Animals > Imports > Policies / Procedures  

BSE import policy for bovine animals and their products

AHPD-DSAE-IE-2005-9-1

December, 2005

Main Page - BSE

1. Bovine animals

For the purpose of this policy, bovine animals consist of cattle and bison. Taxonomically they are classified as members of the Subfamily Bovinae¹ from the genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).

2. Importing commodities into Canada

Depending on the nature of the commodity, certain BSE related restrictions may be applicable. Those commodities listed in section 3 may be generally imported into or transit Canada regardless of the BSE status of a country while commodities listed in sections 4 and 5 may be subjected to certain restrictions depending on the BSE status of the country, which is determined on the basis of a risk assessment as detailed in Appendix 1. However, before undertaking a risk assessment for a particular country it is important to determine the range of commodities for which a country is seeking market access. In many cases it is likely that a risk assessment will not be required. For example, if a country that has reported BSE cases within the preceding seven years is interested in just exporting meat and meat products, cell lines and veterinary biologics to Canada, a risk assessment would not be necessary as the measures for these commodities are the same regardless of whether it would be classified as Category 2 (controlled BSE-risk) or Category 3 (undetermined BSE-risk). On the other hand, a risk assessment would be required before a country, that has not reported BSE, could export these commodities without BSE related restrictions to determine if it qualifies for Category 1 (negligible BSE-risk).

If a risk assessment has not been undertaken for a particular country the applicable measures are those prescribed for countries as having an undetermined BSE-risk (Category 3). It is important to note that before a particular commodity can be imported other conditions must still be met. For example, before meat and meat products can be imported, the Canadian Food inspection Agency (CFIA) must evaluate and approve the meat inspection system of a country and specific measures for other diseases of concern must also be met. In addition, there may be other restrictions impacting on the end use of the product within Canada, for example, restrictions governing the end use of bovine blood and blood products in the preparation of drugs (including pharmaceuticals, and natural health care products), which are under the mandate of Health Canada. It is the responsibility of the importer to ensure compliance with the specific requirements of the Canadian regulatory authority responsible for the end use of imported products.

Table 1 summarises the list of commodities covered by this import policy in sections 3-5 and their associated BSE-related restrictions detailed in section 6. Commodities not included in this table will be assessed on a case by case basis taking into account the nature of the product, the methods of production and proposed use with applicable conditions developed on the basis of a risk assessment.

In developing measures necessary to protect human or animal life or health World Trade Organization Members have certain rights and obligations, which are detailed in the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) as well as the SPS provisions of the North American Free Trade Agreement (NAFTA). One important obligation relates to the concept of equivalence, which is the capability of different sanitary measures to achieve the same outcome. In applying this policy, provided a trading partner can objectively demonstrate that its measures achieve the same level of protection as those required by Canada, it is the Government of Canada’s intention that the trading partner’s measures be accepted as equivalent.

Table 1: BSE-related restrictions for certain commodities derived from bovine animals or containing material of bovine origin. Note that this table provides a general summary. For a complete description of the applicable conditions refer to the relevant section in the text.

3. Commodities that can be imported into or transit Canada regardless of the BSE status of an exporting country

The following commodities derived from bovine animals can be imported into or transit Canada regardless of the BSE status of an exporting country:

• milk and milk products;
• semen and in vivo derived bovine embryos collected and handled in accordance with the recommendations of the International Embryo Transfer Society;
• hides and skins;
• gelatin and collagen prepared exclusively from hides and skins (excluding hides and skins from the head);
• protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives made from this tallow²;
• dicalcium phosphate (with no trace of protein or fat)²;
• deboned skeletal muscle meat (excluding mechanically separated meat) from bovine animals 30 months of age or less, which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM;
• blood and blood by-products, from bovine animals which were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a pithing process, or to a pithing process, and which were subject to ante-mortem and post-mortem inspections and were not suspect or confirmed BSE cases, and which has been prepared in a manner to avoid contamination with SRM.

4. Commodities prohibited from importation into Canada

Ruminant derived meat-and-bone meal or greaves, or any commodities containing such products are specifically prohibited from importation into Canada unless a risk assessment has been undertaken and the country is classified as Category 1 (negligible BSE-risk).

An exemption from this prohibition may be considered on a case-by-case basis if the materials used in the production of ruminant derived meat-and-bone meal or greaves, or any commodities containing such products have undergone a treatment or process to eliminate the BSE-agent equivalent to that applied in Canada. Details of the treatment or process deemed to be equivalent together with supporting data and references as appropriate should be provided to CFIA for approval.

