ASTM E2449-05(2013)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2449 − 05(Reapproved 2013)
Standard Guide for
Irradiation of Pre-packaged Processed Meat and Poultry
Products to Control Pathogens and Other Microorganisms
This standard is issued under the fixed designation E2449; 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 Processed Meat and Poultry. Information on the handling of processed
meat and poultry prior to and after irradiation is also provided.
This guide is intended to serve as a set of recommendations to be followed when using irradiation
technologywhereapprovedbyanappropriateregulatorycontrolauthority.Itisnottobeconstruedas
setting forth rigid requirements for the use of irradiation.While the use of irradiation involves certain
essential requirements to attain the objective of the treatment, some parameters can be varied in
optimizing the process.
This guide has been prepared from a Code of Good Irradiation Practice published by the
International Consultative Group on Food Irradiation (ICGFI) under the auspices of the Food and
AgricultureOrganization(FAO),theWorldHealthOrganization(WHO),andtheInternationalAtomic
Energy Agency (IAEA). (1)
1. Scope 2. Referenced Documents
1.1 This guide outlines procedures for the irradiation of 2.1 ASTM Standards:
pre-packaged refrigerated and frozen processed meat and E170Terminology Relating to Radiation Measurements and
poultry products. Dosimetry
F1356PracticeforIrradiationofFreshandFrozenRedMeat
NOTE1—TheCodexAlimentariusCommissiondefines“meat”(includ-
and Poultry to Control Pathogens and Other Microorgan-
ing poultry and game) as “the edible part of any mammal slaughtered in
isms
an abattoir,” and “poultry meat” as “the edible part of slaughtered
domesticated birds, including chicken, turkeys, ducks, geese, guinea-
F1640Guide for Selection and Use of Packaging Materials
fowls, or pigeons.” (CAC/RCP 13-1976)
for Foods to Be Irradiated
NOTE 2—Current U.S. regulations limit the definition of livestock
E2232Guide for Selection and Use of Mathematical Meth-
species to cattle, sheep, swine, goat, horse, mule, or other equine and
ods for CalculatingAbsorbed Dose in Radiation Process-
poultry species to chicken, turkey, duck, goose, and guinea (2, 3).
ing Applications
1.2 This guide addresses all refrigerated and frozen meat
E2303Guide for Absorbed-Dose Mapping in Radiation
and poultry products NOT covered by Guide F1356.
Processing Facilities
1.3 This guide provides information regarding absorbed
2.2 ISO/ASTM Standards:
doses used for inactivation of parasites and reduction of
51204Practice for Dosimetry in Gamma Irradiation Facili-
bacterial load. Such doses are typically less than 10 kilogray
ties for Food Processing
(kGy).
51261 GuidefortheSelectionandCalibrationofDosimetry
Systems for Radiation Processing
51431 Practice for Dosimetry in Electron and X-ray
1 (Bremsstrahlung) Irradiation Facilities for Food Process-
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
Processing and is the direct responsibility of Subcommittee E61.05 on Food
ing
Irradiation.
Current edition approved Jan. 1, 2013 Published January 2013. Originally
approved in 2005. Last previous edition approved in 2005 as E2449–05. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E2449-05R13. contact ASTM Customer Service at service@astm.org. 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
E2449 − 05 (2013)
51539Guide for the Use of Radiation Sensitive Indicators 4.4 Radiation processing of the final product in its packag-
ing is a critical control point (CCP) of a Hazard Analysis of
2.3 Codex Alimentarius Commission Recommended Inter-
CriticalControlPoints(HACCP)conceptfortheproductionof
national Codes of Practice and Standards:
Processed Meat and Poultry. It serves as an important measure
CAC/RCP 13-1976,Rev. 1985 - Recommended Interna-
tocontrolanyresidualriskfrompathogenmicroorganismsjust
tional Code of Hygienic Practice for Processed Meat and
before the product reaches the consumer.
