Developed: October 16, 2001
Latest Revision: September 20, 2005
Implementation Guideline for Transmissible Spongiform
Encephalopathy (TSE) Testing
1 Purpose
This guideline aims to ensure the safety of meat, following the identification of Bovine
Spongiform Encephalopathy (hereinafter referred to as “BSE”) case in Japan. To relieve the
public concerns, tests shall be conducted for Transmissible Spongiform Encephalopathy
(hereinafter referred to as “TSE”), based on the Abattoirs Law (Law No. 114 in 1953;
hereinafter referred to as “the Law”), to ensure that TSE-infected bovine, sheep and goat shall
not be distributed for food, while contributing to the assessment of TSE infection status in
Japan.2 Necessity of TSE tests
To ensure safety of meat at abattoirs, it is necessary to exclude flesh, etc. derived from
TSE-infected animals, which may be contaminated by high-density abnormal prion protein, in
combination to adequate removal of specified risk materials, in which abnormal prion is
accumulated. For this purpose, TSE tests shall be conducted in conformity of Article 14 of the
Law.
3 Instructions concerning application for TSE tests, and notes on receiving the tests
(1) Applicants for carcass inspection shall be instructed beforehand on the following issues.
Instructions shall be also given to related businesses as necessary.
a Applicants shall indicate the ages of bovines on a month basis, when submitting
application for carcass inspection stipulated in Section 1, Article 15 of the
Implementation Rules for the Abattoirs Law (hereinafter referred to as “Rules”).
Applicants shall also attach documents identifying month ages of the bovines, such
as copy of database for individual identification of cattle, in conformity with the
Law Concerning Special Measures for the Management and Transmission of
Information on Individual Identification of Cattle (Law No. 72 in 2003); calf
registration certificate (issued by the Wagyu Registry Association), and/or pedigree
registration certificate (issued by the Japan Holstein Registry Association) as
necessary.
As for sheep and goat, it is desirable to attach documents identifying month ages of
the sheep or goat, such as sheep/goat pedigree registration certificate (issued by the
Japan Livestock Technology Association).
b Applicants shall also make prior confirmation on the information concerning names,
addresses, etc. of senders/raisers of the cattle. This information is necessary for
survey by the supervising livestock agencies, in case of TSE tests turn positive.
(2) Attention shall be paid on the following points, when receiving application for carcass
inspection.
a Confirm the month ages of applied bovines, in both the “age” column of carcass
inspection application and documents specified in (1) a.
As for the month ages of sheep/goat, confirm the documents as specified in (1) a, if
such documents are attached.
b If information as specified (1) b is not clear, instruct the applicant to make
necessary confirmations.
4 Ante-mortem inspection
(1) In the inspection based on provisions of Section 1, Article 14 of the Law, conduct the
dentition examination for bovines, and make comprehensive judgment of month ages,
referring to the documents stipulated in 3 (1) a, attached to the carcass inspection
application. If the third incisor tooth is present, the bovine shall be judged 30 months or
older, regardless of the information on carcass inspection application.Conduct the dentition examination for sheep and goat as well. Eruption of the second
permanent molars (in both upper and lower jaws) shall be an indicator for the judgment of
12 months old.
(2) Also check the existence of strange cries, turning around and other abnormal behaviors,
ataxia and other nervous symptoms, combined with the results of gait checks.
Refer to the video concerning clinical symptoms of Transmissible Spongiform
Encephalopathy, dispatched based on the Clerical Notice dated March 26, 2003, for the
implementation of ante-mortem inspection.
5 Measures based on the results of ante-mortem inspection
(1) If the tested bovine, sheep or goat corresponds to 4 (2) as a result of ante-mortem
inspection, and is suspected of TSE-infection (“suspected case” as stipulated in Article 2
of the Domestic Animal Infectious Diseases Control Law), slaughtering or dressing of
such bovine/sheep/goat shall be prohibited in accordance with the provisions of Item 1,
Article 16 of the Law, because slaughtering or dressing of such livestock may lead to
contamination by the infectious agent (i.e. abnormal prion protein).
(2) If a meat inspection station takes the measure stipulated in (1), that station shall notify the
fact to the applicant, the abattoir founder, and other related parties. The station shall also
report to food sanitation departments of the relevant prefectures and municipalities
operating health centers (hereinafter referred to as “prefectures”), which shall in turn
report to livestock departments of the relevant prefectures. The information shall be also
provided to food sanitation departments and livestock departments of the prefectures
supervising the sender’s location.
