Safe commodity assessments for OIE listed aquatic animal diseases

Safe commodity assessments
for OIE listed aquatic
animal diseases
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ISBN: 978-92-95108-22-6
Contents
Introduction ......................................................................................................................................... 7
Chapter I: Assessments for OIE listed diseases of amphibians ...................................................... 9
1.
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis ............... 9
A. Assessments using criteria in Article 5.4.1. (for Article 8.1.3. point 1) ....................................... 9
B. Assessments using criteria in Article 5.4.2. (for Article 8.1.12. point 1).................................... 17
2.
Aquatic animal product assessments for infection with ranavirus................................................. 19
A. Assessments using criteria in Article 5.4.1. (for Article 8.2.3. point 1)...................................... 19
B. Assessments using criteria in Article 5.3.2. (for Article 8.2.12. point 1).................................... 27
Chapter II: Assessments for OIE listed diseases of crustaceans .................................................. 31
1.
Aquatic animal product assessments for crayfish plague ............................................................. 31
A. Assessments using criteria in Article 5.41. (for Article 9.1.3. point 1)....................................... 31
B. Assessments using criteria in Article 5.4.2. (for Article 9.1.11. point 1).................................... 39
2.
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis.... 40
A. Assessments using criteria in Article 5.4.1. (for Article 9.3.3. point 1)...................................... 40
B. Assessments using criteria in Article 5.4.2. (for Article 9.3.11. point 1).................................... 53
3.
Aquatic animal product assessments for infectious myonecrosis virus ........................................ 55
A. Assessments using criteria in Article 5.4.1. (for Article 9.4.3. point 1)...................................... 55
B. Assessments using criteria in Article 5.4.2. (for Article 9.4.11. point 1).................................... 64
4.
Aquatic animal product assessments for necrotising hepatopancreatitis...................................... 66
A. Assessments using criteria in Article 5.4.1. (for Article 9.5.3. point 1)...................................... 66
B. Assessments using criteria in Article 5.4.2. (for Article 9.5.11. point 1).................................... 75
5.
Aquatic animal product assessments for Taura syndrome ........................................................... 77
A. Assessments using criteria in Article 5.4.1. (for Article 9.6.3. point 1)...................................... 77
B. Assessments using criteria in Article 5.4.2. (for Article 9.6.11. point 1).................................... 84
6.
Aquatic animal product assessments for white spot disease........................................................ 86
A. Assessments using criteria in Art. 5.4.1. (for Art. 9.7.3. point 1)............................................... 86
B. Assessments using criteria in Article 5.4.2. (for Article 9.7.11. point 1).................................... 93
Assessments of the safety of aquatic animal commodities
3
Contents
7.
Aquatic animal product assessments for white tail disease ......................................................... 95
A. Assessments using Criteria in Art. 5.4.1. (for Article.9.8.3. point 1).......................................... 95
B. Assessments using Criteria in Article 5.4.2. (for Article 9.8.11. point 1) ................................. 102
8.
Aquatic animal product assessments for infection with yellow head virus .................................. 104
A. Assessments using criteria in Article 5.4.1. (for Article 9.2.3. point 1) .................................... 104
B. Assessments using criteria in Article 5.4.2. (for Article 9.2.11. point 1) .................................. 111
Chapter III: Assessments for OIE listed diseases of molluscs ................................................... 113
1.
Aquatic animal product assessments for infection with abalone herpesvirus ............................. 113
A. Assessments using Criteria in Article 5.4.1. (for Article 11.1.3. point 1) ................................. 113
B. Assessments using Criteria in Article 5.4.2. (for Article 11.1.11. point 1) ............................... 117
2.
Aquatic animal product assessments for Infection with Bonamia exitiosa .................................. 118
A. Assessments using criteria in Article 5.4.1. (for Article 11.2.3. point 1) .................................. 118
B. Assessments using criteria in Article 5.4.2. (for Article 11.2.11. point 1) ................................ 123
3.
Aquatic animal product assessments for infection with Bonamia ostreae................................... 124
A. Assessments using criteria in Article 5.4.1 (for Article 11.3.3. point 1) ................................... 124
B. Assessments using criteria in Article 5.4.2. (for Article 11.3.11. point 1) ................................ 127
4.
Aquatic animal product assessments for infection with Marteilia refringens ............................... 128
A. Assessments using criteria in Article 5.4.1. (for Article 11.4.3. point 1) .................................. 128
B. Assessments using criteria in Article 5.4.2. (for Article 11.4.11. point 1) ................................ 131
5.
Aquatic animal product assessments for infection with Perkinsus marinus ................................ 132
A. Assessments using criteria in Article 5.3.1. (for Article 11.5.3. point 1) .................................. 132
B. Assessments using criteria in Article 5.4.2. (for Article 11.5.11. point 1) ................................ 134
6.
Aquatic animal product assessments for infection with Perkinsus olseni.................................... 135
A. Assessments using criteria in Article 5.4.1. (for Article 11.6.3. point 1) .................................. 135
B. Assessments using criteria in Article 5.4.2. (for Article 11.6.11. point 1) ................................ 137
7.
Aquatic animal product assessments for infection with Xenohaliotis californiensis .................... 138
A. Assessments using criteria in Article 5.4.1. (for Article 11.7.3. point 1) .................................. 138
B. Assessments using criteria in Article 5.4.2. (for Article 11.7.11. point 1) ................................ 141
4
Assessments of the safety of aquatic animal commodities
Contents
Chapter IV: Assessments for OIE listed diseases of fish ............................................................. 143
1.
Aquatic animal product assessments for epizootic haematopoietic necrosis ............................. 143
A. Assessments using criteria in Article 5.4.1. (for Article 10.1.3. point 1).................................. 143
B. Assessments criteria in Article 5.4.2. (for Article 10.1.11. point 1) ......................................... 149
2.
Aquatic animal product assessments for infection with Aphanomyces invadans (epizootic
ulcerative syndrome)................................................................................................................... 151
A. Assessments using criteria in Article 5.4.1. (for Article 10.2.3. point 1).................................. 151
B. Assessments criteria in Article 5.4.2. (for Article 10.2.11. point 1) ......................................... 160
3.
Aquatic animal product assessments for infection with Gyrodactylus salaris ............................. 162
A. Assessments using criteria in Article 5.4.1. (for Article 10.3.3. point 1).................................. 162
B. Assessments using criteria in Article 5.4.2. (for Article 10.3.11. point 1)................................ 178
4.
Aquatic animal product assessments for infectious haematopoietic necrosis virus.................... 180
A. Assessments using criteria in Article 5.4.1. (for Article 10.6.3. point 1).................................. 180
B. Assessments using criteria in Article 5.4.2. (for Article 10.6.11. point 1)................................ 191
5.
Aquatic animal product assessments for infection with infectious salmon anaemia virus .......... 194
A. Assessments using criteria in Article 5.4.1. (for Article 10.4.3. point 1).................................. 194
B. Assessments using criteria in Article 5.4.2. (for Article 10.4.15. point 1)................................ 205
6.
Aquatic animal product assessments for Koi herpesvirus disease ............................................. 208
A. Assessments using criteria in Article 5.4.1. (for Article 10.7.3. point 1).................................. 208
B. Assessments for criteria in Article 5.4.2. (for Article 10.7.11. point 1) .................................... 218
7.
Aquatic animal product assessments for red sea bream iridovirus............................................. 221
A. Assessments using Criteria in Article 5.4.1. (for Article 10.8.3. point 1) ................................. 221
B. Assessments using Criteria in Article 5.4.2. (for Article 10.8.11. point 1) ............................... 227
8.
Aquatic animal product assessments for spring viraemia of carp ............................................... 229
A. Assessments using criteria in Article 5.4.1. (for Article 10.9.3. point 1).................................. 229
B. Assessments using criteria in Article 5.4.2. (for Article 10.9.11. point 1)................................ 235
9.
Aquatic animal product assessments for viral haemorrhagic septicaemia virus ......................... 237
A. Assessments using criteria in Article 5.4.1. (for Article 10.10.3. point 1)................................ 237
B. Assessments using Criteria in Article 5.4.2. (for Article 10.10.11. point 1) ............................. 249
Assessments of the safety of aquatic animal commodities
5
Contents
10. Aquatic animal product assessments for viral infection with Salmonid alphavirus (SAV) .......... 252
A. Assessments using criteria in Article 5.4.1. (for Article 10.5.3. point 1) .................................. 252
B. Assessments using Criteria in Article 5.4.2. (for Article 10.5.11. point 1) ............................... 264
References ....................................................................................................................................... 269
6
Assessments of the safety of aquatic animal commodities
Introduction
The World Organisation for Animal Health (OIE) is recognised under the World Trade Organization
Agreement on the Application of Sanitary and Phytosanitary Measures as the international standardsetting organisation of reference for measures relating to animal diseases, including zoonoses. In light
of the rapid growth of trade in aquatic animals and aquatic products in recent decades and the risk this
presents for the spread of aquatic animal diseases globally, countries are strongly encouraged to
respect and apply the health standards in the Aquatic Animal Health Code (the Aquatic Code).
Application of the OIE standards facilitates safe trade while avoiding the imposition of unjustified trade
barriers relating to the protection of aquatic animal health.
The OIE has continued developing ´commodity-based trade´ as an approach to facilitate safe trade in
products of aquatic and terrestrial animals. This approach takes into account the contribution of the
product presentation, commercial processing and intended use of the products to the management of
disease risks. This approach has been applied to each of the OIE listed aquatic animal diseases and
has enabled the identification of products that may be traded safely, without the application of disease
specific measures, regardless of the disease status of the aquatic animal population for each OIE
listed aquatic animal disease.
In May 2009, the OIE World Assembly of Delegates adopted Chapter 5.4. ‘Criteria to assess the
safety of aquatic animal commodities’. The criteria in Article 5.4.1 address products for any purpose
and risk management is based on the absence of the pathogenic agent in the commodity or the
inactivation of the pathogenic agent by standard commercial processing. The criteria in Article 5.4.2.
address trade in products for retail trade intended for human consumption, where risk management is
based on the negligible probability that aquatic animals will be exposed to discarded waste materials
containing viable pathogenic agents.
Since 2009 the OIE has convened an ad hoc Group of experts to apply these criteria to each of the
OIE listed aquatic animal diseases against commonly traded aquatic animal products. After
consideration of Member Countries’ comments on draft assessments, the OIE World Assembly of
Delegates has adopted proposed amendments to the list of products listed in the Aquatic Code.
The criteria for assessing the safety of aquatic animal commodities are described in Chapter
5.4. Recommendations relevant to individual OIE listed aquatic animal diseases are included in the
disease-specific chapters, in Article X.X.3 for products for any purpose and in Article X.X.11. or X.X.12
for products for retail trade for human consumption).
This publication includes all of the aquatic animal product assessments performed by the expert group
and provides the scientific rationale for the recommendations on measures for aquatic animal products
in the disease-specific chapters of the Aquatic Code. It is a valuable resource for Veterinary
Authorities and other Competent Authorities responsible for the certification of aquatic animal products
for international trade.
This document will be updated when needed, for example when new assessments against the criteria
in Chapter 5.4 are applied to new OIE listed aquatic animal diseases.
Ingo Ernst
President of the Aquatic Animal Health Standards Commission (2015-2018)
th
NOTE: Chapter and article references provided are based on the 2015 (18 edition) of the Aquatic
Code.
Assessments of the safety of aquatic animal commodities
7
Chapter I: Assessments for OIE listed diseases
of amphibians
1.
Aquatic animal product assessments for infection with
Batrachochytrium dendrobatidis
A) Assessments using criteria in Article 5.4.1.
1. The following aquatic animal products did meet the criteria in Article 5.4.1.:
i) heat sterilised hermetically sealed amphibian products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked amphibian products that have been subjected to heat treatment at 100°C for at
least 1 min (or any equivalent time/temperature equivalent which has been
demonstrated to inactivate Batrachochytrium dendrobatidis) (Table II)
iii) pasteurised amphibian products that have been subjected to heat treatment at 90°C
for at least 10 min (or any time/temperature equivalent which has been demonstrated
to inactivate B. dendrobatidis) (Table III)
iv) mechanically dried amphibian products (i.e. a heat treatment of 100°C for at least
30 min or any time/temperature equivalent which has been demonstrated to inactivate
B. dendrobatidis) (Table IV)
v) amphibian skin leather (Table V).
2. The following aquatic animal products did not meet the criteria in Article 5.4.1.:
i) amphibian meat (skin off, fresh or frozen) (Table VI)
ii) amphibian meat (skin on, fresh or frozen) (Table VII).
Assessments of the safety of aquatic animal commodities
9
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table I
Heat sterilised hermetically sealed amphibian products
Article 5.4.1. Criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
B. dendrobatidis is confined to the
superficial keratin-rich layers of the
epidermis in adult amphibians (Berger,
Speare & Skerratt, 2005; Voyles et al.,
2007). Canned product is likely to consist
of meat only
Yes
Potable water is used to process the
product. There is evidence that
B. dendrobatidis will survive for up to three
weeks in potable tap water (Johnson &
Speare, 2003). However, water potentially
contaminating the product will be subject to
the same temperature/time treatment as
the product and the final product is sealed
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). B. dendrobatidis is
inactivated by heating to 100°C for 1 min
and 60°C for 5 min (Johnson et al., 2003)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Batrachochytrium dendrobatidis will be inactivated by this process. Therefore, heat sterilised hermetically sealed
amphibian products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are
eligible for inclusion in Article 8.1.3. point 1.
10
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table II
Cooked amphibian products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
B. dendrobatidis is confined to the
superficial keratin-rich layers of the
epidermis in adult amphibians (Berger,
Speare & Skerratt, 2005; Voyles et al.,
2007). Cooked product is likely to be
mainly meat, but there is no guarantee
that skin would not also be present
No
AND
NA
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
B. dendrobatidis is inactivated by heating
to 100°C for 1 min and 60°C for 5 min
(Johnson et al., 2003)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Batrachochytrium dendrobatidis will be inactivated by this process. Therefore, cooked amphibian products that
have been subjected to heat treatment at 100°C for at least 1 min (or any time/temperature equivalent which has
been demonstrated to inactivate B. dendrobatidis) are eligible for inclusion in Article 8.1.3. point 1.
Assessments of the safety of aquatic animal commodities
11
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table III
Pasteurised amphibian products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
B. dendrobatidis is confined to the superficial
keratin-rich layers of the epidermis in adult
amphibians (Berger, Speare & Skerratt,
2005; Voyles et al., 2007). Pasteurised
product is likely to be mainly meat, but there
is no guarantee that skin would not also
be present
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent)
(FDA, 2001; Gould, 1999). Batrachochytrium
dendrobatidis is inactivated by heating to
60°C for 5 min (Johnson et al., 2003)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Batrachochytrium dendrobatidis will be inactivated by this process. Therefore, pasteurised amphibian products
that have been subjected to heat treatment at 90°C for at least 10 min (or any time/temperature equivalent which
has been demonstrated to inactivate B. dendrobatidis) are eligible for inclusion in Article 8.1.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
12
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table IV
Mechanically dried amphibian products
Article 5.4.1. criteria
1.
Rationale
Assessment
B. dendrobatidis is confined to the superficial
keratin-rich layers of the epidermis in adult
amphibians (Berger, Speare & Skerratt,
2005; Voyles et al., 2007). Mechanically dried
product is likely to be mainly meat, but there
is no guarantee that skin would not also
be present
No
Water is used in the processing but the product
undergoes a drying process
NA
Artificial drying involves heating at
100°C for 30 min (or equivalent).
B. dendrobatidis is inactivated by
heating to 100°C for 1 min
(Johnson et al., 2003)
Yes
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature,
drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
–
–
–
–
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Batrachochytrium dendrobatidis will be inactivated by this process. Therefore, mechanically dried
amphibian products (i.e. heat treatment at 100°C for at least 30 min or equivalent which has been demonstrated
to inactivate B. dendrobatidis) are eligible for inclusion in Article 8.1.3. point 1.
Assessments of the safety of aquatic animal commodities
13
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table V
Amphibian skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
B. dendrobatidis is present in the
superficial keratin-rich layers of
the epidermis in adult amphibians
(Berger, Speare & Skerratt, 2005;
Voyles et al., 2007)
No
Water is used to process the leather but
the final product is dry and not transported
in water
NA
Skin is exposed to alkaline metal sulphide,
solvents, proteases, acid pH 1.5–4,
chromium or other tanning solutions and
dyes. The final leather product is usually
pH <5. Each step takes between 15 min
to and 24 h in a commercial setting
(Pocket Book for the Leather
Technologist 4th Ed.). pH ≤4 has been
shown to inactivate B. dendrobatidis
(Johnson & Speare, 2005)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates in, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Batrachochytrium dendrobatidis will be inactivated by this process. Therefore, amphibian skin leather products
are eligible for inclusion in Article 8.1.3. point 1.
14
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table VI
Amphibian meat (skin off, fresh or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
B. dendrobatidis is confined to the superficial
keratin-rich layers of the epidermis in adult
amphibians (Berger, Speare & Skerratt,
2005; Voyles et al., 2007). The pathogen
should be removed along with the skin
Yes
Codex Alimentarius Standard CAC/RCP
30-1983 specifies skinless product,
processed using potable water and requires
the skinned meat to be washed in several
changes of chlorinated water (20 ppm to
40 ppm). This is designed to eliminate cross
contamination. B. dendrobatidis has been
shown to be inactivated by 100 ppm chlorine
for 10 min (Johnson et al., 2003) thus the
washing process would not be guaranteed to
inactivate B. dendrobatidis
No
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
NA
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
NA
AND/OR
c) Biological (e.g. fermentation)
NA
CONCLUSION
Amphibian meat (skin off, fresh or frozen) may contain B. dendrobatidis. Therefore, amphibian meat (skin off,
fresh or frozen) is not eligible for inclusion in Article 8.1.3. point 1.
Assessments of the safety of aquatic animal commodities
15
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table VII
Amphibian meat (skin on, fresh or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
B. dendrobatidis is present in the
superficial keratin-rich layers of
the epidermis in adult amphibians
(Berger, Speare & Skerratt, 2005;
Voyles et al., 2007)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
B. dendrobatidis will survive freezing at
–19°C for at least one week (Van Sluys et
al., 2008)
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
NA
AND/OR
c) Biological (e.g. fermentation)
NA
CONCLUSION
Amphibian meat (skin on, fresh or frozen) may contain Batrachochytrium dendrobatidis. Therefore, amphibian
meat (skin on, fresh or frozen) is not eligible for inclusion in Article 8.1.3. point 1.
16
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
B) Assessments using criteria in Article 5.4.2.
1. The following aquatic animal products did meet the criteria in Article 5.4.2.:
i) amphibian meat (skin off, fresh or frozen) (Table I).
2. The following aquatic animal products did not meet the criteria in Article 5.4.2.:
i) amphibian meat (skin on, fresh or frozen) (Table II).
Table I
Amphibian meat (skin off, fresh or frozen)
Article 5.4.2. criteria
1.
The commodity is prepared and packaged for
retail trade for human consumption
Rationale
Assessment
It is part of commodity definition
Yes
It includes only a small amount of raw waste
tissues generated by the consumer
As meat portions tend to be small, the
waste bone quantity could be a relatively
large proportion of the product
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
B. dendrobatidis is present in the
superficial keratin-rich layers of the
epidermis in adult amphibians
(Berger, Speare & Skerratt, 2005;
Voyles et al., 2007). Thus, the waste
tissue (bone) would not be expected to
have the pathogenic agent present
Yes
AND/EITHER
2.
OR
3.
CONCLUSION
Amphibian meat (skin off, fresh or frozen) that is prepared and packaged for retail trade for human consumption
may produce amounts of waste that cannot be considered small; however B. dendrobatidis is unlikely to be
present in the waste generated. Therefore, amphibian meat (skin off, fresh or frozen) that is prepared and
packaged for retail trade for human consumption is eligible for inclusion in Article 8.1.12.
Assessments of the safety of aquatic animal commodities
17
Aquatic animal product assessments for infection with Batrachochytrium dendrobatidis
Table II
Amphibian meat (skin on, fresh or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
As meat portions tend to be small, the
waste skin would be a relatively large
proportion of the product
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
B. dendrobatidis is present in the
superficial keratin-rich layers of the
epidermis in adult amphibians (Berger,
Speare & Skerratt, 2005; Voyles et al.,
2007). B. dendrobatidis will survive
freezing at –19°C for at least
one week (Van Sluys et al., 2008)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Amphibian meat (skin on, fresh or frozen) that is prepared and packaged for retail trade for human consumption
may produce amounts of waste that cannot be considered small; B. dendrobatidis may be found in the waste.
Therefore, amphibian meat (skin on, fresh or frozen) that is prepared and packaged for retail trade for human
consumption is not eligible for inclusion in Article 8.1.12.
18
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
2.
Aquatic animal product assessments for infection with ranavirus
A) Assessments using criteria in Article 5.4.1.
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed amphibian products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked amphibian products which have been subjected to 65°C for at least 30 min
(or any time/temperature equivalent which has been demonstrated to inactivate all
virus species of the genus Ranavirus in the family Iridoviridae [with the exception of
epizootic haematopoietic necrosis virus and European catfish virus]) (Table II)
iii) pasteurised amphibian products that have been subjected to heat treatment at 90°C
for at least 10 min (or any time/temperature equivalent which has been demonstrated
to inactivate all virus species of the genus Ranavirus in the family Iridoviridae [with the
exception of epizootic haematopoietic necrosis virus and European catfish virus])
(Table III)
iv) mechanically dried amphibian products (i.e. a heat treatment at 100°C for at least
30 min or any time/temperature equivalent which has been demonstrated to inactivate
all virus species of the genus Ranavirus in the family Iridoviridae [with the exception of
epizootic haematopoietic necrosis virus and European catfish virus]) (Table IV).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) amphibian skin leather (Table V)
ii) amphibian meat (skin off, fresh or frozen) (Table VI)
iii) amphibian meat (skin on, fresh or frozen) (Table VII).
Assessments of the safety of aquatic animal commodities
19
Aquatic animal product assessments for infection with ranavirus
Table I
Heat sterilised hermetically sealed amphibian products
Article 5.4.1. criteria
1.
Rational
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Amphibian ranavirus is present in
skin and a wide range of internal
organs (Cunningham et al., 2008).
Available information indicates
that amphibian ranavirus is
additionally present in skeletal
muscle (Cunningham et al.,
1996; Gantress et al., 2003; Miller et
al., 2008)
No
Water is used to process the
product but the water potentially
contaminating the product will be
subject to the same temperature/time
treatment as the product and the final
product is sealed
NA
Commercial canning involves
time/temperature treatments of
121°C for 3 min, or equivalent e.g.
111°C for 36 min (Ababouch,
1999, 2002). The (amphibian)
ranavirus type species, FV3, is
inactivated by heating to 65°C for
30 min (Granoff et al., 1965). TEV, a
strain of FV3, is inactivated within
2 min at 56°C (Wolf et al., 1968).
Another amphibian ranavirus, BIV,
displayed a 99.9% reduction in
titre after 30 min at 56°C and was
inactivated after 2 h (Speare &
Smith, 1992)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Ranavirus will be inactivated by this process. Therefore, heat sterilised hermetically sealed amphibian
products (i.e. a heat treatment at 121°C for at least 3.6 min or temperature/time equivalent) are eligible for
inclusion in Article 8.2.3. point 1.
20
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
Table II
Pasteurised amphibian products
Article 5.4.1. criteria
1.
Rationale
Assessment
Amphibian ranavirus is present in skin and a
wide range of internal organs (Cunningham
et al., 2008). Available information indicates
that amphibian ranavirus is additionally
present in skeletal muscle (Cunningham et
al., 1996; Gantress et al., 2003; Miller et
al., 2008)
No
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at 90°C
for 10 min (or temperature/time equivalent,
e.g. 86°C for 37 min) (FDA, 2001;
Gould, 1999). The (amphibian) ranavirus
type species, FV3, is inactivated by heating
to 65°C for 30 min (Granoff et al., 1965).
TEV, a strain of FV3, is inactivated within
2 min at 56°C (Wolf et al., 1968).
Another amphibian ranavirus, BIV, displayed
a 99.9% reduction in titre after 30 min at
56°C and was inactivated after 2 h
(Speare & Smith, 1992)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Virus species of the genus Ranavirus in the family Iridoviridae are highly likely to be inactivated by this process.
Therefore, pasteurised amphibian products that have been subjected to heat treatment at 90°C for 10 min (or any
pasteurisation equivalent which has been demonstrated to inactivate all virus species of the genus Ranavirus in
the family Iridoviridae [with the exception of epizootic haematopoietic necrosis virus and European catfish
virus]) are eligible for inclusion in Article 8.2.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
21
Aquatic animal product assessments for infection with ranavirus
Table III
Mechanically dried amphibians
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Amphibian ranavirus is present in skin and a
wide range of internal organs (Cunningham
et al., 2008). Available information indicates
that amphibian ranavirus is additionally
present in skeletal muscle (Cunningham et
al., 1996; Gantress et al., 2003; Miller et
al., 2008)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
Water is used to process the product but
the end product is not shipped in water
NA
Artificially drying involves heating at
100°C for 30 min (or equivalent).
The (amphibian) ranavirus type species,
FV3, is inactivated by heating to 65°C for
30 min (Granoff et al., 1965). TEV, a
strain of FV3, is inactivated within
2 min at 56°C (Wolf et al., 1968).
Another amphibian ranavirus, BIV,
displayed a 99.9% reduction in titre after
30 min at 56°C and was inactivated after
2 h (Speare & Smith, 1992)
Yes
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
NA
AND/OR
c) Biological (e.g. fermentation)
NA
CONCLUSION
Ranavirus will be inactivated by this process. Therefore, mechanically dried amphibians (i.e. a heat treatment at
100°C for at least 30 min or equivalent) are eligible for inclusion in Article 8.2.3. point 1.
22
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
Table IV
Cooked amphibian products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Amphibian ranavirus is present in skin
and a wide range of internal organs
(Cunningham et al., 2008). Available
information indicates that amphibian
ranavirus is additionally present in
skeletal muscle (Cunningham et al., 1996;
Gantress et al., 2003; Miller et al., 2008)
No
The end product is not shipped in water
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The (amphibian) ranavirus type species,
FV3, is inactivated by heating to 65°C for
30 min (Granoff et al., 1965). TEV, a
strain of FV3, is inactivated within 2 min
at 56°C (Wolf et al., 1968). Another
amphibian ranavirus, BIV, displayed a
99.9% reduction in titre after 30 min at
56°C and was inactivated after 2 h
(Speare & Smith, 1992)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Ranaviruses (any members of the genus Ranavirus in the family Iridoviridae with the exception of epizootic
haematopoietic necrosis virus and European catfish virus) may display different levels of resistance to heat
treatment. Cooked amphibian products which have been subjected to treatment at 65°C for 30 min (or any time
temperature equivalent which has been demonstrated to inactivate all species of the genus Ranavirus in the
family Iridoviridae [with the exception of epizootic haematopoietic necrosis virus and European catfish virus])
are eligible for inclusion in Article 8.2.3. point 1.
Assessments of the safety of aquatic animal commodities
23
Aquatic animal product assessments for infection with ranavirus
Table V
Amphibian skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Ranavirus is found in the skin
(Cunningham et al., 2008)
No
Water is used to process the leather
but the final product is dry and not
transported in water
NA
Skin is exposed to alkaline metal
sulphide, solvents, proteases, acid
pH 1.5–4, chromium or other tanning
solutions and dyes. The final leather
product is usually pH <5. Each step
takes between 15 min and 24 h in a
commercial setting (Pocket Book for
the Leather Technologist, 4th Ed.).
Ranavirus infectivity (FV1) is reduced
by 99% within 15 s at pH 2 and 20 min
at pH 3 (Granoff et al., 1966). TEV
infectivity is reduced by 99% after
30 min at pH 3 (Wolf et al., 1968).
Exposure to pH values below 4 was
found to reduce the number of plaqueforming units of FV3. However, after
2 h of exposure significant numbers of
PFU remained (Baumwald et al., 1984)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
The treatments involved in producing amphibian skin leather will significantly reduce the infectivity of ranavirus,
but it is uncertain whether it would be fully inactivated. Therefore, amphibian skin leather is not eligible for
inclusion in Article 8.2.3. point 1.
24
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
Table VI
Amphibian meat (skin off, fresh or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Amphibian ranavirus is present in skin
and a wide range of internal organs
(Cunningham et al., 2008). Available
information indicates that amphibian
ranavirus is additionally present
in skeletal muscle (Cunningham et
al., 1996; Gantress et al., 2003; Miller et
al., 2008)
No
If the amphibians are infected the water
is likely to be contaminated
NA
Freezing does not inactivate ranavirus
(Braunwald et al., 1984)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
No
AND/OR
c) Biological (e.g. fermentation)
No
CONCLUSION
Ranavirus may be present in amphibian meat and the meat would not be subjected to a treatment that would
inactivate the virus. Therefore, amphibian meat (skin off, fresh or frozen) is not eligible for inclusion in
Article 8.2.3. point 1.
Assessments of the safety of aquatic animal commodities
25
Aquatic animal product assessments for infection with ranavirus
Table VII
Amphibian meat (skin on, fresh or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Amphibian ranavirus is present in skin
and a wide range of internal organs
(Cunningham et al., 2008). Available
information indicates that amphibian
ranavirus is additionally present in
skeletal muscle (Cunningham et
al., 1996; Gantress et al., 2003; Miller et
al., 2008)
No
If the amphibians are infected the water
is likely to be contaminated
NA
Freezing does not inactivate ranavirus
(Braunwald et al., 1984)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
No
AND/OR
c) Biological (e.g. fermentation)
No
CONCLUSION
Ranavirus may be present in amphibian meat and the meat would not be subject to a treatment that would
inactivate the virus. Therefore, amphibian meat (skin on, fresh or frozen) is not eligible for inclusion in
Article 8.2.3. point 1.
26
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
B) Assessments using criteria in Article 5.4.2.
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.2.:
i) none.
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) amphibian meat (skin off, fresh or frozen) (Table I)
ii) amphibian meat (skin on, chilled or frozen) (Table II)
iii) amphibian carcases (chilled or frozen) (Table III).
Table I
Amphibian meat (skin off, fresh or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
Waste generated would be bone with
attached tendons and muscle tissue.
The waste quantity could be a relatively
large proportion of the product
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
Available information indicates that
amphibian ranavirus is present in skeletal
muscle (Cunningham et al., 1996; Gantress
et al., 2003; Miller et al., 2008). Amphibian
ranavirus is also present in a wide range of
internal organs (Cunningham et al., 2008).
No data are available for bone tissue
No
AND/EITHER
2.
OR
3.
CONCLUSION
Amphibian meat (skin off, fresh or frozen) that is prepared and packaged for retail trade for human consumption
would produce wastes that cannot be considered negligible. Therefore, amphibian meat (skin off, fresh or
frozen) is not eligible for inclusion in Article 8.2.12.
Assessments of the safety of aquatic animal commodities
27
Aquatic animal product assessments for infection with ranavirus
Table II
Amphibian meat (skin on, chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
Waste generated would be skin,
and bone with attached tendons and
muscle tissue. The waste quantity
could be a relatively large proportion of
the product
No
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
Ranavirus is present in skin
(Cunningham et al., 2008). Available
information indicates that amphibian
ranavirus is also present in skeletal
muscle (Cunningham et al., 1996;
Gantress et al., 2003; Miller et al.,
2008) and a wide range of internal
organs (Cunningham et al., 2008). No
data are available for bone tissue
No
AND/EITHER
2.
OR
3.
CONCLUSION
Amphibian meat (skin on, chilled or frozen) that is prepared and packaged for retail trade for human
consumption would produce wastes (skin and other tissues) and the pathogenic agent may be found in the
waste. Therefore, amphibian meat (skin on, chilled or frozen) is not eligible for inclusion in Article 8.2.12.
28
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with ranavirus
Table III
Amphibian carcases (skin on or off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
Waste includes bone with attached
tendons and muscle tissue and may
include skin. The waste quantity
could be a relatively large proportion
of the product
No
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
Ranavirus is present in skin
(Cunningham et al., 2008).
Available information indicates that
amphibian ranavirus is also present in
skeletal muscle (Cunningham et al.,
1996; Gantress et al., 2003; Miller et
al., 2008) and a wide range of internal
organs (Cunningham et al., 2008). No
data are available for bone tissue
No
AND/EITHER
2.
OR
3.
CONCLUSIONS
Amphibian carcases (skin on or off) that are prepared and packaged for retail trade for human consumption may
produce amounts of wastes that cannot be considered small; the pathogenic agent may be found in the waste
tissues. Therefore, amphibian carcases (skin on or off) are not eligible for inclusion in Article 8.2.12.
Assessments of the safety of aquatic animal commodities
29
Chapter II: Assessments for OIE listed diseases
of crustaceans
1.
Aquatic animal product assessments for crayfish plague
A) Assessments using criteria in Article 5.4.1. (for Article 9.1.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i)
heat sterilised hermetically sealed crayfish products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii)
cooked crayfish products that have been subjected to heat treatment at 100°C for at
least 1 min or any time/temperature equivalent which has been demonstrated to
inactivate Aphanomyces astaci (Table II)
iii)
pasteurised crayfish products that have been subjected to heat treatment at 90°C for
at least 10 min or to any time/temperature equivalent which has been demonstrated
to inactivate Aphanomyces astaci (Table III)
iv)
frozen crayfish products that have been subjected to –20°C or lower temperatures
for at least 72 h (Table IV)
v)
crayfish oil (Table V)
vi)
crayfish meal (Table VI)
vii) chemically extracted chitin (Table VII).
Assessments of the safety of aquatic animal commodities
31
Aquatic animal product assessments for crayfish plague
Table I
Heat sterilised hermetically sealed crayfish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent is
not present in the tissues from which the commodity is
derived
Aphanomyces astaci is mainly
present in exoskeleton (the cuticle) of
crayfish but may also invade other
tissues (Oidtmann et al., 1997,
2006). All these tissues may be used
in the commodity
No
AND
b) The water (including ice) used to process or transport
the commodity is not contaminated with the pathogenic
agent and the processing prevents cross
contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the commodity
is derived, the treatment or processing to produce
the commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min
or time/temperature equivalent (e.g.
111°C for 36 min) (Ababouch,
1999, 2002). Aphanomyces astaci is
inactivated by boiling (100°C) for
1 min (Oidtmann et al., 2002)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by this process. Therefore, heat sterilised hermetically sealed crayfish
products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are eligible for
inclusion in Article 9.1.3. point 1.
32
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for crayfish plague
Table II
Cooked crayfish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Aphanomyces astaci is mainly present in
exoskeleton (the cuticle) of crayfish but may
also invade other tissues (Oidtmann et al.,
1997, 2006). All these tissues may be used in
the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Aphanomyces astaci is inactivated by boiling
(100°C) for 1 min (Oidtmann et al., 2002)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by this process. Therefore, cooked crayfish products that have been
subjected to heat treatment at 100°C for at least 1 min (or any time/temperature equivalent which has been
demonstrated to inactivate all life stages of A. astaci) are eligible for inclusion in Article 9.1.3. point 1.
Assessments of the safety of aquatic animal commodities
33
Aquatic animal product assessments for crayfish plague
Table III
Pasteurised crayfish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Aphanomyces astaci is mainly present in
exoskeleton (the cuticle) of crayfish but
may also invade other tissues (Oidtmann
et al., 1997, 2006). All these tissues may
be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent)
(FDA, 2001; Gould, 1999).
Aphanomyces astaci spores or mycelium
do not survive 5 min of exposure to 60°C
and 70°C respectively (CEFAS, 2000)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci is highly likely to be inactivated by heat treatment associated with pasteurisation.