5. Commodities that can be imported into or transit Canada subject to certain BSE-related measures

The following commodities derived from bovine animals or containing material of bovine origin are subject to certain BSE-related measures before they can be imported into or transit Canada:

• live animals;
• meat and meat products other than deboned skeletal muscle meat as defined in section 3 (g);
• gelatin and collagen prepared from bones intended for food, animal food, fertilisers, veterinary biologics, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products) or medical devices;
• tallow and tallow derivatives, and dicalcium phosphate, other than protein-free tallow and dicalcium phosphate (with no trace of protein or fat) as defined in section 3 (e) intended for food, animal food, fertilisers, veterinary biologics, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products) or medical devices;
• Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics;
• Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics;
• Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons;
• cell lines;
• veterinary biologics (vaccines, antibody products and diagnostic kits).

The types of measures that are applicable are dependant on the BSE-risk category of the exporting country, which is determined by a risk assessment as outlined in Appendix 1. The relevant measures are set down in section 6 for each of the three BSE-risk categories:

• Category 1. negligible BSE-risk
• Category 2. controlled BSE-risk
• Category 3. undetermined BSE-risk

If a risk assessment has not been undertaken for a particular country the applicable measures are those prescribed for a category 3 country (undetermined BSE-risk). Commodities not included in this section will be assessed on a case by case basis taking into account the nature of the product, the methods of production and proposed end use with applicable conditions developed on the basis of a risk assessment.

6. Risk management measures

6.1. Category 1 Countries (negligible BSE-risk)

6.1.1. Definition

Category 1 countries are those countries that:

• a) have never reported a BSE-case, and where,
  either:

  the conclusion of risk assessment is that the likelihood that BSE exists in the country is negligible,

  or where:

  the conclusion of the risk assessment indicates that the likelihood of the bovine animal population having been exposed to a TSE-agent within the last 7 years is negligible and that the level of surveillance maintained during at least the last 7 years should have detected BSE cases if they were present.

Or:

• b) have not reported BSE-cases in imported and/or indigenous animals for a period of at least seven years and have satisfied each of the following conditions throughout the same period:

  • the likelihood of imported commodities being contaminated or infected with a TSE-agent has remained negligible;
  • the likelihood of bovine animals having been exposed to a TSE that exists in the country’s domestic or wild ruminant population has remained negligible;
  • the measures to eradicate BSE have been maintained;
  • a level of surveillance capable of demonstrating the effectiveness of the eradication measures has been maintained without the detection of any BSE-cases.

The risk assessment for a country in this category must be reviewed regularly to ensure that it continues to qualify as a Category 1 country.

6.1.2. General provisions

• BSE is compulsorily notifiable.
• The Veterinary Administration has authority over any animal suspected or confirmed of having BSE. This is needed to ensure that a thorough investigation is undertaken and that affected animals, when slaughtered or at death, are completely destroyed.

6.1.3. Cell lines and Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

Considering that cell lines and veterinary biologics often contain ingredients from a variety of sources, some of which may have been imported into the country, it is important to ensure that such ingredients do not contain or are not contaminated with the BSE-agent. As a result, certification is required for all cell lines and veterinary biologics that they do not contain any imported ingredients from a country classified as Category 2 (controlled BSE-risk) or Category 3 (undetermined BSE-risk) that may have been:

• prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
• prepared from or contain the following specified risk materials (SRM):
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
  • the small intestine and tonsils from bovine animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement for cell lines and veterinary biologics will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.

6.1.4. Commodities other than cell lines and Veterinary biologics

While specific measures for BSE are not necessary for all other commodities derived from bovine animals, before a particular commodity can be imported other relevant conditions must still be met, for example, the evaluation and approval of the meat inspection system of a country and specific measures for other diseases of concern.

6.2. Category 2 Countries (controlled BSE-risk)

6.2.1. Definition

Category 2 countries are those countries where:

• it is likely that imported commodities were contaminated or infected with a TSE-agent, and/or;
• it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
• either indigenous BSE-cases have been reported, or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
• the measures in place are effectively controlling BSE and are likely to lead to its eradication.

The risk assessment for a country in this category must be reviewed regularly to ensure that it continues to qualify as a Category 2 country.

6.2.2. General provisions

• The feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced in the whole country;
• BSE is compulsorily notifiable;
• The Veterinary Administration has authority over any animal suspected or confirmed of having BSE. This is needed to ensure that a thorough investigation is undertaken and that affected animals, when slaughtered or at death, are completely destroyed.