(3) Even if a meat inspection station takes the measure of prohibiting slaughtering or
dressing in accordance with the provisions of Item 1, Article 16 of the Law, for
bovine/sheep/goat indicating systemic symptoms in which TSE symptoms are not
identified, but for sepsis, severe jaundice, or other reasons than the above, that station
shall also notify the fact to the applicant, the abattoir founder, and other related parties.
The station shall also report to food sanitation departments of the relevant prefectures,
which shall in turn report to livestock departments of the relevant prefectures. The
information shall be also provided to food sanitation departments and livestock
departments of the prefectures supervising the sender’s location.
6 Post-mortem inspection
(1) Inspection for bovines, etc.
a As a rule, screening tests shall be conducted on the day of slaughter for bovines
aged 21 months or older.
Screening tests may be conducted for bovines aged 20 months or younger, if it is
considered necessary by livestock inspectors from disease identification point of
view.
b Results of the screening and confirmatory testing shall be compiled in the following
categories:
a) Bovine aged 24 months or older, indicating suspected symptoms including
movement disorders, perception disorders, reflection/consciousness
disorders and other nervous symptoms, and/or systemic symptoms in
ante-mortem inspection;
b) Bovine aged 30 months or older; and
c) Other bovines.
(2) Tests for sheep and goat, etc.
a As a rule, screening tests shall be conducted on the day of slaughter for sheep/goat
aged 12 months or older.
Screening tests may be conducted for sheep/goat aged 11 months or younger, if it is
considered necessary by livestock inspectors from the standpoint of disease
differentiation.
b Results of the screening and confirmatory testing shall be compiled.
(3) Sampling, etc.
For samples of bovine/sheep/goat, take medulla oblongata through the foramen magnum
opening by using spatula technique and so on. Use part of one side of the medulla
oblongata as sample for screening test, conducted in conformity with “Guideline for
Screening Tests of Transmissible Spongiform Encephalopathy (TSE)” (Attachment 1).
The remainder of medulla oblongata shall be frozen as sample to be sent.
The other side of medulla oblongata shall be fixed with 15 - 20% solution of buffer
formalin, as sample to be sent. This fixation shall be performed promptly after sampling.
If it is difficult, the fixation must be performed promptly after the results of ELISA test
are given.
If medulla oblongata is damaged during the pithing operation, and the position for
sampling is not clear, samples shall be taken from multiple locations.
(4) Measures to be taken in case the screening test turns positive
Following the conclusion of the screening test (i.e. end of the second ELISA test), and the
test results turn out to be positive, then the meat inspection station shall immediately
notify the fact to the applicant, the abattoir founder, and other related parties. The station
shall also report to food sanitation departments of the relevant prefectures, which shall in
turn report to livestock departments of the relevant prefectures. The information shall be
also provided to food sanitation departments and livestock departments of the prefectures
supervising the location of the sender of the relevant bovine/sheep/goat.
To conduct the confirmatory testing for the relevant bovine/sheep/goat, send the samples
put aside in (3) to institutions designated in a separate notice. If the testing should be
conducted by prefectures, the testing shall conform to Separate Attachment 2, “Procedure
for Confirmatory Testing of Transmissible Spongiform Encephalopathy (TSE) by
Prefecturral and City Governments.”
(5) Notification on results of the confirmatory testing
Results of the confirmatory testing shall be notified to food sanitation departments of the
relevant prefectures, by way of the Inspection and Safety Division, Department of Food
Safety, Pharmaceutical and Food Safety Bureau, MHLW (hereinafter referred to as
“Inspection and Safety Division”), from the institution stipulated in (4), which has
conducted the confirmatory testing. If the testing has been conducted by prefectures, the
results shall be notified to the Inspection and Safety Division by way of food sanitation
departments of the relevant prefectures.
Food sanitation departments of the relevant prefectures shall notify the results of
confirmatory testing immediately to the applicant, the abattoir founder, and other related
parties. Food sanitation departments shall also provide information to livestock
departments of the relevant prefectures, as well as food sanitation departments and
livestock departments of the prefectures supervising the sender’s location.
(6) Definitive diagnosis
If the results of screening and confirmatory testing turn out TSE-positive, the Expert
Committee for the Testing of Bovine Spongiform Encephalopathy of the Ministry of
Health, Labour and Welfare shall make the definitive diagnosis.
(7) Measures concerning carcass, etc. during screening and confirmatory testing
While screening and confirmatory testing are underway, dressed carcass, viscera, blood
(to be reused only), bone, hide, heads, legs, tails, etc. of the corresponding
bovine/sheep/goat, including the separated parts to be disposed, shall be stored so that
identification should be available, and that the edible parts should not be contaminated by
microbes, etc. If storage by individual carcass is difficult, several carcasses or a daily
handling lot may be stored together. In case of TSE-positive, such lots may be treated (i.e.
incinerated) together.
