TAHD-DSAT-IE-2005-9-3
July 22, 2011
Amendment: Denmark and Panama added to the list of countries with negligible BSE risk.
This policy, under the legislative authority of the Health of Animals Act and Health of Animals Regulations, specifies BSE-related import or transit conditions intended to manage the zoonotic and animal health risks associated with the presence of the BSE agent in bovine animals of an exporting country.
Situating the BSE import policy within the broader import framework
While this policy deals specifically with bovine spongiform encephalopathy (BSE), it is important to recognize that other factors and diseases may play a role in developing the import conditions necessary to provide an acceptable level of protection for public and animal health. This section addresses those factors.
Under the Health of Animals Regulations, importation of bovine animals, animal products, animal by-products, animal pathogens and other things is allowed under certain conditions. The specific sections of the Regulations are: Part II, (sections 7 to 16); Part III; Part IV; and, Part XIII, (section 160).
CFIA uses the above regulatory authority as the basis for recognition of a specific country, or part of a country, as being free of, or as posing a negligible risk for, a particular disease, depending on a variety of factors which include, but are not limited to the following parameters:
the country having been assessed by CFIA as having an equivalent veterinary infrastructure to Canada's, having an effective and implemented system for detecting and diagnosing diseases, as well as reporting outbreaks, and surveillance data to the international community.
Additional import conditions related to other diseases such as FMD, TB, Brucellosis, are often necessary and can be found either in commodity-specific import directives listed in the Import Policies and Directives Web link or in the Automated Import Reference System (AIRS). The importer of bovine animals or products is obligated to ensure compliance with the specific requirements of other CFIA policies and directives that fall under the legislative authority of the Meat Inspection Act and Meat Inspection Regulations, Feeds Act and Feeds Regulations and the Fertilizers Act and Fertilizers Regulations.
The requirements indicated with respect to the slaughter of bovine animals, namely, ante-mortem and post-mortem inspection, stunning, age determination, and specified risk material (SRM) removal and disposition must comply with the standards set out in the CFIA Manual of Procedures, Annex D, Chapter 17, under the authority of the Meat Inspection Regulations.
The Canada Border Services Agency assists the CFIA with border clearance responsibilities and importers are obligated to meet any requirements of the Canada Border Services Agency Act or other applicable legislation under which Border Services Officers are designated.
Bovine products and by-products used in the preparation of food, cosmetics, drugs (including pharmaceuticals for use in animals, pharmaceuticals and biologics for human use, and natural health products for use in animals or humans) and medical devices are also regulated by Health Canada through product-specific regulatory programs, which are administered under the authority of the Food and Drugs Act and Food and Drugs Regulations. Veterinary biologics and their components are regulated similarly by the CFIA under the Health of Animals Act and Health of Animals Regulations.
It is the responsibility of the prospective importer or licensee to be in compliance with any additional import requirements or restrictions associated with the importation or licensing of a commodity for human use, or administration to animals.
BSE-specific overview
The BSE import policy for bovine animals and animal products, animal by-products, germplasm, animal food, meat, meat by-products and veterinary biologics, of bovine origin, adheres closely to the recommendations of the World Organisation for Animal Health (OIE) and abides by the intent of the North American harmonization of a BSE strategy1.
For the purpose of this policy, bovine animals consist of cattle and bison and their exotic relatives. Taxonomically they are classified as members of the Subfamily Bovinae from the genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).
Depending on the commodity being considered for importation, whether live animals, animal products or by-products of bovine origin, BSE-related conditions may be required if import is allowed.
Canada accepts the OIE classification for country BSE risk categorization. Therefore, CFIA does not routinely carry out independent assessment regarding a country's BSE categorization.
The OIE classifies countries for BSE risk into three categories: 1) negligible risk, 2) controlled risk, or 3) undetermined risk.