6.2.3. Live bovine animals

Certification by the Veterinary Administration that the animal:

• is identified by a permanent identification system enabling it to be traced back to its dam and herd of origin;
• was born after the implementation of the feed ban;
• was not fed ruminant proteins prohibited under the feed ban during its lifetime;
• is not the progeny of a BSE suspect or confirmed female;
• was not reared during its first year of life with a BSE suspect or confirmed case;
• was not born in the same herd and within 12 months of the birth of a BSE suspect or confirmed case.

An exemption from these requirements for live bovine animals will be considered on a case-by-case basis considering the intended use of the animals, for example, animals imported for a temporary stay; animals for immediate slaughter; animals imported for medical use, scientific research or zoological collections; bulls destined for semen production centers.

6.2.4. Meat and meat products from bovine animals other than deboned skeletal muscle meat as defined in section 3 (g)

Certification by the Veterinary Administration that:

• ante-mortem and post-mortem inspection is carried out on all bovine animals from which the meat or meat products originate;
• where the meat or meat products are destined for human consumption they have been passed as fit for human consumption in the country of origin;
• the facility in which the animals are slaughtered and processed is approved and inspected by the Veterinary Administration;
• the animals from which the meat or meat products destined for export originate were not subjected to a stunning process, prior to slaughter, with a device injecting; compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
• the meat and meat products destined for export do not contain:
  • the following specified risk materials (SRM):
    • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column, excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum, from all bovine animals aged 30 months or older;
    • the small intestine and tonsils from bovine animals of all ages;
  • mechanically separated meat from the skull and vertebral column from animals aged 30 months or older;
• the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

6.2.5. Gelatin and collagen prepared from the bones of bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the bones:

• do not include skulls and vertebrae (excluding the vertebrae of the tail) from all animals aged 30 months or older;
• have been subjected to a process which includes all the following steps:
  • pressure washing (degreasing);
  • acid demineralisation;
  • prolonged alkaline treatment;
  • filtration;
  • sterilisation at equal value or higher than 138°C for a minimum of 4 seconds;
  • or, to an equivalent process in terms of infectivity reduction³.

6.2.6. Tallow (other than protein-free tallow as defined in section 3) and dicalcium phosphate (other than protein or fat free dicalcium phosphate as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the tallow or dicalcium phosphate:

• originates from bovine animals:
  • that have been subjected to an ante-mortem and post mortem inspection;
  • were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
• has not been prepared using the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
  • the small intestine and tonsils from animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

6.2.7. For tallow derivatives (other than those made from protein-free tallow as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the tallow derivatives:

• originate from bovine animals:
  • that have been subjected to an ante-mortem and post mortem inspection;
  • were not subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity);
• have not been prepared using the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
  • the small intestine and tonsils from animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive;
• have been produced by hydrolysis, saponification or transesterification using high temperature and pressure.

6.2.8. Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics.

Certification by the Veterinary Administration that the products were not derived from:

• skulls and vertebrae (excluding the vertebrae of the tail) from all animals aged 30 months or older;
• have been subjected to a rigorous process of extraction or purification approved by CFIA.

6.2.9. Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

Certification by the Veterinary Administration that the products and by-products:

• have not been prepared using the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
  • the small intestine and tonsils from animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive;
• have been subjected to a rigorous process of extraction or purification approved by CFIA.

6.2.10. Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons

Certification by the Veterinary Administration that the commercially prepared pet food, ingredients for pet food or pet chews:

• do not contain or have not been prepared using the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all animals aged 30 months or older;
  • the small intestine and tonsils from animals of all ages;
  • the determination of the age of animals meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from these requirements for commercially prepared pet food and finished pet chews will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.

6.2.11. Cell lines of bovine origin

Certification by the Veterinary Administration that the cell lines were:

• not prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
• not prepared from the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
  • the small intestine and tonsils from bovine animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement will be considered on a case-by-case basis considering the nature of the cell lines, their intended use and method of disposal.

6.2.12. Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

Certification by the Veterinary Administration that the veterinary biologics were:

• not prepared from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process (laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity), or;
• not prepared from the following SRM or any protein products derived from them:
  • the skull including the brain, trigeminal ganglia and eyes, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
  • the small intestine and tonsils from bovine animals of all ages;
  • the determination of the age of animals, stunning, dressing and removal, handling and disposition of SRM as inedible material meets the standards prescribed in the Government of Canada’s Meat Hygiene Directive.

An exemption from this requirement for veterinary biologics will be considered on a case-by-case basis considering the nature of the product, the source of materials of bovine origin, the manufacturing methods employed, and the intended use.