Therefore, pasteurised crayfish products that have been subjected to heat treatment at 90°C for 10 min (or any
time/temperature equivalent that has been shown to inactivate all life stages of A. astaci) are eligible for
inclusion in Article 9.1.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
34
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for crayfish plague
Table IV
Frozen crayfish products that have been subjected to –20°C or lower temperatures for at
least 72 h
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Aphanomyces astaci is mainly present
in exoskeleton (the cuticle) of crayfish
but may also invade other tissues
(Oidtmann et al., 1997, 2006). All these
tissues may be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Freezing at –20°C or lower
temperatures for at least 72 h will kill
Aphanomyces astaci (Oidtmann et
al., 2002)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by freezing at –20°C or lower temperatures for at least 72 h. Therefore,
frozen crayfish products that have been subjected to –20°C or lower temperatures for at least 72 h are eligible
for inclusion in Article 9.1.3. point 1.
Assessments of the safety of aquatic animal commodities
35
Aquatic animal product assessments for crayfish plague
Table V
Crayfish oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Aphanomyces astaci is mainly present in
exoskeleton (the cuticle) of crayfish but
may also invade other tissues (Oidtmann
et al., 1997, 2006). All these tissues may
be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Raw material is cooked (may be preheated to 50°C to 60°C before cooking at
temperatures of 95°C to 100°C for 15 min
to 20 min. For energy cost reasons and
nutritional content, some processors use
80°C to 85°C for 20 min). Cooked material
is pressed to produce press liquor and
press liquor is heated to 90°C to 95°C,
which produces oil. Oil is purified with hot
water (at 90°C) (FAO, 1986).
Aphanomyces astaci is inactivated by
boiling (100°C) for 1 min (Oidtmann et
al., 2002)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by this process. Therefore, crayfish oil is eligible for inclusion in Article
9.1.3. point 1.
36
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for crayfish plague
Table VI
Crayfish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Aphanomyces astaci is mainly present in
exoskeleton (the cuticle) of crayfish but
may also invade other tissues (Oidtmann
et al., 1997, 2006). All these tissues may
be used in the commodity
No
Water is used in the processing but the
product undergoes a drying process
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The process involves cooking, usually
boiling at 100°C for at least 3 min, and a
drying step at between 115°C and138°C
(Velez et al., 1991). Aphanomyces astaci
is inactivated by boiling (100°C) for 1 min
(Oidtmann et al., 2002)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by this process. Therefore, crayfish meal is eligible for inclusion in
Article 9.1.3. point 1.
Assessments of the safety of aquatic animal commodities
37
Aquatic animal product assessments for crayfish plague
Table VII
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Aphanomyces astaci is mainly present
in exoskeleton (the cuticle) of crayfish
but may also invade other tissues
(Oidtmann et al., 1997, 2006). All these
tissues may be used in the commodity
No
Water is used in the processing but
given the chemicals used it is unlikely
that water would remain contaminated
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The processing involves heating at
60°C to 70°C for a few h (Gagné,
1993). Aphanomyces astaci spores or
mycelium do not survive exposure for
5 min to 60°C and 70°C respectively
(CEFAS, 2000)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces astaci will be inactivated by this process. Therefore, chemically extracted chitin is eligible for
inclusion in Article 9.1.3. point 1.
38
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for crayfish plague
B) Assessments using criteria in Article 5.4.2. (for Article 9.1.11.
point 1)
1. No aquatic animal products were assessed that meet the criteria in Article 5.4.2.
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) live or fresh crayfish (Table I).
Table I
Live or fresh crayfish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of commodity definition
Yes
It includes only a small amount of waste tissues
Waste includes exoskeleton, legs
No
The pathogenic agent is not normally found in
the waste tissues
Exoskeleton contains Aphanomyces
astaci (Oidtmann et al., 1997, 2006).
The pathogen will remain alive in live
animals. Cold storage at or above 0°C
for normal periods will not kill A. astaci
(CEFAS, 2000)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Live or fresh crayfish that are prepared and packaged for the retail trade for human consumption may produce
amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste. Therefore,
live or fresh crayfish is not eligible for inclusion in Article 9.1.11.
Assessments of the safety of aquatic animal commodities
39
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
2.
Aquatic animal product assessments for infectious hypodermal and
haematopoietic necrosis
A) Assessments using criteria in Article 5.4.1. (for Article 9.3.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 90°C for at
least 20 min (or any time/temperature equivalent which has been demonstrated to
inactivate infectious hypodermal and haematopoietic necrosis virus [IHHNV]) (Table II)
iii) crustacean oil (Table III)
iv) crustacean meal (Table IV).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) chemically extracted chitin (Table V)
ii) pasteurised crustacean products (subjected to heat treatment at 90°C for at least
10 min) (Table VI).
40
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues
including: lymphoid organs, connective
tissue, cuticular epithelium, antennal
gland, heart, nerves, ganglia, gonads and
skeletal muscle in order of frequency
(Owens et al., 1992; Sithigorngul et al.,
2009). Infection may therefore be present
in muscle tissue used in the manufacture
of these products
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent and
the processing prevents cross contamination
of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce
the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Assessments of the safety of aquatic animal commodities
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). There is no
specific information about inactivation of
IHHNV, however it has been classified as
a densovirus in the Parvoviridae family
(Bonami et al., 1990; Shike et al., 2000)
so other parvoviruses can provide proxy
information. A related insect densovirus
was inactivated at pH 2 for 1 h, but was
not affected by pH ≥3, and complete
inactivation was achieved at 70°C for
20 min (Seki, 1986). Canine parvovirus is
inactivated at 100°C after 2 min, but in
excess of 7 h is required at 80°C
(McGavin, 1987). Porcine parvovirus has
been reported to be inactivated after 11 h
to12 h at 55°C (Lund et al., 1996). Bovine
parvovirus is perhaps the best studied
with regard to inactivation conditions.
Sauerbrei & Wutzler (2009) report that
95°C for 2 h results in 1 log10 reduction in
viral titre. Previous studies indicated that
a similar reduction was achieved at
100°C for 30 min (Brauningen et al.,
1994) or 60°C for 6 h (Srivastava & Lund,
1980). Both Rehman (1987) and Mahnel
Yes
41
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
& Von Brodorotti (1981) indicate that
90°C for at least 20 min is required for
inactivation. Given that a
time/temperature equivalent is 111°C for
36 min it is highly likely that this treatment
would inactivate IHHNV
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hypodermal and haematopoietic necrosis virus is highly likely to be inactivated by this process.
Therefore, heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C for at least
3.6 min or time/temperature equivalent) are eligible for inclusion in Article 9.3.3. point 1.
42
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues including:
lymphoid organs, connective tissue, cuticular
epithelium, antennal gland, heart, nerves,
ganglia, gonads and skeletal muscle in order of
frequency (Owens et al., 1992; Sithigorngul et
al., 2009). Infection may therefore be present in
muscle tissue used in the manufacture of
these products
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Cooking involves a heat treatment which is not
well defined, but usually involves boiling.
There is no specific information about
inactivation of IHHNV, however it has been
classified as a densovirus in the Parvoviridae
family (Bonami et al., 1990; Shike et al., 2000)
so other parvoviruses can provide proxy
information. A related insect densovirus was
inactivated at pH 2 for 1 h, but was not
affected by pH ≥3, and complete inactivation
was achieved at 70°C for 20 min (Seki, 1986).
Canine parvovirus is inactivated at 100°C after
2 min, but in excess of 7 h is required at 80°C
(McGavin, 1987). Porcine parvovirus has been
reported to be inactivated after 11 h to 12 h at
55°C (Lund et al., 1996). Bovine parvovirus is
perhaps the best studied with regard to
inactivation conditions. Sauerbrei & Wutzler
(2009) report that 95°C for 2 h results in
1 log10 reduction in viral titre. Previous studies
indicated that a similar reduction was achieved
at 100°C for 30 min (Brauningen et al., 1994)
or 60°C for 6 h (Srivastava & Lund, 1980).
Both Rehman (1987) and Mahnel & Von
Brodorotti (1981) indicate that 90°C for at least
20 min is required for inactivation. Sauerbrei &
Wutzler (2009) acknowledge that the %
moisture of the matrix undergoing heat
treatment is an important factor in determining
Assessments of the safety of aquatic animal commodities
Yes
43
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
inactivation efficiency, with greater % moisture
resulting in more efficient inactivation, and that
the figures for bovine parvovirus (95°C, 2 h
resulting in 1 log10 reduction in titre) were
obtained at extremely low moisture levels, as
was the experiment carried out by Brauningen
et al. (1994). These are therefore not
representative of the situation for cooking
crustaceans. Given the figures for the insect
densovirus (Seki, 1986) and bovine parvovirus
(Mahnel & Von Brodorotti, 1981; Rehman,
1987) it is likely that cooking at 90°C for
20 min or 100°C for 2 min would result in
inactivation of IHHNV
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hypodermal and haematopoietic necrosis is highly likely to be inactivated by this process. Therefore,
cooked crustacean products that have been subjected to heat treatment at 90°C for at least 20 min (or to any
time/temperature equivalent which has been demonstrated to inactivate IHHNV) are eligible for inclusion in Article
9.3.3. point 1.
44
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table III
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues including:
lymphoid organs, connective tissue, cuticular
epithelium, antennal gland, heart, nerves,
ganglia, gonads and skeletal muscle in order
of frequency (Owens et al., 1992; Sithigorngul
et al., 2009). Infection may therefore be
present in muscle tissue used in the
manufacture of these products
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Raw material is cooked (may be pre-heated to
50°C to 60°C before cooking) at temperatures
of 95°c to 100°C for 15 to 20 min. For energy
cost reasons and nutritional content, some
processors use 80°C to 85°C for 20 min).
Cooked material is pressed to produce press
liquor, and press liquor is heated to 90°C to
95°C, which produces oil. Oil is purified with
hot water (at 90°C) (FAO, 1986). There is no
specific information about inactivation of
IHHNV, however it has been classified as a
densovirus in the Parvoviridae family (Bonami
et al., 1990; Shike et al., 2000) so other
parvoviruses can provide proxy information.
A related insect densovirus was inactivated at
pH 2 for 1 h, but was not affected by pH ≥3,
and complete inactivation was achieved at
70°C for 20 min (Seki, 1986). Canine
parvovirus is inactivated at 100°C after 2 min,
but in excess of 7 h is required at 80°C
(McGavin, 1987). Porcine parvovirus has been
reported to be inactivated after 11 h to 12 h at
55°C (Lund et al., 1996). Bovine parvovirus is
perhaps the best studied with regard to
inactivation conditions. Sauerbrei & Wutzler
(2009) report that 95°C for 2 h results in
1 log10 reduction in viral titre. Previous studies
indicated that a similar reduction was achieved
at 100°C for 30 min (Brauningen et al., 1994)
Assessments of the safety of aquatic animal commodities
Yes
45
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
or 60°C for 6 h (Srivastava & Lund, 1980).
Both Rehman (1987) and Mahnel & Von
Brodorotti (1981) indicate that 90°C for at least
20 min is required for inactivation. Sauerbrei &
Wutzler (2009) acknowledge that the %
moisture of the matrix undergoing heat
treatment is an important factor in determining
inactivation efficiency, with greater % moisture
resulting in more efficient inactivation, and that
the figures for bovine parvovirus (95°C, 2 h
resulting in 1 log10 reduction in titre) were
obtained at extremely low moisture levels, as
was the experiment carried out by Brauningen
et al. (1994). These are therefore not
representative of the situation for cooking
crustaceans for oil production. Given the
figures for the insect densovirus (Seki, 1986)
and bovine parvovirus (Mahnel & Von
Brodorotti, 1981; Rehman, 1987) it is likely
that a heat treatment step at 90°C for 20 min
or 100°C for 2 min would result in inactivation
of IHHNV
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hypodermal and haematopoietic necrosis is highly likely to be inactivated by this process. Therefore,
crustacean oil is eligible for inclusion in Article 9.3.3. point 1.
46
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table IV
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues including:
lymphoid organs, connective tissue, cuticular
epithelium, antennal gland, heart, nerves,
ganglia, gonads and skeletal muscle in order
of frequency (Owens et al., 1992; Sithigorngul
et al., 2009). Infection may therefore be
present in muscle tissue used in the
manufacture of these products
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The process involves cooking, usually boiling,
at 100°C for at least 3 min, and a drying step
at between 115°C and 138°C (Velez et al.,
1991). There is no specific information about
inactivation of IHHNV, however it has been
classified as a densovirus in the Parvoviridae
family (Bonami et al., 1990; Shike et al., 2000)
so other parvoviruses can provide proxy
information. A related insect densovirus was
inactivated at pH 2 for 1 h, but was not
affected by pH ≥3, and complete inactivation
was achieved at 70°C for 20 min (Seki, 1986).
Canine parvovirus is inactivated at 100°C after
2 min, but in excess of 7 h is required at 80°C
(McGavin, 1987). Porcine parvovirus has been
reported to be inactivated after 11 h to 12 h at
55°C (Lund et al., 1996). Bovine parvovirus is
perhaps the best studied with regard to
inactivation conditions. Sauerbrei & Wutzler
(2009) report that 95°C for 2 h results in
1 log10 reduction in viral titre. Previous studies
indicated that a similar reduction was achieved
at 100°C for 30 mins (Brauningen et al., 1994)
or 60°C for 6 h (Srivastava & Lund, 1980).
Both Rehman (1987) and Mahnel & Von
Brodorotti (1981) indicate that 90°C for at least
20 min is required for inactivation. Sauerbrei &
Wutzler (2009) acknowledge that the %
moisture of the matrix undergoing heat
Assessments of the safety of aquatic animal commodities
Yes
47
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
treatment is an important factor in determining
inactivation efficiency, with greater % moisture
resulting in more efficient inactivation, and that
the figures for bovine parvovirus (95°C, 2 h
resulting in 1 log10 reduction in titre) were
obtained at extremely low moisture levels, as
was the experiment carried out by Brauningen
et al. (1994). Given the figures for the insect
densovirus (Seki, 1986) and bovine parvovirus
(Mahnel & Von Brodorotti, 1981; Rehman,
1987) it is likely that a heat treatment step at
90°C for 20 min or 100°C for 2 min would
result in inactivation of IHHNV
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hypodermal and haematopoietic necrosis is highly likely to be inactivated by this process. Therefore,
crustacean meal is eligible for inclusion in Article 9.3.3. point 1.
48
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table V
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues
including: lymphoid organs, connective
tissue, cuticular epithelium, antennal gland,
heart, nerves, ganglia, gonads and skeletal
muscle in order of frequency (Owens et al.,
1992; Sithigorngul et al., 2009). Virus could
well be present in the cuticle used in this
process
No
Water is used in the processing but given
the chemicals used it is unlikely that water
would remain contaminated
NA
Hydrochloric acid is used in the processing
and involves heating at 60 C to 70°C for a
few h (Gagné, 1993). There is no specific
information about inactivation of IHHNV,
however it has been classified as a
densovirus in the Parvoviridae family
(Bonami et al., 1990; Shike et al., 2000) so
other parvoviruses can provide proxy
information. A related insect densovirus was
inactivated at pH 2 for 1 h, but was not
affected by pH ≥3, and complete inactivation
was achieved at 70°C for 20 min (Seki,
1986). Canine parvovirus is inactivated at
100°C after 2 min, but in excess of 7 h is
required at 80°C (McGavin, 1987). Porcine
parvovirus has been reported to be
inactivated after 11 h to 12 h at 55°C (Lund
et al., 1996). Bovine parvovirus is perhaps
the best studied with regard to inactivation
conditions. Sauerbrei & Wutzler (2009)
report that 95°C for 2 h results in 1 log10
reduction in viral titre. Previous studies
indicated that a similar reduction was
achieved at 100°C for 30 min (Brauningen et
al., 1994) or 60°C for 6 h (Srivastava &
Lund, 1980). Both Rehman (1987) and
Mahnel & Von Brodorotti (1981) indicate that
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Assessments of the safety of aquatic animal commodities
49
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
90°C for at least 20 min is required for
inactivation. Sauerbrei & Wutzler (2009)
acknowledge that the % moisture of the
matrix undergoing heat treatment is an
important factor in determining inactivation
efficiency, with greater % moisture resulting
in more efficient inactivation, and that the
figures for bovine parvovirus (95°C, 2 h
resulting in 1 log10 reduction in titre) were
obtained at extremely low moisture levels,
as was the experiment carried out by
Brauningen et al. (1994). Given the figures
for the insect densovirus (Seki, 1986) and
bovine parvovirus (Mahnel & Von Brodorotti,
1981; Rehman, 1987) it is likely that a heat
treatment step at 90°C for 20 min or 100°C
for 2 min would result in inactivation of
IHHNV. Parvovirus is also resistant to
exposure to extremely low pH (Sofer et al.,
2003). An insect densovirus is reported to be
inactivated by 1 h at pH 2, but is unaffected
by pH ≥3 (Seki, 1986)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of IHHNV by low pH or heat treatment as usually applied in the process
of chemical extraction of chitin. Therefore, chemically extracted chitin is currently not eligible for inclusion in
Article 9.3.3. point 1.
50
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table VI
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Tissue tropism of IHHNV reported to be
mesodermal and ectodermal tissues including:
lymphoid organs, connective tissue, cuticular
epithelium, antennal gland, heart, nerves,
ganglia, gonads and skeletal muscle in order
of frequency (Owens et al., 1992; Sithigorngul et
al., 2009). Infection may therefore be present in
muscle tissue used in the manufacture of
these products
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at 90°C for
10 min (or equivalent) (FDA, 2001; Gould,
1999). There is no specific information about
inactivation of IHHNV, however it has been
classified as a densovirus in the Parvoviridae
family (Bonami et al., 1990; Shike et al., 2000)
so other parvoviruses can provide proxy
information. A related insect densovirus was
inactivated at pH 2 for 1 h, but was not affected
by pH ≥3, and complete inactivation was
achieved at 70°C for 20 min (Seki, 1986).
Canine parvovirus is inactivated at 100°C after
2 min, but in excess of 7 h is required at 80°C
(McGavin, 1987). Porcine parvovirus has been
reported to be inactivated after 11 h to 12 h at
55°C (Lund et al., 1996). Bovine parvovirus is
perhaps the best studied with regard to
inactivation conditions. Sauerbrei & Wutzler
(2009) report that 95°C for 2 h results in 1 log10
reduction in viral titre. Previous studies indicated
that a similar reduction was achieved at 100°C
for 30 min (Brauningen et al., 1994) or 60°C for
6 h (Srivastava & Lund, 1980). Both Rehman
(1987) and Mahnel & Von Brodorotti (1981)
indicate that 90°C for at least 20 min is required
for inactivation. Sauerbrei & Wutzler (2009)
acknowledge that the % moisture of the matrix
undergoing heat treatment is an important factor
in determining inactivation efficiency, with
Assessments of the safety of aquatic animal commodities
no
51
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
greater % moisture resulting in more efficient
inactivation, and that the figures for bovine
parvovirus (95°C, 2 h resulting in 1 log10
reduction in titre) were obtained at extremely low
moisture levels, as was the experiment carried
out by Brauningen et al. (1994). Given the
figures for the insect densovirus (Seki, 1986)
and bovine parvovirus (Mahnel & Von Brodorotti,
1981; Rehman, 1987) it is likely that a heat
treatment step at 90°C for 20 min or 100°C for
2 min would result in inactivation of IHHNV
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of IHHNV by heat treatment associated with pasteurisation. Therefore,
pasteurised crustacean products that have been subjected to heat treatment at 90°C for 10 min (or to any
time/temperature equivalent) are currently not eligible for inclusion in Article 9.3.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
52
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
B) Assessments using criteria in Article 5.4.2. (for Article 9.3.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen, peeled shrimp (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell on, head on) (Table II).
Table I
Frozen, peeled shrimp (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues because the
entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Frozen, peeled shrimp (shell off, head off) that are prepared and packaged for retail trade for human consumption
normally do not produce waste. Therefore, frozen, peeled shrimp (shell off, head off) is eligible for inclusion in
Article 9.3.11.
Assessments of the safety of aquatic animal commodities
53
Aquatic animal product assessments for infectious hypodermal and haematopoietic necrosis
Table II
Frozen shrimp (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes shell, head and legs, which is
a relatively large volume of waste compared
with the original product volume
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
Head and shell contains the virus. Infected
tissues remain infectious after repeated cycles
of freeze–thawing (Lightner, 1996b)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp (shell on, head on) that are prepared and packaged for the retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste.
Therefore, frozen shrimp (shell on, head on) is not eligible for inclusion in Article 9.3.11.
54
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
3.
Aquatic animal product assessments for infectious myonecrosis virus
A) Assessments using criteria in Article 5.4.1. (for Article 9.4.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 100°C for
at least 3 min (or any time/temperature equivalent which has been demonstrated to
inactivate infectious myonecrosis virus [IMNV]) (Table II)
iii) crustacean oil (Table III)
iv) crustacean meal (Table IV)
v) chemically extracted chitin (Table V).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) pasteurised crustacean products that have been subjected to heat treatment at 90°C
for 10 min (or any time/temperature equivalent) (Table VI)
ii) frozen shrimp (shell off, head off) (Table VII)
iii) frozen shrimp (shell on, head on) (Table VIII).
Assessments of the safety of aquatic animal commodities
55
Aquatic animal product assessments for infectious myonecrosis virus
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic The principal target tissues for IMNV include the
agent is not present in the tissues from
striated muscles (skeletal and less often cardiac),
which the commodity is derived
connective tissues, haemocytes, and the lymphoid
organ parenchymal cells (Lightner et al., 2004;
Poulos et al., 2006; Tang et al., 2005). This
commodity contains meat (muscle)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking) Heat treatment is 121°C for 3.6 min or equivalent
(e.g. 111°C for 36 min) (Ababouch, 1999, 2002).
There is no specific information about inactivation
of IMNV with heat. Infectious myonecrosis virus is
a non-enveloped dsRNA virus and small in size
(approximately 40 nm in diameter), like
betanodaviruses. No specific data are available
but infectious pancreatic necrosis virus (IPNV) and
betanodaviruses can probably serve as
surrogates. Under experimental conditions,
a betanodavirus, sea bass nodavirus, is
inactivated at 60°C within 60 min (Frerichs et
al., 2000)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus is highly likely to be inactivated by this process. Therefore, heat sterilised
hermetically sealed crustacean products are eligible for inclusion in Article 9.4.3. point 1.
56
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic The principal target tissues for IMNV include
agent is not present in the tissues from
the striated muscles (skeletal and less often
which the commodity is derived
cardiac), connective tissues, haemocytes, and the
lymphoid organ parenchymal cells (Lightner et al.,
2004; Poulos et al., 2006; Tang et al., 2005). This
commodity contains meat (muscle)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking) Cooking involves a heat treatment which is
not well defined, but usually involves boiling.
There is no specific information about inactivation
of IMNV by heat treatment. IMNV is a nonenveloped dsRNA virus and small in size
(approximately 40 nm in diameter), like
betanodaviruses. IPNV and betanodaviruses can
probably serve as surrogates. Under experimental
conditions, a betanodavirus, sea bass nodavirus,
is inactivated at 60°C within 60 min (Frerichs et
al., 2000). Based on the information available for
betanodavirus, it is likely that IMNV will be
inactivated by this treatment
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus is highly likely to be inactivated by this process. Therefore, cooked crustacean
products that have been subjected to heat treatment at 60°C for at least 60 min (or any time/temperature
equivalent which has been demonstrated to inactivate IMNV) are eligible for inclusion in Article 9.4.3. point 1.
Assessments of the safety of aquatic animal commodities
57
Aquatic animal product assessments for infectious myonecrosis virus
Table III
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The principal target tissues for IMNV include
the striated muscles (skeletal and less often
cardiac), connective tissues, haemocytes, and
the lymphoid organ parenchymal cells
(Lightner et al., 2004; Poulos et al., 2006;
Tang et al., 2005). Some or all of these tissues
are included in this commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Raw material is cooked (may be pre-heated to
50°C to 60°C before cooking at temperatures
of 95°C to 100°C for 15 to 20 min. For energy
cost reasons and nutritional content, some
processors use 80°C to 85°C for 20 min).
Cooked material is pressed to produce press
liquor, and press liquor is heated to 90°C to
95°C, which produces oil. Oil is purified with
hot water (at 90°C) (FAO, 1986). There is no
specific information about inactivation of
IMNV with heat. The IMNV is a non-enveloped
dsRNA virus and small in size (approximately
40 nm in diameter), like betanodaviruses.
IPNV and betanodaviruses can probably serve
as surrogates. Under experimental conditions,
a betanodavirus, sea bass nodavirus, is
inactivated at 60°C within 60 min (Frerichs et
al., 2000)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus is highly likely to be inactivated by this process. Therefore, crustacean oil is eligible
for inclusion in Article 9.4.3. point 1.
58
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
Table IV
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
The principal target tissues for IMNV
include the striated muscles (skeletal and
less often cardiac), connective tissues,
haemocytes, and the lymphoid organ
parenchymal cells (Lightner et al.,
2004; Poulos et al., 2006; Tang et al.,
2005). Some or all of these tissues are
included in this commodity
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment
or processing to produce the commodity
to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
The process involves cooking, usually
boiling at 100°C for at least 3 min, and a
drying step at between 115°C and 138°C
(Velez et al., 1991). There is no specific
information about inactivation of IMNV with
heat. The IMNV is a non-enveloped dsRNA
virus and small in size (approximately
40 nm in diameter), like betanodaviruses.
IPNV and betanodaviruses can probably
serve as surrogates. Under experimental
conditions, a betanodavirus, sea bass
nodavirus, is inactivated at 60°C within
60 min (Frerichs et al., 2000). Based on the
information available for betanodavirus, it is
likely that IMNV will be inactivated by
this treatment
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus is highly likely to be inactivated by this process. Therefore, crustacean meal is
eligible for inclusion in Article 9.4.3. point 1.
Assessments of the safety of aquatic animal commodities
59
Aquatic animal product assessments for infectious myonecrosis virus
Table V
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
The principal target tissues for IMNV include the
striated muscles (skeletal and less often cardiac),
connective tissues, haemocytes, and the
lymphoid organ parenchymal cells (Lightner et al.,
2004; Poulos et al., 2006; Tang et al., 2005).
Exoskeleton is used for this commodity. The virus is
not normally present in exoskeleton and associated
cuticular epithelium. However, it is possible that
remains of other tissue contaminate the exoskeleton
No?
Water is used in the processing but given the
chemicals used it is unlikely that water would remain
contaminated. The product is not transported
in water.
No
The product is heated at 60°C to 70°C for a few h
(Gagné, 1993). There is no specific information
about inactivation of IMNV with heat. IMNV is a nonenveloped dsRNA virus and small in size
(approximately 40 nm in diameter), like
betanodaviruses. The IPNV and betanodaviruses
can probably serve as surrogates. Under
experimental conditions, a betanodavirus, sea bass
nodavirus, is inactivated at 60°C within 60 min
(Frerichs et al., 2000)
Yes
Hydrochloric acid is used in the processing (Gagné,
1993). There is no specific information about
inactivation of IMNV with acids. Under experimental
conditions, a betanodavirus, sea bass nodavirus, is
inactivated at pH 2 within 42 days (Frerichs et al.,
2000)
No
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature,
drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus is not present in cuticular tissue; however, if the exoskeleton were contaminated
with IMNV, this virus is highly likely to be inactivated by this process. Therefore, chemically extracted chitin is
eligible for inclusion in Article 9.4.3. point 1.
60
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
Table VI
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
The principal target tissues for IMNV include
the striated muscles (skeletal and less often
cardiac), connective tissues, haemocytes,
and the lymphoid organ parenchymal
cells (Lightner et al., 2004; Poulos et al.,
2006; Tang et al., 2005). Some or all of
these tissues are included in this commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or processing
to produce the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at 90°C for
10 min (or equivalent) (FDA, 2001; Gould,
1999). There is no specific information about
inactivation of IMNV with heat. The IMNV is
a non-enveloped dsRNA virus and small in
size (approximately 40 nm in diameter), like
betanodaviruses. The IPNV and
betanodaviruses can probably serve as
surrogates. Under experimental conditions,
a betanodavirus, sea bass nodavirus, is
inactivated at 60°C within 60 min
(Frerichs et al., 2000)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of IMNV with heat treatment associated with pasteurisation.
Therefore, pasteurised crustacean products that have been subjected to heat treatment at 90°C for 10 min (or any
time/temperature equivalent which has been demonstrated to inactivate IMNV) are currently not eligible for
inclusion in Article 9.4.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
61
Aquatic animal product assessments for infectious myonecrosis virus
Table VII
Frozen shrimp (shell off, head off)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
The principal target tissues for IMNV include the
striated muscles (skeletal and less often cardiac),
connective tissues, haemocytes, and the lymphoid
organ parenchymal cells (Lightner et al., 2004;
Poulos et al., 2006; Tang et al., 2005). Some or all
of these tissues are included in this commodity. This
commodity is composed of muscle tissue
No
AND
b) The water (including ice) used to
process or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature,
drying, smoking)
Shrimp are frozen and maintained at a temperature
of –18°C or lower (WHO and FAO, 2009). The IMNV
is a non-enveloped dsRNA virus and small in size
(approximately 40 nm in diameter), like
betanodaviruses. The IPNV and betanodaviruses
can probably serve as surrogates. Under
experimental conditions, a betanodavirus, sea bass
nodavirus, was not inactivated when stored at –20°C
for 1 year (Frerichs et al.., 2000). Similarly, Poulos et
al. (2006) used material derived from frozen shrimp
to induce the disease in specific pathogen-free
(SPF) Penaeus vannamei
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus will not be inactivated by this process. Therefore, frozen shrimp (shell off, head off)
are not eligible for inclusion in Article 9.4.3, point 1.
62
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
Table VIII
Frozen shrimp (shell on, head on)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the
commodity is derived
The principal target tissues for IMNV include the striated
muscles (skeletal and less often cardiac), connective
tissues, haemocytes, and the lymphoid organ parenchymal
cells (Lightner et al., 2004; Poulos et al., 2006; Tang et al.,
2005). All the above-mentioned tissues are part of the
commodity
No
AND
b) The water (including ice) used to
process or transport the commodity
is not contaminated with the
pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity
is derived, the treatment or
processing to produce the
commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature,
drying, smoking)
Shrimp are frozen and maintained at a temperature of –
18°C or lower (WHO and FAO, 2009). The IMNV is a nonenveloped dsRNA virus and small in size (approximately
40 nm in diameter), like betanodaviruses. The IPNV and
betanodaviruses can probably serve as surrogates. Under
experimental conditions, a betanodavirus, sea bass
nodavirus, was not inactivated when stored at –20°C for
1 year (Frerichs et al., 2000). Similarly, Poulos et al.
(2006) used material derived from frozen shrimp to induce
the disease in SPF Penaeus vannamei
No
AND/OR
b) Chemical (e.g. iodine, pH,
salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious myonecrosis virus will not be inactivated by this process. Therefore, frozen shrimps (shell on, head on)
are not eligible for inclusion in Article 9.4.3, point 1.
Assessments of the safety of aquatic animal commodities
63
Aquatic animal product assessments for infectious myonecrosis virus
B) Assessments using criteria in Article 5.4.2. (for Article 9.4.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen shrimp (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell on, head on) (Table II).
Table I
Frozen shrimp (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There is no waste tissue because the entire
commodity is consumed
Yes
AND/EITHER
2.
It includes only a small amount of
waste tissues
OR
3.
The pathogenic agent is not normally found
in the waste tissues
CONCLUSION
Frozen shrimp (shell off, head off) prepared and packaged for retail trade for human consumption produces no
waste. Therefore, frozen shrimp (shell off, head off) is eligible for inclusion in Article 9.4.11.
64
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious myonecrosis virus
Table II
Frozen shrimp (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of
waste tissues
Waste tissues include shell and cephalothorax, which
contains mesodermal tissues
No
The pathogenic agent is not normally
found in the waste tissues
The principal target tissues for IMNV include the
striated muscles (skeletal and less often cardiac),
connective tissues, haemocytes, and the lymphoid
organ parenchymal cells (Lightner et al., 2004; Poulos
et al., 2006; Tang et al., 2005). All the abovementioned tissues are part of the commodity. The
IMNV is a non-enveloped dsRNA virus and small in
size (approximately 40 nm in diameter), like
betanodaviruses. The IPNV and betanodaviruses can
probably serve as surrogates. Under experimental
conditions, a betanodavirus, sea bass nodavirus, was
not inactivated when stored at –20°C for 1 year
(Frerichs et al., 2000). Similarly, Poulos et al. (2006)
used material derived from frozen shrimp to induce the
disease in SPF Penaeus vannamei
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp (shell on, head on) prepared and packaged for retail trade for human consumption generate
amounts of waste that cannot be considered small, and IMNV will not be inactivated by the freezing process.
Therefore, frozen shrimp (shell on, head on) is not eligible for inclusion in Article 9.4.11.
Assessments of the safety of aquatic animal commodities
65
Aquatic animal product assessments for necrotising hepatopancreatitis
4.
Aquatic animal product assessments for necrotising hepatopancreatitis
A) Assessments using criteria in Article 5.4.1. (for Article 9.5.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at
121°C for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 100°C for
at least 3 min (or any time/temperature equivalent which has been demonstrated to
inactivate the necrotising hepatopancreatitis (NHP) bacterium) (Table II)
iii) pasteurised crustacean products that have been subjected to heat treatment at
63°C for 30 min (or any time/temperature equivalent which has been demonstrated to
inactivate the NHP bacterium) (Table III)
iv) crustacean oil (Table IV)
v) crustacean meal (Table V)
vi) chemically extracted chitin (Table VI).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) frozen shrimp (shell off, head off) (Table VII)
ii) frozen shrimp (shell on, head on) (Table VIII).
66
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for necrotising hepatopancreatitis
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
This commodity contains meat (muscle).
The NHP bacterium is present in the
hepatopancreas (Frelier et al., 1992);
examination of muscle tissue for presence
of the bacterium has not been reported in
the literature
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). There is no
specific information about inactivation of the
NHP bacterium with heat. Coxiella burnetii, a
similar type of bacterium (Gram negative,
obligate intracellular bacterium), is
inactivated when milk is pasteurised at 63°C
for 30 min or any time/temperature
equivalent (McGraw-Hill, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Necrotising hepatopancreatitis bacterium will be inactivated by this process. Therefore, heat sterilised
hermetically sealed crustacean products are eligible for inclusion in Article 9.5.3. point 1.
Assessments of the safety of aquatic animal commodities
67
Aquatic animal product assessments for necrotising hepatopancreatitis
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
This commodity contains meat (muscle). The NHP
bacterium is present in the hepatopancreas
(Frelier et al., 1992); examination of muscle tissue
for presence of the bacterium has not been
reported in the literature
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination
of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking) Product is heat treated at 70°C for 30 min.
Product is then dried or frozen. There is no
specific information about inactivation of the
NHP bacterium with heat. Coxiella burnetii, a
similar type of bacterium (Gram negative,
obligate intracellular bacterium), is inactivated
when milk is pasteurised at 63°C for 30 min or
time/temperature equivalent (McGraw-Hill, 2004)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Necrotising hepatopancreatitis bacterium is inactivated by this process. Therefore, cooked crustacean products
that have been subjected to heat treatment at 100°C for at least 3 min (or any time/temperature equivalent which
has been demonstrated to inactivate NHP bacterium) are eligible for inclusion in Article 9.5.3. point 1.
68
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for necrotising hepatopancreatitis
Table III
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
This commodity contains meat (muscle). The
NHP bacterium is present in the
hepatopancreas (Frelier et al., 1992);
examination of muscle tissue for presence
of the bacterium has not been reported in
the literature
No
Product is heat treated at 63°C for 30 min or
any time/temperature equivalent (e.g. 68°C for
3 min). There is no specific information about
inactivation of the NHP bacterium with heat.
Coxiella burnetii, a similar type of bacterium
(Gram negative, obligate intracellular
bacterium), is inactivated when milk is
pasteurised at 63°C for 30 min or
time/temperature equivalent (McGraw-Hill,
2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Necrotising hepatopancreatitis bacterium is inactivated by this process. Therefore, pasteurised crustacean
products that have been subjected to heat treatment at 63°C for 30 min (or any time/temperature equivalent which
has been demonstrated to inactivate the NHP bacterium) are eligible for inclusion in Article 9.5.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
69
Aquatic animal product assessments for necrotising hepatopancreatitis
Table IV
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic The NHP bacterium is present in the
agent is not present in the tissues from
hepatopancreas (Frelier et al., 1992). This organ
which the commodity is derived
may be used to make this product
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking) Raw material is cooked (may be pre-heated to
50°C to 60°C before cooking at temperatures of
95°C to 100°C for 15 to 20 min. For energy cost
reasons and nutritional content, some
processors use 80°C to 85°C for 20 min).
