The following are the current OIE guidlines for monitoring ruminants that were published in 1997. We expect revised guidelines by May of this year I understand.
I noted particularly 3.2.13.3 which was also noted by rsomer in which the US would be under no penalty if they can prove that this US case was imported.
These guidelines are particularily interesting in light of the previous article from UPI where apparently no records of the 20,000 animals tested can be 'found'.
"b)all cases of BSE have been clearly demonstrated to originate directly from importation of live cattle originating from BSE infected countries, provided that the disease is made notifiable and suspect animals are slaughtered, investigated and, if disease is confirmed, completely destroyed and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. points 3) and 4); or"
APPENDIX C
International Animal Health Code
Special Edition 1997
Chapter 3.2.13.
Bovine Spongiform Encephalopathy
(BSE)
Article 3.2.13.1.
Bovine spongiform encephalopathy (BSE) is a progressive nervous disease of adult cattle. BSE has a long incubation period measured in years, and arose from feeding contaminated ruminant protein.
The BSE status of a country can only be determined by continuous surveillance and monitoring. The minimum requirements for effective surveillance are:
1) compulsory notification and clinical investigation of suspect cases;
2) a risk assessment identifying the potential hazards for BSE occurrence:
a) risk arising by:
i) importation of animals or embryos/ova which are potentially infected with a transmissible spongiform encephalopathy (TSE);
ii) importation and feeding of potentially contaminated animal feedstuff to cattle;
b) indigenous risks:
i) consumption, by cattle, of contaminated, animal-derived proteins arising from transmissible spongiform encephalopathy-infected animals and rendering processes which do not inactivate the agent;
ii) potential vertical transmission of BSE from cows originating from infected countries;
3) a continuous BSE surveillance and monitoring system with emphasis on risks identified in point 2) above; and
4) examination in an approved laboratory of brain material from cattle older than 20 months displaying signs of progressive neurologic disease in accordance with the diagnostic techniques set out in the Manual. A sufficient number of investigations as indicated in Table I of the Guidelines for Continuous Surveillance and Monitoring of BSE (Appendix VIII of document 65 SG/12/CS.) should be carried out annually;
in countries where progressive neurologic disease incidence is low, surveillance should be targeted at cattle older than four years of age displaying other progressive disease conditions;
5) records of the number and results of investigations should be maintained for at least seven years.
Each confirmed case should be reported as a separate outbreak.
Article 3.2.13.2.
Countries may be considered free of BSE if:
1) they have implemented a risk management strategy to address any risk, as identified in Article 3.2.13.1. point 2); and
2) The feeding of meat-and-bone meal to cattle derived from ruminants originating from animal TSE infected countries, or countries which do not have an effective and continuous surveillance and monitoring system as described in Article 3.2.13.1 points 3) and 4), has been banned and is effectively enforced;
AND
3) a) there has been no clinical case of BSE, the disease is notifiable, and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. point 3) and 4); or
b)all cases of BSE have been clearly demonstrated to originate directly from importation of live cattle originating from BSE infected countries, provided that the disease is made notifiable and suspect animals are slaughtered, investigated and, if disease is confirmed, completely destroyed and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. points 3) and 4); or
c) BSE has been eradicated (under study).
Article 3.2.13.3.
Veterinary Administrations can authorise without restriction the import or transit through their territory, directly or indirectly, of milk, milk products, tallow, hides and skins originating from healthy animals from countries where BSE has been reported. There is also no scientific evidence of a risk associated with the trade in semen from healthy animals. By-products, such as gelatin and collagen, are considered to be safe if produced by processes (under study) which inactivate any residual BSE infectivity.
Article 3.2.13.4.
When importing from countries with low incidence of BSE, Veterinary Administrations should require:
for cattle
the presentation of an international animal health certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) suspect heifers or cows close to calving are isolated;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the feeding of meat-and-bone meal derived from ruminants to ruminants has been banned and effectively enforced;
6) cattle selected for export:
a) are identified by a permanent mark enabling them to be traced back to the dam and herd of origin;
b) are not the calves of BSE suspect or confirmed females.
Article 3.2.13.5.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for cattle
the presentation of an international animal health certificate attesting, in addition to the requirements set forth in Article 3.2.13.4. that animals for export:
1) either were born after the date on which an effective ban on the use of ruminant meat-and-bone meal in feed for ruminants has been effectively enforced; or
2) were born, raised and had remained in a herd in which no case of BSE had ever been confirmed, and which contains only cattle born on the farm or coming from a herd of equal status; and
3) have never been fed ruminant meat-and-bone meal.
Article 3.2.13.6.