The following countries are recognized as having a negligible BSE risk in accordance with Chapter 11.5 of the OIE Terrestrial Animal Health Code 2010:
The following countries are recognized as having a controlled BSE risk in accordance with Chapter 11.5 of the OIE Terrestrial Animal Health Code 2010:
Exemptions to the conditions for the importation of animals, products and by-products or any other commodities not listed, may be considered on a case-by-case basis, taking into account such factors as the intended use, the nature of the product, the bovine tissues from which it was derived and the manufacturing and processing methods to which it was subjected. Applicable import conditions would be developed on the basis of the outcome of a prior risk assessment.
Note: all definitions within this import policy, unless referenced otherwise, are based on the Health of Animals Act and the Health of Animals Regulations, interpretation, section 2.
Animal: means any member of one of the species regulated by CFIA, and, includes an embryo and a fertilized egg or ovum.
Animal food: means any 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 that do not contain animal products or by-products.
Animal by-product: 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 (Health of Animals Regulations).
Animal product: means an animal product that originated from a bird or from any mammal except a member of the orders Rodentia, Cetacea, Pinnipedia and Sirenia.
Biologics (human): drugs listed on Schedule D of the Food and Drugs Act include names of individual products, product classes and reference to particular sources and methodology. Biologics are manufactured from animals, or micro-organisms, or through the use of animals or micro-organisms. Examples include blood and blood components, insulin, monoclonal antibodies, cytokines, protein hormones and gene therapy products2.
Bovine: means cattle or bison and includes their exotic relatives. Taxonomically they are classified as members of the Subfamily Bovinae from the genus Bos, which includes cattle (Bos taurus and Bos indicus) and bison (Bos bison).
BSE slaughter process: means any process of slaughtering an animal other than a process in which the animal is subjected, before being slaughtered, to a) a stunning process in which a device is used to inject compressed air or gas into the animal's cranial cavity; or b) a pithing process involving laceration, after stunning of the animal, of the animal's central nervous tissue by means of an elongated rod-shaped instrument that is introduced into the animal's cranial cavity.
Cosmetic: 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 perfumes3.
Drug: 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 kept4.
Device: 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 drug5.
Food: 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 whatever6.
Germplasm: 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 egg7.
Meat: 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 recovered meat or meat to which an ingredient other than meat has been added8.
Meat by-product: 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 recovered meat9.
Mechanically recovered meat (MRM): means meat obtained using high pressure to recover the residual raw meat adhering to the bones after other boning processes have been completed10.
Ruminant: means an animal of the suborder Ruminatiae and includes an animal of the family Camelidae.
Specified risk material (SRM): 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 (SRM in Food and Drug Regulations and SRM in Health of Animals Regulations).
Tallow: is an odourless, tasteless, waxy white fat consisting of suet (the hard fat about the kidneys and loins of cattle, sheep, and horses) or fats from other animals11.
Veterinary biologic: 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;12 and includes any veterinary biologic derived through biotechnology (Health of Animals Regulations); veterinary biologics do not include veterinary drugs (which are assigned a DIN number) and are primarily regulated by Health Canada (Veterinary Drugs Directorate) under the authority of the Food and Drugs Act and Regulations.13
An important tool for importers is AIRS which details specific import conditions and required documentation by product type or animal and includes non-BSE-related conditions, such as Foot and Mouth Disease requirements. More guidance on import requirements can also be obtained by contacting the CFIA local animal health office (by province).
The BSE-related import conditions by commodity are indicated below. Any certification requirements in section a) through h) are to address potential cross-contamination with the bovine tissues listed below14 (these tissues are what are legally defined within Canadian legislation as SRM), and as such meet the OIE requirement and Canadian domestic legislative requirements that the commodity contain "no other tissues of cattle". The OIE Code Commission emphasizes that the removal and avoidance of contamination with SRM, as defined by Canada are paramount to manage the human and animal health risks associated with BSE. Measures must be taken to exclude cross-contamination with the below-named tissues during slaughter, harvest and/or handling processes and certification by the veterinary administration of same. Products for human use may have additional conditions applied, in order to satisfy the requirements of Health Canada.
Chapter 11.5 - Bovine Spongiform Encephalopathy
A. Milk, Milk Products and Colostrum
B. Semen and In Vivo Derived Bovine Embryos Collected and Handled in Accordance With the Recommendations of the International Embryo Transfer Society
C. Hides and Skins for Any End Use
Countries of negligible BSE risk
Countries of controlled and undetermined BSE risk - In order to be consistent with Canadian domestic policy
to remove visible brain materials.