Cooked material is pressed to produce press
liquor, and press liquor is heated to 90°C to
95°C, which produces oil. Oil is purified with hot
water (at 90°C) (FAO, 1986). There is no
specific information about inactivation of the
NHP bacterium with heat. Coxiella burnetii, a
similar type of bacterium (Gram negative,
obligate intracellular bacterium), is inactivated
when milk is pasteurised at 63°C for 30 min or
equivalent (McGraw-Hill, 2004)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Necrotising hepatopancreatitis bacterium is inactivated by the cooking process. Therefore, crustacean oil is
eligible for inclusion in Article 9.5.3. point 1.
70
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for necrotising hepatopancreatitis
Table V
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
The NHP bacterium is present in the
hepatopancreas (Frelier et al., 1992), which
may be included in this commodity
No
The process involves cooking, usually boiling, at
100°C for at least 3 min; and a drying step of
between 115°C and 138°C (Velez, 1991). There
is no specific information about inactivation of
the NHP bacterium with heat. Coxiella burnetii, a
similar type of bacterium (Gram negative,
obligate intracellular bacterium), is inactivated
when milk is pasteurised at 63°C for 30 min or
any time/temperature equivalent (McGraw-Hill,
2004). Susceptibility of the NHP bacterium to
drying is unknown. Coxiella burnetii, a similar
type of bacterium (Gram negative, obligate
intracellular bacterium), is resistant to
desiccation. This is believed to be due to
formation of spore-like bodies (Maurin and
Raoult, 1999). It is unknown whether the NHP
bacterium forms spore-like bodies
Yes
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature,
drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Necrotising hepatopancreatitis bacterium is inactivated by the cooking process. Therefore, crustacean meal is
eligible for inclusion in Article 9.5.3. point 1.
Assessments of the safety of aquatic animal commodities
71
Aquatic animal product assessments for necrotising hepatopancreatitis
Table VI
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic Cuticular epithelium is used in the commodity.
agent is not present in the tissues from
The NHP bacterium is present in the
which the commodity is derived
hepatopancreas, but has not been detected in
the cuticle; however, there is uncertainty
because the evaluation of the cuticular section
was not well described and enhanced staining
techniques were not used (Frelier et al., 1992)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic agent:
The product is heated at 60°C to 70°C for a
few h (Gagné, 1993). There is no specific
information about inactivation of the NHP
bacterium with heat. Coxiella burnetii, a similar
type of bacterium (Gram negative, obligate
intracellular bacterium), is inactivated when
milk is pasteurised at 63°C for 30 min or
time/temperature equivalent (McGrawHill, 2004)
Yes
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Hydrochloric acid is used in the processing.
(Gagné, 1993). There is no specific
information about inactivation of the NHP
bacterium under acidic conditions
Unknown
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
It is unknown whether the NHP bacterium is present in cuticular tissue; however, if the exoskeleton were
contaminated with the NHP bacterium it would be inactivated by the heating process. Therefore, chemically
extracted chitin is eligible for inclusion in Article 9.5.3. point 1.
72
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for necrotising hepatopancreatitis
Table VII
Frozen shrimp (shell off, head off)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
This commodity is composed of muscle
tissue. The NHP bacterium is present in
the hepatopancreas (Frelier et al., 1992);
examination of muscle tissue for presence
of the bacterium has not been reported in
the literature
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Shrimp are frozen and maintained at a
temperature of –18°C or lower (WHO and FAO,
2009). There is no specific information about
inactivation of the NHP bacterium at this
temperature. The NHP bacterium is still infective
after freezing of the hepatopancreas at –80°C for
80 days (Crabtree et al., 2006)
Unknown
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is insufficient evidence to assess whether the NHP bacterium will be inactivated by this process. Therefore,
frozen shrimp (shell off, head off) are not eligible for inclusion in Article 9.5.3, point 1.
Assessments of the safety of aquatic animal commodities
73
Aquatic animal product assessments for necrotising hepatopancreatitis
Table VIII
Frozen shrimp (shell on, head on)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
This commodity contains hepatopancreatic
tissue. The NHP bacterium is present in
the hepatopancreas (Frelier et al., 1992)
No
Shrimp are frozen and maintained at a
temperature of –18°C or lower (WHO and
FAO, 2009). There is no specific
information about inactivation of the NHP
bacterium at this temperature. The NHP
bacterium is still infective after freezing of
the hepatopancreas at –80°C for 80 days
(Crabtree et al., 2006)
Unknown
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or processing
to produce the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is insufficient evidence to assess whether the NHP bacterium is inactivated by this process. Therefore,
frozen shrimp (shell on, head on) are not eligible for inclusion in Article 9.5.3. point 1.
74
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for necrotising hepatopancreatitis
B) Assessments using criteria in Article 5.4.2. (for Article 9.5.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell on, head on) (Table II).
Table I
Frozen shrimp (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the definition
Yes
There is no waste tissue because the entire
commodity is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Frozen shrimp (shell off, head off) prepared and packaged for retail trade for human consumption produce no
waste. Therefore, frozen shrimp (shell off, head off) is eligible for inclusion in Article 9.5.11.
Assessments of the safety of aquatic animal commodities
75
Aquatic animal product assessments for necrotising hepatopancreatitis
Table II
Frozen shrimp (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste tissues include shell and
cephalothorax, which represents at least half
of the commodity
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
The NHP bacterium is present in the
hepatopancreas (Frelier et al., 1992), which
is present in the cephalothorax. Shrimp are
frozen and maintained at a temperature of –
18°C or lower (WHO and FAO, 2009). There
is no specific information about inactivation of
the NHP bacterium at this temperature. The
NHP bacterium is still infective after freezing
of the hepatopancreas at –80°C for 80 days
(Crabtree et al., 2006)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp (shell on, head on) prepared and packaged for retail trade for human consumption generate
amounts of waste not considered small. There is insufficient evidence to assess whether the NHP bacterium will
be inactivated by the freezing process. Therefore, frozen shrimp (shell on, head on) is not eligible for inclusion in
Article 9.5.11.
76
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Taura Syndrome
5.
Aquatic animal product assessments for Taura Syndrome
A) Assessments using criteria in Article 5.4.1. (for Article 9.6.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 70°C for at
least 30 min (or to any time/temperature equivalent which has been demonstrated to
inactivate Taura syndrome virus [TSV]) (Table II)
iii) pasteurised crustacean products that have been subjected to heat treatment at 90°C
for 10 min (or to any time/temperature equivalent which has been demonstrated to
inactivate [TSV]) (Table III)
iv) crustacean oil (Table IV)
v) crustacean meal (Table V)
vi) chemically extracted chitin (Table VI).
Assessments of the safety of aquatic animal commodities
77
Aquatic animal product assessments for Taura Syndrome
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Meat contains TSV (Nunan et
al., 2004).
No
Potable fresh water is used to process
the product (WHO/FAO, 2009). The
final product is sealed during transport
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). Although
there is no specific information about
inactivation of TSV, another
picornavirus (foot and mouth disease
virus, FMDV) is inactivated in meat at
70°C for 30 min (OIE, 2011a)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is highly likely to be inactivated by this process. Therefore, heat sterilised hermetically
sealed crustacean products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature
equivalent) are eligible for inclusion in Article 9.6.3. point 1.
78
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Taura Syndrome
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Meat contains TSV
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Although there is no specific information
about inactivation of TSV, another
picornavirus (FMDV) is inactivated in meat at
70°C for 30 min (OIE, 2011a)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is likely to be inactivated by this process. Therefore, cooked crustacean products that have
been subjected to heat treatment at 70°C for at least 30 min (or to any time/temperature equivalent which has been
demonstrated to inactivate TSV) are eligible for inclusion in Article 9.6.3. point 1.
Assessments of the safety of aquatic animal commodities
79
Aquatic animal product assessments for Taura Syndrome
Table III
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Meat contains TSV
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment at 90°C for 10 min or
equivalent (e.g. 86°C for 37 min) (FDA, 2001;
Gould, 1999). Although there is no specific
information about inactivation of TSV,
another picornavirus (FMDV) is inactivated in
meat at 70°C for 30 min (OIE, 2011a)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is likely to be inactivated by this process. Therefore, pasteurised crustacean products that
have been subjected to heat treatment at 90°C for at least 10 min (or any time/temperature equivalent, which has
been demonstrated to inactivate TSV) are eligible for inclusion in Article 9.6.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
80
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Taura Syndrome
Table IV
Crustacean oil
Article 5.4.1. criteria.
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in cuticular epithelium,
ectodermal and mesodermal tissues.
All these tissues may be used in
the commodity
No
Water is used to process the product but
the water is potable and the final product
is sealed
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Raw material is cooked (may be pre-heated
to 50°C to 60°C before cooking at
temperatures of 95° to 100°C for 15 to
20 min. For energy cost reasons and
nutritional content, some processors use
80°C to 85°C for 20 min). Cooked material is
pressed to produce press liquor and press
liquor heated to 90°C to 95°C, which
produces oil. Oil is purified with hot water
(at 90°C) (FAO, 1986). Although there is no
specific information about inactivation of
TSV, another picornavirus (FMDV) is
inactivated in meat at 70°C for 30 min
(OIE, 2011a)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is highly likely to be inactivated by this process. Therefore, crustacean oil is eligible for
inclusion in Article 9.6.3. point 1.
Assessments of the safety of aquatic animal commodities
81
Aquatic animal product assessments for Taura Syndrome
Table V
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in cuticular epithelium,
ectodermal and mesodermal tissues. All
these tissues may be used in the commodity
No
Water is used in the processing but the
product undergoes a drying process
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The process involves cooking, usually boiling
at 100°C for at least 3 min; a drying step of
between 115°C and 138°C is used (Velez,
1991). Although there is no specific
information about inactivation of TSV,
another picornavirus (FMDV) is inactivated in
meat at 70°C for 30 min (OIE, 2011a)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is likely to be inactivated by this process. Therefore, crustacean meal is eligible for
inclusion in Article 9.6.3. point 1.
82
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Taura Syndrome
Table VI
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Virus is present in cuticular epithelium.
This tissue is used in the commodity
No
AND
b) The water (including ice) used to process or
Water is used in the processing but given
transport the commodity is not contaminated with the chemicals used it is unlikely that water
the pathogenic agent and the processing prevents would remain contaminated
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Hydrochloric acid is used in the processing
and involves heating at 60°C to 70°C for a
few h (Gagné, 1993). Although there is no
specific information about inactivation of
TSV, another picornavirus (FMDV) is
inactivated in meat at 70°C for 30 min
(OIE, 2011a)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Taura syndrome virus is likely to be inactivated by this process. Therefore, chemically extracted chitin is eligible
for inclusion in Article 9.6.3. point 1.
Assessments of the safety of aquatic animal commodities
83
Aquatic animal product assessments for Taura Syndrome
B) Assessments using criteria in Article 5.4.2. (for Article 9.4.11. point
1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp (shell on, head on) (Table II).
Table I
Frozen shrimp (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues because the
entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Frozen shrimp (shell off, head off) that are prepared and packaged for retail trade for human consumption
normally does not produce waste. Therefore, frozen shrimp (shell off, head off) is eligible for inclusion in
Article 9.6.11.
84
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Taura Syndrome
Table II
Frozen shrimp (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes shell, cephalothorax, legs
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
Exoskeleton and cephalothorax contains the
virus. Freezing and cold storage for normal
periods will not eliminate the virus (Brock et
al., 1997; Lightner, 1996b)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp (shell on, head on) that are prepared and packaged for retail trade for human consumption may
produce amounts of wastes that cannot be considered small; the pathogenic agent may be found in the waste.
Therefore, frozen shrimp (shell on, head on) is not eligible for inclusion in Article 9.6.11.
Assessments of the safety of aquatic animal commodities
85
Aquatic animal product assessments for white spot disease
6.
Aquatic animal product assessments for white spot disease
A) Assessments using criteria in Article 5.4.1. (for Article 9.7.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 60°C for at
least 1 min (or any time/temperature equivalent which has been demonstrated to
inactivate white spot syndrome virus [WSSV]) (Table II)
iii) pasteurised crustacean products that have been subjected to heat treatment at 90°C
for at least 10 min (or any time/temperature equivalent which has been demonstrated
to inactivate WSSV) (Table III)
iv) crustacean oil (Table IV)
v) crustacean meal (Table V)
vi) chemically extracted chitin (Table VI).
86
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white spot disease
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
The major targets of WSSV infection are
tissues of ectodermal and mesodermal
embryonic origin, especially the cuticular
epithelium and subcuticular connective
tissues (Lightner, 1996a; Momoyama et
al., 1994; Wongteerasupaya et al.,
1995), but WSSV is also found in muscle
tissue (Durand et al., 2003). This
commodity contains muscle tissue
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). The WSSV has
been reported to be inactivated in less
than 120 min at 50°C (Nakano et al.,
1998) and in less than 1 min at 60°C
(Momoyama et al., 1998)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, heat sterilised hermetically sealed
crustacean products (i.e. a heat treatment at 121°C for at least 3.6 min or time/temperature equivalent) are eligible
for inclusion in Article 9.7.3. point 1.
Assessments of the safety of aquatic animal commodities
87
Aquatic animal product assessments for white spot disease
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The major targets of WSSV infection are
tissues of ectodermal and mesodermal
embryonic origin, especially the cuticular
epithelium and subcuticular connective
tissues (Lightner, 1996a; Momoyama et al.,
1994; Wongteerasupaya et al., 1995), but
WSSV is also found in muscle tissue
(Durand et al., 2003). This commodity
contains muscle tissue
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Cooking involves a heat treatment which
is not well defined, but usually involves
boiling. The WSSV has been reported to
be inactivated in less than 1 min at 60°C
(Momoyama et al., 1998)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, cooked crustacean products that have
been subjected to heat treatment at 60°C for at least 1 min (or any time/temperature equivalent which has been
demonstrated to inactivate WSSV) are eligible for inclusion in Article 9.7.3. point 1.
88
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white spot disease
Table III
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
The major targets of WSSV infection are
tissues of ectodermal and mesodermal
embryonic origin, especially the cuticular
epithelium and subcuticular connective
tissues (Lightner, 1996a; Momoyama et
al., 1994; Wongteerasupaya et al., 1995),
but WSSV is also found in muscle tissue
(Durand et al., 2003). This commodity
contains muscle tissue
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent)
(FDA, 2001; Gould, 1999). The WSSV
has been reported to be inactivated in
less than 120 min at 50°C (Nakano et al.,
1998) and in less than 1 min at 60°C
(Momoyama et al., 1998)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, pasteurised crustacean products that
have been subjected to heat treatment at 90°C for at least 10 min (or any time/temperature equivalent which has
been demonstrated to inactivate WSSV) are eligible for inclusion in Article 9.7.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
89
Aquatic animal product assessments for white spot disease
Table IV
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
The major targets of WSSV infection are
tissues of ectodermal and mesodermal
embryonic origin, especially the cuticular
epithelium and subcuticular connective
tissues (Lightner, 1996a; Momoyama et al.,
1994; Wongteerasupaya et al., 1995), but
WSSV is also found in muscle tissue (Durand
et al., 2003). All these tissues may be used in
the commodity
No
AND
b) The water (including ice) used to
process or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
.
a) Physical (e.g. temperature, drying,
smoking)
Raw material is cooked (may be preheated to 50°C to 60°C before cooking at
temperatures of 95° to 100°C for 15 to
20 min. For energy cost reasons and
nutritional content, some processors use
80°C to 85°C for 20 min). Cooked material is
pressed to produce press liquor and press
liquor is heated to 90°C to 95°C, which
produces oil. Oil is purified with hot water
(at 90°C) (FAO, 1986). The WSSV has
been reported to be inactivated in less than
120 min at 50°C (Nakano et al., 1998) and
in less than 1 min at 60°C (Momoyama et
al., 1998)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, crustacean oil is eligible for inclusion
in Article 9.7.3. point 1.
90
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white spot disease
Table V
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The major targets of WSSV infection
are tissues of ectodermal and
mesodermal embryonic origin,
especially the cuticular epithelium and
subcuticular connective tissues
(Lightner, 1996a; Momoyama et al.,
1994; Wongteerasupaya et al., 1995),
but WSSV is also found in muscle
tissue (Durand et al., 2003). All these
tissues may be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The process involves cooking, usually
boiling at 100°C for at least 3 min, and
a drying step of between 115°C and
138°C (Velez, 1991). It has been
reported that WSSV can be inactivated
in less than 1 min at 60°C (Momoyama
et al., 1998)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, crustacean meal is eligible for
inclusion in Article 9.7.3. point 1.
Assessments of the safety of aquatic animal commodities
91
Aquatic animal product assessments for white spot disease
Table VI
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in cuticular
epithelium (Momoyama et al., 1994;
Wongteerasupaya et al., 1995).
This tissue is used in the commodity
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent and
the processing prevents cross contamination
of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Hydrochloric acid is used in the
processing and involves heating at
60°C to 70°C for a few h (Gagné, 1993).
The WSSV has been reported to be
inactivated in less than 120 min at 50°C
(Nakano et al., 1998) and in less than
1 min at 60°C (Momoyama et al., 1998)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
White spot syndrome virus will be inactivated by this process. Therefore, chemically extracted chitin is
therefore eligible for inclusion in Article 9.7.3. point 1.
92
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white spot disease
B) Assessments using criteria in Article 5.4.2. (for Article 9.7.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.2.:
i) frozen shrimp or decapod crustacea (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp or decapod crustacea (shell on, head on) (Table II).
Table I
Frozen shrimp or decapod crustacea (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues because the
entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
CONCLUSION
Frozen shrimp or decapod crustacea (shell off, head off) that are prepared and packaged for retail trade for
human consumption do not produce waste. Therefore, frozen shrimp or decapod crustacea (shell off, head off)
is eligible for inclusion in Article 9.7.11.
Assessments of the safety of aquatic animal commodities
93
Aquatic animal product assessments for white spot disease
Table II
Frozen shrimp or decapod crustacea (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes shell, cephalothorax, legs
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
Exoskeleton and cephalothorax contains
the virus (Durand et al., 2003; Lightner,
1996a; Momoyama et al., 1994;
Wongteerasupaya et al., 1995).
Freezing and cold storage for normal
periods will not eliminate the virus
(Durand et al., 2000)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp or decapod crustacea (shell on, head on) that are prepared and packaged for retail trade for
human consumption may produce amounts of waste that cannot be considered small; the pathogenic agent
may be found in the waste. Therefore, frozen shrimp or decapod crustacea (shell on, head on) is not eligible for
inclusion in Article 9.7.11.
94
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white tail disease
7.
Aquatic animal product assessments for white tail disease
A) Assessments using Criteria in Article 5.4.1. (for Article 9.8.3.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at 121°C
for at least 3.6 min or any time/temperature equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 60°C for at
least 60 min (or any time/temperature equivalent which has been demonstrated to
inactivate Macrobrachium rosenbergii nodavirus [MrNV]) (Table II)
iii) pasteurised crustacean products that have been subjected to heat treatment at 90°C
for at least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate MrNV) (Table III)
iv) crustacean oil (Table IV)
v) crustacean meal (Table V)
vi) chemically extracted chitin (Table VI).
Assessments of the safety of aquatic animal commodities
95
Aquatic animal product assessments for white tail disease
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in muscle tissues
(Arcier et al., 1999; Sahul Hameed et
al., 2004; Tung et al., 1999) and
these may be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min
or equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). Although
there is no specific information on
MrNV, other aquatic nodaviruses are
inactivated after 30 min to 60 min at
60°C (Arimoto et al., 1996; Frerichs
et al., 2000)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
C) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus is highly likely to be inactivated by this process. Therefore, heat
sterilised, hermetically sealed crustacean products (i.e. with a heat treatment at 121°C for at least 3.6 min or
time/temperature equivalent) are eligible for inclusion in Article 9.8.3. point 1.
96
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white tail disease
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Virus is present in muscle tissues
(Arcier et al., 1999; Sahul Hameed et
al., 2004; Tung et al., 1999) and
these may be used in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Cooking involves a heat treatment
which is not well defined, but usually
involves boiling. Although there is no
specific information on MrNV, other
aquatic nodaviruses are inactivated
after 30 to 60 min at 60°C (Arimoto et
al., 1996; Frerichs et al., 2000)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus will be inactivated by this process. Therefore, cooked crustacean
products that has been subjected to heat treatment at 60°C for at least 60 min (or any time/temperature
equivalent which have been demonstrated to inactivate MrNV) are eligible for inclusion in Article 9.8.3. point 1.
Assessments of the safety of aquatic animal commodities
97
Aquatic animal product assessments for white tail disease
Table III
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in muscle tissues (Arcier
et al., 1999; Sahul Hameed et al., 2004;
Tung et al., 1999) and these may be used
in the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent)
(FDA, 2001; Gould, 1999). Although there
is no specific information on MrNV, other
aquatic nodaviruses are inactivated after
30 to 60 min at 60°C (Arimoto et al.,
1996; Frerichs et al., 2000)
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus is likely to be inactivated by this process. Therefore, pasteurised
crustacean products that have been subjected to heat treatment at 90°C for at least 10 min (or to any
time/temperature equivalent that has been demonstrated to inactivate MrNV) are eligible for inclusion in Article
9.8.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
98
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white tail disease
Table IV
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in muscle tissues
(Arcier et al., 1999; Sahul Hameed et
al., 2004; Tung et al., 1999) and these
may be used in the commodity
No
Water is used to process the product but
the water is potable and the final
product is sealed
NA
Raw material is cooked (may be preheated to 50°C to 60°C) before cooking
at temperatures of 95°C to 100°C for
15 to 20 min. For energy cost reasons
and nutritional content, some
processors use 80°C to 85°C for
20 min. Cooked material is pressed to
produce press liquor and press liquor
heated to 90°C to 95°C, which produces
oil. Oil is purified with hot water
(at 90°C) (FAO, 1986). Although there is
no specific information on MrNV, other
aquatic nodaviruses are inactivated after
30 to 60 min at 60°C (Arimoto et al.,
1996; Frerichs et al., 2000)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus is highly likely to be inactivated by this process. Therefore, crustacean
oil is eligible for inclusion in Article 9.8.3. point 1.
Assessments of the safety of aquatic animal commodities
99
Aquatic animal product assessments for white tail disease
Table V
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Virus is present in muscle
tissues (Arcier et al., 1999; Sahul
Hameed et al., 2004; Tung et al.,
1999) and these may be used in
the commodity
No
Water is used in the processing
but the product undergoes a
drying process
NA
The process involves cooking,
usually boiling at 100°C for at least
3 min, and a drying step at between
115°C and 138°C (Velez et al.,
1991). Although there is no specific
information on MrNV, other aquatic
nodaviruses are inactivated after
30 to 60 min at 60°C (Arimoto et
al., 1996; Frerichs et al., 2000)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus is highly likely to be inactivated by this process. Therefore, crustacean
meal is eligible for inclusion in Article 9.8.3. point 1.
100
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white tail disease
Table VI
Chemically extracted chitin
Article 5.4.1. criteria.
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Virus is present in gill, muscle, heart,
stomach, intestine, haemolymph, ovaries
and pleopods (Sahul Hameed et al.,
2004), which are not primary constituents
of the raw material
Yes
Water is used in the processing, but
given the chemicals used it is unlikely
that water would remain contaminated
Yes
Hydrochloric acid is used in the
processing, which involves heating at
60°C to 70°C for a few h (Gagné, 1993).
Although there is no specific information
on MrNV, other aquatic nodaviruses
are inactivated after 30 to 60 min at
60°C (Arimoto et al., 1996, Frerichs et
al., 2000)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Macrobrachium rosenbergii nodavirus is highly likely to be inactivated by this process. Therefore, chemically
extracted chitin is eligible for inclusion in Article 9.8.3. point 1.
Assessments of the safety of aquatic animal commodities
101
Aquatic animal product assessments for white tail disease
B) Assessments using Criteria in Article 5.4.2. (for Article 9.8.11.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.2:
i) frozen shrimp (shell off, head off) (Table I).
2. The following aquatic animal products did not meet the criteria in Article 5.4.2:
i) frozen shrimp (shell on, head on) (Table II).
Table I
Frozen shrimp (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of commodity definition
Yes
There are no waste tissues because
the entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of
waste tissues
OR
3.
The pathogenic agent is not normally found in
the waste tissues
NA
CONCLUSION
Frozen shrimp (shell off, head off) that are prepared and packaged for retail trade for human consumption
normally does not produce waste. Therefore, Frozen shrimp (shell off, head off) are eligible for inclusion in
Article 9.8.11.
102
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for white tail disease
Table II
Frozen shrimp (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of commodity definition
Yes
It includes only a small amount of
waste tissues
Waste includes shell, cephalothorax, legs
No
The pathogenic agent is not normally
found in the waste tissues
It would be expected that waste material
could contain the pathogenic agent
because the virus is found in gills, head
muscle, heart, ovaries and pleopods
(Sahul Hameed et al., 2004). There is no
information regarding persistence of the
virus in frozen tissues
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp (shell on, head on) that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste.
There is no evidence that freezing inactivates the Macrobrachium rosenbergii nodavirus. Therefore, frozen
shrimp (shell on, head on) is not eligible for inclusion in Article 9.8.11.
Assessments of the safety of aquatic animal commodities
103
Aquatic animal product assessments for infection with yellow head virus
8.
Aquatic animal product assessments for infection with yellow
head virus
A) Assessments using criteria in Article 5.4.1. (for Article 9.2.3. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed crustacean products (i.e. a heat treatment at
121°C for at least 3.6 min or equivalent) (Table I)
ii) cooked crustacean products that have been subjected to heat treatment at 60°C for at
least 15 min (or any time/temperature equivalent which has been demonstrated to
inactivate yellow head virus [YHV]) (Table II)
iii) pasteurised crustacean products that have been subjected to heat treatment at
90°C for at least 10 min (or any equivalent time/temperature equivalent which has
been demonstrated to inactivate YHV) (Table III)
iv) crustacean oil (Table IV)
v) crustacean meal (Table V)
vi) chemically extracted chitin (Table VI).
104
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with yellow head virus
Table I
Heat sterilised hermetically sealed crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The YHV targets tissues of ectodermal
and mesodermal origin including
lymphoid organs, haemocytes,
haematopoietic tissue, gill lamellae and
spongy connective tissue of the
subcutis, gut, antennal gland, gonads,
nerve tracts and ganglia
(Chantanachookin et al., 1993;
Lightner, 1996a). All or some of these
tissues can make up the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). The YHV has
been reported to be inactivated by heat
at 60°C for 15 min (Flegel et al., 1995)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, heat sterilised hermetically sealed crustacean
products (i.e. a heat treatment at 121°C for at least 3.6 min or time/temperature equivalent) are eligible for
inclusion in Article 9.2.3. point 1.
Assessments of the safety of aquatic animal commodities
105
Aquatic animal product assessments for infection with yellow head virus
Table II
Cooked crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
The YHV targets tissues of ectodermal
and mesodermal origin including lymphoid
organs, haemocytes, haematopoietic
tissue, gill lamellae and spongy
connective tissue of the subcutis, gut,
antennal gland, gonads, nerve tracts and
ganglia (Chantanachookin et al., 1993;
Lightner, 1996a). All or some of these
tissues can make up the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Cooking involves a heat treatment which
is not well defined, but usually involves
boiling. The YHV has been reported to be
inactivated by heat at 60°C for 15 min
(Flegel et al., 1995)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation).
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, cooked crustacean products that have been
subjected to heat treatment at 60°C for at least 15 min (or any time/temperature equivalent which has been
demonstrated to inactivate YHV) are eligible for inclusion in Article 9.2.3. point 1.
106
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with yellow head virus
Table III
Pasteurised crustacean products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
The YHV targets tissues of ectodermal
and mesodermal origin including lymphoid
organs, haemocytes, haematopoietic
tissue, gill lamellae and spongy
connective tissue of the subcutis, gut,
antennal gland, gonads, nerve tracts and
ganglia (Chantanachookin et al., 1993;
Lightner, 1996a). All or some of these
tissues can make up the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent)
(FDA, 2001; Gould, 1999). The YHV has
been reported to be inactivated by heat at
60°C for 15 min (Flegel et al., 1995)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, pasteurised crustacean products that have
been subjected to heat treatment at 90°C for at least 10 min (or any time/temperature equivalent which has
been demonstrated to inactivate YHV) are eligible for inclusion in Article 9.2.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
107
Aquatic animal product assessments for infection with yellow head virus
Table IV
Crustacean oil
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the commodity
is derived
The YHV targets tissues of ectodermal and
mesodermal origin including lymphoid organs,
haemocytes, haematopoietic tissue, gill lamellae
and spongy connective tissue of the subcutis,
gut, antennal gland, gonads, nerve tracts and
ganglia (Chantanachookin et al., 1993; Lightner,
1996a). All or some of these tissues can make
up the commodity
No
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity
is derived, the treatment or
processing to produce the
commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
Raw material is cooked (may be pre-heated to
50°C to 60°C before cooking at temperatures of
95° to 100°C for 15 to 20 min. For reasons of
energy cost and nutritional content, some
processors use 80°C to 85°C for 20 min).
Cooked material is pressed to produce press
liquor, and press liquor is heated to 90°C to
95°C, which produces oil. Oil is purified with hot
water (at 90°C) (FAO, 1986). The YHV has been
reported to be inactivated by heat at 60°C for
15 min (Felgel et al., 1995)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, crustacean oil is eligible for inclusion in Article
9.2.3. point 1.
108
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with yellow head virus
Table V
Crustacean meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The YHV targets tissues of ectodermal
and mesodermal origin including
lymphoid organs, haemocytes,
haematopoietic tissue, gill lamellae and
spongy connective tissue of the
subcutis, gut, antennal gland, gonads,
nerve tracts and ganglia
(Chantanachookin et al., 1993;
Lightner, 1996a). All or some of these
tissues can make up the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The process involves cooking, usually
boiling at 100°C for at least 3 min, with
a drying step at between 115 and
138°C (Velez et al., 1991). The YHV
has been reported to be inactivated
by heat at 60°C for 15 min (Felgel et
al., 1995)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, crustacean meal is eligible for inclusion in
Article 9.2.3. point 1.
Assessments of the safety of aquatic animal commodities
109
Aquatic animal product assessments for infection with yellow head virus
Table VI
Chemically extracted chitin
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
The YHV targets tissues of
ectodermal and mesodermal origin
including lymphoid organs,
haemocytes, haematopoietic tissue,
gill lamellae and spongy connective
tissue of the subcutis, gut, antennal
gland, gonads, nerve tracts and
ganglia (Chantanachookin et al.,
1993; Lightner, 1996a). All or some
of these tissues can make up
the commodity
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Hydrochloric acid is used in the
processing and involves heating at
60° to 70°C for a few h (Gagné,
1993). The YHV has been reported
to be inactivated by heat at 60°C
for 15 min (Felgel et al., 1995)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Yellow head virus will be inactivated by this process. Therefore, chemically extracted chitin is eligible for
inclusion in Article 9.2.3. point 1.
110
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with yellow head virus
B) Assessments using criteria in Article 5.4.2. (for Article 9.2.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.2.:
i) frozen shrimp or decapod crustacea (shell off, head off) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen shrimp or decapod crustaceans (shell on, head on) (Table II).
Table I
Frozen shrimp or decapod crustacea (shell off, head off)
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues because the entire
product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of
waste tissues generated by the
consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
CONCLUSION
Frozen shrimp or decapod crustacea (shell off, head off) that are prepared and packaged for retail trade for
human consumption do not produce waste. Therefore, frozen shrimp or decapod crustacea (shell off, head off)
are eligible for inclusion in Article 9.2.11.
Assessments of the safety of aquatic animal commodities
111
Aquatic animal product assessments for infection with yellow head virus
Table II
Frozen shrimp or decapod crustacea (shell on, head on)
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of
waste tissues generated by the
consumer
Waste includes shell, cephalothorax, legs
No
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
The YHV targets tissues of ectodermal and
mesodermal origin including lymphoid organs,
haemocytes, haematopoietic tissue, gill
lamellae and spongy connective tissue of the
subcutis, gut, antennal gland, gonads, nerve
tracts and ganglia (Chantanachookin et al.,
1993; Lightner, 1996a). Freezing and cold
storage for normal periods will not eliminate the
virus (Durand et al., 2000)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen shrimp or decapod crustacea (shell on, head on) that are prepared and packaged for retail trade for
human consumption may produce amounts of waste that cannot be considered small; the pathogenic agent
may be found in the waste. Therefore, frozen shrimp or decapod crustacea (shell on, head on) are not eligible
for inclusion in Article 9.2.11.
112
Assessments of the safety of aquatic animal commodities
Chapter III: Assessments for OIE listed diseases
of molluscs
1.
Aquatic animal product assessments for infection with
abalone herpesvirus
A) Assessments using criteria in Article 5.4.1. (for Article 11.1.3.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.1.:
i) heat sterilised hermetically sealed abalone products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I)
ii) mechanically dried abalone products (i.e. a heat treatment at 100°C for at least 30 min
or any time/temperature equivalent which has been demonstrated to inactivate
abalone herpesvirus [AbHV]) (Table II).
2. The following aquatic animal products did not meet the criteria in Article 5.4.1. or were not
assessed because they are not believed to be traded internationally:
i) off the shell, eviscerated abalone (chilled or frozen) (Table III).
Assessments of the safety of aquatic animal commodities
113
Aquatic animal product assessments for infection with abalone herpesvirus
Table I
Heat sterilised hermetically sealed abalone products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
The pathogen is found primarily in
association with the ganglia and
nerves (Chang et al., 2005; Hooper et
al., 2007) and so could be present in
the product
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). Warne
(1988) recommends that abalone are
blanched at 70°C for 5 min, followed
by 35 min at 121.1°C or 93 min at
110°C. Information on inactivation
conditions specifically for abalone
herpes virus is lacking; however, koi
herpesvirus was demonstrated to be
inactivated by heating to 50°C for
1 min (Kasai et al., 2005). Cyprinid
herpesvirus-1 and channel catfish virus
are both described as being heat labile
(Wolf, 1988)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Abalone herpesvirus is highly unlikely to survive this process. Therefore, heat sterilised hermetically sealed
abalone products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are
eligible for inclusion in Article 11.1.3. point 1.
114
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with abalone herpesvirus
Table II
Mechanically dried abalone products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The pathogen is found primarily in
association with the ganglia and
nerves (Chang et al., 2005; Hooper et
al., 2007) and so could be present in
the product
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Artificially drying involves heating at
100°C for 30 min (or equivalent).
Information on inactivation conditions
specifically for abalone herpes-like
virus is lacking; however, koi
herpesvirus was demonstrated to be
inactivated by heating to 50°C for
1 min (Kasai et al., 2005). Cyprinid
herpesvirus-1 and channel catfish
virus are both described as being
heat labile (Wolf, 1988)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Abalone herpesvirus is highly unlikely to survive this process. Therefore, mechanically dried abalone products
(i.e. a heat treatment at 100°C for at least 30 min or any time/temperature equivalent) are eligible for inclusion in
Article 11.1.3. point 1.
Assessments of the safety of aquatic animal commodities
115
Aquatic animal product assessments for infection with abalone herpesvirus
Table III
Off the shell, eviscerated abalone (chilled or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
The pathogen is found primarily in
association with the ganglia and
nerves (Chang et al., 2005;
Hooper et al., 2007) and so could
be present in the product
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
There are no published data
regarding tolerance of chilling and
freezing, however the experience
of researchers working with the
virus indicates that it is capable of
surviving for an as yet undefined
period of time at –20°C (Crane M,
pers. comm.). A fish herpesvirus
(Channel catfish virus) was
shown to tolerate freezing at
–20°C for 162 days (Plumb et al.,
1973), whilst ostreid herpevirus-1
survives for several months at
–20°C (Le Deuff et al., 1994)
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is a lack of information regarding the tolerance of abalone herpesvirus to chilling or freezing, however
unpublished evidence and the behaviour of similar pathogens indicates that the virus is likely to survive
chilling or freezing. Chilled or frozen product could therefore contain abalone herpesvirus. Therefore, off the
shell, eviscerated abalone (chilled or frozen) are not eligible for inclusion in Article 11.1.3. point 1.