When importing from countries with a low incidence of BSE, Veterinary Administrations should require:
for fresh meat (bone-in or deboned) and meat products from cattle
the presentation of an international sanitary certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) ante mortem inspection is carried out on all bovines;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the meat products do not contain brain, eyes, spinal cord or distal ileum from cattle over six months of age which were born before the date on which the feed ban referred to in paragraph 5) of Article 3.2.13.4. was effectively enforced.
Article 3.2.13.7.
When importing from countries with high incidence of BSE, Veterinary Administration should require:
for fresh bone-in meat from cattle
the presentation of an international sanitary certificate attesting, in addition to the requirements set forth in Article 3.2.13.6., that:
1) the tissues listed in Article 3.2.13.12. are removed from all cattle at slaughter and destroyed;
2) the cattle from which the meat originates:
a) were born after the date on which a ban on the use of ruminant meat-and-bone meal in feed for ruminants has been effectively enforced; or
b) were born and had only been kept in herds in which no case of BSE had been recorded; and
c) have never been fed ruminant meat-and-bone meal.
Article 3.2.13.8.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for fresh deboned meat and meat products from cattle
the presentation of an international sanitary certificate attesting that the conditions in Article 3.2.13.7. apply or alternatively that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) ante mortem inspection is carried out on all bovines;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the tissues listed in Article 3.2.13.12. are removed from all cattle at slaughter and destroyed;
6) nervous and lymphatic tissues exposed during the cutting process have been removed and destroyed.
Article 3.2.13.9.
When importing from countries with a low incidence of BSE, Veterinary Administrations should require:
for bovine embryos/ova
the presentation of an international animal health certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) suspect heifers or cows close to calving are isolated;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the feeding of meat-and-bone meal derived from ruminants to ruminants has been banned and effectively enforced;
6) embryos/ova for export are derived from females which:
a) are not affected with BSE;
b) are not the daughters of BSE affected females; and
c) were not suspected of being so affected at the time of embryo collection.
Article 3.2.13.10.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for bovine embryos/ova
the presentation of an international animal health certificate attesting that embryos/ova for export are derived from females which comply with the conditions in Article 3.2.13.5. and paragraph 6) of Article 3.2.13.9.
Article 3.2.13.11.
Meat-and-bone meal containing any ruminant protein which originates from countries with a high incidence of BSE, should not be traded between countries.
Meat-and-bone meal containing any ruminant protein which originates from countries with a low incidence of BSE, should not be traded between countries for use in ruminant feed. For other uses, it should have been processed in plants which are approved and regularly controlled by the Veterinary Administration following validation that each plant can achieve the processing parameters described in Appendix 4.3.3.1.
Article 3.2.13.12.
Bovine brains, eyes, spinal cord, tonsils, thymus, spleen and distal ileum (tissues under study) and protein products derived from them from cattle over six months of age originating from countries with a high incidence of BSE should not be traded between countries.
Bovine brains, eyes, spinal cord and distal ileum (tissues under study) and protein products derived from them from cattle over six months of age which originate from countries with a low incidence of BSE and were born before the date on which the feed ban referred to in point 5) of Article 3.2.13.4. was effectively enforced, should not be traded between countries, unless they comply with the provisions of Article 3.2.13.11.
Article 3.2.13.13.
Careful selection of source materials is the best way to ensure maximum safety of ingredients or reagents of bovine origin used in the manufacture of medicinal products.
Countries wishing to import bovine materials for such purposes should therefore consider the following factors:
1) the BSE status of the country and herd(s) where the animals have been kept, as determined under the provisions of Article 3.2.13.1. and Article 3.2.13.2.;
2) the age of the donor animals;
3) the tissues required and whether or not they will be pooled samples or derived from a single animal.
Additional factors may be considered in assessing the risk from BSE, i.e.:
1) precautions to avoid contamination during collection of tissues;
2) the process to which the material will be subjected during manufacture;
3) the amount of material to be administered;
4) the route of administration.
1Shrieber, R. 1997. Presentation to the FDA Transmissible Spongiform Encephalopathy Advisory Committee, April 23, 1997. Transcript is available in hard copy or on disk from Freedom of Information, HFI-35, Food and Drug Administration, Rockville, MD 20857.
2Office International des Epizooties. 1997. International Animal Health Code, Special Edition, Chapter 3.2.13. pp. 267-274, Paris.
* * * * * * * * * * * *
Reprinted by permission from the Office International des Epizooties.
I noted particularly 3.2.13.3 which was also noted by rsomer in which the US would be under no penalty if they can prove that this US case was imported.
