to matter of mass dm, material. thus
D 5 dε¯⁄dm
The SI unit of absorbed dose is the gray (Gy), where one gray is equivalent to the absorption of 1 joule per kilogram of the
specified material (1 Gy = 1 J/kg).
3.1.1.1 Discussion—
A standard definitionthe SI unit of absorbed dose appears in Terminologyis the gray E170.(Gy), where one 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 pest—any species, strain or bio type of plant, animal or pathogenic agent injurious to plant or plant products (2).
3.1.6 process load—volume of material with a specified product loading configuration irradiated as a single entity.
3.1.7 quarantine pest—a pest of potential economic importance to an endangered area and not yet present there, or present but
not widely distributed and being officially controlled (3).
3.1.8 quarantine treatment—pertaining to the killing, removal, or rendering infertile of regulated plant pests on host material
that has been placed in quarantine (or seized and detained) by regulatory authorities because of the potential or actual presence
of a quarantine pest (4).
3.1.9 regulated non-quarantine pest—non-quarantine pest whose presence in plants for planting affects the intended use of those
plants with an economically unacceptable impact and which is therefore regulated within the territory of the importing contracting
party (3).
3.1.10 regulated pest—quarantine pest or a regulated non-quarantine pest (3).
3.1.11 transport system—the conveyor or other mechanical means 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 52628, Terminology E3083, and ISO Terminology 12749-4. Definitions in these documents are compatible with ICRU
Report 85a, and therefore, may be used as alternative references. Where appropriate, definitions used in this standard have been
derived from, and are consistent with, general metrological definitions given in the VIM.
4. Significance and Use
4.1 The purpose of radiation treatment, as discussed in this guide, is to minimize the pest risk and to maximize the safety
associated with the movement and use of fresh agricultural produce.
4.2 Irradiation as a phytosanitary treatment can prevent development or emergence of the adult stage where adults are not
present in the agricultural produce (for example, fruit flies) or sterilize the adult where that stage is present (for example, weevils).
(4)
5. Selection of Fresh Agricultural Produce for Irradiation
5.1 Most fresh agricultural produce is not adversely affected at the minimum doses indicated in 8.5.2. In particular, the
following fruits have been found to be tolerant of those minimum doses: apple, cantaloupe, carambola, cherry, citrus, currant, date,
fig, grape, guava, honeydew melon, kiwi, lychee, mango, muskmelon, nectarine, papaya, peach, prune, raspberry, strawberry, and
tomato.
5.2 Some fresh agricultural produce may be damaged or exhibit unacceptable changes in shelf-life, color, taste, or other
properties at the minimum doses indicated in 8.5.2, making it necessary to evaluate the effects of irradiation on the fruit at the
required dose level. Differences among varieties, origins, growing and harvest conditions,,conditions, and elapsed time between
harvest and processing should be considered.
F1355 − 19
5.3 Irradiation of product will result in a distribution of absorbed dose in a process load, which is characterized by a maximum
and minimum absorbed dose. Thus, in addition to evaluating the suitability of treating product at the minimum dose necessary to
inactivate pests, tolerance of the product to the expected maximum dose should be evaluated.
6. Packaging and Product Loading Configuration
6.1 Guide F1640 provides guidance on packaging materials in contact with food during irradiation.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 produce as part of the effort to ensure phytosanitary
integrity (for example, see Ref7 (CFR5) 305.31).).
6.3 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 Practices 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 (8.3).
7. Pre-Irradiation Product Handling and Treatment
7.1 Fresh agricultural produce intended to be irradiated should be of good overall quality and reflect the results of good
agronomic practices.
7.1.1 Upon receipt at the irradiation facility, inspect packages and containers of the commodities according to relevant Good
Manufacturing Practices (GMPs) to ensure that their integrity has not been compromised. See for example 21 CFR 110.