D. Gelatin and Collagen Prepared Exclusively from Hides and Skins
E. Tallow with a Maximum Level of Insoluble Impurities of 0.15 Percent in Weight and Derivatives Made From This Tallow
F. Dicalcium Phosphate (with no trace of protein or fat)
G. Meat and Meat By-Products
1. deboned skeletal muscle meat, excluding mechanically recovered meat
All Countries
Certification by the veterinary administration that:
2. all other meat and meat by-products, including bone-in meat
Countries of negligible BSE risk
Certification by the veterinary administration was derived from cattle 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 that the country complies with conditions in Article 11.5.3 of the OIE Terrestrial Animal Health Code 2010 and:
Countries of controlled BSE risk
Certification by the veterinary administration that the country complies with conditions in Article 11.5.4 of the OIE Terrestrial Animal Health Code 2010 and:
Countries of undetermined BSE risk
Certification by the veterinary administration that:
H. Blood and Blood By-Products for Inedible Uses
Blood and blood by-products for Edible Uses (i.e. for food, cosmetics, drugs [including pharmaceuticals, biologicals for human use and natural health products], veterinary biologics or medical devices).
Countries of negligible BSE risk
Certification by the veterinary administration that the country complies with conditions in Article 11.5.3 of the OIE Terrestrial Animal Health Code 2010 and:
Countries of controlled BSE risk and Countries of undetermined BSE risk
Certification by the veterinary administration that the country complies with conditions in Article 11.5.4 of the OIE Terrestrial Animal Health Code 2010 and:
I. Live Animals
Countries of negligible BSE risk and Countries of controlled BSE risk
Certification by the veterinary administration that the country complies with conditions in either Article 11.5.3 of the OIE Terrestrial Animal Health Code 2010 or Article 11.5.4 of the OIE Terrestrial Animal Health Code 2010, as applicable, and where there has been an indigenous case:
Countries of undetermined BSE risk
Importation of live animals from countries of undetermined BSE risk is restricted. Case by case evaluations are possible in order to grant derogations to this restriction under CFIA's Import permitting system.
J. Ruminant-Derived Meat and Bone Meal (or greaves) or any Commodities Containing Such Products
Countries of negligible BSE risk
Certification by the veterinary administration that the country complies with conditions in either Article 11.5.3 of the OIE Terrestrial Animal Health Code 2010; and
In the case of countries of negligible BSE risk where indigenous cases of BSE have occurred, certification by the veterinary administration that these commodities were derived from bovine animals that were born after the date from which the ban on the feeding of ruminant animals with meat and bone meal (or greaves) derived from ruminants was effectively enforced.
Countries of controlled BSE or of undetermined BSE risk
Importation of these commodities from countries of controlled and undetermined BSE risk is restricted. Case by case evaluations are possible in order to grant derogations to this restriction under CFIA's Import permitting system.
K. Gelatin and Collagen Prepared from Bones
L. Tallow with Greater than 0.15 Percent Insoluble Impurities in Weight and Tallow Derivatives Made from Such Tallow
M. Dicalcium Phosphate Containing Protein or Fat
The dicalcium phosphate (containing protein or fat) is a by-product of gelatin production, produced according to the conditions for the importation of the commodity gelatin and collagen prepared from bones.
N. Products Produced by Subjecting Bones to Rigorous Processes of Extraction and Purification such as Ossein, Bone Ash, Bone Charcoal and Bone Oil
O. Products and By-Products Produced by Rigorous Processes of Extraction and Purification Such as Animal Glue, Oleosterin, Triglycerides, Glycerol, and Sorbitan Esters
P. Animal By-Products (bone meal, meat meal, blood meal, organ meats, rendered animal fats, gluestock, meat, inedible meat) as Ingredients Within Commercially Prepared, Finished Pet Food, Pet Treats, and Stuffed Pet Chews
For specific details regarding importation of ingredients for the manufacture of the pet food, please refer to the Rendered Products and Inedible Products import directive for both BSE and non-BSE requirements or to AIRS.