116
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with abalone herpesvirus
B) Assessments using criteria in Article 5.4.2. (for Article 11.1.11.)
1. The following aquatic animal products did meet the criteria in Article 5.4.2:
i) off the shell, eviscerated abalone meat (chilled or frozen) (Table I).
Table I
Off the shell, eviscerated abalone (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is a part of the commodity definition
Yes
It includes only a small amount of
waste tissues
Given that the animal has been eviscerated it
is likely that there is no waste, the product
being consumed in its entirety
Yes
The pathogenic agent is not normally
found in the waste tissues
The pathogen is found primarily in
association with the ganglia and nerves
(Chang et al., 2005; Hooper et al., 2007) and
so could be present in any discarded tissue
No
AND/EITHER
2.
OR
3.
CONCLUSION
Off the shell, eviscerated abalone meat (chilled or frozen) that is prepared and packaged for retail trade for
human consumption does not produce waste. Therefore, off the shell, eviscerated abalone meat (chilled or
frozen) is considered to be eligible for inclusion in Article 11.1.11.
Assessments of the safety of aquatic animal commodities
117
Aquatic animal product assessments for infection with Bonamia exitiosa
2.
Aquatic animal product assessments for infection with
Bonamia exitiosa
A) Assessments using criteria in Article 5.4.1. (for Article 11.2.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) frozen oyster meat (Table I)
ii) frozen half-shell oysters (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) chilled oyster meat (Table III)
ii) chilled half-shell oysters (Table IV).
3. The following aquatic animal products were not assessed because they are not believed
to be traded internationally using species susceptible to B. exitiosa:
i) heat sterilised treated hermetically-sealed abalone products
ii) pasteurised abalone products.
118
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Bonamia exitiosa
Table I
Frozen oyster meat
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The product includes all tissues of the
oyster except the shell and a portion
of the adductor muscle. B. exitiosa is
an intrahaemocytic parasite that is
also seen extracellularly. The
protozoan will occur in all tissues of
the oyster
No
B. exitiosa will not survive the
freezing process. In addition,
B. exitiosa does not form spores or
cysts (Dinamani et al., 1987). In
general, protozoa require a
cryopreservation technique with
preservative in order to survive frozen
storage (Dalgleish, 1972)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia exitiosa will be inactivated by this process. Therefore, frozen oyster meat is eligible for inclusion in
Article 11.2.3. point 1.
Assessments of the safety of aquatic animal commodities
119
Aquatic animal product assessments for infection with Bonamia exitiosa
Table II
Frozen half shell oysters
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The product includes all tissues of the
oyster except the shell and a portion
of the adductor muscle. B. exitiosa is
an intrahaemocytic parasite that is
also seen extracellularly. The
protozoan will occur in all tissues of
the oyster
No
B. exitiosa will not survive
the freezing process. In addition,
B. exitiosa does not form spores or
cysts (Dinamani et al., 1987).
In general, protozoa require a
cryopreservation technique with
preservative in order to survive frozen
storage (Dalgleish, 1972)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia exitiosa will be inactivated by this process. Therefore, frozen half shell oysters are eligible for
inclusion in Article 11.2.3. point 1.
120
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Bonamia exitiosa
Table III
Chilled oyster meat
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
The product includes all tissues of the
oyster except the shell and a portion
of the adductor muscle. B. exitiosa is
an intrahaemocytic parasite that is
also seen extracellularly. The
protozoan will occur in all tissues of
the oyster
No
B. exitiosa may survive the low
temperatures used for refrigeration.
No specific data were found for this
organism, but under experimental
conditions B. ostreae, a similar
pathogen, survived refrigeration at
4°C for 48 h (Arzul et al., 2009)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia exitiosa may not be inactivated by this process. Therefore, chilled oyster meat is not eligible for
inclusion in Article 11.2.3. point 1.
Assessments of the safety of aquatic animal commodities
121
Aquatic animal product assessments for infection with Bonamia exitiosa
Table IV
Chilled half shell oysters
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent is
not present in the tissues from which the commodity
is derived
The product includes all tissues of
the oyster except the shell and a
portion of the adductor muscle.
B. exitiosa is an intrahaemocytic
parasite that is also seen
extracellularly. The protozoan will
occur in all tissues of the oyster
No
B. exitiosa may survive the low
temperatures used for
refrigeration. No specific data
were found for this organism, but
under experimental conditions
B. ostreae, a similar pathogen,
survived refrigeration at 4°C for
48 h (Arzul et al., 2009)
No
AND
b) The water (including ice) used to process or transport
the commodity is not contaminated with the
pathogenic agent and the processing prevents cross
contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or processing
to produce the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia exitiosa will not be inactivated by this process. Therefore, chilled half shell oysters are not eligible for
inclusion in Article 11.2.3. point 1.
122
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Bonamia exitiosa
B) Assessments using criteria in Article 5.4.2. (for Article 11.2.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) chilled oyster meat (Table I)
ii) chilled half-shell oysters (Table II).
Table I
Chilled oyster meat
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues because
the entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Chilled oyster meat that is prepared and packaged for retail trade for human consumption does not produce
waste. Therefore, chilled oyster meat is eligible for inclusion in Article 11.2.12.
Table II
Chilled half-shell oysters
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
The waste generated includes half of
the shell with piece of adductor
muscle attached. B. exitiosa does not
occur in the shell therefore only a
small amount of relevant waste tissue
is produced
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Chilled half-shell oysters that are prepared and packaged for retail trade for human consumption produce small
amounts of waste. Therefore, chilled half-shell oysters are eligible for inclusion in Article 11.2.11.
Assessments of the safety of aquatic animal commodities
123
Aquatic animal product assessments for infection with Bonamia ostreae
3.
Aquatic animal product assessments for infection with Bonamia ostreae
A) Assessments using criteria in Article 5.4.1. (for Article 11.3.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) frozen oyster meat (Table I)
ii) frozen half-shell oysters (Table II).
2. The following aquatic animal products were not assessed because they are not believed
to be traded internationally:
i) heat sterilised hermetically sealed oyster products
ii) pasteurised oyster products.
124
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Bonamia ostreae
Table I
Frozen oyster meat
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The product includes all tissues of the
oyster except the shell and a portion of
the adductor muscle. Bonamia ostreae
is an intrahaemocytic parasite (Pichot et
al., 1979) and will occur in all tissues of
the oyster
No
The commodity is processed with clean
seawater or potable water (WHO/FAO,
2009). B. ostreae does not occur in
freshwater; survival is favoured by high
salinity (OIE, 2011b)
No
B. ostreae will not survive the freezing
process (B. ostreae does not form
spores or cysts); in general, protozoa
require a cryopreservation technique
with preservative in order to survive
frozen storage (Dalgleish, 1972)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia ostreae will be inactivated by this process. Therefore, frozen oyster meat is eligible for inclusion in
Article 11.3.3. point 1.
Assessments of the safety of aquatic animal commodities
125
Aquatic animal product assessments for infection with Bonamia ostreae
Table II
Frozen half-shell oysters
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The product includes all tissues of the
oyster except the shell and a portion of
the adductor muscle. Bonamia ostreae
is an intrahaemocytic parasite (Pichot et
al., 1979) and will occur in all tissues of
the oyster
No
The commodity is processed with clean
seawater or potable water (WHO/FAO,
2009). Bonamia ostreae does not occur
in freshwater; survival is favoured by
high salinity (OIE, 2011b)
No
Bonamia ostreae will not survive the
freezing process; protozoa require a
cryopreservation technique with
preservative in order to survive frozen
storage (Dalgleish, 1972)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Bonamia ostreae will be inactivated by this process. Therefore, frozen half-shell oysters are eligible for
inclusion in Article 11.3.3. point 1.
126
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Bonamia ostreae
B) Assessments using criteria in Article 5.4.2. (for Article 11.3.11.)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) chilled oyster meat (Table I)
ii) chilled half-shell oysters (Table II).
Table I
Chilled oyster meat
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There are no waste tissues
because the entire product is
consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Chilled oyster meat that is prepared and packaged for retail trade for human consumption does not produce
waste. Therefore, chilled oyster meat is eligible for inclusion in Article 11.3.11.
Table II
Chilled half-shell oysters
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
The waste generated includes half
of the shell with a piece of adductor
muscle attached
Yes
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
Bonamia ostreae does not occur in
the shell
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled half-shell oysters that are prepared and packaged for retail trade for human consumption produce small
amounts of waste. Therefore, chilled half-shell oysters are eligible for inclusion in Article 11.3.11.
Assessments of the safety of aquatic animal commodities
127
Aquatic animal product assessments for infection with Marteilia refringens
4.
Aquatic animal product assessment for infection with
Marteilia refringens
A) Assessments using criteria in Article 5.4.1. (for Article 11.4.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed mollusc products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) pasteurised mollusc products (Table II).
128
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Marteilia refringens
Table I
Heat sterilised hermetically sealed mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in
the tissues from which the
commodity is derived
M. refringens infects the digestive tract. Young
plasmodia are found mainly in the epithelium of
labial palps and the stomach (Grizel et al., 1974).
Sporulation takes place in the digestive gland
tubules and ducts. Propagules are released into the
lumen of the digestive tract (Audemard et al., 2002)
No
AND
b) The water (including ice) used to
process or transport the commodity
is not contaminated with the
pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity
is derived, the treatment or
processing to produce the
commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
Heat treatment is 121°C for 3.6 min or equivalent
(e.g. 111°C for 36 min) (Ababouch, 1999, 2002).
There is no specific information about inactivation of
M. refringens. M. sydneyi is 100% inactivated by
60°C for 24 h, 99.5% inactivated by 200 ppm
chlorine for 2 h and 100% inactivated by 200 ppm
chlorine for 4 h. Another protozoan parasite,
Perkinsus marinus, is inactivated after 1 h at 50°C or
1 h exposure to fresh water, and 97% mortality
occurs after 30 min at 60°C (Bushek et al., 1997;
Soudant et al., 2005; Wesche et al., 1999)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt,
smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Marteilia refringens will be inactivated by this process. Therefore, heat sterilised hermetically sealed mollusc
products (i.e. a heat treatment at 121°C for at least 3.6 min or equivalent) are eligible for inclusion in
Article 11.4.3. point 1.
Assessments of the safety of aquatic animal commodities
129
Aquatic animal product assessments for infection with Marteilia refringens
Table II
Pasteurised mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
M. refringens infects the digestive tract.
Young plasmodia are mainly found in the
epithelium of labial palps and the stomach
(Grizel et al., 1974). Sporulation takes
place in the digestive gland tubules and
ducts. Propagules are released into the
lumen of the digestive tract. (Audemard et
al., 2002)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
There are a number of published
standards for pasteurisation of mollusc
products, including 52°C for 22 min
(Andrews et al., 2003), cool pasteurisation
at 50°C for 10 min or traditional
pasteurisation at 75°C for 8 min (CruzRomero et al., 2007). There is a lack of
information as to whether this process
inactivates Marteilia refringens
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of M. refringens with this process. Therefore, pasteurised mollusc
products are not eligible for inclusion in Article 11.4.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
130
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Marteilia refringens
B) Assessments using criteria in Article 5.4.2. (for Article 11.4.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) mollusc meat (chilled or frozen) (Table I)
ii) half-shell oysters (chilled or frozen) (Table II).
Table I
Mollusc meat (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There is no waste tissue because
the entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
OR
3.
The pathogenic agent is not normally found in the
waste tissues
–
CONCLUSION
Oyster and mussel meat (chilled) that is prepared and packaged for retail trade for human consumption does
not produce waste. Therefore, oyster and mussel meat (chilled) is considered to be eligible for inclusion in
Article 11.4.11.
Table II
Half-shell oyster (chilled)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
The waste consists of half the
shell with a piece of adductor
muscle attached
Yes
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
M. refringens does not occur in
the shell
Yes
AND/EITHER
2.
OR
3.
CONCLUSION
Half-shell oysters (chilled) that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, half-shell oysters (chilled) are eligible for inclusion in Article 11.4.11.
Assessments of the safety of aquatic animal commodities
131
Aquatic animal product assessments for infection with Perkinsus marinus
5.
Aquatic animal product assessment for infection with
Perkinsus marinus
A) Assessments using criteria in Article 5.4.1. (for Article 11.5.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed mollusc products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) pasteurised mollusc products (Table II).
Table I
Heat sterilised hermetically sealed mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
The pathogenic agent can be found
in gut epithelium, connective tissue
of all organs and haemocytes
(Mackin, 1951)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min
or equivalent (e.g. 111°C for
36 min) (Ababouch, 1999, 2002).
It is highly likely that Perkinsus
marinus is inactivated by this
treatment (Bushek et al., 1997;
Soudant et al., 2005)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
It is highly likely that Perkinsus marinus is inactivated by this process. Therefore, heat sterilised hermetically
sealed mollusc products (i.e. a heat treatment at 121°C for at least 3.6 min or equivalent) are eligible for
inclusion in Article 11.5.3. point 1.
132
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Perkinsus marinus
Table II
Pasteurised mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
The pathogenic agent can be found in gut
epithelium, connective tissue of all organs
and haemocytes (Mackin, 1951)
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
There are a number of published
standards for pasteurisation of mollusc
products including 52°C for 22 min
(Andrews et al., 2003), cool
pasteurisation at 50°C for 10 min or
traditional pasteurisation at 75°C for
8 min (Cruz-Romero et al., 2007). There
is lack of information as to whether this
process inactivates Perkinsus marinus
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of Perkinsus marinus with this process. Therefore, pasteurised
mollusc products are not eligible for inclusion in Article 11.5.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
133
Aquatic animal product assessments for infection with Perkinsus marinus
B) Assessments using criteria in Article 5.4.2. (for Article 10.5.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) mollusc meat (chilled and frozen) (Table I)
ii) half-shell oysters (chilled and frozen) (Table II).
Table I
Mollusc meat (chilled and frozen)
Article 5.4.2. criteria
1.
Rationale
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Assessment
It is part of the commodity definition
Yes
There is no waste tissue because
the entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
–
CONCLUSION
Mollusc meat (chilled and frozen) that is prepared and packaged for retail trade for human consumption does
not produce waste. Therefore, mollusc meat (chilled and frozen) is considered to be eligible for inclusion in
Article 11.5.11.
Table II
Half-shell oysters (chilled and frozen)
Article 5.4.2. criteria
1.
Rationale
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
The waste consists of half the shell
with a piece of adductor muscle
attached
Yes
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
Perkinsus marinus does not occur
in the shell
Yes
AND/EITHER
2.
OR
3.
CONCLUSION
Half-shell oysters (chilled and frozen) that are prepared and packaged for retail trade for human consumption
produce small amounts of waste. Therefore, half-shell oysters (chilled and frozen) are eligible for inclusion in
Article 11.5.11.
134
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Perkinsus olseni
6.
Aquatic animal product assessments for infection with Perkinsus olseni
A) Assessments using criteria in Article 5.4.1. (for Article 11.6.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed mollusc products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) pasteurised mollusc products (Table II).
Table I
Heat sterilised hermetically sealed mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The pathogenic agent can be found in
epithelia, connective tissue, muscle fascicles
and blood spaces (Villlalba et al., 2004)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). Although there is
no specific information about inactivation of
Perkinsus olseni, Perkinsus marinus is
inactivated by 1 h at 50°C or 1 h of exposure
to fresh water, and 97% mortality occurs
after 30 min at 60°C (Bushek et al., 1997;
Soudant et al., 2005)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
It is likely that Perkinsus olseni is inactivated by this process. Therefore, heat sterilised hermetically sealed
mollusc products (i.e. a heat treatment at 121°C for at least 3.6 min or equivalent) are eligible for inclusion in
Article 11.6.3. point 1.
Assessments of the safety of aquatic animal commodities
135
Aquatic animal product assessments for infection with Perkinsus olseni
Table II
Pasteurised mollusc products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
The pathogenic agent can be found in
epithelia, connective tissue, muscle
fascicles and blood spaces (Villlalba et
al., 2004)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
There are a number of published
standards for pasteurisation of mollusc
products including 52°C for 22 min
(Andrews et al., 2003), cool
pasteurisation at 50°C for 10 min or
traditional pasteurisation at 75°C for
8 min (Cruz-Romero et al., 2007). There
is a lack of information as to whether this
process inactivates Perkinsus olseni
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of Perkinsus olseni with this process. Therefore, pasteurised
mollusc products are not eligible for inclusion in Article 11.6.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
136
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Perkinsus olseni
B) Assessments using criteria in Article 5.4.2. (for Article 10.6.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) mollusc meat (chilled and frozen) (Tale I)
ii) half-shell molluscs (chilled and frozen) (Table II).
Table I
Mollusc meat (chilled and frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
There is no waste tissue because the
entire product is consumed
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
–
CONCLUSION
Mollusc meat (chilled and frozen) that is prepared and packaged for retail trade for human consumption does
not produce waste. Therefore, mollusc meat (chilled and frozen) is considered to be eligible for inclusion in
Article 11.6.11.
Table II
Half-shell molluscs (chilled and frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
The waste consists of half the shell with a
piece of adductor muscle attached
Yes
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
Perkinsus olseni does not occur in
the shell
Yes
AND/EITHER
2.
OR
3.
CONCLUSION
Half-shell molluscs (chilled and frozen) that are prepared and packaged for retail trade for human consumption
produce small amounts of waste. Therefore, half-shell molluscs (chilled and frozen) is eligible for inclusion in
Article 11.6.11.
Assessments of the safety of aquatic animal commodities
137
Aquatic animal product assessments for infection with Xenohaliotis californiensis
7.
Aquatic animal product assessments for infection with
Xenohaliotis californiensis
A) Assessments using criteria in Article 5.4.1. (for Article 11.7.3.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.1.:
i) heat sterilised hermetically sealed abalone products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I).
2. The following aquatic animal products did not meet the criteria in Article 5.4.1.:
i) off the shell, eviscerated abalone (chilled or frozen) (Table II).
Table I
Heat sterilised hermetically sealed abalone products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
K. californiensis infects the
epithelium of the oesophagus and
intestine only (Berthe 2003;
Friedman et al., 2000). Only foot
muscle is edible, the viscera are
waste tissues
Yes
Clean seawater or potable water is
used to process the product
(WHO/FAO, 2009). There is no
information available on survival of
X. californiensis in fresh water, nor
the response to chlorine or other
water sterilising agents.
Transmission studies (Friedman et
al., 2002; Moore et al., 2001)
indicate that the organism can
survive in seawater for an
undefined time. The water used
may therefore be contaminated, but
any water used in the early stages
of processing would then be subject
to time/temperature treatments. The
final product is hermetically sealed
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
138
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Xenohaliotis californiensis
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min
or equivalent (e.g. 111°C for
36 min) (Ababouch, 1999, 2002).
Warne (1988) indicates that
abalone are blanched at 70°C for
5 min, followed by 35 min at
121.1°C or 93 min at 110°C.
Information on inactivation
conditions specifically for
K. californiensis is lacking;
however, similar rickettsial
organisms in fish are reported to be
inactivated at 56°C for 1 h (Chen et
al., 2000), while Birkbeck et al.
(2004) used 100°C for 30 min to
heat inactivate Piscirickettsia
salmonis
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Xenohaliotis californiensis is highly unlikely to survive this process. Therefore, heat sterilised hermetically
sealed abalone products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent)
are eligible for inclusion in Article 11.7.3. point 1.
Assessments of the safety of aquatic animal commodities
139
Aquatic animal product assessments for infection with Xenohaliotis californiensis
Table II
Off the shell, eviscerated abalone (chilled or frozen)
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
K. californiensis infects the
epithelium of the oesophagus and
intestine only (Berthe, 2003;
Friedman et al., 2000)
Yes
Clean seawater or potable water is
used to process the product
(WHO/FAO, 2009). There is no
information available on survival of
X. californiensis in fresh water, nor
the response to chlorine or other
water sterilising agents.
Transmission studies (Friedman et
al., 2002; Moore et al., 2001)
indicate that the organism can
survive in seawater for an
undefined time. The water used
may therefore be contaminated
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
The agent is expected to survive chilling
at +4°C. There is no specific information
regarding the freeze tolerance of
K. californiensis, however a similar
intracellular rickettsial pathogen
(Piscirickettsia salmonis) is reported to
suffer a 100-fold reduction in TCID50 after
freezing at –20°C. This 2D reduction in
titre may eliminate rickettsiae in water
used for freezing and processing,
however without knowledge of the level of
infection in the water there cannot be
certainty about this
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Given that there is uncertainty regarding the water used in processing and the effects of freezing, off the shell
eviscerated abalone (chilled or frozen) could contain Xenohaliotis californiensis. Therefore, off the shell
eviscerated abalone (chilled or frozen) are not eligible for inclusion in Article 11.7.3. point 1.
140
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Xenohaliotis californiensis
B) Assessments using criteria in Article 5.4.2. (for Article 11.7.11.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.2.:
i) off the shell, eviscerated abalone (chilled or frozen) (Table I).
Table I
Off the shell, eviscerated abalone (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste tissues
generated by the consumer
Given that the animal has been
eviscerated it is likely that there is
no waste, the product being
consumed in its entirety
Yes
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
The pathogen is found primarily in
the oesophagus and intestine
(Berthe, 2003; Friedman et al.,
2000), which are removed
Yes
AND/EITHER
2.
OR
3.
CONCLUSION
Off the shell, eviscerated abalone (chilled or frozen) that is prepared and packaged for retail trade for human
consumption does not produce waste. Therefore, off the shell, eviscerated abalone (chilled or frozen) is
considered to be eligible for inclusion in Article 11.7.11. for Xenohaliotis californiensis.
Assessments of the safety of aquatic animal commodities
141
Chapter IV: Assessments for OIE listed diseases
of fish
1.
Aquatic animal product assessments for epizootic haematopoietic
necrosis
A. Assessments using criteria in Article 5.4.1. (for Article 10.1.13. point
1)
The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed fish products (i.e. a heat treatment at 121°C for at least
3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to heat treatment at 90°C for at least
10 min (or any time/temperature equivalent which has been demonstrated to inactivate
epizootic haematopoietic necrosis virus [EHNV]) (Table II)
iii) mechanically dried eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min or
any time/temperature equivalent which has been demonstrated to inactivate EHNV)
(Table III)
iv) fish skin leather (Table IV)
v) fish oil (Table V)
vi) fish meal (Table V).
Assessments of the safety of aquatic animal commodities
143
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table I
Heat sterilised hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
EHN virus (EHNV) is present in muscle
and other edible tissues (Ariel et al.,
2009)
No
Potable fresh water is used to process
the product (WHO/FAO, 2009). The
final product is sealed during transport
NA
Commercial canning involves
time/temperature treatments of 121°C
for 3.6 min, or equivalent e.g. 111°C for
36 min (Ababouch, 1999, 2002). EHNV
is inactivated after 15 min at 60°C
(Langdon, 1989)
Yes
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Epizootic haematopoietic necrosis virus will be inactivated by this process. Therefore, heat sterilised
hermetically sealed fish products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature
equivalent) are eligible for inclusion in Article 10.1.3. point 1.
144
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
EHN virus (EHNV) is present in
muscle and other edible tissues
(Ariel et al., 2009)
No
Potable fresh water is used to
process the product (WHO/FAO,
2009). The final product is sealed
during transport
NA
Pasteurisation involves heating at
90°C for 10 min (or equivalent, e.g.
86°C for 37 min) (FDA, 2001; Gould
1999). EHNV is inactivated after
15 min at 60°C (Langdon, 1989)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Epizootic haematopoietic necrosis virus will be inactivated by this process. Therefore, pasteurised fish
products that have been subjected to heat treatment at 90°C for at least 10 min or any time/temperature
equivalent that has been demonstrated to inactivate EHNV are eligible for inclusion in Article 10.1.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
145
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table III
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
The EHN virus (EHNV) can be found
in skin (Redacliff & Whittington, 1996)
No
Potable freshwater is used to process
the product (WHO/FAO, 2009). The
final product is sealed during
transport
NA
Skin is exposed to alkaline metal
sulphide, solvents, proteases, acid
pH 1.5–4, chromium or other tanning
solutions and dyes. The final leather
product is usually pH <5. Each step
takes between 15 min and 24 h in a
commercial setting (Pocket Book for
the Leather Technologist 4th Ed.).
Exposure to pH <4 or>12 h for 1 h will
inactivate EHNV (Langdon, 1989)
Yes
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Epizootic haematopoietic necrosis virus will be inactivated by this process. Therefore, fish skin leather
products are eligible for inclusion in Article 10.1.3. point 1.
146
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table IV
Mechanically dried eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
EHN virus (EHNV) is present in
muscle and other edible tissues (Ariel
et al., 2009)
No
Potable fresh water is used to
process the product (WHO/FAO,
2009). The final product is sealed
during transport
NA
Artificial drying involves heating at
100°C for 30 min (or equivalent).
EHNV is inactivated after 15 min at
60°C (Langdon, 1989)
Yes
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
NA
AND/OR
c) Biological (e.g. fermentation)
NA
CONCLUSION
Epizootic haematopoietic necrosis virus will be inactivated by this process. Therefore, mechanically dried
eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min or any time/temperature equivalent) are
eligible for inclusion in Article 10.1.3. point 1.
Assessments of the safety of aquatic animal commodities
147
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table V
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
EHN virus (EHNV) occurs in multiple
tissues in infected fish. Fish oil is derived
from whole fish or by-products of
processing
No
If the fish are infected the water is likely
to be contaminated
No
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is
extremely low. Raw material is cooked
(may be pre-heated to 50°C to 60°C
before cooking at temperatures of 95°C
to 100°C for 15 min to 20 min. For energy
cost reasons and nutritional content,
some processors use 80°C to 85°C for
20 min). Cooked material is pressed to
produce press liquor and presscake that
can be dried (75°C to 80°C, ≥30 min)
and milled to presscake meal. Press
liquor is heated to 90°C to 95°C, which
produces oil and stick-water. Oil is
purified with hot water (at 90°C). Stickwater is evaporated at ≥100°C (<130°C)
and the resulting fish solubles are added
to the presscake. Presscake and fish
soluble mix is dried at 75°C to 80°C for
≥30 min to reduce water content to
≤12%. This is then milled to give whole
fishmeal. EHNV is inactivated after
15 min at 60oC (Langdon, 1989)
Yes
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Epizootic haematopoietic necrosis virus will be inactivated by this process. Therefore, fish oil and fish meal are
eligible for inclusion in Article 10.1.3. point 1.
148
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for epizootic haematopoietic necrosis
B. Assessments criteria in Article 5.4.2. (for Article 10.1.11. point1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) fillets or steaks (chilled or frozen) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in Article
5.4.2.:
i) eviscerated fish (chilled or frozen) (Table II)
ii) naturally dried eviscerated fish (Table III).
Table I
Fillets or steaks (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes skin and bones
Yes
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
EHN virus (EHNV) can be present in skin
(Redacliff & Whittington, 1996). EHNV can
persist in frozen fish tissues for more than
2 years and in chilled fish tissues for more
than 1 week (Langdon, 1989)
No
AND / EITHER
2.
OR
3.
CONCLUSION
Fillets or steaks (chilled or frozen) that are prepared and packaged for retail trade for human consumption
may produce small amounts of waste. Therefore, this product is considered to be eligible for inclusion in
Article 10.1.11. for epizootic haematopoietic necrosis.
Assessments of the safety of aquatic animal commodities
149
Aquatic animal product assessments for epizootic haematopoietic necrosis
Table II
Eviscerated fish (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, backbone and skin
Yes
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
EHN virus (EHNV) can be present in gills
and skin (Redacliff & Whittington, 1996) and
in brain (Langdon et al., 1988). EHNV can
persist in frozen fish tissues for more than 2
years and in chilled fish tissues for more
than 1 week (Langdon, 1989)
No
AND / EITHER
2.
OR
3.
CONCLUSION
Eviscerated fish (chilled or frozen) that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; epizootic haematopoietic necrosis virus may be
found in the waste (skin and gills). Therefore, this product is not considered eligible for inclusion in Article
10.1.11. for EHN.
Table III
Naturally dried eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, backbone and skin
No
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
EHN virus (EHNV) can be present in skin
(Redacliff & Whittington, 1996) and in brain
(Langdon et al., 1988)
No
AND / EITHER
2.
OR
3.
CONCLUSION
Naturally dried eviscerated fish that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; epizootic haematopoietic necrosis virus may be
found in the waste tissues. Therefore, this product is not considered eligible for inclusion in Article 10.1.11.
for EHN.
150
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments assessments for infection with Aphanomyces invadans
2.
Aquatic animal product assessments for infection with Aphanomyces
invadans (epizootic ulcerative syndrome)
A) Assessments using criteria in Article 5.4.1. (for Article 10.2.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to heat treatment at 90°C for at
least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate Aphanomyces invadans) (Table II)
iii) mechanically dried eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min
or any time/temperature equivalent that has been demonstrated to inactivate
Aphanomyces invadans) (Table III)
iv) fish oil (Table IV)
v) fish meal (Table IV)
vi) frozen eviscerated fish (Table V)
vii) frozen fillets or steaks (Table VI).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) fish skin leather (Table VII)
ii) naturally dried eviscerated fish (Table VIII).
Assessments of the safety of aquatic animal commodities
151
Aquatic animal product assessments for infection with Aphanomyces invadans
Table I
Heat sterilised hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Aphanomyces invadans is present in
muscle and other edible tissues (Ahmed
et al., 1999; Callinan et al., 1989;
Chinabut et al., 1995; Chinabut &
Roberts, 1999; Das & Mukherjee, 1998;
Miyazaki & Egusa, 1972, 1973; Noga et
al., 1988)
No.
Water is used to process the product but
the water is potable and the final product
is sealed
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min).
Although there is no specific information
about inactivation of A. invadans, it is
known that Aphanomyces astaci is
inactivated by boiling (100°C) for 1 min
(Oidtmann et al., 2002). It is assumed
that boiling (100°C) for 1 min would have
a similar effect on A. invadans
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans will be inactivated by this process. Therefore, heat sterilised hermetically sealed fish
products (i.e. a heat treatment at 121°C for at least 3.6 min or equivalent) are eligible for inclusion in Article
10.2.3. point 1.
152
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Aphanomyces invadans
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Aphanomyces invadans is present in
muscle and other edible tissues
(Ahmed et al., 1999; Callinan et al.,
1989; Chinabut et al., 1995; Chinabut
& Roberts, 1999; Das & Mukherjee,
1998; Miyazaki & Egusa, 1972, 1973;
Noga et al., 1988)
No
Water is used to process the product
but the water is potable and the final
product is sealed
NA
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (or equivalent) (FDA,
2001; Gould, 1999). Spores or
mycelium of the related
Aphanomyces astaci do not survive
5-min exposure to 60°C or 70°C
(CEFAS, 2000). It is assumed that
such heat treatment would have a
similar effect on A. invadans
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans is highly likely to be inactivated by this process. Therefore, pasteurised fish products
that have been subjected to heat treatment at 90°C for 10 min or any time/temperature equivalent that has been
demonstrated to inactivate A. invadans are eligible for inclusion in Article 10.2.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
153
Aquatic animal product assessments for infection with Aphanomyces invadans
Table III
Mechanically dried eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
c) There is strong evidence that the pathogenic agent is
not present in the tissues from which the commodity is
derived
Aphanomyces invadans is
present in muscle and other
edible tissues (Ahmed et al.,
1999; Callinan et al., 1989;
Chinabut et al., 1995;
Chinabut & Roberts, 1999; Das
& Mukherjee, 1998; Miyazaki &
Egusa, 1972, 1973; Noga et
al., 1988)
No
AND
b) The water (including ice) used to process or transport
the commodity is not contaminated with the
pathogenic agent and the processing prevents cross
contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or processing
to produce the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Artificial drying involves heating
at 100°C for 30 min
(or equivalent). Although there is
no specific information about
inactivation of A. invadans at this
temperature, it is known that
Aphanomyces astaci is
inactivated by boiling (100°C) for
1 min (Oidtmann et al., 2002).
Based on data available for
A. astaci, A. invadans is unlikely
to survive this process
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans is highly likely to be inactivated by this process. Therefore, mechanically dried
eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min or time/temperature equivalent) is eligible for
inclusion in Article 10.2.3. point 1.
154
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Aphanomyces invadans
Table IV
Fish oil and meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Aphanomyces invadans occurs in multiple tissues in
infected fish (Ahmed et al., 1999; Callinan et al.,
1989; Chinabut et al., 1995; Chinabut & Roberts,
1999; Das & Mukherjee, 1998; Miyazaki & Egusa,
1972, 1973; Noga et al., 1988). Fish oil and meal are
derived from whole fish or by-products of processing
No
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
If the fish are infected he water is likely to be
contaminated
No
AND
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity is
derived, the treatment or processing to
produce the commodity to be traded
inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
During production, fish oil and fish meal undergo
multiple heat treatments and the final water content
of the product is extremely low. Raw material is
cooked (may be pre-heated to 50°C to 60°C before
cooking at temperatures of 95°C to 100°C for 15 to
20 min). For energy cost reasons and nutritional
content, some processors use 80°C to 85°C for
20 min. Cooked material is pressed to produce press
liquor and presscake that can be dried (75°C to
80°C, ≥30 min) and milled to presscake meal. Press
liquor is heated to 90°C to 95°C, which produces oil
and stick-water. Oil is purified with hot water (at
90°C). Stick-water is evaporated at ≥100°C
(<130°C) and the resulting fish solubles are added to
the presscake. Presscake and fish soluble mix is
dried at 75°C to 80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. Spores or mycelium of the related
Aphanomyces astaci do not survive 5 min of
exposure to 60°C or 70°C respectively (CEFAS,
2000). It is assumed that such heat treatment would
have a similar effect on A. invadans
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans is highly likely to be inactivated by this process. Therefore, fish meal and oil are
eligible for inclusion in Article 10.2.3. point 1.
Assessments of the safety of aquatic animal commodities
155
Aquatic animal product assessments for infection with Aphanomyces invadans
Table V
Frozen eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Aphanomyces invadans occurs in
multiple tissues in infected fish,
including muscle tissue (Ahmed et al.,
1999; Callinan et al., 1989; Chinabut
et al., 1995; Chinabut & Roberts,
1999; Das & Mukherjee, 1998;
Miyazaki & Egusa, 1972, 1973; Noga
et al., 1988)
No
If the fish are infected the water is
likely to be contaminated
No
There are no published studies on the
survival of A. invadans after it has
been exposed to low temperatures
such as those used for freezing.
Studies undertaken with A. astaci
have shown that A. astaci mycelium
kept at –20°C for 72 h is not viable
(Oidtmann et al., 2002). Based on the
studies undertaken for A. astaci, it is
assumed that A. invadans is
inactivated by exposure to
commercial freezing temperatures
until sold to the end consumer
yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
2a.
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans is highly likely to be inactivated by this process. Therefore, eviscerated frozen fish is
eligible for inclusion in Article 10.2.3. point 1.
156
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Aphanomyces invadans
Table VI
Frozen fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Aphanomyces invadans occurs in
multiple tissues in infected fish,
including muscle tissue (Ahmed et al.,
1999; Callinan et al., 1989; Chinabut
et al., 1995; Chinabut & Roberts,
1999; Das & Mukherjee, 1998;
Miyazaki & Egusa, 1972, 1973; Noga
et al., 1988)
No
If the fish are infected the water is
likely to be contaminated
No
There are no published studies on the
survival of A. invadans after it has
been exposed to low temperatures
such as those used for freezing.