6.3. Category 3 Countries (undetermined BSE-risk)

6.3.1. Definition

Category 3 countries are those countries where

either:

• a risk assessment has not been undertaken, completed⁴ or subjected to a regular review,

or where:

• it is likely that imported commodities were contaminated or infected with a TSE-agent, and/or;
• it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
• either indigenous BSE-cases have been reported or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
• the measures in place are unlikely to effectively control or eradicate BSE.

6.3.2. Live bovine animals

This commodity is prohibited from Category 3 countries (undetermined BSE-risk).

An exemption from this prohibition for live bovine animals will be considered on a case-by-case basis considering the intended use of the animals, for example, animals imported for a temporary stay; animals for immediate slaughter; animals imported for medical use, scientific research or zoological collections; bulls destined for semen production centers.

6.3.3. Meat and meat products from bovine animals other than deboned skeletal muscle meat as defined in section 3 (g)

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.4.

6.3.4. Gelatin and collagen prepared from the bones of bovine animals

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.5.

6.3.5. Tallow (other than protein-free tallow as defined in section 3) and dicalcium phosphate (other than protein or fat free dicalcium phosphate as defined in section 3) derived from bovine animals

This commodity is prohibited from Category 3 countries (undetermined BSE-risk).

6.3.6. For tallow derivatives (other than those made from protein-free tallow as defined in section 3) derived from bovine animals and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.7.

6.3.7. Products derived from bovine animals by subjecting bones to rigorous processes of extraction and purification such as ossein, bone ash, bone charcoal and bone oil and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.8.

6.3.8. Products and by-products derived from bovine animals that have been subjected to rigorous processes of extraction and purification such as animal glue, oleosterin, triglycerides, glycerol, sorbitan esters and intended for food, animal food, fertilisers, or as unprocessed material for the preparation of cosmetics, drugs (including pharmaceuticals and natural health products), medical devices or veterinary biologics

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.9.

6.3.9. Commercially prepared pet food and finished pet chews, such as dried processed ears, pizzles, hooves or tendons

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.10.

6.3.10. Cell lines of bovine origin

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.11.

6.3.11. Veterinary biologics (vaccines, antibody products and diagnostic kits) containing material of bovine origin intended for use in animals

The conditions set down for this commodity are the same as those specified for a Category 2 country (controlled BSE-risk) in section 6.2.12.

Appendix 1

A. Determining the BSE-risk category of a country:

A risk assessment, to determine the BSE-risk status of the bovine animal population and allocate an exporting country to a particular BSE-risk category consists of four parts:

• Release assessment
• Exposure assessment
• Consequence assessment
• Risk estimation

A complete risk assessment should be undertaken for those countries that have either not reported BSE-cases or have only reported BSE-cases in imported animals. For countries that have reported BSE cases in indigenous animals it may not be necessary to undertake a detailed release and exposure assessment. Rather, a consequence assessment may be all that is required to determine if BSE is being effectively controlled.

The risk assessment must be reviewed regularly to ensure that adequate account is taken of changes in risk factors that could affect the BSE-risk status of a country, including:

• the detection of BSE in a previously unaffected country that may have exported commodities of concern to the country being evaluated;
• changes in the country’s import policies and/or practices;
• data and/or information that was previously unavailable is provided;
• changes to the OIE Code;
• new scientific findings such as the confirmation of natural cases of BSE in sheep;
• new diagnostic techniques, for example a live animal test;
• changes in assumptions;
• changes in the human epidemiology of BSE.

A.1. Release assessment

The release assessment determines the likelihood that a transmissible spongiform encephalopathy (TSE) agent has been introduced into the exporting country via importation of the following commodities potentially contaminated with a TSE agent:

• meat-and-bone meal or greaves;
• live animals;
• animal feed and feed ingredients;
• products of animal origin for human consumption (with the exception of those commodities that can be imported into or transit Canada without BSE-related restrictions as listed in section 3);
• products of animal origin for in vivo use in bovine animals.

The range of commodities included here is based on a consideration that all the evidence to date indicates that the vast majority of BSE cases have arisen through the ingestion of animal food contaminated with the BSE-agent, with vertical transmission from dam to offspring potentially accounting for only a very small number of cases. Although there have been no reports of BSE cases having arisen through the use of in vivo products contaminated with a TSE-agent, considering the potential for widespread exposure, such products also need to be taken into account.