Latest Revision: September 20, 2005
Implementation Guideline for Transmissible Spongiform
Encephalopathy (TSE) Testing
1 Purpose
This guideline aims to ensure the safety of meat, following the identification of Bovine
Spongiform Encephalopathy (hereinafter referred to as “BSE”) case in Japan. To relieve the
public concerns, tests shall be conducted for Transmissible Spongiform Encephalopathy
(hereinafter referred to as “TSE”), based on the Abattoirs Law (Law No. 114 in 1953;
hereinafter referred to as “the Law”), to ensure that TSE-infected bovine, sheep and goat shall
not be distributed for food, while contributing to the assessment of TSE infection status in
Japan.2 Necessity of TSE tests
To ensure safety of meat at abattoirs, it is necessary to exclude flesh, etc. derived from
TSE-infected animals, which may be contaminated by high-density abnormal prion protein, in
combination to adequate removal of specified risk materials, in which abnormal prion is
accumulated. For this purpose, TSE tests shall be conducted in conformity of Article 14 of the
Law.
3 Instructions concerning application for TSE tests, and notes on receiving the tests
(1) Applicants for carcass inspection shall be instructed beforehand on the following issues.
Instructions shall be also given to related businesses as necessary.
a Applicants shall indicate the ages of bovines on a month basis, when submitting
application for carcass inspection stipulated in Section 1, Article 15 of the
Implementation Rules for the Abattoirs Law (hereinafter referred to as “Rules”).
Applicants shall also attach documents identifying month ages of the bovines, such
as copy of database for individual identification of cattle, in conformity with the
Law Concerning Special Measures for the Management and Transmission of
Information on Individual Identification of Cattle (Law No. 72 in 2003); calf
registration certificate (issued by the Wagyu Registry Association), and/or pedigree
registration certificate (issued by the Japan Holstein Registry Association) as
necessary.
As for sheep and goat, it is desirable to attach documents identifying month ages of
the sheep or goat, such as sheep/goat pedigree registration certificate (issued by the
Japan Livestock Technology Association).
b Applicants shall also make prior confirmation on the information concerning names,
addresses, etc. of senders/raisers of the cattle. This information is necessary for
survey by the supervising livestock agencies, in case of TSE tests turn positive.
(2) Attention shall be paid on the following points, when receiving application for carcass
inspection.
a Confirm the month ages of applied bovines, in both the “age” column of carcass
inspection application and documents specified in (1) a.
As for the month ages of sheep/goat, confirm the documents as specified in (1) a, if
such documents are attached.
b If information as specified (1) b is not clear, instruct the applicant to make
necessary confirmations.
4 Ante-mortem inspection
(1) In the inspection based on provisions of Section 1, Article 14 of the Law, conduct the
dentition examination for bovines, and make comprehensive judgment of month ages,
referring to the documents stipulated in 3 (1) a, attached to the carcass inspection
application. If the third incisor tooth is present, the bovine shall be judged 30 months or
older, regardless of the information on carcass inspection application.Conduct the dentition examination for sheep and goat as well. Eruption of the second
permanent molars (in both upper and lower jaws) shall be an indicator for the judgment of
12 months old.
(2) Also check the existence of strange cries, turning around and other abnormal behaviors,
ataxia and other nervous symptoms, combined with the results of gait checks.
Refer to the video concerning clinical symptoms of Transmissible Spongiform
Encephalopathy, dispatched based on the Clerical Notice dated March 26, 2003, for the
implementation of ante-mortem inspection.
5 Measures based on the results of ante-mortem inspection
(1) If the tested bovine, sheep or goat corresponds to 4 (2) as a result of ante-mortem
inspection, and is suspected of TSE-infection (“suspected case” as stipulated in Article 2
of the Domestic Animal Infectious Diseases Control Law), slaughtering or dressing of
such bovine/sheep/goat shall be prohibited in accordance with the provisions of Item 1,
Article 16 of the Law, because slaughtering or dressing of such livestock may lead to
contamination by the infectious agent (i.e. abnormal prion protein).
(2) If a meat inspection station takes the measure stipulated in (1), that station shall notify the
fact to the applicant, the abattoir founder, and other related parties. The station shall also
report to food sanitation departments of the relevant prefectures and municipalities
operating health centers (hereinafter referred to as “prefectures”), which shall in turn
report to livestock departments of the relevant prefectures. The information shall be also
provided to food sanitation departments and livestock departments of the prefectures
supervising the sender’s location.
(3) Even if a meat inspection station takes the measure of prohibiting slaughtering or
dressing in accordance with the provisions of Item 1, Article 16 of the Law, for
bovine/sheep/goat indicating systemic symptoms in which TSE symptoms are not
identified, but for sepsis, severe jaundice, or other reasons than the above, that station
shall also notify the fact to the applicant, the abattoir founder, and other related parties.