These guidelines are particularily interesting in light of the previous article from UPI where apparently no records of the 20,000 animals tested can be 'found'.
"b)all cases of BSE have been clearly demonstrated to originate directly from importation of live cattle originating from BSE infected countries, provided that the disease is made notifiable and suspect animals are slaughtered, investigated and, if disease is confirmed, completely destroyed and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. points 3) and 4); or"
APPENDIX C
International Animal Health Code
Special Edition 1997
Chapter 3.2.13.
Bovine Spongiform Encephalopathy
(BSE)
Article 3.2.13.1.
Bovine spongiform encephalopathy (BSE) is a progressive nervous disease of adult cattle. BSE has a long incubation period measured in years, and arose from feeding contaminated ruminant protein.
The BSE status of a country can only be determined by continuous surveillance and monitoring. The minimum requirements for effective surveillance are:
1) compulsory notification and clinical investigation of suspect cases;
2) a risk assessment identifying the potential hazards for BSE occurrence:
a) risk arising by:
i) importation of animals or embryos/ova which are potentially infected with a transmissible spongiform encephalopathy (TSE);
ii) importation and feeding of potentially contaminated animal feedstuff to cattle;
b) indigenous risks:
i) consumption, by cattle, of contaminated, animal-derived proteins arising from transmissible spongiform encephalopathy-infected animals and rendering processes which do not inactivate the agent;
ii) potential vertical transmission of BSE from cows originating from infected countries;
3) a continuous BSE surveillance and monitoring system with emphasis on risks identified in point 2) above; and
4) examination in an approved laboratory of brain material from cattle older than 20 months displaying signs of progressive neurologic disease in accordance with the diagnostic techniques set out in the Manual. A sufficient number of investigations as indicated in Table I of the Guidelines for Continuous Surveillance and Monitoring of BSE (Appendix VIII of document 65 SG/12/CS.) should be carried out annually;
in countries where progressive neurologic disease incidence is low, surveillance should be targeted at cattle older than four years of age displaying other progressive disease conditions;
5) records of the number and results of investigations should be maintained for at least seven years.
Each confirmed case should be reported as a separate outbreak.
Article 3.2.13.2.
Countries may be considered free of BSE if:
1) they have implemented a risk management strategy to address any risk, as identified in Article 3.2.13.1. point 2); and
2) The feeding of meat-and-bone meal to cattle derived from ruminants originating from animal TSE infected countries, or countries which do not have an effective and continuous surveillance and monitoring system as described in Article 3.2.13.1 points 3) and 4), has been banned and is effectively enforced;
AND
3) a) there has been no clinical case of BSE, the disease is notifiable, and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. point 3) and 4); or
b)all cases of BSE have been clearly demonstrated to originate directly from importation of live cattle originating from BSE infected countries, provided that the disease is made notifiable and suspect animals are slaughtered, investigated and, if disease is confirmed, completely destroyed and an effective and continuous surveillance and monitoring system is practised, as described in Article 3.2.13.1. points 3) and 4); or
c) BSE has been eradicated (under study).
Article 3.2.13.3.
Veterinary Administrations can authorise without restriction the import or transit through their territory, directly or indirectly, of milk, milk products, tallow, hides and skins originating from healthy animals from countries where BSE has been reported. There is also no scientific evidence of a risk associated with the trade in semen from healthy animals. By-products, such as gelatin and collagen, are considered to be safe if produced by processes (under study) which inactivate any residual BSE infectivity.
Article 3.2.13.4.
When importing from countries with low incidence of BSE, Veterinary Administrations should require:
for cattle
the presentation of an international animal health certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) suspect heifers or cows close to calving are isolated;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the feeding of meat-and-bone meal derived from ruminants to ruminants has been banned and effectively enforced;
6) cattle selected for export:
a) are identified by a permanent mark enabling them to be traced back to the dam and herd of origin;
b) are not the calves of BSE suspect or confirmed females.
Article 3.2.13.5.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for cattle
the presentation of an international animal health certificate attesting, in addition to the requirements set forth in Article 3.2.13.4. that animals for export:
1) either were born after the date on which an effective ban on the use of ruminant meat-and-bone meal in feed for ruminants has been effectively enforced; or
2) were born, raised and had remained in a herd in which no case of BSE had ever been confirmed, and which contains only cattle born on the farm or coming from a herd of equal status; and
3) have never been fed ruminant meat-and-bone meal.
Article 3.2.13.6.