Naturally occurring TSEs have been reported in several species from which these commodities are derived. They are all members of the Order Artiodactyla (even toed ungulates)⁵ and belong to the suborder Ruminantia (the ruminants). The species involved are domestic cattle from the subfamily Bovinae, which are affected by bovine spongiform encephalopathy (BSE); domestic sheep and goats from the subfamily Caprinae, which are affected by scrapie; and both wild and farmed deer and elk from the family Cervidae, which are affected by chronic wasting disease (CWD). It is worth noting that a naturally occurring TSE has not been reported in Camelids (llamas, alpacas, vicunas and camels). While they are not classified as ruminants per se they are closely related, belonging to the suborder Tylopda.

Apart from BSE none of these TSEs have been reported to affect species other than their natural hosts under field conditions. BSE has been reported in both domestic cats and a number of other species from the family Felidae held in zoological gardens in the United Kingdom (UK). In addition BSE was found in several ruminant species, also in zoological gardens in the UK. These animals all belong to the family Bovidae⁶, the same family in which cattle, sheep and goats are found. Recently, BSE was confirmed in a dairy goat in France⁷. This was the first recorded naturally occurring case of BSE affecting a commercially reared ruminant animal other than cattle.

Cross species transmission studies have demonstrated all of these TSEs are capable of infecting species other than their natural host. For instance, cattle are susceptible to experimental challenge with scrapie and CWD. Similarly sheep and goats are susceptible to BSE⁸, ⁹ and recently BSE has been confirmed in non-human primates (macaque monkeys) following oral challenge¹⁰. However, significant uncertainty remains regarding the likelihood of natural challenge and infection with these TSEs in non-host species. Experimental challenge studies involving deer, elk and camelids have not been reported in the literature to date. Although cattle have been successfully challenged with CWD intracerebrally there appears to be a significant species barrier. These findings are supported by field observations over a number of years where cattle, which were co-pastured with CWD-affected deer, did not develop the disease¹¹. Whether or not this is indicative of a species barrier in deer or elk for BSE is uncertain.

While the ultimate origin of BSE remains elusive there has been considerable speculation concerning the role of a TSE agent from another mammalian species such as scrapie in sheep¹². In addition, readily commercially diagnostic techniques that could easily discriminate between a TSE-agent such as scrapie and BSE have not been validated until recently (2005) ¹³, ¹⁴.

Considering that:

• the origin of BSE remains uncertain;
• naturally occurring TSEs have been reported in a number of closely related ruminant species;
• cross-species transmission studies have confirmed that at least several of these species are susceptible to a TSE from another host species;
• significant uncertainty remains regarding the likelihood of natural challenge and infection with any of these TSEs;
• tests that could discriminate readily between the various TSE agents have not been commercially available until recently (2005).

the range of species to consider in the release assessment from which the commodities listed at the beginning of this section are likely to be derived, consist of the following animals, hereafter collectively referred to as ruminants:

• bovine animals¹⁵
• sheep and goats
• deer and elk

Since BSE has a prolonged incubation period and by the time it is detected in the bovine animal population it is likely to have been present for the equivalent of two to three incubation periods¹⁶ or more, the release assessment should extend back over at least the last 15 years and preferably since the early 1980s.

Factors to consider in the release assessment include:

• the nature, extent and duration of past and current import legislation and policies relative to the TSEs;
• whether any or all of the commodities being considered have been imported from countries that have either reported a TSE in imported or indigenous animals or from countries with an undetermined BSE-risk, and if so:
  • the period during which these commodities were imported and their respective quantities.

A.2. Exposure assessment

For the purposes of determining the BSE status of the bovine animal population of an exporting country an exposure assessment:

• identifies and describes the biological pathways necessary for the exposure of bovine animals to a TSE-agent through imported commodities and/or from a TSE that already exists in the country’s domestic or wild ruminant population;
• determines the likelihood that bovine animals have been exposed to a TSE-agent via these pathways;
• estimates the likely extent, timing and duration of exposure to a TSE-agent in the bovine animal population.

The rationale for including all TSEs in the exposure assessment is based on a consideration that significant uncertainties remain concerning:

• the origin of BSE;
• the potential for the BSE-agent to naturally infect species other than bovine animals such as sheep and goats, which may then be indistinguishable from scrapie;
• the potential for other TSEs, such as scrapie and chronic wasting disease, to infect bovine animals naturally and be indistinguishable from BSE.