7.2 Radiation can be applied to these commodities in bulk, in-line prior to packaging, or in commercial packages. However,
some countries may require that pest-proof packaging be in place prior to irradiation.
7.3 Fresh agricultural produce should be appropriately segregated or otherwise safeguarded prior to irradiation as part of the
effort to ensure phytosanitary integrity.
7.4 Normal storage procedures should be used prior to radiation treatment. Pre-irradiation storage should include appropriate
temperature and atmospheric conditions. Information on storage conditions is provided in ISO Standards (see 2.4).
7.5 Handling of the commodities in an irradiation facility should be in accordance with relevant and current GMPs. There are
no special requirements for handling of the commodities prior to irradiation except for providing control measures to prevent
post-irradiation re-contamination in storage facilities and for ensuring separation of irradiated and non-irradiated product.
7.6 Product Separation—It may not be possible to distinguish irradiated from non-irradiated product by inspection. It is
essential therefore important that appropriate means integral with facility design, means, such as physical barriers, or clearly
defined staging areas, be used to separatemaintain non-irradiated product separate from irradiated product.
NOTE 1—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 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 radiation-sensitive indicators is provided in ISO/ASTM Guides 51261 and 51539, respectively.
8. Irradiation
8.1 Standard Operating Procedures (SOPs)—Standard operating procedures for food irradiation are documented procedures for
ensuring that the absorbed-dose that are used to ensure that the technologically established dose range and irradiation conditions
selected by the radiation processor are adequate under commercial processing conditions to achieve the intended effect achievable
on a specific product in a specific facility. These procedures should be established and validated by qualified persons having
knowledge in irradiation requirements specific for the food and the irradiation facility (see CAC/RCP 19).
8.1.1 Installation qualification, operational qualification, performance qualification and process control should be performed
following the requirements of ISO/ASTM Practices 51702, 51608, or 51649.
8.2 Radiation Sources—The sources of ionizing radiation that may be employed in irradiating fresh agricultural produce are
limited to the following (see CX STAN 106):
60 137
8.2.1 Isotopic Sources—gamma rays from the radionuclides Co (1.17 and 1.33 MeV) or Cs (0.66 MeV);MeV) (see
ISO/ASTM Practice 51702);
8.2.2 Machine Sources—X-rays and accelerated electrons.electrons (see ISO/ASTM Practices 51608 and 51649).
NOTE 2—The Codex Alimentarius Commission as well as regulations in some countries currently limit the maximum electron energy and nominal
X-ray energy for the purpose of food irradiation (CX STAN 106 and Ref21 (CFR,6) 179.26).).
8.3 Absorbed Dose:
8.3.1 Absorbed Doses Required to Accomplish Specific Effects—Food irradiation specifications provided by the owner of the
product should include minimum and maximum absorbed dose limits: a minimum necessary to ensure the intended effect, and a
F1355 − 19
maximum to prevent product degradation. One or both of these limits may be prescribed by regulation for a given application. See,
for example, FDA and USDA regulations (75, 7).CFR 305.31 and 21 CFR 179.25. The irradiation process must be configured to
ensure that the absorbed dose achieved is within these limits throughout each process load. Once this capability is established, the
absorbed dose values for each production run must be monitored and recorded (see 11.2.211.1.3).
8.3.2 Doses to Control Various Pests—Appendix X1 lists the many quarantine pests of fresh agricultural produce. Additional
information on the use of irradiation as a quarantine treatment for pests on fresh agricultural produce can be found in the
International Database on Commodity Tolerance on the IAEA website (5) or the USDA website (6). The sensitivity of a pest to
radiation varies with the life stage of the pest at the time of irradiation (see Note 3). The effect of irradiation at one stage may carry
over to, and be more apparent in, a later stage.
NOTE 3—Infestation of a fruit with fruit flies occurs when the adult female lays eggs in the agricultural produce. Later, these eggs hatch and larvae
emerge. These larvae feed and develop in the fruit a
...