Poultry Products
CAC/RCP 1-1969,Rev. 3-1997, Amd. 1999, A Recom-
4.5 The “Recommended International Code of Practice for
mendedInternationalCodeofPractice,GeneralPrinciples
Radiation-processing of Food” (CAC/RCP 19-1979) of the
of Food Hygiene
Codex Alimentarius identifies the essential practices to be
CAC/RCP 19-1979, Rev. 2003Recommended International
implemented to achieve effective radiation processing of food,
Code of Practice for Radiation-processing of Food
in general, in a manner that maintains quality and yields food
CX STAN 1-1985,Rev. 1991, Amd. 2001 - General Stan-
products that are safe and suitable for consumption.
dard for the Labelling of Prepackaged Foods
CX STAN 106 –1983,Rev. 2003 - General Standard for
5. Pre-Irradiation Product Handling
Irradiated Food
5.1 Product should be handled in an environment that does
CAC/GL21-1997Principles for the establishment and appli-
notincreasetheriskofcontaminationfromphysical,chemical,
cation of microbiological criteria for Food
or biological hazards. Minimize microbial contamination and
3. Terminology growth by following relevant standards of Good Manufactur-
ing Practice (GMPs); see for example U.S. Food and Drug
3.1 Definitions:
Administration (FDA) GMPs (4), U.S. Food Safety and In-
3.1.1 Other terms used in this guide may be defined in
spection Service (FSIS) Standard Sanitary Operating Proce-
Terminology E170.
dures(SSOPs) (5),CACRecommendedInternationalCodesof
3.1.2 absorbed dose—Quantity of ionizing radiation energy
Practice, (CAC/RCP 13-1976 and CAC/RCP 1-1969)(see 2.3)
imparted per unit mass of a specified material. The SI unit of
and HACCP (6, 7).
absorbed dose is the gray (Gy), where 1 gray is equivalent to
theabsorptionof1jouleperkilogramofthespecifiedmaterial
5.2 Pre-Irradiation Inspection—Inspect packages and con-
(1 Gy = 1 J/kg).
tainers of processed meat and poultry upon receipt at the
3.1.2.1 Discussion—Astandard definition of absorbed dose
irradiation facility to ensure that the product is suitable for
appears in Terminology E170 .
irradiation (see 5.2.1, 5.2.2, and 5.2.3). Written acceptance
criteria for product temperature, package integrity and inspec-
3.1.3 D -value —absorbed dose required to reduce the
microbial population in a given food by 90% (1 log ). tion frequency, as applicable, should be established by the
product owner and agreed to by management of the irradiation
3.1.4 dose distribution—variationinabsorbeddosewithina
facilitypriortoacceptingproductfromtheowner.Also,criteria
process load exposed to ionizing radiation.
for handling product unsuitable for irradiation should be
3.1.5 process load—a volume of material with a specified
established.
loading configuration irradiated as a single entity.
5.2.1 Product Temperature—Upon receipt, using a cali-
3.1.6 transport system—conveyor or other mechanical sys-
bratedtemperature-sensingdevice,measurethetemperatureof
tem used to move the process load through the irradiator.
the product at a pre-determined location and frequency as
specified by HACCP and GMPs. Temperature should be
4. Significance and Use
between −2 and +4°C for refrigerated processed meat and
4.1 The principal purpose of irradiation is to reduce the
poultry or −18°C or lower for frozen processed meat and
number of pathogenic bacteria, such as Campylobacter, Es-
poultry.
cherichia coli 0157:H7, Listeria monocytogenes, Staphylococ-
5.2.2 Package Integrity—Perform a visual inspection of the
cus aureus or Salmonella spp., in processed meats and poultry
product packaging to ensure there is no evidence of compro-
to make these foods safer for human consumption.
mised or damaged product.
NOTE 3—Ionizing radiation doses below 10 kGy will reduce but not 5.2.3 Product Inventory—Count the number of containers
eliminate spores of pathogenic bacteria including those of Clostridium
and verify the description/identification of the product to be
botulinum, Clostridium perfringens and Bacillus cereus.
irradiated and compare with the documentation from the
4.2 Irradiation treatment can extend the shelf life of pro-
productowner.Acomparisonofthispre-irradiationcountwith
cessed meats and poultry by reducing the numbers of vegeta-
a count performed after irradiation provides a check that all
tive spoilage bacteria, such as Pseudomonas species and lactic
products received have been irradiated.
acid bacilli.
5.2.4 Product Identification—A unique identification num-
ber for tracking the product throughout the irradiation process
4.3 Irradiation treatment also inactivates parasites such as
should be issued and documented for the incoming product.
Trichinella spiralis and Toxoplasma gondii.