Factors to consider that would lead to the exposure of bovine animals in the exporting country to a TSE-agent include:

• the intended use of imported ruminants or products derived from such animals;
• the identification and tracking of imported ruminants including their ultimate fate, whether they were tested for a TSE and if their carcass or parts of their carcass potentially entered the animal feed chain;
• animal demographics which describes the extent of knowledge of the population structure of ruminant animals including culling and slaughter practices and disposal of dead or condemned animals;
• the epidemiological situation concerning all TSE-agents in the animal population of the country;
• the nature, scope, duration and evidence of enforcement and/or compliance with any legislation relative to TSEs including:
  • control and/or eradication programs;
  • controls over material potentially containing a TSE-agent such as a specified risk materials (SRM) ban;
  • controls over rendering methods and parameters;
  • controls on the production, distribution and consumption of animal feed.
• the nature, extent and compliance with any bans, whether voluntary or compulsory, on the feeding of material potentially containing a TSE-agent, including meat-and-bone meal or greaves, to ruminant animals;
• measures to prevent cross-contamination of animal feed with material potentially containing a TSE-agent , whether voluntary or compulsory and evidence of enforcement and/or compliance;
• disposal practices:
  • waste generated in slaughterhouses, meat processing facilities, domestic households, restaurants or any other facility involved in the processing and preparation of fresh meat and meat products that potentially contain a TSE-agent;
  • ruminant animals that die on farm, are dead on arrival in a slaughterhouses and that are condemned at ante or post-mortem inspection.
• rendering practices including dedication of lines, facilities and the parameters of the rendering process;
• methods of animal feed manufacture including ingredients and dedication of lines or facilities;
• farming and husbandry practices that could lead to bovine animals consuming feed potentially contaminated with a TSE-agent;
• measures to prevent the contamination of domestically manufactured products destined for in vivo use with material potentially containing a TSE-agent.

The risk assessment may be concluded at this point if the likelihoods of both the release and exposure assessments are considered to be negligible.

A.3. Consequence assessment

A.3.1. For countries that have either not reported BSE-cases or have only reported BSE-cases in imported animals

In this situation it is assumed that, if the outcome from the exposure assessment is that the likelihood of bovine animals having been exposed to a TSE-agent cannot be considered to be negligible, BSE infected animals are likely to exist in the population.

A consequence assessment determines:

• the likelihood that BSE-cases would be detected if present in the bovine animal population;
• the likelihood that any measures introduced for BSE, whether pre-emptive or in response to the detection of BSE-cases in imported animals, would effectively control BSE or lead to its eradication.

A.3.2. For countries that have reported BSE-cases in indigenous animals

A consequence assessment determines:

• the likelihood that current and past measures are either effectively controlling BSE or will lead to its eventual eradication.

Factors to consider in addition to those listed under the exposure assessment include:

• an evaluation of the capacity of a country’s Veterinary Service and legislative support for BSE surveillance, eradication and control;
• details and results of BSE control and/or eradication programs including the measures taken in response to the detection of a BSE case ;
• opportunities for recycling and amplification of the BSE-agent through the consumption by bovine animals of meat-and-bone meal or greaves, or other feed or feed ingredients potentially contaminated with ruminant derived meat-and-bone meal or greaves;
• the existence, duration and extent of on-going awareness program for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals to encourage reporting of all cases of neurological disease in adult bovine animals and fallen stock;
• the existence and implementation date of compulsory notification and investigation of all bovine animals showing clinical signs consistent with BSE;
• the existence, duration and extent of BSE surveillance and monitoring systems taking into account the guidelines in Appendix 3.8.4 of the Code;
• details of the diagnostic procedures for BSE, including:
  • case definitions for BSE-suspects and surveillance candidates including their age;
  • whether an examination in an approved laboratory of brain or other tissues is undertaken;
  • the laboratory procedures for screening and confirmation of BSE.

A.4. Risk estimation

The criteria for determining the BSE-risk category of a country, based on the outcomes from the release, exposure and consequence assessments are outlined in the following sections:

A.4.1. Category 1. Negligible BSE-risk

• a) For countries that have never reported a BSE-case
  Either:

  • If the conclusions of both the release and exposure assessment are negligible the overall risk is estimated to be negligible and the country is classified as negligible BSE-risk (Category 1).

  Or:

  • If the overall conclusion of the release and exposure assessment is greater than negligible, but the likelihood of exposure during at least the last 7 years is negligible, and the level of surveillance maintained during throughout this period should have detected BSE cases if they were present, the country is classified as negligible BSE-risk (Category 1).

• b) For countries that have reported BSE-cases in imported and/or indigenous animals

Before the country can be considered as presenting a negligible BSE-risk it should satisfy each of the following conditions for a period of at least seven years:

• the likelihood of imported commodities referred to in section A.1 being contaminated or infected with a TSE-agent must remain negligible;
• the likelihood of bovine animals having been exposed to a TSE that exists in the country’s domestic or wild ruminant population must remain negligible;
• the measures to eradicate BSE must be maintained to ensure that the likelihood of bovine animals being exposed to a TSE-agent remains negligible;
• a level of surveillance capable of demonstrating the effectiveness of eradication measures has been maintained without the detection of any BSE-cases.