Studies undertaken with A. astaci
have shown that A. astaci mycelium
kept at –20°C for 72 h is not viable
(Oidtmann et al., 2002). Based on the
studies undertaken for A. astaci, it is
assumed that A. invadans is
inactivated by exposure to
commercial freezing temperatures
until sold to the end consumer
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Aphanomyces invadans is highly likely to be inactivated by this process. Therefore, frozen fillets or steaks are
eligible for inclusion in Article 10.2.3. point 1.
Assessments of the safety of aquatic animal commodities
157
Aquatic animal product assessments for infection with Aphanomyces invadans
Table VII
Fish skin leather
Criteria 5.3.1.
1.
Rationale
Assessment
Aphanomyces invadans can be found in
skin (Sosa et al., 2007b; Vishwanath et
al., 1997)
No
Water is used to process the leather but
the final product is dry and not
transported in water
NA
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
Skin is exposed to alkaline metal
sulphide, solvents, proteases, acid
pH 1.5–4, chromium or other tanning
solutions and dyes. The final leather
product is usually pH <5. Each step takes
between 15 min and 24 h in a commercial
setting (Pocket Book for the Leather
Technologist 4th Ed.). There are currently
no published studies investigating the
effect of pH on A. invadans in the
relevant pH range
Unknown
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of Aphanomyces invadans with this process. Therefore, fish skin
leather is currently not eligible for inclusion in Article 10.2.3. point 1.
158
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Aphanomyces invadans
Table VIII
Naturally dried eviscerated fish
Criteria 5.3.1.
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Aphanomyces invadans occurs in
multiple tissues in infected fish
(Ahmed et al., 1999; Callinan et al.,
1989; Chinabut et al., 1995;
Chinabut & Roberts, 1999; Das &
Mukherjee, 1998; Miyazaki &
Egusa, 1972, 1973; Noga et al.,
1988). Fish meal is derived from
whole fish or by-products of
processing
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
There are no published studies on
the survival of A. invadans after it
has been exposed to dry conditions
for defined periods of time.
Furthermore, there are no data on
the viability of A. invadans with
respect to water content of the
substrate. Natural drying may
involve exposing the product to a
range of temperatures. Therefore,
the product cannot be assessed on
the basis of the temperature to
which the product has been
exposed
Unknown
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is uncertainty about the inactivation of A. invadans with this process. Therefore, naturally dried
eviscerated fish is not eligible for inclusion in Article 10.2.3. point 1.
Assessments of the safety of aquatic animal commodities
159
Aquatic animal product assessments for infection with Aphanomyces invadans
B. Assessments criteria in Article 5.4.2. (for Article 10.1.11. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) chilled fillets or steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) chilled eviscerated fish (Table I).
Table I
Chilled eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer.
Waste includes head, backbone and skin
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
Aphanomyces invadans is present in muscle,
skin and other tissues (Ahmed et al., 1999;
Callinan et al., 1989; Chinabut et al., 1995;
Chinabut & Roberts, 1999; Das & Mukherjee,
1998; Miyazaki & Egusa, 1972, 1973; Noga
et al., 1988). There are no published studies
on the survival of A. invadans after it has
been exposed to low temperatures such as
those used for chilling. Studies undertaken
with A. astaci have shown that A. astaci
mycelium or spores kept at 0, 5, or 10°C
were still viable after 2 weeks. Mycelium
survived temperatures of –5°C for 7 days and
–20°C for 48 h (CEFAS, 2000; Oidtmann et
al., 2002). It is therefore assumed that A.
invadans may be still viable beyond the
expected shelf life of chilled products
No
AND / EITHER
2.
OR
3.
CONCLUSION
Chilled eviscerated fish that are prepared and packaged for retail trade for human consumption may produce
amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste (skin, head
tissue). Therefore, this product is not eligible for inclusion in Article 10.2.11. for EUS.
160
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Aphanomyces invadans
Table II
Chilled fillets or steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition.
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes skin and bones.
Yes
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
Aphanomyces invadans is present in
muscle, skin and other tissues (Ahmed et
al., 1999; Callinan et al., 1989; Chinabut
et al., 1995; Chinabut & Roberts, 1999;
Das & Mukherjee, 1998; Miyazaki &
Egusa, 1972, 1973; Noga et al., 1988).
There are no published studies on the
survival of A. invadans after it has been
exposed to low temperatures such as
those used for chilling. Studies
undertaken with A. astaci have shown
that A. astaci mycelium or spores kept at
0, 5, or 10°C were still viable after two
weeks. Mycelium survived temperatures
of –5°C for seven days and –20°C for
48 h (CEFAS, 2000; Oidtmann et al.,
2002). It is therefore assumed that
A. invadans may be still viable beyond
the expected shelf life of chilled products
No
AND / EITHER
2.
OR
3.
CONCLUSION
Chilled fillets or steaks that are prepared and packaged for retail trade for human consumption produce small
amounts of waste. Therefore, this product is eligible for inclusion in Article 10.2.11. for EUS.
Assessments of the safety of aquatic animal commodities
161
Aquatic animal product assessments for infection with Gyrodactylus salaris
3.
Aquatic animal product assessments for Gyrodactylosis
(Gyrodactylus salaris)
A. Assessments using criteria in Article 5.4.1. (for Article 10.3.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i)
heat sterilised, hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii)
pasteurised fish products that have been subjected to a heat treatment at 63°C for at
least 30 min (or any time/temperature equivalent that has been demonstrated to
inactivate G. salaris) (Table II)
iii)
mechanically dried, eviscerated fish (i.e. a heat treatment at 100°C for at least
30 min or any time/temperature equivalent that has been demonstrated to inactivate
G. salaris) (Table III)
iv)
naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table IV)
v)
frozen, eviscerated fish that have been subjected to temperatures of –18°C or lower
(Table V)
vi)
frozen fish fillets or steaks that have been subjected to temperatures of –18°C or
lower (Table VI)
vii) chilled, eviscerated fish that have been harvested from seawater with a salinity of at
least 25ppt (Table VII)
viii) chilled fish fillets or steaks derived from fish that have been harvested from seawater
with a salinity of at least 25ppt (Table VIII)
ix)
chilled fish products from which the skin, fins and gills have been removed (Table IX)
x)
fish roe (Table X)
xi)
fish oil and fish meal (Table XI)
xii) fish skin leather (Table XII).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) chilled, eviscerated fish harvested from seawater with a salinity of less than 7.5 ppt
(Table XIII)
ii) chilled fillets or steaks from fish harvested from seawater with a salinity of less than
7.5 ppt (Table XIV).
162
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table I
Heat sterilised, hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
1) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Skin may be present in the commodity.
Gyrodactylus salaris is present on the
skin, fins and gills of fish living in fresh
water (Jensen & Johnsen, 1992). Infected
fish transferred from fresh water to
seawater of 7.5 ppt or higher become free
of the parasite by 56 days after transfer
(Soleng & Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
Potable fresh water is used to process the
product. The final product is sealed. G.
salaris is readily inactivated by
disinfectants (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.). G. salaris does not produce
eggs (OIE, 2009)
Yes
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). This is a cooking
process that this monogenean worm will
not be able to survive
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, heat sterilised, hermetically sealed fish
products are eligible for inclusion in Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
163
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
The commodity is composed primarily of
skeletal muscle. Skin, fins and gills are
unlikely to be a part of this commodity.
Gyrodactylus salaris is present on the
skin, fins and gills of fish living in
freshwater (Jensen & Johnsen, 1992).
Infected fish transferred from fresh water
to seawater of 7.5 ppt or higher become
free of the parasite by 56 days after
transfer (Soleng & Bakke, 1997)
Yes
Potable fresh water is used to process
the product. The final product is sealed.
G. salaris is readily inactivated by
disinfectants (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.). G. salaris does not
produce eggs (OIE, 2009)
Yes
Pasteurisation involves heating at 63°C
for 30 min (or equivalent). Survival of G.
salaris at high water temperatures
(greater than 25°C) has not been studied
systematically (OIE, 2009). However, it is
highly unlikely that the worm will survive
this temperature/time regime
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, pasteurised fish products are eligible for
inclusion in Article 10.3.3. point 1.
164
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table III
Mechanically dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Skin, fins and gills are part of the
commodity. Gyrodactylus salaris is
present on the skin, fins and gills of fish
living in fresh water (Jensen & Johnsen,
1992). Infected fish transferred from
fresh water to seawater of 7.5 ppt or
higher become free of the parasite by
56 days after transfer (Soleng &
Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
Potable freshwater is used to process
the product. The final product is not
transported in water. G. salaris is
readily inactivated by disinfectants
(Mo TA, 2010, OIE Reference
Laboratory for Gyrodactylosis, pers.
comm.). G. salaris does not produce
eggs (OIE, 2009)
Yes
Mechanical drying involves heating at
100°C for 30 min (or equivalent)
(OECD, 2008). G. salaris requires an
aqueous environment in order to
survive (Mo TA, 2010, OIE Reference
Laboratory for Gyrodactylosis, pers.
comm.). In addition, the worm will not
survive this temperature/time regime
Yes
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, mechanically dried, eviscerated fish are
eligible for inclusion in Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
165
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table IV
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Skin, fins and gills are part of the
commodity. Gyrodactylus salaris is
present on the skin, fins and gills of fish
living in fresh water (Jensen & Johnsen,
1992). Infected fish transferred from fresh
water to seawater of 7.5 ppt or higher
become free of the parasite by 56 days
after transfer (Soleng & Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
Potable fresh water is used to process
the product. The final product is not
transported in water. G. salaris is readily
inactivated by disinfectants (Mo TA,
2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.). G. salaris
does not produce eggs (OIE, 2009)
Yes
Natural drying involves exposure to the
sun and/or wind (OECD, 2008). G. salaris
requires an aqueous environment in
order to survive (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, naturally dried, eviscerated fish are eligible
for inclusion in Article 10.3.3. point 1.
166
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table V
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Skin, fins and gills may be part of the
commodity. Gyrodactylus salaris is
present on the skin, fins and gills of fish
living in fresh water (Jensen & Johnsen,
1992). Infected fish transferred from fresh
water to seawater of 7.5 ppt or higher
become free of the parasite by 56 days
after transfer (Soleng & Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
Potable fresh water is used to process the
product. The final product is transported
in frozen potable water. G. salaris is
readily inactivated by disinfectants (Mo
TA, 2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.). G. salaris
does not produce eggs (OIE, 2009)
Yes
Fish are frozen and maintained at a
temperature of –18°C or lower
(WHO/FAO, 2009). G. salaris does not
survive the freezing process (Mo TA,
2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, frozen, eviscerated fish are eligible for
inclusion in Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
167
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table VI
Frozen fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Skin may be part of the commodity.
Gyrodactylus salaris is present on the skin,
fins and gills of fish living in freshwater
(Jensen and Johnsen, 1992). Infected fish
transferred from freshwater to seawater of
7.5 ppt or higher become free of the
parasite by 56 days after transfer (Soleng
and Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
Potable fresh water is used to process the
product. The final product is transported in
frozen potable water. G. salaris is readily
inactivated by disinfectants (Mo TA, 2010,
OIE Reference Laboratory for
Gyrodactylosis, pers. comm.). G. salaris
does not produce eggs (OIE, 2009)
Yes
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). G. salaris does not survive the
freezing process (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment
or processing to produce the commodity
to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, frozen fish fillets and steaks are eligible for
inclusion in Article 10.3.3. point 1.
168
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table VII
Chilled, eviscerated fish that have been harvested from seawater with a salinity of at least
25 ppt
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Skin, fins and gills may be part of the
commodity. Gyrodactylus salaris is
present on the skin, fins and gills of fish
living in fresh water (Jensen & Johnsen,
1992). Infected fish transferred from fresh
water to seawater of 7.5 ppt or higher
become free of the parasite by 56 days
after transfer (Soleng & Bakke, 1997)
Yes
Potable fresh water is used to process the
product (WHO/FAO, 2009). The final
product is transported out of water, or on
ice made from potable water. G. salaris is
readily inactivated by disinfectants (Mo
TA, 2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.). G. salaris
does not produce eggs (OIE, 2009)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris does not occur on this commodity if fish have been reared for at least two months in fullstrength seawater. Therefore, chilled, eviscerated fish that have been harvested from seawater with a salinity of
at least 25 ppt are eligible for inclusion in Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
169
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table VIII
Chilled fillets and steaks derived from fish that have been harvested from seawater with a
salinity of at least 25 ppt
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Skin is part of the commodity.
Gyrodactylus salaris is present on the
skin, fins and gills of fish living in
fresh water (Jensen & Johnsen,
1992). Infected fish transferred from
fresh water to seawater of 7.5 ppt or
higher become free of the parasite by
56 days after transfer (Soleng &
Bakke, 1997)
Yes
Potable fresh water is used to
process the product (WHO/FAO,
2009). The final product is
transported out of water, or on ice
made from potable water. In addition,
G. salaris is readily inactivated by
disinfectants (Mo TA, 2010, OIE
Reference Laboratory for
Gyrodactylosis, pers. comm.).
G. salaris does not produce eggs
(OIE, 2009)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris does not occur on this commodity. Therefore, chilled fillets and steaks derived from fish
that have been harvested from seawater with a salinity of at least 25 ppt are eligible for inclusion in Article 10.3.3.
point 1.
170
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table IX
Chilled fish products from which the skin, fins and gills have been removed
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of disease agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Gyrodactylus salaris is present on the
skin, fins and gills of fish living in fresh
water (Jensen & Johnsen, 1992).
G. salaris does not occur in this
commodity
Yes
Potable fresh water is used to process
the product (WHO/FAO, 2009).
The final product is transported out of
water, or on ice made from potable
water. In addition, G. salaris is readily
inactivated by disinfectants (Mo TA,
2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.).
G. salaris does not produce eggs
(OIE, 2009)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the disease agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris does not occur on this commodity. Therefore, chilled fish products from which the skin,
fins and gills are eligible for inclusion in Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
171
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table X
Fish roe
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Gyrodactylus salaris is present on the
skin, fins and gills of fish living in fresh
water (Jensen & Johnsen, 1992).
G. salaris does not occur in this
commodity
Yes
Potable fresh water is used to process
the product (WHO/FAO, 2009). The final
product is transported out of water. In
addition, G. salaris is readily inactivated
by disinfectants (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.). G. salaris does not
produce eggs (OIE, 2009)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the disease agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris does not occur on this commodity. Therefore, fish roe is eligible for inclusion in Article
10.3.3. point 1.
172
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table XI
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Fish oil is derived from whole fish or byproducts of processing. Skin, fins and gills
may be part of the commodity. G. salaris is
present on the skin, fins and gills of fish living
in fresh water (Jensen & Johnsen, 1992).
Infected fish transferred from fresh water to
seawater of 7.5 ppt or higher become free of
the parasite by 56 days after transfer (Soleng
& Bakke, 1997)
No (freshwater fish)
Yes
(marine
fish)
Non-potable fresh water may be used during
the process
No
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is
extremely low. Raw material is cooked (may
be pre-heated to 50–60°C before cooking at
temperatures of 95–100°C for 15–20 min).
For reasons of energy cost and nutritional
content, some processors use 80–85°C for
20 min. Cooked material is pressed to
produce press liquor and presscake that can
be dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to
90–95°C, which produces oil and stick-water.
Oil is purified with hot water (at 90°C). Stickwater is evaporated at ≥100°C (<130°C) and
the resulting fish solubles are added to the
presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce
water content to ≤12%. This is then milled to
whole fishmeal. Survival of G. salaris at high
water temperatures (greater than 25°C) has
not been studied systematically (OIE, 2009).
However, it is highly unlikely that the worm
will survive the temperatures used during this
process. In addition, G. salaris requires an
aqueous environment in order to survive (Mo
TA, 2010, OIE Reference Laboratory for
Gyrodactylosis, pers. comm.). Both fish oil
and fish meal have low water activity
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agentpathogenic agent
and the processing prevents cross
contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Assessments of the safety of aquatic animal commodities
173
Aquatic animal product assessments for infection with Gyrodactylus salaris
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, fish oil and fish meal are eligible for inclusion
in Article 10.3.3. point 1.
174
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table XII
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
This commodity is composed of skin with fins
removed. G. salaris is present on the skin, fins
and gills of fish living in fresh water (Jensen &
Johnsen, 1992). Infected fish transferred from
fresh water to seawater of 7.5 ppt or higher
become free of the parasite by 56 days after
transfer (Soleng & Bakke, 1997)
No (freshwater fish)
Yes (marine
fish)
Non-potable fresh water may be used to
process the leather but the final product is dry
and not transported in water
No
The final commodity is dry, and G. salaris
requires an aqueous environment in order to
survive (Mo TA, 2010, OIE Reference
Laboratory for Gyrodactylosis, pers. comm.).
Fish skin leather has low water activity
Yes
Skin is exposed to alkaline metal sulphide,
solvents, proteases, acid pH 1.5–4, chromium
or other tanning solutions and dyes. The final
leather product is usually pH <5. Each step
takes between 15 min and 24 h in a
commercial setting (Pocket Book for the
Leather Technologist 4th Ed.). G. salaris is
sensitive to acidic solutions. At pH 5.0, all
parasites were eliminated from living finfish
hosts by 9 days post-exposure (the water
temperature was 12°C) (Soleng et al., 1999)
Yes
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity is
derived, the treatment or processing to
produce the commodity to be traded
inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will be inactivated by this process. Therefore, fish skin leather is eligible for inclusion in
Article 10.3.3. point 1.
Assessments of the safety of aquatic animal commodities
175
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table XIII
Chilled, eviscerated fish harvested from seawater with a salinity of less than 7.5 ppt
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Skin, fins and gills may be part of the
commodity. G. salaris is present on
the skin, fins and gills of fish living in
fresh water (Jensen & Johnsen,
1992). Infected fish transferred from
fresh water to seawater of 7.5 ppt or
higher become free of the parasite by
56 days after transfer (Soleng &
Bakke, 1997)
No
Potable fresh water is used to
process the product (WHO/FAO,
2009). The final product is
transported out of water, or on ice
made from potable water. In addition,
G. salaris is readily inactivated by
disinfectants (Mo TA, 2010, OIE
Reference Laboratory for
Gyrodactylosis, pers. comm.).
G. salaris does not produce eggs
(OIE, 2009)
Yes
Fish are chilled and maintained at a
temperature approaching that of
melting ice (WHO/FAO,
2009). G. salaris may survive in
dechlorinated water at 3°C for
approximately 60 h, however viability
may be low. One of 14 G. salaris
worms kept in vitro for 24 h at 10°C
was able to reinfect a fish host
(Olstad et al., 2006)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will not be inactivated by this process. Therefore, chilled, eviscerated fish harvested from
seawater with a salinity of less than 7.5 ppt are not eligible for inclusion in Article 10.3.3. point 1.
176
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table XIV
Chilled fillets and steaks from fish harvested from seawater with a salinity of less than 7.5 ppt
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Skin is part of the commodity. G. salaris is
present on the skin, fins and gills of fish
living in fresh water (Jensen & Johnsen,
1992). Infected fish transferred from fresh
water to seawater of 7.5 ppt or higher
become free of the parasite by 56 days
after transfer (Soleng & Bakke, 1997)
No
Potable fresh water is used to process the
product (WHO/FAO, 2009). The final
product is transported out of water, or on
ice made from potable water. In addition,
G. salaris is readily inactivated by
disinfectants (Mo TA, 2010, OIE
Reference Laboratory for Gyrodactylosis,
pers. comm.). G. salaris does not produce
eggs (OIE, 2009)
Yes
Fish are chilled and maintained at a
temperature approaching that of melting
ice (WHO/FAO, 2009). G. salaris may
survive in dechlorinated water at 3°C for
approximately 60 h, however viability may
be low. One of 14 G. salaris worms kept
in vitro for 24 h at 10°C could reinfect a
fish host (Olstad et al., 2006)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Gyrodactylus salaris will not be inactivated by this process. Therefore, chilled fillets and steaks from
fish harvested from seawater with a salinity of less than 7.5 ppt are not eligible for inclusion in Article 10.3.3.
point 1.
Assessments of the safety of aquatic animal commodities
177
Aquatic animal product assessments for infection with Gyrodactylus salaris
B. Assessments using criteria in Article 5.4.2. (for Article 10.3.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) no products were identified.
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.
i) chilled, eviscerated fish harvested from water of less than 7.5 ppt (Table I)
ii) chilled fillets and steaks from fish harvested from water of less than 7.5 ppt (Table II).
Table I
Chilled, eviscerated fish harvested from seawater with a salinity of less than 7.5 ppt
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and
bones
No
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
G. salaris is found on the skin, fins and
gills (Jensen & Johnsen, 1992).
G. salaris may survive in dechlorinated
water at 3°C for approximately 60 h,
however viability may be low. One of 14
G. salaris worms kept in water (off the
host) for 24 h at 10°C reinfected a fish
host (Olstad et al., 2006). G. salaris is a
viviparous worm and one individual can
lead to a severe infestation (Peeler &
Thrush, 2004)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled, eviscerated fish that are prepared and packaged for retail trade for human consumption may produce
amounts of waste that cannot be considered small, and G. salaris may be found in the waste despite chilling.
Therefore, chilled, eviscerated fish harvested from seawater with a salinity of less than 7.5 ppt are not eligible
for inclusion in Article 10.3.11.
178
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Gyrodactylus salaris
Table II
Chilled fillets or steaks from fish harvested from seawater with a salinity of less than 7.5 ppt
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of
waste tissues generated by the
consumer
Waste may include skin and bones. G. salaris
is a viviparous worm and one individual can
lead to a severe infestation (Peeler &
Thrush, 2004)
Yes
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
G. salaris is found on the skin, fins and gills
(Jensen & Johnsen, 1992). G. salaris may
survive in dechlorinated water at 3°C for
approximately 60 hours, however viability may
be low. One of 14 G. salaris worms kept in
water (off the host) for 24 h at 10°C reinfected
a fish host (Olstad et al., 2006)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled fillets or steaks from fish harvested from seawater with a salinity of less than 7.5 ppt that are prepared
and packaged for retail trade for human consumption produce small amounts of waste, however one parasite
can result in a severe infestation if released inadvertently. Therefore, this product is not eligible for inclusion in
Article 10.3.11.
Assessments of the safety of aquatic animal commodities
179
Aquatic animal product assessments for infectious haematopoietic necrosis virus
4.
Aquatic animal product assessments for infectious hematopoietic
necrosis virus
A. Assessments using criteria in Article 5.4.1. (for Article 10.6.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised, hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to a heat treatment at 90°C for at
least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate IHNV) (Table II)
iii) mechanically dried, eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min
or any time/temperature equivalent that has been demonstrated to inactivate IHNV)
(Table III)
iv) fish oil and fish meal (Table IV)
v) fish skin leather (Table V).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) frozen, eviscerated fish (Table VI)
ii) frozen fish fillets or steaks (Table VII)
iii) chilled, eviscerated fish (Table VIII)
iv) chilled fish fillets or steaks (Table IX)
v) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table X).
180
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table I
Heat sterilised, hermetically sealed fish product
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, skin and fins may be present in the
commodity. IHNV is present in muscle,
heart, brain, gill, skin, skin mucus, fins,
pyloric caecae, intestines, kidney, spleen,
liver and stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra et
al., 1989, 1995; Yamamoto & Clermont,
1990; Yamamoto et al., 1990)
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). IHNV is heatsensitive under experimental conditions.
IHNV is inactivated within 10 min at 100°C
(Amend et al., 1969). IHNV was inactivated
within 30 seconds at 90°C (Traxler &
Richard, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus will be inactivated by this process. Therefore, heat sterilised,
hermetically sealed fish products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature
equivalent) are eligible for inclusion in Article 10.6.3. point 1.
Assessments of the safety of aquatic animal commodities
181
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Pasteurised fish products include
edible portions of the fish. IHNV is
present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and
stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra
et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et al.,
1990)
No
Pasteurisation involves heating at
90°C for 10 min (or equivalent) (FDA,
2001; Gould, 1999). Under
experimental conditions, IHNV is
inactivated within 30 seconds at 90°C
(as determined by bioassay) (Traxler
& Richard, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus will be inactivated by this process, and sealed pasteurised fish
products that have been subjected to heat treatment at 90°C for 10 min, or to any time/temperature equivalent
that has been demonstrated to inactivate IHNV, are eligible for inclusion in Article 10.6.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
182
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table III
Mechanically dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
Muscle, bones, head, gills, skin, and fins
may be part of the commodity. IHNV is
present in muscle, heart, brain, gill, skin, skin
mucus, fins, pyloric caecae, intestines,
kidney, spleen, liver and stomach (Brudeseth
et al., 2002; Engelking & Kaufman, 1994; La
Patra et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et al., 1990)
No
Mechanical drying involves heating at 100°C
for 30 min (or equivalent) (OECD, 2008).
Under experimental conditions, IHNV is
inactivated in 10 min at 100°C (Amend et al.,
1969). IHNV was inactivated within
30 seconds at 90°C (Traxler &
Richard, 2004)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus will be inactivated by this process. Therefore, mechanically dried,
eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min or any time/temperature equivalent that has
been demonstrated to inactivate IHNV) are eligible for inclusion in Article 10.6.3. point 1.
Assessments of the safety of aquatic animal commodities
183
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table IV
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Fish oil is derived from whole fish or by-products of
processing. IHNV is present in muscle, heart,
brain, gill, skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and stomach
(Brudeseth et al., 2002; Engelking & Kaufman,
1994; La Patra et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et al., 1990)
No
During production, fish oil and fish meal undergo
multiple heat treatments and the final water
content of the product is extremely low. Raw
material is cooked (may be pre-heated to 50–60°C
before cooking at temperatures of 95–100°C for
15–20 min). For reasons of energy cost and
nutritional content, some processors use 80–85°C
for 20 min). Cooked material is pressed to produce
press liquor and presscake that can be dried (75–
80°C, ≥30 min) and milled to presscake meal.
Press liquor is heated to 90–95°C, which produces
oil and stick-water. Oil is purified with hot water (at
90°C). Stick-water is evaporated at ≥100°C
(<130°C) and the resulting fish solubles are added
to the presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. Under experimental conditions, IHNV is
inactivated in 10 min at 100°C (Amend et al.,
1969). IHNV was inactivated within 30 seconds at
90°C (Traxler & Richard, 2004)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment
or processing to produce the commodity
to be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is inactivated by this process. Therefore, fish oil and fish meal are
eligible for inclusion in Article 10.6.3. point 1.
184
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table V
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
This commodity is composed of skin with
fins removed. IHNV is present in muscle,
heart, brain, gill, skin, skin mucus, fins,
pyloric caecae, intestines, kidney, spleen,
liver and stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra et
al., 1989, 1995; Yamamoto & Clermont,
1990; Yamamoto et al., 1990)
No
Skin is exposed to alkaline metal
sulphide, solvents, proteases, acid pH
1.5–4, chromium or other tanning
solutions and dyes. The final leather
product is usually pH <5. Each step takes
between 15 min and 24 h in a commercial
setting (Pocket Book for the Leather
Technologist 4th Ed.). IHNV is acid
sensitive (Pietsch et al., 1977). IHNV is
inactivated below pH 5.0 (time to
inactivation was not available)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is inactivated by this process and fish skin leather is therefore eligible
for inclusion in Article 10.6.3. point 1.
Assessments of the safety of aquatic animal commodities
185
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table VI
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Head, gills, muscle, skin, fins, bones and
gills may be part of the commodity. IHNV
is present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and
stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra et
al., 1989, 1995; Yamamoto & Clermont,
1990; Yamamoto et al., 1990)
No
Fish are frozen and maintained at a
temperature of –18°C or lower
(WHO/FAO, 2009). IHNV will survive in
fish frozen for seven months
(temperature not stated) (Amend et al.,
1969)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is unlikely to be inactivated by this process. Therefore, frozen,
eviscerated fish are not eligible for inclusion in Article 10.6.3. point 1.
186
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table VII
Frozen fish fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones and skin may be part of the
commodity. IHNV is present in muscle,
heart, brain, gill, skin, skin mucus, fins,
pyloric caecae, intestines, kidney, spleen,
liver and stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra et al.,
1989, 1995; Yamamoto & Clermont, 1990;
Yamamoto et al., 1990)
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). IHNV will survive in fish frozen for
seven months (temperature not stated)
(Amend et al., 1969)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is unlikely to be inactivated by this process. Therefore, frozen fish
fillets and steaks are not eligible for inclusion in Article 10.6.3. point 1.
Assessments of the safety of aquatic animal commodities
187
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table VIII
Chilled, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Head, gills, muscle, skin, fins, bones
and gills may be part of the
commodity. IHNV is present in
muscle, heart, brain, gill, skin, skin
mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and
stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La
Patra et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et
al., 1990)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Fish are chilled and maintained at a
temperature approaching that of
melting ice (WHO/FAO, 2009). IHNV
remains viable for about 36 weeks at
4°C (Amend et al., 1973). IHNV could
be isolated from fish stored on ice for
several days (Amend et al., 1969)
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is unlikely be inactivated by this process. Therefore, chilled
eviscerated fish are not eligible for inclusion in Article 10.6.3. point 1.
188
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table IX
Chilled fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones and skin may be part of the
commodity. IHNV is present in muscle,
heart, brain, gill, skin, skin mucus, fins,
pyloric caecae, intestines, kidney, spleen,
liver and stomach (Brudeseth et al., 2002;
Engelking & Kaufman, 1994; La Patra et
al., 1989, 1995; Yamamoto & Clermont,
1990; Yamamoto et al., 1990)
No
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). IHNV remains viable for
about 36 weeks at 4°C (Amend et al.,
1973). IHNV could be isolated from fish
stored on ice for several days (Amend et
al., 1969)
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is unlikely to be inactivated by this process. Therefore, chilled fish
fillets and steaks are not eligible for inclusion in Article 10.6.3. point 1.
Assessments of the safety of aquatic animal commodities
189
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table X
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones, head, gills, skin, and fins
may be part of the commodity.
IHNV is present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver, and
stomach (Brudeseth et al., 2002; Engelking
& Kaufman, 1994; La Patra et al., 1989,
1995; Yamamoto & Clermont, 1990;
Yamamoto et al., 1990)
No
Natural drying involves exposure to the sun
and/or wind (OECD, 2008). Typical air
temperatures are 25–30˚C for 1–3 days.
IHNV is heat sensitive; however, strong
evidence for inactivation under the above
time/temperature treatment is not available.
Under experimental conditions, IHNV was
inactivated within 12 h at 32°C (Amend et
al., 1973). IHNV was inactivated in 140 min
at 38°C and within 24 h at 32°C (Gosting &
Gould, 1981). IHNV was inactivated within
three days when stored at 25°C or 35°C
(Traxler & Richard, 2004)
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious hematopoietic necrosis virus is unlikely to be inactivated by this process. Therefore, naturally dried,
eviscerated fish are not eligible for inclusion in Article 10.6.3. point 1.
190
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
B. Assessments using criteria in Article 5.4.2. (for Article 10.6.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen fish fillets and steaks (Table I)
ii) chilled fish fillets and steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen, eviscerated fish (Table III)
ii) chilled, eviscerated fish (Table IV)
iii) naturally dried, eviscerated fish (Table V).
Table I
Frozen fish fillets and steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
CONCLUSION
Frozen fish fillets and steaks that are prepared and packaged for retail trade for human consumption produces
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.6.11.
Table II
Chilled fish fillets and steaks
Article 5.4.2. criteria.
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
CONCLUSION
Chilled fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.6.11.
Assessments of the safety of aquatic animal commodities
191
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table III
Frozen, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
IHNV is present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and stomach
(Brudeseth et al., 2002; Engelking &
Kaufman, 1994; La Patra et al., 1989, 1995;
Yamamoto & Clermont, 1990; Yamamoto et
al., 1990). IHNV will survive in fish frozen for
seven months (temperature not stated)
(Amend et al., 1969)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small and IHNV will not be inactivated by the process of freezing. Therefore, this
product is not considered to be eligible for inclusion in Article 10.6.11.
Table IV
Chilled, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of
waste tissues generated by the
consumer
Waste includes head, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
IHNV is present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver and stomach
(Brudeseth et al., 2002; Engelking & Kaufman,
1994; La Patra et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et al., 1990). IHNV
remains viable for about 36 weeks at 4°C
(Amend et al., 1973). IHNV could be isolated
from fish stored on ice for several days (Amend
et al., 1969)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small and IHNV will not be inactivated by the process of chilling. Therefore, this
product is not considered to be eligible for inclusion in Article 10.6.11.
192
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infectious haematopoietic necrosis virus
Table V
Naturally dried, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of
waste tissues
Waste includes head, gills, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues
IHNV is present in muscle, heart, brain, gill,
skin, skin mucus, fins, pyloric caecae,
intestines, kidney, spleen, liver, and stomach
(Brudeseth et al., 2002; Engelking & Kaufman,
1994; La Patra et al., 1989, 1995; Yamamoto &
Clermont, 1990; Yamamoto et al., 1990).
Natural drying involves exposure to the sun
and/or wind (OECD, 2008). Typical air
temperatures are 25–30°C for 1–3 days. IHNV
is heat-sensitive; however, strong evidence for
inactivation under the above time/temperature
treatment is not available. Under experimental
conditions, IHNV was inactivated within 12 h at
32°C (Amend et al., 1973). IHNV was
inactivated in 140 min at 38°C and within 24 h
at 32°C (Gosting & Gould, 1981). IHNV was
inactivated within 3 days when stored at 25°C
or 35°C (Traxler & Richard, 2004)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Naturally dried, eviscerated fish that are prepared and packaged for retail trade for human consumption
produce amounts of waste that are not small, and IHNV is unlikely to be inactivated by the process of natural
drying. Therefore, this product is not eligible for inclusion in Article 10.6.11.
Assessments of the safety of aquatic animal commodities
193
Aquatic animal product assessments for infection with infectious salmon anaemia virus
5.
Aquatic animal product assessments for infection with infectious
salmon anaemia virus
A. Assessments using criteria in Article 5.4.1. (for Article 10.4.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised, hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to a heat treatment at 90°C for at
least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate ISAV) (Table II)
iii) mechanically dried, eviscerated fish (i.e. a heat treatment at 100°C for 30 min or any
time/temperature equivalent that has been demonstrated to inactivate ISAV) (Table III)
iv) fish oil (Table IV)
v) fish meal (Table IV)
vi) fish skin leather (Table V).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table VI)
ii) frozen, eviscerated fish (Table VII)
iii) frozen fish fillets or steaks (Table VIII)
iv) chilled, eviscerated fish (Table IX)
v) chilled fish fillets or steaks (Table X).
194
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table I
Heat sterilised, hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from
which the commodity is derived
Muscle, skin, fins and bones may be
present in the commodity. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and
therefore will be present in many tissues
(Byrne et al., 1998; Hovland et al., 1994;
Nylund et al., 1996)
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999, 2002). ISAV is heatsensitive under experimental conditions.
ISAV is inactivated within 5 min at 56°C
(Falk et al., 1997). ISAV is inactivated
within 1 min at 60°C (Torgersen, 1998)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the
processing prevents cross contamination of
the commodity to be traded
OR
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus will be inactivated by this process. Therefore, heat sterilised, hermetically
sealed fish products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are
eligible for inclusion in Article 10.4.3. point 1.
Assessments of the safety of aquatic animal commodities
195
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Pasteurised fish products include edible
portions of the fish. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and
therefore will be present in many tissues
(Byrne et al., 1998; Hovland et al., 1994;
Nylund et al., 1996)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at 90°C
for 10 min (or equivalent) (FDA, 2001;
Gould, 1999). ISAV is inactivated within
5 min at 56°C (Falk et al., 1997). ISAV is
inactivated within 1 min at 60°C
(Torgersen, 1998)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus will be inactivated by this process. Therefore, pasteurised fish products that
have been subjected to heat treatment at 90°C for 10 min or to any temperature/time equivalent that has been
demonstrated to inactivate ISAV are eligible for inclusion in Article 10.4.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
196
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table III
Mechanically dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones, head, gills, skin, and fins
may be part of the commodity. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and therefore
will be present in many tissues (Byrne et
al., 1998; Hovland et al., 1994; Nylund et
al., 1996)
No
Mechanical drying involves heating at
100°C for 30 min (or equivalent) (OECD,
2008). ISAV is inactivated within 5 min at
56°C (Falk et al., 1997). ISAV is inactivated
within 1 min at 60°C (Torgersen, 1998)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus will be inactivated by this process. Therefore, mechanically dried, eviscerated
fish (i.e. a heat treatment at 100°C for at least 30 min or any time/temperature equivalent that has been
demonstrated to inactivate ISAV) are eligible for inclusion in Article 10.4.3. point 1.