Q. Dried Processed Rawhide, Cattle Ears, Bull Pizzles, Cow Hooves or Tendons as Pet Chews
R. Veterinary Biologics (vaccines, antibody products, and diagnostic test kits) Derived From or Containing Bovine Tissues
Countries of negligible and controlled BSE risk
Certification by the veterinary administration that the country complies with conditions in either Article 11.5.3 of the OIE Terrestrial Animal Health Code 2010 or Article 11.5.4 of the OIE Terrestrial Animal Health Code 2010, as applicable,
As well as the following requirements as they are indicated on the import permit once issued.
Importation of veterinary biologics, or their components, from countries of negligible risk or controlled risk is authorized by issuance of import permits, dependent upon examination and approval of the manufacturer's certification that the products were not prepared from or were not contaminated, at any point during the manufacturing process with: a) distal ileum of all ages of bovine animals, and b) palatine tonsils, 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.
This is done through facility inspections and examination of manufacturer's documentation and certification for freedom from the above-listed materials. Factors assessed include the following: composition of the product (especially bovine-origin materials); BSE risk status of the country where each of the starting materials and product components were sourced; BSE risk status of the country where the veterinary biologic was manufactured; manufacturing methods; target species and/or potential end uses of the product; and safe handling and disposal of potentially hazardous wastes associated with the imported materials.
Countries of undetermined BSE risk
Importation of veterinary biologics, or their components, from countries of undetermined BSE risk is restricted. Case by case evaluations are possible in order to grant derogations to this restriction under CFIA's Import permitting system.
S. Cell Lines, Culture Media, and Laboratory Reagents Derived From or Containing Bovine Tissues
Countries of negligible, controlled and undetermined BSE risk
Importation of cell lines, culture media and laboratory reagents from countries of negligible, controlled and undetermined BSE risk is authorized by issuance of import permits, dependent upon multiple factors including the intended use and the examination and approval of the manufacturer's certification that the products were not prepared from or were not contaminated at any point during the manufacturing process with: a) distal ileum of all ages of bovine animals; and, b) palatine tonsils, 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 from countries of controlled and undetermined BSE risk.
Importers are advised to reference AIRS for commodity-specific instructions or to contact the CFIA local office (by province) for further information. This policy does not remove any obligation to the Canadian importer to comply with the import requirements of other CFIA programs and/or other government departments.
1. Report of the North American Chief Veterinary Officers on Harmonization of a BSE Strategy, Meeting of the Senior Health Officials of Mexico, Canada and United States, Mexico, March 17 2005, page 4.
2. Summarized from Health Canada, Fact Sheet: Subsequent Entry Biologics in Canada.
3. Food and Drugs Act, Interpretation, Section 2, "Cosmetic"
4. Food and Drugs Act, Interpretation, Section 2, "Drug"
5. Food and Drugs Act, Interpretation, Section 2, "Device"
6. Food and Drugs Act, Interpretation, Section 2, "Food"
7. Health of Animals Regulations, Part II, Importation of Germplasm and Animals, Definitions, Section 10, "Germplasm"
8. Meat Inspection Regulations, Interpretation, Section 2, "Meat"
9. Meat Inspection Regulations, Interpretation, Section 2, "Meat by-product"
10. Canadian Institute of Health Research, Meeting the Challenge of Prion Diseases: Conference Proceedings and Invitational Research Planning Workshop Report, Appendix VIII Glossary of Terms and Acronyms, Mechanically Recovered Meat.
11. Tallow. (2009). In Encyclopaedia Britannica. Retrieved May 25, 2009.
12. Health of Animals Act, Interpretation, Section 2, "Veterinary biologic"
13. Veterinary Biologics Guideline 3.25E Guideline for Importation of Veterinary Biologics.
14. the distal ileum of bovine animals of all ages; and, the palatine tonsils, the skull including the brain, the 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) of all bovine animals aged 30 months or older from controlled and undetermined BSE risk countries.