A.4.2. Category 2. controlled BSE-risk:

If the conclusion of the risk assessment is that:

• it is likely that those commodities referred to in section A.1 were contaminated or infected with a TSE-agent when imported, and/or;
• it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
• either indigenous BSE-cases have been reported, or it is likely that indigenous bovine animals are likely to have been exposed to a TSE-agent, and;
• the measures in place are effectively controlling BSE and are likely to lead to its eradication;
• a level of surveillance capable of demonstrating the effectiveness of the measures to control BSE has been maintained.

the country is classified as controlled BSE-risk (Category 2).

A.4.3. Category 3. Undetermined BSE-risk

If either:

• a risk assessment for a particular country has not been undertaken, completed¹⁷ or subjected to a regular review

Or:

• the conclusion of the risk assessment is that:
  • it is likely that those commodities referred to in section A.1 were contaminated or infected with a TSE-agent when imported, and/or;
  • it is likely that a TSE exists in the country’s domestic or wild ruminant population, and;
  • either indigenous BSE-cases have been reported or it is likely that indigenous bovine animals have been exposed to a TSE-agent, and;
  • the measures in place are unlikely to effectively control or eradicate BSE.

the country is classified as undetermined BSE-risk.

In those situations in which a risk assessment is no longer up to date, provided that the assessment is reviewed with a favourable outcome, the country may revert to its former status. For a country previously classified as undetermined BSE-risk, provided that the measures are modified to ensure that they would effectively control or eradicate BSE, the country could be considered as presenting a controlled BSE-risk.

Original signed by
Dr. Jim Clark
A/Director
Animal Health and Production Division

Appendix 2

Glossary of legal definitions

Animal

• Health of Animals Act - includes an embryo and a fertilized egg or ovum.

Animal food

• Health of Animals Act - any thing that is capable of being a nutriment for animals and includes any of the constituent elements of an animal ration
• Health of Animal Regulations - food containing an animal product or animal by-product for chickens, turkeys, ducks, geese, ratites, game birds, ruminants, swine or horses but does not include such things as fish meal or vitamin or mineral supplements which do not contain animal products or by-products.

Animal by-product

• Health of Animals Act - includes blood or any of its components, bones, bristles, feathers, flesh, hair, hides, hoofs, horns, offal, skins and wool, and any thing containing any of those things;
• Health of Animals Regulations - means an animal by-product that originated from a bird or from any mammal except a member of the orders Rodentia, Cetacea, Pinnipedia and Sirenia.

Animal product

• Health of Animals Act - includes cream, eggs, milk, non-fertilized ova and semen;
• Health of Animals Regulations - means an animal product that originated from a bird or from any mammal except a member of the orders Rodentia, Cetacea, Pinnipedia and Sirenia.

Animal pathogen

• Health of Animals Regulations - includes any animal pathogen derived through biotechnology.

Bovine

• Health of Animals Regulations - means cattle or bison domestically raised or kept, but for the purposes of the import reference document does not include a bison that has ever been in contact with or part of a wild herd.

Cosmetic

• Food and Drug Act - includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.

Drug

• Food and Drug Act - includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept.

Device

• Food and Drug Act - means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.

Food

• Food and Drug Act - includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.

Germplasm

• Health of Animals Regulations - means semen, male or female germ cells or genetic material taken from a male or female germ cell for the purpose of producing a zygote and includes embryos but does not include a hatching egg.

Meat

• Meat Inspection Regulations - means the edible part of a carcass that is the muscle associated with the skeleton, tongue, diaphragm, heart, gizzard or mammalian oesophagus, with or without accompanying and overlying fat, together with those parts of the bones, skin, sinews, nerves, blood vessels and other tissues that normally accompany the muscle and are not ordinarily removed in dressing a carcass, but does not include the muscle associated with the lips, snout, scalp or ears, mechanically separated meat or meat to which an ingredient other than meat has been added.

Meat product

• Meat Inspection Act - means (a) a carcass, (b) the blood of an animal or a product or by-product of a carcass, or (c) a product containing anything described in (b);
• Meat Inspection Regulations - means edible blood, an edible organ or edible tissue that was derived from the carcass of a food animal, but does not include meat or mechanically separated meat.

Ruminant

• Health of Animals Regulations - means an animal of the suborder Ruminatiae and includes an animal of the family Camelidae.