The station shall also report to food sanitation departments of the relevant prefectures,
which shall in turn report to livestock departments of the relevant prefectures. The
information shall be also provided to food sanitation departments and livestock
departments of the prefectures supervising the sender’s location.
6 Post-mortem inspection
(1) Inspection for bovines, etc.
a As a rule, screening tests shall be conducted on the day of slaughter for bovines
aged 21 months or older.
Screening tests may be conducted for bovines aged 20 months or younger, if it is
considered necessary by livestock inspectors from disease identification point of
view.
b Results of the screening and confirmatory testing shall be compiled in the following
categories:
a) Bovine aged 24 months or older, indicating suspected symptoms including
movement disorders, perception disorders, reflection/consciousness
disorders and other nervous symptoms, and/or systemic symptoms in
ante-mortem inspection;
b) Bovine aged 30 months or older; and
c) Other bovines.
(2) Tests for sheep and goat, etc.
a As a rule, screening tests shall be conducted on the day of slaughter for sheep/goat
aged 12 months or older.
Screening tests may be conducted for sheep/goat aged 11 months or younger, if it is
considered necessary by livestock inspectors from the standpoint of disease
differentiation.
b Results of the screening and confirmatory testing shall be compiled.
(3) Sampling, etc.
For samples of bovine/sheep/goat, take medulla oblongata through the foramen magnum
opening by using spatula technique and so on. Use part of one side of the medulla
oblongata as sample for screening test, conducted in conformity with “Guideline for
Screening Tests of Transmissible Spongiform Encephalopathy (TSE)” (Attachment 1).
The remainder of medulla oblongata shall be frozen as sample to be sent.
The other side of medulla oblongata shall be fixed with 15 - 20% solution of buffer
formalin, as sample to be sent. This fixation shall be performed promptly after sampling.
If it is difficult, the fixation must be performed promptly after the results of ELISA test
are given.
If medulla oblongata is damaged during the pithing operation, and the position for
sampling is not clear, samples shall be taken from multiple locations.
(4) Measures to be taken in case the screening test turns positive
Following the conclusion of the screening test (i.e. end of the second ELISA test), and the
test results turn out to be positive, then the meat inspection station shall immediately
notify the fact to the applicant, the abattoir founder, and other related parties. The station
shall also report to food sanitation departments of the relevant prefectures, which shall in
turn report to livestock departments of the relevant prefectures. The information shall be
also provided to food sanitation departments and livestock departments of the prefectures
supervising the location of the sender of the relevant bovine/sheep/goat.
To conduct the confirmatory testing for the relevant bovine/sheep/goat, send the samples
put aside in (3) to institutions designated in a separate notice. If the testing should be
conducted by prefectures, the testing shall conform to Separate Attachment 2, “Procedure
for Confirmatory Testing of Transmissible Spongiform Encephalopathy (TSE) by
Prefecturral and City Governments.”
(5) Notification on results of the confirmatory testing
Results of the confirmatory testing shall be notified to food sanitation departments of the
relevant prefectures, by way of the Inspection and Safety Division, Department of Food
Safety, Pharmaceutical and Food Safety Bureau, MHLW (hereinafter referred to as
“Inspection and Safety Division”), from the institution stipulated in (4), which has
conducted the confirmatory testing. If the testing has been conducted by prefectures, the
results shall be notified to the Inspection and Safety Division by way of food sanitation
departments of the relevant prefectures.
Food sanitation departments of the relevant prefectures shall notify the results of
confirmatory testing immediately to the applicant, the abattoir founder, and other related
parties. Food sanitation departments shall also provide information to livestock
departments of the relevant prefectures, as well as food sanitation departments and
livestock departments of the prefectures supervising the sender’s location.
(6) Definitive diagnosis
If the results of screening and confirmatory testing turn out TSE-positive, the Expert
Committee for the Testing of Bovine Spongiform Encephalopathy of the Ministry of
Health, Labour and Welfare shall make the definitive diagnosis.
(7) Measures concerning carcass, etc. during screening and confirmatory testing
While screening and confirmatory testing are underway, dressed carcass, viscera, blood
(to be reused only), bone, hide, heads, legs, tails, etc. of the corresponding
bovine/sheep/goat, including the separated parts to be disposed, shall be stored so that
identification should be available, and that the edible parts should not be contaminated by
microbes, etc. If storage by individual carcass is difficult, several carcasses or a daily
handling lot may be stored together. In case of TSE-positive, such lots may be treated (i.e.
incinerated) together.