Assessments of the safety of aquatic animal commodities
197
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table IV
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Fish oil is derived from whole fish or byproducts of processing. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and therefore
will be present in many tissues (Byrne et al.,
1998; Hovland et al., 1994; Nylund et al.,
1996)
No
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is
extremely low. Raw material is cooked (may
be pre-heated to 50–60°C before cooking at
temperatures of 95–100°C for 15–20 min).
For reasons of energy cost and nutritional
content, some processors use 80–85°C for
20 min. Cooked material is pressed to
produce press liquor and presscake that can
be dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to
90–95°C, which produces oil and stickwater. Oil is purified with hot water (at
90°C). Stick-water is evaporated at ≥100°C
(<130°C) and the resulting fish solubles are
added to the presscake. Presscake and fish
soluble mix is dried at 75–80°C for ≥30 min
to reduce water content to ≤12%. This is
then milled to whole fishmeal. ISAV is
inactivated within 5 min at 56°C (Falk et al.,
1997)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus will be inactivated by this process. Therefore, fish oil and fish meal are eligible
for inclusion in Article 10.4.3. point 1.
198
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table V
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
This commodity is composed of skin with fins
removed. ISAV infects endocardial cells,
endothelial cells, leucocytes and erythrocytes,
and therefore will be present in many tissues
(Byrne et al., 1998; Hovland et al., 1994;
Nylund et al., 1996)
No
Skin is exposed to alkaline metal sulphide,
solvents, proteases, acid pH 1.5–4, chromium
or other tanning solutions and dyes. The final
leather product is usually pH <5. Each step
takes between 15 min and 24 h in a
commercial setting (Pocket Book for the
Leather Technologist 4th Ed.). At pH <4.0,
ISAV is inactivated within 30 min (Falk et al.,
1997; Torgersen, 1998)
Yes
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce
the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus will be inactivated by this process. Therefore, fish skin leather is eligible for
inclusion in Article 10.4.3. point 1.
Assessments of the safety of aquatic animal commodities
199
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table VI
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which the
commodity is derived
Muscle, bones, head, gills, skin, and
fins may be part of the commodity.
ISAV infects endocardial cells,
endothelial cells, leucocytes and
erythrocytes, and therefore will be
present in many tissues (Byrne et al.,
1998; Hovland et al., 1994; Nylund et
al., 1996)
No
Natural drying involves exposure to
the sun and/or wind (OECD, 2008).
Typical air temperatures are 25–30°C
for 1–3 days. Under experimental
conditions, ISAV was not inactivated
when exposed to 37°C for two days
(Falk et al., 1997). The response of
ISAV to dessication is unknown
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus is unlikely to be inactivated by this process. Therefore, naturally dried,
eviscerated fish are not eligible for inclusion in Article 10.4.3. point 1.
200
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table VII
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Head, gills, muscle, skin, fins, bones and
gills may be part of the commodity. ISAV
infects endocardial cells, endothelial cells,
leucocytes and erythrocytes, and therefore
will be present in many tissues (Byrne et
al., 1998; Hovland et al., 1994; Nylund et
al., 1996)
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). No data are available; however, five
cycles of freezing (–80°C) and thawing
(20°C) (time period not stated) did not
reduce infectivity (Falk et al., 1997)
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus is unlikely to be inactivated by this process. Therefore, frozen, eviscerated
fish are not eligible for inclusion in Article 10.4.3. point 1.
Assessments of the safety of aquatic animal commodities
201
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table VIII
Frozen fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones and skin may be part of the
commodity. ISAV infects endocardial cells,
endothelial cells, leucocytes and
erythrocytes, and therefore will be present in
many tissues (Byrne et al., 1998; Hovland et
al., 1994; Nylund et al., 1996)
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). No data are available; however, five
cycles of freezing (–80°C) and thawing
(20°C) (time period not stated) did not reduce
infectivity (Falk et al., 1997)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus is unlikely to be inactivated by this process. Therefore, frozen fish fillets and
steaks are not eligible for inclusion in Article 10.4.3. point 1.
202
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table IX
Chilled, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Head, gills, muscle, skin, fins, bones and gills
may be part of the commodity. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and therefore
will be present in many tissues (Byrne et al.,
1998; Hovland et al., 1994; Nylund et al.,
1996)
No
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). ISAV was not inactivated
when stored at 4°C for two weeks (Falk et al.,
1997). ISAV was not inactivated in fish
tissues stored on ice for six days (Torgersen,
1998)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus is unlikely to be inactivated by this process. Therefore, chilled, eviscerated
fish are not eligible for inclusion in Article 10.4.3. point 1.
Assessments of the safety of aquatic animal commodities
203
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table X
Chilled fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent
is not present in the tissues from which the
commodity is derived
Muscle, bones and skin may be part
of the commodity. ISAV infects
endocardial cells, endothelial cells,
leucocytes and erythrocytes, and
therefore will be present in many
tissues (Byrne et al., 1998; Hovland
et al., 1994; Nylund et al., 1996)
No
Fish are chilled and maintained at a
temperature approaching that of
melting ice (WHO/FAO, 2009). ISAV
was not inactivated when stored at
4°C for two weeks (Falk et al., 1997).
ISAV was not inactivated in fish
tissues stored on ice for 6 days
(Torgersen, 1998)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated with
the pathogenic agent and the processing prevents
cross contamination of the commodity to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Infectious salmon anaemia virus is unlikely to be inactivated by this process. Therefore, chilled fish fillets and
steaks are not eligible for inclusion in Article 10.4.3. point 1.
204
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
B. Assessments using criteria in Article 5.4.2. (for Article 10.4.15.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen fish fillets and steaks (Table I)
ii) chilled fish fillets and steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) frozen, eviscerated fish (Table III)
ii) chilled, eviscerated fish (Table IV)
iii) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table V).
Table I
Frozen fish fillets or steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Frozen fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.4.15.
Table II
Chilled fish fillets or steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found in
the waste tissues generated by the consumer
CONCLUSION
Chilled fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.4.15.
Assessments of the safety of aquatic animal commodities
205
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table III
Frozen, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and
bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
ISAV infects endocardial cells,
endothelial cells, leucocytes and
erythrocytes, and therefore will be
present in many tissues (Byrne et al.,
1998; Hovland et al., 1994; Nylund et al.,
1996). No specific data are available;
however, five cycles of freezing at –80°C
and thawing at 20°C (time period not
stated) did not reduce infectivity (Falk et
al., 1997)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small, and ISAV is unlikely to be inactivated by freezing. Therefore, this product
is not eligible for inclusion in Article 10.4.15.
Table IV
Chilled, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and
bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
ISAV infects endocardial cells,
endothelial cells, leucocytes and
erythrocytes, and therefore will be
present in many tissues (Byrne et al.,
1998; Hovland et al., 1994; Nylund et al.,
1996). ISAV was not inactivated when
stored at 4°C for 2 weeks (Falk et al.,
1997). ISAV was not inactivated in fish
tissues stored on ice for 6 days
(Torgersen, 1998)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small, and ISAV is unlikely to be inactivated by chilling. Therefore, this product is
not eligible for inclusion in Article 10.4.15.
206
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with infectious salmon anaemia virus
Table V
Naturally dried, eviscerated fish (including sun-dried)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste may include the head, skin, fins and
bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
Natural drying involves exposure to the sun
and/or wind (OECD, 2008). Typical air
temperatures are 25–30°C for 1–3 days.
ISAV infects endocardial cells, endothelial
cells, leucocytes and erythrocytes, and
therefore will be present in many tissues
(Byrne et al., 1998; Hovland et al., 1994;
Nylund et al., 1996). ISAV could still be
isolated 2 days after exposure to 37°C
(Falk et al., 1997)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Naturally dried, eviscerated fish that are prepared and packaged for retail trade for human consumption
produce amounts of waste that cannot be considered small, and the process is unlikely to inactivate ISAV.
Therefore, this product is not considered to be eligible for inclusion in Article 10.4.15.
Assessments of the safety of aquatic animal commodities
207
Aquatic animal product assessments for Koi herpesvirus disease
6.
Aquatic animal product assessments for koi herpesvirus
A. Assessments using criteria in Article 5.4.1. (for Article 10.7.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised hermetically sealed fish products (i.e. a heat treatment at 121°C for
at least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to heat treatment at 90°C for at
least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate KHV) (Table II)
iii) mechanically dried eviscerated fish (i.e. a heat treatment at 100°C for at least
30 min or any time/temperature equivalent that has been demonstrated to
inactivate KHV) (Table III)
iv) fish oil and fish meal (Table IV).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table V)
ii) frozen, eviscerated fish (Table VI)
iii) frozen fish fillets or steaks (Table VII)
iv) chilled, eviscerated fish (Table VIII)
v) chilled fish fillets or steaks (Table IX).
3. The following aquatic animal products were not assessed because they are not believed
to be traded internationally:
i) fish skin leather.
208
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table I
Heat sterilised hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, skin and fins may be present in the
commodity. KHV has been detected in skin
mucus, gill, liver, gut, kidney, spleen and
brain (Gilad et al., 2004)
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min). Under
experimental conditions, KHV was
inactivated at 50°C for 3 min and at 60°C
for 0.5 min (Kasai et al., 2005)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Koi herpesvirus will be inactivated by this process. Therefore, heat sterilised hermetically sealed fish products
(i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are eligible for inclusion
in Article 10.7.3. point 1.
Assessments of the safety of aquatic animal commodities
209
Aquatic animal product assessments for Koi herpesvirus disease
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Pasteurised fish products include edible
portions of the fish. KHV has been
detected in skin mucus, gill, liver, gut,
kidney, spleen and brain (Gilad et al.,
2004). Muscle tissue has not been
studied systematically.
No
Pasteurisation involves heating at
90°C for 10 min (or time/temperature
equivalent) (FDA, 2001; Gould, 1999).
Under experimental conditions, KHV was
inactivated at 50°C for 3 min and at 60°C
for 0.5 min (Kasai et al., 2005)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Koi herpesvirus will be inactivated by this process. Therefore, pasteurised fish products that have been
subjected to heat treatment at 90°C for 10 minutes, or to any time/temperature equivalent that has been
demonstrated to inactivate KHV, are eligible for inclusion in Article 10.7.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
210
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table III
Mechanically dried eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Muscle, bones, head, gills, skin and fins
may be part of the commodity.
KHV has been detected in skin mucus,
gill, liver, gut, kidney, spleen and brain
(Gilad et al., 2004). Muscle tissue has
not been studied systematically
No
Mechanical drying involves heating at
100°C for 30 min (or equivalent)
(OECD, 2008). Under experimental
conditions, KHV was inactivated at
50°C for 3 min and at 60°C for 0.5 min
(Kasai et al., 2005)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Koi herpesvirus will be inactivated by this process. Therefore, mechanically dried eviscerated fish (i.e. a heat
treatment at 100°C for at least 30 min or any time/temperature equivalent that has been shown to inactivate
KHV) are eligible for inclusion in Article 10.7.3. point 1.
Assessments of the safety of aquatic animal commodities
211
Aquatic animal product assessments for Koi herpesvirus disease
Table IV
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Fish oil and fish meal are derived from whole
fish or by-products of processing. KHV has been
detected in skin mucus, gill, liver, gut, kidney,
spleen and brain (Gilad et al., 2004). Muscle
tissue has not been studied systematically
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
During production, fish oil and fish meal undergo
multiple heat treatments and the final water
content of the product is extremely low. Raw
material is cooked (may be pre-heated to 50–
60°C before cooking at temperatures of 95–
100°C for 15–20 min. For energy cost reasons
and nutritional content, some processors use
80–85°C for 20 min. Cooked material is pressed
to produce press liquor and presscake that can
be dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to 90–
95°C, which produces oil and stick-water. Oil is
purified with hot water (at 90°C). Stick-water is
evaporated at ≥100°C (<130°C) and the
resulting fish solubles are added to the
presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. Under experimental conditions, KHV
was inactivated at 50°C for 3 min and at 60°C
for 0.5 min (Kasai et al., 2005)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Koi herpesvirus will be inactivated by this process. Therefore, fish meal and fish oil are eligible for inclusion in
Article 10.7.3. point 1.
212
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table V
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Muscle, bones, head, gills, skin and fins
may be part of the commodity. KHV has
been detected in skin mucus, gill, liver,
gut, kidney, spleen and brain (Gilad et al.,
2004). Muscle tissue has not been
studied systematically
No
Natural drying involves exposure to the sun
and/or wind (OECD, 2008). Typical air
temperatures are 25–30°C for 1–3 days.
Under experimental conditions, KHV was
detected in untreated fresh water samples
stored at 25°C for 1 day but not by 3 days.
The response of KHV to dessication is
unknown (Shimizu et al., 2006)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Koi herpesvirus is unlikely to be inactivated by this process. Therefore, naturally dried, eviscerated fish are not
eligible for inclusion in Article 10.7.3. point 1.
Assessments of the safety of aquatic animal commodities
213
Aquatic animal product assessments for Koi herpesvirus disease
Table VI
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Head, gills, muscle, skin, fins, bones and
gills may be part of the commodity. KHV
has been detected in skin mucus, gill,
liver, gut, kidney, spleen and brain (Gilad
et al., 2004). Muscle tissue has not been
studied systematically
No
Fish are frozen and maintained at a
temperature of –18°C or lower
(WHO/FAO, 2009). Response of KHV to
freezing has not been studied
systematically
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is not enough information to assess whether koi herpesvirus is inactivated by this process. Therefore,
frozen, eviscerated fish are not eligible for inclusion in Article 10.7.3. point 1.
214
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table VII
Frozen fish fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones and skin may be part of the
commodity. KHV has been detected in skin
mucus, gill, liver, gut, kidney, spleen and
brain (Gilad et al., 2004). Muscle tissue has
not been studied systematically
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). Response of KHV to freezing has
not been studied systematically
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is not enough information to assess whether koi herpesvirus is inactivated by this process. Therefore,
frozen, fish fillets and steaks are not eligible for inclusion in Article 10.7.3. point 1.
Assessments of the safety of aquatic animal commodities
215
Aquatic animal product assessments for Koi herpesvirus disease
Table VIII
Chilled, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Head, gills, muscle, skin, fins, bones and
gills may be part of the commodity.
KHV has been detected in skin mucus,
gill, liver, gut, kidney, spleen and brain
(Gilad et al., 2004). Muscle tissue has not
been studied systematically.
No
Fish are chilled and maintained at a
temperature approaching that of melting
ice (WHO/FAO, 2009). Response of KHV
to refrigeration has not been studied
systematically
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is not enough information to assess whether koi herpesvirus is inactivated by this process. Therefore,
chilled, eviscerated fish are not eligible for inclusion in Article 10.7.3. point 1.
216
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table IX
Chilled fish fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Muscle, bones and skin may be part of
the commodity. KHV has been detected
in skin mucus, gill, liver, gut, kidney,
spleen and brain (Gilad et al., 2004).
Muscle tissue has not been studied
systematically
No
Fish are chilled and maintained at a
temperature approaching that of melting
ice (WHO/FAO, 2009). Response of KHV
to refrigeration has not been studied
systematically
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is not enough information to assess whether koi herpesvirus is inactivated by this process. Therefore,
chilled fish fillets and steaks are not eligible for inclusion in Article 10.7.3. point 1.
Assessments of the safety of aquatic animal commodities
217
Aquatic animal product assessments for Koi herpesvirus disease
B. Assessments for criteria in Article 5.4.2. (for Article 10.7.11. point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) chilled fish fillets or steaks (Table I)
ii) frozen fish fillets or steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) chilled eviscerated fish (Table III)
ii) frozen eviscerated fish (Table IV)
iii) naturally dried, eviscerated fish (Table V).
Table I
Chilled fish fillets or steaks
Article 5.4.2. criteria
1.
Rationale
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Assessment
It is part of the commodity definition
Yes
Waste includes skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
CONCLUSION
Chilled fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.7.11.
Table II
Frozen fish fillets or steaks
Article 5.4.2. criteria
1.
Rationale
The aquatic animal product is prepared and
packaged for retail trade for human consumption
Assessment
It is part of the commodity definition
Yes
Waste includes skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste tissues
generated by the consumer
OR
3.
The pathogenic agent is not normally found in the
waste tissues generated by the consumer
CONCLUSION
Frozen fish fillets and steaks that are prepared and packaged for retail trade for human consumption produces
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.7.11.
218
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for Koi herpesvirus disease
Table III
Chilled eviscerated fish
Article 5.4.2. criteria
1.
Rationale
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and
bones
No
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
KHV has been detected in skin mucus,
gill, liver, gut, kidney, spleen and brain
(Gilad et al., 2004). There is no specific
information about survival of KHV at
refrigeration temperatures
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small. It is unknown whether koi herpesvirus will be inactivated by freezing.
Therefore, this product is not eligible for inclusion in Article 10.7.11.
Table IV
Frozen eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
KHV has been detected in skin mucus, gill,
liver, gut, kidney, spleen and brain (Gilad et
al., 2004). There is no specific information
about survival of KHV at temperatures
below 0°C
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that are not small. It is unknown whether koi herpesvirus will be inactivated by freezing.
Therefore, this product is not eligible for inclusion in Article 10.7.11.
Assessments of the safety of aquatic animal commodities
219
Aquatic animal product assessments for Koi herpesvirus disease
Table V
Naturally dried eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, bones, fins and skin
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
KHV has been detected in skin mucus, gill,
liver, gut, kidney, spleen and brain (Gilad et
al., 2004). Under experimental conditions,
KHV was detected in untreated fresh water
samples stored at 25°C for one day but not
by three days. The response of KHV to
dessication is unknown (Shimizu et al., 2006)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Naturally dried eviscerated fish that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste
tissues and there is no information on the likelihood of inactivation of koi herpesvirus during natural drying.
Therefore, this product is not eligible for inclusion in Article 10.7.11.
220
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for red sea bream iridovirus
7.
Aquatic animal product assessments for red sea bream iridovirus
A. Assessments using Criteria in Article 5.4.1. (for Article 10.8.3.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.1:
i) heat sterilised hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to heat treatment at 90°C for
10 min (or any time/temperature equivalent that has been demonstrated to inactivate
RSIV) (Table II)
iii) mechanically dried eviscerated fish (i.e. a heat treatment at 100°C for 30 min or any
time/temperature equivalent that has been demonstrated to inactivate RSIV) (Table III)
iv) fish skin leather (Table IV)
v) fish oil (Table V)
vi) fish meal (Table V).
Assessments of the safety of aquatic animal commodities
221
Aquatic animal product assessments for red sea bream iridovirus
Table I
Heat sterilised hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Red sea bream iridovirus (RSIV) occurs in
multiple tissues in infected fish. RSIV DNA
has been detected in muscle tissue (Choi et
al., 2006) and characteristic basophilic
inclusion bodies reported in muscle (Jung et
al., 1997), but the viability of the pathogen
is unknown
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
NA
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
Commercial canning involves time
temperature treatments of 121°C for 3.6
minutes, or equivalent e.g. 111°C for 36 min
(Ababouch, 1999, 2002) RSIV is inactivated
after 30 min at 56°C (Nakajima &
Sorimachi, 1994)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Red sea bream iridovirus will be inactivated by this process. Therefore, heat sterilised hermetically sealed fish
products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are eligible for
inclusion in Article 10.8.3. point 1.
222
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for red sea bream iridovirus
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
RSIV DNA has been detected in muscle
tissue (Choi et al., 2006) and
characteristic basophilic inclusion bodies
reported in muscle (Jung et al., 1997), but
viability of the pathogen is unknown
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at 90°C
for 10 min (or equivalent) (FDA; 2001;
Gould; 1999). This is equivalent to 52 min
at 85°C (FDA, 2001), RSIV is inactivated
after 30 min at 56°C (Nakajima &
Sorimachi, 1994)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Red sea bream iridovirus will be inactivated by this process. Therefore, pasteurised fish products that have
been subjected to heat treatment at 90°C for 10 min or to any time/temperature equivalent that has been
demonstrated to inactivate RSIV are eligible for inclusion in Article 10.8.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic
animal products. There are a number of time/temperature combinations that may be used depending on the product.
Officially specified conditions will tend to be determined by the requirement to inactivate bacteria of concern to food safety.
As such both the United States of America Food and Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C
for 10 min is required to achieve a 6D reduction in Clostridium botulinum. Inactivation standards for Listeria monocytogenes
are considerably lower. It is proposed therefore, that in the first instance a standard of 90°C, 10 min is used. Where possible,
minimum time/temperature conditions sufficient to inactivate the pathogen of concern will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
223
Aquatic animal product assessments for red sea bream iridovirus
Table III
Mechanically dried eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
RSIV occurs in multiple tissues in
infected fish
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
Temperatures for mechanical drying are in
excess of 100°C for 30 min. RSIV is
inactivated after 30 min at 56°C (Nakajima
& Sorimachi, 1994)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Red sea bream iridovirus will be inactivated by this process. Therefore, mechanically dried eviscerated fish (i.e.
a heat treatment at 100°C for 30 min or any time/temperature equivalent that has been demonstrated to
inactivate RSIV) are eligible for inclusion in Article 10.8.3. point 1.
224
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for red sea bream iridovirus
Table IV
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
No evidence that the virus is present in
the skin. One study reported no
histopthological changes characteristic
of RSIV infection in skin (Jung et
al., 1997)
Yes
Water is used to process the leather but
the final product is dry and not
transported in water
Yes
Skin is exposed to alkaline metal
sulphide, solvents, proteases, acid pH
1.5–4, chromium or other tanning
solutions and dyes. The final leather
product is usually pH <5. Each step
takes between 15 min and 24 h in a
commercial setting (Pocket Book for
the Leather Technologist
4th Ed.). Nakajima & Sorimachi
(1994) report that RSIV is sensitive to
pH 3. Similarly, pH <4 or >12 for 1 hour
will inactivate another iridovirus in fish
(epizootic haematopoietic necrosis
virus, EHNV; Langdon ,1989)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Even if RSIV was present in the skin, it would be inactivated by this process. Therefore, fish skin leather is
eligible for inclusion in Article 10.8.3. point 1.
Assessments of the safety of aquatic animal commodities
225
Aquatic animal product assessments for red sea bream iridovirus
Table V
Fish oil and fish meal
Article 5.4.1. criteria
1.
Absence of pathogenic agent in the
traded commodity:
1a.
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
Rationale
Assessment
RSIV occurs in multiple tissues in infected fish.
Fish oil is derived from whole fish or by-products
of processing
No
If the fish are infected the water is likely to be
contaminated
No
AND
1b.
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity is
derived, the treatment or processing
to produce the commodity to be
traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
During production, fish oil and fish meal undergo
multiple heat treatments and the final water
content of the product is extremely low. Raw
material is cooked (may be pre-heated to 50–
60°C before cooking at temperatures of 95–
100°C for 15-20 min). For reasons of energy cost
and nutritional content, some processors use 80–
85°C for 20 min). Cooked material is pressed to
produce press liquor and presscake that can be
dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to 90–
95°C, which produces oil and stick-water. Oil is
purified with hot water (at 90°C). Stick-water is
evaporated at ≥100°C (<130°C) and the
resulting fish solubles are added to the
presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. RSIV is inactivated after 30 min at 56°C
(Nakajima & Sorimachi, 1994)
AND/OR
b) Chemical (e.g. iodine, pH, salt,
smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Red sea bream iridovirus will be inactivated by this process. Therefore, fish oil and fish meal are eligible for
inclusion in Article 10.8.3. point 1.
226
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for red sea bream iridovirus
B. Assessments using Criteria in Article 5.4.2. (for Article 10.8.11.
point 1)
1. The following aquatic animal products did meet the criteria in Article 5.4.2
i) fillets or steaks (chilled or frozen) (Table I).
2. The following aquatic animal products did not meet the criteria in Article 5.4.2.:
i) eviscerated fish (chilled or frozen) (Table II)
ii) naturally dried eviscerated fish (including air-dried, flame-dried and sun-dried)
(Table III).
Table I
Fillets or steaks (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the commodity definition
AND/EITHER
2.
It includes only a small amount of
waste tissues generated by the
consumer
Waste may include skin and pin bones. Of
these, only skin is likely to be of relatively large
proportion compared with commodity volume
Yes
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
Cells containing characteristic basophilic
inclusion bodies are found in bone but not skin
(Jung et al., 1997). Bone waste can be
characterized as a relatively small proportion of
the commodity
No
OR
3.
CONCLUSION
Fillets or steaks (chilled or frozen) that are prepared and packaged for retail trade for human consumption
produce only small amounts of waste. Therefore, these products are eligible for inclusion in Article 10.8.11. for
red sea bream iridovirus.
Assessments of the safety of aquatic animal commodities
227
Aquatic animal product assessments for red sea bream iridovirus
Table II
Eviscerated fish (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for
human consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of
waste tissues generated by the
consumer
Waste includes head, backbone and skin
No
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer.
RSIV is reported in gill (Choi et al., 2006; Jung
et al., 1997), eyes and meninges (Jung et al.,
1997). Nakajima & Sorimachi (1994) report
RSIV to be stable to repeated freezing and
thawing. Largemouth bass iridovirus is reported
to be stable at –10°C (Plumb & Zilberg, 1999)
and tiger salamander iridovirus remains viable
for 7 months at –20°C (Bollinger et al., 1999)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Eviscerated fish (chilled or frozen) that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste
(skin and gills). Therefore, these products are not eligible for inclusion in Article 10.8.11. for RSIV.
Table III
Naturally dried eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, backbone and skin
No
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
RSIV is reported from gill (Choi et al., 2006;
Jung et al., 1997), eyes and meninges (Jung
et al., 1997)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Naturally dried eviscerated fish that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste
tissues. Therefore, this product is not eligible for inclusion in Article 10.8.11. for RSIV.
228
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for spring viraemia of carp
8.
Aquatic animal product assessment for spring viraemia of carp
A. Assessments using criteria in Article 5.4.1. (for Article 10.9.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised hermetically sealed fish products ( at 121°C for at least 3.6 min or
equivalent) (Table I)
ii) pasteurised fish products that have been subjected to heat treatment at 90°C for at
least 10 min (or any time/temperature equivalent that has been demonstrated to
inactivate SVCV) (Table II)
iii) mechanically dried eviscerated fish (i.e. heat treatment of 100°C for at least 30 min or
any time/temperature equivalent that has been demonstrated to inactivate SVCV)
(Table III)
iv) fish oil (Table IV)
v) fish meal (Table IV).
2. The following aquatic animal products were not assessed because they are not believed
to be traded internationally:
i) fish skin leather.
Assessments of the safety of aquatic animal commodities
229
Aquatic animal product assessments for spring viraemia of carp
Table I
Heat sterilised hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
High titres of spring viraemia of carp virus
(SVCV) occur in the liver and kidney of infected
fish, but much lower titres occur in the spleen,
gills and brain (Faisal & Ahne, 1984; Fijan et
al., 1971)
No
AND
b) The water (including ice) used to
process or transport the commodity is
not contaminated with the pathogenic
agent and the processing prevents
cross contamination of the commodity
to be traded
NA
OR
2.
Even if the pathogenic agent is
present in, or contaminates, the
tissues from which the commodity is
derived, the treatment or processing to
produce the commodity to be traded
inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min) (Ababouch,
1999, 2002). Information on the heat sensitivity
of SVCV is lacking. However, other
rhabdoviruses such as VHSVand IHNV have
been demonstrated to be heat sensitive under
experimental conditions. VHSV is inactivated
within 1 min at 90°C and IHNV within
30 seconds at 90°C (Traxler & Richard, 2004)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Spring viraemia of carp will be inactivated by this process. Therefore, heat sterilised hermetically sealed fish
products (i.e. a heat treatment at 121°C for at least 3.6 min or equivalent) are eligible for inclusion in Article
10.9.3. point 1.
230
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for spring viraemia of carp
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic agent is
not present in the tissues from which the commodity
is derived
High titres of SVCV occur in the
liver and kidney of infected fish,
but much lower titres occur in the
spleen, gills and brain (Faisal &
Ahne, 1984; Fijan et al., 1971)
No
AND
b) The water (including ice) used to process or transport
the commodity is not contaminated with the
pathogenic agent and the processing prevents cross
contamination of the commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or processing
to produce the commodity to be traded inactivates
the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Pasteurisation involves heating at
90°C for 10 min (FDA, 2001;
Gould, 1999). Information on the
heat sensitivity of SVCV is
lacking. However, other
rhabdoviruses such as VHS and
IHN have been demonstrated to
be heat sensitive under
experimental conditions. VHSV is
inactivated within 1 min at 90°C
and IHNV within 30 seconds at
90°C (Traxler & Richard, 2004)
No
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Spring viraemia of carp virus is highly likely to be inactivated by this treatment. Therefore, pasteurised fish
products that have been subjected to heat treatment at 90°C for 10 minutes, or any equivalent that has been
demonstrated to inactivate SVCV, are eligible for inclusion in Article 10.9.3. point 1
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
231
Aquatic animal product assessments for spring viraemia of carp
Table III
Mechanically dried eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
SVC virus can be present in gills and
brain (Faisal & Ahne, 1984; Fijan et
al., 1971)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
Water is used to process the product but
water is absent from the end product
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Artificial drying involves heating at 100°C
for 30 min (or equivelant). Information on
the heat sensitivity of SVCV is lacking.
However, other rhabdoviruses such as
VHS and IHN have been demonstrated to
be heat sensitive under experimental
conditions. VHSV is inactivated within
1 min at 90°C and IHNV within
30 seconds at 90°C (Traxler &
Richard, 2004)
Yes
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Spring viraemia of carp virus will be inactivated by this process. Therefore, mechanically dried eviscerated fish
(i.e. a heat treatment at 100°C for at least 30 min or equivalent) are eligible for inclusion in Article 10.9.3.
point 1.
232
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for spring viraemia of carp
Table IV
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
High titres of SVCV occur in the liver and
kidney of infected fish, but much lower
titres occur in the spleen, gills and brain
(Faisal & Ahne, 1984; Fijan et al., 1971).
Fish oil is derived from whole fish or byproducts of processing
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
NA
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
Assessments of the safety of aquatic animal commodities
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is
extremely low. Raw material is cooked
(may be pre-heated to 50–60°C before
cooking at temperatures of 95–100°C for
15–20 min). For reasons of energy cost
and nutritional content, some processors
use 80–85°C for 20 min. Cooked material
is pressed to produce press liquor and
presscake that can be dried (75–80°C,
≥30 min) and milled to presscake meal.
Press liquor is heated to 90–95°C, which
produces oil and stick-water. Oil is
purified with hot water (at 90°C). Stickwater is evaporated at ≥100°C (<130°C)
and the resulting fish solubles are added
to the presscake. Presscake and fish
soluble mix is dried at 75–80°C for
≥30 min to reduce water content to
≤12%. This is then milled to whole
fishmeal. Information on the heat
sensitivity of SVCV is lacking. However,
other rhabdoviruses such as VHS and
IHN have been demonstrated to be heat
sensitive under experimental conditions.
VHSV is inactivated within 1 minat 90°C
and IHNV within 30 seconds at 90°C
(Traxler & Richard, 2004)
Yes
233
Aquatic animal product assessments for spring viraemia of carp
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Spring viraemia of carp virus will be inactivated by this process. Therefore, fish oil and fish meal are eligible for
inclusion in Article 10.9.3. point 1.
234
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for spring viraemia of carp
B. Assessments using criteria in Article 5.4.2. (for Article 10.9.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) fillets or steaks (chilled or frozen) (Table I).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
i) eviscerated fish (chilled or frozen) (Table II)
ii) naturally dried eviscerated fish (Table III).
Table I
Fillets or steaks (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared and
packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
Waste includes skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally found
in the waste tissues generated by the
consumer
CONCLUSION
Fillets or steaks (chilled or frozen) that are prepared and packaged for retail trade for human consumption
produce only small amounts of waste. Therefore, this product is considered to be eligible for inclusion in
Article 10.9.11. for SVC.
Assessments of the safety of aquatic animal commodities
235
Aquatic animal product assessments for spring viraemia of carp
Table II
Eviscerated fish (chilled or frozen)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, backbone and skin
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
SVC virus can be present in gills and brain
(Faisal & Ahne, 1984; Fijan et al., 1971)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Eviscerated fish (chilled or frozen) that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste.
Therefore, this product is not eligible for inclusion in Article 10.9.11. for SVC.
Table III
Naturally dried eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the commodity definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste includes head, backbone and skin
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
SVC virus can be present in gills and brain
(Faisal & Ahne, 1984; Fijan et al., 1971)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Naturally dried eviscerated fish that are prepared and packaged for retail trade for human consumption may
produce amounts of waste that cannot be considered small; the pathogenic agent may be found in the waste
tissues. Therefore, this product is not eligible for inclusion in Article 10.9.11. for SVC.
236
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
9.
Aquatic animal product assessments for viral haemorrhagic septicaemia
virus
A. Assessments using criteria in Article 5.4.1. (for Article 10.10.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.1.:
i) heat sterilised, hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to a heat treatment at 90°C for
10 min (or any time/temperature equivalent that has been demonstrated to inactivate
VHSV) (Table II)
iii) mechanically dried, eviscerated fish (i.e. a heat treatment of 100°C for 30 min or any
time/temperature equivalent that has been demonstrated to inactivate VHSV)
(Table III)
iv) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table IV)
v) fish oil and fish meal (Table V)
vi) fish skin leather (Table VI).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) frozen, eviscerated fish (Table VII)
ii) frozen fish fillets or steaks (Table VIII)
iii) chilled, eviscerated fish (Table IX)
iv) chilled fish fillets or steaks (Table X).
Assessments of the safety of aquatic animal commodities
237
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table I
Heat sterilised, hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, skin and fins may be present in the
commodity. VHSV is present in multiple
tissues of finfish including muscle, heart,
spleen, kidney, blood, intestine, testes,
ovaries, eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981; Hedrick et
al., 2003; Iida et al., 2003; Neukirch, 1986;
Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982)
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999; Ababouch, 2002). VHSV
is heat-sensitive under experimental
conditions. VHSV is inactivated within 1 min
at 90°C (Traxler and Richard, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process. Therefore, heat sterilised, hermetically
sealed fish products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are
eligible for inclusion in Article 10.10.3. point 1.
238
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Pasteurised fish products include edible
portions of the fish. VHSV is present in
multiple tissues of finfish including
muscle, heart, spleen, kidney, blood,
intestine, testes, ovaries, eye, skin and
brain (Castric & de Kinkelin, 1980;
Enzmann, 1981; Hedrick et al., 2003; Iida
et al., 2003; Neukirch, 1986; Nishizawa et
al., 2006; Wizigmann & Hoffmann, 1982)
No
Pasteurisation involves heating at 90°C
for 10 min (or equivalent) (FDA, 2001;
Gould, 1999). VHSV is heat sensitive
under experimental conditions. VHSV is
inactivated within 5 min at 60°C when
suspended in kidney homogenate
(Traxler & Richard, 2004) and is
inactivated between 1 and 5 min at 70°C
and 75°C (Traxler & Richard, 2004;
Vestergård Jørgensen, 1974). VHSV is
inactivated within 1 min at 90°C (Traxler
& Richard, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process. Therefore, pasteurised fish products
that have been subjected to heat treatment at 90°C for 10 min, or to any time/temperature equivalent that has
been demonstrated to inactivate VHSV, are eligible for inclusion in Article 10.10.3. point 1.
Note: Pasteurisation is a food treatment process that is well defined for milk products, but is not well defined for aquatic animal products.