Specified risk material

• Food and Drug Regulations and Health of Animals Regulations - means (a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and (b) the distal ileum of cattle of all ages.
  • Through the application of the Meat Hygiene Directive (2003-18 of July 24, 2003), issued under the Meat Inspection Regulations, the tissues that are to be removed to ensure that SRM are excluded consist of:
    • the skull including the brain, trigeminal ganglia and eyes, the tonsils, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all cattle ¹⁸ aged 30 months or older;
    • the small intestine from cattle of all ages.
  • For the purpose of this BSE import policy this same list of tissues, not only from cattle but also from bison, is defined as SRM, that is:
    • the skull including the brain, trigeminal ganglia and eyes, the tonsils, the spinal cord and the vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum from all bovine animals aged 30 months or older;
    • the small intestine from bovine animals of all ages.

Veterinary biologic

• Health of Animals Act means (a) a helminth, protozoa or micro-organism, (b) a substance or mixture of substances derived from animals, helminths, protozoa or micro-organisms, or (c) a substance of synthetic origin that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in animals;
• Health of Animal Regulations - includes any veterinary biologic derived through biotechnology.

¹ Integrated Taxonomic Information System. http://www.itis.usda.gov

² Products intended for human consumption from a Category 2 country (controlled BSE-risk) or a Category 3 country (undetermined BSE-risk) must not be prepared from material containing SRM or be derived from bovine animals subjected to a stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial cavity or to a pithing process.

³ Details of the process deemed to be equivalent and supporting data and references should be provided to CFIA for approval prior to the importation of this commodity.

⁴ In some situations it may not be possible to complete the risk assessment as a result of insufficient and or poor quality data.

⁵ The Ultimate Ungulate Page. http://www.ultimateungulate.com/index.html

⁶ OIE, Technical Disease Cards, BSE, 2004. http://www.oie.int/eng/maladies/fiches/a_B115.htm Bovidae (domestic cattle, nyala [Tragelaphus angasi], greater kudu [Tragelaphus strepsiceros] and presumed similar origin for cases in gemsbok [Oryx gazella], Arabian oryx [Oryx leucoryx], eland [Taurotragus oryx], scimitar-horned oryx [Oryx dammah] and bison [Bison bison]). Felidae (domestic cat and presumed bovine origin in cheetah [Acinonyx jubatus], puma [Felis concolor], ocelot [Felis pardalis] and tiger [Panthera tigris]). Experimentally transmissible to cattle, pigs, sheep, goats, mice, mink, marmosets and macaque monkeys.

⁷ EUROPA - Food and Feed Safety. BSE/Scrapie - TSE in goats. February 2005. http://www.europa.eu.int/comm/food/food/biosafety/bse/goats_index_en.htm

⁸ Lasmezas CI. The transmissible spongiform encephalopathies. Rev. sci. tech. Off. Int. Epiz., 2003, 22 (1), 23-36

⁹ Schreuder BEC, Somerville RA. Bovine spongiform encephalopathy in sheep? Rev. sci. tech. Off. Int. Epiz., 2003, 22 (1), 103-120

¹⁰ Lasmézas CI, Comoy E, Hawkins S, Herzog C, Mouthon F, Konold T, Auvré F, Correia E, Lescoutra-Etchegaray N, Salès N, Wells G, Brown P, Deslys J-P. Risk of oral infection with bovine spongiform encephalopathy agent in primates. The Lancet, Volume 365, Issue 9461, 26 February 2005-4 March 2005, Pages 781-783

¹¹ Salman MD. Chronic Wasting Disease in Deer and Elk: Scientific Facts and Findings. J. Vet. Med. Sci. 65 (7): 761-768, 2003

¹² Prince MJ, Bailey JA, Barrowman PR, Bishop KJ, Campbell GR, Wood JM. Bovine Spongiform Encephalopathy. Rev. sci. tech. Off. Int. Epiz, 2003, 22 (1) 37-60

¹³ Heim D. Kihm U. Risk management of transmissible spongiform encephalopathies in Europe. Rev. sci. tech. Off. Int. Epiz, 2003, 22 (1), 179-199

¹⁴ VLA lunches new discriminatory diagnostic test. April, 2005. http://www.defra.gov.uk/news/2005/050404h.htm

¹⁵ In this policy the term bovine refers to animals belonging to the Genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).

¹⁶ The average incubation period is approximately 5 - 6 years.

¹⁷ In some situations it may not be possible to complete the risk assessment as a result of insufficient and or poor quality data.

¹⁸ The Meat Hygiene Directive defines cattle as animals of the species Bos taurus or Bos indicus; but not including other ruminants such as bison, muskox, yak or water buffalo.