5.3 Pre-Irradiation Storage:
5.3.1 Refrigerated Processed Meats and Poultry—the prin-
Available from the Joint FAO/WHO Food Standards Programme, Joint Office,
FAO, Via delle Terme di Caracalla, 00100 Rome, Italy. cipal requirement for pre-irradiation storage is maintenance of
E2449 − 05 (2013)
the product temperature between −2 and +4°C without freez- 7. Irradiation
ing. Pre-irradiation storage at the irradiation facility should be
7.1 Standard Operating Procedures (SOPs)—A standard
minimized to approximately one day or less, whenever pos-
operating procedure for food irradiation is a written procedure
sible.
that is used to ensure that the absorbed dose range and
irradiation conditions selected by the radiation processor are
NOTE 4—Holding product under refrigeration for an unduly long time
would violate principles of GMPs because such treatment may result in
adequate under commercial processing conditions to achieve
excessive growth of psychrotrophic bacteria and undesirable changes in
the intended effect on a specific product in a specific facility.
products.
The procedures shall be established by qualified persons
5.3.2 Frozen Processed Meats and Poultry—maintain the
having knowledge in irradiation requirements specific to the
product temperature at or below −18°C at all times. The
food and the irradiation facility (21 CFR 179.25).
relativelyshortdurationoffrozenstoragepriortoirradiationis
7.2 Radiation Sources—The sources of ionizing radiation
not particularly critical under normal commercial conditions.
that may be employed in irradiating food products are limited
However, freezing does not provide an unlimited product life
to the following: (see CX STAN 106-1983)
without loss of quality, and the pre-irradiation storage period
7.2.1 Isotopic Sources—gamma rays from the radionuclides
should therefore be minimized.
60 137
Co (1.17 and 1.33 MeV) or Cs (0.66 MeV);
5.4 Product Separation—It may not be possible to distin-
7.2.2 Machine Sources—X-rays and accelerated electrons.
guish irradiated from un-irradiated product by visual inspec-
NOTE6—TheCodexAlimentariusCommissionaswellasregulationsin
tion.Itisthereforeimportantthatappropriatemeansintegralto
some countries currently limit the maximum electron energy and nominal
the facility design, such as physical barriers or clearly defined
X-ray energy for the purpose of food irradiation (CX STAN 106-1983).
staging areas, be used to maintain un-irradiated product sepa-
7.3 Dosimetry System—Select and calibrate a dosimetry
rate from irradiated product.
system appropriate for the radiation source being used, the
NOTE 5—Radiation-sensitive indicators undergo a color change when
range of absorbed doses required, and the environmental
exposed to radiation in the pertinent dose range. These indicators may be
conditions (e.g., product temperature, irradiation cell tempera-
useful within the irradiation facility as a visual check for determining
ture) expected during irradiation (see ISO/ASTM 51204,
whether or not a product has been exposed to the radiation source. They
51261 and 51431) (8).
are not dosimeters intended for measuring absorbed dose and must not be
used as a substitute for proper dosimetry. Information about dosimetry
7.4 Absorbed Dose—
systems and the proper use of radiation-sensitive indicators is provided in
7.4.1 Absorbed Doses Required to Accomplish Specific
ISO/ASTM Guides 51261 and 51539, respectively.
Effects: The owner of the processed meat or poultry product
shall provide required minimum and maximum absorbed dose
6. Packaging and Product Loading Configuration
limits (9): the lowest dose necessary to ensure the intended
6.1 Packaging Materials:
effect (e.g., microbial load reduction, pathogen inactivation),
6.1.1 Use packaging materials suitable to the product con-
andthehighestdosethatdoesnotnegativelyaffecttheproduct
sidering any planned processing (including irradiation) and
quality through the formation of off-flavors, aromas and color
consistent with any regulatory requirements (see Guide
changes (8,9).Oneorbothoftheselimitsmaybeprescribedby
F1640). Packaging materials should provide appropriate gas
government authorities for a given application. The sensitivity
and moisture permeability to maintain product quality.
toirradiationofprocessedmeatandpoultryproductvarieswith
6.1.2 For frozen processed meats and poultry, the package
the type and product formulation, the packaging atmosphere,
should be as free as possible of voids or open spaces. Such
the product temperature during irradiation, and other factors.
spaces can cause a form of desiccation known as “freezer
Experience indicates that a higher minimum dose may be
burn.”
required for frozen product than that for product irradiated in
6.2 Product Loading Configuration:
the refrigerated state to achieve the same intended objective.
6.2.1 Thesize,shape,densityandloadingconfigurationofa
7.4.2 Absorbed Dose for the Control of Pathogenic
processloadtobeirradiatedshouldbedeterminedprimarilyby
Bacteria—Pathogenic bacteria that may be present in or on
considering design parameters of the irradiation facility. Criti-
processed meat and poultry products, include Salmonella
cal design parameters include the characteristics of product
species, Campylobacter jejuni, Escherichia coli O157:H7,
transport systems an
...