There are a number of time/temperature combinations that may be used depending on the product. Officially specified conditions will tend
to be determined by the requirement to inactivate bacteria of concern to food safety. As such both the United States of America Food and
Drug Administration (FDA, 2001) and Gould (1999) indicate that 90°C for 10 min is required to achieve a 6D reduction in Clostridium
botulinum. Inactivation standards for Listeria monocytogenes are considerably lower. It is proposed therefore, that in the first instance a
standard of 90°C, 10 min is used. Where possible, minimum time/temperature conditions sufficient to inactivate the pathogen of concern
will be detailed in each assessment.
Assessments of the safety of aquatic animal commodities
239
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table III
Mechanically dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones, head, gills, skin, and fins may
be part of the commodity. VHSV is present in
multiple tissues of finfish including muscle,
heart, spleen, kidney, blood, intestine, testes,
ovaries, eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981; Hedrick et
al., 2003; Iida et al., 2003; Neukirch, 1986;
Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982)
No
Mechanical drying involves heating at 100°C
for 30 min (or equivalent) (OECD, 2008).
VHSV is heat sensitive under experimental
conditions. VHSV is inactivated within 1 min
at 90°C (Traxler & Richard, 2004)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process. Therefore, mechanically dried,
eviscerated fish (i.e. a heat treatment at 100°C for at least 30 min or any time/temperature equivalent that has
been demonstrated to inactivate VHSV) are eligible for inclusion in Article 10.10.3. point 1.
240
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Table IV
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Muscle, bones, head, gills, skin, and
fins may be part of the commodity.
VHSV is present in multiple tissues of
finfish including muscle, heart, spleen,
kidney, blood, intestine, testes, ovaries,
eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981;
Hedrick et al., 2003; Iida et al., 2003;
Neukirch, 1986; Nishizawa et al., 2006;
Wizigmann & Hoffmann, 1982)
No
Natural drying involves exposure to the
sun and/or wind (OECD, 2008). Typical
air temperatures are 25–30°C for 1–3
days. VHSV is heat sensitive. Under
experimental conditions, at
temperatures from 25°C to 35°C,
VHSV in kidney homogenate is
inactivated in <24 h (Traxler &
Richard, 2004)
Yes
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the commodity
to be traded
OR
2.
Even if the pathogenic agent is present in, or
contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process. Therefore, naturally dried, eviscerated
fish are eligible for inclusion in Article 10.10.3. point 1.
Assessments of the safety of aquatic animal commodities
241
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table V
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Fish oil is derived from whole fish or byproducts of processing. VHSV is present in
multiple tissues of finfish including muscle,
heart, spleen, kidney, blood, intestine, testes,
ovaries, eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981; Hedrick et
al., 2003; Iida et al., 2003; Neukirch, 1986;
Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982)
No
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is extremely
low. Raw material is cooked (may be preheated to 50–60°C before cooking at
temperatures of 95–100°C for 15–20 min).
For reasons of energy cost and nutritional
content, some processors use 80–85°C for
20 min). Cooked material is pressed to
produce press liquor and presscake that can
be dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to 90–
95°C, which produces oil and stick-water. Oil
is purified with hot water (at 90°C). Stickwater is evaporated at ≥100°C (<130°C) and
the resulting fish solubles are added to the
presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. VHSV is heat sensitive under
experimental conditions. VHSV is inactivated
between 5 and 30 min at 60°C (Traxler &
Richard, 2004) and is inactivated between
1 and 5 min at 70°C and 75°C (Traxler &
Richard, 2004; Vestergård Jørgensen, 1974)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
Physical (e.g. temperature, drying, smoking)
AND/OR
242
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Aquatic animal product assessments for viral haemorrhagic septicaemia virus
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process and fish oil and fishmeal are therefore
eligible for inclusion in Article 10.10.3. point 1.
Assessments of the safety of aquatic animal commodities
243
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table VI
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
This commodity is composed of skin with fins
removed. VHSV is present in multiple tissues
of finfish including muscle, heart, spleen,
kidney, blood, intestine, testes, ovaries, eye,
skin and brain (Castric & de Kinkelin, 1980;
Enzmann, 1981; Hedrick et al., 2003; Iida et
al., 2003; Neukirch, 1986; Nishizawa et al.,
2006; Wizigmann & Hoffmann, 1982)
No
The fish skin is exposed to alkaline metal
sulphide, solvents, proteases, acid pH 1.5–4,
chromium or other tanning solutions and
dyes. The final leather product is usually pH
<5. Each step takes between 15 min and
24 h in a commercial setting (Pocket Book for
the Leather Technologist 4th Ed.). VHSV is
acid labile. Experimental in vitro studies
indicate that time to at least 99.9%
inactivation at pH 2.5 was <60 min (de
Kinkelin and Scherrer, 1970; Vestergård
Jørgensen, 1973). At pH 3 the time was
<180 min (Ahne, 1982); at pH 4, 1 log
reduction was seen within 5 min (de Kinkelin
and Scherrer, 1970)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus will be inactivated by this process. Therefore, fish skin leather is eligible
for inclusion in Article 10.10.3. point 1.
244
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Table VII
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the pathogenic
agent is not present in the tissues from which
the commodity is derived
Head, gills, muscle, skin, fins and gills
may be part of the commodity.
VHSV is present in multiple tissues of
finfish including muscle, heart, spleen,
kidney, blood, intestine, testes, ovaries,
eye, skin and brain (Castric & de Kinkelin,
1980; Enzmann, 1981; Hedrick et al.,
2003; Iida et al., 2003; Neukirch, 1986;
Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982)
No
Fish are frozen and maintained at a
temperature of –18°C or lower
(WHO/FAO, 2009).
VHSV will survive freezing for at least 2
weeks (Arkush et al., 2006). VHSV was
isolated from non-eviscerated fish frozen
at –20°C for up to 8 months (Wolfb et al.,
1968)
No
AND
b) The water (including ice) used to process or
transport the commodity is not contaminated
with the pathogenic agent and the processing
prevents cross contamination of the
commodity to be traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which the
commodity is derived, the treatment or
processing to produce the commodity to be
traded inactivates the pathogenic agent:
a) Physical (e.g. temperature, drying, smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus is unlikely to be inactivated by this process. Therefore, frozen
eviscerated fish are not eligible for inclusion in Article 10.10.3. point 1.
Assessments of the safety of aquatic animal commodities
245
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table VIII
Frozen fish fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle and skin may be part of the
commodity. VHSV is present in multiple
tissues of finfish including muscle, heart,
spleen, kidney, blood, intestine, testes,
ovaries, eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981; Hedrick et
al., 2003; Iida et al., 2003; Neukirch, 1986;
Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982)
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). VHSV will survive freezing for at least
2 weeks (Arkush et al., 2006). VHSV was
isolated from non-eviscerated fish frozen at –
20°C for up to 8 months (Wolfb et al., 1968)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus is unlikely to be inactivated by this process. Therefore, frozen fish fillets
and steaks are not eligible for inclusion in Article 10.10.3. point 1.
246
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Table IX
Chilled, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Head, gills, muscle, skin, fins and gills may
be part of the commodity. VHSV is present
in multiple tissues of finfish including
muscle, heart, spleen, kidney, blood,
intestine, testes, ovaries, eye, skin and
brain (Castric & de Kinkelin, 1980;
Enzmann, 1981; Hedrick et al., 2003; Iida
et al., 2003; Neukirch, 1986; Nishizawa et
al., 2006; Wizigmann & Hoffmann, 1982)
No
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). Vestergård Jørgensen
(1974) could not isolate VHSV from dead
trout kept at 4°C for 7 days
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
VHSV is unlikely to be inactivated by this process. Therefore, chilled eviscerated fish are not eligible for
inclusion in Article 10.10.3. point 1.
Assessments of the safety of aquatic animal commodities
247
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table X
Chilled fish fillets or steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the traded
commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle and skin may be part of the
commodity. VHSV is present in multiple
tissues of finfish including muscle, heart,
spleen, kidney, blood, intestine, testes,
ovaries, eye, skin and brain (Castric & de
Kinkelin, 1980; Enzmann, 1981; Hedrick
et al., 2003; Iida et al., 2003; Neukirch,
1986; Nishizawa et al., 2006; Wizigmann
& Hoffmann, 1982)
No
Fish are chilled and maintained at a
temperature approaching that of melting
ice (WHO/FAO, 2009). Vestergård
Jørgensen (1974) could not isolate VHSV
from dead trout kept at 4°C for 7 days
No
AND
b) The water (including ice) used to process or
transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present in,
or contaminates, the tissues from which
the commodity is derived, the treatment or
processing to produce the commodity to
be traded inactivates the pathogenic
agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Viral haemorrhagic septicaemia virus is unlikely to be inactivated by this process. Therefore, chilled fish fillets
and steaks are not eligible for inclusion in Article 10.10.3. point 1.
248
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B. Assessments using Criteria in Article 5.4.2. (for Article 10.10.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen fish fillets and steaks (Table I)
ii) chilled fish fillets and steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
iii) frozen, eviscerated fish (Table III)
iv) chilled, eviscerated fish (Table IV).
Assessments of the safety of aquatic animal commodities
249
Aquatic animal product assessments for viral haemorrhagic septicaemia virus
Table I
Frozen fish fillets and steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
No
Conclusion
Frozen fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
only small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.10.11.
Table II
Commodity under consideration (Chilled fish fillets and steaks)
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
No
CONCLUSION
Chilled fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
only small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.10.11.
250
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Table III
Frozen, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is
prepared and packaged for retail trade
for human consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of
waste tissues generated by the
consumer
Waste may include head, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues generated
by the consumer
VHSV is present in multiple tissues of finfish
including muscle, heart, spleen, kidney, blood,
intestine, testes, ovaries, eye, skin and brain
(Castric & de Kinkelin, 1980; Enzmann, 1981;
Hedrick et al., 2003; Iida et al., 2003; Neukirch,
1986; Nishizawa et al., 2006; Wizigmann &
Hoffmann, 1982). VHSV will survive freezing for
at least 2 weeks (Arkush et al., 2006). VHSV
was isolated from non-eviscerated fish frozen at
–20°C for up to 8 months (Wolfb et al., 1968)
No
AND/EITHER
2.
OR
3.
CONCLUSION
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that cannot be considered small and VHSV may not be inactivated by the process of freezing.
Therefore, this product is not considered to be eligible for inclusion in Article 10.10.11.
Table IV
Chilled, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste may include head, skin, fins and bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
VHSV is present in multiple tissues of finfish
including muscle, heart, spleen, kidney, blood,
intestine, testes, ovaries, eye, skin and brain
(Castric & de Kinkelin, 1980; Enzmann, 1981;
Hedrick et al., 2003; Iida et al., 2003;
Neukirch, 1986; Nishizawa et al., 2006;
Wizigmann & Hoffmann, 1982). Vestergård
Jørgensen (1974) could not isolate VHSV
from dead trout kept at 4°C for seven days
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that cannot be considered small, and VHSV will not be inactivated by the process of chilling.
Therefore, this product is not considered to be eligible for inclusion in Article 10.10.11.
Assessments of the safety of aquatic animal commodities
251
Aquatic animal product assessments for infection with Salmonid alphavirus
10. Aquatic animal product assessments for infection with Salmonid
alphavirus
A. Assessments using criteria in Article 5.4.1. (for Article 10.5.3.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in
Article 5.4.1.:
i) heat sterilised, hermetically sealed fish products (i.e. a heat treatment at 121°C for at
least 3.6 min or any time/temperature equivalent) (Table I)
ii) pasteurised fish products that have been subjected to a heat treatment at 90°C for
10 min (or any time/temperature equivalent that has been demonstrated to inactivate
SAV (Table II)
iii) mechanically dried, eviscerated fish (i.e. a heat treatment of 100°C for 30 min or any
time/temperature equivalent that has been demonstrated to inactivate SAV) (Table III)
iv) fish oil and fish meal (Table IV)
v) fish skin leather (Table V).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.1.:
i) naturally dried, eviscerated fish (i.e. sun-dried or wind-dried) (Table VI)
ii) frozen, eviscerated fish (Table VII)
iii) frozen fish fillets or steaks (Table VIII)
iv) chilled, eviscerated fish (Table IX)
v) chilled fish fillets or steaks (Table X).
252
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Aquatic animal product assessments for infection with Salmonid alphavirus
Table I
Heat sterilised, hermetically sealed fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, skin and fins may be present in the
commodity. Infection with SAV may induce a
viraemia during the acute phase. SAV has
been detected by RT-PCR or virus isolation in
the following tissues: blood, brain, gill, and
heart (Graham et al., 2006; Graham et al.,
2007; Jansen, et al., 2010; Graham et al.,
2011) as well as in mucus and faeces
(Graham et al., 2012). Demonstration of
presence or absence of viable virus in skin,
fins, skeletal muscle and other tissues has
not been systematically studied in
fish undergoing slaughter/destruction
although all ages of finfish can experience
infection with SAV
No
Heat treatment is 121°C for 3.6 min or
equivalent (e.g. 111°C for 36 min)
(Ababouch, 1999; Ababouch, 2002). SAV is
heat-sensitive under experimental conditions.
SAV is inactivated within 1 h at 60°C.
(Graham et al., 2007)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to
be traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus will be inactivated by this process. Therefore, heat sterilised, hermetically sealed fish
products (i.e. a heat treatment at 121°C for at least 3.6 min or any time/temperature equivalent) are eligible for
inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
253
Aquatic animal product assessments for infection with Salmonid alphavirus
Table II
Pasteurised fish products
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
Pasteurised fish products include edible portions
of the fish. Infection with SAV may induce a
viraemia during the acute phase. SAV has been
detected by RT-PCR or virus isolation in the
following tissues: blood, brain, gill, and heart
(Graham et al., 2006; Graham et al., 2007;
Jansen, et al., 2010; Graham et al., 2011) as well
as in mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of viable
virus in skin, fins, skeletal muscle and other
tissues has not been systematically studied in
fish undergoing slaughter/destruction although all
ages of finfish can experience infection with SAV
No
Pasteurisation involves heating at 90°C for
10 min (or equivalent) (FDA, 2001; Gould, 1999).
SAV is heat sensitive under experimental
conditions. SAV is inactivated within one hour at
60°C in liquid media in the presence of organic
matter (Graham et al., 2007). A 60 min
temperature combination that is equivalent to
90°C for 10 min is reached at 83°C i.e. 90°C for
10 min delivers that same thermal treatment as
83°C for 60 min. This exceeds 60°C for 60 min.
Therefore, SAV would be expected to be
inactivated (UK Food Safety Agency, 2014)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus will be inactivated by this process. Therefore, pasteurised fish products that have been
subjected to heat treatment at 90°C for 10 min, or to any time/temperature equivalent that has been
demonstrated to inactivate SAV, are eligible for inclusion in point 1 of Article 10.5.3.
254
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Aquatic animal product assessments for infection with Salmonid alphavirus
Table III
Mechanically dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones, head, gills, skin, and fins may
be part of the commodity. Infection with
SAV may induce a viraemia during the acute
phase. SAV has been detected by RT-PCR
or virus isolation in the following tissues:
blood, brain, gill, and heart (Graham et al.,
2006; Graham et al., 2007; Jansen, et al.,
2010; Graham et al., 2011) as well as in
mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of
viable virus in skin, fins, skeletal muscle and
other tissues has not been systematically
studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV
No
Mechanical drying involves heating at 100°C
for 30 min (or equivalent) (OECD, 2008). SAV
is heat sensitive under experimental
conditions. SAV is inactivated within 1 h at
60°C (Graham et al., 2007)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus will be inactivated by this process. Therefore, mechanically dried, eviscerated fish (i.e. a
heat treatment at 100°C for at least 30 min or any time/temperature equivalent that has been demonstrated to
inactivate SAV) are eligible for inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
255
Aquatic animal product assessments for infection with Salmonid alphavirus
Table IV
Fish oil and fish meal
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Fish oil is derived from whole fish or byproducts of processing. Infection with
SAV may induce a viraemia during the acute
phase. SAV has been detected by RT-PCR
or virus isolation in the following tissues:
blood, brain, gill, and heart (Graham et al.,
2006; Graham et al., 2007; Jansen, et al.,
2010; Graham et al., 2011) as well as in
mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of
viable virus in skin, fins, skeletal muscle and
other tissues has not been systematically
studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV
No
During production, fish oil and fish meal
undergo multiple heat treatments and the
final water content of the product is extremely
low. Raw material is cooked (may be preheated to 50–60°C before cooking at
temperatures of 95–100°C for 15–20 min).
For reasons of energy cost and nutritional
content, some processors use 80–85°C for
20 min). Cooked material is pressed to
produce press liquor and presscake that can
be dried (75–80°C, ≥30 min) and milled to
presscake meal. Press liquor is heated to
90–95°C, which produces oil and stick-water.
Oil is purified with hot water (at 90°C). Stickwater is evaporated at ≥100°C (<130°C) and
the resulting fish solubles are added to the
presscake. Presscake and fish soluble mix is
dried at 75–80°C for ≥30 min to reduce water
content to ≤12%. This is then milled to whole
fishmeal. SAV is heat sensitive under
experimental conditions. SAV is inactivated
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
256
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Aquatic animal product assessments for infection with Salmonid alphavirus
within 1 h at 60°C in liquid media in the
presence of organic matter (Graham et al.,
2007)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus will be inactivated by this process. Therefore, fish oil and fishmeal are eligible for
inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
257
Aquatic animal product assessments for infection with Salmonid alphavirus
Table V
Fish skin leather
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity
is derived
This commodity is composed of skin with fins
removed. Infection with SAV may induce a
viraemia during the acute phase. SAV has
been detected by RT-PCR or virus isolation
in the following tissues: blood, brain, gill, and
heart (Graham et al., 2006; Graham et al.,
2007; Jansen, et al., 2010; Graham et al.,
2011) as well as in mucus and faeces
(Graham et al., 2012). Skin tissue has not
been tested
No
The fish skin is exposed to alkaline metal
sulphide, solvents, proteases, acid pH 1.5–4,
chromium or other tanning solutions and
dyes. The final leather product is usually pH
<5. Each step takes between 15 min and
24 h in a commercial setting (Pocket Book for
the Leather Technologist 4th Ed.). SAV is
acid labile. In experimental in vitro studies
virus titre dropped to undetectable levels
within 5 min at pH4, when HCl is used. When
HCl is used to induce the pH drop, but also
formic acid, SAV titres drop by 4 log10 if
exposed to pH4 for 5 min, and is not
detectable after one day (Graham et al.,
2007)
Yes
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus will be inactivated by this process. Therefore, fish skin leather is eligible for inclusion in
point 1 of Article 10.5.3.
258
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Salmonid alphavirus
Table VI
Naturally dried, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle, bones, head, gills, skin, and fins may
be part of the commodity. Infection with
SAV may induce a viraemia during the acute
phase. SAV has been detected by RT-PCR
or virus isolation in the following tissues:
blood, brain, gill, and heart (Graham et al.,
2006; Graham et al., 2007; Jansen, et al.,
2010; Graham et al., 2011) as well as in
mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of
viable virus in skin, fins, skeletal muscle and
other tissues has not been systematically
studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV
No
Natural drying involves exposure to the sun
and/or wind (OECD, 2008). Typical air
temperatures are 25–30°C for 1–3 days
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is insufficient evidence to assess this commodity. Therefore, naturally dried, eviscerated fish are not
eligible for inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
259
Aquatic animal product assessments for infection with Salmonid alphavirus
Table VII
Frozen, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Head, gills, muscle, skin, and fins may be
part of the commodity. Infection with
SAV may induce a viraemia during the acute
phase. SAV has been detected by RT-PCR
or virus isolation in the following tissues:
blood, brain, gill, and heart (Graham et al.,
2006; Graham et al., 2007; Jansen, et al.,
2010; Graham et al., 2011) as well as in
mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of
viable virus in skin, fins, skeletal muscle and
other tissues has not been systematically
studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). SAV will survive freezing at –20°C for
at least 48 weeks (Graham et al., 2007)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus is unlikely to be inactivated by this process. Therefore, frozen, eviscerated fish are not
eligible for inclusion in point 1 of Article 10.5.3.
260
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Salmonid alphavirus
Table VIII
Frozen fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle and skin may be part of the
commodity. Infection with SAV may induce a
viraemia during the acute phase. SAV has
been detected by RT-PCR or virus isolation in
the following tissues: blood, brain, gill, and
heart (Graham et al., 2006; Graham et al.,
2007; Jansen, et al., 2010; Graham et al.,
2011) as well as in mucus and faeces
(Graham et al., 2012). Demonstration of
presence or absence of viable virus in skin,
fins, skeletal muscle and other tissues has
not been systematically studied in
fish undergoing slaughter/destruction
although all ages of finfish can experience
infection with SAV
No
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). SAV will survive freezing at –20°C for
at least 48 weeks (Graham et al., 2007)
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
Salmonid alphavirus is unlikely to be inactivated by this process. Therefore, frozen fish fillets and steaks are
not eligible for inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
261
Aquatic animal product assessments for infection with Salmonid alphavirus
Table IX
Chilled, eviscerated fish
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Head, gills, muscle, skin, and fins may be
part of the commodity. Infection with
SAV may induce a viraemia during the acute
phase. SAV has been detected by RT-PCR
or virus isolation in the following tissues:
blood, brain, gill, and heart (Graham et al.,
2006; Graham et al., 2007; Jansen, et al.,
2010; Graham et al., 2011) as well as in
mucus and faeces (Graham et al., 2012).
Demonstration of presence or absence of
viable virus in skin, fins, skeletal muscle and
other tissues has not been systematically
studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV
No
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). No data are available on
the survival of SAV in fish tissues at this
temperature
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is insufficient evidence to assess chilled, eviscerated fish. Therefore, chilled, eviscerated fish is not
eligible for inclusion in point 1 of Article 10.5.3.
262
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Aquatic animal product assessments for infection with Salmonid alphavirus
Table X
Chilled fish fillets and steaks
Article 5.4.1. criteria
1.
Rationale
Assessment
Absence of pathogenic agent in the
traded commodity:
a) There is strong evidence that the
pathogenic agent is not present in the
tissues from which the commodity is
derived
Muscle and skin may be part of the
commodity. Infection with SAV may induce a
viraemia during the acute phase. SAV has
been detected by RT-PCR or virus isolation in
the following tissues: blood, brain, gill, and
heart (Graham et al., 2006; Graham et al.,
2007; Jansen, et al., 2010; Graham et al.,
2011) as well as in mucus and faeces
(Graham et al., 2012). Demonstration of
presence or absence of viable virus in skin,
fins, skeletal muscle and other tissues has
not been systematically studied in
fish undergoing slaughter/destruction
although all ages of finfish can experience
infection with SAV
No
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). No data are available on
the survival of SAV in fish tissues at this
temperature
No
AND
b) The water (including ice) used to process
or transport the commodity is not
contaminated with the pathogenic agent
and the processing prevents cross
contamination of the commodity to be
traded
OR
2.
Even if the pathogenic agent is present
in, or contaminates, the tissues from
which the commodity is derived, the
treatment or processing to produce the
commodity to be traded inactivates the
pathogenic agent:
a) Physical (e.g. temperature, drying,
smoking)
AND/OR
b) Chemical (e.g. iodine, pH, salt, smoke)
AND/OR
c) Biological (e.g. fermentation)
CONCLUSION
There is insufficient evidence to assess criterion 2a. Therefore, chilled fish fillets and steaks are not eligible for
inclusion in point 1 of Article 10.5.3.
Assessments of the safety of aquatic animal commodities
263
Aquatic animal product assessments for infection with Salmonid alphavirus
B. Assessments using criteria in Article 5.4.2. (for Article 10.5.11.
point 1)
1. The following aquatic animal products were assessed and did meet the criteria in Article
5.4.2.:
i) frozen fish fillets and steaks (Table I)
ii) chilled fish fillets and steaks (Table II).
2. The following aquatic animal products were assessed and did not meet the criteria in
Article 5.4.2.:
iii) frozen, eviscerated fish (Table III)
iv) chilled, eviscerated fish (Table IV).
264
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Salmonid alphavirus
Table I
Frozen fish fillets and steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer.
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
No
CONCLUSION
Frozen fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.5.11.
Table II
Chilled fish fillets and steaks
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
Waste may include skin and bones
Yes
AND/EITHER
2.
It includes only a small amount of waste
tissues generated by the consumer
OR
3.
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
No
CONCLUSION
Chilled fish fillets and steaks that are prepared and packaged for retail trade for human consumption produce
small amounts of waste. Therefore, this product is eligible for inclusion in Article 10.5.11.
Assessments of the safety of aquatic animal commodities
265
Aquatic animal product assessments for infection with Salmonid alphavirus
Table III
Frozen, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste may include head, skin, fins and
bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
Infection with SAV may induce a viraemia
during the acute phase. SAV has been
detected by RT-PCR or virus isolation in the
following tissues: blood, brain, gill, and heart
(Graham et al., 2006; Graham et al., 2007;
Jansen, et al., 2010; Graham et al., 2011) as
well as in mucus and faeces (Graham et al.,
2012). Demonstration of presence or
absence of viable virus in skin, fins, skeletal
muscle and other tissues has not been
systematically studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV.
Fish are frozen and maintained at a
temperature of –18°C or lower (WHO/FAO,
2009). SAV will survive freezing at –20°C for
at least 48 weeks (Graham et al., 2007)
No
AND/EITHER
2.
OR
3.
CONCLUSIONS
Frozen, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that cannot be considered small and Salmonid alphavirus may not be inactivated by the
process of freezing. Therefore, frozen, eviscerated fish is not considered to be eligible for inclusion in Article
10.X.12.
266
Assessments of the safety of aquatic animal commodities
Aquatic animal product assessments for infection with Salmonid alphavirus
Table IV
Chilled, eviscerated fish
Article 5.4.2. criteria
1.
The aquatic animal product is prepared
and packaged for retail trade for human
consumption
Rationale
Assessment
It is part of the definition
Yes
It includes only a small amount of waste
tissues generated by the consumer
Waste may include head, skin, fins and
bones
No
The pathogenic agent is not normally
found in the waste tissues generated by
the consumer
Infection with SAV may induce a viraemia
during the acute phase. SAV has been
detected by RT-PCR or virus isolation in the
following tissues: blood, brain, gill, and heart
(Graham et al., 2006; Graham et al., 2007;
Jansen, et al., 2010; Graham et al., 2011) as
well as in mucus and faeces (Graham et al.,
2012). Demonstration of presence or
absence of viable virus in skin, fins, skeletal
muscle and other tissues has not been
systematically studied in fish undergoing
slaughter/destruction although all ages of
finfish can experience infection with SAV.
Fish are chilled and maintained at a
temperature approaching that of melting ice
(WHO/FAO, 2009). No data are available on
the survival of SAV in fish tissues at this
temperature
No
AND/EITHER
2.
OR
3.
CONCLUSION
Chilled, eviscerated fish that are prepared and packaged for retail trade for human consumption produce
amounts of waste that cannot be considered small, and there is insufficient evidence to assess this commodity
against some of the criteria. Therefore, chilled, eviscerated fish is not considered to be eligible for inclusion in
Article 10.5.11.
Assessments of the safety of aquatic animal commodities
267
References
References
Ababouch L. (1999). – Heat treatment of foods. Spoilage problems associated with canning. In
Encyclopaedia in Food Microbiology (R. Robinson, C. Blatt & P. Patel, eds). Academic Press Limited,
London, United Kingdom, 1016–1023. doi:10.1006/rwfm.1999.0780.
Ababouch L. (2002). – HACCP in the fish canning industry. In Safety and Quality Issues in Fish
Processing (H.A. Bremner, ed.). Woodhead Publishing Limited, Cambridge, United Kingdom, 31–53.
doi:10.1533/9781855736788.1.31.
Ahmed G.U. & Hoque M.A. (1999). – Mycotic involvement in epizootic ulcerative syndrome of
freshwater fishes of Bangladesh: A histopathological study. Asian Fis. Sci., 12, 381–390.
Ahne W. (1982). – Vergleichende Untersuchungen über die Stabilität von vier fischpathogener Viren
(VHSV, PFR, SVCV, IPNV). Zentralbl. Veterinärmed., B, 29, 457–476. doi:10.1111/j.14390450.1982.tb01248.x.
Amend D.F., Yasutake W.T. & Mead R.W. (1969). – A hematopoietic virus disease of rainbow trout
and
sockeye
salmon.
Trans.
Am.
Fish.
Soc.,
98,
796–804.
doi:10.1577/15488659(1969)98[796:AHVDOR]2.0.CO;2.
Amend D.F., Yasutake W.T., Fryer J.L., Pilcher K.S. & Wingfield W.H. (1973). – Infectious
hematopoietic necrosis. In Symposium on the major communicable fish diseases in Europe and their
control. Technical Paper, 17 (Suppl. 2), European Inland Fisheries Advisory (EIFAC), Food and
Agriculture Organization of the United Nations (FAO), 80–98.
Andrews L.S., DeBlanc S., Veal C.D. & Park D.L. (2003). – Response of Vibrio parahaemolyticus
O3:K6 to a hot water/cold shock pasteurization process. Food Addit. Contam., 20 (4), 331–334.
doi:10.1080/0265203031000060896.
Arcier J.M., Herman F., Lightner D.V., Redman R.M., Mari J. & Bonami J.R. (1999). – A viral disease
associated with mortalities in hatchery reared post larvae of the giant freshwater prawn
Macrobrachium rosenbergii. Dis. Aquat. Organisms, 38, 177–181. doi:10.3354/dao038177.
Ariel E., Nicolajsen N., Christophersen M.B., Holopainen R., Taptovaara H. & Jensen B.B. (2009). –
Propagation and isolation of ranaviruses in cell culture. Aquaculture, 314, 159–164.
doi:10.1016/j.aquaculture.2009.05.019.
Arimoto M., Sato J., Maruyama K., Mimura G. & Furusawa I. (1996). – Effect of chemical and physical
treatments on the inactivation of striped jack nervous necrosis virus (SJNNV). Aquaculture, 143 (1),
15–22. doi:10.1016/0044-8486(96)01261-6.
Arkush K.D., Mendonca H.L., McBride A.M., Yun S., McDowell T.S. & Hedrick R.P. (2006). – Effects
of temperature on infectivity and of commercial freezing on survival of the North American strain of
viral hemorrhagic septicemia virus (VHSV). Dis. Aquat. Organisms, 69, 145–151.
doi:10.3354/dao069145.
Arzul I., Gagnaire B., Bond C., Chollet B., Morga B., Ferrand S., Robert M. & Renault T. (2009). –
Effects of temperature and salinity on the survival of Bonamia ostreae, a parasite infecting flat oysters
Ostrea edulis. Dis. Aquat. Organisms, 85, 67–75. doi:10.3354/dao02047.
Assessments of the safety of aquatic animal commodities
269
References
Audemard C., Le Roux F., Barnaud A. Collins C., Sautour B., Sauriau P.-G., De Montaudouin X.,
Coustau C., Combes C. & Berthe F.C.J. (2002). – Needle in a haystack: involvement of the copepod
Paracartia grani in the life cycle of the oyster pathogen Marteilia refringens. Parasitology, 124 (3),
315–323. doi:10.1017/s0031182001001111.
BASF. – Pocket Book for the Leather Technologist. 4th Ed. BASF, Aktiengesellschaft 67056,
LudwigShafen, Germany. Available at: www.scribd.com/doc/19251902/Pocket-Book-for-the-LeatherTechnologists (accessed on 6 February 2012).
Baumwald J., Nonnenmacher H. & Tripier-Darcy F. (1984). – Frog virus 3 envelope: protective role
and incidence on the early steps of infection. Ann. Inst. Pasteur/Virol., 135 (3), 233–243.
doi:10.1016/S0769-2617(84)80025-8.
Berger L., Speare R. & Skerratt L.F. (2005). – Distribution of Batrachochytrium dendrobatidis and
pathology in the skin of green tree frogs Litoria caerulea with severe chytridiomycosis. Dis. Aquat.
Organisms, 68, 65–70. doi:10.3354/dao068065.
Berthe F.C.J. (2003). – Disease card – Withering syndrome of the abalone. Available at:
library.enaca.org/health/diseaselibrary/disease_card_for_WSA.pdf (accessed on 6 February 2012).
Birkbeck T.H., Rennie S., Hunter D., Laidler L.A. & Wadsworth S. (2004). – Infectivity of a Scottish
isolate of Piscririckettsia salmonis for Atlantic salmon Salmo salar and immune response of salmon to
this agent. Dis. Aquat. Organisms, 60 (2), 97–103. doi:10.3354/dao060097.
Bollinger T.K., Mao J., Schock D., Brigham R.M. & Gregory V. (1999). – Pathology, isolation and
preliminary molecular characterisation of a novel iridovirus from tiger salamanders in Saskatchewan.
J. Wildl. Dis., 35(3), 413–429. doi:10.7589/0090-3558-35.3.413.
Bonami J.R., Trumper B., Mari J., Brehelin M. & Lightner D.V. (1990). – Purification and
characterization of the infectious haematopoietic necrosis virus of penaeid shrimps. J. Gen. Virol., 71,
2657–2664. doi:10.1099/0022-1317-71-11-2657.
Brauningen S., Fischer I. & Peters J. (1994). – The temperature stability of bovine parvovirus.
Zentralbl. Hyg. Umweltmed., 196, 270–278.
Brock J.A., Gose R.B., Lightner D.V. & Hasson K.W. (1997). – Recent developments and an overview
of Taura syndrome of farmed shrimp in the Americas. In Disease in Asian Aquaculture 111 (T.W.
Flegel & I.H. Hopkins, eds). Fish Health Section Asian Fisheries Society, Manila, pp. 275–283.
Brudeseth B.E., Castric J., Evensen Ø. (2002). – Studies on pathogenesis following single and double
infection with viral hemorrhagic septicemia virus and infectious hematopoietic necrosis virus in
rainbow trout (Oncorhynchus mykiss). Vet. Pathol., 39, 180–189. doi:10.1354/vp.39-2-180.
Bushek D., Holley R. & Kelly M. (1997). – Chlorine tolerance of Perkinsus marinus. J. Shellfish Res.,
16, 260. (Abstract).
Byrne P.J., MacPhee D.D., Ostland V.E., Johnson G. & Ferguson H.W. (1998). – Haemorrhagic
kidney syndrome of Atlantic salmon, Salmo salar L. Bull. Eur. Assoc. Fish Pathol., 16, 68–72.
doi:10.1046/j.1365-2761.1998.00071.x.
Callinan R.B., Fraser G.C. & Virgona J.L. (1989). – Pathology of red spot disease in sea mullet, Mugil
cephalus L., from eastern Australia. J. Fish Dis., 12, 467–479. doi:10.1111/j.13652761.1989.tb00558.x.
270
Assessments of the safety of aquatic animal commodities
References
Castric J. & de Kinkelin P. (1980). – Occurrence of viral haemorrhagic septicaemia in rainbow trout
Salmo gairdneri Richardson reared in sea-water. J. Fish Dis., 3, 21–27. doi:10.1111/j.13652761.1980.tb00180.x.
Centre for Environment, Fisheries and Aquaculture Science (CEFAS) (2000). – Summary final report:
effects of exposure to high and low temperatures on the survival of the crayfish plague fungus A.
astaci in vitro and in vivo. Australian Quarantine and Inspection Service, Canberra; cited in Oidtmann
et al. 2002.
Chang P.H., Kuo S.T., Lai S.H., Yang H.S., Ting Y.Y., Hsu C.L. & Chen H.C. (2005). – Herpes-like
virus infection causing mortality of cultured abalone Haliotis diversicolor supertexta in Taiwan. Dis.
Aquat. Organisms, 65, 23–27. doi:10.3354/dao065023.
Chantanachookin C., Boonyaratpalin S., Kasornchandra J., Direkbusarakom S., Aekpanithanpong U.,
Supamattaya K., Sriuraitana S. & Flegel T.W. (1993). – Histology and ultrastructure reveal a new
granulosis-like virus in Penaeus monodon affected by yellow-head disease. Dis. Aquat. Organisms,
17, 145–157. doi:10.3354/dao017145.