When importing from countries with a low incidence of BSE, Veterinary Administrations should require:
for fresh meat (bone-in or deboned) and meat products from cattle
the presentation of an international sanitary certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) ante mortem inspection is carried out on all bovines;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the meat products do not contain brain, eyes, spinal cord or distal ileum from cattle over six months of age which were born before the date on which the feed ban referred to in paragraph 5) of Article 3.2.13.4. was effectively enforced.
Article 3.2.13.7.
When importing from countries with high incidence of BSE, Veterinary Administration should require:
for fresh bone-in meat from cattle
the presentation of an international sanitary certificate attesting, in addition to the requirements set forth in Article 3.2.13.6., that:
1) the tissues listed in Article 3.2.13.12. are removed from all cattle at slaughter and destroyed;
2) the cattle from which the meat originates:
a) were born after the date on which a ban on the use of ruminant meat-and-bone meal in feed for ruminants has been effectively enforced; or
b) were born and had only been kept in herds in which no case of BSE had been recorded; and
c) have never been fed ruminant meat-and-bone meal.
Article 3.2.13.8.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for fresh deboned meat and meat products from cattle
the presentation of an international sanitary certificate attesting that the conditions in Article 3.2.13.7. apply or alternatively that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) ante mortem inspection is carried out on all bovines;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the tissues listed in Article 3.2.13.12. are removed from all cattle at slaughter and destroyed;
6) nervous and lymphatic tissues exposed during the cutting process have been removed and destroyed.
Article 3.2.13.9.
When importing from countries with a low incidence of BSE, Veterinary Administrations should require:
for bovine embryos/ova
the presentation of an international animal health certificate attesting that:
1) the disease is compulsorily notifiable;
2) affected cattle are slaughtered and completely destroyed;
3) suspect heifers or cows close to calving are isolated;
4) an effective and continuous surveillance and monitoring system is practised in accordance with Article 3.2.13.1.;
5) the feeding of meat-and-bone meal derived from ruminants to ruminants has been banned and effectively enforced;
6) embryos/ova for export are derived from females which:
a) are not affected with BSE;
b) are not the daughters of BSE affected females; and
c) were not suspected of being so affected at the time of embryo collection.
Article 3.2.13.10.
When importing from countries with a high incidence of BSE, Veterinary Administrations should require:
for bovine embryos/ova
the presentation of an international animal health certificate attesting that embryos/ova for export are derived from females which comply with the conditions in Article 3.2.13.5. and paragraph 6) of Article 3.2.13.9.
Article 3.2.13.11.
Meat-and-bone meal containing any ruminant protein which originates from countries with a high incidence of BSE, should not be traded between countries.
Meat-and-bone meal containing any ruminant protein which originates from countries with a low incidence of BSE, should not be traded between countries for use in ruminant feed. For other uses, it should have been processed in plants which are approved and regularly controlled by the Veterinary Administration following validation that each plant can achieve the processing parameters described in Appendix 4.3.3.1.
Article 3.2.13.12.
Bovine brains, eyes, spinal cord, tonsils, thymus, spleen and distal ileum (tissues under study) and protein products derived from them from cattle over six months of age originating from countries with a high incidence of BSE should not be traded between countries.
Bovine brains, eyes, spinal cord and distal ileum (tissues under study) and protein products derived from them from cattle over six months of age which originate from countries with a low incidence of BSE and were born before the date on which the feed ban referred to in point 5) of Article 3.2.13.4. was effectively enforced, should not be traded between countries, unless they comply with the provisions of Article 3.2.13.11.
Article 3.2.13.13.
Careful selection of source materials is the best way to ensure maximum safety of ingredients or reagents of bovine origin used in the manufacture of medicinal products.
Countries wishing to import bovine materials for such purposes should therefore consider the following factors:
1) the BSE status of the country and herd(s) where the animals have been kept, as determined under the provisions of Article 3.2.13.1. and Article 3.2.13.2.;
2) the age of the donor animals;
3) the tissues required and whether or not they will be pooled samples or derived from a single animal.
Additional factors may be considered in assessing the risk from BSE, i.e.:
1) precautions to avoid contamination during collection of tissues;
2) the process to which the material will be subjected during manufacture;
3) the amount of material to be administered;
4) the route of administration.
1Shrieber, R. 1997. Presentation to the FDA Transmissible Spongiform Encephalopathy Advisory Committee, April 23, 1997. Transcript is available in hard copy or on disk from Freedom of Information, HFI-35, Food and Drug Administration, Rockville, MD 20857.
2Office International des Epizooties. 1997. International Animal Health Code, Special Edition, Chapter 3.2.13. pp. 267-274, Paris.
* * * * * * * * * * * *
Reprinted by permission from the Office International des Epizooties.
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