Chen M.F., Yun S., Marty G.D., McDowell T.S., House M.L., Appersen J.A., Guenther T.A., Arkush
K.D. & Hedrick R.P. (2000). – A Piscirickettsia salmonis-like bacterium associated with mortality of
white seabass Atractoscion nobilis. Dis. Aquat. Organisms, 43 (2), 117–126. doi:10.3354/dao043117.
Chinabut S. & Roberts R.J. (1999). – Pathology and Histopathology of Epizootic Ulcerative Syndrome
(EUS). Aquatic Animal Health Research Institute, Bangkok.
Chinabut S., Roberts R.J., Willoughby G.R. & Pearson M.D. (1995). – Histopathology of snakehead,
Channa striatus (Bloch), experimentally infected with the specific Aphanomyces fungus associated
with epizootic ulcerative syndrome (EUS) at different temperatures. J. Fish Dis., 18, 41–47.
doi:10.1111/j.1365-2761.1995.tb01264.x.
Choi S., Kwon S., Nam Y., Kim S. & Kim K. (2006). – Organ distribution of red sea bream iridovirus
(RSIV) DNA in asymptomatic yearling and fingerling rock bream (Oplegnathus fasciatus) and effects
of water temperature on transition of RSIV into acute phase. Aquaculture, 256 (1/4), 23–26.
doi:10.1016/j.aquaculture.2006.01.026.
Crabtree B.G., Erdman M.M., Harris D.L. & Turney Harris I. (2006). – Preservation of necrotizing
hepatopancreatitis bacterium (NHPB) by freezing tissue collected from experimentally infected
Litopenaeus vannamei. Dis. Aquat. Organisms, 70, 175–179. doi:10.3354/dao070175.
Cruz-Romero M., Kelly A.L. & Kerry J.P. (2007). – Effects of high pressure and heat treatments on
physical and biochemical characteristics of oysters (Crassostrea gigas). Innov. Food Sci. Emerg.
Technol., 8 (1), 30–38. doi:10.1016/j.ifset.2006.05.002.
Cunningham A.A., Langton T.E.S., Bennett P.M., Lewin J.F., Drury S.E.N., Gough R.E. & MacGregor
S.K. (1996). – Pathological and microbiological findings from incidents of unusual mortality of the
common frog (Rana temporaria). Philos. Trans. Roy. Soc. Lond., B, Biol. Sci., 351, 1539–1557.
doi:10.1098/rstb.1996.0140.
Cunningham A.A., Tems C.A. & Russel P.H. (2008). – Immunohistochemical demonstration of
ranavirus antigen in the tissues of infected frogs (Rana temporaria) with systemic haemorrhagic or
cutaneous ulcerative disease. J. Comp. Pathol., 138, 3–11. doi:10.1016/j.jcpa.2007.08.003.
Assessments of the safety of aquatic animal commodities
271
References
Dalgleish R.J. (1972). – Theoretical and practical aspects of freezing parasitic protozoa. Aust. Vet. J.,
48, 233–239. doi:10.1111/j.1751-0813.1972.tb05143.x.
Das B.K. & Mukherjee S.C. (1998). – Symptomatology and histopathology of epizootic ulcerative
syndrome in rohu, Labeo rohita (Ham.). Indian. J. Fish., 45, 315–319.
De Kinkelin P. & Scherrer R. (1970). – Le virus d’Egtved. I. Stabilité, développement et structure du
virus de la souche danoise F1. Ann. Rech. Vét., 1, 17–30.
Dinamani P., Hine P.M. & Jones J.B. (1987). – Occurrence and characteristics of the haemocyte
parasite Bonamia sp. in the New Zealand dredge oyster Tiostrea lutaria. Dis. Aquat. Organisms, 3,
37–44. doi:10.3354/dao003037.
Durand S.V., Redman R.M., Mohney L.L., Tang-Nelson K., Bonami J.R. & Lightner D.V. (2003). –
Qualitative and quantitative studies on the relative virus load of tails and heads of shrimp acutely
infected with WSSV. Aquaculture, 216, 9–18. doi:10.1016/S0044-8486(02)00230-2.
Durand S.V., Tang K.F.J. & Lightner D.V. (2000). – Frozen commodity shrimp: potential avenue for
introduction of white spot syndrome virus and yellow head virus. J. Aquat. Anim. Hlth, 12, 128–135.
doi:10.1577/1548-8667(200006)012<0128:FCSPAF>2.0.CO;2.
Engelking H.M. & Kaufman J. (1994). – Infectious hematopoietic necrosis virus (IHNV) found in four
geographically distinct feral populations of salmonids in Oregon. Fish Health Section/American
Fisheries Society Newsletter, 22 (1), 10–12.
Enzmann P.J. (1981). – Rapid identification of VHSV-virus from trout by inmunofluorescence. In
International symposium on fish biologics: serodiagnostics and vaccines (S. Karger, ed.). Dev. Biol.
Standard., 49, 57–62.
Faisal M. & Ahne W. (1984). – Spring viremia of carp virus (SVCV): comparison of immunoperoxidase,
fluorescent antibody and cell culture isolation techniques for detection of antigen. J. Fish Dis., 7, 57–
64. doi:10.1111/j.1365-2761.1984.tb00906.x.
Falk K., Namork E., Rimstad E., Mjaaland S. & Dannevig B.H. (1997). – Characterization of infectious
salmon anemia virus, an orthomyxo-like virus isolated from Atlantic salmon (Salmo salar L.). J. Virol.,
71 (12), 9016–9023.
Fijan N., Petrinec Z., Sulimanovic D. & Zwillenberg L.O. (1971). – Isolation of the viral causative agent
from the acute form of infectious dropsy of carp. Vet. Arhiv, 41, 125–138.
Flegel T.W., Sriurairatana S., Wongteerasupaya C., Boonsaeng V., Panyim S. & Withyachumnarnkul
B. (1995). – Progress in characterization and control of yellow-head virus of Penaeus monodon. In
Swimming Through Troubled Water: Proc. of the special session on shrimp farming (C. Browdy & S.
Hopkins, eds). Aquaculture, San Diego, February, World Aquaculture Society, Baton Rouge, LA,
United States of America, 76–83.
Food and Agriculture Organization of the United Nations (FAO) (1986). – The production of fishmeal
and oil. FAO Fisheries Technical Papers T142, FAO, Rome, 63 pp.
Food and Drug Administration of the United States of America (FDA) (2001). – Fish and fisheries
products
hazards
and
controls
guidance,
3rd
Ed.
Available
at:
www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/Fishan
dFisheriesProductsHazardsandControlsGuide/default.htm (accessed on 19 February 2010).
272
Assessments of the safety of aquatic animal commodities
References
Frelier P.F., Sis R.F., Bell T.A. & Lewis D.H. (1992). – Microscopic and ultrastructural studies of
necrotizing hepatopancreatitis in Pacific white shrimp (Penaeus vannamei) cultured in Texas. Vet.
Pathol., 29, 269–277. doi:10.1177/030098589202900401.
Frerichs G.N., Tweedie A., Starkey W.G. & Richards R.H. (2000). – Temperature, pH and electrolyte
sensitivity, and heat, UV and disinfection inactivation of sea bass (Dicentrarchus labrax) neuropathy
virus. Aquaculture, 185, 13–24. doi:10.1016/S0044-8486(99)00337-3.
Friedman C.S., Andree K.B., Beauchamp K.A., Moore J.D., Robbins T.T., Shields J.D. & Hedrick R.P.
(2000). – Candidatus Xenohaliotis californiensis, a newly described pathogen of abalone, Haliotis spp.,
along the West coast of North America. Int. J. Syst. Evolut. Microbiol., 50 (2), 847–855.
doi:10.1099/00207713-50-2-847.
Friedman C.S., Biggs W., Shields J.D. & Hedrick R.P. (2002). – Transmission of withering syndrome
in black abalone, Haliotis cracherodii Leach. J. Shellfish Res., 21 (2), 817–824.
Gagné N. (1993). – Production of chitin and chitosan from crustacean waste and their use as a food
processing aid. Masters thesis, McGill University, Montreal, National Library of Canada, Ottawa, ON,
Canada.
Gantress J., Maniero G.D., Cohen N. & Robert J. (2003). – Development and characterization of a
model system to study amphibian immune responses to iridoviruses. Virology, 311, 254–262.
doi:10.1016/S0042-6822(03)00151-X.
Gilad O., Yun S., Zagmutt-Vergara F.J., Leutenegger C.M., Bercovier H. & Hedrick R.P. (2004). –
Concentrations of a Koi herpesvirus (KHV) in tissues of experimentally infected Cyprinus carpio koi as
assessed by real-time TaqMan PCR. Dis. Aquat. Organisms, 60 (3), 179–187.
doi:10.3354/dao060179.
Gosting L.H. & Gould R.W. (1981). – Thermal inactivation of infectious hematopoietic necrosis and
infectious pancreatic necrosis viruses. Appl. Environ. Microbiol., 41, 1081–1082.
Gould G.W. (1999). – Sous vide foods: conclusions of an ECFF botulinum working party. Food
Control, 10, 47–51. doi:10.1016/S0956-7135(98)00133-9.
Graham D.A., Jewhurst H.L., McLoughlin M.F., Branson E.J., McKenzie K., Rowley H.M., Todd D.
(2007). – Serological, virological and histopathological study of an outbreak of sleeping disease in
farmed rainbow trout Oncorhynchus mykiss. Dis. Aquat. Org., 74, 191–197. doi:10.3354/dao074191.
Graham D.A., Brown A., Savage P. & Frost P. (2012). – Detection of salmon pancreas disease in the
faeces and mucus of Atlantic salmon Salmon salar by real-time RT-PCR and cell culture following
experimental challenge. J. Fish Dis., 35, 949–951. doi:10.1111/j.1365-2761.2012.01427.x.
Graham D.A., Jewhurst H., McLoughlin M.F., Sourd P., Rowley H.M., Taylor C. & Todd D. (2006). –
Sub-clinical infection of farmed Atlantic salmon Salmo salar with salmonid alphavirus – a prospective
longitudinal study. Dis. Aquat. Org., 72, 193–199. doi:10.3354/dao072193.
Graham D.A., Staples C., Wilson C.J., Jewhurst H., Cherry K., Gordon A. & Rowley H.M. (2007). –
Biophysical properties of salmonid alphaviruses: influence of temperature and pH on virus survival. J.
Fish Dis., 30, 533–543. doi:10.1111/j.1365-2761.2007.00811.x.
Assessments of the safety of aquatic animal commodities
273
References
Granoff A., Came P.E. & Breeze D.C. (1966). – Viruses and renal carcinoma of Rana pipiens I. The
isolation and properties of virus from normal and tumor tissue. Virology, 29, 133–148.
doi:10.1016/0042-6822(66)90203-0.
Granoff A., Came P.E. & Rafferty K.A. (1965). – The isolation and properties of viruses from Rana
pipiens: Their possible relationship to the renal adenocarcinoma of the leopard frog. Ann. N.Y. Acad.
Sci., 126 (1), 237–255. doi:10.1111/j.1749-6632.1965.tb14278.x.
Grizel H., Comps M., Bonami J.-R., Cousserans F., Duthoit J.-L. & Le Pennec M.-A. (1974). –
Recherches sur l’agent de la maladie de la glande digestive de Ostrea edulis Linné. Sci. Pêche Sci.
Pêche, 240, 7–30.
Hedrick R.P., Batts W.N., Yun S., Traxler G.S., Kaufman J. & Winton J.R. (2003). – Host and
geographic range extensions of the North American strain of viral hemorrhagic septicemia virus. Dis.
Aquat. Organisms, 55, 211–220. doi:10.3354/dao055211.
Hooper C., Hardy-Smith P. & Handlinger J. (2007). – Ganglioneuritis causing high mortalities in
farmed Australian abalone (Haliotis laevigata and Haliotis rubra). Aust. Vet. J., 85 (5), 188–192.
doi:10.1111/j.1751-0813.2007.00155.x.
Hovland T., Nylund A., Watanabe K. & Endresen C. (1994). – Observation of infectious salmon
anaemia virus in Atlantic salmon, Salmo salar L. J. Fish Dis., 17, 291–296. doi:10.1111/j.13652761.1994.tb00224.x.
Iida H., Mori K., Nishizawa T., Arimoto M. & Muroga K. (2003). – Fate of viral hemorrhagic septicemia
virus in Japanese flounder Paralichthys olivaceus challenged by immersion. Fish Pathol., 38, 87–91.
doi:10.3147/jsfp.38.87.
Jansen M.D., Wasmuth M.A., Olsen A.B., Gjerset B., Modahl I., Breck O., Haldorsen R.N., Hjelmeland
R. & Taksdal T. (2010). – Pancreas disease (PD) in sea-reared Atlantic salmon, Salmo salar L., in
Norway; a prospective, longitudinal study of disease development and agreement between diagnostic
test results. J. Fish Dis., 33, 723–736. doi:10.1111/j.1365-2761.2010.01176.x.
Jensen A.J. & Johnsen B.O. (1992). – Site specificity of Gyrodactylus salaris Malmberg, 1957
(Monogenea) on Atlantic salmon (Salmo salar L.) in the River Lakselva, northern Norway. Can. J.
Zool., 70, 264–267. doi:10.1139/z92-039.
Johnson M.L. & Speare R. (2003). – Survival of Batrachochytrium dendrobatidis in water: Quarantine
and disease control implications. Emerg. Infect. Dis., 9 (8), 922–925. doi:10.3201/eid0908.030145.
Johnson M.L. & Speare R. (2005). – Possible modes of dissemination of the amphibian chytrid
Batrachochytrium dendrobatidis in the environment. Dis. Aquat. Organisms, 65, 181–186.
doi:10.3354/dao065181.
Johnson M.L., Berger L., Philips L. & Speare R. (2003). – Fungicidal effects of chemical disinfectants,
UV light, dessication and heat on the amphibian chytrid Batrachochytrium dendrobatidis. Dis. Aquat.
Organisms, 57, 255–260. doi:10.3354/dao057255.
Jung S., Miyazaki T., Miyata M., Danayadol Y. & Tanaka S. (1997). – Pathogenicity of iridovirus from
Japan and Thailand for the Red Sea Bream Pagrus major in Japan, and histopathology of
experimentally infected fish. Fish. Sci., 63 (5), 735–740.
274
Assessments of the safety of aquatic animal commodities
References
Kasai H., Muto Y. & Yoshimizu M. (2005). – Virucidal effects of ultraviolet, heat treatment and
disinfectants against koi herpesvirus (KHV). Fish Pathol., 40 (3), 137–138. doi:10.3147/jsfp.40.137.
Langdon J.S. (1989). – Experimental transmission and pathogenicity of epizootic haematopoietic
necrosis virus (EHNV) in redfin perch, Perca fluviatilis L., and 11 other teleosts. J. Fish Dis., 12, 295–
310. doi:10.1111/j.1365-2761.1989.tb00318.x.
Langdon J.S., Humphrey J.D. & Williams L.M. (1988). – Outbreaks of an EHNV-like iridovirus in
cultured rainbow trout, Salmo gairdneri Richardson, in Australia. J. Fish Dis., 11, 93–96.
doi:10.1111/j.1365-2761.1988.tb00527.x.
LaPatra S.E., Lauda K.A., Jones G.R., Walker S.C., Shewmaker B.S. & Morton A.W. (1995). –
Characterization of IHNV isolates associated with neurotropism. Vet. Res., 26, 433–437.
LaPatra S.E., Rohovec J.S. & Fryer J.L. (1989). – Detection of infectious hematopoietic necrosis virus
in fish mucus. Fish Pathol., 24, 197–202. doi:10.3147/jsfp.24.197.
Le Deuff R.M., Nicolas J.L., Renault T. & Cochennec N. (1994). – Experimental transmission of a
herpes-like virus to axenic larvae of Pacific oyster, Crassostrea gigas. Bull. Eur. Assoc. Fish Pathol.,
14 (2), 69–72.
Lightner D.V. (1996b). – The penaeid shrimp virues IHHNV and TSV: Epizootiology, production
impacts and role of international trade in their distribution in the Americas. Rev. Sci. Tech. Off. Int.
Epiz., 15, 579–601.
Lightner D.V., Pantoja C.R., Poulos B.T., Tang K.F.J., Redman R.M., Pasos de Andrade T. & Bonami
J.R. (2004). – Infectious myonecrosis: new disease in Pacific white shrimp. Global Aquacult. Adv., 7,
85.
Lightner D.V.E. (1996a). – A Handbook of Shrimp Pathology and Diagnostic Procedures for Diseases
of Cultured Penaeid Shrimp. World Aquaculture Society, Baton Rouge, LA, United States of America.
Lund B., Jensen V.F., Have P. & Ahring B.K. (1996). – Inactivation of virus during anaerobic digestion
of manure in laboratory scale biogas reactors. Antonie Van Leeuwenhoek, 69 (1), 25–31 (abstract).
doi:10.1007/BF00641608.
Mackin J.G. (1951). – Histopathology of infection of Crassostrea virginica Gmelin by Dermocystidium
marinum Mackin, Owen and Collier, 1950. Bull. Marine Sci. Gulf Caribb., 1, 72–87.
Mahnel H. & Von Brodorotti H.S. (1981). – Thermoinactivation of viruses by microwaves. Zentralbl.
Veterinärmed., 28 (7), 509–517 (abstract). doi:10.1111/j.1439-0450.1981.tb01770.x.
Maurin M. & Raoult D. (1999). – Q Fever. Clin. Microbiol. Rev., 12 (4), 518-553.
McGavin D. (1987). – Inactivation of canine parvovirus by disinfectants and heat. J. Small Anim.
Pract., 28, 523–535. doi:10.1111/j.1748-5827.1987.tb01446.x.
McGraw-Hill (2004). – Concise Encyclopedia of Science and Technology. 5th Ed., McGraw-Hill
Publisher.
Miller D.L., Rajeev S., Brookins M., Cook J., Whittington L. & Baldwin C.A. (2008). – Concurrent
infection with ranavirus, Batrachochytrium dendrobatidis and Aeromonas in a captive anuran colony.
J. Zoo Wildl. Med., 39(3), 445–449. doi:10.1638/2008-0012.1.
Assessments of the safety of aquatic animal commodities
275
References
Miyazaki T. & Egusa S. (1972). – Studies on mycotic granulomatosis in freshwater fish I. Mycotic
granulomatosis in goldfish. Fish Pathol., 7, 15–25. doi:10.3147/jsfp.7.15.
Miyazaki T. & Egusa S. (1973). – Studies on mycotic granulomatosis in freshwater fish III. Bluegill.
Mycotic granulomatosis in bluegill. Fish Pathol., 8, 41–43. doi:10.3147/jsfp.8.41.
Momoyama K., Hiraoka M., Nakano H. & Sameshima M. (1998). – Cryopreservation of penaeid rodshaped DNA virus (PRDV) and its survival in sea water at different temperatures. Fish Pathol., 33, 95–
96. doi:10.3147/jsfp.33.95.
Momoyama K., Hiraoka M., Nakano H., Koube H., Inouye K. & Oseko N. (1994). – Mass mortalities of
cultured kuruma shrimp, Penaeus japonicus, in Japan in 1993: Histopathological study. Fish Pathol.,
29, 141–148. doi:10.3147/jsfp.29.141.
Moore J.D., Robbins T.T., Hedrick R.P. & Friedman C.S. (2001). – Transmission of the Rickettsialeslike prokaryote “Candidatus Xenohaliotis californiensis” and its role in withering syndrome of California
abalone, Haliotis spp. J. Shellfish Res., 20 (2), 867–874.
Nakajima K. & Sorimachi M. (1994). – Biological and physico-chemical properties of the iridovirus
isolated from cultured red sea bream, Pagrus major. Gyobyo Kenhyu (Fish Pathol.), 29 (1), 29–33.
doi:10.3147/jsfp.29.29.
Nakano H., Hiraoka M., Sameshima M., Kimura T. & Momoyama K. (1998). – Inactivation of penaeid
rod-shaped DNA virus (PRDV), the causative agent of penaid acute viremia (PAV), by some chemical
and physical treatments. Fish Pathol., 33, 65–71. doi:10.3147/jsfp.33.65.
Neukirch M. (1986). – Demonstration of persistent viral haemorrhagic septicaemia (VHS) virus in
rainbow trout after experimental waterborne infection. J. Vet. Med., B, 33, 471–476.
doi:10.1111/j.1439-0450.1986.tb00058.x.
Nishizawa T., Savaş H., Işıdan H., Üstündağ C., Iwamoto H. & Yoshimizu M. (2006). – Genotyping
and pathogenicity of viral hemorrhagic septicemia virus from free-living turbot (Psetta maxima) in a
Turkish coastal area of the Black Sea. Appl. Environ. Microbiol., 72, 2373–2378.
doi:10.1128/AEM.72.4.2373-2378.2006.
Noga E.J., Levine J.F., Dykstra M.J. & Hawkins J.H. (1988). – Pathology of ulcerative mycosis in
Atlantic menhaden Brevoortia tyrannus. Dis. Aquat. Organisms, 4, 189–197. doi:10.3354/dao004189.
Nunan L.M., Tang-Nelson K. & Lightner D.V. (2004). – Real-time RT-PCR determination of viral copy
number in Penaeus vannamei experimentally infected with Taura syndrome virus. Aquaculture, 229,
1–10. doi:10.1016/S0044-8486(03)00365-X.
Nylund A., Krossøy B., Watanabe K. & Holm J.A. (1996). – Target cells for the ISA virus in Atlantic
salmon (Salmo salar L.). Bull. Eur. Assoc. Fish Pathol., 16, 68–72.
Oidtmann B., El-Matbouli M., Fischer H., Hoffmann R.W., Klärding, K., Schmidt, I. & Schmidt R.
(1997). – Light microscopy of Astacus astacus L., under normal and selected pathological conditions
with special emphasis on porcelain disease and crayfish plague. Freshwater Crayfish, 11, 465–480.
Oidtmann B., Geiger S., Steinbauer P., Culas A. & Hoffmann R.W. (2006). – Detection of
Aphanomyces astaci in North American crayfish by polymerase chain reaction. Dis. Aquat.
Organisms, 72, 53–64. doi:10.3354/dao072053.
276
Assessments of the safety of aquatic animal commodities
References
Oidtmann B., Heitz E., Rogers D. & Hoffmann R.W. (2002). – Transmission of crayfish plague. Dis.
Aquat. Organisms, 52, 159–167. doi:10.3354/dao052159.
Olstad K., Cable J., Robertsen G. & Bakke T.A. (2006). – Unpredicted transmission strategy of
Gyrodactylus salaris (Monogenea: Gyrodactylidae): survival and infectivity of parasites on dead hosts.
Parasitology, 133, 33–41. doi:10.1017/S0031182006009966.
Organisation for Economic Co-operation and Development (OECD) (2008). – Multilingual Dictionary of
Fish
and
Fish
Products.
5th
Ed.
370
pp.
Available
at:
lysander.sourceoecd.org/vl=1159829/cl=37/nw=1/rpsv/fishdictionary2008/index.htm
(accessed
in
January 2010).
Owens L., Anderson I.A., Kenway M., Trott L. & Benzie J.A.H. (1992). – Infectious hypodermal and
haematopoietic necrosis virus (IHHNV) in a hybrid penaeid prawn from tropical Australia. Dis. Aquat.
Organisms, 14, 219–228. doi:10.3354/dao014219.
Peeler E.J. & Thrush M.A. (2004). – Qualitative analysis of the risk of introducing Gyrodactylus salaris
into the United Kingdom. Dis. Aquat. Organisms, 62, 103–113. doi:10.3354/dao062103.
Pichot Y., Comps M., Tige G., Grizel H. & Rabouin M.A. (1979). – Recherches sur Bonamia ostreae
gen. n., sp. n., parasite nouveau de l’huitre plate Ostrea edulis L. Rev. Trav. Inst. Pêches Marit., 43,
131–140.
Pietsch J.P., Amend D.F. & Miller C.M. (1977). – Survival of infectious hematopoietic necrosis virus
held under various environmental conditions. J. Fish. Res. Board Can., 34, 1360. doi:10.1139/f77-195.
Plumb J.A. & Zilberg D. (1999). – Survival of largemouth bass iridovirus in frozen fish. J. Aquat. Anim.
Hlth, 11, 94–96. doi:10.1577/1548-8667(1999)011<0094:SOLBII>2.0.CO;2.
Plumb J.A., Wright L.D. & Jones V.L. (1973). – Survival of channel catfish virus in chilled, frozen and
decomposing
catfish.
Prog.
Fish-Culturist,
35,
170–172.
doi:10.1577/15488659(1973)35[170:SOCCVI]2.0.CO;2.
Poulos B.T., Tang K.F.J., Pantoja C.R., Bonami J.R. & Lightner D.V. (2006). – Purification and
characterization of infectious myonecrosis virus of penaeid shrimp. J. Gen. Virol., 87, 987–996.
doi:10.1099/vir.0.81127-0.
Redacliff L.A. & Whittington R.J. (1996). – Pathology of epizootic haematopoietic necrosis virus
(EHNV) infection in rainbow trout (Oncorhynchus mykiss Walbaum) and redfin perch (Perca fluviatilis
L). J. Comp. Pathol., 115 (2), 103–115. doi:10.1016/S0021-9975(96)80033-8.
Rehman S. (1987). – Virucidal effect of the heat treatment of waste food for swine. Tierärztl. Umsch.,
42, 892–896 (abstract).
Sahul Hameed A.S., Yoganandhan K., Sri Widada J. & Bonami J.R. (2004). – Experimental
transmission and tissue tropism of Macrobrachium rosenbergii nodavirus (MrNV) and its associated
extra small virus (XSV). Dis. Aquat. Organisms, 62 (3), 191–196. doi:10.3354/dao062191.
Sauerbrei A. & Wutzler P. (2009). – Testing thermal resistance of viruses. Arch. Virol., 154, 115–119.
doi:10.1007/s00705-008-0264-x.
Seki H. (1986). – Effects of physicochemical treatments on a silkworm densonucleosis virus
(Yamanashi isolate) of the silkworm, Bombyx mori. Appl. Entomol. Zool., 21 (4), 515–518.
Assessments of the safety of aquatic animal commodities
277
References
Shike H., Dhar A.K., Burns J.C., Shimizu C., Jousset F.X., Klimpel K.R. & Bergoin M. (2000). –
Infectious hypodermal and haematopoietic necrosis virus of shrimp is related to mosquito
brevidensoviruses. Virology, 277 (1), 167–177. doi:10.1006/viro.2000.0589.
Shimizu T., Yoshida N., Kasai H. & Yoshimizu M. (2006). – Survival of koi herpesvirus (KHV) in
environmental water. Fish Pathol., 41, 153–157. doi:10.3147/jsfp.41.153.
Sithigorngul P., Hajimasalaeh W., Longyant S., Sridulyakul P., Rukpratanporn S. & Chaivisuthangkura
P. (2009). – Simple immunoblot and immunohistochemical detection of Peneaus stylirostris
densovirus using monoclonal antibodies to viral capsid protein expressed heterologously. J. Virol.
Meth., 162, 126–132. doi:10.1016/j.jviromet.2009.07.026.
Sofer G., Lister D.C. & Boose J.A. (2003). – Virus inactivation in the 1990s – and into the 21st
century:Part 6: Inactivation methods grouped by virus. BioPharm Int., 42–68.
Soleng A. & Bakke T.A. (1997). – Salinity tolerance of Gyrodactylus salaris (Platyhelminthes,
Monogenea): laboratory studies. Can. J. Fish. Aquat. Sci., 54, 1837–1845. doi:10.1139/cjfas-54-81837.
Soleng A., Poleo A.B.S., Alstad N.E.W. & Bakke T.A. (1999). – Aqueous aluminum eliminates
Gyrodactylus salaries (Platyhelminthes, Monogenea) infections in Atlantic salmon. Parasitology, 119,
19–25. doi:10.1017/S0031182099004436.
Sosa E.R., Landsberg J.H., Stephenson C.M., Forstchen A.B., Vandersea M.W. & Litaker R. (2007). –
Aphanomyces invadans and ulcerative mycosis in estuarine and freshwater fish in Florida. J. Aquat.
Anim. Hlth, 19, 14–26. doi:10.1577/H06-012.1
Soudant P., Chu F.L.E. & Lund E.D. (2005). – Assessment of the cell viability of cultured Perkinsus
marinus (Perkinsea), a parasitic protozoan of the eastern oyster, Crassostrea virginica, using
SYBRgreen-propidium iodide double staining and flow cytometry. J. Eukar. Microbiol., 52, 492–499.
doi:10.1111/j.1550-7408.2005.00058.x.
Speare R. & Smith J.R. (1992). – An iridovirus-like agent isolated from the ornate burrowing frog
Limnodynastes ornatus in northern Australia. Dis. Aquat. Organisms, 14, 51–57.
doi:10.3354/dao014051.
Srivastava R.N. & Lund E. (1980). – The stability of bovine parvovirus and its possible use as an
indicator for the persistence of enteric viruses. Water Res. (Oxford)., 14 (8), 1017–1021
doi:10.1016/0043-1354(80)90146-3.
Tang K.F.J., Pantoja C.R., Poulos B.T., Redman R.M. & Lightner D.V. (2005). – In situ hybridisation
demonstrates that Litopenaeus vannamei, L. stylirostris and Penaeus monodon are susceptible to
experimental infection with infectious myonecrosis virus (IMNV). Dis. Aquat. Organisms, 63, 261–265.
doi:10.3354/dao063261.
Torgersen Y. (1998). – Physical and chemical inactivation of the infectious salmon anaemia (ISA)
virus. In Proc. of the 6th annual New England farmed fish health workshop, Eastport, Maine, United
States of America, (Annex 5), 44–53.
Traxler G. & Richard J. (2004). – Thermal Inactivation of Infectious Hematopoietic Necrosis (IHN)
Virus and Viral Hemorrhagic Necrosis (VHS) Virus. Fisheries and Oceans Canada, Pacific Biological
Station, Nanaimo, British Columbia, Canada.
278
Assessments of the safety of aquatic animal commodities
References
Tung C.W., Wang C.S. & Chen S.N. (1999). – Histological and electron microscopic study on
Macrobrachium muscle virus (MMV) infection in the giant freshwater prawn, Macrobrachium
rosenbergii (De Man), cultured in Taiwan. J. Fish Dis., 22, 319–323. doi:10.1046/j.13652761.1999.00172.x.
United
Kingdom
Food
Safety
Agency,
Available
at:
vacuumpackingtraining.food.gov.uk/module3/section2/?panel=1#panel1 (access on 31 January 2014).
Van Sluys M., Kriger K.M., Phillot A.D., Campbell R., Skerratt L.F. & Hero J.-M. (2008). – Storage of
samples at high temperatures reduces the amount of amphibian chytrid fungus Batrachochytrium
dendrobatidis DNA detectable by PCR assay. Dis. Aquat. Organisms, 81, 93–97.
doi:10.3354/dao01953.
Velez S.A., Allen J.C., Keery C.M. & Adkinson R.W. (1991). – Evaluation of crab and crawfish waste
meals as protein sources for growing dairy heifers. J. Dairy Sci., 74 (1), 234–242.
doi:10.3168/jds.S0022-0302(91)78165-4.
Vestergård Jørgensen P.E. (1973). – Inactivation of IPN and Egtved virus. Rivista Italiana di
Piscicoltura e Ittiopatologia, 8, 107–108.
Vestergård Jørgensen P.E. (1974). – A study of viral diseases in Danish rainbow trout, their diagnosis
and control. PhD Thesis, Copenhagen, Denmark, 101 pp.
Villlalba A., Reece K.S., Camino Ordaas M., Casas S.M. & Figueras A. (2004). – Perkinsosis in
molluscs: A review. Aquat. Living Resour., 17, 411–432. doi:10.1051/alr:2004050.
Vishwanath T.S., Mohan C.V. & Shankar K.M. (1997). – Clinical and histopathological characterization
of different types of lesions associated with epizootic ulcerative syndrome (EUS). J. Aquacult. Trop.,
12, 35–42.
Voyles J., Berger L., Young S., Speare R., Webb R., Warner J., Rudd D., Campbell R. & Skerratt L.F.
(2007). – Electrolyte depletion and osmotic imbalance in amphibians with chytridiomycosis. Dis.
Aquat. Organisms, 77, 113–118. doi:10.3354/dao01838.
Warne D. (1988). – Manual on Fish Canning, FAO Fisheries Technical Paper T285. Food and
Agriculture Organization of the United Nations (FAO), Rome, 71 pp.
Wesche S.J., Adlard R.D. & Lester R.J.G. (1999). – Survival of spores of the oyster pathogen Marteilia
sydneyi (Protozoa, Paramyxea) as assessed using fluorogenic dyes. Dis. Aquat. Organisms, 36, 221–
226. doi:10.3354/dao036221.
Whittington R., Kearns C., Hyatt A., Hengstberger S. & Rutzou T. (1996). – Spread of epizootic
haematopoietic necrosis virus (EHNV) in redfin perch (Perca fluviatilis) in southern Australia. Aust.
Vet. J., 73, 112–114. doi:10.1111/j.1751-0813.1996.tb09992.x.
Wizigmann G. & Hoffmann R. (1982). – Vergleichende lichtmikroskopische und immunhistologische
Untersuchugen bei der viralen hämorrhagischen Septikämie (VHS) der Regenbogenforelle. Zentralbl.
Veterinärmed., B, 29, 782–788. doi:10.1111/j.1439-0450.1982.tb01198.x.
Wolf K. (1988). – Fish Viruses and Fish Viral Diseases. Cornell University Press, Ithaca, New York,
476 pp.
Wolf K., Bullock G.L., Dunbar C.E. & Quimby M.C. (1968). – Tadpole edema virus: A viscerotropic
pathogen for anuran amphibians. J. Infect. Dis., 118 (3), 253. doi:10.1093/infdis/118.3.253.
Assessments of the safety of aquatic animal commodities
279
References
Wolf K., Bullock G.L., Dunbar C.E. & Quimby M.C. (1968b). – Progress in Sport Fishery Research. US
Department of the Interior, Resource Publication, 77, 138–139.
Wongteerasupaya C., Vickers J.E., Sriurairatana S., Nash G.L., Akarajamorn A., Boonsaeng V.,
Panyim S., Tassanakajon A., Withyachumnarnkul B. & Flegel T.W. (1995). – A non-occluded,
systemic baculovirus that occurs in cells of ectodermal and mesodermal origin and causes high
mortality in the black tiger prawn Penaeus monodon. Dis. Aquat. Organisms, 21, 69–77.
doi:10.3354/dao021069.
World Health Organization and Food and Agriculture Organization of the United Nations (WHO/FAO)
(2009). – Code of Practice for Fish and Fishery Products, 1st Ed. WHO/FAO, Rome, Italy.
World Organisation for Animal Health (OIE) (2011). – Manual of Diagnostic Tests for Aquatic Animals,
6th Ed. OIE, Paris. Available at: www.oie.int/en/international-standard-setting/terrestrialmanual/access-online/ (accessed on 6 February, 2012).
World Organisation for Animal Health (OIE) (2011a). – Terrestrial Animal Health Code, Chapter 8.5.
Foot
and
mouth
disease.
OIE,
Paris.
Available
at:
web.oie.int/eng/normes/mcode/en_chapitre_1.8.5.htm (accessed on 27 June 2011).
World Organisation for Animal Health (OIE) (2011b). – Aquatic Animal Health Code. OIE, Paris.
Yamamoto T. & Clermont T.J. (1990). – Multiplication of infectious hematopoietic necrosis virus in
rainbow trout following immersion infection: organ assay and electron microscopy. J. Aquat. Anim.
Hlth, 2, 261–270. doi:10.1577/1548-8667(1990)002<0261:MOIHNV>2.3.CO;2.
Yamamoto T., Batts W.N., Arakawa C.K. & Winton J.R. (1990). – Multiplication of infectious
hematopoietic necrosis virus in rainbow trout following immersion infection: whole-body assay and
immunohistochemistry.
J.
Aquat.
Anim.
Hlth,
2
(4),
271–280.
doi:10.1577/15488667(1990)002<0271:MOIHNV>2.3.CO;2.
________________
280
Assessments of the safety of aquatic animal commodities